Ablechild (Parents for A Label and Drug-Free Education), is a national non-profit founded in 2001, by these two mothers who each had personal experiences with being coerced by the public school system to label and drug their children for ADHD. Patty and Sheila went from being victims to become national advocates for the fundamental rights of all parents and children in the US.

Now with thousands of members, Ablechild acts as an independent advocate on behalf of parents whose children have been subjected to mental health screening and psychiatric labeling and drugging, and as a proponent for children in foster care who are improperly treated with psychotropic drugs, many times off-label, without informed consent.

Long Battle Against Coerced Drugging

Roughly eight years ago, on September 26, 2002, then Chairman the US House Government Reform Committee, Congressman Dan Burton (R-IN), held a hearing on the “Overmedication of Hyperactive Children,” prompted by a series in the New York Post.

“It’s estimated that 4 to 6 million children in the United States take Ritalin every single day,” Burton said in his opening statement. He pointed out that Ritalin was a Schedule II stimulant under the Federal Controlled Substances Act, that research showed it was a more potent transport inhibitor than cocaine, and use in the US had increased over a 500% since 1990. The Schedule II category also includes drugs such as cocaine, morphine, and Oxycontin.

On one side of the issue, Burton said, they would hear from the associations of psychiatrists and an organization known as Children and Adults with Attention Deficit Hyperactivity Disorder (CHADD), and they believed 13% of the US population suffered from an attention disorder and it should be treated with medication.

At the other end of the discussion, he said, was the Citizens Commission for Human Rights (CCHR), and concerned parents, who challenged the legitimacy of calling ADHD a neurobiological disorder and raised questions about giving psychiatric drugs to children. Two of these “concerned parents” were Patty Weathers and Neil Bush, the brother of then President Bush, who was pressured by a private school in Houston to drug his son with Ritalin after he was misdiagnosed with ADHD by the school.

Unsung Hero: Patty Weathers

At the hearing, Patty testified about the ordeal she and her son, Michael, went through in a public school in New York State that began in 1997. When Michael entered first grade, the teacher told Patty his learning development was not normal and he would not be able to learn without medication.

“Near the end of first grade, the school principal took me into her office and said that unless I agreed to put Michael on medication, she would find a way to transfer him to a special education center,” Patty told the committee.

At this point, his teacher filled out an actor’s profile for boys, an ADHD checklist, and sent it to his pediatrician, she said. “This checklist, along with a 15-minute evaluation by the pediatrician, led to my son being diagnosed with ADHD and put on Ritalin.”

Michael was not given a physical exam prior to the prescribing of Ritalin and no exams were conducted during appointments when refills for prescriptions were written.

“I would never have subjected my son to being labeled with a mental disorder if I had known that it was a subjective diagnosis,” Patty told the panel. “I would not have allowed my son to be administered drugs if I had been given full information about the documented side effects and the risks.”

“At no time was I offered any alternatives to my son’s needs, such as tutoring or standard medical testing.” she said. “The school’s one and only solution was to have my child drugged.”

Early on, Michael experienced the common side effects of Ritalin, such as sleep problems and loss of appetite, and by the third grade, Michael became withdrawn, stopped socializing with other children, and began chewing on pencils and other objects. He was then put on Dextrostat, an amphetamine, which only worsened the problems.

But instead of recognizing the drug side effects, the school psychologist then claimed Michael had either bipolar or social anxiety disorder and needed to see a psychiatrist. The psychologist gave Patty the number for a psychiatrist to call and the psychiatrist talked to her and Michael for a short time, and “again, with the aid of school reports, diagnosed him with social anxiety disorder,” she recalled.

Without telling her it was not approved for children, the psychiatrist prescribed the antidepressant, Paxil, saying it was a “wonder drug for kids.” “Those were her exact words,” Patty told the committee.

The drug cocktail caused even more horrendous side effects, until Michael’s behavior became so out of character that Patty could not even recognize her own son. “Through this whole ordeal, the school psychologist’s favorite saying was that it was trial and error,” she said. “If one drug didn’t work, try another.”

After watching Michael become violent, psychotic, hear voices and hallucinate, Patty stopped giving him the drugs. Not recognizing that he was going through withdrawal, the psychiatrist wanted to hospitalize Michael and try different sedatives and antipsychotics until they found “the right one,” but Patty refused to allow it.

After she became unwilling to give Michael the drugs, “the school threw him out,” she told the panel. “As a final blow, they proceeded to call Child Protective Services on my husband and I, charging us with medical neglect for refusing to drug our child,” she said.

The complaint filed by the school stated in part: “[Michael's] behavior at school is bizarre: He hears voices and appears delusional, he chews on his clothes and paper, he talks to himself and rambles when he talks.”

A month-long investigation cleared the charges and independent psychiatrists determined the bizarre behaviors were caused by the drugs and Michael did not need hospitalization. Medical testing by Dr Mary Ann Block, a Texas osteopathic physician, later showed that Michael suffered from anemia, hypoglycemia and allergies. When those conditions were treated, any attention problems disappeared.

On August 7, 2002, the New York Post ran a front-page article featuring Patty’s story. Within a few days, over 65 parents came forward to describe similar stories of coercion and intimidation used by school districts to strong arm them into drugging their kids.

Unsung Hero: Sheila Matthews

Connecticut mom, Sheila Matthews, turned on the TV one day and saw Patty testifying on C-Span at a hearing titled, “Behavioral Drugs in Schools,” on September 29, 2000, before the US House Subcommittee on Oversight and Investigations, Committee on Education and the Workforce.

Sheila immediately related with Patty because she was then going through what she would later call the “ADHD nightmare,” of being pressured to put her 7-year-old son on Ritalin, after he was screened and diagnosed with ADHD by a school psychologist, with claims he would “self-medicate” and end up a drug addict if she did not medicate him.

While testifying at this hearing, Patty explained that being labeled made Michael feel worse about himself and “like a freak” because he “had to be drugged to go to school.”

She also voiced her concerns for other families over the intimidation tactics used by schools to coerce parents into drugging their children. “If I didn’t have family members who were willing to financially back my son and I in my son’s cause, it is entirely possible that my son would have ended up in a psychiatric ward,” she told the panel.

That very day, Sheila made up her mind to expose the misleading information being given to parents about so-called mental disorders in public schools and expose the coercive tactics being used on parents who refused to label and drug their children.

She wanted to meet Patty so she contacted the Congressional office and they put her in touch with Marla Filidei, Vice President of CCHR International. Marla hooked her up with Patty, and together, they founded Ablechild.

National Spokespersons

Over the past ten years, Patty and Sheila have become national spokespersons. The normally shy, quiet Patty has made appearances on more than two dozen media programs including ABC’s Good Morning America, the Today Show on NBC, Hannity & Colmes, on Fox, CNN’s Lou Dobbs, A&E’s Investigative Reports, and Montel Williams.

She has also been interviewed for stories in major newspapers including the New York Times, New York Post, USA Today, and Christian Science Monitor, as well as Time, People, and Redbook magazines, and has been interviewed by Gary Null, Sean Hannity, Michael Regan, and other popular radio talk show hosts.

In February 2001, Patty received a “Human Rights Award,” from CCHR, and was recognized for standing up against the injustice of psychiatric labeling and drugging of children in public schools at the group’s annual banquet. Sheila received an award from CCHR in 2002, and was recognized for her hard work and role as national spokesperson.

Sheila has also appeared on TV numerous times including shows on CNN, NBC and Fox, and has been interviewed on many talk radio programs. Her story has also been featured in major newspapers and magazines.

In her home state of Connecticut, Sheila worked with State Representative, Lenny Winkler (a nurse by trade), to secure passage of the first state law in the country that restricts schools from suggesting psychiatric diagnosing and drugging of any child as a condition of attending school. She testified before the Connecticut State Assembly about her own personal experience with the school trying to pressure her to put her son on Ritalin and the lack of validity of the disorders children are being labeled with.

Sheila was with the Connecticut Governor when he signed the bill into law in 2001 and told USA Today that she was thrilled “because it gives parents an awareness that there should be a clear difference between education and medication.”

“No other industry has total access to our children the way the psychiatric community does, and I think this new law is just the beginning of changes to come,” she told Kelly Patricia O’Meara, in an interview for Insight News.

“Kids should be off-limits as targets of convenience for the drug industry,” Sheila said. “I want the mental-health industry out of our schools.”

However, any victory celebration was short lived because in September 2001, a number of family orientated magazines began running the first ever ads for ADHD drugs. “It seems like every time we take a step forward, they come back and hit us harder,” Patty told Time magazine.

After the Connecticut law was passed, Sheila continued to work with other parents on state and federal levels to pass similar bills. By 2003, seven states had passed laws against schools coercing parents to drug their children or expelling students whose parents refused to medicate them.

On a national level, both Sheila and Patty made many trips to Washington to educate lawmakers. In September 2001, Patty and CCHR’s Bruce Wiseman and Marla Filidei, briefed legislators at a national congress of the “National Foundation of Women Legislators,” and gained their unanimous approval of a model law in the “Child Medication Safety Act (CMSA),” which mandates that: “State educational agencies develop and implement policies and procedures that will prohibit school personnel from requiring a child to obtain a prescription for a controlled substance such as Ritalin as a condition of attending school or receiving services.”

In both October and November of 2001, Sheila traveled to Washington with Marla and Lawrence Smith, whose 11-year-old son died of a heart attack caused by Ritalin, to meet with key lawmakers and discuss the crisis of children being diagnosed and drugged in schools and the need for federal legislation to end it. They also worked with Congressional staff to get co-sponsors for the CMSA

In July 2002, the nationally syndicated columnist and radio show host, Armstrong Williams, featured Sheila, Patty and Lawrence Smith in a radio show on safeguarding children from being labeled and drugged in public schools.

The next month, Patty appeared on NBC’s Today Show, on August 8, 2002, and the same day, the New York Post ran an article reporting that Patty was calling for a state wide tracking system to determine how widespread forced drugging was in schools.

Strongest Foe Funded by ADHD Drug Makers

In March 2003, Patty, Michael, and Sheila appeared on a Montel Williams show on promoting “A Parents Right to Choose,” along with Connecticut Rep, Lenny Winkler, Bruce Wiseman, Patricia Marks, Dr Mary Ann Block, and Vicky and Steve Dunkle, whose 10-year-old daughter died from Desipramine toxicity, after the antidepressant was prescribed for ADHD as a result of pressure from school officials to medicate the child.

The guests covered everything from the subjective diagnosis of mental disorders, with no confirming medical testing, to the many side effects of psychiatric drugs, to the fact that most children involved in school shootings were on psychiatric drugs. They warned that due to coercion in schools, parents all over the country were losing the right to choose whether their kids would take powerful drugs, including stimulants, referred to as “kiddie cocaine.” At the end of the program, Montel asked the audience to write to Congress asking for federal legislation against the coerced drugging of school children.

After the show aired, CHADD, the main front group for the stimulant makers, organized a letter writing campaign to Montel, who they said “mocked” ADHD, as part of responding to “offensive media depictions” of ADHD, they claimed in CHADD’s 2002-2003 Annual Report.

The group also published an open letter to Montel, saying no one would “dispute that unnecessarily placing a child on medication is deplorable.”

“But the greater travesty is delaying proper diagnosis and effective treatment for those who truly need it,” CHADD said. “The sad truth is that many more children with mental disorders slip unrecognized past the gatekeepers of mental health services than those who are improperly diagnosed.”

In April 2003, Ablechild issued a press release blasting CHADD for lobbying against the CMSA with claims that only a “handful” of incidents had occurred involving parents being coerced by schools to drug their children.

In lobbying to CHADD’s membership, the group’s CEO, E Clarke Ross, used the electronic newsletter, “News from CHADD,” to raise questions about whether the problem was common enough to require federal legislation and called such cases “isolated and highly publicized.” Because a number of states and school boards had passed laws or resolutions, Ross claimed the federal bill was “legislative overkill.”

However, for a May 13, 2003 investigative report on the CMSA published in Insight magazine, in which Ross again referred to “a few highly publicized cases,” Kelly Patricia O’Meara interviewed Mike Stokke, deputy chief of staff to the Speaker of the House at the time, and found cases of school personnel demanding that parents drug children as a condition of staying in school were far from isolated in numbers or areas.

In case after case, Stokke told Insight, “when we started meeting some of these families who have been through this problem, such as in New York, New Jersey and Connecticut, we saw the coercive action of the state come in and say that the teacher says you have to take these drugs.”

“And if you don’t it’s child neglect and the child is taken away from the parents,” he said.

“Many of the parents that we talk to are people who have the means to fight back but what is troubling,” he said, “is that there are many families out there in similar situations who don’t have the means to fight the system.”

In the press release, Ablechild noted that CHADD was only opposing the CMSA because its livelihood was at stake being the group was funded by stimulant makers. Complaints about the funneling of money through CHADD, to increase drug sales and the diagnosis of ADHD, were discussed at length during the September 29, 2002, hearing on the use of behavioral drugs in schools. Portions of a 1995 report on the matter, by the US Drug Enforcement Administration, were even read into the record.

“It has recently come to the attention of the DEA that Ciba-Geigy, the manufacturer of Ritalin, marketing under the brand name Ritalin, contributed $748,000 to CHADD from 1991 to ’94,” the agency reported. “The DEA has concerns that the depth of the financial relationship with the manufacturer was not well known to the public, including CHADD members, that have relied upon CHADD for guidance as it pertains to the diagnosis and treatment of their children,” it wrote.

The agency was particularly concerned that most of the ADHD material prepared for public consumption by CHADD, and made available to parents, did not address the potential or actual abuse of Ritalin. Instead, it was portrayed as a benign, mild substance that’s not associated with abuse or any serious side effects.

CHADD received $848,000 from Novartis in 2001, according to testimony at the hearing.

Kids Disabled for Cash

On its website, CHADD provides a link to a webpage on “Disability Benefits,” and tells parents that some kids with ADHD can be declared disabled and receive benefits including “cash payments,” under the federal Supplemental Security Income program.

“Children under age 18 who have disabilities, including some children with AD/HD, can receive SSI if they meet eligibility criteria,” CHADD says. “The SSI program can provide monthly cash payments based on family income, qualify the child for Medicaid health care services in many states, and ensure referral of a child into the system of care available under State Title V programs for Children with Special Health Care Needs.”

At the congressional hearing ten years ago, Colorado Representative, Bob Schaffer, reported concerns about Federal cash incentives to label children with ADHD, and specifically the two that resulted in cash payments to parents and schools.

In 1990, the SSI program made low-income parents eligible for a cash benefit of more than $450 a month for each ADHD child, and in 1991, the Department of Education made it so schools could receive more than $400 a year for students with ADHD, under the Individuals With Disabilities Education Act (IDEA).

Both cash incentives coincided with a dramatic rise in the number of children labeled with ADHD. In 1989, children citing mental impairments, including ADHD but not retardation, made up only 5% of disabled kids on SSI. But that figure rose to nearly 25% by 1995. Between 1990 and 1992, the number of ADHD diagnoses jumped from about one million to over three million, Schaffer informed the committee.

The IDEA also had a “child find” provision which required states to actively seek out kids who may qualify for special education in order to receive Federal special education funds, Patti Johnson, a member of the Colorado State Board of Education, told the panel. In many states, schools had also become authorized Medicaid providers and collected funds for children labeled with one of the learning or behavior disorders, she reported.

“Between SSI, Medicaid and IDEA, we have turned schools into aggressive identifiers of disabled children,” Schaffer told the panel. “Without a doubt we are subsidizing the aggressive pursuit of children with disabilities.”

“It is not resulting in accurate diagnosis,” he said. “It is resulting in an over diagnosis.”

Roughly a decade after the hearing, the new book, Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America by Robert Whitaker, reports that the number of kids receiving SSI checks due to mental illness increased 35-fold between 1987 and 2007, from 16,200 to 561,569.

Drug Money Pours In

Despite non-stop criticism over being in the pocket of the pharmaceutical industry, money from ADHD drug makers continues to pour into CHADD year after year.

The group’s Income & Expense Reports, show CHADD received $507,000 in 2002, $674,000 in 2003, and five years later, the amounts nearly tripled. For the fiscal year of July 1, 2007 to June 30, 2008, CHADD received a total of $1,205,000, from Eli Lilly, J&J’s McNeil division, Novartis, Shire US, and UCB. In addition, 64% of sales and advertising, or $466,104, came from drug companies.

The next year’s report shows CHADD received a total of $1,174,626, from Lilly, J&J’s McNeil division, Novartis, and Shire, and 57.2 % of sales and advertising, or $412,500, was from drug companies.

For the year 2008, Lilly’s full year grant report lists a $200,000 donation to CHADD. The 2008 IRS filing for the Eli Lilly Foundation also shows a $50,000 gift, a drop from the $100,000 given to CHADD in 2007. Lilly’s 2009 grant report lists a $130,000 donation and the first quarter report for 2010 shows a $50,000 grant for CHADD. Lilly is the only ADHD drug maker required to post grant reports online, so there is no way to break down how much money is pouring into CHADD from the other companies.

The group’s 2008 IRS filing lists CHADD’s most significant activity as, “provides support for individuals with Attention Deficit/Hyperactivity Disorders.” Yet the non-profit blew $330,000 on its annual conference and another $114,950 on a 20th Anniversary Gala that same year, according to the 2008 I&E report.

Also, in sharp contrast to the yearly SSI income of about $8,000 for persons disabled by ADHD, the group’s 2008-2009 tax forms lists compensation for CEO Ross as $187,747, and the next two highest paid officials of this “non-profit” earn $130,217 and $121,095.

Landslide Vote

On May 21, 2003, the CMSA passed by a landslide vote of 425-1 in the House. On May 27, 2003, Sheila and Patty appeared on the national radio show Scams and Scandals, for a program about the need for the Act to end the abuse of parents by schools. During the show, they asked all parents who had experienced abuse similar to theirs to go online and sign Ablechild’s petition.

The next month, Sheila was featured in her hometown newspaper, The New Canaan Advertiser, in a front-page article on June 5, 2003 with the headline: “Mother pushing Congress to prevent schools from ADD testing,” with details of her campaign to enact federal legislation. The article profiled AbleChild, and criticized CHADD for its industry funding and opposition to the CMSA.

When public health officials in the UK and US announced that Paxil increased the risk of suicide in children in June 2003, Sheila pushed her Governor’s office to issue a press release warning against the use of Paxil with kids. In July 2003, the Associated Press reported that the Department of Children and Family Services in Connecticut planned to stop using Paxil to treat young people with depression.

The New American published an article titled, “Drugging Our Kids,” by William Norman Gregg in August 2003, and covered Patty and Michael’s story in depth, along with similar cases reported by other parents including Neil Bush and two families in which children died as a result of coerced drugging.

On February 20, 2004, Patty spoke on the nationally syndicated Joyce Riley radio show, and discussed the need for the CMSA in the wake of recent FDA hearings on the link between antidepressants and suicide, including Paxil, the drug Michael was prescribed.

Patty and Michael were both on CNN’s Lou Dobbs on April 15, 2004. Patty noted the need for the CMSA, evidenced by nearly 1,000 signatures on Ablechild’s website from parents with similar stories. Michael described how bad it felt to be on medications and Patty warned about the lack of informed consent given to parents regarding both the diagnoses of mental disorders and the drugs used as treatment.

The next month, Patty led a protest of hundreds of parents, children and human rights activists at the opening of the American Psychiatric Association’s annual conference in New York City, saying parents were fed up with psychiatrists telling them their children’s behavior was a “mental disorder” requiring dangerous drugs.

Sheila was again featured in her hometown newspaper on May 10, 2004, in an article about the need for an investigation by the Connecticut Attorney General into the drugging of children in foster care. Sheila was quoted throughout and promoted passage of CMSA.

Another federal bill that was introduced as a “Prohibition on Mandatory Medication,” amendment to the IDEA in April 2003, was passed by the House and Senate on May 13, 2004, and banned state and local educational agency personnel from requiring a child to take a drug covered by the Controlled Substance Act as a condition of attending school, receiving an evaluation, or receiving services. Key wording from the CMSA was included in the amendment.

On September 13, 2004, Patty testified at an FDA advisory panel hearing on the need for black box warnings on antidepressants about the risk of suicide and violence. “The FDA had enough evidence 14 years ago to issue these warning labels,” she told the committee.

She also testified about the lack of science behind psychiatric labels given to children. “Parents are told that their child has a chemical imbalance or a neurobiological illness,” she testified. “We risked our child’s life based on this fundamental lie.”

“The FDA is well aware that there are no x-rays, biopsies, blood tests or brain scans that verify these mental disorders as a disease or illness,” she said. “The FDA should not be condoning or approving these drugs without evidence of disease, illness or physical abnormality that would justify risking our children’s lives with a harmful and potentially lethal drug.”

The hearing ended with a vote by the panel in favor of black box warnings.

In November 2004, Patty was interviewed by a French TV producer for a news program in France, similar to 60 Minutes, focused on the pressuring of parents by schools in American to put children on psychiatric drugs. Other guests included Vicky Dunkel and Tom Woodward, whose daughter committed suicide after being prescribed an SSRI.

On February 17, 2005, Patty testified at a hearing titled, “ADHD Diagnosis, Treatment & Consequences,” in New York City, and told the story of what happened when Michael was labeled mentally ill in a public school and she refused to keep drugging him.

“The irony of the whole ordeal was that I was charged with medically neglecting my son, when there was no proof that anything was medically wrong with him,” she testified.

The next month, the Ladies Home Journal ran an article titled, “A Generation out of Control,” with a sub-heading that read: “A record four million children — some as young as 2 — are being diagnosed with ADHD and many are being put on powerful medications, perhaps for life.”

The article featured Sheila, and Patricia Marks, another Connecticut mom whose son was misdiagnosed with ADHD. The article discussed the dangers of teachers diagnosing kids in schools to solve classroom problems and warned parents to make sure and rule out undiagnosed medical conditions that might manifest as ADHD.

Also in March, in letters to the US Attorney for the District of Minnesota and the FDA, Ablechild called for an investigation into the role of antidepressants in a school shooting by Jeff Weise in Red Lake, Minnesota, who was on Prozac when he went on a rampage, killing his grandfather first, and then fellow students and teachers at his school, before committing suicide with the same gun.

In a press release, Ablechild expressed outrage and frustration with the FDA for “continuing to turn a blind eye to the all so obvious link to violence and mania that these drugs are having on our youth, and even more, their deadly link to uncontrolled school terror that has occurred from coast to coast.”

In October 2005, Sheila issued a statement from Ablechild strongly opposing TeenScreen, a program aimed at screening kids for mental illness in schools. “TeenScreen is nothing more than the bio-behavioral health industry’s attempt to garnish big government funding for useless programs that profitably promote a course of recommended psychotropic drug “treatment” which has been clearly liked to suicide and violent behavior,” she warned.

In October 2006, Sheila appeared on The Big Story with John Gibson on Fox, in a segment titled “Investigating the Link: Antidepressants & Violence,” based on recent school shootings in Pennsylvania and Colorado, and spoke of the need to investigate the correlation between psychiatric drugs and school shooters, and toxicology tests to determine whether shooters were on drugs. As the founders of Ablechild, parents came to them all the time, Sheila said. “Their children are committing suicide on these drugs and we’re very concerned.”

At the end of the show, the reporter noted particular concern about the fact that 30 million Americans were taking antidepressants, and being that 5% would develop mania, there could be “a million and a half potential maniacs waiting to explode.”

Focus On Drug Side Effects

Over the years, Ablechild has also focused on educating the pubic on drug side effects and MedWatch, the FDA’s adverse drug reaction reporting system. On December 13, 2006, Sheila testified at the FDA advisory hearing on the risk of suicide with adults on SSRIs and presented the results of two surveys showing a lack of public knowledge about Medwatch, and asked the FDA to initiate campaigns to let consumers know where and how to report ADRs, as consumers detect adverse effects sooner than providers.

In June 2007, Shelia, along with two CCHR representatives, met with Washington lawmakers regarding the renewal of the “Prescription Drug User Fee Act.” The new Act was signed into law in September 2007, with key measures to help increase public knowledge about prescription drug risks, as well as better safety monitoring by the FDA.

On November 6, 2007, Ablechild issued a news alert to warn that despite the black box warnings, the mental health industry was continuing to downplay the suicide risk of antidepressants. Based on information posted within the MedWatch system, “an estimated 63,000 suicides have been committed by people under the influence of antidepressants,” the alert reported.

It also noted that most parents were not aware that at least eight school shooters “were under the influence of antidepressants documented to cause not only suicidal ideation but also mania, psychosis, hostility, hallucinations and even ‘homicidal behavior.’”

With 1.5 million children on antidepressants in the US alone, “Ablechild is deeply concerned about the number of children being prescribed the powerful and potentially lethal drugs,” the alert stated.

In December 2007, Sheila called into a National Public Radio program, when the topic was the recently passed FDA reform bill, and discussed a new requirement that all print ads include an 800 number and information on reporting side effects to MedWatch. She also noted the importance of the new clinical drug trial registry that would be available on the internet, and the elimination of conflicts of interest on FDA advisory committees.

Protect Youngest Victims

In 2008, Ablechild teamed up with Amy Philo’s “Unite for Life” coalition of advocacy groups in efforts to protect unborn children and nursing infants from forced drugging through their mothers’ ingestion of drugs, by lobbying against a bill called the “Mothers Act,” for short, aimed at screening pregnant women and new mothers for mental illness.

The Act “quite simply is a feeder line for the psycho-pharmaceutical industry and will result in more mothers and infants being put at risk for being prescribed antidepressants and other dangerous psychiatric drugs,” AbleChild warned in a letter made available on its website for persons to sign and send to members of Congress.

In April 2008, Patty, Amy Philo, Marla Fidili from CCHR, Mathy Downing, whose 12-year-old daughter committed suicide after being given Zoloft off-label for test anxiety, and about 40 more advocacy allies, went to Washington to lobby against the Mother’s Act.

The latest evidence of infants being harmed by psychiatric drugs ingested by their mothers was reported on July 2, 2010, with a Medscape Today headline, “Psychotropic Medications Linked to Serious Adverse Drug Reactions in Children,” for a study by Danish researchers of 4,500 adverse drug reactions (ADRs), in children younger than 17, listed in the national Danish ADR database between 1998 and 2007.

The results showed 429 reports were from psychotropic drugs, with the largest share from stimulants at 42%, followed by antidepressants with 31%, and antipsychotics at 24.5%.

Almost 19%, or 80 of the ADRs, were for children between the age of birth and 2. All but one was serious, with two deaths associated with the SSRIs Celexa and Prozac. These findings were “probably due to the mothers’ intake of psychotropic medicine, primarily antidepressants and antipsychotics, during pregnancy,” the study authors wrote.

Sheila and Patty, along with Amy Philo, Mathy Downing, and Vicky Dunkle, received an “Outstanding Achievement Award for Children’s Rights,” in February 2009, at CCHR’s annual banquet, highlighted by a video tribute featuring much of their work.

In April 2009, Sheila drafted a petition in support of the “Parental Consent Act,” and made it available on Ablechild’s website for persons to sign and send to members of Congress. Introduced by Texas Congressman and physician, Ron Paul, the bill prohibits federal funds from being used to establish or implement any universal or mandatory mental health screening program for public school students and establishes a parent’s right to refuse screening of a child without fear of being charged with child abuse or neglect. In an April 30, 2009 speech, Paul pointed out that “parents are already being threatened with child abuse charges if they resist efforts to drug their children.”

“Imagine how much easier it will be to drug children against their parents’ wishes if a federally-funded mental-health screener makes the recommendation,” he said.

Million Kids Misdiagnosed With ADHD

After a decade of work by Sheila and Patty to expose the fraud behind labeling kids with ADHD, on August 17, 2010, USA Today reported that a new study from Michigan State University found nearly 1 million children may have been misdiagnosed with ADHD, not because of any real behavioral problems, but because they were the youngest in the class.

Children who are the youngest in their grades are 60% more likely to be diagnosed with ADHD than the oldest kids, according to the study published in the Journal of Health Economics. In fifth and eighth grade, the youngest children were more than two times as likely to be on Ritalin compared with the oldest students, the study found.

Oral arguments in the case took place on October 12, 2010, but a final decision won’t be known for months. The most recent drug injury preemption case decided by the Court was also against Wyeth and the ruling came down in favor of plaintiff, Diane Levine.

The Court took the Bruesewitz case to determine whether 18-year-old Hannah, disabled by injuries she received from Wyeth’s diphtheria, tetanus and pertussis (DPT) vaccine at 6-months-old in 1992, has the right to bring a lawsuit against Wyeth after the Vaccine Court, set up by the 1986 National Childhood Vaccine Injury Act, refused compensation even though she will require life-long care and her vaccine was traced to a lot that had 65 adverse reactions including two deaths, 39 emergency room visits, and 6 hospitalizations.

After compensation was denied, the family filed suit against Wyeth in Pennsylvania and argued that the vaccine Hannah received was defectively designed and had a known safer vaccine been used her injuries could have been avoided.

Wyeth filed for summary judgment and the lower court dismissed the case holding that the 1986 vaccine law preempted all design defect claims. In March 2009, the Third Circuit Court of Appeals affirmed the ruling and the family filed a petition for review in the Supreme Court.

“Amici—all of whom support the routine vaccination of children against a host of vaccine-preventable infectious diseases—urge this Court to affirm the judgment of the Third Circuit below,” the brief filed by the 22 groups states.

The term “host” inadequately describes the number of “routine” shots kids get today, along with the increased risk of injury. Before 1986, children’s vaccines included diphtheria, tetanus, pertussis, measles, mumps, rubella and inactivated poliovirus. Since the Vaccine Injury Act was passed, nine new vaccines have been added, including hepatitis B, rotavirus, haemophilus influenzae type b, pneumococcal, influenza, varicella, hepatitis A, meningococcal, human papillomavirus (for girls), or an additional 46 doses for girls and 43 for boys, the CDC’s 2009 Recommended Immunization Schedule shows.

Amici Anything But Impartial

JB Handley, co-founder of Generation Rescue, as well as co-founder and contributor to Age of Autism, says whenever he meets pediatricians he asks what percentage of their revenue comes from vaccine administration. “The number always astounds me,” he said on Age of Autism. “The answers I get are that anywhere from 50-80% of their revenue comes from giving vaccines.”

In addition to their individual income from giving shots, Wyeth is now owned by Pfizer and over the past few years, the grant reports of the two companies show millions of dollars pouring into the American Academy of Pediatrics and many of the “partnering health organizations” that signed off on the brief.

For instance, Pfizer’s 2009 report lists two grants to the Academy totaling $56,000 and Wyeth donated $630,000 to benefit the group in 2009. Wyeth also gave the Academy $345,919 in 2008. The group received $524,080 from Pfizer in the first two quarters of 2010 alone.

In 2009, the Academy presented the “President’s Certificate for Outstanding Service” award to Dr Paul Offit, whose least offensive nickname, of many, is “Dr Proffit.”

Offit was also called the “poster child” for the term “biostitute,” by Robert Kennedy Jr at a green vaccine rally in Washington in 2008, for making himself the spokesperson for the vaccine industry and pretending to be an independent scientist without disclosing his ties to, and the millions of dollars he’s made off, the vaccine industry.

“The AAP is honoring Dr. Offit in recognition of his ongoing commitment to promote immunization,” the Academy’s October 16, 2009 announcement stated, without mentioning the financial windfalls he received due to his “commitment to promote immunization.”

On December 9, 2009, a report on Offit was published on Age of Autism with the headline, “Counting Offit’s Millions: More on How Merck’s Rotateq Vaccine Made Paul Offit Wealthy,” by Dan Olmsted and Mark Blaxill, authors of the new book, “Age of Autism: Mercury Medicine and A Manmade Epidemic.”

The report points out that Paul Offit, “vaccine entrepreneur and public health spokesperson, has earned approximately $10 million in income from Rotateq® royalties through 2009 and stands to earn a total of between $13-35 million over the life of his rotavirus vaccine patents.”

The analysis by Blaxill and Olmsted found that Offit’s future royalty income is tied to the vaccine’s future sales in the US and international markets, which gives him a strong financial stake in both the specific success of the rotavirus vaccine category and the global reputation of vaccines in general.

The American Academy of Family Physicians also signed off on the amicus brief. This group, along with its state chapters and Foundation, received a combined total of more than $5 million from Pfizer in 2009, and another $856,772 from Wyeth. In the first half of 2010, Pfizer gave the Family Physician groups $1,334,165.

Another signer, the American Medical Association, received grants worth $751,500 from Pfizer and a $5,000 grant from Wyeth in 2009. The Association received $447,400 from Pfizer in the first two quarters of 2010.

Several other members of the group that ganged up on Hannah in the brief also received plenty from the vaccine makers. Pfizer gave $55,000 to the National Foundation for Infectious Diseases in 2009, and Wyeth gave $45,000. In 2008, the Foundation received $2,153,500 Wyeth, and Pfizer gave it $58,500 in the first half of 2010.

In 2009, the Infectious Diseases Society of America received $15,000 from Wyeth and $65,000 in 2008.

The American Public Health Association received three grants totaling $200,000 from Pfizer in 2009.

The March of Dimes and its Foundation combined got $4,500 from Wyeth in both 2008 and 2009. Pfizer gave the groups $14,500 in the first half of 2010.

In 2009, Wyeth gave the National Association of Pediatric Nurse Practitioners Foundation four grants totaling $175,150 and three worth $70,000 in 2008.

Parents of Kids with Infectious Diseases received $75,000 from Wyeth in 2009.

The Immunization Action Coalition was paid $95,000 by Wyeth in 2009 and $136,743 in 2008.

Every Child By Two received nearly a million dollars, or $950,000, from Wyeth in 2009, and $350,000 in 2008.

In the August 4, 2008 report, “Every Child By Two: A Front Group for Wyeth,” JB Handley points out that Craig Engesser, an employee of Wyeth with a title of Senior Director, Professional Affairs, was on the Board of Every Child By Two for as far back as he could track. In fact, Engesser had even served as the group’s treasurer.

Handley also noted that Paul Offit had recently joined the group’s Board.

For the year 2006, Handley found IRS filings showed Wyeth gave Every Child By Two $350,769 and page 23 of the filing read: “Wyeth Vaccine: Ensure all children from birth to Age 2 are fully immunized.”

The National Healthy Mothers, Healthy Babies Coalition received $200,000 from Pfizer in 2009, and Wyeth gave the Georgia chapter $500 in 2008. Other corporate sponsors listed on the group’s website in 2009 included Merck, GlaxoSmithKline, Johnson & Johnson and Sanofi-Pasteur.

Amici for Hannah

Amicus briefs were also submitted in support of the Bruesewitz family in September 2009 and June 2010, by attorneys from the state of New York, Mary Holland and Robert Krakow, on behalf of the National Vaccine Information Center and its cofounders, parent advocates who helped draft the 1986 legislation, the New Jersey Coalition for Vaccine Choice, No Mercury, Truth About Gardasil, Age of Autism, National Autism Association, Autism One, SafeMinds, Autism United, US Autism and Asperger Association, Talk About Curing Autism, Generation Rescue, and the Elizabeth Birt Center for Autism Law and Advocacy.

It would require too much space to list every organization, but all together more than 25 signed off on the briefs – none of which receive money from vaccine makers. Basically the question to be answered by the Supreme Court is:  Does § 22(b)(1) preclude all vaccine design-defect claims even if the vaccine’s side effects were avoidable?

“The legislative history suggests that all the stakeholders – Congress, parents, manufacturers and physicians – understood that victims preserved the right to take design defect claims to court,” the June brief says. “Respondent and its amici appear to be trying to achieve through the judiciary what they failed to obtain through Congress.”

In fact, the brief includes several statements made at the time the Act was passed that suggest that Congress recognized that victims, who duly filed for compensation in the Vaccine Program, could take design defect claims to court under Section 22(b).

For instance, when presenting the Act to the full House of Representatives for a vote, Rep Henry Waxman, the chief sponsor of the Act, stated that civil claims for “inadequately researched” vaccines would be preserved under Section 22. Waxman’s description of this claim, that a vaccine’s design did not take adequate account of avoidable safety risks, would likely be a design defect, the brief notes.

“Furthermore, the Committee explicitly rejected the opportunity to create a broad exemption for all design defect claims when it considered the Act,” it says. “Proposals were considered by the Committee that would have explicitly preempted all design defect claims, but the final version did not contain those provisions.”

“By rejecting language that would have barred all design defect claims,” the attorneys wrote, “Congress showed its intent to permit courts to decide on a case-by-case which side effects were genuinely ‘unavoidable.’”

“The Act and its legislative history simply do not make sense without the understanding that the tort system remains an available alternative for such cases,” the brief says. “And Congress’ intent to keep the courthouse doors open is even more important today than it was in 1986.”

“The significance of the Bruesewitz case relates to all vaccine injury – it goes to the heart of whether Vaccine Court is fulfilling the role Congress set for it, and whether it is possible to challenge the design safety of a vaccine in any court in the United States,” Holland explained in a March 10, 2010 commentary on Age of Autism.

“For the autism community, the case could not be more central,” she says, “it will determine whether the 5,000 petitioners in the Omnibus Autism Proceeding can continue their claims in state and federal courts if Vaccine Court ultimately dismisses their claims.”

Right about now, paranoia in the vaccine industry is no doubt running at an all time high since the announcement of the first award in a vaccine-autism case in September 2010 for another girl named Hannah, with $1.5 million to start and $500,000 a year for life to pay for her care. “Those familiar with the case believe the compensation could easily amount to $20 million over the child’s lifetime,” CBS News reported on September 10, 2010.

Hannah was “described as normal, happy and precocious in her first 18 months,” until “she was vaccinated against nine diseases in one doctor’s visit,” in July 2000, CBS said.

A government study titled, “The Prevalence of Parent-Reported Diagnosis of Autism Spectrum Disorder among Children in the United States, 2007,” evaluated the number of children in the US who currently had an Autism Spectrum Disorder diagnosis in 2007, based on data from a national Survey of Children’s Health, and found that 1 in 91 children between the ages of 3 and 17 carried an ASD diagnosis.

”Even more alarming, for the subset of children between ages 6 and 14 immunized during the 1990′s the prevalence is actually 1 in 71 children with an autism diagnosis,” Age of Autism reported.

”This age group represents children in the U.S. with the highest exposure to thimerosal, the mercury preservative routinely used until CDC, AAP and industry recommended its removal “as soon as possible” from all childhood vaccines,” AoA explained.

It’s obvious that parents no longer trust claims by the government and drug companies about harmless vaccines. On October 17, 2010, in the Huffington Post, Kim Stagliano, managing editor of AoA and author of the new book, “All I Can Handle I’m No Mother Teresa,” reported that a new study from CS Mott Children’s Hospital found 89% of parents think vaccine safety is the most important topic in medical research today.

“That makes sense, since the American pediatric vaccine schedule now includes 48 vaccinations before the age of six,” Stagliano says. “Parents are facing vaccination choice issues at every pediatric visit.”

Fictional Fear Factors

In the brief filed by the groups with all the money from Wyeth and Pfizer, when warning that vaccine makers might flee the market if they have to face the threat of lawsuits and unpredictable litigation costs, they argue that the number of vaccine makers has not greatly increased since 1986 and refer to the “precarious state of the vaccine industry.”

“The preemption of all design defect claims is critical to Congress’s objective of stabilizing the vaccine market and safeguarding the Nation’s vaccine supply,” they claim.

First of all, the vaccine industry is not in dire financial straights;  in fact, far from it. On June 11, 2009, Kalorama Information issued a press release for the vaccine sales forecast in a market analysis report with the headline, “New Report Forecasts More Than Doubling of Vaccine Sales by 2013.”

“Few areas of pharmaceuticals have seen the fast-moving developments in the marketplace that the vaccine market has,” Kalorama noted. The press release described 2008 as another “stellar year for the world vaccine market,” in which sales “grew 21.5% since 2007 to reach $19.2 billion.”

A year earlier, Kalorama reported that stronger than anticipated revenues for flu vaccines and the “surprising commercial success” of Merck’s Gardasil had led to $16.3 billion in vaccine sales in 2007, “an increase of 38% over 2006 sales of $11.7 billion.”

However: “Vaccine manufacturers face many challenges in bringing new vaccines to market,” the amicus brief points out, with a note to: “See Paul A. Offit, Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?, 24 Health Affairs 622, 623-629 (2005).”

The brief goes on to complain about how much the cost of developing vaccines has increased. “Between 1991 and 2003, for instance, costs for research and development, post licensure clinical studies, and production process improvements grew from $231 million to $802 million,” it said, citing Stanley A Plotkin, et al, Vaccines 38 (5th ed 2008). Plotkin was a co-inventor with Offit on the Rotateq vaccine.

But in any event, the high prices charged for vaccines today wipe out those costs in record time. For instance, Rotateq runs close to $200 for a 3 dose series and when you multiply that by the CDC’s calculation of more than 4 million babies born each year in the US, annual sales come to over $800 million in this country alone. Wyeth’s pneumococcal vaccine “makes $2 billion a year in sales,” according to a July 25, 2008 report by CBS News.

About a year ago, Dr Proffit was shilling for vaccine makers in the October 18, 2009 Wall Street Journal by claiming infants should get 2 regular flu and 2 swine flu vaccines, without mentioning that all 4 contained the mercury-based preservative, thimerosal. “Children ages six months to nine years who have never received a flu vaccine before are recommended to receive two doses of both the H1N1 and seasonal-flu vaccine about a month apart,” Offit said.

With the headline, “Most flu shots contain mercury, but few know it,” on November 13, 2007, the Milwaukee Journal Sentinel reported that when using the standards set for methyl mercury consumption, a 22-pound baby getting the flu shot “would get more than 25 times the amount of mercury considered safe.”

In the WSJ article, Offit was identified only as “chief of infectious disease” at the Children’s Hospital of Philadelphia, when in fact he holds a “$1.5 million dollar research chair at Children’s Hospital, funded by Merck,” according to CBS News.

That bit of advice from Offit in the WSJ could potentially drum up over 4,000,000 new customers every year for shot givers and vaccine makers in the US for flu vaccines alone. Last year, the September 14, 2009 Los Angeles Times reported that physician offices usually “charge about $25 to $75 for the seasonal shot, including administration fees.”

“If you are immunizing a child for the first time, the child may need two shots,” the Times said. “Ask the healthcare professional giving the shot if you will have to pay two fees.”

For the sake of simplicity, let’s say doctors threw in both seasonal flu shots for one fee of $75. The total amount made from vaccinating 4,000,000 babies would be $300 million.

The Times said the H1N1 shot would be free, although doctor’s offices and clinics may charge an administrative fee. But the swine flu shots were in no way free. Tax payers paid vaccine makers a fortune as a result of the pig flu hoax. However, for the sake of non-argument, let’s say the shot givers only charged $10 per infant to give each of the two swine flu vaccines. They would still make $80 million.

Will Health Care Workers Revolt?

The fact that health care workers have an aversion to flu vaccines is likely the best testament to the lack of benefits and potential harms associated with vaccines including the inability to sue for compensation if injured. It only stands to reason that if vaccines worked so great, this group would be the first in line to get them.

But a new policy statement by the American Academy of Pediatrics, in a paper in the October, 2010 issue of their official journal, Pediatrics, gives notice of plan to force health care workers to get flu vaccines with the heading, “Recommendation for Mandatory Influenza Immunization of All Health Care Personnel.”

The Academy claims that “despite the efforts of many organizations to improve influenza immunization rates with the use of voluntary campaigns, influenza coverage among health care personnel remains unacceptably low.”

Mandatory influenza immunization for all health care personnel is “ethically justified, necessary and long overdue to ensure patient safety,” the group said in a statement.

“The influenza vaccine is safe, effective, and cost-effective, so health care organizations must work to assuage common fears and misconceptions about the influenza virus and the vaccine,” the Academy claims.

Their paper reports that in January 2010, the CDC estimated the percentage of health care personnel who received vaccines was only 61.9% for seasonal flu, 37.1% for swine flu, and only 37.1% received both the seasonal and swine flu vaccines.

However, it’s not like the industry is suffering from a lack of flu shot customers even when health care workers refuse to get them. In 2009 alone, multi-national corporations took home profits of $2.8 billion in influenza vaccine sales, according to an October 2010 report by Barbara Loe Fisher, co-founder of the National Vaccine Information Center.

By comparison, since the Vaccine Injury Act was passed roughly 25 years ago, the vaccine court has paid out less than $2 billion. Of the more than 13,550 petitions filed covering all vaccines, compensation for injuries was only awarded in about 2,500 cases.

Of course, the estimates in the paper, if true at all, would have come from the same CDC that was run for years by Julie Gerberding and has put out the trumped up claim year after year that 36,000 people in the US die of the flu annually, with the death number never changing even when vaccination rates greatly increase.

In a December 21, 2009 Pharmalot Blog, Ed Silverman reported that Gerberding, “who until this year was the director of the US Center for Disease Control and Prevention, was named president of Merck’s vaccine division.”

As the former “top dog” at the CDC, she “has plenty of experience overseeing the selection of recommended immunizations,” FiercePharma noted on December 22, 2009.

“Autism activists, particularly those who believe vaccines are a primary cause of regressive autism, are often derided for conspiratorial comments about the CDC and Big Pharma,” JB Handley pointed out on the Pharmalot blog.

“This one is making us look more sane every day,” he said.

On October 7, 2010, Barbara Loe Fisher reported that doctors at Children’s Hospital of Philadelphia (Dr Proffit’s Kingdom), are ordering all employees to get a flu shot every year or be sent home for two weeks without pay to “think about it.”

“Anyone, who still refuses to get a flu shot after that, is fired,” she wrote. And that goes for not just doctors and nurses, she says, but every person who has anything to do with the health care facility, including students, volunteers, and contract workers.

“An exception could be made if the doctors in charge approve a “medical exemption” to vaccination, which, today,” Fisher warns, “is about as hard to get as a job.”

Under a new policy announced on April 5, 2010, pilots diagnosed with depression can seek permission from the Federal Aviation Administration to take one of four SSRIs, including Eli Lilly’s Prozac, Pfizer’s Zoloft, and Forest Laboratories’ Celexa and Lexapro.

“The FAA should reverse its ruling before it’s too late and hundreds of lives are lost when a pilot becomes impulsive, suicidal or violent — or just loses his sharpness — under the influence of antidepressant medication,” said SSRI expert, Dr Peter Breggin, in an April 19, 2010 Huffington Post commentary.

The Citizens Commission on Human Rights is also calling on the FAA to rethink allowing pilots to take SSRI in light of a new report issued last month by the National Transportation Safety Board, on a February 1, 2008 plane crash in North Carolina, by a crazy acting pilot on Zoloft, that killed all six persons on board

The report said the pilot failed to maintain control of the plane during instrument flying conditions and “deliberately descended below the minimum descent altitude.” The plane stalled and crashed while circling after an aborted landing.

“Review of the cockpit voice recorder (CVR) audio revealed that the pilot had displayed some non-professional behavior before initiating the approach,” the NTSB reported.

The CVR recorded the pilot singing: “Save my life I’m going down for the last time,” before beginning a commentary in which he told passengers: “If anybody back there believes in the good Lord, I believe now would be a good time to hit your knees.”

A review of medical records documented that “from December 4, 2006 through December 31, 2007, the pilot had filled 6 prescriptions for 30 tablets of 50 mg sertraline (Zoloft),” the report said.

The records indicated that he had been treated previously with two other antidepressant medications for “anxiety and depression” and a history of “impatience” and “compulsiveness,” the NTSB noted.

An investigation of another plane crash, resulting in two fatalities in Kingsport, Tennessee, in August 2003, found Zoloft in the blood and liver of a private flight instructor, according to an accident report by the NTSB.

In the policy statement published in the Federal Register, the FAA seems to justify the use of these drugs via the fully debunked “chemical imbalance in the brain” theory when writing: “All these medications are SSRIs, antidepressants that help restore the balance of serotonin, a naturally occurring chemical substance found in the brain.”

“Increasingly accepted and prevalently used, these four antidepressants may be used safely in appropriate cases with proper oversight and have fewer side effects than previous generations of antidepressants,” the FAA wrote, with no citation to any scientific paper to back up this assertion.

In fact, the current labels on SSRIs warn that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients treated for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.”

“Even when not severe, these reactions impair judgment and increase the likelihood of accidents and violence,” according to Dr Breggin.

CCHR has set up a great website with a one-of-a-kind search engine that allows the public and officials to access the database on side effects reported to the FDA on SSRIs, and every other psychiatric drug. The site also has a search engine to access all the International warnings and studies on psychiatric drugs which have been summarized so they are easy to understand, even to a lay person

Input Only From the Choir

On April 6, 2010, Bob Fiddaman, author of the long-running popular website and blog, “Seroxat Sufferers,” sent a request to the FAA, under the Freedom of Information Act, seeking information on the change in policy.

In the Federal Register, the FAA claims it came to its decision after “careful consideration.” However, in the 58 pages of documents sent to Fiddaman on June 9, 2010 (and kindly shared with this author), there is no mention of consultations with any of the prominent SSRI experts who may have offered a contrary view.  Like Peter Breggin, for instance.

The FAA’s response to Fiddaman shows the agency has been discussing the policy change since at least 2008. In response to a request for “minutes of meetings where the change in the policy was on the agenda,” as well as a list of “members present and a declaration of interests of each of the members,” the FAA sent a copy of a July 18, 2008, Memorandum, with a summary from one consultants’ meeting. Three outside experts attended but there were no declarations of interests, or lack thereof, by anyone at the meeting.

The summary noted that the consultants “unanimously agreed that the concept of allowing certain airmen taking antidepressant medication was reasonable and safe.” But the  “unanimous consensus” was that only Prozac and Zoloft “were appropriate medications due to the longevity of their use and overall safety.”

“They also felt that only these two should be considered initially, and no other medications considered at this time,” the summary reported.

In responding to the question of whether the new policy would apply to Air Traffic Controllers, the FAA said the “new policy does not presently apply to Air Traffic Control Specialist (ATCS) because the administrative details of the monitoring and follow-up of these employees are yet to be determined. The plan is that ATCSs will eventually be included in a program of this type.”

In response to a request for any information “given to FAA from outside parties that relate to the FAA’S recent change in policy regarding pilots on antidepressant medication,” the FAA sent copies of documents received from the Aerospace Medical Association, the Airline Pilots Association Aeromedical Office, the International Airline Pilots Association, and the United States Army.

“In developing the new policy, the FAA also utilized a variety of medical research literature available in the public domain,” the response said. “We used internet sites such as, but not limited to: The National Library of Medicine PubMed site and the FDA Medwatch.”

The documents Fiddaman received show consideration of a 2003 study of aviation accidents that found SSRIs in 61 pilot fatalities between 1990-2001, in which the psychological condition and/or the drug use was determined to be the cause, or a factor in 16 of the accidents, or 31%.

However, there was no mention of a later November 2006 study titled, “Pilot Medical History and Medications Found in Post Mortem Specimens for Aviation Accidents,” led by Dennis Canfield, from the FAA’s Civil Aerospace Medical Institute, in the Aviation, Space, and Environmental Medicine journal.

For this study, toxicological evaluations were performed on 4,143 pilots involved in fatal aviation accidents during the period between January 1, 1993, through December 31, 2003, to identify all pilots found positive for medications used to treat cardiovascular, psychological, or neurological conditions.

The evaluations found one-hundred dead pilots with SSRIs in their systems including forty with Prozac, twenty-six with Zoloft, twenty-one with Paxil, and thirteen with Celexa.

Less than a month after the new policy was announced, in Aviation International News, on May 1, 2010, Matt Thurber reported that in a review of 127 accidents in the NTSB database since 1991, containing the word “antidepressant,” only three were nonfatal.

“In 124 of those accidents, 211 people were killed,” Thurber said. “In accident after accident, antidepressants … were found in the tissues of dead pilots, and the pilots had falsified their medical certificate applications to show that they had never been treated for psychiatric problems.”

Drug Free For All

No doubt in large part to Fiddaman’s multi-year non-stop campaign to inform the world about the dangers of Paxil, pilots will still not be allowed to use it.

However, some of the people who submitted comments to the FAA on the new policy thought the agency should open up the friendly skies to more psychotropic drug use. For instance, on June 16, 2010, a person commenting under the name, Anonymous, told the FAA:  “This review should be expanded to include ADHD medications.”

“Many pilots are diagnosed as having ADHD and take medication to assist them. Many of the medications used today to assist adults are derivatives of drugs issued to military pilots to remain alert during missions,” Anonymous said. “I strongly encourage the FAA to review the use of ADHD medication so the pilots using medications to manage their symptoms can finally come out of the shadows.”

On June 23, Gregorio Guillen wrote and asked: “How about those pilots wanting to take prescription low dose Sertraline to treat premature ejaculation and not necessarily depression?”

Gregorio wants to know whether they “are going to be affected by this rule?”

A pilot named Paul Reed, asked the FAA to: “Please consider allowing migraine treatments with anti-depressants to be included in this rule,” on June 17.

But on the other hand, on June 17, Patric Barry wrote: “If the pilot population is permitted to use such medication, the temptation to increase the dose when a pilot is feeling “a little off” is too great a risk — to amend the rules to allow an inch, some pilots will feel compelled to take a mile.”

“That is simply an unacceptable risk to the general population and passengers relying on the stability of the pilot group to safeguard and protect public safety,” he told the FAA.

Dr Jeffrey Welker also believes it is “a bad idea to allow individuals being treated for depression with medications to hold a current valid medical,” and “we should be looking very close at these individuals after treatment for mental stability.”

“I base this opinion on my professional and personal observations of 25 years in practice,” he said in a comment on June 25.

All of the comments submitted can be found by going to the FAA’s Regulations and Policies Web page.

SSRIs Impair Roadways

It makes no sense to put planes full of people at risk by allowing pilots to fly on SSRIs when a study as far back as December 2006, in the “Journal of Clinical Psychiatry,” reported that about seven out of every ten people who take antidepressants have impaired driving ability in a car, and 16% have severe motor impairments.

In addition, “reckless driving is one of the most commonly reported adverse effects of antidepressants,” Dr Breggin reports.

After taking antidepressants, disinhibited, agitated or angry drivers find themselves exploding into road rage or using their cars as instruments of suicide,” he says. “This is one of the first antidepressants reactions that clinicians like myself began noticing soon after Prozac hit the marketplace.

In his book, Medication Madness, Dr Breggin describes how an ordinarily calm, model citizen became suicidal on Paxil and drove his car into a helpless policeman in order to knock him over and get his gun so the man could kill himself with it. Although the man seriously injured the cop, he failed to get the gun.

In another case, a man described as kind and gentle turned psychotic while on Zoloft and drove his automobile into a barrier in attempt to kill his passenger wife because he believed her body was harboring an alien beast that wanted to destroy him and all of humanity.

“The other part of this story that the FAA seems to be missing is that for all but the most extreme cases of depression, antidepressant drugs have been scientifically proven — through multiple clinical trials — to work no better than placebo,” says Mike Adams in the April 5, 2010 report, “Medicated in the Cockpit.”

“These pilots would do just as well taking capsules filled with olive oil as they do on patented, monopoly-priced SSRI drugs,” he points out.

The current price of the four SSRIs at DrugStore.com, for 90 pills at a middles dose, is $600 for Prozac, $365 for Zoloft, $320 for Celexa, and $270 for Lexapro.  Much to the delight of the SSRI makers, the FAA’s new policy will likely encourage pilots to keep paying for their useless drugs forever.

As a main component of the Psychopharmaceutical Industrial Complex, the so-called “patient advocacy” organizations have become the leading force behind the American epidemic of mental illness over the past two decades.

Drug makers, and their foundations, funnel millions of dollars to these non-profits every year. In return, the leaders recruit their members as foot soldiers to carry out the latest marketing campaigns and to provide a fire-wall so that no money trail can be tracked back to the drug companies.

Gigantic Pyramid

The psychiatric front groups form a gigantic pyramid and once pharmaceutical money enters the system through a major organization, it gets channeled into a huge spider-web that weaves through many groups, making it nearly impossible to keep track of where it came from or where it all went. Often, when the grant reports of the drug companies list a large donation to one organization, the annual reports of the other groups will show smaller gifts from that same organization.

The “charity” groups are exempt from income tax and the “contributions” funneled through them are tax deductible. The money is used for disease mongering campaigns to both market disorders and pressure public health care programs and private insurers to pay for expensive treatments.

“Presenting themselves as patient advocacy groups is highly disingenuous not only to their membership, many of which may have a sincere desire to help a loved one or a family member with mental problems, but to legislators, the press and the American public — for they have consistently lobbied for legislation that benefits the mental health and pharmaceutical industries which fund them, and not patients they claim to represent,” according to Citizens Commission on Human Rights International, a mental health watchdog group.

In a June 2, 2010, commentary titled, “Psychiatric Fads and Overdiagnosis,” on the Psychology Today website, Dr Allen Frances points out that it “is too bad that there is no advocacy group for normality that could effectively push back against all the forces aligned to expand the reach of mental disorders.

The leaders of the supposedly “non-profits” earn outrageously high salaries, along with excellent benefit packages, while many of the patients they claim to represent are encouraged to seek federal disability payments of under $700 a month, and apply for public housing, food stamps, and Medicaid, to make ends meet. The top officials will often move from a leadership role in one organization to a higher position in another.

The drug makers rely on the front groups to do their bidding any time profits are threatened. For instance, if the FDA is considering adding a black box warning about a deadly side effect to a drug’s label, which may result in a drop in sales, representatives of front groups will show up at the FDA advisory panel hearings to testify against adding the warning.

They will also lobby FDA panels whenever there is a chance to increase profits, such as enlarging the drug customer base. In June 2009, the Psychopharmacologic Drugs Advisory Committee was set to meet to evaluate AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa for use with 13- to 17-year olds diagnosed with schizophrenia, and 10- to 17-year olds diagnosed with pediatric bipolar disorder.

On June 8, 2009, nine front groups issued a joint statement urging the panel to vote to approve all three drugs for kids. The groups signing the letter included the American Academy of Child and Adolescent Psychiatry, American Foundation for Suicide Prevention, American Psychiatric Association, Child and Adolescent Bipolar Foundation, Children and Adults with Attention-Deficit/Hyperactivity Disorder, Families for Depression Awareness, Mental Health America, National Alliance on Mental Illness, and the National Council for Community Behavioral Healthcare.

“As advocates for people living with mental illnesses, we strongly urge the FDA to carefully consider the importance of viable treatment options for bipolar disorder and schizophrenia in pediatric and adolescent populations,” they wrote. “Access to safe and effective treatments, including more information about all treatment options, is crucial to treating these serious and complex conditions in children and adolescents.”

In an obvious attempt to downplay the serious side effects of the antipsychotics, the groups stated: “Other treatments for grave childhood illnesses such as cancer can cause hair loss, nausea, compromised immune systems and even death. However, few people question the necessity of these aggressive forms of treatment.”

“Like cancer,” they wrote, “aggressive treatment may be needed for some patients with bipolar disorder and schizophrenia, diseases with a higher risk of death than some forms of cancer.”

The National Council for Community Behavioral Healthcare only recently began showing up in public pharma campaigns with the other front groups. Last year it was listed as a supporter of one of the most evil customer recruitment schemes ever devised, targeting the roughly four million pregnant women who give birth in the US each year, through passage of federal legislation known as the “Mothers Act.”

On its website, the Council is described as “a non-profit association representing 1,300 mental health and addictions treatment and rehabilitation organizations.” But a review of the few grant reports available on drug companies found this non-profit received over a half a million dollars since 2008, from Eli Lilly and Wyeth alone.

Lilly’s grant reports shows a $440,000 donation in 2008, and another $25,000 grant in 2009. The Council also received $20,000 in 2008, and $10,000 in 2009, from Wyeth (now owned by Pfizer). For the first quarter of 2010, Lilly’s lists two grants to the Council totaling $90,000.

The front groups all have “experts” serving on advisory or scientific boards and committees from major universities and government agencies, who have financial relationships with drug makers of one kind or another. Some organizations even have drug company officials, often from marketing and sales departments, sitting on boards and committees. Many of the same people will serve in multiple groups within the pyramid.

For example, Dr Herbert Pardes, a former director of the NIMH, is president of the scientific board of the National Alliance for Research on Schizophrenia and Depression (NARSAD). He is also a past president of the American Psychiatric Association, and served as chairman of the APA’s Council on Research for several years. A bio on the internet says he is a regular advisor to the National Alliance for the Mentally Ill (NAMI), the Anxiety Disorders Association of American, and Mental Health America. He has also served on the board of TeenScreen and is a charter associate member of the Depression and Bipolar Support Alliance.

Collapse of the Pyramid?

For several years, with Iowa’s Republican Senator, Charles Grassley, leading the charge, the US Senate Finance Committee has been investigating pharmaceutical industry funding, as it relates to marketing practices, involving Continuing Medical Education, consulting arrangements, publications in medical journals, the non-profit professional and patient advocacy organizations, and the conflicts of interest among academics who receive federal funding from the National Institutes of Health through research grants to major universities.

The Committee oversees spending in public health care programs, such as Medicaid and Medicare, for coverage of more than 100 million Americans, including mental health treatment and prescription drugs.

The “drug industry’s most powerful means of boosting the bottom line is funding research, which allows companies to control, or at least influence, a great deal of what gets published in the medical journals, effectively turning supposedly objective science into a marketing tool,” Shannon Brownlee explained in an April, 2004, Washington Monthly report titled, “Doctors Without Borders.”

By penetrating the wall that once existed around academic researchers,” she says, “drug companies have gained access to the “thought leaders” in medicine, the big names whose good opinion of an idea or a product carries enormous weight with other physicians.”

“Companies target academic KOLs, or Key Opinion Leaders, in the lexicon of marketing, and woo them with invitations to sit on scientific advisory committees, or to serve as members of speakers’ bureaus, which offer hefty fees for lending their prestige to a company and touting its products at scientific meetings and continuing medical education conferences,” she reports.

Grassley’s investigations at major universities turned up more conflicted academics in the field of psychiatry than in any other specialty. His chief investigator, Paul Thacker, developed a system where he would request conflict-of-interest records on psychiatrists from their universities and simultaneously ask drug companies to provide reports on what they paid the same researchers.

Some of the biggest names in the field appear on the list of psychiatrists who failed to disclose all their financial benefits from drug companies, which thus far includes three from Harvard, Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zachery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, outgoing president of the American Psychiatric Association, and chair of psychiatry at Stanford; Martin Keller, a former chair of psychiatry at Brown; Karen Wagner and Augustus John Rush from the University of Texas; and Fredrick Goodwin, of George Washington University, and also the host of a radio show called “Infinite Minds,” that was broadcast for years by National Public Radio.

All of the above “KOLs” have served as officials, or on boards and committees, of major front groups, and many have received awards, consulting and speakers fees, and research funding from various organizations.

Ensuing Outrage

The revelation that millions of dollars have been flowing from drug makers to academics in psychiatry, undetected for a decade, has drawn outrage and demands for more accountability in the entire field. “Financial transparency and full disclosure is not just an advocacy position anymore,” says anti-drugging proponent, Vince Boehm. “This is rapidly becoming the order of the day.”

“While the efforts of advocates were crucial in precipitating this amazing shift in public policy,” he says, “our efforts were unwittingly helped by the massive greed of our opponents and the public furor that ensued.”

“Events such as the Biederman scandal at Harvard and other equally disgusting problems of the same proportions have provoked public outrage,” he points out.

Back on June 18, 2008, Dr Bruce Levine, author of, “Surviving America’s Depression Epidemic,” issued a warning in an Alternet commentary. “If those physicians who are not drug-company shills want to save their profession they might want to start taking aggressive actions against their colleagues who are on the take,” he said.

“Perhaps it will help motivate clean physicians to be reminded that history shows that any institution — no matter how large and powerful — can arrogantly cross those lines leading to its demise,” he advised.

On the Health Care Renewal website, Dr Bernard Carroll, former head of Duke’s psychiatry department, says the leaders of the major professional and scientific organizations, like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry, may not be stepping up to the plate publicly because “perhaps they are confounded by the awkward fact” that some of the exposed individuals “are current and past presidents of these very organizations.”

They may also be confounded by the “awkward fact,” that all the medical journals, textbooks and other literature put out by the so-called “professional” groups in the field of psychiatry are filled with ghostwritten infomercials, fraudulently crediting the shills on Grassley’s list as authors, with major universities following their names, and nothing short of a mass book burning event will erase all the false advertising.

About a year ago, Grassley asked eight leading medical journals to describe their policies and practices regarding ghostwriting as part of a “broader effort to establish transparency with regard to financial relationships between the pharmaceutical industry and medical professionals,” according to his July 2, 2009 press release.

In a June 16, 2010, letter to the editor of the Miami Herald, Dr John Nardo, a former faculty member in Emory’s Department of Psychiatry, alluded to this problem while complaining about the fact that the University of Miami has “hired a a chairman for the Department of Psychiatry, Dr. Charles Nemeroff, who has become the poster child for what’s wrong with academic medicine in our country.”

“Nemeroff was relieved of his chairmanship at Emory University in Atlanta for failing to disclose conflicts of interest in his publications and presentations,” he said. “That means that he was a well-paid frontman for a number of drug manufacturers.”

“Now it has been revealed that many of his articles were ghost-written by the drug companies and that he recommended a drug, Paxil, as safe for pregnant women when, in fact, it can cause congenital heart defects in newborns,” Nardo wrote.

“One has to wonder what the people at UM are thinking?” he said. “Or if they’re thinking at all?”

Nardo’s letter is related to the latest scandal, in the seemingly never-ending Charles Nemeroff saga, which now involves the Director of the National Institute of Mental Health, Thomas Insel, who apparently worked behind the scenes to help Nemeroff get hired at the University of Miami, after he was kicked off the chair of psychiatry at Emory, according to a June 6, 2010, article by Paul Basken in the “Chronicle of Higher Education.”

Bernard Carroll, who was Nemeroff’s boss for over 6 years while Nemeroff was a professor at Duke, says Nemeroff probably called in some markers. Because back in 1994, Nemeroff found Insel a position at Emory when Insel was facing nonrenewal of a research job at NIMH. And, in addition to being Insel’s boss at Emory, Nemeroff also lobbied for Insel’s appointment as NIMH director, and soon after Insel moved to the NIMH, he appointed Nemeroff as an advisor, Carroll says.

In a November 5, 2009, press release, UM announced Nemeroff’s hiring and described him as “one of the world’s leading experts in the field of psychiatry.”

Although not a peep was said about his fall from grace or the problems Nemeroff caused at Emory, the release stated: “He moved to Emory in 1991 as chairman of psychiatry. There he took an average department to become one of the top ten in the country.”

On January 4, 2010, Ed Silverman posted a Pharmalot blog under the title, “Charles Nemeroff and the House That Glaxo Built,” with a link to a December 30, 2009, headline for a story by BlockShopper, in South Florida, that read: “Psychiatrist spends $1.91M on Miami 6BD.”

Dr. Charles B. Nemeroff and Gayle Nemeroff bought a six-bedroom, seven-bath home at 1780 Espanola Dr. in Miami from David and Carolyn Shulevitz for $1.91 million on Dec. 4, ” BlockShopper reported.

In addition to pointing out that Nemeroff had taken a new job at UM, Silverman wrote, “the new home appears big enough to house plenty of consulting materials.”

The next day, he informed readers that the first house that Glaxo built for Nemeroff in Atlanta was up for sale at a price of $1.25 million. “This one sports just five bedrooms, but still plenty of room for storing consulting materials,” he wrote.

The Emory investigation found Nemeroff was paid more than $960,000 by Glaxo, from 2000 through 2006, but he listed less than $35,000 on disclosure forms. All totaled, he had earnings of $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million, according to Grassley’s reports.

The real outrage toward Insel stems from the reporting that Pascal Goldschmidt, dean of the UM’s medical school, told Baskin that Insel guaranteed him Nemeroff would be allowed to apply for NIH research grants, even though Emory had suspended Nemeroff’s work on an NIH grant, and in December 2008, placed a 2-year ban on Nemeroff applying for NIH funding. Goldschmidt claimed Emory’s ban “was an immediate reaction to the political pressure that the university was under.”

Further fanning the flames was the Chronicle’s revelations that Nemeroff is serving on the NIH expert panels that help decide “which grant applications win federal financing,” at a time when there is still an ongoing investigation into the NIH’s lack of oversight of Emory and conflicts of interest involving Nemeroff, by the Department of Health and Human Services Office of Inspector General.

After reading Baskin’s article, Grassley fired off a letter to Daniel Levinson, the Inspector General, on June 7, 2010. “I was extremely disturbed to read a story today in The Chronicle of Higher Education,” he told the IG.

“For almost a year,” he wrote, “Dr. Charles Nemeroff has been under investigation by your office for failing to fully disclose his conflicts of interest regarding his grants from the National Institute of Mental Health (NIMH).”

“During this same time, The Chronicle of Higher Education reports that the Director of the NIMH was assisting Dr. Nemeroff in obtaining a new job and made assurances that Dr. Nemeroff would be able to apply for new NIMH grants,” he said. “I ask that you look into this matter and proceed as you deem appropriate.”

On June 7, 2010, Grassley sent a letter to UM president, Donna Shalala, basically stating the same thing except he told her: “I was also troubled by Dr. Goldschmidt’s comments that a ban against Dr. Nemeroff from receiving NIH grants was ‘an immediate reaction to the political pressure that the university was under.”

“President Shalala,” he wrote, “I hope that you would agree — contrary to Dr. Goldschmidt’s views that disciplining researchers for failing to disclose conflicts of interest is merely a political issue — that enforcing federal conflict of interest policy involves ethical and legal issues that ensure taxpayer trust.”

In response to the letter, Grassley asked her to provide “all emails and communications by Dr. Goldschmidt,” regarding Nemeroff’s conflicts of interest and Nemeroff’s work and/or grants with the NIH, and “all emails and communications by Dr. Nemeroff,” regarding the same, along with all conflict of interest forms filed by Nemeroff with UM.

Money Laundering Operation

Dr Daniel Carlat, author of the Carlat Psychiatry Blog, and the new book, Unhinged: the Trouble With Psychiatry, explains that “much of the continuing medical education (CME) industry in the United States is a legalized money laundering operation,” in a June 10, 2008 blog.

“Rather than paying doctors directly to give accredited CME courses (which is illegal), drug companies pay third party companies to create the courses,” he says. “The checks are actually written by the education company, but the ultimate source is clearly the sponsoring pharmaceutical company.”

The Harvard scandal represents the “perfect storm” of the CME industry money laundering operation, Carlat reported on his blog.

It’s clear that “the majority of money received by these doctors did not come directly from drug companies, but indirectly from various third party companies,” he says. “And this is likely the key to the mystery of why the doctors assumed they could ethically hide these payments.”

After going through the list of payments posted in the Congressional Record, Carlat found it appeared that “the vast majority of the money eventually reported by the Harvard Trio, a combined $4.2 million over 7 years, was drug company money that was laundered and processed to seem like it wasn’t drug company money.”

“The most glaring example,” he says, “comes from Dr. Wilens disclosures.”

Grassley posted slightly more than a third of Wilens’ payments ($612,303 out of a total of $1.6 million). Only $69,915 of this (11%) came directly from drug companies. Most of the money ($542,388) came from various third party companies, many, possibly all of which, are CME companies, Carlat reports.

The biggest tool the industry has for off-label promotion is continuing education,” says Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center, involved with a program called PharmedOut, created to educate doctors about the prescribing influences of big drug companies, in the Star-Ledger on June 6, 2010.

“Physicians have freedom of speech and aren’t under the same constraints as industry employees,” she explained.

When drugs are prescribed for off-label or unnecessary uses, public health care programs not only have to pay for the drugs, they must also pay the prescribing doctors’ fees and the cost of medical care for any injuries caused by the drugs.

Government spending tied to psychiatric drugs has gone through the roof in the past two decades due to the bilking of public programs. And no doubt as a result, pharma CEOs are earning over the top pay packages. In 2008, the head of J&J pulled in $29.1 million, Abbott Labs’ CEO took home $28.3 million, the top dog at Bristol-Myers earned over $23 million, Lilly’s CEO pulled down close to $13 million, Pfizer’s took home over $15.5 million, Wyeth’s CEO earned nearly $26 million, and Forest Labs’ top official was paid more than $6.5 million, according to the AFL-CIO’s “Executive Pay Watch” website.

American Psychiatric Association

Early on in his investigation, Grassley asked the “American Psychiatric Association,” for an accounting of money received from drug companies and foundations created by drug companies. In 2006, the industry accounted for about 30% of the Association’s $62.5 million in financing, or about $18.75 million, according to the New York Times.

The 38,000 member APA describes itself as “a national medical specialty society whose physician members specialize in the diagnosis, treatment, prevention and research of mental illnesses.”

The outgoing president of the APA is Alan Schatzberg, the same guy whose name appears on the Grassley list.

The “American Psychiatric Foundation,” is the charitable and public educational arm of the APA, according to its website. In 2009, the Foundation’s 15 member board of directors included four Vice Presidents from the drug companies Pfizer, Eli Lilly, and J&J’s Janssen Pharmaceutica division.

On its website, the Foundation identifies drug companies that donate but does not give the exact amount. For example, AstraZeneca, Bristol-Myers, Lilly, Forest, Janssen, and Wyeth are listed as giving “$40,000 and above.” However, the few grant reports publicly available show drug companies may be giving more than ten times that amount. Lilly donated $450,000 to the Foundation in 2007, in addition to the $400,000 given to the American Psychiatric Association.

The Foundation also received one grant from Lilly for $241,915 in 2009, and another $20,000 donation to fund the Foundation’s Newsletter. The Foundation received $102,961 from Pfizer, and $205,400 from Wyeth, in 2009, as well.

In the first quarter of 2010, the Foundation received grants from Lilly of $36,000, $10,000 and $18,000. Pfizer gave the Foundation $20,000 in the first quarter of 2010.

Pfizer’s 2008 grant report shows donations of more than $700,000 to the American Psychiatric Association. Lilly gave the APA grants totaling more than $600,000 in both the first and second quarter of 2008. Wyeth donated $43,831 in 2008.

Lilly’s 2009 report shows the APA received four grants of $154,575, $142,575, $142,575, and $154,575. Pfizer gave the group $250,000 in 2009.

The American Psychiatric Institute for Research and Education (APIRE), is another philanthropic arm of the APA, established in 1998 “to establish the leadership role of the APA in contributing to the scientific base of psychiatric practice and policy,” with a stated mission to “improve the quality of psychiatric care through research, education, health policy analysis, and dissemination.”

For the March 6, 2010, paper, “Pharmaceutical Philanthropic Shell Games,” in Psychiatric Times, Lisa Cosgrove, PhD and Harold J. Bursztajn, MD investigated the financial relationships of the APIRE board members with pharmaceutical companies that manufacture psychiatric drugs and found 9 of the 16 board members have industry ties.

“The fact that over half of APIRE’s board has financial ties to industry is problematic, and it is noteworthy that this percentage is a highly conservative estimate,” they wrote.

“Current disclosure policies do not require reporting of pooled industry monies (eg, when companies give large sums of money to academic departments, units, hospitals, and medical schools)—even when direct benefit, such as salary, may be derived from pooled funds,” they point out.

In addition, one board member who reported “no disclosure” in an APA publication “was found to be on the speakers’ bureau of multiple pharmaceutical companies,” they note.

The APA is currently revising psychiatry’s billing bible, the DSM-V. “Approximately 68% of the members of the DSM-V task force reported having industry ties, which represents a relative increase of 20% over the proportion of DSM-IV task force members with such ties,” Cosgrove and Bursztajn report.

“Also, of the 137 DSM-V panel members who have posted disclosure statements, 77 (56%) have reported having industry ties, such as holding stock in pharmaceutical companies, serving as consultants to industry, or serving on company boards—no improvement over the 56% of DSM-IV members who were found to have such industry relationships,” they point out.

The APA also issues “Clinical Practice Guidelines,” with recommendations for the use of specific drugs for mental disorders. “Ninety percent of the authors of 3 major clinical practice guidelines in psychiatry had financial ties to companies that manufacture drugs explicitly or implicitly identified in the guidelines as recommended therapies for the respective mental illnesses,” according Cosgrove and Bursztain.

They also found the corporate advisory council of the Foundation “is made up of pharmaceutical companies that contribute significant funding to APF and that manufacture medications recommended in the APA’s CPG.”

On June 11, 2010, the Wall Street Journal reported that the APA “has seen a $7.5 million decrease in pharmaceutical industry dollars over the past year – a more than 10% cut in revenue, which funds its research and education activities.”

“The biggest changes at the APA have come at its money making annual meeting,” the Journal said. “Over the past three years it has been phasing out industry sponsored symposia – dinners and talks.” This translated to a loss of $1.8 million to $1.9 million in industry funding between 2008 and 2009, an APA official told the Journal.

However, according to Martha Rosenberg’s coverage of the group’s annual meeting in a May 31, 2010, Scoop article, although 200 protestors were chanting “no drugging kids for money,” and “no conflicts of interest,” at the convention hall, “polarizing figures” were still present at this year’s event.

For instance, she writes: “Sitting next to outgoing APA president Alan F. Schatzberg, MD, even as protestors chanted outside, was Charles Nemeroff, MD, former psychiatry chairman at Emory University who was investigated by Congress.”

“And a paper presented about attention deficit hyperactivity disorder (ADHD) was co-written by Harvard’s Joseph Biederman, MD, also investigated by Congress for pharma financial links and considered the father of the pediatric bipolar disorder craze,” she reports.

“Nemeroff was signing the Textbook of Psychopharmacology which he co-edited with Schatzberg, also investigated by Congress. Schatzberg, psychiatry chairman at Stanford, consults to seven drug companies, owns stock and patents with others and is on Sanofi-Aventis’ Speakers Bureau according to the meeting’s Daily Bulletin,” she wrote.

National Alliance on Mental Illness

Last year, the National Alliance on Mental Illness became the first patient advocacy group to come under investigation by Grassley’s Committee. In a letter to Michael Fitzpatrick, Executive Director of NAMI, in April 2009, Grassley asked for “an accounting of industry funding that pharmaceutical companies or foundations established by these companies have provided,” to NAMI since January 2005.

“Based upon reporting in the New York Times,” Grassley said, “I have come to understand that money from the pharmaceutical industry shapes the practices of non-profit organizations which purport to be independent in their viewpoints and actions.”

“Specifically, it is alleged that pharmaceutical companies give money to non-profits in an attempt to garner favor in ways that increase sales of their products,” he explained.  

The disclosures provided to Grassley revealed that the National NAMI group receives nearly two-thirds of its funding from the pharmaceutical industry. Between 2006 and 2008, drug companies, and their foundations, gave the group almost $23 million.  

After receiving Grassley’s letter, NAMI’s executive director sent out an email to many NAMI supporters and stated in part: “NAMI does not engage in product promotion, endorsement, licensure or certification of any product, service or program owned by a corporate sponsor.”

However, Philip Dawdy pointed out the falsity of that claim on his Furious Seasons website.

“Fitzpatrick has certainly engaged in product pimpery for J&J/Janssen,” he wrote in his daily blog. To substantiate the “pimpery” charge, Dawdy provided a link to a blog he wrote on December 21, 2006, in response to a J&J press release put out to promote its Risperdal’s me-too drug, Invega, with Fitzpatrick praising the drug using his official title of “Executive Director, National Alliance on Mental Illness.”

“New and efficacious treatment options, like INVEGA, provide significant opportunities for more people with schizophrenia to manage their disease as they work with their treatment teams to live more fulfilling and productive lives,” Fitzpatrick stated in the press release.

In her book, Side Effects, Alison Bass tells a story of how James McNulty, NAMI president from 2002 to 2004, failed to disclose that he was being paid thousands of dollars by drug companies to promote their products to NAMI members, and others, at speaking engagements. “In a particularly intriguing twist,” she notes on her website, “McNulty laundered this drug company money through a state chapter of NAMI.” Bass further explains how the scheme worked for funneling the cash to McNulty:

He would be paid thousands of dollars to speak about the benefits of various antidepressants — McNulty himself suffered from depression — and rather than pay him directly, companies such as Eli Lilly, the maker of Prozac, Pfizer, the maker of Zoloft, and GlaxoSmithKline, which made Paxil, would give his speaking fees to the Rhode Island chapter of NAMI, which would then cut McNulty a check.

On May 8, 2008, when the APA announced the members of the work groups who would develop the DSM5, James McNulty was listed as a task force member with an expert qualification of “President Emeritus,” of NAMI.

Each year, NAMI gives awards to “Exemplary Psychiatrists,” at its annual banquet. In 2008, a May 5, press release reported that “support for the awards” is provided by Eli Lilly and Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

NAMI was named as a defendant, right along with Pfizer, in a Medicaid fraud lawsuit filed by whistleblower, Mark Westlock, involving the illegal promotion of Geodon. Pfizer “conspired” with NAMI to act as a front organization in the off-label promotion of Geodon, the complaint says. Pfizer turned “NAMI into a Trojan Horse for the illegal marketing scheme to promote Geodon,” for use with children on the NAMI website.

Laurie Flynn, the former executive director of NAMI, and current leader of Columbia University’s TeenScreen, even went so far as to claim that with the advent of atypical antipsychotic medicines “the long-term disability of schizophrenia can come to an end,” the complaint alleges.

In addition to Geodon, the drugs currently marketed by Pfizer, through NAMI and the pyramid of front groups, include the antidepressants Zoloft, Nardil, Sinequan, Effexor and Pristiq, Xanax for anxiety, the anticonvulsants, Neurontin and Lyrica, and the anti-smoking drug, Chantix, and the ED drug, Viagra.

In September 2009, the US Department of Justice announced that Pfizer would pay the largest single criminal fine, and largest combined federal and state health care fraud settlement in the history of the DOJ. The company agreed to pay $2.3 billion, with $1.3 billion in criminal fines, “to resolve criminal and civil health care liability relating to fraudulent marketing and the payment of kickbacks,” according to the government’s “Stop Medicare Fraud Website.”

The charges included paying kickbacks to health care providers to “induce them to prescribe,” or “in connection with marketing,” for a list of thirteen drugs that included Geodon, Zoloft, Lyrica and Viagra. The six whistleblowers received a combined total of roughly $100 million for helping the government.

Brian Kenney and Tavy Deming of the Pennsylvania firm of Kenney Egan McCafferty & Young, represented the Geodon whistleblowers. The off-label marketing allegations were first made in a lawsuit filed on behalf of Harrisburg psychiatrist, Dr Stefan Kruszewski.

The antipsychotic was approved only for adults with schizophrenia or acute manic or mixed episodes of bipolar disorder, but Pfizer illegally promoted it for off-label conditions that included depression, bipolar maintenance, mood disorder, anxiety, aggression, dementia, ADHD, obsessive compulsive disorder, autism, PSTD, and for pediatric, adolescent and geriatric patients, according to the complaint.

Less than “5% of the United States population is diagnosed with schizophrenia or bipolar disorder, yet in 2008 Geodon surpassed the blockbuster benchmark of $1 billion in sales,” Attorney Deming reported in a September 2, 2009 press release.

As part of its marketing campaign, Pfizer claimed that Geodon had a safe metabolic profile when compared to other antipsychotics, such as Zyprexa, Seroquel and Risperdal, and urged doctors to switch patients to Geodon. The switching campaign “endangered patients by ignoring or materially understating Geodon’s serious, and even life threatening, side effects,” Attorney Kenney said in the press release.

On September 3, 2009, Kruszewski told the Philidelphia Inquirer that Pfizer sales representatives pushed him to prescribe Geodon to children for such symptoms as anxiety and agitation.

“Pfizer targeted pediatrics and adolescents to expand off-label use and maintained on its payroll an army of more than 250 child psychiatrists nationwide,” Kenney reported in the press release.

“Pfizer regularly paid generous speaking fees to these child psychiatrists to give what were basically promotional lectures about the benefits of Geodon to their peers, who were naturally also child psychiatrists,” he said.

Apparently, NAMI will continue on with business as usual, except now it will disclose the amounts of Pharma gifts. In 2009, NAMI received 84 payments over $5,000 from different sources, according to an April 2010, analysis by John Mack, on his popular Pharma Marketing Blog. Of payments totaling $4,737,610, Mack found $3,836,750, or 81%, came from major drug companies, with the largest amounts coming from antipsychotic makers, including $1,255,000 from AstraZeneca, followed by Lilly with $750,500, and Bristol-Myers giving 506,250. Wyeth’s 2009 grant report shows donations to all NAMI groups totaling $268,000.

In October 2009, Grassley sent letters to all fifty state NAMI chapters asking them to disclose income from pharmaceutical companies and their foundations. On April 26, 2010, Grassley sent a letter to the leaders of NAMI National and included a chart showing the top 10 state chapters receiving the most money from January 2005 to October 2009, totaling $3.84 million.

Also in October 2009, NAMI CEO Fitzpatrick told the New York Times: “For at least the years of ’07, ’08 and ’09, the percentage of money from pharma has been higher than we have wanted it to be,” and promised the industry’s share of NAMI fund raising would drop “significantly” in 2010.

However, NAMI’s grant report for the first quarter of 2010, shows the group received $1,247,128 from drug companies and foundations, or only $2,212 less than the $1,249,340 it received in the first quarter of 2009. So far this year, Lilly gave NAMI groups over $84,000, and Pfizer’s report shows $78,000 went to NAMI groups.   Conspicuously missing from NAMI’s 2010 first quarter report is AstraZeneca, being the Seroquel maker gave the National group $905,000 in the last quarter of 2009. It may be that Astra was too busy rounding up the more than $520 million it agreed to pay the Federal government and State Medicaid programs in April 2010, to resolve fraud allegations related to the off-label marketing of Seroquel.

Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” said Attorney General, Eric Holder, in an April 27, 2010, DOJ press release.

But Astra can’t be hurting financially because in 2008, even though it makes up only about 5% of the world population, the US accounted for over $3 billion of the roughly $4.45 billion in world-wide Seroquel sales. It was Astra’s second-best selling drug that year, behind the heartburn drug Nexium, and the fifth top selling drug in sales overall in the US. The price of Seroquel at DrugStore.com that year was $839 for hundred middle dose tablets in December 2008. By August 23, 2009, the price had increased by $50 to $890 for the same number of pills.

“A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years,” Dr Roy Poses points out on the Health Care Renewal website.

“This was a well thought out marketing campaign that operated on many levels,” said Brian Kenney, one of the attorneys who again represented, Dr Kruszewski, one of two whistleblowers in this case as well, in an April 28, 2010 press release.

“AstraZeneca orchestrated scientific studies, ghost written articles, and the payment of large fees to academic psychiatrists to act as ‘thought leaders’ to promote the drug off label,” he noted.

“The success can be seen in the huge numbers the campaign generated with 4.9 billion in sales in 2009,” Kenney pointed out.

“It’s particularly disconcerting that AstraZeneca successfully co-opted large portions of psychiatric academic community,” he added.

“The manipulation and misuse of Seroquel scientific data to support AstraZeneca’s off-label marketing campaign was the most disturbing aspect of the case to me,” Kruszewski said in the press release. “There were strong indications from AstraZeneca’s earliest clinical trials that Seroquel increased the risk of diabetes and induced profound sedation out of proportion to its weak antipsychotic effects.”

“In the elderly population, they basically marketed Seroquel as an expensive sleeping pill and put hundreds of thousands of patients at risk for serious medical complications, premature cardiovascular disease, pneumonias, and premature death,” he reported.

In addition to paying $520 million, Astra had to enter into a 5-year corporate integrity agreement that requires the company to post information about payments to doctors on its website, which no doubt will include payments funneled through front groups like NAMI, for Continuing Medical Education programs, speaker fees, research grants, and the various awards given out each years.

Because according to the DOJ press release, the government contends that Astra “promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored Continuing Medical Education programs.”

“The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel,” it says. “In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.”

According to a recent report by Jim Edwards on BNET, former NAMI policy director and board member, Jim Dailey, was a paid consultant for Astra’s Seroquel marketing team, and was paid $600, plus airfare and limousine service, to attend one Seroquel consultant meeting in December 2003.

A picture taken at the meeting shows Dailey, along with current NAMI CEO, Fitzpatrick, and Chuck Harmon, NAMI director of corporate relations, meeting with several Astra sales executives. The agenda for the meeting was: Seroquel vision, Role of Advocacy Groups, Increasing role of State/Medicaid with MH issues and MAP initiatives, and Ensuring access for patients.

Edwards explains that “MAP” sometimes stands for “Medication Algorithm Project.” NAMI, along with J&J’s Robert Wood Johnson Foundation, is identified in a Medicaid fraud lawsuit filed against J&J by former federal fraud investigator, Allen Jones, and joined by the Texas attorney general, as participating in off-label marketing schemes to increase the sales of Risperdal, including the “Texas Medication Algorithm Project,” and “Texas Children’s Medication Algorithm Project.”

Latest Plan of Attack

On June 17, 2010, under the headline, “Psychotropic Drug Abuse in Foster Care Costs Government Billions,” Politics Daily reported that the Senate Subcommittee on Federal Financial Management, has asked the Government Accountability Office to look into the drugging of foster care children, who are typically concurrently enrolled in Medicaid.

“The investigators will attempt to account for estimates in the hundreds of millions of dollars of possible fraud arising from prescriptions for drugs explicitly barred from Medicaid coverage,” according to the report.

“Often young patients under state supervision are also prescribed three or four high-risk drugs at a time — all paid for by Medicaid,” it pointed out.

“The GAO is collecting data from Oregon, Massachusetts, Florida, Maryland, Minnesota and Texas, to search for patterns of abuse,” Politics said. “This effort marks the first time suspicion of Medicaid fraud related to psychotropic drugs has been examined at the federal level.”

Alaska attorney, and founder of the Law Project for Psychiatric Rights, Jim Gottstein, told Politics that the increase of antipsychotic use in foster care amounts to “drug companies sacrificing children’s lives on the altar of corporate profits.”

In attempt to put a stop to the rampant off-label psychiatric drugging of foster kids, and other children on Medicaid, in Alaska, Gottstein and PsychRights have filed a Medicaid fraud lawsuit against a number of prescribing doctors, drug companies, pharmacies, and insurance companies in that state.

After learning NAMI was pulling in two-thirds of its funding from Pharma, Grassley sent disclosure requests to over 30 more non-profits.

•  Read Part I, Part II, and Part III.

•  The final part in this series will cover the psychiatric front groups contacted including the Depression and Bipolar Support Alliance, Mental Health America, the National Alliance for Research on Schizophrenia and Depression, Screening for Mental Health, Children and Adults with Attention Deficit/Hyperactivity Disorder, and the National Center for Mental Checkups at Columbia University, or better known as TeenScreen.

•  This series is sponsored by the International Center for the Study of Psychiatry and Psychology

The Psychopharmaceutical Industrial Complex (PPIC) is a symbiotic system composed of the American Psychiatric Association, the pharmaceutical industry, public relations and advertising firms, patient support organizations, the National Institute of Mental Health, managed care organizations, and the flow of resources and money among these groups, according to an October 1, 2009 paper in the Journal of Mental Health Counseling, by Dr Thomas Murray, director of Counseling and Disability Services at the University of North Caroline School of Art.

Murray’s paper draws parallels between cult indoctrination and PPIC techniques and notes the similarities between cult members and mental health consumers who are vulnerable to losing their identities to the PPIC.

The PPIC and “its adherence to the disease model pervades mainstream culture and greatly impacts psychotherapy,” he says. “Consequently, the effects of the PPIC may have resulted in some psychiatric consumers adopting disease-model messages in ways similar to cult indoctrination.”

“Consumer adoption of the disease model can create obstacles to treatment when hope is fundamental,” he advises.

Murray says his most difficult cases “involve clients who have in essence been drawn into the PPIC and have become resigned to the disease model with little sense of empowerment to overcome their emotional problems.”

“These are the consumers who have little self-efficacy and little hope that they have options other than to suffer,” he reports.

“Insurance companies rely on pharmaceuticals to contain costs (and limit psychotherapy sessions), and reimbursement depends on a diagnosis of a diseased brain,” Murray notes.

For psychiatrists, insurance “companies typically encourage short medication visits by paying nearly as much for a 20-minute medication visit as for 50 minutes of therapy,” according to the April 19, 2010, New York Times article, “Mind Over Meds,” by Dr Daniel Carlat, author of the Carlat Psychiatry Blog, and the new book, Unhinged: the Trouble With Psychiatry.

Psychiatrists have become enthralled with diagnosis and medication and have given up the essence of their profession — “understanding the mind,” Carlat reports in his book.

“We have become obsessed with psychopharmacology and its endless process of tinkering with medications, adjusting dosages, and piling on more medications to treat the side effects of the drugs we started with,” he says. “We have convinced ourselves that we have developed cures for mental illnesses … when in fact we know so little about the underlying neurobiology of their causes that our treatments are often a series of trials and errors.”

Back in December 2003, a study in Psychiatric Services on “financial disincentives” for psychotherapy noted that psychiatrists could earn about $263 an hour doing three 15-minute “medication management” sessions, verses about $156 for a 45 to 50-minute therapy session, representing a pay cut of close to 41% per hour for doing therapy only.

The most common excuse given for the high rate of prescribing psychiatric drugs is that talk, behavioral, cognitive or other forms of non-drug treatment cost too much. However, in 2008, more than $24 billion worth of antidepressants and antipsychotics were dispensed. “Such expenditure would employ 240,000 psychotherapists earning an annual income of $100,000 to provide 6 million hours of psychotherapy averaging 25 client-hours a week,” Murray estimates.

These figures do not include what would be possible using the additional revenue generated by the sales of antianxiety, hypnotic, and psychostimulant drugs, he says.

Drug Makers Pay Prescribing Shrinks Top Dollar

Vermont is one of the few states that requires pharmaceutical companies to disclose the money spent on marketing drugs to prescribers each year. In 2009, the report by the state’s Attorney General, showed that during the period July 1, 2007, through June 30, 2008, pharmaceutical companies spent approximately $2.9 million, in a state with a population of less than 609,000, on consulting and speaker fees, travel expenses, gifts, and other payments to or for physicians, hospitals, universities and others authorized to prescribe or dispense pharmaceutical products.

“The greatest amount of expenditures went to psychiatrists as a group, totaling nearly half a million dollars; one psychiatrist received over $112,000, the greatest amount of pharmaceutical marketing dollars spent on any single person,” the report states.

Eleven psychiatrists made the top 100 recipients list with an average payment total of $43,473. Shrinks also received the highest pay in 2007, when 11 earned a total of $626,379, or about 20% of the total payments made that year.

The top five spenders in last year’s report were Eli Lilly, Pfizer, Novartis, Merck and Forest Pharmaceuticals, with $242,730 listed for the promotion of depression medications and $217,983 for ADHD drugs.

Lilly was the top spender in Vermont for 3 years in a row. The company’s psychiatric drug portfolio includes Zyprexa, Prozac, Cymbalta, Strattera, and Symbyax, a combination of Prozac and Zyprexa. A list of drugs in the report shows the most marketing dollars went for Lilly’s ADHD drug Strattera and spending on its antidepressant Cymbalta was second. Forest’s Lexapro ranked fifth and Pfizer’s atypical antipsychotic Geodon was in the thirteenth position.

The drug makers now even have general practitioners wildly writing prescriptions for psych drugs. A study in the September 2009 journal, Psychiatric Services, reported that 59% of prescriptions for mental health drugs in the US are written by family doctors, not psychiatrists.

Drug Peddling in the Military

In a joint project with Northwestern University’s Medill School of Journalism, the Center for Public Integrity reviewed travel disclosure forms filed by Department of Defense personnel from 1998 through 2007, and found the medical industry was the largest sponsor of free travel, accounting for about 40% of all trips.

According to their June 2009 report, “Pentagon Travel,” there were 8,700 trips by DOD personnel paid for by the health care industry, at a price tag of more than $10 million, with sponsors that included drug and device makers as well as health foundations and trade groups often funded by those companies.

“Drug companies and device manufacturers spent about $1.7 million for more than 1,400 trips taken by DOD doctors, medical researchers, pharmacists, and other health care employees over the decade, creating relationships that pose serious conflict of interest issues, according to medical ethics experts,” the Center said in a study summary titled, “Medical Industry Showers DOD with Free Travel.”

“Of special interest to the industry were DOD employees who prescribe, purchase, or recommend the use of drugs or medical equipment,” the Center notes.

DOD’s pharmacy system employees, who can influence which drugs are selected at base pharmacies, took more than 400 trips, worth over $400,000, from medical industry sources, according to the Center’s analysis.

The review found drug companies paid more than $115,000 for trips to destinations that included Orlando, Las Vegas, San Diego, New York City, New Orleans, Paris, and Rome.

Shahram Ahari worked as a sales rep for Eli Lilly in 1999 and 2000, and described how he used free meals, trips, and unrestricted grants to subtly seduce civilian physicians into prescribing Lilly’s drugs. The strategy was to make friends with doctors and pharmacists to get them talking about the drugs and then reward them with additional perks for prescribing the drugs.

“The return on dividends is phenomenal,” Ahari says in the summary. “If it costs them a thousand dollars for a dinner, that’s a [patient’s drug] payment for one month.”

“If they fly you on the Concord to Paris for five grand, even if they get one patient out of it, it’s a lifetime of cash,” he pointed out.

From fiscal year 2000 to fiscal year 2006, the Pentagon’s prescription drug spending more than tripled from $1.6 billion to $6.2 billion, according to an April, 2008 Government Accountability Office report.

The head of the DOD’s pharmaceutical program, Rear Admiral Thomas McGinnis, banned his own staff from going on company-paid trips, but other military pharmacy staff took about 400 trips, the Center points out.

Drug spending hit $6.8 billion in 2008, said McGinnis, and “the GAO expects DOD pharmaceutical spending to reach $15 billion by 2015,” according to the summary.

In a May 19, 2009, report for MSNBC titled, “U.S. military: Heavily armed and medicated, Melody Petersen pointed out that military physicians “can be swayed by the aggressive promotional efforts of the pharmaceutical industry just like civilian doctors often are.”

Military rules limit the handouts doctors can take from drug companies, she says. “A doctor can go to a dinner paid for by a drug company, but the meal’s value can’t be more than $20, and the value of all gifts received from a company over the course of a year can’t exceed $50. ”

However, drug companies find ways to work around the limits. For instance, Petersen reports that when “thousands of military and federal health-care professionals met in November (2008) for the annual meeting of the Association of Military Surgeons of the United States (AMSUS), more than 80 pharmaceutical companies and other health-care firms were on hand.”

“The companies helped pay for that San Antonio event in exchange for the opportunity to set up booths in the convention hall, where sales reps pressed doctors to prescribe their products or to use their medical equipment and devices,” she notes.

The 6-day meeting also included a celebration, she reports, “15 military and federal doctors and other health professionals received awards that included cash prizes provided by various drug companies.”

On March 17, 2010, Navy Times ran the headline, “Medicating the Military,” to report a Military Times investigation that found 1 in 6 service members is on some form of psychiatric drug.

“And many troops are taking more than one kind, mixing several pills in daily “cocktails” — for example, an antidepressant with an antipsychotic to prevent nightmares, plus an anti-epileptic to reduce headaches — despite minimal clinical research testing such combinations,” the Times noted.

The investigation also found that drugs originally developed to treat bipolar disorder and schizophrenia are now commonly used to treat symptoms of post-traumatic stress disorder, such as headaches, nightmares, nervousness and fits of anger.

“It’s really a large-scale experiment. We are experimenting with changing people’s cognition and behavior,” says Dr Grace Jackson, a former Navy psychiatrist and author of the book Drug-Induced Dementia: A Perfect Crime, in the article.

Troops and military health care providers told Military Times that these drugs are also being prescribed, consumed, shared and traded in combat zones, despite some restrictions on the deployment of troops using those drugs.

The Times investigation of records obtained from the Defense Logistics Agency showed $1.1 billion was spent on common psychiatric and pain medications from 2001 to 2009, and the use of psychiatric drugs had increased 76% overall, since the start of the current wars.

Orders for antipsychotics rose by more than 200%, and annual spending more than quadrupled, from $4 million in 2001, to $16 million in 2009. Orders for anti-anxiety drugs and sedatives increased 170%, and spending rose from $6 million to about $17 million. Annual orders of anticonvulsants had a 70% increase, with spending more than doubled, from $16 million to $35 million.

Antidepressants orders had a 40% gain, but an overall decrease in spending, from $49 million in 2001 to $41 million in 2009, due to the arrival in recent years of cheaper generic versions of the drugs.

Collateral Damage

During the same time frame, from 2001 to 2009, the Army’s suicide rate increased more than 150%, from 9 per 100,000 soldiers to 23 per 100,000, and the Marine suicide rate increased about 50%, from 16.7 per 100,000 in 2001, to 24 per 100,000 marines in 2009.

In a June 20, 2009, commentary for Huffington Post titled, “Antidepressants Cause Suicide and Violence in Soldiers,” Dr Peter Breggin, author of Medication Madness: The Role of Psychiatric Drugs in Violence, Suicide, and Murder, dismisses the theory that the increased use of prescription of drugs in the military is a response to increased depression among the soldiers.

“In reality,” he says, “the use of psychiatric drugs escalates when, and only when, drug companies and their minions target new markets.”

“In this case, the armed services have been pushing drugs as a cheap alternative to taking genuine care of the young men and women in our military,” he states. “Instead of shortening tours of duty, instead of temporarily removing stressed-out soldiers from combat zones, and instead of providing counseling — the new army policy is to drug the troops.”

“During Vietnam, a mere 1% our troops were taking prescribed psychiatric drugs,” he reports. “By contrast, in the past year one-third of marines in combat zones were taking psychiatric drugs.”

In Medication Madness, Breggin evaluated more than fifty cases of suicide, violence, mania and crime induced by psychiatric medications, especially the new antidepressants.

Atypical antipsychotics produce a potentially disastrous “metabolic syndrome” that includes elevated blood sugar, elevated cholesterol, elevated blood pressure, and severe obesity, according to Breggin in a 2009 Psychiatric Drug Facts Newsletter.

“They can also cause direct harm to the function of the heart,” he says. “Overall, it’s a prescription for cardiac disease and premature death.”

As far as claiming the increase in suicides is due to increased horrors in the current wars, California neurologist, Dr Fred Baughman, points out: “Who can claim that one war is any more horrible, evil or effecting than another?”

“What jumps out as different about these wars,” he says, “are veterans and soldiers saturated with psychiatric drugs, and kept on the front lines or sent back to the front lines time after time.”

“These frequent, sudden deaths occurring in the military are due to its policy of reckless, anti-scientific, psychiatric drugging,” he warns.

Veterans Dying

“Official figures regarding military “suicides” also have to be taken with a grain of salt,” Baughman says.

In 2008, after reading an article in the Charleston Gazette, titled “Vets Taking Post Traumatic Stress Disorder Drugs Die in Sleep,” Baughman began to investigate veterans dying in their sleep because the deaths did not make sense. “Young men in their twenties do not suddenly die for no reason,” he points out.

He specifically investigated the deaths of four West Virginia veterans who died unexpectedly in their sleep in 2008, including Andrew White, Eric Layne, Nicholas Endicott and Derek Johnson. At the time, Stan White, Andrew’s father, knew of eight such cases in Kentucky, Ohio and West Virginia.

Baughman learned that all four veterans had been diagnosed with PTSD and all were taking the same three-drug cocktail consisting of Seroquel, an atypical antipsychotic, Paxil, an antidepressant, and the anti-anxiety drug, Klonopin.

His investigation determined they did not commit suicide or go into a coma, as a result of an accidental mixed drug overdose, as suggested by the military. “None of the veterans who died in their sleep were drunk, drugged, or overdosed when they went to bed, they all appeared normal,” Baughman says.

Within a year, he had learned of between 70 and 80 more similar cases. “These are undoubtedly sudden cardiac deaths,” he reports, “due to the prescription of antipsychotics and antidepressants.”

“Although antipsychotics and antidepressants have been proven to increase the risk of sudden cardiac death, they are routinely prescribed together, as if no such risk is known,” Baughman warns.

He points to the January 2009 study, Ray et al., which reported that antipsychotics double the risk of sudden cardiac death, and that on March 17, 2009, Whang et al. reported antidepressants, as well, increase the rate of sudden cardiac deaths.

Sudden cardiac death has been defined as the “unexpected natural death” from a cardiac cause. Some studies suggest that 85 to 90% of these deaths result from ventricular tachyarrhythmias and medications may contribute to the risk of these underlying arrhythmias. Ray et al. found atypical antipsychotics increased the risk for arrhythmias.

As of May 24, 2010, by conducting Google searches on the internet, veteran’s wife, Diane VandeBurgt, of Charleston, found 128 deaths of veterans using terms such as “dead in barracks,” “in bed,” “at work station.” Diane’s husband quit taking Seroquel, prescribed as sleep aid as part of his PTSD treatment, after experiencing many terrible side effects.

Andrew White joined the Marines because he wanted to follow in the footsteps of his older brothers. One brother served in the army and the other in the Navy.

Andrew returned from Iraq in September of 2005 and less than two weeks later his brother was killed in Afghanistan. “Andrew had not even emptied his bags when we all had to deal with this loss,” his mother Shirley recalls. Shirley and her husband, Stan, have been on a non-stop mission to find answers for Andrew’s death and the deaths of other veterans.

The soldiers, veterans, and their families deserve the truth about this epidemic of antipsychotic-antidepressant sudden cardiac deaths in the military, Baughman states.

“Most importantly,” he says, “they cannot be allowed to continue to cover up these deaths and dole out psychiatric drug cocktails as they are doing to the exclusion of psychotherapy.”

“The number of Americans on government disability due to mental illness skyrocketing from 1.25 million in 1987 to over 4 million today is an iatrogenic, physician induced epidemic that will only mount in the future,” Dr Baughman says. “The utter, complete fraud based on the fiction of psychiatric diseases has got to stop.”

Invented Diseases

Unlike a medical diagnose that indicates a probable cause, treatment and prognosis, mental disorders are voted into existence by committees representing the American Psychiatric Association, a roughly 38,000 member professional group, that gets to decide what is normal, and what is not, for the more than 300 million other people in the US.

The APA’s “Diagnostic and Statistical Manual for Mental Disorders IV (DSM IV),” contains all the billable mental disorders and amounts to nothing much more than a bunch of checklists of symptoms. The original 1952 version contained just over 100 disorders. By the fourth edition the number had more than tripled to over 350. The DSM5 is due for publication in May 2013.

The DSM is immensely important to drug makers because the FDA will not approve a medication to treat a disorder unless the condition is listed in the manual. For the DSM IV, fifty-six percent of the 170 panel members, and one-hundred percent of the experts involved in writing diagnostic criteria for “mood disorders” and “schizophrenia and other psychotic disorders,” for which medication is standard treatment, had financial ties to the drug companies, according to a 2006 study titled, “Financial Ties Between DSM-IV Panel Members and Pharmaceutical Industry,” in the Psychotherapy and Psychosomatics journal.

The leading categories of financial interest for panel members were research funding (42%), consultancies (22%) and speakers bureau (16%).

The authors of the DSM 5 have agreed to limit their industry income to $10,000 or less per year until the completion of their work. But as Dr J Wesley Boyd, an academic psyhiatrist, pointed out in an April 11, 2009 editorial in the Boston Globe:

Even if these individuals adhere to the stated income limits, how much pharmaceutical funding is being funneled into the authors’ respective departments by way of lectureships, endowed chairs, or sponsored research? And if the authors are free to resume their usual heavier ties to industry after 2012, how can the promise of big payouts later not influence their current work?

In 2003, a group of psychiatric survivors went on a hunger strike in California with the goal of forcing the APA and the National Alliance on Mental Illness to acknowledge that there was no scientific proof for the claim that mental illness was biological in nature. Three weeks into the strike, the APA issued a statement admitting that “brain science has not advanced to the point where scientists or clinicians can point to readily discernible pathologic lesions or genetic abnormalities that in and of themselves serve as reliable or predictive bio-markers of a given mental disorder or mental disorders as a group.”

The marketing strategy in psychiatry is to invent diagnoses out of thin air and call them diseases as a means to prescribe drugs, says Dr Baughman.

“They take entirely normal people and create patients by diagnosing them with fictional diseases,” Baughman says. “It’s a total fraud.”

To validate this point, he tells how he helped a father in Canada, whose son had been diagnosed with multiple disorders, write a letter to Health Canada, an agency similar to the FDA, asking for information on ways to validate a diagnosis of mental illness.

In a November 10, 2008 response letter, Health Canada stated: “For mental/psychiatric disorders in general, including depression, anxiety, schizophrenia and ADHD, there are no confirmatory gross, microscopic or chemical abnormalities that have been validated for objective physical diagnosis. Rather, diagnoses of possible mental conditions are described strictly in terms of patterns of symptoms that tend to cluster together.”

Baughman then wrote a similar inquiry to the FDA Commissioner, and forwarded a copy of Health Canada’s letter. Donald Dobbs, from the Center for Drug Evaluation and Research, consulted with the FDA’s new drug review division, and responded to Baughman’s inquiry by stating: “…they concurred with the response you enclosed from Health Canada. Psychiatric disorders are diagnosed based on a patient’s presentation of symptoms that the larger psychiatric community has come to accept as real and responsive to treatment. We have nothing more to add to Health Canada’s response.”

“The entirely bogus stigmatizing labels are a barcode on the forehead of a child, and once a label gets in a record, it sticks,” Baughman warns. “These children are going to have problems getting health insurance and trouble finding employment.”.

As a neurologist, “I would say that a third to a half of all the patients I saw had no organic disease,” he says. “Now contrast that with a 2002 survey of child psychiatrists, where 91% of the kids were given a drug.”

“It’s not just psychiatry, it’s pediatrics, neurologists, family practitioners, and psychologists all across the country,” he states. “They have all become members of the child drugging establishment.”

An alarming study by researchers from Thomson Reuters and the US Substance Abuse and Mental Health Services Administration reviewed 472 million prescriptions for psychiatric drugs from August 2006 and July 2007, and found general practitioners wrote more than half of prescriptions in two main classes of drugs, 62% of antidepressants and 52% of stimulants. Family doctors also wrote 37% of prescriptions for antipsychotics, and 22% of anti-mania drugs, the study showed.

The researchers were especially concerned over antipsychotics being prescribed by general practitioners. The fact that antipsychotics may be more complex to prescribe, have some potentially serious side-effects, “emphasizes the need to understand the adequacy of care being provided by a GP,” said Tami Mark, director of analytic strategies for the healthcare and science business of Thomson Reuters.

Attack on Child Drugging

The massive drugging of America’s children, particularly poor, disadvantaged children and youth through Medicaid and in foster care, is an unfolding public health catastrophe of massive proportions, according to Alaskan attorney, Jim Gottstein, the leader the Law Project for Psychiatric Rights. Gottstein and PsychRights have made attacking this problem a priority.

In letters to several federal lawmakers in May 2009, Gottstein reported the massive Medicaid Fraud involved in the prescribing of psychiatric drugs to children covered by Medicaid. Copies of the letters were also sent to Kathleen Sebelius, Secretary of Health & Human Services, Kerry Weems, Acting Administrator, CMS, and Joyce Branda, Director of the Department of Justice Commercial Litigation Branch (Frauds).

“The fraudulent activities of drug companies in promoting off-label pediatric use of psychiatric drugs … has begun to be exposed, but the psychiatric drugging of America’s children and youth goes on unabated,” Gottstein advises in the letters.

While preparing the filing of a lawsuit to prohibit the State of Alaska from paying for psychiatric drugs prescribed off-label to children covered by Medicaid in Alaska, Gottstein led an investigation that determined the vast majority of psychiatric drugs prescribed to kids on Medicaid constitute fraud. A tremendous percentage of the prescriptions did not qualify for reimbursement the letters point out:

“For example, no anti-convulsants masquerading as “mood stabilizers,” such as Depakote or Tegretol, have been approved for pediatric psychiatric use or supported by any of the compendia. However, these drugs, especially Depakote, are routinely paid for by Medicaid without any apparent consideration that the practice has been prohibited by Congress.

“With respect to the second generation neuroleptics, no pediatric use of Seroquel, Zyprexa or Geodon is approved by the FDA or supported by any of the designated compendia. Risperdal is approved for very narrow uses, as is Abilify, but even when prescribed for these indications, they are almost always prescribed concurrently with another drug(s), which is not FDA approved or supported by any of the designated compendia.”

In 2007, through a state FOI request, PsychRights found Alaska Medicaid was paying approximately $123,000 per month for anticonvulsants prescribed to kids and $288,000 for second generation neuroleptics for a “total averaging approximately $411,000 per month in improper Medicaid payments in Alaska alone.”

“Extrapolating this to the entire country,” the letters state, “there is over $2 Billion in Medicaid payments for psychiatric drugs to children and youth that Congress has explicitly prohibited.”

“In truth,” Gottstein says, “this is the smallest amount because typically two or more of these drugs are administered concurrently, in what is called polypharmacy, none of which has been approved by the FDA for pediatric use or supported by any of the designated compendia.”

“It is hard to come up with an adjective that adequately conveys the horror this is inflicting on America’s children and youth,” he states. “Suffice it to say that when the country wakes up to the carnage this has caused, it will be recognized as the largest iatrogenic (doctor caused) public health disaster in history.”

In January 2010, PsychRights announced the unsealing of a major Medicaid Fraud lawsuit against psychiatrists, their employers, pharmacies, state officials, and a medical education and publishing company for their roles in submitting fraudulent claims to Medicaid. The complaint was filed on April 27, 2009, under the federal False Claims Act which allows private parties to bring fraud actions on behalf of the Government, but was kept under seal until January 2010. The defendants include more than a dozen child psychiatrists, Alaska officials, health care agencies, and pharmacies.

PsychRights has also developed a streamlined model Qui Tam Complaint for use by interested attorneys around the country. The complaint is drafted for former foster children to bring the lawsuits and receive the whistleblower’s share of the recovery, but anyone with knowledge of specific offending prescriptions, such as parents and mental health workers, can bring suit.

Last fall, Gottstein gave presentations on how to file and conduct these types of cases at the national conventions of the National Association for Rights Protection and Advocacy (NARPA), and the Internation Center for the Study of Psychiatry and Psychology.

While PsychRights is not bringing these cases for the money, such lawsuits represent a tremendous financial opportunity for attorneys to do well by doing good. “These are about as open and shut as cases can get,” Gottstein says, “it is Medicaid fraud to cause or submit prescriptions to Medicaid for reimbursement if they are not for a medically accepted indication. End of story.”

• Read Part I and Part II.

• Part IV of this series will cover the role of Patient Support Organizations in the American Epidemic of Mental Illness)

• This series is sponsored by the International Center for the Study of Psychiatry and Psychology.

In March 2010, the US Department of Health & Human Services Substance Abuse & Mental Health Service Administration Center for Mental Health Services announced $16.5 million in funding for “Mental Health Transformation Grants,” one of SAMHSA’s services grant programs.

“In order to complement but not duplicate the efforts of other CMHS programs, FY 2010 funding for MHTG will focus on services for adults with or at-risk for serious mental illnesses,” the agency noted.

Applications were required to implement evidence-based or best practices that would create or expand capacity to address one or more of five Strategic Initiatives, including: “Prevent mental illness through outreach, screening, and early interventions for adults with early signs of mental illness or who are at risk, and promote wellness through holistic treatment approaches.”

An evidence-based practice, or EBP, refers to approaches to prevention or treatment that are validated by some form of documented research evidence. As an example of a practice that could be implemented, SAMHSA listed under “Prevention and Wellness: Early Intervention,” the “Early Detection and Intervention for the Prevention of Psychosis Program (EDIPPP),” along with a link to its website.

EDIPPP is a national program replicating the “Portland Identification and Early Referral,” or “PIER,” a treatment research program at the Main Medical Center, in Portland, Maine.

On a webpage for PIER on the Center’s Website, under “Project Overview,” it states: “The goals are to improve outcomes and prevent the onset of the psychotic phase of illnesses like Bipolar Disorder, Major Depression, and Schizophrenia.”

“This is the first program in the United States to identify the entire population of at risk young persons and offer them treatment,” PIER said in a September 26, 2005 press release.

EDIPPP was funded through a $14.4 million million grant for the “National Demonstration of Early Detection, Intervention and Prevention of Psychosis in Adolescents and Young Adults,” from the Robert Wood Johnson Foundation, and is “designed to prevent psychosis in teens and young adults,” according to an April 10, 2007, announcement on RWJF’s launch of the program.

“The national program is expanding PIER’s success during the past seven years in identifying and treating young people experiencing subtle and early symptoms that herald the onset of serious mental illness,” a November 2007 report in Behavioral Healthcare, by Dr James Maier, a research psychiatrist with PIER, notes.

EDIPPP works with people between the ages of 12 and 25, with an average age of persons entering the program between 15 and 16.

“Widespread dissemination of this early intervention model throughout the United States offers tremendous hope and optimism for combating some of the most devastating and costly illnesses that can afflict young people and their families,” Maier claims.

The RWJF grant set up additional EDIPPP sites in Sacramento, California; Salem, Oregon; Ypsilanti, Michigan; and Glen Oaks, New York. A site in Albuquerque, New Mexico was added in 2008.

RWJF also funds a booklet for professionals, on how to prevent mental illness with early detection titled, “Recognizing and Helping Young People at Risk for Psychosis: A Professional’s Guide,” which can be downloaded free off the internet.

From the start, PIER has always been primarily funded by RWJF, according to its website. However, on October 13, 2003, Mental Health Weekly reported that the program had received a $3.9 million grant from the National Institute of Mental Health, and a parallel $2 million grant from the Center for Mental Health Services intended for a related program in early identification of non-psychotic disabilities.

In Portland, young people typically are referred to PIER by high school guidance counselors, pediatricians, or other clinicians who attended presentations about PIER’s work, visited the PIER Website, and are familiar with the early warning symptoms that suggest the onset of a psychotic illness, according to the report in Behavioral Healthcare.

Mental Illness According to PIER

In a fact sheet posted to “Dispel the Myths,” the PIER website claims that, “Mental disorders are as easy to diagnose as asthma, diabetes, and cancer.”

“Treatments are effective 60%-80% of the time, success rates that meet or exceed success rates for cutting edge treatment for heart disease,” the sheet states.

“In many cases, PIER does use medications,” the Websites says. “We believe that some of the newer medications effectively improve thinking and combat early symptoms.”

“Research suggests these medications may have a protective effect against changes in the brain that cause mental illness,” it reports.

Under costs, it reads: “For now, services provided by PIER staff are supported by grants. However, if certain medications, medical tests, or neurological assessments are ordered, there will be a charge.”

The PIER program was founded in 2000, by Dr William McFarlane, and after 10 years in operation, on May 28, 2010, the ChangeMyMind website listed only two “case studies and impact stories that illustrate the effectiveness of the Early Detection and Intervention for the Prevention of Psychosis Program.”

Medicated for Life

Virtually every person entering the PIER program is prescribed antipsychotics, such as Risperdal or Invega, marketed by Johnson & Johnson, the parent company of the Robert Wood Johnson Foundation. These prescriptions are off-label because antipsychotics are not FDA approved to “prevent” mental illness in any age group.

An August 2008 article, by Charles Schmidt in Discover magazine, highlighted the PIER program with a byline that stated: “A new mix of therapy and medication may stave off psychosis among teens at risk.”

Schmidt discussed the case of Camila (not her real name), who entered the program in September 2001, when she was 14. “Camila and her family stuck with PIER for the four-year treatment program, which ended formally in 2005, and still keep in touch with counselors there,” he reports.

However, “Camila’s health still hinges on antipsychotic medication,” Schmidt says. “In the summer of 2007 she went off the drugs for a spell and her strange feelings returned.”

He notes that her reliance on antipsychotics raises issues. “On the one hand, it shows that the threat of psychosis hasn’t really been removed, it’s just been held in check.”

“What we hope is that the benefits of treatment will be lifelong,” McFarlane says in the article. “We don’t have any empirical evidence to support that yet, but what we’ve seen is that young people who still haven’t converted to psychosis after about three years of our treatment don’t seem to be at much risk.”

While he suggests that over time, some patients may be able to go off medications, McFarlane acknowledges that PIER hasn’t developed a plan for managing that process, Schmidt reports.

“As to when or if they can go off medication, that’s hard to say,” he told Schmidt. “I think many of our patients don’t feel a need to stop; they certainly don’t feel oppressed by it. At a certain point it becomes a personal choice.”

A fortune can be made from these life-long antipsychotic customers. In April 2010, the price for one box of Invega, at a middle dose, was $1,373 at DrugStore.com. Risperdal went for $788 per 90 pills. The cost was $1,395 for 100 tablets of Abilify. Seroquel cost $997 per 100. One-hundred capsules of Geodon sold for $918 and Zyprexa cost $1,523 for a hundred 10mg pills.

In 2003, McFarlane told Mental Health Weekly that with about 3% of the population at risk for a serious mental illness, Greater Portland could expect about 75 young people to develop a disorder each year.

RWJF Front Group

The founder of RWJF, Robert Wood Johnson, was chairman of Johnson & Johnson for over 30 years, from 1932 to 1963, as a member of the drug maker’s founding family. Throughout the years, the majority of the Foundation’s money has come from investments in J&J stock. RWJF’s board of trustees has always been stacked with the drug company’s executives. For instance, current and past trustees have held positions at J&J such as President, CEO, Vice President, Chairman of the Board, and Treasurer, and have served along side another family heir on the board, Robert Wood Johnson IV.

RWJF is listed in a Medicaid fraud lawsuit, filed against J&J by whistleblower, Allen Jones, a former federal fraud investigator, and joined by the Texas attorney general, as providing funding for illegal marketing schemes to increase the off-label sales of Risperdal, including funding the development of the “Texas Medication Algorithm Project (TMAP),” which required doctors to prescribe the newest, most expensive antipsychotics, antidepressants, anticonvulsants, and ADHD drugs to patients covered by public programs, like Medicaid and Medicare, who were diagnosed with mental disorders, and a nearly identical set of child drugging guidelines known as the “Texas Children’s Medication Algorithm Project (CMAP).”

In addition to Risperdal and Invega, J&J also markets the ADHD drug Concerta, and Topamax, an anticonvulsant.

A May 11, 2005, report by RWJF on the results of the funding of TMAP grants totaling $2,389,581 to the University of Texas Southwestern Medical Center at Dallas and a grant of $353,747 to the Texas Department of Mental Health and Mental Retardation, describes the supposed “Problem,” that led to the creation of the TMAP drugging guidelines as:

In the 1980′s and 1990′s, as pharmaceutical companies began producing new and more efficacious medications to treat people with serious mental disorders such as depression, bipolar disorder, and schizophrenia, the question arose of how to choose the most appropriate treatment options. Concerns about wide variation in prescribing practices by physicians and complaints from consumer advocates about the negative consequences of this variation spurred the creation of evidence-based guidelines and medication treatment algorithms.

The “Contacts” for the grants listed in the report were Dr A John Rush, for the University, and Dr Steven Shon for the state of Texas. Shon was fired in October 2006, after the Texas attorney general determined that J&J had improperly influenced him to make Risperdal a preferred drug on TMAP. In 2008, Rush was added to a list of psychiatric academics who failed to disclose all the payments they received from drug companies, by Senator Charles Grassley, as part of an investigation conducted on behalf of the US Senate Finance Committee, which oversees Medicaid and Medicare spending.

As a main component of the off-label marketing schemes, the lawsuits against the antipsychotic makers allege that the drug companies “seeded” the medical literature with reports and papers purporting to be written by “experts” when they were actually ghostwritten with the names of experts attached after the fact.

In its report on the TMAP grant results, RWJF boasts that: “More than 50 articles on the Texas Medication Algorithm Project have appeared in the Journal of Clinical Psychiatry, Psychiatry Research, Managed Care, Health Services Research, Journal of the American Academy of Child and Adolescent Psychiatry and other peer-reviewed journals.”

“Over the next two years, Project Directors Rush and Shon and their colleagues plan to publish additional articles on other areas of interest,” the report said.

On August 18, 2008, a Dallas Morning News headline read: “Conflict of interest fears halt children’s mental health project,” in reference to the Children’s Medication Algorithm Project. “A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list,” the News wrote.

To date, four of the five atypical makers have settled fraud charges involving the illegal off-label marketing of antipsychotics, including for use with children. Eli Lilly paid $1.4 billion for Zyprexa, Bristol-Myers Squibb’s fine was $515 million for Abilify, Pfizer paid $301 for Geodon, and AstraZeneca just forked out $520 million for Seroquel.

But the fines are merely chocked up to the cost of doing business. For instance, although AstraZeneca paid a whopping $520 million fine, Seroquel had sales of $4.9 billion in 2009, with more than half coming from the US. Overall, antipsychotics were the top-earning class of drugs in the US, in both 2008 and 2009, with sales of $14.6 billion in 2009, according to IMS Health.

J&J is the only atypical maker that has not settled the off-label marketing charges against it — yet. However, two units of J&J “will pay more than $81 million to resolve criminal and civil claims over illegal promotion of the epilepsy drug Topamax,” according to Bloomberg news on April 29, 2010.

Also, over the past 2 months, J&J’s McNeil division has recalled over 40 varieties of child and baby medications after the FDA found massive safety and manufacturing violations at a plant in Fort Washington, Pennsylvania, including formulations of Tylenol, Motrin, Zyrtec and Benadryl. The FDA also found problems with “strength, quality and purity.”

The FDA’s inspection report notes that J&J received about 46 consumer complaints “regarding foreign materials, black or dark specks [in their drugs] from June 2009 to April 2010.” J&J had knowledge of problems since May 2009, which means it was allowing children and infants to ingest potentially poisonous drugs for a year before the product recall took place.

Time Magazine as Promoter

On June 22, 2009, the RWJF website posted a link to download the full text of an article in Time magazine, by John Cloud titled, “Staying Sane May Be Easier Than You Think,” who reported: “The most exciting research in mental health today involves not how to treat mental illness but how to prevent it in the first place.”

“In fact,” Cloud said, “many mental illnesses — even those like schizophrenia that have demonstrable genetic origins — can be stopped or at least contained before they start.”

“This isn’t wishful thinking but hard science,” he claimed.

The article discussed a report by the National Academics, “an organization of experts who investigate science for the Federal Government,” nearly two years in the making, “on how to prevent mental, emotional and behavioral disorders.” A quick check found one of the sponsors of the National Academies to be RWJF.

“The report concludes that pre-empting such disorders requires two kinds of interventions,” Cloud said, “first, because genes play so important a role in mental illness, we need to ensure that close relatives (particularly children) of those with mental disorders have access to rigorous screening programs.”

“Second,” he noted, “we must offer treatment to people who have already shown symptoms of illness (say, a tendency to brood and see the world without optimism) but don’t meet the diagnostic criteria for a full-scale mental illness (in this case, depression).”

“Some prevention programs even prescribe psychiatric medications, including antipsychotics and antidepressants, to people who aren’t technically psychotic or depressed,” Time reported.

“This is a big concern,” Joseph Rogers, founder of the Philadelphia-based National Mental Health Consumers’ Self-Help Clearinghouse told Cloud. “Because, gee, if you miss, you can really do more harm with some of these drugs than good.”

“But those who contributed to the National Academies report say preventing the suffering of people with mental illness is worth the risk of some false positives, partly because of the enormous cost of treating mental illness after it’s struck,” Cloud reported.

The article profiled PIER and McFarlane, who was described as “one of the world’s top authorities on preventing mental illness.”

According to Time, the “National Institute of Mental Health is funding a trial of McFarlane’s work, and while he is still writing up his data for publication, his anecdotal results are promising: most of the kids are so far avoiding a first psychotic episode.”

Preemptive Drugging Unsupported

In a 2008 paper titled, “Atypical Antipsychotic Agents For the Schizophrenia Prodrome: Not a Clear First Choice,” published in the International Journal of Risk & Safety in Medicine, Dr Stefan Kruszewski, a psychiatrist, and Dr Richard Paczynski, a neurologist, both from Harrisburg, Pennsylvania, explain, “Pharmacologic intervention at the earliest stages of suspected psychotic illness is an intuitively appealing concept and a logical extension of the current approach to many other diseases of the central nervous system.”

“However,” they report, “a critical analysis of the results of structured clinical investigations which have explored the use of ATAPs for new-onset psychotic symptoms raises safety concerns and does not support pre-medication in this setting as a preventive strategy.”

“Over the past several years,” the paper states, “a voice has emerged in the international psychiatric community recommending early prescription of the atypical antipsychotic agents (ATAPs) for adolescents and young adults who appear to show signs consistent with a schizophrenia prodrome. Early use is predicated on the possibility that ATAPs may prevent progression to full-blown psychotic illness in this high-risk population. ”

“This trend has been encouraged despite a paucity of data which clearly support the effectiveness of these agents for this indication, and despite evidence of adverse side effects including,” the authors note.

These circumstances prompted their literature review, “focusing on the five published studies that have explicitly addressed the preventative efficacy of the most widely prescribed ATAPs in structured (i.e., non-anecdotal) clinical settings.”

In the summary and conclusion section of the paper, the authors report that the results from the available controlled trials reviewed are in line with several of the conclusions of the naturalistic study by Cornblatt et al. “That is, early prescription of ATAPs to adolescents and young adults seeking medical attention for prodromal psychotic symptoms is associated with high rates of medication non-adherence.”

“Additionally,” they say, “the introduction of ATAPs was not associated with reduction in the rate of conversion to formal psychosis beyond that explainable by chance and/or the introduction of bias secondary to baseline imbalances, inadequate blinding or even differential psychosocial supports.”

“We suggest caution in making any assumptions that justify changes in prescription-writing behavior when it involves patients who are at high risk for developing long-term psychotic illnesses but have never demonstrated sustained psychosis (psychotic illness by DSM-IV criteria),” Kruszewski and Paczynski advise.

“This would include but is not limited to persons with suspected schizophrenia prodrome,” they add.

“Even in the hands of experienced investigators using detailed screening protocols in controlled settings, only one-quarter to one-third of high-risk patients converted to full-blown psychosis,” they report.

“Consequently,” they warn, “if early use of ATAPs continues as a quasi-standard of care for new-onset psychotic symptoms, a large majority of these often young individuals will be exposed unnecessarily to poorly defined but likely substantial risks, including but not limited to obesity, hyperlipidemia, metabolic syndrome, increased rates of type II diabetes mellitus and extrapyramidal syndromes, both acute and chronic.”

“Considerations of safety must come first when the preventative efficacy of these agents remains so poorly defined,” they conclude.

• Read Part I.

• Part III of this series will highlight the Psychiatric Industrial Complex as the driving force behind the American Epidemic of Mental Illness.

• This series is sponsored by the International Center for the Study of Psychiatry and Psychology.

These statistics come from a new book titled, Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America, by award winning journalist, Robert Whitaker, who also authored Mad in America.

For the book, Whitaker reviewed 50 years of outcomes in the medical literature, for adults with schizophrenia, anxiety, depression, and bipolar illness, and the childhood disorders of ADHD, depression and juvenile bipolar disorder, to see whether medications had altered the long-term course of the disorders and whether drugs could bring on new or more severe psychiatric symptoms.

His intent was to assess whether this paradigm of care increased the risk that a person would become chronically ill, or ill with disabling symptoms, he reports in his Mad in America blog, on the Psychology Today website.

“Although we, as a society, believe that psychiatric medications have “revolutionized” the treatment of mental illness, the disability numbers suggest a very different possibility,” he wrote in the April 28, 2010, Huffington Post.

On April 29, 2010, Alternet published an interview with Whitaker by Dr Bruce Levine, with the headline question of, “Are Prozac and Other Psychiatric Drugs Causing the Astonishing Rise of Mental Illness in America?”

The “literature is remarkably consistent in the story it tells,” Whitaker told Levine. “Although psychiatric medications may be effective over the short term, they increase the likelihood that a person will become chronically ill over the long term.”

“In addition, the scientific literature shows that many patients treated for a milder problem will worsen in response to a drug — say have a manic episode after taking an antidepressant — and that can lead to a new and more severe diagnosis like bipolar disorder,” he said. “That is a well-documented iatrogenic pathway that is helping to fuel the increase in the disability numbers.”

During the interview, Whitaker discusses his research on the increase of juvenile bipolar disorder in the US, as an example of how prescribing psychiatric drugs to children can actually cause mental illness.

“When you research the rise of juvenile bipolar illness in this country, you see that it appears in lockstep with the prescribing of stimulants for ADHD and antidepressants for depression,” he reports.

“Prior to the use of those medications, you find that researchers reported that manic-depressive illness, which is what bipolar illness was called at the time, virtually never occurred in prepubertal children,” he explains.

“But once psychiatrists started putting “hyperactive” children on Ritalin, they started to see prepubertal children with manic symptoms,” he reports.

“Same thing happened when psychiatrists started prescribing antidepressants to children and teenagers,” Whitaker says. “A significant percentage had manic or hypomanic reactions to the antidepressants.”

“Thus, we see these two iatrogenic pathways to a juvenile bipolar diagnosis documented in the medical literature,” he states.

The bipolar kids often end up on cocktails of heavy-duty drugs, including antipsychotics such as Zyprexa, Risperdal, Invega, Seroquel, Abilify and Geodon, which cause a host of physical problems and possible cognitive decline over the long term, he told Levine.

“When you add up all this information, you end up documenting a story of how the lives of hundreds of thousands of children in the United States have been destroyed in this way,” Whitaker says.

In fact, he thinks that “the number of children and teenagers that have ended up “bipolar” after being treated with a stimulant or an antidepressant is now well over one million.”

“This is a story of harm done on an unimaginable scale,” he told Levine.

Levine, an author himself of Surviving America’s Depression Epidemic, describes Anatomy of an Epidemic as the “most important book on psychiatric treatment in a generation.”

Role of American Psychiatric Association

In 2006, the 38,000 member strong, American Psychiatric Association, received 30% of their funding, or more than $20 million, from the pharmaceutical industry.

This year’s attendees at the group’s annual meeting last month in New Orleans “had to brave 200 protestors chanting ‘no drugging kids for money’ and ‘no conflicts of interest’ to get into the convention hall,” according to Martha Rosenberg’s May 30, 2010 report in OpEd News.

“If there were a take home message at the APA meeting about the blizzard of ADHD, bipolar and personality disorders threatening adults and children, it was don’t wait,” Rosenberg says. “These dangerous conditions, likened to cancer and diabetes, won’t go away.”

“Thanks to genetic advancements, psychiatric disease risks can now be detected and treated before symptoms surface, said presenters, fostering early treatment paradigms that are pretty Brave New World: People being told they have a disease they can’t feel that needs immediate and lifelong treatment at hundreds of dollars a month or their health will suffer,” she reports.

“Preemptive psychiatric drugging is likely the most dangerous idea that has come along since lobotomy,” warns the prolific anti-drugging activist, Vince Boehm.

As far as drugs, there was no star of the show, Rosenberg says. “The Next Big Thing was not a new drug at all but adjunctive therapy also known as adding existing drugs to existing drugs because they don’t work right.”

“Throwing good drugs after bad, popularized with the antipsychotic Abilify,” she explains, “has only been enhanced by a study in the January JAMA that found antidepressants don’t work for mild depression at all.”

“Antipsychotics are also being “enhanced” by adding drugs to offset weight gain and lethargic side effects,” she reports.

“The pharmaco-fraudulence which has taken over psychiatry today is absolutely breathtaking,” says Dr Nathaniel Lehrman, former Clinical Director of Kingsboro Psychiatric Center, Brooklyn NY.

“There is absolutely no rationale for adding antipsychotics to antidepressants in the treatment of depression other than the hope that somehow the patient will feel better when new medication is added when the old is not enough,” he reports.

Lehrman can think of no medication “which is really specific for anything in psychiatry.”

“The effect of all these medications is largely happenstance,” he says. “If something happens to make the patient feel better while taking a particular medication, the latter will be credited.”

Catalog of Mental Disorders

In January 2010, the APA released a draft for the 5th edition of the Diagnostic and Statistical Manual, or DSM-V, also known as the Billing Bible of psychiatry, with the official definitions of normal and abnormal. Criticisms of the revisions and the task force have been non-stop.

In a March, 2010 analysis in Psychiatric Times, Lisa Cosgrove and Harold Bursztajn reported that approximately 68% of the members of the DSM5 task force had financial ties to the pharmaceutical industry, a 2% increase over the task force members of the DSM4 with such ties.

The draft criteria for “Temper Dysregulation Disorder with Dysphoria,” has specifically come under attack as “one of the most dangerous and poorly conceived suggestions for DSM5,” by Dr Allen Frances, who was chairman of the DSM-IV Task Force, in his “DSM5 in Distress” blog on the Psychology Today Website.

“Apparently, the Work Group was trying to correct excessive diagnosis of childhood bipolar disorder—but its suggestion is so poorly written that it could not possibly accomplish this goal and instead would it would create a new monster,” he advises.

“The ‘diagnosis’ would be very common at every age in the general population and would promote a large expansion in the use of antipsychotic medications, with all of the serious attendant risks,” he warns.

“While trying to rescue kids who are now misdiagnosed as bipolar,” Frances says, “it will undoubtedly open the door to the misdiagnosis of normal kids who happen to be temperamental or in difficult family circumstances.”

The syndrome was first called “severe mood dysregulation (SMD),” but the Childhood Disorders Work Group decided to rename it “temper dysregulation with dysphoria (TDD),” because (a) the new name is more descriptive; and (b) the name of DSM diagnoses does not typically include a denotation of severity, according to the group’s report.

In any event, the prescribing of psychiatric drug cocktails will continue no matter what they end up calling the new disorder. If TDD is a form of BD, “first-line treatment would consist of atypical antipsychotic medication and/or mood stabilizers,” the group states in the report. “On the other hand, if TDD is on a continuum with unipolar depressive disorders, anxiety disorders, and ADHD, first-line treatment would consist of serotonergic reuptake inhibitor antidepressants (SSRI’s) and stimulants.”

In a March 8, 2010 article in Skeptic Magazine, Dr John Sorboro warned that the “folks writing the new DSM-V are even considering a new classification of ‘prodromal’ disorders, which means you may qualify for diagnosis of a mental disorder just based on the hunch of your psychiatrist.”

“Psychiatrists get paid for treating mental illness,” he says. “There is a strong motivation for them to look at things they used to attribute to chronic personality, or just life, and see them as psychiatric illness.”

“These changes have nothing to do with any real definitive science or specific tests that can effectively demonstrate who has a disorder,” Sorbora notes. “It’s little more than psychiatry repackaging people with different labels.”

“Who gets what label has a lot more to do with politics and the economics of psychiatry than it does with any true understanding of the developmental or biologic underpinnings of specific behavior let alone whether we choose to see ‘different’ as ‘disordered,’ he points out.

Sorboro says following the money has led many people to seriously question “the motivations of some of psychiatry’s most prolific researchers who shape how people get diagnosed, what disorder label they are given, and what drugs they are prescribed.”

He notes Senator Charles Grassley’s ongoing investigation to determine the full extent of industry fees paid to psychiatric researchers, and that “some of the biggest names in the business have been accused of misconduct.”

The “biggest names in the business,” identified by Grassley thus far, include Harvard University’s Joseph Biederman, Thomas Spencer and Timothy Wilens; Charles Nemeroff and Zachery Stowe from Emory University; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, the president of the American Psychiatric Association from Stanford University; Martin Keller at Brown University; Karen Wagner and A John Rush from the University of Texas; and Fredrick Goodwin, the former host of a radio show called Infinite Minds, broadcast for years by National Pubic Radio.

“Among all the problematic suggestions for DSM5, the proposal for a ‘Psychosis Risk Syndrome’ stands out as the most ill conceived and potentially harmful,” according to Dr Frances, in his “DSM5 in Distress” blog on the Psychology Today Website.

“This is a clearly the prescription for an iatrogenic public health disaster,” he warns.

“The whole concept of early intervention rests on three fundamental pillars — being able to diagnose the right people and then providing them with a treatment that is effective and safe,” he explains. “Psychosis Risk Syndrome” fails badly on all three counts, he warns.

“The false positive rate would be alarming,” he says, “70% to 75% in the most careful studies and likely to be much higher once the diagnosis is official, in general use, and becomes a target for drug companies.”

“Hundreds of thousands of teenagers and young adults (especially, it turns out, those on Medicaid) would receive the unnecessary prescription of atypical antipsychotic drugs,” he warns.

“There is no proof that the atypical antipsychotics prevent psychotic episodes,” he says, “but they do most certainly cause large and rapid weight gains (see the recent FDA warning) and are associated with reduced life expectancy—to say nothing about their high cost, other side effects, and stigma.”

“Imagine the human tragedies that follow the mislabeling of 70% of children as severely mentally ill, who are then exposed to extremely toxic drugs that induce diabetes, cardiovascular disease, and a host of other severe adverse effects,” warned Vera Hassner Sharav, founder and president of the Alliance for Human Research Protection, in a February 10, 2010 Infomail.

Unnecessary Drugging

“We are going to have an epidemic of young adults with yet-to-be-determined neurological problems due to the long term use of psychotropic drugs,” warns Washington DC psychiatrist Dr Joseph Tarantolo, Board Chairperson of the International Center for the Study of Psychiatry and Psychology.

An epidemic is defined as 1% of the population and there will be far more than 1% injured by these drugs, he says.

Every human being is at risk of becoming “psychotic,” he states. “It has been said that in the Nazi Germany concentration camps psychosis was 100%.”

“Once one agrees that something is universal, one is simply trying to describe the human condition, not make a medical diagnosis,” Tarantolo advises.

Dr Stefan Kruszewski, a graduate of Princeton University and Harvard Medical School, has seen many patients who experienced one or more episodes of psychosis from medications, illicit drug withdrawal, acute stress, metabolic conditions, PTSD or other psychiatric diagnoses, “who recovered and did not re-experience problems later in life.”

In his extensive clinical experience with psychotic individuals, “recovery after psychosis has been the “norm,” not the exception,” he says

“More significantly, and somewhat contrary to the prevailing psychiatric professional view,” he notes, “the overwhelming majority of my clients in who I observed this ‘norm’ did NOT require psychiatric medicines to sustain them.”

“And, many of them who were prescribed antipsychotic medications to ‘thwart’ another psychotic episode fared somewhat worse than those who were not prescribed any combination of antipsychotics and mood stabilizers,” he adds.

Dr Thomas Edward Bratter is president and founder of the John Dewey Academy in Massachusetts, a residential, voluntary, educational-treatment school for gifted but self-destructive adolescents. This drug and medicine-free facility uses compassionate psychotherapy.

Most students arrive at the Academy with multi DSM-IV labels to justify prescribing psychotropic poisons and receiving third party payments, Bratter says, and have been “raped by the pejorative psychiatric cartel.”

He calls the “Psychosis Risk Syndrome” criminal because “such a diagnosis ignores the awesome toxic power of a negative self-fulfilling prophesy which maximizes failure by perpetrating the unproven myth of mental illness.”

“There needs to be a class action against those who would endorse this movement,” he says, and Bratter would gladly testify on behalf of children and adolescents who need to be protected from such a toxic and damaging conspiracy.

Toxicology expert, Dr Lawrence Plumlee, is president of the Chemical Sensitivities Disorders Association, and editor of The Environmental Physician of the American Academy of Environmental Medicine.

The Chemical Sensitivity Disorders Association was established to provide information and support to chemically sensitive people; to disseminate information to physicians, scientists and other interested persons; and to encourage research on chemical sensitivity disorders and minimizing hazards to human health.

Plumlee is concerned about the DSM5 proposal by the Somatic Symptom Disorders Work Group, to change the name of the category “Somatic Symptom Disorders,” to “Complex Somatic Symptom Disorder.”

“The new draft DSM manual proposes that chronic fatigue syndrome, fibromyalgia, and multiple chemical sensitivity are ‘somatiform’ disorders requiring psychiatric consultation,” he says. “It’s the same old story of psychiatry trying to extend its diagnostic labels and drug treatments to new populations.”

This is “an effort by psychiatry to psychiatrize physical illnesses and to try to suppress the complaints of these patients by prescribing psychiatric drugs,” Plumlee says.

“But experience is showing that the psychiatric procedures and drugs are making patients worse,” he advises.

Using psychiatric diagnoses and drugs on diseases of neurotoxicity helps the chemical companies in two ways, he reports. “It fools some people into thinking that poisoned people are crazy, thus getting the poisoners (chemical companies) off the hook,” and two, “it sells more chemicals (psychiatric drugs) to treat those who really need detoxification, not more chemicals in their bodies. ”

• Part II of this series with show how tax dollars are being used to fuel the American Epidemic of Mental Illness

• This series is sponsored by the International Center for the Study of Psychiatry and Psychology.

According to an expert witness report filed in a Georgia lawsuit by Dr Robert Nelson, a former 20-year employee of the FDA and National Institute of Health, “the 1/500 EPS labeling was inaccurate and misleading from the moment the oral dosage form was approved.”

In citing a 2008 study on the causes of TD at a university-based movement disorder clinic, Nelson reports that from 2000-2006, metoclopramide induced TD “was more common than any other cause, accounting for 34.5%” of all cases, or 87 out of 250.

Reglan is approved only for the short term treatment (12 weeks max) of gastroesophageal reflux disease (GERD), in adults who have not responded to other therapies, and for diabetic gastroparesis, for two to 8 weeks.

In the February 2009 letters notifying the drug makers of a need for a black box, the FDA stated, “we have become aware of continued spontaneous reports to the FDA of tardive dyskinesia associated with metoclopramide use. Exposure greater than 12 weeks was evident in a majority of these reports.”

In fact, a telephone survey conducted by then Reglan maker (AH Robins), back in 1985, “found that 38% of Reglan users took the drug for between one and two years and another 46% of Reglan users took the drug for three to six months,” Dr Bob West, a pharmacologist and toxicoligist, says in a report filed in a Louisiana lawsuit.

Devastating Disorder

Tardive dyskinesia is one of the most devastating of all drug-induced movement disorders, according to Dr Peter Breggin, author of about twenty books, including “Medication Madness.”

“The abnormal movements or spasms can strike any of the muscles that are under voluntary control, including muscles of the face, eyes, mouth, tongue, neck, shoulders, arms, legs, hands, and feet,” he says. “Breathing, speaking, and swallowing can also be impaired.”

“Tardive dyskinesia often looks so “strange” or “bizarre” that it is mistaken for a mental illness rather than a neurological disorder,” he notes.

Reglan can also cause uncontrolled muscle spasms (dystonia), Neuroleptic Malignant Syndrome, Parkinsonism, depression, thoughts of suicide, and suicide. Common side effects include feeling restless, sleepy, tired, dizzy, or exhausted, headache, confusion, and trouble sleeping, according to a June 9, 2009, FDA approved medication guide.

Pregnant Women Targeted

Four months after the black box for TD was announced, a New England Journal of Medicine study claimed that Reglan was safe for pregnant women with morning sickness.

The news of the study was sent out to all the media outlets and a massive off-label marketing campaign followed to promote the sale of Reglan to pregnant women, with journalists publishing almost identical talking points.

Reporter, Linda Johnson, put out articles through the Associated Press newswire which resulted in headlines such as, “Study Suggests Drug Is Safe For Morning Sickness,” popping up all over the internet and for major media stories for a couple weeks.

For instance, in a June 10, 2009 article that appeared in USA Today, on Fox and ABC news Websites, and even in the UK’s Guardian on June 12, 2009 Johnson wrote: “For the first time, a large study shows that pregnant women who suffer morning sickness are not risking harm to their babies if they take a certain anti-nausea drug.”

“The result may lead more doctors to prescribe the drug metoclopramide and women to feel less guilty about using it during their baby’s crucial first few months of development, experts said,” she reported. Johnson never mentioned the black box for TD in her articles.

The June 10 headline for the same article on the MSNBC Website read: “Morning sickness drug shown safe for babies.” On June 11, a Johnson article appeared in the Boston Globe and the same story was in the Durango Herald News as late as June 22.

To begin with, running headlines claiming that Reglan is safe based on the NEJM study was misleading and irresponsible because the majority of women, 2,502 out of 3,458, only took Reglan for 7 days, or less, in the first trimester. The average duration of fetal exposure was about a week. Only 164 took the drug for 22 days or more. Plus, the study only looked at harm at birth with no later follow-up on the babies.

There was no mention in the actual study of the black box for TD, or any other adverse effects, that could harm the mom or the fetus. Yet, the Los Angeles Times ran a June 10 story with claims that the “first study of the anti-nausea drug metoclopramide in pregnant women has found that it is safe for both fetuses and mothers.” The Times failed to mention any side effects but included the main talking point that as “many as 80% of pregnant women suffer morning sickness in the first trimester.”

Huge Customer Base

Over four million women give birth each year in the US, according to the CDC. The study reported that between 50% and 80% of pregnant women get morning sickness. Those numbers translate into between 2 and 3.2 million new Relgan customers in the US alone, year in and year out.

The women in the NEJM study took three 10mg tablets per day. The current price of Reglan at DrugStore.com is $182 for 100 tablets. Each pregnant woman could buy 2 or 3 months of Reglan for the first trimester, plus the study notes that nausea and vomiting “can continue beyond the first trimester.” Two months of the drug at a cost of $364, times 2.5 million women, could potentially ring up $910 million each year.

Successful campaign

It sounds like the study’s kick-off will definitely boost sales. “I think that women will be comforted by this,” Dr Keith Eddleman, director of obstetrics at Mount Sinai Medical Center in New York, told Johnson in an AP article. “Most women are reluctant (to take anti-nausea medicine) just because of the stories they’ve heard and the perception that taking something in the first trimester can cause harm.”

“There are very few drugs approved for use in the first trimester of pregnancy,” Dr Jennifer Niebyl, a professor of obstetrics and gynecology at the University of Iowa, told Time Magazine on June 10, 2009.

“But this study could lead to metoclopramide getting approved to treat morning sickness because this is good data with big numbers,” she said. “These findings may change practice and help people to be less hesitant to use the drug.”

Dr Laura Riley, a Massachusetts General Hospital obstetrician and spokeswoman for the Society for Maternal Fetal Medicine, told Johnson women are far more cautious than doctors about medication. “For some who are on the fence, it’ll allow them to take it.”

The chairman of obstetrics and gynecology at St John’s Health Center in Santa Monica, Dr James Moran, told the LA Times that he thinks the findings should be replicated but that he “wouldn’t hesitate to use Reglan at all.”

Infants heavily dosed

Reglan is also marketed off-label to nursing mothers to stimulate breast milk even though the medication guide warns women that the drug “can pass into breast milk and may harm your baby.”

Reglan is also used to treat GERD in newborns, especially premature babies. Any use with infants is off-label. Yet a study in the June 2006, Pediatrics journal titled, “Reported Medication Use in the Neonatal Intensive Care Unit: Data From a Large National Data Set,” found Reglan was one of the 10 drugs reported most commonly for the NICU.

A Medline abstract for a paper in the January 2005, Movement Disorders Journal, reported the “first documented case of tardive dyskinesia in an infant,” developed at 2 months “after a 17-day treatment with metoclopramide for gastroesophageal reflux.”

The “Pediatric Gastroesophageal Reflux Clinical Practice Guidelines,” in the October 2009, Journal of Pediatric Gastroenterology and Nutrition, warn that “Metoclopramide commonly produces adverse side effects in infants and children, particularly lethargy, irritability, gynecomastia, galacctorhea, and extrapyramidal reactions and has caused permanent tardive dyskinesia.”

An infant treated for GERD, born to a mother who took Reglan for morning sickness and to increase breast milk, would undergo triple exposure.

Women Need Warnings

“Women need to be aware of the potential risk Reglan poses to themselves and their children,” according to Roger Drake, the lead Reglan attorney at the California-based Baum, Hedlund, Aristei & Goldman law firm, in cases of persons who developed TD.

Concerns about tardive dyskinesia extend to children and infants, especially babies born prematurely, who may have been treated with Reglan to stimulate their digestive system, Drake reports.

He points out that no studies have been conducted to examine the risk of tardive dyskinesia in babies whose mothers take Reglan, even though the drug makers know that Reglan is used in such circumstances.

The adverse effects for babies are the same as for adults, he says, but infants are more at risk because there are no FDA approved dosing requirements established for the safe use of Reglan with children of any age, much less infants.

Baum Hedlund has two decades of experience representing thousands of injured clients against drug companies.

Roughly 150 suicide cases were settled for an average of about $2 million, and about 300 cases involving suicide attempts were settled for an average of $300,000, according to a December 14, 2009 report by Bloomberg News. Glaxo paid an average of about $50,000 each to resolve about 3,200 cases linking Paxil to addiction problems. The drug giant has also paid about $400 million to end antitrust, fraud and design claims, Bloomberg reports.

All total, Glaxo has paid out close to $1 billion to resolve Paxil lawsuits since the drug came on the market in1992. The company’s provision for all legal matters and other non-tax disputes as of the end of 2008 was listed as $3.09 billion in its annual report.

The first birth defect trial, in over 600 cases filed, resulted in a verdict for the plaintiffs on October 13, 2009, and an award of of $2.5 million in compensatory damages for the the family of Lyam Kilker, who was born with three cardiac birth defects after his mother took Paxil while pregnant.

In the Kilker trial, Glaxo’s lead attorney was King & Spalding partner, Chilton Varner, and Sean Tracey, from Houston, led the family’s legal team.

Andy Vickery, of the Houston firm of Vickery, Waldner and Mallia, is the lead attorney in several Paxil birth defect cases. The first case set for trial is unique in that it involves Delaney Novak, an infant born with heart defects on April 4, 2002, to Laura and Derek Novak, after Laura was prescribed Paxil off label for migraine headaches.

The Novak case is also unique among the Paxil birth defect cases because Delaney’s parents had their insurance with United Healthcare, and Laura was part of the study that Glaxo contracted for, which resulted in the initial warning letter about birth defects in September 2005.

According to Vickery, Glaxo conducted a study on Wellbutrin (bupropion), another antidepressant, after discovering a possible link to birth defects. “The review found no problems with Wellbutrin, but discovered that a significant number of mothers who had been prescribed Paxil (nearly twice as many as those who had not taken the drug) had children born with heart defects,” he says.

Doctors Ra-id Abdulla, David Healy, Shira Kramer and Suzanne Parisian testified as the experts for the plaintiffs in the first trial. All told the jury they believed Paxil caused Lyam’s heart defects. Doctors Abdulla, Healy and Kramer are also expert witnesses in the Novak case.

Ingenix Study in First Trial

The Ingenix study, with lead researcher, J Alexander Cole, was conducted using data from the Ingenix Research Data Mart, containing insurance information from UnitedHealthcare. The study was not supposed to look at Paxil.

During the testimony of several witnesses in the first trial, the jury was shown a February 7, 2003 e-mail in which Glaxo employee, Graham Cottam, stated that he had informed Anne Bell, the project leader for Paxil, about plans to do the Ingenix pregnancy study on Wellbutrin, and “Anne wanted to be sure that we will not be looking specifically SSRIs or Paxil.”

Doctor Suzanne Parisian, a former FDA scientist, testified that the initial 2002 proposal was “to do a large database study for Bupropion in pregnancy.”

There was “nothing that addresses Paxil,” she told the jury. The “procedure had never been designed to specifically look at Paxil.”

But when the data was broken out for Paxil in the original study, it “showed the increased risk and the pregnancy was changed to Category D,” she explained.

The FDA later requested that Paxil be studied, according to the testimony of Glaxo employees and documentation, she said.

The famous neuropyschopharmacologist and professor of psychiatry from Cardiff University in Wales, Dr. David Healy, explained that Glaxo had hopes that the study would show Wellbutrin as an antidepressant that did not cause birth defects and the company could apply to the FDA to have it classified as a pregnancy category B drug instead of a C.

“It would give the message,” he said, “that this of the drugs we have available to use for women of childbearing years, this would be one of the safer ones.”

Healy told the jury that there was “no reason from the scientific point of view why they would not want to also look at Paxil.”

“And this appeared to be the FDA’s view,” he said, “because FDA said, well, you looked at Bupropion, why don’t you look at Paxil, also,” a couple years later.

When asked whether by the year 2003, he could think of any scientific reason not to do a pregnancy study with Paxil, Healy replied, “No, I can’t.”

In fact, Tracey showed the jury an internal company email written by a Glaxo employee two years later in August 2005, around the time that the results on Paxil from the Ingenix study came out, who asked the question: “Why hasn’t the company gathered data on this until now, 13, I think, years after the product was approved?”

In the case of the study on Wellbutrin, there were only 16 reports of birth defects that indicated there was a signal to do the study, Parisian told the jury. While an internal analysis conducted by Glaxo on Paxil in 2000, showed 79 cases of birth defects.

In September 2005, the conclusions of the Ingenix study were: “The use of paroxetine in the first trimester of pregnancy was associated with an increased risk of congenital malformations compared with other drugs.”

“To your knowledge, prior to 2005 did GSK ever do a single epidemiological study to determine whether or not Paxil caused birth defects?” attorney, Adam Peavey, asked Parisian.

“Not that I have seen,” she said.

Ingenix Downside

During the testimony of Dr. Shira Kramer, an epidemiologist, Tracey put up a slide on the Cole paper that was published in 2007.

The paper was on a study conducted by epidemiologists who were employed by Glaxo to do the research, Kramer explained. It was a continuation of the Ingenix study that looked at Wellbutrin and then Paxil. One of the co-authors was Sara Ephross, an employee of Glaxo.

Kramer was asked to explain the importance of the Cole study. “First of all,” she said, “it was a cohort study comparing … people exposed to Paxil … to people who were exposed to other SSRIs.”

“So one very key thing for you to remember is that here the … unexposed group is not people who were not exposed to SSRIs, they were exposed to SSRIs,” she told the jury.

“That’s a very important point,” she said, “because if SSRIs are a risk factor for cardiac defects, birth defects, then the relative risk that will be generated in this study is going to be lower than it normally would if truly people were unexposed to SSRIs.”

“The other thing that is important to keep in mind,” she told the jury, “is that the information was obtained from an administrative claims database called the Ingenix Research Data Mart. ”

“There was no individual, either examination or interviewing of anyone,” she explained. “The information was extracted from administrative claims data that was available.”

“The other thing that’s important,” she said, “is that initially the population that was studied covered the years 1995 to 2002, and then after the fact an additional two years were added to the study.”

“The published results, based on all of the years that were eventually included in this study, were an odds ratio for all cardiovascular malformations related to Paxil exposure of 1.46, which means that individuals who took Paxil were at 46 percent increased risk of their child having a cardiovascular malformation diagnosed at birth compared to individuals who took other, other SSRIs,” Kramer explained.

“In the second odds ratio of 1.68,” she said, “showing a 68 percent increased risk, now we are comparing women who took Paxil either alone or in combination with another SSRI, compared to the other SSRI group, either alone or in combination with other SSRIs, mono- or polytherapy.”

The published study contained an asterisk that said: “An interim analysis performed by Cole, et al, using births occurring between ’95 and 2002 found an odds ratio of 2.0 for the association between first trimester Paxil use and cardiac birth defects.”

Kramer was asked to explain what that statement was referring to. “Initially, the study was designed to include the years 1995 through 2002 with a sampling ratio of controls to cases of 7 to 1,” she said. “That was the protocol.”

“And when that analysis was done, the odds ratio, instead of being 1.46, which ultimately is what was published, was actually higher, it was 2,” she told the jury.

“That means that the exposed group had a risk of a child with a cardiac malformation two times that of the group not exposed to Paxil,” she added.

The odds ration got smaller when the Glaxo researchers, the authors of the study, “added in two additional years of data with a different sampling ratio,” Kramer explained.

It is not appropriate for an epidemiologist to do that, she said, because “you are changing the rules after you look at the data.”

It “really raises the questions as to, are you trying to influence the data,” she noted.

“I can say very clearly,” she told the jury, “that that is not considered to be appropriate conduct, scientific conduct. ”

“What you are supposed to do is set up a study protocol in advance and follow it, and not change it after you have looked at the results,” Kramer explained.

It is not appropriate to find out the results and change it in the middle, she said, “for obvious reasons, it looks like you are manipulating the data to make it come out looking a certain way.”

“And if you want to do an unbiased, fair study,” she told the jury, “the only appropriate plan of action is to develop a study protocol ahead of time, to follow it, and to analyze the results and not to fool with it, not to fiddle with it and not to change it.”

While testifying, Kramer explained the meaning of “underpowering” a study. You need to have “a sufficient number of people in a study in order to test a certain research question,” she said.

“And if you are going to apply statistical tests to the data that you generate,” she told the jury, “you need to have enough people in that study to have generated enough cases of the outcome and you need to have enough people who are exposed.”

“Now, this case,” she said, “we have got a relatively rare exposure to Paxil, we have a relatively rare outcome, which is congenital cardiac birth defects, so you need to study very, very large populations in order to achieve statistical significance at these levels that we have been discussing.”

She said the “investigators, the research team,” dictates the size of the study.

Kramer went over the reasons why the odds ratio in the Cole study might be attenuated, or lower. It’s “very clear that there are certain characteristics of this study that are making this odds ratio probably lower than it really would be given certain characteristics of the study design,” she told the jury.

“One of the them is that the controls are really not unexposed to the SSRIs,” she said. “They are exposed to drugs in the same class.”

We have “observed in epidemiological literature that other SSRIs are associated with an increased risk of cardiac malformations,” she told the jury. “Therefore, it is likely that since that’s the comparison group, we have got an odds ratio in this study that’s lower than it probably would be.”

The second reason was that the analysis only included live births. “So you are missing fetuses who were miscarried,” she said. “And then there are many miscarriages that are due to birth defects.”

“You are missing fetuses that are aborted, electively aborted, because of known cardiac or other congenital malformations,” she told the jury. “You are missing stillbirths.”

And with a follow up for only nine months, she said, “you are missing congenital cardiac defects that aren’t detected until later.”

“So you have got a fairly substantial population that is not really being captured in this study of exposed fetuses,” she pointed out.

Closing Recap

During closing arguments, Tracey reminded the jury about the e-mail with Anne Bell’s statement to make sure Paxil was not included in the Ingenix study, and said: “This document … two years before this child is born, they are affirmatively saying: We do not want to look at Paxil in pregnancy.”

In her closing argument, Varner told the jury: “Now, Mr. Tracey has talked to you about Anne Bell this morning.”

“He has said that GSK would have done anything to avoid looking at the risk for Paxil,” she pointed out.

“Well, ladies and gentlemen,” Varner said, “GSK funded the study that did look at Paxil for the risk and published preliminary findings in August of 2005.”

As soon “as even a possible link emerged in all of 2005, GSK reacted promptly and proactively to notify both FDA and doctors,” she told the jury.

“It went immediately to FDA. It immediately changed its label,” she said. “And it immediately sent out letters to doctors telling them about the changes.”

In his final summation, Tracey told the jury, “I want to talk to you about the Ingenix study because Ms. Varner said something that is very, very important.”

“She said when they found out what she says is August of 2005, within 21 days, they changed the label. Within 21 days, the doctors got the news,” he recounted.

What “she forgets to tell you is that two years prior to this, Anne Bell said, Don’t study the drug,” Tracey told the jury.

“Had they not listened to Anne Bell,” he said, “had they studied the drug in 2003, Michelle David wouldn’t be sitting here because the warning would have gone out like that.”

“We would have been two years ahead of the game,” he pointed out.

“GlaxoSmithKline did not want to study the drug,” Tracey told the jury. “The FDA made them study Paxil.”

“It was not some sort of voluntary we’re just a good drug company trying to get along,” he said. “It was we don’t want to study it and they’re forcing us to study it.”

Paxil Off-Label Promotion

Paxil is not FDA approved for use by pregnant women, so all mothers who gave birth to infants with heart defects received the drug off label. In Andy Vickery’s first case set for trial, Delaney Novak was born with heart defects after his mother, Laura, was prescribed Paxil for migraine headaches, another unapproved use.

Dr. Dee Mangin is an expert witness in the Novak case. Her research and published work has focused on rational prescribing, and the influence of drug company promotion both to physicians and direct to consumers. She submitted a report on October 13, 2009, which outlines Glaxo’s off label promotion of Paxil around the time of Laura’s pregnancy.

In her report, Mangin defines off-label use as the “practice of prescribing drugs for a purpose outside the scope of a drug’s approved label – often an unproven use or one that has not been widely tested.”

“While it is legal to prescribe off label in the United States, it is illegal for companies to promote off label use,” she notes.

“The risks of off label promotion,” she says, “are that it could lead to exposure of patients to the risks of a medicine for no benefit, and furthermore they may be denied other more effective treatment.”

“GlaxoSmithKline from 2000,” Mangin says, “mounted a multifaceted and targeted national promotional campaign that employed explicit strategies designed to promote sales of Paxil in pregnant women and women of reproductive age.”

An exhibit cited in the report from a “Paxil Tactical Marketing Plan in 2000,” states: “New Paxil data with high media interest, hot flash, postpartum, depression, pregnancy, and lactation will position Paxil as the drug of choice for women.”

“One of the known reasons that physicians change their prescribing behavior is as a response to the volume of evidence containing the same message that the physician is exposed to,” she wrote. “The so-called “Carpet Bombing” technique used in the Paxil campaign feeds directly into this.”

“There are a number of strategies companies can use to highlight use for off label conditions including distribution of individual scientific articles discussing the off label indication and use of the drug as well as mentions of off label use by key opinion leaders in continuing medical education,” the report explains.

“In relation to the off label prescribing for migraine,” Mangin says, “there is no evidence of any effectiveness over placebo for SSRIs in migraine prevention.”

Yet a paper titled, “Paroxetine in the Treatment of Chronic Daily Headache,” by Carol Foster, MD, and Jacklyn Bafaloukos, RN, that was distributed to doctors, specifically states: “The dramatic improvement in the patients in our study suggests that paroxetine appears to be a safe and effective drug for the treatment of chronic daily headache.”

“The strategies outlined where reprints about treatment of migraine with paroxetine, large numbers of form letters containing summaries of studies of use in headache were sent to physicians and detailing and providing free samples to physicians likely to treat women with migraine were therefore encouraging use of Paxil and exposure to its risks when in reality it is no more effective in this situation than a sugar pill,” Mangin reports.

Encouragement “of unapproved use for migraine further attempted to expand the market beyond that which was medically justified and likely to lead to unnecessary exposure to the risks of Paxil,” she advises.

In an August 11, 2009 deposition, Laura’s doctor testified that Glaxo sales representatives would commonly leave reprints of articles on off label uses and salespeople did discuss the literature on the off label use of Paxil for migraines with him. One of the sales representatives visiting the doctor at the time stated in a deposition that it was his habit to distribute all such articles.

But most importantly, the doctor said he would not have prescribed Paxil to Laura had Glaxo told him back in 2000, or early 2001, that there was an association between Paxil and birth defects. He further noted that there was no benefit from Paxil that would outweigh the risks of birth defects and that he had not used Paxil in his practice since the Dear Doctor letter warned about birth defects.

Delaney suffers from a septal heart defect. “None of the information from the medical records of the family or their statements on potential genetic, environmental and pharmaceutical causes of heart defects indicates any other factor more likely to have caused her condition than the Paxil exposure,” Mangin points out.”It is clear that if the prescribing doctor had been informed of the risk of heart defects, Laura Novak would not have been exposed to Paxil,” she notes.

In the report’s conclusion, Mangin states: “It is my opinion that this promotional campaign for Paxil was inappropriate given the scientific knowledge and what was known by the company at the time.”

“The degree of comfort with the use of this medication in the reproductive years and pregnancy is likely to be influenced by GSK’s misleading promotional campaign where concerns were minimized, efficacy was overstated, the idea of off label prescribing was seeded for migraine, and lastly the marketing specifically targeted a group at higher risk in terms of safety concerns – pregnant women and women in the reproductive age group,” she reports.

“This Paxil promotional campaign was irresponsible, and potentially disastrous from a public health perspective as it was likely to expose a much greater proportion of the population to these potential harms,” she concludes.

Glaxo’s Phone Book

During closing arguments on October 8, 2009, Tracey told the jury regarding Glaxo: “They have a telephone book full of doctors.”

Referring to an exhibit introduced during the trial, he said: “This is all the doctors that they pay to give speeches on their behalf to push their drug, to sell it, to convince other doctors to prescribe their drug.”

While Healy was testifying, Tracey had him go over some of names of doctors in the book that included Lori Altshuler, Vivian Burt, Lee Cohen, Charles Nemeroff, Jeffrey Newport, Zachary Stowe, Katherine Wisner and Kimberly Yonkers. None of these doctors appeared to testify on Glaxo’s behalf in the trial.

What “they did was aggressively market this drug to women,” Tracey told the jury.

All “these names of people that they ghost-wrote articles for to get the doctors … to sell the drug,” he noted.

Doctor Healy told you that “they altered the prescribing practices in this country,” he recounted. “What they set out to do, they succeeded in doing. They got doctors to prescribe the drug to women.”

“And they did it,” Tracey said, “by having seminars where they would put these doctors, experts in the field, on their payroll, that the doctors would go and listen to, unwittingly knowing what they are really hearing is a marketing campaign.”

In reference to another exhibit viewed during the trial, Tracy said: “This document describes that it worked. When the doctors came out, these are the comments they made after attending these seminars: Will prescribe Paxil to pregnant women. My comfort in treating depression in pregnancy has increased. Treating pregnant patients with confidence. Will feel more comfortable giving Paxil to pregnant women.”

In citing $765 million in the US alone, between 1997 and 2005, Tracey told the jury: “This is the number for over a nine-year period this company spent to convince doctors to sell their drug, to prescribe their drug to women of childbearing years.”

“And they got a heck of a return on it,” he said. “Net. After expenses. Almost 14 billion dollars for a nine-year period.”

“Out of the 700 million dollars they spent trying to sell this drug to people,” Tracey stated, “there is not one shred of evidence in the record about how much money they spent to try to figure out whether it was going to induce birth defects.”

“And as far as I can tell in the record,” he said, “after they bought it, they did one animal study and they didn’t spend another penny.”

“Drug companies frequently hire outside firms to draft a manuscript touting a company’s drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work,” the Associated Press said on August 19, 2009. “Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.”

Between 2000 and 2002, articles from the CASPPER program appeared in five medical journals. On August 21, 2009, Jim Edwards on BNET, described the CASSPER ghostwriting brochure. The document shows that the intent of CASSPER was to flood the market with ghostwritten information, he said. It stated: “Paxil Product Management has budgeted for 50 articles for 2000.”

The trial in Kilker v Glaxo ended on October 13, 2009, with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The family was award $2.5 million.

Ghostwriting 101

The world-renowned neuropsychopharmacologist from the UK, Dr David Healy, testified as an expert witness for the plaintiffs in the Kilker trial.

While testifying, Healy explained the process of ghostwriting to the jury. He said ghostwriting probably began seriously in the 1980s. “It’s where an article appears under the name of usually a fairly distinguished person in the field,” he testified.

But it involves more than just the true author being concealed, he told the jury. “It’s a process where the ghostwriters work for companies who are very good at getting articles into the best journals in the field, like the New England Journal of Medicine, and recruiting some of the best known names in the field to be the apparent authors of the articles.”

“They may come from one of the big named universities like Princeton or whoever, but the actual fact the person who appears to be the author isn’t the true author,” he said. “If you were to read the article, you often don’t get any hints of who the true author of the article actually was.”

Ghostwriting impacts doctors in the real world trying to make decisions on whether to prescribe a drug in several ways, Healy told the jury. For instance, he said, if he was doing his own writing, he “would write an article on the drug, warts and all.”

“But if the article has been written by a ghostwriter working for one of the pharmaceutical companies,” he said, “the chances are the warts are somehow going to vanish.”

“The article will talk about the good aspects of the drug and will leave out the risky issues which are probably the most important things for the practicing doctor to know,” he explained.

If the ghost author comes from an extremely distinguished university, doctors reading the article will think it has to be right, he said. “The simple fact that the article is going to be apparently written by this big named person and appears in an extremely good journal means that most average doctors will think this has to be true,” he told the jury.

It’s not just the case of the doctor who reads the article being deceived, he said. “It’s the fact that the credibility of the institution is and the name is being used to sell the drug, as well.”

Healy came face-to-face with ghostwriting when one of the drug companies offered to ghostwrite his articles, he said. Since then, he has researched the ghostwriting process to assess how common it is.

The assessment found that “at least half, maybe more, of the articles that appear in major journals under the names of the best known people in the field, are ghostwritten when they have to do with pharmaceutical drugs,” he told the jury.

“If they have to do with the drugs that are being sold at the moment, the ones that are fashionable at the moment, then these articles are highly likely to be ghostwritten even when they appear in the very best journals,” Healy said.

Ghostwriting Up Close

While testifying, Healy told the jury that he was familiar with companies that Glaxo hired to ghostwrite literature and put other doctors’ names on it. “I think the leading firm in the field was one called STI,” he said. “This stands for Scientific Therapeutics Information.”

The jury was shown a July 28, 2003, document sent to the Glaxo product manager for Paxil, by Sally Laden, working for STI, which stated: “Thank you for offering me the chance to work with you to write two review articles.”

“This letter summarizes my fees for this project,” Laden wrote. “The safety paper is priced higher because of a greater number of named authors and the anticipated additional work involved in assessing the CR data in progress.”

For the development of the manuscript, and up to five drafts, the price quoted was $12,000. One of the topics for a manuscript was on the safety of antidepressants in breast-feeding.

“The first draft will be the first run through the material,” Healy told the jury. “She will have put the article together laying out the issues, laying out the references, structuring the paper up in the way that the journal she actually expects that this paper is going to go to will want the article structured.”

Draft 2 goes back to Glaxo again and the author, whoever is actually going to put their name on the paper. Then draft 3 goes back to Glaxo and the author for sign-off, and then there will be a final version that goes to the journal, Healy explained. Then draft 5 is revisions from journal reviewers, he said.

He noted that Laden said the safety paper is more expensive because there was going to be more authors. “I should emphasize that more authors here does not mean more authors writing the paper,” Healy told the jury. “It means more names appearing on the authorship line.”

“She has to recruit people and the people whose names are on the authorship line get paid for being authors,” he explained.

Sally Laden’s “name has appeared on a range of different articles that have been produced for GlaxoSmithKline, not just on the issue of giving drugs to women of childbearing years but across the board,” Healy said.

During Healy’s testimony, the family’s lead attorney from Houston, Sean Tracey, introduced the actual manuscript by STI. “This is an article that is going to go to a journal,” Healy said. “It has been authored by Ms. Laden, contrary to what appears there.”

The names Zachary Stowe and Jeffrey Newport appeared on the authorship line. Healy noted that Draft 4 stated: “Final article cover page to be removed.”

“The cover page will be removed,” he explained, “because the journal will treat the article quite differently if they think that the true author is not on the authorship line.”

Healy said the paper was an example of ghostwriting. “It is going to go to a journal called Psychopharmacology Bulletin,” he testified. “And in this particular issue of the journal where this paper later comes out, every paper in that issue of the journal has to do with Paxil.”

The jury was then shown the actual article that was published and it was the exact same article but without Laden’s name on it.

Healy testified that Stowe runs the women’s mental health program at Emory University and publishes on SSRIs and women’s health issues, with publications favorable to Paxil, and also gives seminars and talks for other doctors which outline “how it can be a good thing to treat women of childbearing years with Paxil.”

He was not allowed to tell the jury how much Glaxo had paid Stowe over the last year or two, which was revealed by an investigation led by Iowa Senator, Charles Grassley, as the ranking Republican on the US Senate Finance Committee. The amount Stowe got paid “is not public knowledge where you can show me a document that says it,” the judge said.

However, Stowe’s Glaxo earnings are most certainly public knowledge. A google search in December 2009, with the following three key words in quotes, “Stowe” “GSK” “paid,” brought up 15,800 hits.

On June 10, 2009, in reference to Stowe, the Wall Street Journal reported, “Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women.”

The National Institute of Mental Health said “it is reviewing Stowe’s activities, prompted by a letter from a U.S. Senate committee that said Stowe received $253,700 in 2007 and 2008 for “essentially promotional talks” for the drug maker GlaxoSmithKline,” the June 11, 2009 Atlanta Journal-Constitution reported.

The charts with dates for Stowe’s promotional talks reveal that many times he gave two talks for Glaxo on the same date and made five grand per day, in addition to payment for all traveling expenses. On one date, he billed $96 for meals alone.

For ready reference, the list of academics in the field of psychiatry identified by Grassley’s investigation thus far, as not fully disclosing money from drug companies, includes Joseph Biederman, Thomas Spencer and Timothy Wilens at Harvard; Charles Nemeroff and Zackery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association, from Stanford; Martin Keller at Brown University; Karen Wagner and A John Rush from the University of Texas; and Fred Goodwin, the former host of the radio show, “Infinite Minds,” broadcast for years by National Pubic Radio, before it was thrown off the air.

The supplement to the Spring 2003, Psychopharmacology Bulletin, found online, sure enough shows the ghostwritten paper, “Clinical Management of Perinatal Depression: Focus on Paroxetine,” with the names Stowe and Newport, along with papers by Martin Kelly, Charles Nemeroff, Alan Schatzberg, Karen Wagner, and Kim Yonkers, for a total of fourteen Paxil papers altogether.

Under “Disclosure,” the article ghostwritten by Laden stated: “This work was supported by an unrestricted educational grant from GlaxoSmithKline. Doctor Stowe serves as scientific advisor for and receives research grants from Pfizer and GlaxoSmithKline. He also receives grant support from Wyeth.”

The disclosure that the work was supported with a grant from Glaxo would not tell a doctor reading the paper that it was actually written by somebody else, Healy said.

While testifying, Healy explained that an “unrestricted educational grant, if I were to receive one, it would assume that I am saying things that are relatively favorable to the pharmaceutical company who has given me the educational grant.”

“If I am saying things hostile to the drug,” he said, “I will not get an unrestricted educational grant, although the word “unrestricted” suggests that I should.”

Stowe’s undisclosed income above was from Glaxo alone. In August 2007, he was listed as an author on a study titled, “Atypical Antipsychotic Administration During Late Pregnancy,” in the American Journal of Psychiatry.

According to the disclosure section, Stowe has received research support from Glaxo, Pfizer, and Wyeth, has served on advisory boards for Glaxo, Wyeth, and Bristol-Myers Squibb, and has served on speaker’s bureaus and/or received honoraria from Glaxo, Lilly, Pfizer, and Wyeth.

The second author on the ghostwritten paper, Jeffrey Newport, is the associate director of Emory’s Women’s Program. Newport was also an author on the “Atypical Antipsychotic” study. He has received research support from Glaxo, Lilly, Janssen, the National Alliance for Research on Schizophrenia and Depression, NIH, and Wyeth, and he has served on speaker’s bureaus for Glaxo, AstraZeneca, Lilly, Pfizer, and Wyeth, according to the disclosures.

The next person the jury heard about was Charles Nemeroff. He was also an author on the atypical study. Nemeroff was the Chief of Psychiatry at Emory, until he lost the position last year, Healy told the jury. “He’s possibly best known or was the best known psychiatrist in the United States.”

“He influenced an awful lot of heads of departments, professors of psychiatry, general people within the field of academic mental health, and through them and an awful lot of prescribing doctors here in the U.S. And, indeed, perhaps worldwide,” Healy testified.

A link to “Articles” on the Emory website in mid-2009, brought up roughly 90 studies and papers that include the co-author Nemeroff.

Healy said he believed Nemeroff was one of the founding members of the Paxil advisory board and he participated in continuing medical education seminars with talks on Paxil.

Nemeroff would have been “the key person in producing the kinds of talks with slides that would have been held for large audiences of doctors, and then those slides and talks would have been distributed out to different doctors in the field who hadn’t been at the major meetings as he gave his talk,” Healy told the jury.

During his testimony, Tracey showed Healy a document from a continuing medical education seminar titled, “Fertility, Mood and Motherhood,” and Healy said the material for the seminar was prepared by Glaxo for Nemeroff. It was again supported by an unrestricted educational grant from Glaxo and Nemeroff “was reimbursed for his role in this,” Healy pointed out.

Healy was also not allowed to testify about Nemeroff’s fall from grace at Emory, how much he was paid by Glaxo, or his failure to disclose over a million dollars from drug companies.

Dr Bernard Carroll, a past chairman of the department of psychiatry at Duke University Medical Center, summarized the Nemeroff saga well on the Healthcare Renewal website on November 3, 2008, in writing: “The fallout to date includes his severance from several NIH-funded projects at Emory University School of Medicine, a freeze of NIH funding for a major center grant, and his stepping down from Emory’s chair of psychiatry while an internal investigation proceeds.”

During her cross examination of Healy, Glaxo’s lead attorney, Chilton Varner, presented an exhibit showing a continuing medical education presentation given by Nemeroff.

“Can you see that in this continuing medical education program Doctor Nemeroff says that paroxetine, sertraline, fluvoxamine, (are) not associated with increased risk of teratogenicity or other complications?” she asked Healy.

“Yes, I do,” he replied.

In small print, the disclosure for the presentation showed Nemeroff had received research grants and participated in the speakers bureau and consulted for Glaxo, Eli Lilly, Solvay and Pfizer.

During re-direct, Tracey asked Healy to tell the jury what the actual results of the study that Nemeroff was discussing in the presentation showed, and specifically when Paxil was looked at alone. The results “showed that there was a 1.8-fold increase in the odds ratio of a birth defects to the women who have been taking Paxil during pregnancy,” Healy testified.

“Overall, for this group of drugs there was an increase in risk,” he said, “but specifically for Paxil the risk was greatly increased.”

“And beyond that,” Healy stated, “what isn’t included here in the conclusions, overall there was a — on this group of drugs, there was a doubling of the rate of miscarriages on the drug compared with the rate of miscarriage for the women who are being compared who weren’t on the drug.”

“There was also an increased rate of women going on to voluntarily abortions on the drug,” he added.

One of the lead authors on the study was Gideon Koren. “Doctor, without giving any details,” Tracey asked Healy, “do you know whether Doctor Koren has ties to the pharmaceutical industry?”

“I know he has,” Healy said.

During his opening statement, Tracey told the jury that 1998 was a big year for Paxil because a study came out by a doctor named Gideon Koren, and a researcher named Kulin, that looked at Paxil and two other SSRIs.

The study compared women who took SSRIs, to women who didn’t take any SSRIs, and the number of birth defects in the two groups was the same. “So Doctor Koren concluded that SSRIs appear to be safe,” Tracey said.

“Within, literally within 24 hours,” he told the jury, “GSK’s marketing machine cranked up and they faxed this information to their entire sales force.”

And the sales force took this information and began to use it to sell to women, he noted. “What they didn’t tell anybody was this,” Tracey said. “That when you separated Paxil out from the other SSRIs, you saw that Paxil was causing birth defects, that there was an increased risk of birth defects in this study in these women when you looked at Paxil by itself.”

“That was not in the paper,” he said. “That information was not found out until two years ago.”

While testifying, Healy was barred from telling the jury about Koren’s involvement in one the biggest academic research scandals in history a few years back when he sent vicious anonymous letters to discredit fellow researchers and denied doing so until DNA evidence from postage stamps proved he was lying years later. In September 2003, the Canadian Association of University Teachers reported on the disciplining of Koren in the CAUT Bulletin as follows:

“The Ontario College of Physicians and Surgeons has formally reprimanded University of Toronto professor of medicine Dr. Gideon Koren. He had written anonymous harassing letters about Dr. Nancy Olivieri and three colleagues during Olivieri’s dispute with the Hospital for Sick Children, the University of Toronto and Apotex Inc. He then had lied repeatedly to conceal his responsibility. The college also cited him for additional misconduct, in research.”

The Teachers Association further explained in the Bulletin: “The college’s finding of research misconduct was in relation to a study on a drug to treat a blood disorder in children that Koren and Olivieri had once collaborated on. Olivieri identified risks that the drug was ineffective and caused liver damage, and voiced her concerns despite legal warnings from its maker, Apotex. Koren differed and, contrary to accepted norms, published an article on the drug using data from other researchers, including Olivieri, without their knowledge or consent.”

“Koren had received hundreds of thousands of dollars in funding from Apotex after the company had terminated the drug trials in its efforts to prevent Olivieri from disclosing risks to patients, as well as the hundreds of thousands of dollars in funding he had received during the trials,” the newsletter reported, citing an journal article by the authors of “The Olivieri Report.”

Apotex marketed a generic version of Paxil, or paroxetine.

The penalty had been jointly proposed to the discipline committee through prior agreement between Koren’s attorney and counsel for the college, the Bulletin noted. In its decision, the committee said it was “deeply troubled by this case” and “seriously considered administering a more severe penalty” than that proposed, as it wished “to express unequivocally its condemnation of Dr. Koren’s misconduct.”

Glaxo Money Still Flowing

In a December 14, 2009 report on Pharmalot, Ed Silverman noted that Glaxo had published a list of fees paid out to US healthcare professionals for speaking and consulting services for the three month period of April 1, 2009 to June 30, 2009. “By its own tally, Glaxo paid $14.6 million to approximately 3,700 US docs and other healthcare professionals,” he reported.

Although Glaxo paid out millions of dollars over the years to the doctors discussed in this article, not one of them was called to testify as an expert in the first birth defect trial.

“The FDA’s expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent,” says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.

“Rather than focus on protecting children’s safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children–thereby ensuring that far greater numbers of children will be victimized and die,” according to Sharav.

A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.

On November 17, 2008, on the popular Furious Seasons website, Philip Dawdy reported that Zyprexa had killed 3,455 people between 1997 and early 2008, based on a review of an FDA staff document with a summary of adverse events in the agency’s database.

From 1993 through the first three months of 2008, 1,207 children on Risperdal suffered serious adverse events, including 31 who died, according to a report in the November 18, 2008 New York Times.

The deaths included a 9-year-old child, receiving Risperdal for the unapproved use of ADHD, who suffered a stroke twelve days after starting the drug. At least 11 of the deaths were in children whose treatment was for an unapproved use.

In May 2009, CBS News reported that Risperdal was causing boys to grow breasts due to increased prolactin levels caused by the drug. The news segment featured a boy who was prescribed Risperdal for ADHD, and had to undergo a double mastectomy to remove the breasts.

Philadelphia attorney, Steve Sheller, represents six boys who developed breasts after taking Risperdal, in lawsuits against Johnson & Johnson. Two have had mastectomies.

On June 3, 2009, Medscape reported that findings presented at the American Psychiatric Association annual Meeting, on the preliminary results from the “Metabolic Effects of Antipsychotics in Children” study, “show that 12 weeks of initial antipsychotic treatment was associated with significant mean increases in overall adiposity and percentage of body fat, as well as a decrease in whole-body insulin sensitivity.”

“Further,” Medscape said, “the investigators found antipsychotic treatment was also linked to significant increases in body-mass index (BMI) percentile and fasting plasma triglyceride levels, both clinically available indicators of adverse metabolic changes associated with increased adiposity.”

In terms of live-long health issues: “This is a serious problem,” says Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, and past president of the American College of Cardiology.

“The substantial increase in body fat and increased insulin resistance will almost certainly lead to a higher lifelong incidence of diabetes,” he warns.

“Diabetes is a major cause of heart attack, stroke, kidney failure, blindness, and limb amputation,” Dr Nissen points out.

In an April 2008, editorial, in Psychotherapy and Psychosomatics, titled, “Irrational Healers,” Dr David Healy, author of the new book Mania: A Short History of Bipolar Disorder writes:

For fifty years, the antipsychotics were viewed as too dangerous to use outside secondary care and were largely restricted to those with chronic psychotic disorders where the trade-off between hazards and benefits justified treatment.

Yet now a new generation of possibly even more problematic antipsychotics is being given to preschoolers, in North America, on the basis that they might have a disorder that most of the rest of the world does not believe happens in children.

“FDA officials are ignoring the real world tragedies–drug-induced deaths of children,” Sharav warns.

On June 6, 2009, the Topeca Capital Journal reported on the death of a Kansas toddler, Destiny Hager, and the confirmation by an autopsy that the child died of fecal impaction, after taking Seroquel and Geodon, with “antipsychotic drugs present in concentrations considered therapeutic in adults.”

Child psychiatrist, Vernon Kliewer, diagnosed Destiny with bipolar disorder and prescribed the drugs. State regulators recently “completed a two-year investigation of Kliewer that found the doctor violated Kansas law while treating Destiny and five other children,” the Journal reported.

A September 14, 2007 petition filed by the Kansas Board of Healing Arts, says Kliewer diagnosed Destiny with Bipolar Disorder in March 2006, at 3-years-old, and she died on April 4, 2006.

The petition contains 6 counts and details the prescribing of multiple drugs by Kliewer to six children including two more 3-year-olds, one 4-year-old and two 2-year-olds. In one case, he began treating a child at 2-years-old and between January 2003 and November 2006, prescribed a total of 9 drugs for the girl, including Risperdal, Abilify, Seroquel, and Geodon.

“The doctor negotiated a settlement in February with the Board of Healing Arts that didn’t require him to admit wrongdoing,” the Journal said. “He voluntarily stopped treating patients under age 6.”

The Board placed Kliewer’s medical license on indefinite probation and ordered him to pay $13,079 to cover the investigation expenses, the Journal reported. Kliewer must also have another physician monitor his treatment of bipolar patients.

“Tragically, most physicians have not been trained or encouraged to think rationally about the hazards of monotherapy, let alone polypharmacy in children,” says Dr Grace Jackson, author of Rethinking Psychiatric Drugs: A Guide to Informed Consent and the new book Drug Induced Dementia — a perfect crime.

“Mental health professionals have an ethical duty to inform parents about the potential lethality of drug combinations,” she advises.

On June 5, 2009, Dawdy posted a link to the FDA’s briefing package on Furious Seasons, available to members of the advisory panel, and posted portions of the introduction by FDA psychiatry products chief, Thomas Laughren, including the following comments on side effects caused by the drugs:

“Adverse reactions that can occur with drugs in the class of atypical antipsychotic drugs include, among others, somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms, and tardive dyskinesia.

“These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of possible effects on growth and development,” Laughren noted.

In April 2009, Gabriel Meyers, a 7-year-old Florida boy, committed suicide by hanging in the bathroom of a foster care home. In the last few days of his life: “He was told his mother no longer had visitation rights, that he would probably be going back to Ohio, where he alleged he had been abused; the doctor changed his medication, he changed foster homes and he got a new counselor,” George Sheldon, secretary of the Department of Children and Families, stated in the May 12, 2009 St Petersburg Times.

In the year leading up to his suicide, Gabriel had been on the stimulant drugs Adderall and Vyvanse, the SSRI antidepressant Lexapro, Zyprexa, and Eli Lilly’s Symbyax, a drug containing both Zyprexa and Prozac, recently FDA approved for “treatment resistant” depression.

Gabriel was on Symbyax and Vyvanse when he died and neither prescription had been authorized by either his parents, or a court order signed by a judge, in violation of Florida law. He was listed as being on only Adderall in the Department of Children and Families’ database.

“On six separate occasions, Gabriel’s caseworker, Lawrence Chusid, documented that DCF had “parental consent” for the child’s medications,” according the May 9, 2009, St Petersburg Times.

“But in the hundreds of records in Gabriel’s file released by DCF late last month, there is only one form signed by his mother, Candace, a blanket authorization for medical treatment for her son,” dated June 29, 2008, the Times reports.

The labeling on Prozac and Symbyax, contains a black box warning of an increased risk of suicide in children. Instead of discouraging the concomitant use of these two powerful medications, Lilly has encouraged such practices by “designing its own “combination” capsule which contains both Prozac and Zyprexa,” says attorney, Andy Vickery, of the Houston law firm, Vickery, Waldner & Mallia, who is involved in Zyprexa suicide litigation.

“The actual number and rate of completed suicides for patients in clinical trials on antipsychotic drugs, as submitted to the FDA, is higher on Zyprexa than on any of the other drugs in this class,” he reports.

“Specifically,” he says, “Lilly reported that, of 2500 patients on Zyprexa, there were 12 completed suicides, as compared to none on placebo.”

For several years, a system called the Medicaid Drug Therapy Management Program was supposed to be monitoring the prescribing habits of doctors for children covered by Florida Medicaid. However, Gabriel’s shrink, Dr Sohail Punjwani, had been red-flagged as having “problematic” prescribing practices in every quarter since the monitoring began in 2006.

According to the Miami Herald: “Punjwani defended the use of psychiatric drugs on children, even if they are not approved for such use, saying the lack of approval stems from the reluctance of drug makers and the medical establishment to launch clinical trials on children.”

“The anti-psychotic drugs, he added, are used routinely to treat mood instability and insomnia among children,” the Herald reported.

The doctor told the Herald that he did not even remember Gabriel. On May 12, 2009, the Herald reported that a “lawmaker who chairs a state Senate committee on children has asked the state to investigate the doctor who treated a foster child who killed himself.”

“In separate letters to the Florida Board of Medicine and the Agency for Health Care Administration, state Sen. Ronda R. Storms, a Brandon Republican who chairs the Children, Families and Elder Affairs Committee, requested investigations leading to a “full report,” according to the Herald.

Following Gabriel’s death, DCF Secretary Sheldon directed a review of the files for every Florida foster child to ensure that any child prescribed psychotropic drugs was accurately recorded in the Department’s system. He also directed a verification of the existence of a parental consent, or a court order signed by a judge, authorizing each child to receive such medication.

The results of the review in a May 28, 2009 report indicate: “No record of consent or judicial order was found for 16.2% of the 2,669 children receiving psychotropic medication.”

On December 13, 2006, four-year-old Rebecca Riley died in a Hull, Massachusetts as a result of a drug overdose. At a mere 28-months-old, Dr Kayoko Kifuji, a psychiatrist at Tufts New England Medical Center in Boston, diagnosed Rebecca with ADHD and bipolar disorder, and subsequently prescribed, Seroquel, Depakote, an antiseizure drug, and clonidine, a blood pressure medication.

The medical examiner noted, “Rebecca’s heart and lungs were damaged and found that this was due to prolonged abuse of these prescription drugs, rather than one incident,” according to police reports.

The legal filings show the two other Riley children, ages 6 and 11 at the time of Rebecca’s death, were also diagnosed with bipolar disorder and ADHD, by the same doctor, and kept on the same 3-drug cocktail for years.

Rebecca’s parent have been charged with murder under the theory that they overdosed the child in attempt to sedate her and she did not bring in government disability payments.

On February 7, 2007, the day after the parents pleaded not guilty to the charges, Dr Kifuji entered into a voluntary agreement with the Massachusetts Board of Registration in Medicine to not practice medicine pending an investigation. “The Agreement entered into by Dr. Kifuji will remain in effect until further order of the Board,” the Board’s February 7, 2007 press release stated.

In April 2008, attorney, Andrew Meyer Jr, filed a malpractice lawsuit against Dr Kifuji on behalf of Rebecca’s estate. “This child was subject to mostly telephone prescriptions and a slipshod diagnosis,” he told the Boston Globe on April 4, 2008.

In an editorial titled, “How many more Rebecca Rileys?, in the January 9, 2009 Patriot Ledger, the author of, “From Difficult to Delightful in Just 30 Days,” Dr Jacob Azerrad, wrote: “To diagnose a 2-year-old as bipolar by adult standards is crazy.”

“A key issue is the misuse of psychiatric diagnostic labels to explain bad behavior in children,” he wrote. “This has resulted in the drugging of young children to a degree unprecedented in our history.”

“Our preschool children are far too young to defend themselves,” he said. “It’s up to parents to “say no to drugs” and teach their children that life is meant to be learned and experienced – it’s not just a pill to be swallowed.”

On March 5, 2009, Weymouth News reported that a “psychiatrist who prescribed drugs for the late Rebecca Riley, who was four at the time of her death, can be charged with malpractice.”

“A Suffolk County tribunal determined on March 5 that there was enough evidence to charge Dr. Kayoko Kifuji,” the News noted.

“Rebecca Riley’s doctor now the target of a grand jury,” was the headline in the May 1, 2009 Patriot Ledger. “Already the target of a civil medical malpractice lawsuit, the psychiatrist who prescribed the drugs that killed 4-year-old Rebecca Riley is now the subject of a grand jury criminal investigation,” reporter Lane Lambert wrote.

“If the grand jury does find the … psychiatrist criminally liable for Rebecca’s death, she could face involuntary-manslaughter charges,” Lambert noted.

Evidence of the grand jury investigation surfaced “amid fresh legal action in both the civil and criminal cases,” Lambert said. “Kifuji’s lawyers asked a Suffolk County judge to postpone her deposition in the civil case indefinitely, and close the entire court record to the public.”

Kifuji’s attorney “said a deposition would force the doctor to claim her Fifth Amendment right not to incriminate herself while the grand jury was looking at the case,” according to the report. The judge denied both motions, it noted.

An attorney for Rebecca estate said Kifuji is scheduled to give a deposition in the civil case on July 6, 2009, after the grand jury is finished. In the March 5, Weymouth News article, Kifuji’s attorney said the murder charges against the Rileys make it difficult to decide if she can be faulted for Rebecca’s death.

“This is not something bizarre that she (Kifuji) did,” he said. “A number of fine doctors feel this was appropriate.”

Back on September 30, 2007, Katie Couric interviewed Dr Joseph Biederman, whose research Dr Kifuji has said influenced her, in a 60 Minutes segment tiled “What Killed Rebecca Riley?”

When questioned about the rise in young children with bipolar disorder, Biederman told Couric: “The average age of onset is about four.”

“It’s solidly in the preschool years,” he stated.

The results of an investigation led by Senator Charles Grassley, on behalf of the Senate Finance Committee, revealed that between 2000 to 2007, Biederman earned at least $1.6 million from drug companies but failed to report at least $1.4 to Harvard University.

On February 26, 2009, Biederman was questioned under oath in a deposition for litigation titled, In re Risperdal/Seroquel/Zyprexa Litigation, Case Code 274, Alma Avila as next fried of Amber Avila versus Johnson & Johnson Company et al, in the Superior Court of New Jersey, Middlesex County.

At one point, when questioned about his participation in medical education events as a paid speaker, he blamed a decline in invitations to speak over the past year on Grassley’s investigation and inferred that the investigation was brought on by media hype over Rebecca’s death.

When asked if he had any idea why he received fewer invitations, Biederman said: “There has been some accusations by Senator Grassley about issues of conflict of interest; and while the investigation is going on, I agreed not to speak.”

“What is the nature of Senator Grassley’s investigation of you?” attorney, Fletch Trammell, asked.

“Senator Grassley read, there was an article in The Boston Globe about a little girl in town that the parents are accused of first-degree murder,” Biederman noted.

“In fact, you may have seen it,” he told the attorney.

“The accusation has been upgraded from second-degree to first-degree murder,” he pointed out.

“But because the child was diagnosed with bipolar illness, it captured the imagination of the media and there was an article in The Boston Globe that talked about the diagnosis and how controversial that is and particularly as it pertains to preschoolers,” Biederman continued.

“And in the article the reporter got — I sent my standard disclosure forms, so he wrote that I have extensive relationships with fifteen or so pharmaceutical companies,” he stated.

“So Senator Grassley wrote a letter to the institution, to Harvard and Mass. General, asking for details,” he said. “And that has been the cascade of events.”

“So Senator Grassley became interested in you because of these people who were accused of killing their kid?” the attorney asked Biederman.

“Senator Grassley claims to be interested in issues of conflict of interest and is interested in making sure that the universities have tight conflict-of-interest rules,” Biederman said. “I have no dispute with that.”

“What interactions have you had with Senator Grassley or his staff?” the attorney asked.

“None,” Biederman stated. “Senator Grassley’s interactions are with Mass. General and with Harvard, not with me directly.”

Biederman said the hospital was paying a law firm to represent him in the matter of Grassley’s investigation and for the deposition.

He acknowledged having a professional relationship with Janssen, Eli Lilly, Bristol-Myers Squibb, AstraZeneca and Pfizer, the makers of atypical antipsychotics. “I have a professional relationship with dozens of manufacturers,” Biederman said.

“In the course of carrying out these relationships with all these drug manufacturers, does the relationship always involve them giving you money?” the attorney asked.

“Most of the time,” Biederman replied.

On March 27, 2009, the New York Times reported that, “Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.”

The researchers, Doctors Joseph Biederman, Thomas Spencer and Timothy Wilens “are named in the subpoena, which was sent … to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines,” the Times noted.

Up until June 10, the researchers and doctors in the field of psychiatry identified by Grassley’s investigation included Charles Nemeroff from Emory University; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association, from Stanford University; Martin Keller at Brown University; Karen Wagner and Augustus John Rush from the University of Texas; and Fred Goodwin, the former host of the radio show, “Infinite Minds,” broadcast for years by National Pubic Radio.

But on June 10, the name Zachary Stowe was added to the list, with a Wall Street Journal headline: “Emory Psychiatrist Cited in Conflicts of Interest.”

“Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women,” the Journal wrote.

Stowe is the director of the “Women’s Mental Health Program” at Emory. Its website says the focus his “clinical research is the use of psychotropic medications during pregnancy and lactation, the psychobiology of mood disorders during pregnancy and the postpartum period, and the impact of maternal mental illness on fetal and neonatal exposures.”

The latest off-label marketing scheme in the works involves federal legislation expected to come up for a vote soon in the US Senate called the Mothers Act. This one involves a plan to screen all pregnant women for a long list of pregnancy related “mood” and “anxiety” disorders.

After covering the Pharma’s off-label marketing schemes using mental illness screening scams since mid-2004, beginning with TeenScreen, the Mothers Act is no different than the others, aside from the fact that a whole new treatment industry was built up around it, and more profiteers are involved. But then, Pharma could hardly expect to keep selling drugs through middle-man pushers forever, while keeping the massive profits to itself.

Amy Philo, the leader of “Unite for Life,” a coalition of 50 groups against the bill, warns that the Mother’s Act is: “Trolling for Mental Patients in a Maternity Ward Near You.”

“If you’ve never been ‘Teen Screened’ in high school, quizzed by a college counselor about your potential perfectionism, mood swings, or alcohol use- or told you might go crazy if you don’t start taking drug x, consider yourself among the fortunate, fading few,” Amy advises.

“Imagine yourself pushing a baby into the world in a hospital somewhere in America,” Amy says, “only to be greeted by a friendly, neighborhood-psychological-screener the very moment baby begins munching down on his first meal.”

“Would either of you like a DSM-IV Mental Disorder diagnosis code with that milk?”

With no psychiatric drugs FDA approved as safe for use by pregnant and nursing mothers and doctors rightfully reluctant to prescribe any drugs harmful to the fetus, a new customer recruitment scheme was needed and the Mothers Act fit the bill.

Opposition to the Act stems from the certainty that it will lead to more forced drugging of infants with no voice of their own to prevent it, with antidepressants, antipsychotics, and antiseizure drugs that cause birth defects, a withdrawal syndrome and many other serious health problems, through pregnant and nursing mothers.

The Act is modeled after a mandatory screening law enacted in New Jersey, the home state of the bill’s main sponsor, Senator Robert Menendez, and also the home state for many drug companies. Attempts to pass the federal version have failed for the past 8 years.

The postpartum websites strung out all over the internet to promote the bill, many run by people benefiting financially from the new treatment industry they created, argue that the Act does not call for mandatory screening, without mentioning that the screening language was removed last year due to strong opposition.

“There is NO MANDATED screening,” Susan Stone wrote in a blog on the website for her treatment center, PerinatalPro, on May 29, 2009.

On May 12, 2009, the Herald News reported that the Act “lacks one vote for approval” in the US Senate, citing a speech made by Menendez, during a press conference. Menendez told the Herald that the national bill would not mandate screening. “Hopefully, states would adopt screening,” he said.

This statement, in May of this year, clearly shows that the goal of passing the federal legislation is to set the stage for states to pass mandatory screening laws, like the one in New Jersey.

A June 16, 2006, press release, by Menendez and Senator Richard Durbin, announcing the bill stated, the “Act was introduced in response to a recently passed, first-of-its-kind New Jersey law requiring doctors and nurses to educate and screen expectant mothers about PPD.”

The Theraurus on my computer lists “require” as an alternate word for “mandatory.”

On June 8, 2009, New Jersey.com ran the headline: “E-mail: Drug lobbyist targeted Menendez to help with importation bill,” and reported that the subject line of the email said: “URGENT”

The email called for New Jersey drug companies to ask Menendez to be their champion on an amendment that would effectively kill any attempt to allow cheaper drugs to be imported from other countries, according to the report.

“We need to locate a Democratic lead cosponsor for the second degree amendment,” the e-mail said.

“Can … [Johnson & Johnson], Merck, Novartis, Pfizer and the other New Jersey companies coordinate and contact Senator Menendez’s office and ask him to take the lead?”

The strategy to pursue Menendez became known when the email from the Pharmaceutical Research and Manufacturers of America, the industry trade group, ended up with Senator John McCain, a drug importation advocate. “And McCain read it on the Senate floor – twice,” the article notes.

“Menendez’s office said that while he supports the drug companies’ position, he did not act as their champion,” according to New Jersey.com.

The Mothers Act refers to “entities,” as being eligible for grants and participating in research and the development of screening methods and treatments and delivery.

The bill states: “The Secretary may make grants to eligible entities for projects for the establishment, operation, and coordination of effective and cost-efficient systems for the delivery of essential services to individuals with a postpartum condition and their families.”

Under definitions, it says the term ‘eligible entity’– “means a public or nonprofit private entity;” and “includes a State or local government, public-private partnership, recipient of a grant under section 330H (relating to the Healthy Start Initiative), public or nonprofit private hospital, community-based organization, hospice, ambulatory care facility, community health center, migrant health center, public housing primary care center, or homeless health center.”

“Lawmakers have not specified what constitutes an “entity” so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing,” according to Kelly Patricia O’Meara in May 7, 2009 article, “Stress Testing the Mothers Act.”

“Where is the guarantee that the “entities” are not pharmaceutical front-men?”, she writes.

“Given that this research will be used to develop questions or tests for screening new mothers for possible mental disorders, one might find it important to know that the research has integrity and has been validated by the scientific community, free of pharmaceutical largesse,” O’Meara points out.

The Act also calls for a “a coordinated national campaign to increase the awareness and knowledge of postpartum conditions.” Activities under such a campaign may– “include public service announcements through television, radio, and other means;” which will basically provide the new pregnancy-related treatment industry with a tax-payer funded mass advertising campaign.

It would be interesting to know whether “entities” would include the treatment centers owned by Susan Stone and Karen Kleiman, and whether their programs would be eligible for funding. At the “Postpartum Stress Center,” Kleiman teaches seminars for professional training with ads on her website and the heading: “Become an Expert in the Treatment of Postpartum Mood Disorders.”

The first sentence in “Highlights” for this training states: “This is a crash course on diagnosis, screening, assessment, treatment options.” The fee is $750 for a 10-hour course, but they do throw in a book titled The Postpartum Stress Center’s Guide to Enhancing your PPD Private Practice: A checklist for successful practice, for the $750.

For this gig alone, Karen could make $7,500 per seminar by simply recruiting 10 trainees. Nearly all the websites pitch in to promote conferences and seminars, so rounding up 10, or even 20, trainees would likely not be too difficult.

The website shows 4 seminars a year, meaning Karen could earn roughly $30,000 for 40 hours of teaching people how to “Become an Expert.” And if she could round up 20 trainees per class, she could make $60,000 a year, putting her up there with all the other highly paid speakers within the new industry.

In her May 29, 2009 blog, Susan mentions how the Act might help fund “inpatient maternal mental health” programs all across the US. “Just this morning,” she says, “I completed an interview with Parenting Magazine, which plans to feature an article about the nation’s first inpatient maternal mental health unit at UNC, Chapel Hill, NC, as well as focus on the federal legislation and how this bill might help fund other such programs across the country.”

Many sites provide links to “experts” and treatment programs. For instance, Katherine Stone runs “Postpartum Progress,” and in December 2008, she had links to the “Top Women’s PPMD Treatment Programs & Specialists.”

The first program on the list was Dr Stowe’s at Emory, which primarily focuses on “the evaluation and treatment of emotional disorders during pregnancy and the postpartum period,” the website states.

In 2008, Dr Stowe was the primary investigator of an National Institutes of Health grant where the stated purpose was “to stimulate vigorous debate with the emphasis on the reproductive safety of antidepressant medications,” according to Grassley’s June 2, 2009 letter to the president of Emory.

During a 2008 deposition in a Paxil birth defect case, Stowe said that around “80% of his Emory salary ($187,000) comes from his NIH grants,” the letter notes. His total Emory salary was $232,000.

In 2007, Paxil maker, GlaxoSmithKline, paid Stowe $154,400 for 57 promotional talks. He also received $99,300 in the first ten months of 2008 for 38 promotional talks for antidepressant drugs, according to Grassley.

Stowe’s undisclosed income above was from one drug maker. In August 2007, he was listed as an author on a study titled, “Atypical Antipsychotic Administration During Late Pregnancy: Placental Passage and Obstetrical Outcomes,” in the American Journal of Psychiatry.

According to the disclosure section, Stowe has received research support from Glaxo, Pfizer, and Wyeth. He has served on advisory boards for Wyeth, Bristol-Myers Squibb, and Glaxo, and he has served on speaker’s bureaus and/or received honoraria from Lilly, Glaxo, Pfizer, and Wyeth.

Dr Jeffrey Newport is the associate director of Emory’s Women’s Program. Newport was also an author on the “Antipsychotic,” study. He has received research support from Lilly, Glaxo, Janssen, the National Alliance for Research on Schizophrenia and Depression, NIH, and Wyeth, and, he has served on speaker’s bureaus for AstraZeneca, Lilly, Glaxo, Pfizer, and Wyeth, according to the disclosures.

On June 14, 2007, Katherine Stone posted a blog with the headline: “Upcoming Event in Asheville Features My Psychiatrist!”, in an evening for prescribing clinicians called “Postpartum Mood Disorders: A Systemic Approach to Biopsychosocial Treatment.”

“The key speaker will be Dr. Jeffrey Newport, associate director of the Emory Women’s Mental Health Program here in Atlanta and also my psychiatrist!!!!”, she said. “I have firsthand knowledge that Dr. Newport rocks.”

An online announcement shows Dr Stowe gave a seminar titled, “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough.” The moderator for the seminar was Charles Nemeroff, who earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory, according to Grassley.

On July 23, 2008, an article by Nemeroff titled: “Weighing Risk and Benefit for Treatment of Depression in Pregnancy and PostPartum,” was available on Medscape. The Medscape website stated, “This article is temporarily unavailable,” on March 17, 2009.

Nemeroff stepped down as chair of the psychiatry department in 2008 after an Emory found he had failed to report more than $800,000 from Glaxo from 2000 to 2006. “That matter is now being probed by the inspector general for the U.S. Department of Health and Human Services,” according to the Wall Street Journal.

The Act’s passage, after eight years of solid efforts, would set the stage for the screening of all pregnant women for a whole list of mental disorders. The bill has already passed in the US House of Representatives and will soon be up for a vote in the Senate.

The definition section of the Act specifically states that the term “postpartum condition” means “postpartum depression or postpartum psychosis.” There is not one word about perinatal “mood” or “anxiety” disorders in the bill.

The transformation of the postpartum language in the Act to further the formation of a new cottage industry for treating multiple disorders can be traced back to websites such as Postpartum Progress, Postpartum Support International, and a site called PerinatalPro, which leads directly to the treatment center owned by the site’s creator Susan Stone.

On January 26, 2009, Susan cranked out an announcement on the internet with the headline: “U.S. Senator Robert Menendez reintroduces important postpartum depression legislation in Senate today!!”

However, in Stone’s message to the pubic the “postpartum depression” in the headline suddenly transforms into “perinatal mood disorders,” and she warns of a crisis of epidemic proportions in stating:

“The statistics we have on the numbers of women suffering from perinatal mood disorders (which range from 12 – 22% in the research) easily exceed the incidence associated with a public health crisis.”

“And remember,” she says, “these statistics, do NOT include the suffering of women who miscarry, endure stillbirths, give up babies for adoption or terminate pregnancies, all of whom are also susceptible to these devastating disorders and whose circumstances are included in the furthering of research and support being sought.”

In her message, Susan reports: “Today, I had the joy of participating in a conference call with the office of Senator Menendez and the other organizational sponsors of The Melanie Blocker Stokes MOTHERS Act where we received a heads up that U.S. Senator Robert Menendez was hoping to reintroduce the bill today.”

While the Mothers Act refers to helping women with postpartum depression and psychosis only, the bill’s top promoters, obviously kept in the loop by the main sponsor in the Senate, clearly have a larger customer recruitment scheme in the works.

On a Postpartum Progress page with a heading, “WHAT IS WRONG WITH ME?!” the website’s creator, Katherine Stone, explains that the word perinatal “refers in this case to the period during and after pregnancy.”

“Among the mental disorders women face during this time, there are two main types: anxiety disorders and mood disorders,” she advises.

“Anxiety disorders include generalized anxiety disorder, obsessive compulsive disorder, post-traumatic stress disorder and panic disorder,” she reports.

“Mood disorders include depression, bipolar disorder and psychosis,” she explains. Under the heading “Postpartum Post-Traumatic Stress Disorder,” she writes:

All you have to do to be at risk for getting postpartum PTSD is to have the perception of a traumatic childbirth — in other words, even if your doctors and nurses feel that everything went fairly normally, if it was upsetting and scary and unexpected to you that’s what counts.

She concludes with the misleading statement that, “all of these illnesses are completely treatable.”

Katherine’s bio claims she “is a nationally-recognized, award-winning advocate for women with perinatal mood and anxiety disorders.”

In the Menendez press release on January 26, 2009, there was no mention of “mood” and “anxiety” disorders. If he was not in on this disease mongering plot, he would have told these two broads to knock it off by now.

Drugging for Profit

Although no psychiatric drug has been FDA approved as safe for use by pregnant and nursing mothers, the treatment for all the perinatal mental disorders calls for the new generation of antidepressants, along with atypical antipsychotics and epilepsy drugs, now commonly referred to as “mood stabilizers.”
The atypical antipsychotics are Seroquel by AstraZeneca, Risperdal and Invega marketed by Janssen, a division of Johnson & Johnson, Geodon by Pfizer, Abilify from Bristol-Myers Squibb, Novartis’ Clozaril, and Eli Lilly’s Zyprexa. The average price for these drugs on DrugStore.com is about $900 for a hundred pills.

The SSRI and SNRI antidepressants include GlaxoSmithKline’s Paxil and Wellbutrin, Pfizer’s Zoloft, Celexa and Lexapro from Forest Labs, Luvox by Solvay, Wyeth’s Effexor and Pristiq, and Lilly’s Prozac, Cymbalta, and Symbyax, a pill with Zyprexa and Prozac combined. The price of these drugs, on average, is about $300 for ninety pills at DrugStore.com.

On March 23, 2009, Philip Dawdy reported on the popular website Furious Seasons that, “in a sign of just how bizarre things have gotten in DC, the FDA today approved Symbyax for treatment resistant depression, meaning depression that hasn’t responded to two anti-depressants.”

“So the FDA just approved a drug that’s known to cause diabetes, epic weight gain and suicidality to treat depression,” he said. “This makes so much sense!”

The antipsychotics are now the top money-makers. In overall prescription sales in the US, they led all classes of drugs in 2008, with sales of $14.6 billion, according to IMS Health. Anticonvulsants came in fourth with $11.3 billion in sales, followed by antidepressants at fifth with sales of $9.6 billion.

The Epilepsy Foundation estimates that one million women in the US have epilepsy, but the number of women taking anticonvulsants is reported to be two to three times higher than women with epilepsy. The prices for these drugs can run as high as $929 for 180 tablets of Glaxo’s Lamictal, and $1170 for 180 tablets of J&J’s Topamax.

Numerous recent reports have linked the use of drugs such as Depakote, Neurontin, Lamictal and Tegretol with not only suicide but also birth defects, including heart defects, brain damage, and mental retardation.

Big Pharma Funds Mothers Act Supporters

As of April 9, 2009, the groups supporting the Mother’s Act listed on PerinatalPro with Big Pharma funding traceable through their annual reports and the grant reports of Eli Lilly and Pfizer for 2007 and 2008, include the American College of Obstetricians and Gynecologists, American Psychiatric Association, Association of Maternal and Child Health Programs, Children’s Defense Fund, Depression and Bipolar Support Alliance, March of Dimes, Mental Health America (MHA), National Alliance for the Mentally Ill (NAMI), National Association of Social Workers, National Council for Community Behavioral Healthcare, and the Suicide Prevention Action Network USA.

Pfizer’s 2008 grant report shows the Association of Maternal and Child Health Programs, received $10,000 for “General Operating Support.” Florida’s Bureau of Maternal and Child Health received funding from Lilly and Pfizer to launch a three-pronged maternal depression awareness initiative consisting of education, screening and advocacy, according to the July, 2005 paper, Improving Maternal and Infant Mental Health: Focus on Maternal Depression, by Ngozi Onunaku.

Collaborating partners also included the American College of Obstetricians and Gynecologists, University of Miami, and Florida’s Department of Mental Health, Onunaku reports. Public awareness efforts reached the Florida State Legislature, who passed a resolution to establish April as women’s depression screening month.

Onunaku listed the Lilly and Pfizer funded Florida project as an example of state and community efforts that may be useful in reaching the goal of increasing maternal depression awareness. In the paper, he reported the following:

Prenatal depression occurs during pregnancy when mothers-to-be experience hormonal and biological changes, stress, and the demands of pregnancy. Approximately 14-25% of pregnant women have enough depressive symptoms to meet the criteria for a clinical diagnosis.

The use of medication to treat maternal depression is controversial; there is concern about mothers taking medication during pregnancy and after delivery, especially while breastfeeding. Research suggests that infant development is not adversely affected by certain kinds of medication.

There is equal consideration regarding the possible risks posed to a child whose mother is severely depressed and needs medication but remains untreated.

In 2008, Lilly gave the American College of Obstetricians and Gynecologists $16,000, and a $2,000 donation was made in the third quarter of 2007.

Lilly gave the American Psychiatric Association grants worth more than $600,000 in both the first and second quarters of 2008. In 2007, the group received over $400,000 from Lilly. The drug maker gave roughly $450,000 more to the American Psychiatric Foundation for the APA fellowship program. Pfizer donated more than $700,000 to the “non-profit” APA in 2008.

The National Council for Community Behavioral Healthcare is described as “a non-profit association representing 1,300 mental health and addictions treatment and rehabilitation organizations,” on its website. This gang received $200,000 from Lilly in the first quarter of 2008, and another $215,000 in the fourth quarter.

Mother’s Act supporter, Suicide Prevention Action Network USA, has merged with the American Foundation for Suicide Prevention, according to a November 6, 2008 press release announcement.

A year earlier, Emory University reported that Charles Nemeroff had been elected president of the American Foundation for Suicide Prevention and would begin serving his three-year tenure in January 2008.

Emory’s press release noted that Nemeroff had served on the AFSP’s national board of directors since 1999 and had “been a member of the Foundation’s Scientific Council for more than 10 years and was named chair of the Council in 2007.”

In about the same time frame between 2000 and 2007, Senator Charles Grassley’s Senate Finance Committee investigation found that Nemeroff had earned more than $2.8 million from drug companies, but failed to disclose at least $1.2 million to Emory.

On November 3, 2008, Dr Bernard Caroll summed up Nemeroff’s fall from grace on the Healthcare Renewal website as follows:

The fallout to date includes his severance from several NIH-funded projects at Emory University School of Medicine, a freeze of NIH funding for a major center grant, and his stepping down from Emory’s chair of psychiatry while an internal investigation proceeds.”

Dr. Nemeroff’s credibility is under a cloud, to say the least, and his influence is rapidly waning. . . . In the hardnosed, commercial world of Continuing Medical Education, for instance, the signs are that Dr. Nemeroff is toast. Whereas he once coordinated multi-city traveling CME road shows and a parade of spots on CME websites like Medscape, his profile now is suffering. Go to this Medscape website, for instance. You will find that his current Expert Viewpoint spots are missing, replaced by the message, “This article is temporarily unavailable.

Nemeroff’s Bio on the Emory Website on December 22, 2008 listed his Clinical Interests as: “Depression and antipsychotic pharmacological therapy, social phobias, fetal effects of pre- and post-natal drug therapy, depression, mood disorders, antipsychotic therapy.”

Lilly’s 2008 grant report shows the Suicide Prevention Action Network USA received one $10,000 grant and another $70,000 grant. The American Foundation for Suicide Prevention also received three grants worth $78,000.

Lilly’s 2007 report shows the Action Network received $10,000 in one quarter and $70,000 in another. The Foundation got $25,000 in 2007. The 2004 spring issue of USA’s Network News reports that: “Network News is funded by a grant from the Eli Lilly and Company Foundation.”

The Summer 2005 Network News noted that “Donations Sustain SPAN USA.”

The donor list shows Pfizer gave over $10,000. The group received more than $1,000 from Bristol-Meyers, Janssen, and Novartis. Forest Pharmaceuticals gave over $500.

The 2006 Spring Network News announced the “Friend for Life” sponsors. Forest and the industry’s trade group, PhRMA donated over $15,000. Pfizer gave between $10,000 and $14,999. Solvay was listed as giving between $6,000 and $9,999 and companies that gave between $2,000 and $5,999 were AstraZeneca and Bristol-Myers. J&J, Lilly and Novartis each donated between $500 and $1,999.

As expected, the two most notorious front groups, NAMI and MHA, received the most money from psychiatric drug makers. NAMI’s annual reports list about every drug company on the planet as a corporate partner without specifying how much each donated. But the grant reports of Lilly and Pfizer for 2007 and 2008 show NAMI groups received millions of dollars from those two drug makers alone.

In the fourth quarter of 2008, Pfizer gave NAMI a grant of $132,000 to fund a campaign that best describes the drug maker’s goal called the “Campaign for the Mind of America.” In the third quarter, Pfizer doled out another $225,000 to fund the same campaign.

Lilly is also funding the Campaign for the Mind, with grants of $450,000 in both 2007 and 2008. Lilly also provides extra funding to NAMI groups all over the country for the “Walk for the Mind of America.” In 2007, walking money totaled $17,000 in the first quarter, $11,500 in the second, and $13,000 for the third and fourth combined. In 2008, Lilly’s “Walk for the Mind” quarterly totals were $11,500, $24,000, $12,500 and $2,000.

In 2007, NAMI presented a $50,000 “Mind of America Scientific Research Award” to Dr A John Rush. He also landed on the Grassley hit list last fall for not disclosing drug company money to the University of Texas.

On April 6, 2009, Senator Grassley sent a letter to NAMI asking for the disclosure of all funding from drug makers and industry created foundations over the past few years.

Mental Health America groups also received millions of dollars from Pfizer and Lilly alone in 2007 and 2008. This group runs a “Campaign for America’s Mental Health” and received grants of $200,000 and $300,000 in 2008 from Pfizer to fund it. Lilly gave $300,000 to fund this Campaign in 2007.

MHA’s 2006 annual report shows the group received over $1 million each from Lilly, Bristol-Myers, and Wyeth. Janssen and Pfizer gave between $500,000 and $1,000,000, and AstraZeneca and Forest donated between $100,000 and $499,000. Glaxo gave between $50,000 and $100,000 in 2006.

The most troubling donation to this Mothers Act supporter is a $20,000 Pfizer grant to a Georgia group to fund: Project Healthy Moms: Education for Prevention/Treatment for Perinatal Depression Disorders, which apparently ended up, at least in part, in the pocketbook of Katherine Stone.

The Georgia group’s June 8, 2008 e-news said the grant was for: “Project Healthy Moms: What You Need To Know About Perinatal Mood Disorders.”

The $20,000 funded 1-hour speaking events with Katherine, “aimed at educating practitioners and the general public throughout Georgia about prevention of and treatment for such illnesses as ante partum depression, postpartum depression, postpartum anxiety/OCD and postpartum psychosis,” the newsletter said.

Katherine was described as a “former postpartum OCD sufferer and author of Postpartum Progress, the most widely-read blog in the United States on postpartum mood disorders.”

E-news said attendees would learn: “One size does NOT fit all: Why postpartum depression is just part of a spectrum of mood disorders women may experience & what to look for.”

The newsletter only listed 5 scheduled events but told readers to contact Katherine directly by email or phone to schedule more. E-news did acknowledge that: “This special hour of learning is made possible by a grant from Pfizer,” but listed no amount.

The leaders of these “non-profits” are also making out like bandits. In 2006, NAMI’s top dog, Michael Fitzpatrick, had a salary of $212,281, and $10,090 in employee benefit contributions and deferred compensation plans, for a 35-hour work week.

MHA’s 2002 tax returns show the CEO and President, Michael Faenza, received compensation of $306,727, and another $35,275 in contributions to employee benefit plans and deferred compensation that year, for a 35 hour work week.

The Depression and Bipolar Support Alliance received $37,510 from Lilly in 2007 and $20,000 in 2008. This group provides live links to form letters that can be filled in and sent to Congress members asking them to vote for the Mother’s Act. The two Stone gals provide links to the Mothers Act alerts put out by the Alliance on their websites.

The group’s 2007 Annual Report shows this non-profit received between $150,000 and $499,000 from AstraZeneca, Pfizer, and Wyeth. Abbott, Cyberonics, Lilly, Forest, Glaxo, Organon, and Otsuka American Pharmaceuticals gave between $10,000 and $149,999.

The report also notes that a “First-ever DBSA Hope Award” for lifetime achievement was presented to Frederick Goodwin. Back in August 2002, the speakers at the annual conference of the Alliance included three stars from the Grassley hit list, Goodwin, Nemeroff and Joseph Beiderman.

The front groups team up with a “non-profit” called “Screening for Mental Health,” to carry out mental illness screening days all over the country every year. Their websites also provide live links to internet screening programs set up by this firm.

Up to 2008, the SMH had received close to $5 million from drug companies. Lilly gave the firm $124,000 in 2007 and $100,000 in 2008.

Finally, the Children’s Defense Fund received a grant for $125,000 in 2003 from the Robert Wood Johnson Foundation. The March of Dimes got $6,500 from Pfizer in 2008, and the National Association of Social Workers also received $7,500 from Pfizer.

Amy Philo, a young Texas mother who survived what can only be described as a postpartum ambush by the psycho-pharmaceutical cartel, is at the forefront of the “Unite for Life” coalition fighting against the Mothers Act. As of April 25, 2009, the Unite coalition had thirty-five organizations signed on as opposed to the legislation. Needless to say, none of them were listed in the grant reports of Lilly or Pfizer.

Amy was screened and drugged because she got extremely concerned about her baby and had a panic attack after watching him nearly choke to death. “I lived through forced hospitalization, drugging, and four months of being homicidal, suicidal, and psychotic because of Zoloft,” she recounts on her website.

“No mother should have to live through what I have,” she states.

Over a recent three to four year period, Amy found there were 1,031 documented deaths of babies caused by psychiatric drug exposure reported to the FDA’s MedWatch system.

Amy recently learned that the National Association of Certified Professional Midwives has withdrawn their support from the Mothers Act. However, she reports a new addition to the list of supporters is the National Healthy Mothers, Healthy Babies Coalition. A quick check of their website found the group’s corporate sponsors include Wyeth, Glaxo, J&J, Merck, and Sanofi Pasteur.

* This article was sponsored by the Pogust, Braslow & Millrood law firm in Conshohocken, Pennsylvania

Women fought for years to gain acceptance of the fact that many female health problems were real and not symptoms of hypochondria. The psycho-pharmaceutical cartel’s profit-driven invention of an epidemic of pregnancy-related mental disorders will wipe out a century of work toward that acceptance.

Sadly, the end result of this latest marketing scheme will be that the relatively few women who truly do suffer from postpartum depression will not be taken seriously.

The Mother’s Act legislation has already passed in the US House of Representatives. A majority vote in the Senate would represent a major coup for a multi-billion dollar industry.

“Like many of the acts of Congress, the real beneficiary will not be the mothers and their children but the “mental health” workers who will be handsomely paid and the drug companies that are behind this legislation,” says Steve Hayes, the director of he Novus Medical Detox Center, in the center’s July 31, 2008 newsletter.

“The drug store chains will expand more because more people will be hooked on these dangerous drugs,” he points out.

“Doctor’s offices will be more crowded because we know that these dangerous drugs often lead to serious health side effects that will require medical treatment,” he writes.

The advocacy groups battling against passage of the Mother’s Act are nearly equal in number to the Act’s supporters, and include Unite for Life, AbleChild, the International Center for the Study of Psychiatry and Psychology; Alliance for Human Research Protection; International Coalition For Drug Awareness; Law Project for Psychiatric Rights, Mindfreedom International, and the Citizens Commission on Human Rights.

Same Old Song and Dance

The Mother’s Act technique has been used again and again in this country. A new sub-group of people is identified as not receiving enough treatment for mental disorders and the drug makers funnel money to front groups to fund the disease marketing campaign and set up screening programs.

The internet is now flooded with reports about the rise in pregnancy related disorders and the places to find treatment. Websites with names like “Postpartum Progress” and “PerinatalPro,” provide links to programs that claim women need screening for postpartum depression, bipolar disorder, schizophrenia, anxiety disorder, panic disorder, obsessive-compulsive disorder, post traumatic stress disorder, and eating disorders.

However, nowhere to be found, are reports about the sub-groups targeted in the past and all the depressed and anxious patients who became mentally healthy as a result of being screened and treated.

Dr David Cohen, a professor of Social Work at Florida International University and co-author with Dr Peter Breggin of the book, Your Drug May Be Your Problem, gave a keynote address titled, “Needed: Critical Thinking About Psychiatric Medications,” at the International Conference on Social Work in Health and Mental Health, in Quebec City, Canada in May 2004, and noted the following:

For the past 50 years, physicians in the West have been prescribing psychotropic drugs systematically to hundreds of millions of people to alter undesirable and disruptive emotions and behavior.”

“For the treatment of every single psychological affliction in men and women, in all ethnic groups, from the toddler to the aged, taking psychotropic drugs is now the cornerstone remedy, all other efforts secondary.”

“Despite the reliance on psychopharmaceuticals, however, not even modest improvements in the incidence, prevalence, relapse rate, duration, or long-term outcome of any condition routinely treated today with psychotropics, such as depression and schizophrenia, can be discerned.

Childbearing Years Represent Huge Market

Childbearing years cover women from roughly sixteen to fifty and the Mother’s Act proves the drug makers will go to any lengths to hold onto this market.

“The labels for antidepressants warn of the increased risk of SSRI-induced suicidality in youth and young adults, the women most likely to become pregnant,” Dr Breggin, author of the new book, Medication Madness, points out. “So the drugs not only threaten to cause the death of the mother through suicide but the death of the child through lethal birth defects as well,” he advises.

“The exposed fetus is at risk for a variety of potentially serious disorders, from cardiovascular anomalies to withdrawal symptoms at birth,” Dr Breggin warns.

“If pregnant women feel anxious or sad,” he says, “they should seek counseling or family therapy with the child’s father involved, along with other sources of emotional support.”

In February, with little to no fanfare, the FDA said it was once again evaluating the risk of birth defects of SSRI and SNRI antidepressants due to the number of adverse event reports.

Pregnant women and nursing mothers are rarely told that antidepressants take anywhere from three to six weeks to work, if they work at all. “We know that the natural history of depression means that many patients will improve within weeks whether treated or not,” says Dr David Healy, author of Let Them Eat Prozac.

“The overwhelming majority of women who are prescribed antidepressants are at little or no risk for suicide or other adverse outcomes from their nervous state,” he points out

“Treatment runs the risk of stigmatizing the person,” he says, “as well as giving them problems that they didn’t have to being with.”

“Only one in ten women will likely have a true response to an antidepressant even if they are depressed, so nine women will be subject to the risks for the one who might benefit,” he states.

According to Jonathan Leo, an Associate Professor at Lincoln Memorial University in Tennessee, whose website, Chemical Imbalance is focused on debunking the “chemical imbalance” in the brain myth, the public health argument goes something like this:

“Helping one out of every ten does not sound very good but if you give the medications to 10 million people then you are helping one million.”

“This may be of little consolation to the nine million people exposed to potential side-effects,” he points out.

In December 2008, the FDA announced that anticonvulsants, widely prescribed as “mood” stabilizers, would now carry a warning about an increased risk of suicidality. They are also known to cause serious birth defects.

New Best Sellers — Atypical Antipsychotics

For a decade and a half, the new antidepressants were not only the best selling psychiatric drugs in the US, they became the top selling class of medications.

However, in 2008, antipsychotic revenues, at more than $14 billion, topped all other classes of drugs in the US, surpassing even cholesterol medications. The rest of the world apparently has not gone mad because the US accounted for over $3 billion of the close to $4.5 billion of worldwide sales of Seroquel, the fifth top selling drug in the US last year.

Anticonvulsants were the fourth class of drugs in terms of revenue, with over $11 billion in sales. Antidepressants held the fifth position, earning their makers more than $9.5 billion in 2008.

Like the SSRIs before them, the atypical antipsychotics are now prescribed off-label for everything from mild depression to anxiety to sleep problems to PTSD and ADHD, and for one reason. They are the biggest money-makers. The prices at a middle dose as of April 2009 on DrugStore.com were: Abilify 90 tablets $1230, Geodon 100 capsules $787, Invega 100 tablets $1168, Risperdal 90 tablets $716, Seroquel 100 tablets $839, and Zyprexa 90 tablets $1195.

The drugs were originally approved only to treat schizophrenia and later the manic episodes in patients with bipolar disorder. The National Institute of Health estimates that schizophrenia effects 2.4 million adults in any given year and 5.6 million adults have bipolar disorder.

“The story’s pretty clear, and pretty embarrassing for the profession of psychiatry, which has allowed itself to be led by marketing,” Dr Robert Rosenheck, a psychiatrist at Yale who has studied the expanded use and effectiveness of the atypical antipsychotics, told the LA Times on April 13, 2009.

“We know now what these companies’ strategies are: The number of people with schizophrenia is limited, so the road to profitability goes through soccer moms. They need to market these drugs to ordinary people who have dissatisfactions in life,” he said.

Antipsychotics come with serious side effects, some of them lethal. “The atypicals can cause a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems,” according to Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski.

Diabetes is a major cause of vascular disease and the number one cause of adult blindness, end-stage kidney disease and non-traumatic amputations, according to a 2006 report by the National Association of State Mental Health Program Directors.

“The atypicals have some of the same neurological side effects as SSRIs,” Dr Kruszewski says. “They also cause tardive dyskinesia, an often irreversible movement disorder.”

“Tardive dyskinesia looks so “strange” or “bizarre,” that it is often mistaken for a mental illness rather than a neurological disorder,” Dr Breggin reports.

“One variety,” he explains, “involves painful spasms of muscles that can literally torture the victim, and another involves an agonizing inner agitation that drives people to move their arms or legs, or to pace.”

“In some cases, the severe pain of tardive dyskinesia causes patients to become exhausted and ultimately disabled,” he reports.

“Tardive dyskinesia occurs at a cumulative rate of 4-7% per year in otherwise healthy patients treated with antipsychotics,” Dr Breggin says. “After taking the drugs for only a few years, 20% or more will be afflicted and older patient have an even higher risk.”

Helpless Children Harmed

There is no way to predict the adverse effects on the organs and bodies of children who receive psychiatric drugs filtered through pregnant and nursing mothers.

A study in the February 2004 journal Pediatrics reported abnormal sleep patterns, heart rhythms, and levels of alertness in babies exposed to SSRIs in the womb. The lead author, Dr. Philip Zeskind, told the Sunday Telegraph: “What we’ve found is that SSRIs disrupt the neurological systems of children, and that this is more than just a possibility, and we’re talking about hundreds of thousands of babies being exposed to these drugs during pregnancy.”

“These babies are bathed in serotonin during a key period of their development and we really don’t know what it’s doing to them or what the long-term effects might be,” he warned.

A year and a half later, Christine K sat in a neonatal intensive care unit and watched and waited as her baby lie in an incubator with tubes and needles stuck all over his body for four days.

After a single bout of psychosis following a traumatic event in her life, a psychiatrist labeled Christine schizophrenic and kept her on Paxil, Risperdal and Depakote for five years. When she became pregnant, the shrink told her the drugs were safe for the fetus. In fact, she insisted that Christine keep taking them even when she asked to go off the concoction six months into her pregnancy after reading that Paxil could harm her baby.

After looking up more information on the internet, Christine decided to wean herself off the drugs in her seventh month against doctors’ advice. However, when she tried to explain that she quit taking the medications long before the infant was born, Christine was informed that he would still have to remain in intensive care due to the fact that he had been exposed to the drugs in the womb early on.

For the first two years of life, the baby would not sleep for any length of time — waking up every two or three hours. For the first three months, his whole body would jump at the least little sound even when he was asleep. He could not suck hard enough to nurse and resisted bottles. For the first year, he required hours of feeding attempts each day to make sure he received enough formula.

He was three last October and still has a strong aversion to eating — “including cake, cookies and all the things kids will normally eat even if nothing else,” his mother says.

“He was well over 2-years-old before he started sleeping through the night,” she reports.

In addition to the extra hospital costs for intensive care, “in the first three years of his life, this child has needed more medical care and doctor’s appointments than my other three children combined,” Christine reports.

In this case, the problems were nondescript. Doctors do not know enough about the effects of psychiatric drugs on the developing fetus to know if or how to treat them. “All I can do is watch and wait and hope they resolve on their own,” she says.

Christine is by no means a supporter of the Mother’s Act. She was scared and worried for a year after her son came home from the hospital but not from postpartum depression, she says. “It was mostly guilt and fear over what the drugs may have done to my baby.”

Drugged into Madness

The drugging cycle with women often starts with a loose diagnosis of postpartum depression. “My daughter was one of those poor souls prescribed an antidepressant for a “possible” case of mild postpartum depression with no warning about the adverse effects of the drug,” says Marcia Christensen of Australia.

“This caused a devastating cascade of events with further prescribing of multiple classes of antidepressants, atypical antipsychotics, Lithium and electro-convulsive therapy,” Marcia recalls.

“She made several attempts on her own life, developed type I diabetes and had her liberty denied over a 3 year period,” Marcia recounts.

Her daughter, Rebekah Beddoe, has documented the family’s ordeal in the book Dying for a Cure, in which she describes her decline from an ambitious, successful career women to a chronic mental patient as a result of being diagnosed with postpartum depression.

After a kick-off with Zoloft, Rebekah was on six different drugs within two years, diagnosed with a myriad of different disorders and feeling like a psychiatric hospital might be her permanent home. Electric shock treatment came in the midst of numerous suicide attempts.

She credits a BBC documentary on SSRIs with saving her life because she immediately recognized that the bizarre behaviors began shortly after she took the first drug. Rebecca decided they had to go and gradually weaned off each medication one by one. It took her 9 months to get off the antidepressant because the withdrawal problems were so severe.

Rebecca and Christine are not rare cases. Mixtures of antipsychotics, antidepressants and anticonvulsants, now used as “mood” stabilizers, are regularly prescribed for the all “anxiety” and “mood” disorders sought to be marketed via the Mother’s Act. Drug cocktails represent dollar signs. A woman like Christine, taking Depakote, Paxil and Risperdal, can easily ring up over $15,000 a year for the drug makers alone in the US.

The doctors make out like bandits as well. “Psychiatry has increasingly replaced psychotherapy with something called “medication management,” which largely consists of symptom assessment and prescription updates,” Dr. Bruce Levine, author of, “Surviving American’s Depression Epidemic,” reports in the August 13, 2008 Huffington Post.

“Medication management typically takes ten or fifteen minutes and is scheduled every two to three months,” he explains.

While psychiatrists bill about half as much as they do for a psychotherapy hour, they can conduct a minimum of four sessions for every one psychotherapy session, he says.

Many psychiatrists do five- or ten-minute sessions, so they can complete five or six in the same hour that it would take to do a psychotherapy therapy session, including preparation and note writing, Dr Levine reports.

“The bottom line,” he says, “is that psychiatrists who offer only medication management routinely make nearly triple the income as do psychiatrists who provide mostly psychotherapy.”

* Article sponsored by the Houston law firm of Vickery, Waldner & Mallia

For years, the research that showed SSRI antidepressants (selective serotonin reuptake inhibitors) were dangerous and practically useless was kept hidden, while the studies published and presented to potential prescribers painted a glowing picture of success. These days, a person would be hard pressed to find someone who does not have a family member or friend labeled mentally ill and taking drugs like Prozac, Paxil, Zoloft, Lexapro and Celexa, or their chemical cousins Effexor, Cymbalta and Wellbutrin.

About once a year, a new round of headlines about all the money made by the SSRI pushers comes and goes; but nothing really ever seemed to stick, until now.

The Senate Finance Committee, with the ranking Republican, Senator Charles Grassley, leading the charge, is investigating GlaxoSmithKline regarding new revelations in a report filed in litigation showing that the company manipulated the numbers on adverse events related to suicidality in clinical trials back in 1989, to make it appear that Paxil did not increase the risk of patients experiencing suicidal behavior when, in fact, trial subjects on Paxil were eight times more likely to attempt or commit suicide than patients taking placebos.

Quite a few of the top pushers are also under investigation by the Committee due to revelations that millions of dollars has changed hands between the SSRI makers and the academics who signed off on some of the most fraudulently reported research in the history of modern medicine. A full list of names is easy to compile by scanning the literature on SSRI studies conducted on children. The same names appear repeatedly.

In alphabetical order, the Fortune 500 team of pushers, at a minimum, includes Drs Joseph Biederman, David Brent, Jeffrey Bridge, Daniel Casey, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer, and Karen Wagner.

Truth Buried in Litigation Graveyard

On February 6, 2007, the world famous historian on psycho-pharmacology, Dr David Healy, published a commentary entitled, “Why you should never trust new wonder drugs,” in the UK’s Daily Mail stating:

Ten years ago, I sat faced with boxes and boxes that contained a dirty secret. Inside were thousands of confidential internal company documents about Prozac.

The secret they revealed was that public statements about the safety of the drug were a lie; that the company knew Prozac was responsible for a raised risk of suicide and was only slightly more effective than a placebo.

Several years later, Dr Healy recounts, he was faced with the secrets of Paxil. “No one outside the two companies, and few within them,” he writes, “knew what those boxes contained; I saw them because I was an expert witness in a court case.”

“Documents pried out of companies by American court cases,” he says, “have become the main way we have of discovering the truth about some of our best-selling drugs.”

“The scientific literature, the very place doctors would look for a warning,” he writes, “contained barely a hint of problems.”

“What’s more, no one seems likely ever to have to answer for what appears to be fraud,” he points out.

“In other organizations when evidence of disregard for public safety emerges, heads roll,” Dr Healy said. “But there have been no resignations following these drug disasters — barely a flicker of embarrassment.”

The UK’s medicines “watchdog,” the British Medicines and Healthcare Products Regulatory Agency, he reports, “has never taken any action against the academics who make fraudulent claims in ghostwritten articles, nor doctors working for the companies who repeat such claims, even when they have been shown to be untrue.”

“And no one in Britain,” he points out, “has any means of finding out why their husband or child might have died.”

Seven years before Dr Healy wrote this commentary, in a Prozac case for which he served as an expert witness, the plaintiff’s legal team learned that Eli Lilly had withheld evidence in a jury trial when the May 7, 2007 Boston Globe reported that Lilly had agreed to pay $20 million for the rights to a patent on a new version of Prozac that would reduce “akathisia,” the very side effect long believed to increase the risk of suicidal behavior, three months before the trial began.

While testifying under oath, Lilly researcher, Gary Tollefson, had told the jury, “there is absolutely no medically sound evidence of an association between any antidepressant medicine, including Prozac, and the induction of suicidal ideation or violence.”

When in fact, the wording in the patent for the new formula stated “fluoxetine (Prozac) produces a state of inner restlessness (akathisia), which is one of its more significant side effects,” and the “adverse effects which are decreased by administering the R(-) isomer of fluoxetine include but are not limited to headaches, nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal thoughts and self mutilation.”

Patients who lived to talk about a failed suicide attempt have described the SSRI-induced akathisia, as being so unbearable that their only option for relief seemed to be death.

America’s Most Wanted

Dr Daniel Casey was a major player in the SSRI drug-push and useful in many ways to the companies promoting the drugs. He was the chairman of the very first FDA advisory committee that met in 1991, to decide whether a warning about the increased risk of suicide should be added to the label of Prozac, the first SSRI approved in the US, and voted it down. He was also the chairman of the advisory panel that voted to approve Zoloft for Pfizer later that same year.

Bob Sorenson was a sales representative for Pfizer for 21 years. He moved to Oregon shortly before Zoloft was approved. During the first week at his new location, Pfizer’s chief of marketing at the time told him he needed to start calling on a doctor by the name of Dr Daniel Casey at the V.A. in Portland because he was very important to the company.

Dr Casey worked at the V.A., but never treated patients for depression, Mr Sorenson says. “His expertise [was] psychotropic drugs and experimentation.”

The chief of marketing said he was interested in finding out what Dr Casey thought of the company’s new drug, Zoloft. The company tried to call on him that day, but Dr Casey was not in. Mr Sorenson called on him later in the week and learned that Dr Casey was the lead investigator on Zoloft, which was up for approval by the FDA advisory committee Dr Casey chaired.

“He said I shouldn’t be there, but I did ask how it looks for the drug and he said very well,” Mr Sorenson recalls.

Dr Casey ended up making a ton of money from Zoloft. “He told me personally one time that he made enough from Pfizer in one year to purchase two cars,” Mr Sorenson reports.

Dr Casey became a member of Pfizer’s Advisory Board for Zoloft, which meant “all expense paid trips,” including honorariums, to anywhere Pfizer wanted him to advise, at any location in the world, Mr Sorenson explains.

“Many speakers were sought out that would only give lectures that put Zoloft in a positive light,” he notes, “there was no room for a balanced lecture.”

“Dr Casey later became one of the most sought after speakers for the Pfizer promotion of Zoloft,” he says, “the reps loved him because of his positioning of Zoloft.”

Mr Sorenson was often told to take information to speakers, “including Dr Casey, to have them add the information to their lectures,” he reports. “I look back at it now and see how wrong it was,” he states.

“As far as the suicide issue,” Mr Sorenson says, “the standard company line was that parents and doctors should be monitoring these kids because after being on Zoloft they finally feel good enough that they can carry out their suicide tendencies.”

“Another tactic was to blame Paxil and Effexor,” he recalls, “it was those drugs that caused suicidal tendencies, not Zoloft.”

“Finally,” he notes, “the statement was made that if they didn’t take Zoloft, they probably would have committed suicide anyway.”

Sales reps would practice and rehearse these statements at sales meetings to be able to respond to concerns or objections raised by Doctors about Zoloft’s relationship to suicidality, he says. “There would be contests as to who could detail the drug the best with objections,” he recalls.

Pfizer was able to get rid of employees and still keep them quiet, he says, by offering severance packages of up to a year’s salary, while forcing them to sign a confidentiality agreement, in which they promised not to sue, or speak adversely about Pfizer, as part of the deal.

Many people were so surprised at being terminated that they felt forced to sign because Pfizer kept the pressure on, he explains. They feared they wouldn’t find another job before financial problems set in, but regretted signing the agreement later, he says.

Mr Sorenson did not sign an agreement when he was fired. His young son had developed cancer, but Pfizer expected him to continue to attend out-of-town meetings and refused to believe that his son was terminally ill, he recalls. After 20 years with the company, Mr Sorenson was let go when he insisted that he needed to remain near his dying son and distraught wife. The Sorenson’s son passed away on April 1, 2005.

Going rate for Legal Drug Pushers

SEC filings for Cypress Bioscience provide a good source for estimating how much money legal drug pushers can make each year, from each company, because the names of several appear in these filings. According to its website, “Cypress Bioscience is committed to developing and commercializing pharmaceutical products and personalized medicine laboratory services that allow physicians to serve unmet medical needs.”

Drs Martin Keller and Charles Nemeroff, two of the most prolific depression-mongers, have served on the company’s board of directors, on its scientific advisory board and as consultants for this company. Under their 2004 Consulting Agreements, Cypress was required to pay them $50,000 per year for services rendered up to and including “two days per fiscal quarter.” In addition, the company could request additional services at a rate of $5,000 per day.

During 2003, Dr Nemeroff was paid $19,000 for additional services under his agreement, and Dr Keller was paid an extra $18,000. But they were only making $2,000 per day that year. As members of the Psychopharmacology Advisory Board, Dr Nemeroff earned $19,000 and Dr Keller $18,000 in 2003.

For their service as directors of the company in 2002, they each received $24,000. They were also offered stock options regularly. Cypress is only company. A bio on Dr Keller in a July 25, 2002 agenda for an annual meeting states that he is also a consultant to, “Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Janssen, Merck, Inc, Organon, Otsuka Pharmacia/Upjohn, Pharmastar, Pfizer, Inc. and Wyeth-Ayerst Laboratories.”

It also shows he serves on the scientific advisory boards of, “Bristol-Myers Squibb, Cephalon, Cyberonics, Inc., Eli Lilly, Forest Laboratories, Merck, Inc, Mitsubishi, Organon, Pfizer, Sepracor, Scirex, SmithKline Beecham, Somerse, Vela Pharmaceuticals and Wyeth-Ayerst.”

Dr David Dunner and a few more of the usual suspects appear in the Cypress SEC filings as advisory board members as well.

Dr Nemeroff’s role in the prostitution of research is legendary. In April 2004, Shannon Brownlee, author of, “Overtreated,” wrote an article in the Washington Monthly entitled, “Doctors Without Borders,” after he was caught failing to disclose his financial ties to the companies whose treatments he promoted in a paper in Nature Neuroscience, and noted:

With financial ties to nearly two dozen drug and biotech companies, Dr. Charles B. Nemeroff may hold some sort of record among academic clinicians for the most conflicts of interest.

A psychiatrist, a prominent researcher, and chairman of the department of psychiatry and behavioral science at Emory University in Atlanta, Nemeroff receives funding for his academic research from Eli Lilly, AstraZeneca, Pfizer, Wyeth-Ayerst–indeed from virtually every pharmaceutical house that manufactures a drug to treat mental illness.

He also serves as a consultant to drug and biotech companies, owns their stocks, and is a member of several speakers’ bureaus, delivering talks–for a fee–to other physicians on behalf of the companies’ products.

Dr Nemeroff stood to “reap as much as $1 million in stock” from just one company that manufactured one of the products in his Nature Neuroscience paper, she noted.

“But the drug industry’s most powerful means of boosting the bottom line is funding research,” Ms Brownlee writes, “which allows companies to control, or at least influence, a great deal of what gets published in the medical journals, effectively turning supposedly objective science into a marketing tool.”

She notes how companies are able to routinely delay or prevent the publication of data and specifically how the majority of studies which found antidepressants to be no better than placebos, “never saw print in medical journals.”

In conclusion, she states, “I’m struck more than anything by the apparent lack of shame among clinicians when it comes to this issue.”

Two years later, on July 19, 2006, the Wall Street Journal reported that the journal Neuropsychopharmacology, published by the American College of Neuropsychopharmacology (ACNP), planned to publish a correction of a favorable review of a new depression treatment device because it failed to list the ties of the eight academic authors to the device maker, Cyberonics, including lead author Dr Nemeroff, the editor of Neuropsychopharmacology at that time. The FDA had approved the VNS device in July 2005 over the objections of “more than 20″ FDA scientists, Bloomberg reported a day earlier on July 18, 2006.

“This is about as classic an example as you’ll ever find of conflict of interest and manipulation by thought leaders who are beholden to corporations,” Dr Bernard Carroll, a member of the ACNP, told Bloomberg. “This article is a piece of a slick, skillfully coordinated PR campaign directed by the corporation,” he said.

Ten days before the Wall Street Journal article, Cyberonics had sponsored a little noticed symposium on treatment-resistant depression at the annual Collegium Internationale Neuro-Psychopharmacologicum Meeting. The main presenters at the July 9, 2006 event were Drs Nemeroff, Dunner, and Keller (the lead author of the infamous Paxil “Study 329” on adolescents).

“In recent years, new treatment modalities have emerged, among them, the only FDA-approved treatment option specifically designed for this patient population, VNS Therapy,” Dr Dunner stated in a press release for the event.

Dr Dunner was one of the authors vouching for the new device in the Neuropsychopharmacology paper. However, a “stamp of approval” from this guy should be taken with a grain of salt. Back in March 1995, he also vouched for Paxil as lead author of a study titled, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo,” in the journal of European Neuropsychopharmacology. However, he later admitted that he never reviewed any of the actual data from that study.

Dr Nemeroff apparently learned nothing from the public embarrassment of the previous scandals. Last week, he was forced to step down as Chair of Emory’s psychiatry department. According to a December 23, 2008 posting by Ed Silverman, on the popular blog, Pharmalot:

Under pressure from a US Senate Finance Committee investigation, renowned psychiatrist Charles Nemeroff is giving up the post he held for 17 years and must follow new restrictions on his outside activities, according to an Emory University statement.

Emory’s own investigation found Nemeroff received more than $800,000 from Glaxo, which paid Nemeroff more than any other drugmaker, but he never reported the fees. There were more than 250 speaking engagements between 2000 and 2006.

“Moreover, Emory will not submit any National Institutes of Health grant or other sponsored grant or contract requests in which Nemeroff is listed as an investigator or has any other role for a period of at least two years,” Pharmalot reports.

All total, Dr Nemeroff earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory, according to the Senator.

Dr Keller’s disclosure records are under investigation as well He also appears center stage in a new book by former Boston Globe reporter, Alison Bass, called, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial. The book contains a treasure trove of insider revelations with specifics on Dr Keller’s endless conflicts of interest, along with other academics on the take. However, Ms Bass first broke the Keller story back on October 4, 1999, in the Globe, when she reported that he was forced to forfeit “hundreds of thousands of dollars” in state grant money in 1998.

She explained how in the same year that Dr Keller authored a review article in Biological Psychiatry, and concluded that the newer antidepressants Zoloft, Bristol-Meyer’s Serzone, and Wyeth’s Effexor were more effective, he received $77,400 in personal income and $1.2 million in research funding from Bristol-Myers, as well as $8,785 in personal income from Wyeth.

In Side Effects, she notes that Dr Keller did not report any income to the IRS from Glaxo for 1998, but says he did receive money from the Paxil maker, and also earned $62,500 from Celexa maker Forest Labs that year.

Dr Keller published 3 studies, “with colleagues,” in the Journal of the American Medical Association and the Journal of Clinical Psychiatry, touting the efficacy of Zoloft in 1998, and received $218,000 in personal income and more than $3 million in research funding from Pfizer the same year, Ms Bass reports.

The “colleagues,” referred to include the all-time champion of child drugging, Dr Joseph Biederman, the main promoter of the bogus epidemic of childhood bipolar disorder. He too is under investigation for taking $1.6 million from drug companies between 2000 and 2007, and only disclosing a fraction of that amount to Harvard. On December 30, 2008, Harvard’s teaching hospital, Massachusetts General announced that Dr Biederman was no longer participating in several industry-funded trials and had agreed to “not to participate in any outside activities that are paid for or sponsored by industry, such as consulting activities or speaking engagements.”

In most of the SSRI trials conducted on children, “colleagues,” will also include Dr Graham Emslie of Prozac fame, and the Zoloft Czar, Dr Karen Wagner, both from the University of Texas.

Back in April 2004, the British Medical Journal published a paper by a research team led by Dr Jon Jureidini, head of the department of psychological medicine at Women’s and Children’s Hospital in Australia, after a review of the clinical trial data on the safety and efficacy of antidepressant use with children. The review included the published trials, along with some unpublished data made public by the Committee on Safety of Medicines in the UK.

The Australian team was extremely critical of the published papers on the major trials of Prozac, Paxil and Zoloft, with Emslie, Wagner and Keller listed as lead authors. “In discussing their own data,” the team wrote, “the authors of all of the four larger studies have exaggerated the benefits, downplayed the harms, or both.”

“It is vital,” they wrote, “that authors, reviewers, and editors ensure that published interpretations of data are more reasonable and balanced than is the case in the industry-dominated literature on childhood antidepressants.”

Seven months later, the New York Times ran a report by Barry Meier on November 29, 2004, throwing another spotlight on the trail of corruption within the SSRI research factories, and zeroed in on Dr Wagner. He noted that, from 1998 to 2001, she was one of several researchers participating in more than a dozen industry-funded pediatric trials of antidepressants and other drugs, and that some of the results were published, but many were not.

In her Zoloft study, Dr Wagner acknowledged that she had received “research support” from several drug makers including Pfizer, which paid $80,000 to the center in connection with the test, Mr Meier reports. But she did not state that she received “sizable payments” from Pfizer for work related to the study, he says.

The same month that patients were first recruited for the Zoloft trial, in a financial filing with the school in December 1992, Dr Wagner reported that she received more than $10,000 from Pfizer, with no further details. A lawyer for the school told Meier that Dr Wagner said Pfizer had paid her $20,500 during the course of the Zoloft trial. But records for payments she received in speaking and consulting fees could not be located.

In September, Dr Wagner’s name was added to the Senator Grassley’s investigative roster, along with Dr John Rush. Between 2000 and 2005, Glaxo alone paid Dr Wagner $160,404, but only $600 was disclosed to the University, according to the Senator. She was also paid over $11,000 in 2002, by Eli Lilly, and that money was not disclosed either. Lilly paid Dr Rush $17,802 in 2001, but he only reported $3,000, Senator Grassley said.

Dr Emslie’s financial trail to the drug makers gained media attention last summer due to his prominent role in the Texas Children’s Medication Algorithm Project, and the creation of a drug formularies for children. He was chairman of the panel that wrote guidelines instructing doctors to prescribe SSRIs off-label to kids for depression in 1998. On August 18, 2008, the Dallas Morning News ran the headline: “Conflict of interest fears halt children’s mental health project.”

“A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list,” the News reported. University disclosure forms indicate that Dr Emslie “has made at least $130,000 in drug company speakers fees and consulting contracts since 2002,” the paper noted.

In discussing the investigation of Dr Wagner on the Senate floor, Dr Grassley pointed out that she was a co-author on Paxil Study 329. In 2001, when the study was published, Glaxo “reported paying her $18,255,” he said. “Study 329 was cited in a New York case where GlaxoSmithKline was charged with ‘repeated and persistent fraud,’” the Senator added.

Dr Emslie was also a co-author on the Paxil study and a check of the full list for 329, reveals that 5 of the co-authors appear with Dr Emslie on the guidelines for the “Children’s Medication Algorithm Project,” including Karen Wagner, Boris Birmaher, Barbara Geller, Neil Ryan and Michael Strober. Dr Rush’s name is also on the Texas guidelines but he moved to Singapore last August.

Ever since the warnings about birth defects started trickling out a few years ago, the drug companies apparently have been plotting to find ways to reverse their negative impact. But the most sinister plot ever developed is a bill moving for approval in the US Senate right now called the “Melanie Blocker-Stokes Mother’s Act,” to set up the screening of all pregnant women for mental illness.

The bill is promoted under the ruse of screening for postpartum depression. But a true picture of the target population of this massive drug pushing scheme is evident in the propaganda submitted to support the passage of the original bill in the US House of Representatives and the programs already in place in various states.

The legislation was first introduced in the House in January 2007 by Illinois Democrat Bobby Rush. Under “Background and Need for Legislation,” House Report 110-375 states in part:

“Depression is twice as common in women as it is in men, with its peak incidence during the primary reproductive years–ages 25 to 45. Because women are more likely to experience depression during these years, they are especially vulnerable to developing depression during pregnancy and after childbirth.”

In February 2007, the “Postpartum Mood Disorders Prevention Act,” was introduced in Illinois. The orchestrated attempts to pass this bill included planting reports in the media with claims that pregnant women are at risk for a whole list of mental disorders. For instance, on March 1, 2007 an article in the Naperville Sun stated:

“New moms face increased risks for not only postpartum depression, but also bipolar disorder, schizophrenia, obsessive-compulsive disorder, anxiety and other disorders, according to one of the largest studies of psychiatric illness after childbirth.”

The websites set up by the industry-backed front groups supporting the Mother’s Act have links to programs that claim new mothers need to be screened for “postpartum” depression, bipolar disorder, schizophrenia, psychosis, anxiety disorder, panic disorder, obsessive-compulsive disorder, post traumatic stress disorder, and eating disorders.

When extending the drug-net to all pregnant women, the groups omit the term “postpartum” and claim women need to be screened for “perinatal” (which means both before and following birth) disorders. In December 2007, Illinois enacted “The Perinatal Mental Health Disorders Prevention and Treatment Act,” with the stated purpose “to increase awareness and to promote early detection and treatment of perinatal depression.”

But here again, the mention of “depression” only is deceiving because the websites of hospitals in Illinois show they are screening for the entire gamut of disorders mentioned above. Advocate Good Samaritan Hospital in Downers Grove offers “Perinatal Depression Support Services.”

“Any woman who is thinking about becoming pregnant, is pregnant, or had a baby within the past year can be affected by depression or other mood disorders,” their website says.

“Mental health screening under the guise of identifying individuals who are impaired from some supposed mental disturbance is typically simply another front for pharmaceutical marketing,” according to Dr Bose Revenel, co-author with psychologist John Rosemond of the new book The Diseasing of America’s Children.

“Most are funded or the initiative is provided via pharmaceutical companies and medications are typically promoted as a supposed ‘solution,’” he says.

“The problem here is that, among other things, the drugs promoted have been shown to have potentially serious side effects and their effectiveness compared to placebo only trivial,” Dr Revenel reports.

“Furthermore,” he says, “the campaign ignores safe and potentially effective interventions such as dietary and nutritional changes and supplements as well as cognitive therapy – all of which are completely free of potential adverse effects, with effectiveness that rivals or exceeds that of the drugs.”

“If the screening only picked up women likely to benefit from treatment, then maybe it would be justified,” says Dr David Healy, a leading expert on psychiatric drugs from the UK and author of The Creation of Psychopharmacology.

“But screening will pick up a quarter or a third or more of all pregnant women and will lead to many of these being treated who do not need treatment,” he warns. “Over 25% of women might be diagnosed where very few of those are likely to need treatment.”

Although no psychotropic drug has FDA approval for use during pregnancy, the recommended treatment for all these so-called “disorders” consists of the newest most expensive antidepressants, antipsychotics, and anticonvulsants. The common practice is to prescribe three or four different drugs at a time for years on end.

The antipsychotics that will benefit as a result of the Mother’s Act include Seroquel by AstraZeneca, Risperdal marketed by Janssen, a division of Johnson & Johnson, Geodon by Pfizer, Abilify from Bristol-Myers Squibb, Novartis’ Clozaril, and Eli Lilly’s Zyprexa.

Lilly also sells two antidepressants, Prozac and Cymbalta, and Symbyax, a combination of Zyprexa and Prozac. The other SSRI (selective serotonin reuptake inhibitor) and SNRI (selective norepinephrine reuptake inhibitor) antidepressants include GlaxoSmithKline’s Paxil and Wellbutrin, Pfizer’s Zoloft, Celexa and Lexapro from Forest Labs, Luvox by Solvay, and Wyeth’s Effexor.

Pregnancy as a cottage industry

New Jersey Democrat Robert Menendez is the lead sponsor of the Mother’s Act in the Senate. New Jersey is home to a long list of drug companies. The bill was first introduced in May 2007, but was stuck in committee until Senate Majority Leader Harry Reid introduced an $11 billion omnibus package called “Advancing America’s Priorities Act.” Senator Reid tried to get the Act passed on July 22, 2008 by slipping it in the omnibus, but failed.

The Act is supported by a drug-funded coalition bent on turning pregnancy into a cottage industry. On September 25, 2008, Susan Dowd Stone, a member of “Postpartum Support International (PSI),” self-described as the “bill’s lead organizational sponsor,” issued a Legislation Update, obviously to pump out propaganda through the internet.

“Hundreds of thousands of women across the country suffer at the hands of postpartum depression every year, and they deserve better than the ideological games being played with legislation intended to bring them relief,” Senator Menendez declares in the Update.

“This is a cause I am committed to seeing through, and I will continue to stand up on behalf of mothers suffering from this condition until the blockade is cleared,” he vows.

“We will again await its inevitable passage at the next Congressional session when reason may more strongly prevail,” Ms Stone writes in the Update.

A gal named Katherine Stone runs the “Postpartum Progress” blog, described as the “most widely-read blog in the United States on these illnesses.” She serves on PSI’s board of directors as the public relations outreach chairwoman.

Her blog provides links to the “Top Women’s PPMD Treatment Programs & Specialists.” Dr Shari Lusskin is listed as a “top” specialist. She is an advisory council member for PSI. On her website under “Pregnancy-related Mood Disorders,” the standard talking point about “pregnancy related mood disorders” being prevalent is restated as follows:

“Panic Disorder, Generalized Anxiety Disorder, Obsessive Compulsive Disorder, and Eating Disorders may also develop or worsen during pregnancy and postpartum. Women with Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder are particularly vulnerable during pregnancy and postpartum.”

A May 28, 2005 presentation brochure shows Dr Lusskin is a paid speaker for Glaxo, AstraZeneca, Pfizer and Wyeth.

The postpartum blogs are also used to sell books written by the “experts” and promote drug company funded conferences. For instance, on May 13, 2008, Postpartum Progress put out an ad for a June 25, 2008 conference at the University of Minnesota, titled, “Motherhood, Mood Disorders & Anxiety: Before & After Pregnancy.” The listed sponsors included AstraZeneca and the National Alliance for Mental Illness (NAMI), the most notorious industry backed front group on the planet.

Eli Lilly is logically the top giver to NAMI and many other front groups because it has the most drugs to peddle. Several class action lawsuits currently filed against Lilly specifically allege that Lilly funneled money to NAMI to aid in the off-label marketing of Zyprexa.

Between 2003 and 2005, Lilly donated $3 million to NAMI, according to the May 28, 2006 Philadelphia Inquirer. Lilly’s disclosure records show NAMI groups received more than $700,000 from the company in the first quarter of 2008. NAMI’s 2007 Annual Report lists Abbott Labs, AstraZeneca, Bristol-Myers, Eli Lilly, Forest Labs, Glaxo, Janssen, Pfizer, Wyeth and Solvay as “Corporate Partners.”

The NAMI website reports that the “National Depression Screening Day” and the “Stop a Suicide Today” campaign are endorsed by the American Psychiatric Association and are conducted in partnership with the American Association of Suicidology, Suicide Prevention Action Network USA, the National Suicide Prevention Lifeline, Suicide Prevention Resource Center, and Mental Health America.

In 2006, the pharmaceutical industry accounted for about 30% of the American Psychiatric Association’s $62.5 million in financing, according to the July 12, 2008 New York Times. Lilly’s first quarter grant report for 2007 shows Lilly provided the APA with two grants worth over $412,000. The Suicide Prevention Action Network received $10,000 from Lilly in the first quarter of 2007.

Mental Health America’s annual report shows the group received over $1 million from Bristol-Myers, Lilly and Wyeth in 2006. Janssen and Pfizer gave between $500,000 and $1,000,000, and AstraZeneca and Forest Labs donated between $100,000 and $499,000. Glaxo gave the group between $50,000 and $100,000 in 2006.

Other funding sources listed on the MHA website include three treatment centers for eating disorders with links to their websites. The National Association of Anorexia Nervosa and Associated Disorders estimates that the average cost of private inpatient treatment is $30,000 or more a month, according to an April 27, 2006 report by Women’s enews.

On May 21, 2008, the president of the Depression and Bipolar Support Alliance (“DBSA”), Sue Bergeson, posted a message on Bipolarconnect.com, saying Illinois Senator Dick Durbin’s office had called to say they were having “a hard time making headway” with the Mother’s Act. She informed readers that “more than 800,000 women will develop a diagnosable postpartum mood disorder this year! And this number doesn’t include the 7.5% of women who will develop major depression during pregnancy.”

At the end of the article, Ms Bergeson provided a link and urged people to take “30 seconds” to send a letter to their Senators.

The 2006 Annual Report of DBSA shows AstraZeneca gave the group more than $500,000 in 2006. Companies that donated between $150,000 and $499,000 include Abbott, Bristol-Myers and Wyeth. Forest Labs, Glaxo, Janssen, Pfizer, and Shire Pharmaceuticals each gave between $10,000 and $149,000. Lilly is listed in the section titled, “Matching Gift Companies,” in the report.

Battle lines drawn

A number of influential advocacy groups have come out against the Act including the International Center for the Study of Psychiatry and Psychology; Alliance for Human Research Protection; International Coalition For Drug Awareness; Law Project for Psychiatric Rights, Mindfreedom International, AbleChild, and the National Association for Rights Protection and Advocacy.

The website, UniteForLife.org is run by Amy Philo, the Texas mother at the forefront of the “Unite for Life” campaign against the Act. Amy’s story provides a poster perfect example of what will happen to hundreds of thousands of women all over the county if the bill is passed.

Amy was labeled mentally ill and told she needed to be on drugs by a nurse making a home visit simply because she got very upset after watching her first-born infant almost choke to death a few days after he was born.

When she followed the nurse’s advice and went to the doctor, the Ob-Gyn would not even take two minutes to listen to Amy talk about what had happened or allow her to explain why she was experiencing such over-whelming fear and anxiety.

Instead of viewing this young mother’s reaction to the near-death of her infant as a normal response, the doctor told her she had a panic attack and sent her home with samples packets of the antidepressant, Zoloft, to prevent postpartum depression, apparently expecting her to get over her traumatic experience by taking a pill.

There were no warning labels on the samples and the doctor did not alert Amy to any of the potential side effects. “He told me Zoloft was perfectly safe for me and the baby and it would make my baby happy too,” she recalls.

Within three days, the Zoloft pushed Amy into a state where she started having thoughts of first killing her baby and later of killing her husband, her mother, herself and even her pets. When Amy confessed to having these thoughts, instead of recognizing the side effects of Zoloft and stopping the drug, the medical professionals upped the dose, locked her up in a mental ward away from her baby, and tried to add Zyprexa, to the mix.

They never told Amy why they wanted her to take Zyprexa, but the sheet they gave her said it was for schizophrenia, she recalls. Amy refused to take it because she wanted to nurse and was afraid the drug would harm the baby.

She finally lied her way out of the hospital by claiming she no longer had the bizarre thoughts because she wanted to be with her baby and family. But in reality, Amy battled the obsession with suicide and homicide for months waiting for Zoloft to work.

“The constant ideas of homicide were followed by thoughts of suicide to protect my son from me,” she says. “I never had thoughts like this in my life before I took Zoloft.”

They also tried to get Amy to take the sleeping pill, Ambien, the anti-anxiety drug, Klonopin, and Celexa, another antidepressant, even though she was nursing. “I always just said no to those,” Amy says.

The Ob-Gyn told Amy that she might have to remain on Zoloft for life and without the drug she was not in control enough to have more children. The pediatrician told her, “what’s really scary is that PPD seems to get worse each time and you have a 90% chance of getting it after your next baby,” she recalls.

She finally quit taking the Zoloft against medical advice and the obsessive thoughts of homicide and suicide stopped and never returned. Amy and her husband have since had a second child with no problem whatsoever without the Zoloft.

She recently obtained copies of her medical records, which show she was labeled with obsessive-compulsive disorder and major depression. Those stigmatizing labels will remain in her records forever with no acknowledgment that Zoloft caused the ordeal.

“Antidepressant-induced mania commonly results in a false diagnosis of a new disorder leading to stigmatization and a possible lifetime of unnecessary, harmful treatment with drugs,” says Dr Peter Breggin, author of the new book, Medication Madness, and the man often referred to as the “conscience of psychiatry.”

Drug companies have a big financial incentive to promote these drugs. According to DrugStore.com, a 30-day supply of 20 mg Zyprexa costs $725.93. A 30-day supply of 100 mg Zoloft is $104.84. Klonopin costs $65.93 for 30-days of 2 mg tablets. The price of a 30-day supply of 10 mg Ambien is $145.99, and 20 mg Celexa costs $96.99 for 30-days. Amy’s two-day stay in the mental ward cost her family’s insurance company about $8,000 and an $800 co-payment for Amy and her husband.

The assertion that all these sick women are going without treatment is absurd. More prescriptions are written for psychiatric drugs every year in this country than for antibiotics or diabetes medications. On June 30, 2008, CNN Money reported that, for the “sixth year in a row,” antidepressants were the number one class of drugs prescribed in the US in 2007. CNN cited a report by the pharmacy benefit manager, Medco Health Solutions, that said 16% of women ages 20-44 take antidepressants.

In 2007, the branded atypical antipsychotics generated $15.9 billion in manufacturer sales in the seven major global markets, with $12.3 billion of those sales in the US, according to an April 2008 report by Sandra Chow on the Decision Resources website.

Thousands of infants harmed

In a September 18, 2008 letter to members of Congress urging them to vote against the Mother’s Act, Unite For Life reported that the estimated number of antidepressant-caused infant deaths and injuries over the past four years, based on data from the FDA’s MedWatch, were: 4,360 babies born with serious or life-threatening birth defects; 4,160 babies born with potentially fatal heart defects or heart disease; 2,900 spontaneous abortions; and 3,000 premature births.

The so-called experts supporting the Mother’s Act constantly minimize the risks. However, a study titled, “Acute Neonatal Effects of Cocaine Exposure During Pregnancy,” in the September 2005 Archives of Pediatric and Adolescent Medicine describes adverse effects for cocaine exposed babies eerily similar to those in babies born to mothers taking antidepressants:

“Several central and autonomic nervous system findings, which included hypertonia, jitteriness or tremors, high-pitched cry, difficulty arousing, irritability, excessive suck, and hyperalertness, were noted more frequently on the initial physical examination in the cocaine-exposed cohort. During the hospitalization, the diagnoses of seizures and autonomic instability were more frequently noted in cocaine-exposed infants.”

The warnings and precautions section on current labeling for SSRIs and SNRIs contains the following statement:

Neonates exposed “late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. … Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome.”

Besides the agony endured by these infants and their families, the additional medical costs are enormous. In 2005, commercial insurers paid an average of $4,247 per day for babies in neonatal intensive care, according to Thomson Healthcare. Direct health care costs for a premature baby average $41,610 or 15 times higher than the $2,830 for a healthy, full-term delivery, a March of Dimes May 2007 report on Preterm Birth estimates.

Advocates of the Mother’s Act claim mental illness poses a greater risk to the mother than drug use to fetus. “The problem with this claim is that there is no consideration for the immense stress a mother has to endure when her baby is sick due to this drug use,” says Kate Gillespie, an attorney who handles birth defect litigation at the Los Angeles based Baum, Hedlund, Aristei & Goldman law firm.

“Not to mention the far greater stress that is created by having to constantly deal with life and death health issues, like severe heart defects and respiratory problems, such as persistent pulmonary hypertension of the newborn, caused by SSRI medication,” she notes.

Baum Hedlund is currently representing over 200 families whose babies were born with birth defects ranging from congenital heart defects to PPHN after the mothers used SSRIs.

(Written as part of the SSRI Litigation Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldman‘s Pharmaceutical Litigation Department)

Former FDA officials from the Bush Administration organized this industry funded front group a few years ago and made Peter Pitts, President, and Robert Goldberg, Vice President. DrugWonks is the defacto media outlet used to distribute information over the internet as a services to drug company clients of the public relations firm Manning Selvage and Lee, where Mr Pitts is Senior Vice President of Global Affairs.

In a September 1, 2006 posting, Mr Pitts bragged that DrugWonks received over 100,000 visits in August 2006. “And considering we’re not a ‘mass’ blog, we think that’s pretty terrific,” he noted.

“According to Technorati (the folks who measure blog audience numbers) of the 55 million blogs out there, drugwonks.com has cracked the elite top 100,000. We’re Number 92,165,” he reported on December 22, 2006.

A partial list of Big Pharma loyalists who have served, or currently serve, in the Bush Administration’s FDA, can be found in a June 30, 2006 blog, in which Mr Pitts provides the details of what he described as the “memorable launch party” for “the Center for Medicine in the Public Interest (the public policy home of drugwonks.com.)”

Memorable for many reasons, he said, but mostly because of who attended. The attendees included FDA Deputy Commissioners, Janet Woodcock and Dr Scott Gottlieb. That would be the Dr Gottlieb who was recruited for a job at the FDA from MS&L, before moving on to employment with the drug company Novartis.

Anna Barker, the deputy director of the National Cancer Institute, also attended the bash, along with Julie Goon, described by Mr Pitts as “the new White House health care policy guru.”

Referred to as a “former FDA colleague,” Daniel Troy, former chief counsel of the FDA, best known as the Godfather of Preemption, was at the party and serves on the CMPI advisory board. He recently landed a top job with MS&L client GlaxoSmithKline.

John Taylor, the former National Institute of Mental Health director, now a CMPI board member, also attend the grand-opening, along with Dr Fred Goodwin, who sits on a CMPI board and belongs to a gang of academic quacks paid by the makers of SSRI antidepressants like Paxil, Prozac and Zoloft, to sign their names to bogus studies misrepresenting the efficacy of the drugs and concealing the suicide risks.

The keynote speaker for the kick-off party was former FDA Commissioner, Mark McClellan, described by Mr Pitts as, “the hardest working man in health care.”

Slanderland in cyberspace

Mr Pitts and Mr Goldberg operate as a two-man Guerilla hit squad on DrugWonks. Its their job to recognize any reports in the media that could be damaging to the FDA, or negatively effect Big Pharma profits, and publish a response to discredit or distort the story and lessen the impact.

They keep a running tab of all persons who represent a threat to Big Pharma with some of the most highly respected medical experts in the world at the top of their hit list. New enemies are added all time and among those regularly attacked are lawmakers on the powerful committees in Congress that oversee health care, career scientists at the FDA, reporters who write damaging articles, and public health advocates.

The mere mention of a “Black Box Warning,” is a threat to drug profits and requires immediate damage control. For instance, on October 24, 2005, in response to a request by the consumer safety group, Public Citizen, for a black box warning on erectile dysfunction drugs, Mr Pitts ridiculed the leader of group by writing:

Sidney Wolfe, Public Citizen’s General Secretary of Junk Science has just filed a Citizen’s Petition with the FDA calling for a Black Box warning on ED medications because of 48 events of NAION (non-arteritic ischemic optic neuropathy, a loss of vision that is frequently irreversible).

“Suggesting that Sidney have his eyes examined would only be a partial diagnosis,” Mr Pitts wrote in the blog.

He was particularly annoyed over Dr Wolfe saying FDA “has once again failed in this responsibility. These drugs need much stronger warnings, especially a black box warning such as the one we have proposed.”

“USA Today” was attacked on November 15, 2007, under the headline: “USA Today Adds Its Own Avandia Warning,” for quoting FDA career scientist, Dr David Graham, when discussing the cardiac risks of GlaxoSmithKline’s diabetes drug, Avandia, instead of talking to the FDA official from the CMPI team. “Here’s USA Today crawling through the mud — past Janet Woodcock who officially speaks for the FDA — to talk to David Graham about Avandia,” Mr Goldberg wrote.

Road to Extinction

In a July 30, 2008 blog, Mr Pitts seemed really rattled over a story by Alicia Mundy in the Wall Street Journal with some pretty good hints that the tribe of CMPI Guerillas promoting Big Pharma’s agenda, with the help of industry insiders at the FDA, might soon be on the path to extinction, when reporting that:

Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising.

Leading the drive are Rep John Dingell (D Mich) and Senator Chuck Grassley (R Iowa), she said. “Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry,” Ms Mundy reported.

In a DrugWonks rapid response, Mr Pitts asked, “isn’t the FDA already an entirely independent government agency?”

“To lay the groundwork for their FDA overhaul,” Ms Mundy reports, “Messrs. Dingell and Grassley and their allies have ordered about 20 investigations of drugs and issues involving the FDA.”

“Mr. Grassley began his campaign to overhaul the FDA in 2004 during an uproar about the agency’s slow reaction to potential links between popular antidepressants and teen suicides,” she notes. “Now he has four staffers and a parade of FDA whistleblowers helping him investigate a plethora of FDA controversies, such as its approval of the antibiotic Ketek,” she reports.

Mr Pitts calls this revelation about the opening of a new website to air criticisms of top FDA officials, “some really shoddy reporting”:

“Some current and former FDA safety reviewers have opened a whistleblower website to air their concerns that FDA leaders are pushing them to approve some drugs”

He points out that this site defines itself as “a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful directives by US FDA upper management – directives that put public health at avoidable risk.”

Apparently Mr Pitts took the time to check it out and found Jim Dickinson, who is not a former FDA employee, registered the website, and is a “long-time FDA antagonist,” he says. But then Mr Pitts is a “long-time antagonist” of Senator Grassley and whistleblowers as well. He can be found taunting the Senator on DrugWonks as early as November 18, 2005, in calling him, “the new father-confessor of disgruntled FDA employees.”

On February 21, 2008, he posted the headline, “Not the real FDA – a Grahamatization,” in highlighting what he described as an, “Interesting omnibus piece from by Warren Ross of Medical Marketing & Media on the various slings and arrows being tossed at the worlds premier medical regulatory agency,” in which Mr Pitts just happens to be quoted.

“Here’s what I had to say,” he writes in the blog, “about the David Grahmatization of the whistleblower culture.”

Pitts also takes a dim view of people who go outside the agency to complain. A professional, he maintains, should not “weep and whine and try to get decisions made that are based on politics rather than on science.” Whistleblowers, he acknowledges, at least deserve “grudging respect” for letting it be known who they are, “but what is truly damaging are the silent leakers” who try to force political pressure on FDA decisions. “The motive may be either to get drugs approved or not approved—it cuts both ways.”

The blog concludes with the comment: “As Jimmy Durante said, ‘I’m surrounded by assassins.’”

Mr Pitts seemed particularly riled up over Ms Mundy’s report that Senator Grassley believes the FDA Office of New Drugs has been compromised by its relations with industry lobbyists, and among them “former top FDA officials.”

“And what does that mean?” He demands to know on DrugWonks. “Any evidence to back up such blowhard accusations?” He asks in his blog.

FDA officials “are too cozy with the companies they regulate,” Senator Grassley told the Journal, and new leadership must “fix the culture.”

“What does “too cozy” mean?” Mr Pitts asks in his blog. “Really, what does it mean?” He demands to know.

Industry insider protection by DrugWonks

Mr Goldberg identified three cozy FDA officials that lawmakers wanted gone in a blog on February 20, 2008, when responding to what he described as “Anna Mathews puff piece” on Bart Stupak, the Michigan Democratic Congressman, in the Wall Street Journal.

Under the headline “WSJ Overlooks Stupak Stupor,” Mr Goldberg wrote: “Good thing she didn’t include this stirring Stupak statement — from an LA Times article — about why Andy von Eschenbach, Sandy Kweder, Janet Woodcock and the FDA’s cafeteria guy should resign…”

The drug companies know that this administration … will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice.

On April 23, 2008, in the midst of the Heparin scandal, Mr Goldberg ran the headline: “Heparin Hypocrisy — Hyped Up Safety Fears on ADHD Drugs — Does Medicaid Kill Poor People,” and wrote: “Yet another show trial held by another congressional committee on the FDA… There have been four or five over the last two months on heparin alone.”

“Andy von Eschenbach,” he said, ‘who is gaining momentum, along with the FDA, in shifting the agency towards a science and systems based approach to regulation — using real time technology to promote full time compliance — has to sit and take the following from the likes of Bart Stupak (D-Michigan)”:

Last year, this nation’s regulatory failures resulted in dead dogs and cats. This year, it has tragically led to the deaths of people,” said Rep. Bart Stupak, D-Mich. “If we don’t make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us.

“That’s rich,” Mr Goldberg said, “coming from a guy who helped push up the suicide rates by scaring parents away from antidepressants. and who is pushing for drug importation at a time when Al Qaeda and Hezbollah are involved in drug counterfeiting.”

“Andy must have to shower after sitting through such a show trial,” he added.

“Meanwhile the Steve Nissen fear factory spews out another piece of tabloid medicine: EKG monitoring of all kids getting stimulants for ADHD,” Mr Goldberg continued, referring to the world-renowned cardiologist from the Cleveland Clinic.

“Now there’s a way to achieve Nissen (who has never studied ADHD) goal of making a physician’s hand quiver before writing a scrip for the drug,” he wrote.

Evidence of “cozy” relationships can also be found in the names of the guests at the “memorable launch party.” On August 24, 2005, Mr Pitts pumped out syrupy defense when the Seattle Times criticized the FDA’s hiring of industry insider, Scott Gottlieb, directly from the MS&L stable. Without mentioning that he also was employed by MS&L, Mr Pitts wrote:

Scott Gottlieb is a lot of things. Public servant. Physician. Pundit. He is my former colleague at the FDA. Most importantly, he is my friend.

And my blood boils with anger and frustration at today’s scurrilous attack on him in the Seattle Times.

Scott I know personally. I know that he takes his work at the FDA seriously. I know that he takes his government oath to protect the public health seriously. I know that he is highly ethical and honest. And I know how much this article must hurt him personally.

And, I’m sure, that is precisely why certain lupine elements are gleefully forwarding this ugly hit piece to their friends and colleagues.

“If people don’t agree with his policy positions they should dispute them, firmly, strongly, logically — and respectfully,” Mr Pitts wrote.

“That they have chosen character assassination only shows the weakness of their intellectual arguments as well as their disappointing lack of character,” he wrote. “For shame.”

On January 15, 2006, Dr Sidney Wolf, was again ridiculed when the LA Times cited his criticisms of what Mr Pitts described as the FDA’s “new and better way to establish drug safety that solves a one of the more serious problems in drug development, namely that animal studies are often a poor and inaccurate substitute for what happens in human.”

The “better way” involved earlier testing on humans. Dr Wolf questioned whether the FDA had a strong enough scientific argument for speeding the early stages of drug research, the Times noted.

In his blog, Mr Pitts dismisses the legitimacy of Dr Wolf’s concerns with the statement: “Sid Wolfe has opposed every effort to speed drugs to dying patients since he has been on his anti-patient jihad starting in 1970.”

“Wolfe has a self-interest in trashing new medicines,” he also explained, “since his organization makes money by hawking a book Worst Pills, Best Pills that argues the most drugs are dangerous.”

Blowhard accusations

The majority of proof to support Senator Grassley‘s “blowhard accusations,” will likely come directly from the CMPI website and the years of incriminating blogs by Mr Pitts and Mr Goldberg filled with nothing but lobbying campaigns for the drug companies.

Rarely does a month pass where the two top bananas are not pumping out propaganda to boost profits for MS&L clients Eli Lilly, Glaxo and Pfizer, with false claims that SSRIs are effective and do cause suicide, along with vicious attacks on anyone who says otherwise.

On February 15, 2008, Mr Goldberg was again blaming a non-existent decline in the prescribing of SSRIs, and the increased suicides, on Rep Stupak, as head of the Health subcommittee on Energy Commerce. He held “several fear-drenched hearings about antidepressants in 2003-2004,” and he “is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide,” Mr Goldberg wrote. “So the question is,” he said:

“And this guy is head of the Health subcommittee? Why is he being taken seriously? Why isn’t he being held accountable?”

In the blog, Mr Goldberg includes the following statements made by Rep Stupak a hearing, which he claims are “scientifically incorrect,” “misleading” and “dangerous”:

SSRI’s have not been proven effective in treating adolescent depression. To the contrary their use may actually increase the suicide rate of its young patients.

In response to these reports of increased suicide rates with SSRI use, FDA officials suppressed their own post marketing surveillance, prohibited FDA employees from discussing the report, and launched an investigation to find the person who leaked information to the press. Today, SSRIs remain on the market without a clear medical benefit to the patient.

“There should be a black box warning around everything Stupak says regarding medicines,” Mr Goldberg declares, “particularly SSRIs which have been shown to benefit patients and are associated with a decline in suicides.”

Prolific smear campaigns are directed at medical experts who testify against Big Pharma in litigation or government hearings. A life-time reputation of credibility and high regard may be targeted for assassination as punishment for this capital crime. Attempts to destroy the reputation of Dr David Healy, the world-famous expert on psychopharmacology, with 20 books to his name, appear frequently on DrugWonks. For instance, on December 19, 2006, Mr Pitts wrote:

Dr. Healy recently testified at the FDA hearing on antidepressants. He is a psychiatry professor at Cardiff University in Wales but also, according to the New York Times, has worked for plaintiff’s lawyers in cases brought against pharmaceutical companies. That’s transparency.

“When I served as Associate Commissioner at the FDA, Dr. Healy visited with me — but he never mentioned that he worked for the tort bar,” Mr Pitts said. “That’s dishonesty.”

The untold story here is that Dr Healy traveled to Washington on his own dime in 2004, for the meeting of the FDA Advisory Committee to consider the suicide risks of SSRIs. During his visit, Dr Healy and a group of people that included parents of children who committed suicide while taking SSRIs, also met with Mr Pitts and other FDA officials.

As a follow-up to the meeting, Dr Healy prepared a lengthily report with summaries of all the available suicide data on each SSRI, including his own studies, and sent copies to Mr Pitts and the other FDA officials, free of charge. Dr Healy’s trip to Washington to testify at the advisory committee meeting in December 2006, was also on his own dime.

In an email, Dr Healy was asked whether he would like to respond to the above allegations by Mr Pitts on DrugWonks. In a return email, Dr Healy explained that he consults as an expert in litigation for drug companies and trial lawyers alike, and wrote:

When I went into the FDA to meet with Peter Pitts, I made no efforts to conceal my links to trial attorneys — some of whom were at the meeting — and no efforts were made to conceal my links to the pharmaceutical industry, all of which were well known.

“I went,” he said, “because in my experience Republicans such as Senator Grassley and staffers working for them such as Emilia DeSanto have appeared more concerned about and more effective on the issue than anyone else and as a Republican appointee I thought Peter Pitts’ heart might be in the right place.”

“What was not well-known at the time was that Peter Pitts was transiting between working for pharmaceutical companies – or perhaps not even transiting,” Dr Healy wrote. “I’m not sure how many of us would have felt it worth going if we had known his background,” he noted.

“Retrospectively,” Dr Healy says, “it seems astonishing to me now that with people like Peter Pitts in FDA that it was ever possible to bring the suicidality issues to light.”

It seems even more astonishing after reading Mr Goldberg’s blog on February 15, 2008, which declares: “And again, there is no link to SSRIs and in increase in suicides, rather some unclear evidence based on an unvalidated measure called suicidality that includes just talking about self harm in general.”

On March 9, 2008, Mr Goldberg called Dr Healy an expert “whose flawed study about SSRI’s and suicide triggered a series of events which lead to less SSRI use and more suicide.”

However, on July 24, 2008, Pharmalot’s Ed Silverman reported on data just released by the Agency for Healthcare Research and Quality, a unit of the US Health and Human Services Department that showed antidepressant prescriptions rose in 2005.

“The increase amounted to roughly 10 percent, and that occurred in a year in which new and controversial Black Box warnings were added to the labeling on the medications,” he wrote.

In addition, government statistics for 2005, the year the warnings were added, show there was no increase in suicides. In fact, suicide deaths were down in all age groups. For children aged 5 to 14, there were 285 in 2004, and 270 in 2005. In young people aged 15 and 24, the number of suicides was 4,316 in 2004, and dropped to 4,139 in 2005.

Mountains of evidence

Much more evidence can able found in blogs beginning on December 10, 2007, which was another a memorable day at CMPI, when Mr Pitts announced that CMPI would present a new award called “The Golden Clipboard,” to those “who stand in the way of medical progress.”

Those “who stand in the way of medical progress,” refers to persons involved in exposing the FDA’s failure to protect the public from drugs such as the diabetes drug Avandia, Vioxx, and SSRI antidepressants, due to cozy relationships with the makers of the drugs.

CMPI published the names for the top award, and the runner-up winners of the Bronze Clipboard and Silver Clipboard on DrugWonks on December 21, 2007, along with comments about why they were chosen.

The highest honor went to Dr Graham: “For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety.”

“David Graham ostensibly works for the FDA,” Mr Pitts said, “but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite ‘conversations.’”

“Setting aside Dr. Graham’s contribution to the Vioxx Populi literature — which an FDA advisory committee considered to be a rather shoddy piece of research – he also helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides,” he explained.

Mr Pitts also credited Dr Graham for “his assertion that Avandia should be taken off the market,” and said, Dr Graham is AKA (also known as) “Dr. Precautionary Principle.”

The Bronze award went to California Democratic Congressman Henry Waxman, who “is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia,” Mr Pitts pointed out.

His oversight hearing “helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular,” the blog said.

Dr Nissen had to settle for the Silver Clipboard, but his “persistent undermining of the FDA came close to winning him Clipboard top honors for 2007,” Mr Pitts pointed out.

Many of the blogs leading up to the awards seemed to indicate that Dr Graham, Dr Nissen and Rep Waxman were locked in a tight race. But a review of all the blogs on DrugWonks clearly showed that Senator Grassley was never ruled out as the top contender.

For instance, on August 20, 2005, Mr Pitts ran the headline: “Leaves of Grassley. Not a Whit of Sense,” and referred to Mr Grassley as the “Senator from Blameland,” and “Body Slam Chuck, the King of Destructive Criticism.”

Mr Pitts was annoyed over the Senator’s comments about the FDA after Merck lost the first Vioxx trial, in stating: “The Food and Drug Administration was also negligent in the Vioxx case … Those running the nation’s public safety agency repeatedly dismissed the concerns of their own scientists and seemed to do everything possible to keep the public in the dark about emerging problems with Vioxx.”

“And talk about bellying up to the tort bar!” Mr Pitts wrote. “I wonder how much more money the Senator will get from the trial lawyer lizards as a reward for such vituperative rants?”

Of course, he failed to mention that the contributions by the “lizards” could never match the money doled out on Capitol Hill every year by the pharmaceutical industry.

Mr Goldberg’s April 18, 2007, blog pretty much pre-announced the winner with the headline: “David Graham: Public Health Enemy,” and the statement that:

Members of Congress and senior officials of the FDA should be ashamed of themselves for giving Graham the chance to not only rant on about Vioxx and SSRIs but to make the same claims about Ketek and drugs for schizophrenia.

But all the Clipboard winners should feel equally honored by the CMPI awards, because judging by the number of slanderous attacks they each received, their combined efforts to expose drug safety issues and fix the broken FDA are obviously what’s working.

Read Part 1.

However, for all intents and purposes, the mission of CMPI front group is to promote back-door efforts at tort reform, including pushing complete drug maker immunity through federal preemption, to pump out rapid-response propaganda on the internet to deflate scandals involving the pharmaceutical industry and the FDA, and to discredit anyone who would dares to criticize the industry or the FDA.

Former FDA associate commissioner, Peter Pitts, is the president. He is also the Senior Vice President of Global Health Affairs at Manning Selvage and Lee, a Public Relations firm described as “a top five healthcare communications practice with a 50-year history,” representing, “major pharmaceutical, biotech and medical device companies.”

Former FDA chief counsel, Daniel Troy, the Godfather of preemption, sits on an advisory board for CMPI. His bio brags that he “played a principal role in FDA’s generally successful assertion of preemption in selected product liability cases.” He represented drug companies before he was chief counsel and returned to the same role when he left.

In the March 8, 2008, Mother Jones magazine, Stephanie Mencimer points out that Mr Troy’s “career is an illustration of how the Bush administration’s revolving door has allowed industry lawyers to radically reshape regulatory agencies to benefit the big businesses they once represented and then profit from those changes when they return to the private sector.”

Robert Goldberg is vice president of CMPI. He was previously the Director of the Manhattan Institute’s Center for Medical Progress and Chairman of its 21st Century FDA Task Force, according to his bio.

On the CMPI website, Mr Pitts and Mr Goldberg set up the internet blog, DrugWonks, supposedly to provide a forum that offers “rigorous and compelling research on the most critical issues affecting current drug policy.”

But in truth, DrugWonks serves as a defacto media outlet to provide services offered by MS&L to pharmaceutical clients and to counteract damaging information as it comes out in the media with rapid responses on the internet.

“Media is the lifeblood of MS&L and our healthcare practice,” the firm explains on its website. “Our experts immerse themselves in the needs and changes occurring within the media,” it says.

MS&L services include: “Developing communications strategies to support or thwart issues, including outreach to key agenda-setters, coalition-building, e-fluencer campaigns and media outreach”.

Under the leadership of Mr Pitts in the Global Affairs unit, “MS&L helps clients understand and influence government thinking on key health policy issues,” according to the website. “Monitoring emerging health issues to protect clients, particularly legislative and regulatory activities,” is a service offered.

To that end, whenever the “monitoring” spots a potential problem for an industry client involving the FDA or legislation pending or investigations in Congress, Mr Pitts and Mr Goldberg automatically shift into overdrive to either deflate, deflect or defend with information released on the internet through DrugWonks.

In 2006, tax records show, CMPI spent $210,000, to influence the media through a large conference, DrugWonks, editorials in published in major newspapers, and multimedia programs and podcasts, according to Slate Magazine.

In the line of fire

DrugWonks is also used to pump out unsubstantiated, vicious and unprofessional comments aimed at destroying the reputations and credibility of anyone who dares to speak out against the pharmaceutical industry or the FDA, including doctors, researchers, lawmakers and even journalists.

Attorneys are regularly attacked, but only those who defend the little guy against the drug giants. Those who represent industry clients receive the highest praise. The same goes for expert witnesses. An medial expert who consults with attorneys for a plaintiff is referred to as “a gun for hire.” Those on the other side have only the best of intentions.

Mr Pitts and Mr Goldberg demonstrate a special “fondness” for all consumer advocacy groups and public health activists who criticize the FDA or pharmaceutical industry. They are referred to collectively with titles like “whack jobs,” or “conflict of interest capos,” or “Luddites,” whatever that means.

They attacked four medical journals in one whack in a December 10, 2005, blog on DrugWonks. “Too many people are now not taking important medicines for pain, depression and other illnesses because the NEJM, JAMA, The Lancet and the British Medical Journal have allowed their political love fest with the leftists in the media and their hatred of drug companies to pollute their ability to remain objective,” the blog said.

In June 2008, Mr Pitts and Mr Goldberg double-teamed Senator Charles Grassley (R Iowa), and reporter, Gardiner Harris, for three days when the New York Times reported on the investigation by the Senate Finance Committee into the nondisclosure of millions of dollars received by Harvard academics Joseph Biederman, Timothy Wilens and Thomas Spencer from drug companies.

Mr Pitts was especially incensed over the Mr Harris’ acknowledgment of Dr Biederman as: “A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children.”

“How did a phrase like “fuel an explosion” make it past an editor?” he demanded to know in a June 9, 2008 blog. “This is journalism?” he asked.

“The McCarthyite Mugging of Joe Biederman,” was the June 8, 2008 headline on DrugWonks, where Mr Goldberg refers to the investigation as the, “Grassley witch-hunt,” and credits the Times’ story in large part to, “Charles Grassley’s McCarthyite machine.”

There are other agendas at play here, Mr Pitts claimed on June 9, 2008. “When it comes to Conflicts of Interest,” he says, “its COI polloi.”

“The not-so-hidden agenda,” he explains, “is that anyone who supports the use of psychiatric pharmaceuticals for any reason needs to be humiliated and destroyed.”
Mr Goldberg says the non-disclosures amount to nothing more than “bad bookkeeping” or a “bookkeeping problem.” His theory might hold water if not for the fact that the problem continued for 7 years before Senator Grassley caught the glitch. The investigation of money paid to academic included about 30 psychiatrists at 20 universities, at last count.

Conflicted DrugWonker exposed

Its seems Mr Pitts himself does always disclose that he’s sleeping with the devil. However, bloggers on Pharmalot, and other popular websites, made his bed partners widely known after a conflict of interest scandal erupted over his appearance on the radio show, Prozac Nation: Revisited, aired on The Infinite Mind, and broadcast by National Public Radio on March 26, 2008.

CMPI board member, Dr Fred Goodman, hosted the show and told the audience: “There is no credible scientific evidence linking antidepressants to suicide or violence.”

On May 6, 2008, Ed Silverman’s Pharmalot headline read: “NPR: On The Air, But Not In The Open,” for a report on “Stealth Marketers,” by Shannon Brownlee and Jeanne Lenzer, in Slate Magazine with the byline: “Are doctors shilling for drug companies on public radio?” In describing the SSRI discussion on “Prozac Nation,” the authors noted:

The segment featured four prestigious medical experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown.

Not mentioned, Slate says, was the fact that all four experts had financial ties to the antidepressant makers. Mr Pitts was identified only as “a former FDA official.” “Also unmentioned were the ‘unrestricted grants’ that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac,” Slate wrote.

Infinite Mind spoke to Mr Pitts on the show as “a former FDA associate commissioner who was involved in the FDA’s 2004 “black box” labeling of antidepressants as carrying a risk of suicidal thoughts and behavior, and who was at the time the “go-to” guy for the FDA on that issue,” according to Bill Lichtenstein, Senior Executive Producer of Infinite Mind, in a May 9, 2008 written response to “Stealth Marketers,” posted on Pharmalot.

“What we didn’t know, because he didn’t disclose it to us,” Mr Lichtenstein says, “was that Pitts is currently working for a public relations firm whose clients include major pharmaceutical companies.”

The MS&L website shows Mr Pitts’ many drug company clients include Lilly, Pfizer and GlaxoSmithKline, the marketers of the SSRI antidepressants Prozac, Zoloft and Paxil.

Mr Pitts also failed to mention his PR job when he appeared on NPR’s Talk of the Nation and News Hour with Jim Lehrer, according to Mr Lichtenstein. He posted a link to “Prozac Nation,” on DrugWonks in April, 2008 without disclosing the conflicts of interests when describing the experts as well.

In their article, Ms Brownlee and Ms Lenzer noted the undisclosed affiliations of Mr Pitts and Dr Goodman with CMPI, which they described as “an industry-funded front, or “Astroturf” group, which receives a majority of its funding from drug companies.”

In a blog defending himself, Mr Pitts wrote: “I think it’s important to note that, per full disclosure, I was never asked. I would like to assume that when I am called for interviews that the producers have done their due diligence.”

“I also want to be clear that on the other programs mentioned,” he said, “I was asked by the producers about my various affiliations. I answered fully and honestly — and the decision was made not to mention it on the air.”

“When you go to www.cmpi.org, one click on my name tells you everything,” Mr Pitts pointed out. Which begs the question of how would listeners to a radio program know to look for a link on this website when his association with CMPI is not even mentioned?

When the story broke, blogger, Lisa Van S, kicked off the internet slugfest on Pharmalot on May 6, 2008, by writing: “Peter Pitts, Have you no shame!!… Does anyone have the DSMIV diagnosis for habitual Lieing [sic -- ed.].”

Over at DrugWonks on May 6, Mr Goldberg began a “destroy the messenger” campaign against Ms Lenzer, in a blog titled, “I Dream of Jeannie … Retracting,” and the comment, “Talk about tight Jeannes!” with a January 17, 2005, New York Times article titled, “Dispute Puts a Medical Journal Under Fire,” pasted in the blog.

The “Dispute” refers to an article by Ms Lenzer in the January 2005 BMJ, which reported that the FDA was to review confidential Eli Lilly documents that had been sent to the BMJ by an anonymous source and that these documents had gone “missing” during a 1994 product liability suit filed against Lilly. After Lilly complained, the BMJ investigated the matter and issued a retraction of the “missing” statement and explained:

The BMJ did not intend to suggest that Eli Lilly caused these documents to go missing. As a result of the investigation, it is clear that these documents did not go missing.

The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents in these claims. The BMJ is happy to set the record straight and to apologise to Eli Lilly for this statement, which we now retract, but which we published in good faith.

Out of Ms Lenzer’s whole article, one single statement was retracted, but on DrugWonks, Mr Goldberg wrote: “BMJ was forced to retract one of her articles.”

Later in the same blog he wrote: “Here is the BMJ retraction AND apology as it pertains to Lenzer’s unethical and sleazy behavior,” and pasted a copy of the retraction which shows that only one statement was corrected.

The Lenzer distraction idea was obviously chosen as the main talking point early because Mr Pitts pasted the exact same articles on Pharmalot. But on May 7, blogger pg, responded with a January 17, 2005 article that said the Associated Press reported that BMJ editor, Kamran Abbasi, said the apology was limited to the issue of whether the documents were missing from the court case. On May 13, Professor Jonathan Leo, a well-recognized SSRI expert, posted comments on the Slate website and quoted an e-mail to CNN from Kamram Abbasi, which stated:

The London-based BMJ, formerly called the British Medical Journal, did not retract its contention that the documents show the antidepressant is linked to increased risk of suicide or violence. All we have retracted is the statement that these documents went missing.

Pharmalot’s pg, posted quotes from Lilly documents in a May 9, blog, from exhibits in a Prozac trial presented to the jury in a timeline to show that Lilly knew Prozac caused patients to become violent or suicidal long before the drug was approved in 1988. For example, a May 1984 document states: “During the treatment with the preparation (Prozac) 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation (Prozac) …”

In a May 7, Pharmalot blog, Mr Pitts complained that the Slate article did not mention issues he raised about media coverage of the SSRI debate during an interview with one of the journalists. “A robust debate on the SSRI issue is very important,” he wrote. “Trying to stifle debate by personal attacks just shows a lack of intellectual rigor — and cowardice,” he said.

Pharmalot’s pg, responded to this charge by writing, “Personal Attacks – a Few Examples?” with links to 5 blogs on DrugWonks. In a May 8 blog, pg, posted this example: “…Where will Healy, David Graham and the rest go to wash the blood off their hands? And will the FDA do the right thing and stop handing black boxes out to protect themselves from Senator Grassley and the press?”

Attacks of this kind are posted all over DrugWonks, as part of a PR campaign to restart the mass sale of SSRIs to children obviously. The claim is that the black box suicide warning is causing all these kids to kill themselves because doctors are afraid to prescribe the drugs to depressed kids, and the persons who fought to add the warning are responsible for the deaths.

After reading the blogs written by Mr Pitts and Mr Goldberg, Pharmalot’s Eskimo wrote: “Mr. Pitts, looking at all those posts on drugwonks.com, I couldn’t tell who was making the personal attacks, the ‘kooks’ and the ‘document stealers’ or the site’s authors who label them that way.”

On May 8, in a blog with the DrugWonks headline, “Slate ‘n Slime,” Mr Goldberg wrote: “Shannon Brownlee and Jeanne Lenzer did a smear job on Peter and Dr. Fred Goodwin in Slate.” He also stated:

Drugwonks rarely expects other bloggers to focus on substance . Rather, we are flogged for the source of our contributions as if others uncovered a corrupt connection instead of the truth, which is that we proactively provided information.

In the same blog, Mr Goldberg later wrote: “we will do what ever it takes, including legal action, when facts are deliberately omitted, misrepresented and distorted and then willfully repeated to set the records straight.”

“We are aware that our critics don’t have the intellectual bandwidth or the maturity to actually engage on the issues or respectfully disagree or debate,” he said. “Still we expect accuracy and for others to provide some context even as they take their shots as they are entitled to in a free society.”

The next day in a Pharmalot blog, Jane reported that: “drugwonks changed their article – it orginally was titled “Slime-alot, Slime a lttile then ignore the real issues” and threatened to sue Ed.” That would be the Ed Silverman who runs Pharmalot.

In response to DrugWonks blogs accusing critics of lacking intellectual bandwidth and being immature, several Pharmalot bloggers simply pasted more links to more blogs written by Mr Goldberg and Mr Pitts on DrugWonks. But a May 9 blog from pg stated: “Woah Mr Pitts. What a shame you sold YOUR intellectual bandwidth (and your integrity) out to the pharmaceutical industry.”

In the end, the war ignited by “Prozac Nation” would rage on for weeks. Finally, on May 27, 2008, under a heading, “Disturbing Behavior,” Mr Goldberg claimed that he and Mr Pitts had gotten a taste of what others were subjected to on a regular basis, described as:

abuse from out-of-control and obsessive hatemongers who receive succor and support — or at the very least — uncritical coverage by the media as the fail to engage on the substance of issues and instead attack motives and indulge in misleading and distorted use of selective reporting.

“Our willingness to challenge those who have been responsible for scaring people from using antidepressants have diverted attention away from the consequences of a decrease in use with blind fury,” he said, “moving from antidepressants to antipsychotics without regard to the original argument or point, harping instead on funding sources with an obsession that reveals a lack of intellectual bandwidth and genuine hatred that borders on the personal.”

“The blogs that have allowed these posting — unfiltered — know better and bear a responsibility for allowing the attacks and vitriol to become so unhinged and personal,” Mr Goldberg wrote, and specifically mentioned Pharmalot.

“These are sad, hateful people,” he said, “The problem is they often reflect and influence the thinking of people like Brownlee and Lenzer who are considered mainstream.”

“We at CMPI are simply trying to insure that people get the right medicine at the right time,” he says. “No more, no less.”

Major story gone missing

Mr Pitts never misses a change to promote preemption on DrugWonks by publishing new stories about CMPI advisory board member, and former FDA chief counsel, Daniel Troy, who kicked-off the preemption campaign by filing the first FDA brief in support of a drug maker in an SSRI suicide case while serving as chief counsel. However, notably missing in the month of July, is a story on DrugWonks bragging about Mr Troy’s new job at Glaxo. But Ed Silverman reported the news on Pharmalot on July 22, 2008, writing:

The preemption prince is joining the big drugmaker as senior vice president and general counsel on September 2. This is a coup for Glaxo, because Troy is widely known – some might say notorious – for being supportive of the pharmaceutical industry.

He also laid the groundwork for the current legal battle over preemption, which says FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness.

In response to the news, Pharmalot blogger, Laurie, wrote: “Wow.. GSK takes on the one person who has been the poster boy for all that’s bad with pharma and the FDA…way to help your public relations.”

The fact is, Glaxo hired the “poster boy” while facing mounting legal problems due to concealing Paxil’s suicide risk for decades. With the kinds of insider information he could bring to the table, Mr Troy was already the best man for the job. But also important was likely the fact that he knew people were dying from Paxil for years and never cared.

Glaxo has been under investigation by the Department of Justice since 2004 over Paxil. In June 2008, the Wall Street Journal reported a widening of that investigation. In February 2008, Senator Grassley started a new investigation by the Finance Committee, after an expert witness report in a Paxil-suicide case was unsealed by a court that showed Glaxo knew back 1989, that Paxil patients in clinical trials were 8 times more likely to attempt or commit suicide than patients taking a placebo.

The Committee’s investigation of the money paid to academics also includes Paxil researcher, Dr Martin Keller at Brown University, who oversaw the Glaxo-funded trials on children, and was the lead author on the fraudulent papers used to promote the off-label sale of Paxil to children with false claims that it worked and did not cause suicide.

On June 23, 2008, Mr Pitts made a feeble attempt to throw out some sort of defense for his MS&L client with the DrugWonks headline: “What’s Behind the Paxil Investigation?”

“There’s money in it, maybe for the plaintiffs attorneys,” he wrote. “But there is also the Holy Grail of overturing FDA pre-emption,” he added.

The main problem with this theory is that Mr Pitt’s buddy, Dan Troy, seems to be the only attorney moving up the pay ladder.

In Stealth Marketers, Ms Lenzer and Ms Brownlee report that CMPI took in more than $1.4 million from the pharmaceutical industry in 2006. Mr Pitts was asked to identify the companies and apparently decided against it. “I don’t want to go into that,” he told Slate.

With all that drug money rolling in, CMPI could surely afford to hire an editor to clean up the blogs of the media expert and his side kick on DrugWonks. Although allowances for errors in typing, grammar and spelling are commonly extended to internet bloggers, the daily ramblings of Mr Pitts and Mr Goldberg appear on the official CMPI website and should, at least, be legible.

Less than a year ago, in the April 26, 2007 Chicago Sun-Times, Fran Spielman reported that Chicago aldermen were accusing the Daley administration “of being asleep at the switch while low-income housing projects developed by the now-indicted Tony Rezko collapsed into disrepair.”

“The spigot of loans, grants and tax credits should have been cut off when the first of 30 taxpayer-supported Rezko buildings in Chicago fell into disrepair, the aldermen said,” according to the report.

Instead, Spielman said, a “Sun-Times investigation showed that the city, state and federal governments kept the gravy train rolling — to the tune of $100 million between 1989 and 1998.”

The lending continued, the Times noted, even as the city repeatedly sued Rezko’s development company, Rezmar, “for such basics as no heat.”

“They were going after people for being slum landlords in one department and loaning them money in another,” said Alderman Freddrenna Lyle.

Obama now wants to bring this dog and pony show to Washington. I can see it now. His former boss, Allison Davis, at the Davis, Miner & Barnhill law firm, that served as a hub for Rezko’s thriving slumlord business for a decade before Davis quit and became partners with Rezko, will be appointed to head the Department of Housing and Urban Development.

Davis and his partners, which include his sons Jared and Cullen, have received more than $100 million in taxpayer subsidies to build and rehab apartments and homes over the past 10 years and have made at least $4 million in development fees, according to the Times.

“Davis has gotten deal after deal from the mayor, helping to make Davis one of the city’s top developers,” Tim Novak noted in the November 7, 2007 Sun-Times.

There’s already a plan in place to guarantee that the Chicago model of “community development” is carried out in the White House. In his Plan to Fight Poverty in America, Obama says, “we should create an Affordable Housing Trust Fund to develop affordable housing in mixed-income neighborhoods.”

The Plan will create a “White House Office of Urban Policy” to develop a strategy for metropolitan America, and Obama will appoint a Director of Urban Policy who will report directly to him, as president, to “coordinate all federal urban programs,” the Plan states.

Mayor Daley will probably be hired for this gig. The Plan explains that Obama will task his new Director “to work across federal agencies and with community and business leaders to identify and address the unique economic development barriers of every major metropolitan area in the country.”

While climbing the political ladder, Obama held himself out to be a champion of rights for minority-owned businesses. According to an article on Black Enterprize.com, “it is Obama’s strong record when it comes to supporting minority-owned businesses that has black business leaders working overtime to send the 42-year-old congressman to Washington.”

However, an example of the Chicago version of a minority-owned business is DV Urban Realty Partners, where Allison Davis, who is an African-American millionaire many times over, owns 51%, and Robert Vanecko, Mayor Daley’s nephew, owns 49%.

On July 18, 2007, Obama discussed his plan to deal with urban poverty in a speech at the Town Hall Education Arts and Recreation Center in Washington and started out by tugging the heart strings by invoking the name of Bobby Kennedy and stated:

“It’s been four decades since Bobby Kennedy crouched in a shack along the Mississippi Delta and looked into the wide, listless eyes of a hungry child. Again and again he tried to talk to this child, but each time his efforts were met with only a blank stare of desperation.

“And when Kennedy turned to the reporters traveling with him, with tears in his eyes he asked a single question about poverty in America: ‘How can a country like this allow it?’”

“Forty years later,” Obama said, “we’re still asking that question.”

First of all, “Barack Obama, you are no Robert Kennedy,” and we’re still asking the question because the careers of politicians like Obama are funded by a political mafia which has turned helping the poor into a cottage industry.

During his speech, Obama himself spelled out why low-income housing developers get away with funneling tax dollars through poor people in cities like Chicago without drawing any scrutiny, when he stated:

“These Americans cannot hire lobbyists to roam the halls of Congress on their behalf, and they cannot write thousand-dollar campaign checks to make their voices heard. They suffer most from a politics that has been tipped in favor of those with the most money, and influence, and power.”

In Obama’s case, a whole gang of slumlords in Illinois made their “voices heard” by writing campaign checks to fund his rise to fame. But as long as the focus of the slumlord allegations remains solely on a crook named Rezko, the other members of the gang will not get the credit they deserve.

One fact is beyond dispute. Without the fundraising of his political Godfather, Rezko, Obama’s rise to power would not have occurred. However, Rezko was not the pied piper of Hamlin who led Illinois politicians astray. It’s the other way around. Without the cooperation of the corrupt government officials, Rezko would not have been able to fund their political campaigns.

In Illinois, favored politicians are joined at the hip when it comes to fundraising. For instance, from 1999 through 2006, an analysis by the Chicago Tribune shows Obama took in more than $1.5 million from some 700 people who also contributed to Mayor Daley during his political career.

A cursory review of Illinois campaign records shows Allison Davis and his family members giving close to $16,000 to Obama’s presidential campaign. The Sun-Times reports that Davis has donated more than $400,000 to dozens of political campaigns, and the top beneficiaries include Mayor Daley, Blagojevich and Obama.

The truth about all the scams run by the political mafia operating in Illinois is only coming out now because of Rezko’s corruption trial, and if the Democrats want to lose any chance of winning the White House, all they have to do is nominate Obama.

This case is only the first of what could be many to go to trial. Other criminal charges are pending against several people listed in the indictment, and civil lawsuits have been filed against many of the same people and are awaiting the outcome of the criminal cases.

If Obama had an ounce of respect for Democratic voters, he’d drop out of the race before the details of the corruption in Illinois spread to the rest of the country. If the leaders of the Democratic party had a lick of sense, they would inform Obama right now that under no circumstances will his name be on the ballot come fall.

Political junkies know the details of all the sordid scandals swirling around Obama in Chicago, but the average American voter does not have a clue.

The prosecution team is led by the US Attorney for Northern Illinois, Patrick Fitzgerald, of Scooter Libby fame; the same guy who put the last Illinois Governor behind bars and convicted a host of government officials from the Daley administrations who were involved in what prosecutors called “pervasive fraud” to rig city hiring for 12 years with persons who got out the vote for Mayor Daley, and the candidates he endorsed, as well as numerous crooks rounded up during the scandal involving Daley’s Hired Truck program.

The list of names in the indictment includes about eight persons referred to as “Co-Schemers,” and reads like a “who’s who list” of major campaign donors to Obama, Blagojevich, Daley and other powerful Illinois politicians.

Blagojevich is referred to as “Public Official A,” Obama is referred to as a “political candidate,” and there is a list of “Individuals” from “Individual A” all the way up to “Individual HH.”

By now, everybody following the case knows the names of the “Co-Schemers” and “Individuals”, and the Republicans can use the court filings as a roadmap for their plan of attack on Obama. In fact, they are probably editing their talking points for cable news shows as we speak. They no doubt already have video clips in the can of every failed low-income housing project in Chicago connected to Obama to splash across the airwaves the minute he is nominated.

In addition, the Chicago Tribune has two ace reporters, Bob Secter and Jeff Coen, stationed at the courthouse, who provide a daily blog called “Gavel-to-Gavel” on the Tribune website which gives a blow-by-blow account of the live testimony in the trial every few hours.

The names of corrupt politicians and power brokers from both the Democratic and Republican parties are being dropped before the jury like flies. Many of the witnesses, including the main co-defendant, Chicago businessman Stuart Levine, have already pleaded guilty and are testifying under grants of immunity in hope of getting a lighter sentence, which means they have everything to gain by testifying about the other crooks.

Although the Tribune‘s Gavel-to-Gavel coverage is just as good as having a front-row seat in the courtroom, the Obama camp apparently feels the need to monitor the trial first-hand. On March 14, 2008, during an interview with the Sun-Times, a reporter said to Obama: “You have somebody in the courtroom to monitor the trial, right?”

“We may,” he replied, “I think that may be true.”

The case involves the corruption of two state regulatory boards. The investigation, dubbed “Operation Board Games,” by the Feds, began in December 2003, based on information supplied by an informant. Its now obvious that Rezko was aware of the investigation as early as 2004, because during a January 16, 2007, court hearing his attorney, Joe Duffy, told US District Judge Amy St Eve that he was hired in 2004.

“And my guess is you hired Mr. Duffy to deal with the Feds?” the judge said to Rezko, and Rezko replied, “Yes, your Honor.”

The first board controls the Teachers Pension System, which administers pensions and benefits for all Illinois teachers except for those in Chicago, and the Health Facilities Planning Board, which approves all proposals for construction projects that involve medical facilities in Illinois.

The Teacher’s Pension fund has over $30 billion in assets. Investment firms that want to do business with the fund submit proposals, and the board votes on whether to approve the proposal. Some members of the board are elected by teachers in the state, others are appointed by the governor and others serve by virtue of their state office such as the school superintendent.

On Blagojevich took office, the Schemers were able to stack the TRS board with members who would vote whichever way they were told. Once they accomplished that feat, they demanded kickbacks from investment firms in exchange for the approval of their proposals.

Rezko’s partner in the Rezmar development company, Daniel Mahru, is referred to as “Individual Z” in the indictment, and according to court filings, Rezko told Mahru that “$500 million” of TRS money was earmarked for their company. Mahru is reportedly cooperating with federal investigators.

In addition to lining their own pockets, the money gained through the scheme was funneled to the campaigns of Blagojevich and Obama. Prosecutors have identified two $10,000 payments that were made to Obama’s US Senate campaign through straw donors Joseph Aramanda and Elie Maloof, which originated from a kickback paid by investment firm, Glencoe Capital, to secure approval for a $50 million deal.

Aramanda and Maloof also each gave Obama $1,000 for his failed run for Congress in 2000. Once Obama became a US Senator, Aramanda’s son was granted a coveted intern position in Obama’s Senate office in Washington during the summer of 2005, based on a request which the Obama’s camp has admitted came from Rezko.

Levine was appointed to the TRS Board in 2000, by Republican Governor George Ryan and was reappointed in 2003 by Blagojevich. As part of the team led by Levine to rig the votes, Blagojevich appointed, attorney Anthony Abboud, to serve. He is “Individual Q” in the indictment. He has been donating money to Obama’s political career since March 2000, with a total of more than $2,800.

Blagojevich also appointed, attorney Jack Carriglio, or “Individual R.” On June 30, 2003, Carriglio donated $1,000 for Obama’s US Senate campaign.

The TRS story has the makings of a great Hollywood movie with subplots upon subplots. Allison Davis, or “Individual BB,” was a friend of Hollywood producer Tom Rosenberg, who produced the movie, The Human Stain, with Anthony Hopkins and Davis in a small part. He also produced the Oscar winning, Million Dollar Baby.

Rosenberg, or “Individual J,” is a central figure in the case. His investment firm, Capri Capital Advisers, a real estate manager, had done about a billion dollars of business with the TRS in the past and wanted to do more. In 2004, the Schemers tried to coerce a bribe from Rosenberg, or in the alternative a $1.5 million contribution for Blagojevich, in exchange for approval of a $220 million deal.

According to the indictment, Davis admitted to Rosenberg that Rezko, and Blagojevich’s top fund raiser, Christopher Kelly, or Co-Schemer B, had asked Davis who could raise funds for Blagojevich from the state pension system and he volunteered Rosenberg’s name.

During his testimony on April 1, 2008, Levine explained that he was already mad at Rosenberg because he expected $500,000 for help he gave Rosenberg in getting the TRS board to approve a $100 million deal in 2001, but he never came through with the money.

The only benefit Levine received from the deal was that Rosenberg said Levine no longer had to pay him $50,000 a year for lobbying efforts, according to the monitoring by Gavel-to-Gavel.

However, all hell broke lose when Rosenberg refused pay the $1.5 million. During the trial, prosecutors played tapes of phone calls in which comical conversations were discussed between the bipartisan group of Co-Schemers and Individuals, as they were trying to figure out how to deal with Rosenberg and his threats.

The jury heard conversations between Republican power broker, William Cellini, or Co-Schemer A, and Levine, in which they said Rosenberg was threatening to “stand at State and Madison,” and make public the attempt to extort money for Blagojevich’s campaign and that he would “take them all down,” and even threatened to go to the Feds.

They claimed Rosenberg said he considered Rezko and Christopher Kelly the two most likely members of Blagojevich’s inner circle to end up in prison someday, according to Gavel-to-Gavel. Kelly has been charged in a separate case with hiding $1.3 million from the IRS and using money from his business to pay gambling debts with Chicago bookies and Las Vegas casinos.
Levine testified that Rezko wanted things to settle down and quoted Rezko saying, “Mr. Rosenberg was a dangerous individual, and nobody wanted to be put in a dangerous situation.”

Levine said Rezko told him that TRS should grant Capri the $220 million. “But, in fact, that should be the last business that Mr. Rosenberg does with the State of Illinois,” Levine recalled Rezko telling him, according to Gavel-to-Gavel. Levine testified that Rezko said Blagojevich had been briefed on the plan and agreed with it.

During his testimony, Levine also told the jury that Rezko had plans for Blagojevich to run for President. “He said that he had raised a great deal of money for Gov. Blagojevich and that he had great hopes and expectations that Gov. Blagojevich would run for president,” Levine told the jury.

“And although he knew it was a long shot, he was working toward that end,” Levine said.

He also told the jury about an October 29, 2003, trip in a plane he chartered to carry Blagojevich and others to fundraisers in New York, during which Levine thanked Blagojevich for reappointing him to the Planning board and said the governor told him, “Never discuss any state board with me, discuss them with either Tony Rezko or Chris Kelly.”

The TRS part of the story has many subplots. For instance, in 2005, the Feds issued a subpoena to the TRS for records pertaining to a $150 million deal approved for the Carlyle Group, in which Robert Kjellander, or Individual K, described in the August 11, 2005 Sun-Times as the “national Republican Party treasurer,” and “a Springfield lobbyist with close ties to the White House,” was to be paid a $4.5 million fee.

The most famous investor in the Carlyle Group is the family of Osama bin Laden, and its most famous advisor is the first President George Bush. On October 26, 2001, the New York Times reported that the “Saudi family of Osama bin Laden is severing its financial ties with the Carlyle Group, a private investment firm known for its connections to influential Washington political figures.”

“It came largely as a result of public controversy about the family’s stake in a Carlyle fund that invests in buyouts of military and aerospace companies,” a Carlyle executive told the Times.

After the September 11 attacks, the Times noted, “the investment was criticized amid speculation that the family might profit from increased military spending from America’s war on terrorism.”

Kjellander reportedly headed Bush’s reelection campaign in three states and in December 2003, he was able to obtain an invitation from the Bush administration for Levine, Rezko, and Cellini, along with their wives, to attend a Christmas Party at the White House.

Apparently Kjellander is still in good graces with the Republicans because he is “helping plan this September’s Republican National Convention in Minneapolis,” according to John Kass in the March 7, 2008 Chicago Tribune.

The subpoena issued to the TRS in 2005, also included a request for records involving a $10 million investment approved for Hopewell Ventures in 2003, whose principals included David Wilhelm, a former chairman of the Democratic National Committee, who is now a super delegate who openly supports Obama. Wilhelm was a main player in getting members approved to serve on the Health Facilities Planning Board.

The Board is made up of nine members and approval of a project requires a majority of five votes. At the center of this scheme was a proposal by Mercy Health System to gain approval to build a new hospital in Crystal Lake. On April 21, 2004, the board voted to approve the project, even though state analysts said the hospital was not needed.

Levine was also appointed to the Planning Board by a Republican Governor. However, he established himself as a bipartisan crook early in the trial. On March 10, 2008, he told the jury that even before he got involved with the Blagojevich administration, he used to funnel campaign contributions to Democratic candidates through straw donors at the request of former Chicago Alderman Edward Vrdolyak, who has also been indicted on federal fraud and bribery charges in a related case.

Levine’s term on the Board was set to expire in 2004, but the Schemers made sure he remained on the panel. On March 10, 2008, Rezko’s lawyer questioned Susan Lichtenstein, former general counsel to Blagojevich, about a series of email exchanges she had related to the appointments of members to the Board in 2003.

One of the emails was between Lichtenstein and the office of Wilhelm, who ran Blagojevich’s 2002 campaign, which suggested several appointees, including Levine.

“With the e-mails,” Gavel-to-Gavel reports, “Rezko’s lawyers appear to be pushing the point that Rezko wasn’t alone in backing Levine and that Levine’s appointment had a broad array of support.”

While all this was going on, as a state senator, Obama was the chairman of the Senate Committee on Health and Human Services. As such, his name also appeared in the email exchanges as a member of a team working on legislation to keep the board from expiring under a sunset provision of Illinois law.

The email exchanges said, Wilhelm had “worked closely” over six months with state legislators to extend the life of the board and listed Democrat and Republican leaders in the Illinois Senate and House, including Obama.

The exchange with the names of four candidates for the board stated that “our attached recommendations reflect that involvement” with the political leaders.

In the end, the changes made by the lawmakers in 2003 dropped the number of members on the Board from 15 to 9, making it much easier to stack the panel, and by the summer of 2003, the Schemers controlled a 5-bloc vote.

At the time, Thomas Beck was the chairman of panel, and Levine was the vice-chairman. Beck testified, under a grant of immunity, and told the jury that he took a $1,000 donation for Blagojevich when he met with Rezko to seek reappointment.

The persons chosen to guarantee the votes were 3 doctors: Imad Almanaseer, Michel Malek and Fortunee Massuda.

Massuda, or “Individual Y,” gave Obama $2,000 on January 26, 2004. Malek is “Individual FF,” and he donated $10,000 to Obama’s US Senate campaign on June 30, 2003, and another $500 in September 2003.

Almanaseer, or “Individual EE,” contributed $1,000 to Obama on March 12, 2004, and ponied up another $2,000 on May 24, 2004.

This part of the scheme also opens up several subplots. The person responsible for working out the details for the kickback on the Mercy proposal was Jacob Kiferbaum. Kiferbaum was the builder hired by Mercy to construct the new hospital. Levine told the jury about a long history of taking bribes from Kiferbaum, who would then pad his bills to hide the payments. He said the money would be passed through middlemen, such as John Glennon, a prominent Republican insider, who had served on a pension board with Levine.

The new hospital was never built after details about the crimes became known. Kiferbaum has pleaded guilty in the case and is cooperating with the Feds.

When referring to the fact that Obama’s name shows up in the email exchanges as reviewing the recommendations to appoint Levine and the others to the Planning Board, the media is always careful to mention that Obama is not accused of anything.

However, on March 14, 2008, during an interview with the Tribune, Obama was finally asked directly: “Did you have discussions with him [Rezko] about either recommendations that you sought for people or recommendations that he was making?”

“I did not have any formal discussions with Tony,” Obama said, “beyond one individual, and that was Dr. Eric Whitaker, who ultimately became the head of the Illinois Department of Public Health and who had been a longtime friend of mine, who I had known since he was getting his master’s at Harvard and I was at the law school there.”

“He had expressed an interest in that post,” Obama informed the Tribune.

“I think he had applied separately,” Obama said, “but I don’t recall whether I called Tony or he called me.”

“And I simply said, ‘I think this guy is outstanding and is certainly somebody who is worthy of an interview,’” he added.

“And was it your understanding that Tony was going to effectuate that?” the Tribune asked.

“No,” Obama said. “What I knew was, and I don’t think this has been disputed, that he was one of a number of people within the Blagojevich circle who were, you know, helping to screen or interview potential candidates for administration posts.”

The job Obama recommended for his friend paid about $150,000 a year. However, Eric Whitaker is now an executive vice-president of the University of Chicago Medical Center, according to the March 9, 2008, Sun-Times. That would be the same employer that pays Michelle Obama a salary of close to $350,000 as a vice president.

But Obama’s using the lure of the pension funds to raise campaign money goes way back. In 1999, he “was instrumental in the formation of a coalition of black investment firm owners and legislators in Illinois to create an initiative that would award black-owned firms with the management of some of the state’s retirement funds,” according to a 2004 article on Black Enterprise.com.

“He’s out there fighting for us,” said John Rogers, chairman and CEO of Chicago-based Ariel Capital Management in the article. Rogers donated $9,000 to Obama’s US Senate campaign.

“He was a catalyst to pull [everyone] together to create the initiative to have these organizations let minority firms do business with state funds,” said Lee Holland, managing partner and Chief Investment Officer of Holland Capital. Lee Holland, his wife and two of his partners donated $35,000 to Obama’s US Senate campaign. In the October 1, 2007, New York Times, Christopher Drew and Raymond Hernandez reported that:

“Members of the group, the Alliance of Business Leaders and Entrepreneurs, say Mr. Obama checked into their problems and helped start a drive that enabled minority investment executives to win millions of dollars in business from the state’s giant pension funds.”

However, the Times pointed out that Obama’s political career had benefited many times over from his ties to the group. “Several of the businessmen or their wives would help clear the debts from his Congressional race,” the Times wrote, “and six of the group’s members are now among the top fund-raisers for his presidential campaign, according to campaign finance records.”

All totaled, the Times said, employees at more than 30 companies listed on the group’s website and their relatives donated more than $300,000 to help Obama win his US Senate seat in 2004 and “set fund-raising records early in the 2008 presidential race.”

In fact, when Illinois State Senator Emil Jones, Jr became the State Senate president in 2003, he assigned Obama to a committee looking into the pension questions “to help raise his political profile,” according to the Times.

During this period, the Times says, campaign finance records show executives from Ariel Capital, Loop Capital, Holland Capital and Capri Capital, “sharply increased their donations” to Obama’s State Senate campaign fund.

“And once he began his campaign for the United States Senate,” the Times wrote, “they quickly became a fund-raising core that has carried over into the presidential race.”

Obama quit the State Senate committee in late 2003 as his race for the US Senate heated up, “and just as the panel began a series of hearings that produced the most substantial changes,” the Times reports.

The changes generated millions dollars in fees for some of the firms. For instance, Loop saw its fees from one pension fund rise to $2.4 million in 2006, from $5,700 in 2001, and Holland and Ariel both got several hundred million from the pension funds to invest.

John Rogers and two other people at Ariel each bundled at least $50,000 in donations for Obama’s presidential campaign, according to the Times.

An October 3, 2005 article in the Sun-Times, by Chris Fusco and Dave McKinney, reported that Ariel and its top executives also contributed $117,500 to Blagojevich’s campaign.

Although the current criminal case focuses on two boards, the testimony of Jill Hayden, the former head of Blagojevich’s Office of Boards and Commissions, established that the same process was used to fill some 1,500 positions, on 300 boards and commissions, that control a wide variety of regulatory decisions, which would include other pension funds.

Blagojevich appointed Davis to serve on a separate pension board, the Illinois State Board of Investment, which oversees funds for state employees, judges and legislators, and “also has been under federal investigation,” according to the November 7, 2007 Sun-Times.

In the September 23, 2007 Sun-Times, in reference to the “minority owned” DV Urban, of Davis and Robert Vanecko, Tim Novak reported that a “nephew of Mayor Daley stands to make millions of dollars from city-connected pension funds” in “winning business from pension funds for city workers, cops, teachers and CTA employees”.

All total, the pension funds gave DV Urban $68 million. The first investor was the Chicago Teachers Pension Fund, but according to Novak’s report, the board members did not learn that DV Urban was owned by the Mayor’s nephew until 6 months after they voted to approve the investment.

As of September 23, 2007, Davis and Vanecko had received $1 million in management fees and they are “guaranteed at least $3 million in management fees and could make as much as $8.4 million before the pension deal ends on Dec. 31, 2014,” Novak reports.

In addition, Davis and Vanecko will share in any profits from the real estate deals and can earn a 3% fee on the property they develop.

Obama says he met Rezko, when he got a call right out of the blue from David Brint, after he was elected president of the Harvard Law Review, wanting to know if he would be interested in being a developer for Rezko’s real estate company, Rezmar.

Because they read that he was interested in community development work, Obama says, Rezko and his two partners, Mahru and Brint, met with him to discuss the job. “I said no, but I remained friendly with all three of them,” Obama said in the Chicago Tribune on November 1, 2006.

“All three of them remained great contributors of mine,” he added.

And so they did. According to the latest tally given during interviews with the Tribune and Sun-Times on March 14, 2008, the amount attributed to Rezko went from a claim of $50,000 or $60,000 a year ago, to Rezko raising roughly $250,000. In fact, Obama told the Tribune that Rezko “might have raised $50,000 to $75,000″ for one campaign alone in his failed run for Congress in 2000.

The Rezmar connection is a gift that keeps on giving. In February 2007, David Brint gave Obama $4,600, and his wife, Elizabeth gave contributed $2,300. Brint also hosted a fundraiser for Obama in June 2007. Elizabeth donated a couple thousand in 2002 and $2,000 more in 2003 as well.

On March 17, 2000, Mahru gave Obama $1,000, listing himself as president of Rezmar. On March 4, 2004, he donated a whopping $5,000. Mahru also tossed $1,000 to Mayor Daley in 2001 and gave him another $1,500 in 2003.

But then Rezko and Mahru had plenty of money to throw around. By 1998, Rezko had a reported net worth of $34 million and Mahru was worth $14.6 million, according to the “Rezmar who’s who list,” published in the April 24, 2007 Sun-Times.

After turning down the surprise job offer from Rezko, Obama expects voters to believe that he just happened to get hired at the small 12-attorney Davis law firm, which just happened to represent Rezmar in development deals. And then a couple years later, Rezko’s companies just happened to appear on the very first contributions made to the “Friends of Obama” committee to launch his political career as a state senator.

On March 14, when asked by the Sun-Times whether the subject of politics was mentioned at his first meeting with Rezko, Obama stated: “Quite frankly, I don’t recall. I think it was talking about the possibility of me working for him.”

About the same time that Rezko began funding Obama’s campaign for the Illinois senate, Rezmar began developing low-income apartments with three non-profit groups, which were also represented by the Davis law firm, including the Chicago Urban League, the Woodlawn Preservation and Investment Corp, and the Fund for Community Redevelopment and Revitalization.

Bishop Arthur Brazier, described as “a powerful ally of the mayor” by the Sun-Times, founded the Woodlawn Preservation Corp and the Fund for Community Redevelopment.

Davis was the treasurer for Woodlawn when the group went into business with Rezmar and he also served on the board that ran the Fund for Community Redevelopment.

By the time Rezmar started working with the non-profits, two of its earlier projects were having major problems, including a building where the tenants were without heat for five weeks between December 1996 and February 1997. The city had to sue to get the heat turned back on and in fact Chicago sued Rezmar for failing to heat buildings at least a dozen times, according to the Sun-Times.

Obama got a $1,000 campaign donation from Rezmar on January 14, 1997, while those tenets were without heat, Novak reports. Records show that Obama also received a $1,000 contribution from Resko Concessions, a day earlier on January 13, 1997.

Rezmar rehabbed 15 buildings between 1995 and 1998 in partnership with the nonprofits. Each project involved public and private financing including loans from the city or state, federal low-income-housing tax credits and bank loans. The way it was set up, Rezko and Mahru always came out ahead because Rezmar was paid part of the development fees when a deal closed and the remainder when tenants moved in.

The projects were supposed to provide housing for low-income tenents for at least 25 years. “But the first deal Rezmar struck with the Woodlawn Preservation and Investment Corp. collapsed in just six and a half years, when the state sued for foreclosure,” according to a report by Novak in the April 23, 2007 Sun-Times.

Of the buildings managed by Rezko and Mahru, 17 ended up in foreclosure, six buildings are currently boarded up, hundreds of the apartments are vacant and in need of major repairs, and taxpayers are left stuck with millions in unpaid loans, Novak reports.

An “Operation Board Games” investigation should be conducted on the slumlord business in Illinois over the past 15 years. The Chicago Sun-Times reporters, and especially Tim Novak, have already done an excellent job in connecting all the dots.

Daley became Mayor in 1989 and Rezmar got its first city loan of $629,000 the same year, even though Rezko and Mahru had no construction experience. Rezmar stopped making the $2,982 payments three years later and missed 16 payments before the city changed the terms so that Rezmar would only have to pay $465 a month, according to the Sun-Times report by Novak.

Over the years Davis has been appointed to serve on the Illinois Capital Development Board, which oversees state construction projects, and the Chicago Public Building Commission. Daily appointed Davis to the Chicago Plan Commission in 1991, where he stayed until January 2006.

The Plan Commission must approve, disapprove or defer any proposal by a public body or agency “to acquire, dispose, or change any real property within the territorial limits of the city” on the basis of whether or not the referral complies with the city’s long range planning goals and objectives, according to its web site.

After Rezko got Davis appointed to the pension fund Board, Davis helped Rezmar in two major developments as a member of the Plan Commission, even though the two men were business partners. The first vote involved a housing development along the Chicago River at Irving Park Road and was cast a month after Davis won a seat on the Board.

The second was cast a year later in March 2004, for the approval of Rezmar’s proposal for the 62 acre South Loop project. This deal collapsed shortly before Rezko was indicted in October 2006, according to Novak.

Daley made Thomas McNulty, the attorney who acquired the buildings for Rezmar, president of the Chicago Low-Income Housing Trust Fund, a charity run by the city that doles out tax dollars to landlords to subsidize rent payments for the poor. Rezmar received more than $2.7 million from this charity fund, according to the “Rezmar who’s-who list” in the April 24, 2007 Sun-Times.

Mahru was appointed to the Illinois Affordable Housing Advisory Commission in 1993, which helps decide which projects get state funds, by Governor Jim Edgar.

Obama began serving on the board of Woods Fund, a Chicago charity foundation, in 1993, the same year he was hired by Davis’ law firm. In 2000, Davis went to the foundation to help fund his plans to build low income housing. Obama voted to invest $1 million with Neighborhood Rejuvenation Partners, a $17 million partnership that Davis still operates, according to a report by Novak in the November 29, 2007 Sun-Times.

Davis used some of the money to build a 72-unit apartment building for senior citizens, a $10 million project built with a $5.7 million city loan, which earned Davis nearly $700,000 in development fees, Novak says city records show.

Davis’ son Cullen is paid to manage the building, which opened three years ago with a ceremony featuring Mayor Daley.

Kelly King Dibble was the vice president for business development at Rezmar and she became the executive director of the Illinois Housing Development Authority once Blagojevich became Governor. She is now an attorney with, The Northern Trust Company, the same company that financed Obama’s mansion.

Velma Butler, an investor in Rezko’s 62 acre Loop project, also serves on the Illinois Housing Authority. She donated $1,000 to Obama’s US Senate campaign in 2003.

On October 1, 2006, Daley appointed Martin Nesbitt chairperson of the Chicago Housing Authority. The CHA was created for “the purposes of engaging in the development, acquisition, leasing, operation, and administration of a Low Rent Housing Program and other federally assisted programs,” according to the agency’s 2005 annual financial report.

Nesbitt succeeded Sharon Gist Gilliam, according to the CHA web site. Gilliam is a former board member of Rezmar. She told the Sun-Times that she was only on the Rezmar board until 1991. However, the Times found her still listed as a board member in a 1994 biography on the company’s web site.

Daley had appointed Nesbitt commissioner of the Housing Authority on July 9, 2003, and he served as vice chairperson of the Board since January 17, 2006.

Nezbitt is also vice president of the Pritzker Realty Group, where he procures new real estate investment opportunities, retail investments and developments for the Pritzker Group, according to the CHA web site. A quick trip to the Huffington Post site showed tens of thousands of dollars donated to Obama from people with the last name Pritzker in the Chicago area but many people are listed as homemaker or not employed or information requested, so its impossible to sort them out.

Nesbitt is treasurer for Obama’s presidential campaign according to the Center for Public Integrity. Over his political career, Nesbitt has contributed more than $10,000 to Obama’s campaigns.

Michelle Obama was hired as an assistant in Daley’s office by Valerie Jarrett, Daley’s deputy chief of staff in 1991. When Daley appointed Jarrett chairman of the Office of Planning and Development, Michelle became her assistant..

Jarrett is now CEO of the real estate development and management firm, called Habitat, which manages the housing program for the Chicago Housing Authority.

The Commission on Chicago landmarks “is responsible for recommending to the City Council that individual buildings, sites, objects, or entire districts be designated as Chicago Landmarks, thereby providing legal protection,” according to the government web site.

Daley appointed Michelle to serve on the Chicago Landmark Commission. The current chairman of the Commission is Daley’s former chief of staff, David Mosena. Mosena was a member of Obama’s US Senate Finance Committee in 2004, with other members that included Valerie Jarrett, Tony Rezko, Rita Rezko, and Allison Davis. The committee raised more than $14 million, according to Federal Election Commission records, cited by Novak in the Sun-Times on April 23, 2007. Jarrett serves as an advisor to Obama’s presidential campaign.

The Illinois Finance Authority was established by Blagojevich in 2004. Its “role is to support the Governor of Illinois’ economic development agenda,” and “IFA approves about $3 billion in project financing each year,” according to the its site.

Rezko business associate, Ali Ata, was appointed to head the Finance Authority. He is now under indictment in a separate criminal case in which Rezko is also charged. On June 30, 2003, Ata contributed $5,000 to Obama’s US senate campaign.

On June 13, 2007, the Sun-Times reported that as a state senator, “Obama wrote letters to city and state officials supporting his political patron Tony Rezko’s successful bid to get more than $14 million from taxpayers to build apartments for senior citizens.”

“I am writing in support of the New Kenwood LLC’s proposal to build a ninety-seven unit apartment building at 48th and Cottage Grove for senior citizens,” Obama wrote in October 28, 1998 letters to both city and state housing officials. “This project will provide much needed housing for Fourth Ward citizens.”

New Kenwood was set up as another “minority owned” company, where Davis owned 51% and Rezko 49%.

In the Times, Novak reported that the deal included $855,000 in development fees for Rezko and Davis, while Obama was still working at the Davis law firm, for a bid on a project that was “four blocks outside Obama’s state Senate district.”

Although the law firm represented several companies owned by Davis and Rezko when Obama wrote the letters, the firm did not represent New Kenwood in the deal. According to the Sun-Times, Davis and Rezko instead hired a firm owned by Mayor Daley’s brother Michael, “to help them get $3.1 million from bonds issued by the city of Chicago.”

“In addition to the development fees, a separate Davis-owned company stood to make another $900,000 through federal tax credits,” Novak reported in the June 13, 2007 Sun-Times.

The development opened in 2002 and was supposed to be managed by William Moorehead & Associates. William Moorehead was also a client of the Davis law firm and a business partner of Davis. In April 2007, Moorehead told the Times that his company was dropped from the deal before the apartments opened. The apartments are now managed by a company owned by Davis’ son, Cullen Davis, according to Novak.

In the Times article, Novak also noted that Moorehead received a 4-year prison sentence “for stealing more than $1 million from … public housing projects he managed for the Chicago Housing Authority and the U.S. Housing and Urban Development Department, as well as from two developments he co-owned with Davis.”

In a 2006, Moorehead pleaded guilty to fraud and other crimes and admitted stealing more than $600,000 from the Island Terrace and other federally subsidized projects.

During the period when Moorehead was stealing money, the Times reports, he lent Davis $100,000. Davis sent Moorehead a letter on June 15, 2000, and said the sale and refinancing of one of their housing projects had been delayed and wrote: “I need to borrow $100,000 from the Island Terrace resources.”

As part of a plea deal, Moorehead is cooperating in an ongoing federal investigation.

David Brint now owns Brinshore Development. He told the Times that he quit Rezmar four years after the company got its first deal with city because Mahru did not find money for building repairs. Brint and his partners have taken over four failed Rezmar buildings — “in one case paying the city $1 million to settle a $4 million loan made to Rezmar,” according to the Times.

Gary Poter owned the construction company that rehabbed all of Rezmar’s buildings. He was stabbed to death in May 2006, supposedly by a disgruntled employee, according to the Times “Rezmar who’s who” list. Back on March 3, 2004, Poter donated $2,000 to Obama’s US senate campaign and on July 19, 2004, he gave Obama another $1,000.

Its more than obvious that the political mafia of Illinois now has plans to install the new, “White House Office of Urban Policy,” as a means of getting richer by funneling tax dollars through poor people and retirees on a national level via Obama.

The leaders of Democratic party need to tell him that he will not be the nominee and to drop out of the race. If they do not, the Republicans have enough truthful information lined up to drive Obama out before election day.

A month ago, a friend of mine who knew I did not think Obama was qualified to be president, asked me what I would do if he was nominated. I replied that I would vote for him of course, what a dumb question. No more. After a month of research, I could no more support Barack Obama as the leader of this country than I could support another war profiteering Republican.

If he becomes the nominee, all the Democrats in America will be viewed by the rest of the world as either utterly stupid, or totally corrupt. Therefore, for the first time in my life, I have made a conscious decision to take a stand and not vote in a presidential election if the choice is Obama.

A November 2007 report entitled, “Pipeline and Commercial Insight: Pediatric and Adolescent Vaccines,” authored by vaccine analyst, Hedwig Kresse, for the independent market analyst Datamonitor discusses the future outlook for vaccine profits.

The report provides an assessment of products and a patient-based forecast of market size and coverage rates to the year 2016, and predicts that the introduction of high price vaccines will induce rapid growth in the pediatric and adolescent vaccines market.

The report predicts that due to the “promising commercial potential” of new, high-price vaccines, the pediatric and adolescent market will quadruple from approximately $4.3 billion in 2006, to over $16 billion by 2016, across the US, the EU-five including France, Germany, Italy, Spain, and the UK, and Japan.

The crucial factor for success in the pediatric market, the report notes, is the introduction of a product into national vaccination schedules. “Along with reimbursement, this virtually guarantees the rapid uptake and continuously high coverage rates in the target population,” Ms Kresse states.

As an example, she cites Wyeth’s Prevnar, as the first premium price vaccine launched in the US in 2000 for vaccinating infants against pneumonia and meningitis.

Since then, Prevnar has been added to the childhood vaccination schedules in the US and EU-five despite its high price of nearly $320 for the 4-dose regimen. In 2006, Global sales reached almost $2 billion, making Prevnar the first vaccine to attain blockbuster status, according to the report. By 2016, Datamonitor expects the total value of the infant market for pneumococcal vaccines to increase to $2.3 billion.

In June 2006, Merck’s Gardasil was approved for cervical cancer. Because it was the first vaccine offered as a preventive measure for a form of cancer, its approval generated tremendous public attention along with pressure for healthcare authorities to make the vaccine available to teenage girls at a cost of $360 for 3 doses.

“Although most cases of cervical cancer in the developed world can be prevented through the existing pap smear screening programs, the expensive HPV vaccination has been recommended and is reimbursed for teenage girls across the US and Europe,” Ms Kresse reports.

She notes that this decision is driven more by public pressure and excitement about the opportunity to vaccinate against cancer rather than by real need. The widespread publicity has led to a good uptake in the target group of adolescent girls, which is usually hard to reach for vaccination, Ms Kresse points out to investors.

Datamonitor sees a huge commercial opportunity in HPV vaccines, with annual sales of $1.4 billion in teenage girls for the seven major markets by 2016 and a cumulative catch-up opportunity in women aged 13-26 that could add up to over $17 billion until 2016.

But Ms Kresse warns investors that the “lack of medical need” for rotavirus vaccines such as RotaTeq will limit their uptake in most markets. RotaTeq is advertised to combat diarrhea that usually affects infants under the age of two, and was introduced by Merck in the US in 2006, at a price of $200 for the three-dose regimen.

According to Ms Kresse, many countries, but not the US, have refused to add the vaccine to their schedules due to cost-benefit reasons. “In the developed world, rotavirus diarrhea is rarely severe for small infants and quick and efficacious treatment is already available,” she writes. “Consequently, healthcare authorities see no need to widely introduce a very expensive vaccine.”

Datamonitor estimates that annual sales will remain limited to approximately $1 billion across the 7 major markets by 2016 and predicts that the US will account for the majority of sales, being the only country to have recommended the rotavirus vaccine for all infants.

Wyeth’s Prevnar vaccine came on the market in 2000 and is recommended for children under 2. The vaccine was hailed as a breakthrough and had sales of more than $1.5 billion in 2006. Prevnar is given as four shots to children between 2 and 15 months.

On September 18, 2007, NewsMax reported that the vaccine has dramatically curbed pneumonia and other serious illnesses in children but is also having an unfortunate effect: “promoting new superbugs that cause ear infections.”

According to NewsMax, doctors reported finding the first such germ that is resistant to all drugs approved to treat childhood ear infections and 9 toddlers in Rochester, N.Y., have had the bug and that it also may be turning up elsewhere.

It is a strain of strep bacteria not included in the pneumococcal vaccine. Prevnar prevents seven strains responsible for most cases of pneumonia, meningitis and bloodstream infections. But dozens more strains exist and some have become resistant to antibiotics since the vaccine combats the more common strains.

If the new strains continue to spread, “it tells us the vaccine is becoming less effective” and needs to be revised, Dr Dennis Maki, infectious diseases chief at the University of Wisconsin-Madison Hospitals and Clinics, told NewsMax.

A new study in the November 8, 2007 New England Journal of Medicine by researchers at Oregon Health & Science University, supported by the United States Public Health Service, suggests that the schedule for vaccinating and revaccinating against diseases should be reevaluated and adjusted.

The study found that in many cases, the established duration of immunity for vaccines is greatly underestimated, which means that people are getting booster shots when their immunity levels do not require it and those antibody responses caused by viruses such as measles mumps, and rubella remained at protective levels for several decades and in most cases, for life.

The research also reconfirmed a previous finding by Slifka and his colleagues: that the duration of immunity after smallpox vaccination is much longer than previously thought. In that earlier study published in the journal Nature Medicine in 2003, these OHSU researchers observed surprisingly long-lived antiviral antibody responses but they were unable to measure the slow rate of decline.

The study indicates that the duration of immunity after smallpox vaccination is maintained with a calculated half-life of 92 years and that a person who has received the primary series of tetanus vaccine is likely to be protected for 3 decades.

Experts say we have allowed ourselves and our children to be overdosed through a culture dominated by industry marketing influence which has now become dangerously out of control and detrimental to our children’s health. “In the 21st century, it is unacceptable to be marketing medication to infants and children that may not work,” Dr Steven Czinn, chair of the department of pediatrics at the University of Maryland School of Medicine, told Reuters on October 11, 2007.

In the November 19, 2007 Huffington Post article, “Over Medicated and Over-Vaccinated: The Unintended Consequence of Medicines Meant to Protect,” Deirdre Imus asks, “Where are the conflict-free studies that prove giving infants and children 49 immunizations – most of them by age 5, are safe and effective?”

She points out that studies have provided evidence that the over-vaccination of dogs and cats can result in numerous maladies including cancer, skin and ear conditions, arthritis, allergies, diabetes, aggression, behavior problems and other immune system dysfunctions. “There is even a name for the conditions caused by animal over-vaccination, vaccinosis,” she notes.

Ms Imus also points out that the mercury-containing preservative, thimerosal, used in vaccines for over 50 years was removed from animal vaccines in 1992.

“Unfortunately for the kids,” she writes, “it remained in children’s vaccines for another decade and remains in some vaccines like the influenza (25 micrograms) and tetanus vaccine (25 micrograms) today and in trace amounts (3 micrograms) in some immunizations.”

She says most people do not realize is that any liquid waste containing more than 200 parts per billion (ppb) mercury must be deposited at a hazardous waste site and that drinking water cannot exceed 2 ppb mercury.

“But when the influenza vaccines arrive and are injected into pregnant woman and infants as young as six months, those vaccines contain 50,000 ppb mercury,” Ms Imus notes.

This amount of mercury is 250 times higher than hazardous waste, she notes, and according to EPA guidelines, this amount can only be considered safe if a person weighs 550 pounds. “Even trace amounts of mercury in vaccines can be anywhere from 600 to 2000 ppb,” she warns.

On November 13, 2006, PutChildrenFirst.org, a parent-led organization advocating vaccine safety, issued a press release to announce the results of a survey conducted October 27-30, 2006, by Zogby International of over 9,000 Americans to learn their plans for getting flu shots, their knowledge of its ingredients, and who they hold responsible for making sure vaccines are safe.

The survey showed that an overwhelming majority of Americans were unaware that most flu shots contain mercury and that they would refuse a shot with mercury. After learning that mercury is an ingredient, 74% of those polled said they were less likely to get a flu shot and 86% of parents said they were less likely to allow their child to get a shot.

Lisa Handley is a founding parent of PutChildrenFirst.org, whose son Jamison had an adverse reaction to a flu shot with mercury in 2003. “I know firsthand how life-changing a flu shot with mercury can be, since our son began his regression into autism after his flu shot,” she states.

“With everything we know about the dangers of mercury and the havoc it can wreak on young, developing brains, there is no excuse for any vaccine to contain mercury,” says Lyn Redwood, RN, MSN, President of SafeMinds, a nonprofit organization committed to ending mercury-induced neurological disorders.

“The survey reveals that Americans are overwhelmingly in the dark about what is in most flu shots,” Ms Redwood stated in the press release.

“They do not want a known neurotoxin injected into their children, and they believe Congress and medical professionals must be more vigilant about keeping vaccines safe and mercury-free,” she added.

PutChildrenFirst also advises that two recent studies in leading medical journals admitted that limited data exists to support the effectiveness of flu vaccines. One study, in the Journal of the American Medical Association, noted that, “there is scant data on the efficacy and effectiveness of influenza vaccine in young children,” the release notes.

According to Ms Imus, we are beginning to see prescribed vaccines, like the whole cell DPT and Rotovirus, which are later found to be unsafe.

“While physicians warn the public about the over use of antibiotics,” she points out, “it is the physicians themselves that over-prescribed these antibiotics for every ailment under the sun.”

“And like antibiotics,” she writes, “every time a new vaccine was developed, it quickly found its way onto the immunization schedule along with the recommended booster shots.”

“We are now reaping the unintended consequences of the overuse of these medical interventions,” she states. “Instead of being healthier, we have a nation of very sick children.”

Forcing parents to inject poisonous concoctions into innocent, helpless children against their will is a gross violation of their most basic parental rights.

The report entitled, “The Intimidation of Dr. John Buse and the Diabetes Drug Avandia,” summarizes the Committee’s findings regarding GlaxoSmithKline’s intimidation of Dr Buse, an independent scientist who first voiced concerns about Avandia back in 1999.

The Committee points out that Dr Buse is an expert in diabetes with extensive research experience in the thiazolidinedione class of drugs that includes Avandia and states: “Corporate intimidation, the silencing of scientific dissent, and the suppression of scientific views threaten both the public well-being and the financial health of the federal government, which pays for health care.”

In November 2007, the FDA added a black box warning to GlaxoSmithKline’s diabetes drugs Avandia, Avandamet, and Avandaryl about an increased risk of heart attacks, and a boxed warning about an increased risk of heart failure was added in August 2007.

On October 26, 2007, Senator Chuck Grassley (R-Iowa), ranking member of the Finance Committee, sent a letter to FDA Commissioner Andrew von Eschenbach asking him to respond to reports that on October 2, 2007, the agency convened a drug safety oversight board that voted to keep Avandia on the market by a one-vote margin while considering whether to add a second warning.

“The Avandia case continues to present new rounds of questions about the way the FDA monitors and assesses drug risks and decides whether to let the public know about emerging risks,” Senator Grassley said in a press release the same day.

The Senator also asked the Commissioner to explain the conditions governing disclosure of this information. “I have yet to see any public notification of this vote,” he states.

“Accordingly,” he writes, “I would appreciate information from the FDA regarding the internal policies and procedures governing the DSOB and the terms and conditions governing the release of information from the DSOB to the public.”

The Department of Veterans Affairs was among those who voted to remove Avandia from the market and has since removed Avandia from its formulary of approved drugs. On December 6, 2007, two pharmacy benefit managers, Prime Therapeutics and HealthTrans followed suit and announced the removal of Avandia from their formularies.

The studies verifying the dangers of Avandia have been non-stop over the past 6 months. On June 5, 2007, the New England Journal of Medicine published a paper by Dr Jeffrey Drazen, Dr Stephen Morrissey and Dr Gregory Curfman, which drew more attention to the safety concerns that were first reported in a study in the NEJM by Cleveland Clinic cardiologist Dr Steven Nissen and Kathy Wolski, in May 2007.

The paper cites an analysis which showed about a 40% increased risk of myocardial infarction in patients receiving Avandia when compared to patients receiving diabetes drugs such as metformin or a sulfonylurea or a placebo.

On September 11, 2007, the Journal of the American Medical Association published two more studies. The first, co-authored by Dr A Michael Lincoff and Dr Nissen, found Avandia’s main competitor, Actos, appeared to protect diabetic patients from heart attacks, stroke and death by 18%. The second, by Dr. Sonal Singh and researchers at Wake Forest University, concluded that Avandia increased heart attack risks by 42%.

On December 12, 2007, JAMA reported another population-based study by Canadian researchers of patients 66 and older with diabetes, that found thiazolidinedione treatment, primarily with Avandia, was associated with an increased risk of congestive heart failure, acute myocardial infarction, and mortality when compared with other combination oral hypoglycemic agent treatments.

According to the Senate Committee report, if GSK had considered Avandia’s increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr Buse, “instead of trying to smother an independent medical opinion,” some of the 83,000 heart attacks may have been avoided.

The report says the Committee found it “most troubling” that plans to silence Dr Buse involved discussions by GSK executives at the highest levels, including then and current, CEO Jean-Pierre Garnier.

In response to a letter dated May 21, 2007, in which the Committee asked about the retaliation against Dr Buse, the report notes that GSK issued a press release to refute the allegations and the Wall Street Journal reported that, “[GSK] called the suggestion ‘absolutely false.’”

The Committee also points out that CEO Jean-Pierre denied having any knowledge about the intimidation of Dr Buse in a July 25, 2007 interview with The Philadelphia Inquirer, when in fact, emails written in June 1999, show GSK executives discussed Dr Buse in a series of emails they titled, “Avandia Renegade,” and silenced him by complaining to his superiors and threatening to sue him. One email cited in the report states:

“The sentiment of the SB group was to write him a firm letter that would warn him about doing this again…with the punishment being that we will complain up his academic line and to the CME granting bodies that accredit his activities….The question comes up as to whether you think this is a sensible strategy in the future (we don’t really do too much work at UNC to make any threats).”

SB refers to SmithKline Beecham which is now GSK.

The report also cites an email by Dr Tachi Yamada, GSK’s head of research at the time, that was copied to Dr Garnier which discussed plans to retaliate against Dr Buse stating:

“I plan to speak to Fred Sparling, his former chairman as soon as possible. I think there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts–the other is to launch a well planned offensive on behalf of Avandia….”

According to the report, Dr Yamada did in fact call Fred Sparling, the chairman of Dr Buse’s department and GSK also demanded that Dr Buse sign a letter claiming that he was no longer worried about cardiovascular risks of Avandia, which GSK officials referred to as a “retraction letter.”

Emails also show that on July 2, 1999, several GSK officials discussed sharing the “Buse retraction letter” with financial analysts who were evaluating GSK’s products for investors and the report notes that the emails were copied to GSK executives including Dr Garnier.

However, even though Dr Buse appeared to go silent in public after signing the retraction letter, he did voice his concerns in a letter to the FDA Commissioner on March 15, 2000, about the risks associated with Avandia and GSK’s misrepresentations regarding the clinical trial data on the drug.

In the letter, Dr Buse noted the drug’s “consistent negative impact on lipids documented in the FDA registration data as well as a worrisome trend in cardiovascular deaths and severe adverse events in the subjects exposed to rosiglitazone versus active comparators.”

He also urged the FDA to act forcefully to prevent the abuse of clinical trial data by the company. “I have been shown glossy materials claiming that rosiglitazone has been uniquely studied in patients with preexisting cardiac disease including patients with a number of associated conditions (such as unstable angina),” he stated in the letter.

Dr. Buse explained that he knew for a fact that these types of patients were excluded in the Avandia trials because he was the Principle Investigator in one. And while acknowledging that there are probably abuses by all companies that market drugs, he said, “there is something pervasive and systematic that I detect in my travels regarding the marketing of rosiglitazone.”

Somehow, GSK obtained a copy of the FDA letter, and GSK executives faxed it among themselves with a cover note that read: “We need to address this as a company….Looks like Dr. Buse doesn’t buy into our lipid or cardiovascular story.”

According to the Senate report, GSK then drafted a letter to Dr. Buse from one of its executives, Martin Freed, that stated: “I remain concerned about your ongoing aggressive posture towards rosiglitazone and SmithKline Beecham. In my opinion, you have presented to [FDA] several unfair, unbalanced, and unsubstantiated allegations.”

After that, the report notes that Dr. Buse appeared to remain silent for about two years, but voiced his concerns again in a private October 23, 2005 email to Dr Nissen, and described his treatment by GSK after his presentations at the meetings of the Endocrine Society and the ADA and suggested that Avandia may carry increased risks.

“Immediately,” he wrote, “the company’s leadership contact[ed] my chairman and a short and ugly set of interchanges occurred over a period of about a week ending in my having to sign some legal document in which I agreed not to discuss this issue further in public.”

“I was certainly intimidated by them but frankly did not have the granularity of data that you had and decided that it was not worth it,” Dr. Buse told Dr. Nissen.

The Committee’s report says GSK’s behavior at the time that Dr Buse voiced his concerns and since the Committee first brought the allegations about Avandia to light was “less than stellar.”

“Instead of acknowledging the misdeed to investors, apologizing to patients, and pledging to change corporate behavior, GSK launched a public relations campaign of denial,” the report notes.

The Committee also points out that GSK’s concerns over Dr Buse reemerged in 2002, as his professional stature grew and in September 2002, one GSK official described him as the “most powerful Endocrinologist in the Carolinas….” and said, “[H]e is gaining power nationally and internationally.”

In the report, the Committee notes concerns not only about the culture of leadership at GSK, but also a “fear that the situation with Dr. Buse is part of a more troubling pattern of behavior by pharmaceutical executives.”

As an example, the report cites another case in which Stanford University researcher, Dr. Gurkirpal Singh, testified at a November 18, 2004 hearing on Vioxx, and said a Merck executive intimidated him by calling his superiors and warning Dr. Singh that Merck would make life very difficult for him if he persisted in his request for Vioxx data.

“Merck’s intimidation of Dr. Singh as it sought to protect Vioxx bears striking similarities to apparent threats by GSK against Dr. Buse to protect Avandia,” the report notes.

In a November 15, 2007 speech on the Senate floor, Senator Grassley said the Vioxx hearing “turned the spotlight on systematic problems” at the FDA and described in detail how Merck had used power, influence and access to discredit safety expert Dr David Graham and said that it was “troubling” three years later to learn of another case where a drug company used power, influence, and access to intimidate a researcher.

On December 18, 2007, the Los Angeles based Baum, Hedlund, Aristei & Goldman law firm announced the filing of an Avandia lawsuit against GSK on behalf of Rogelio Larosa and his adult son, Eric, in the US District Court, Southern District of California accusing GSK of causing the death of Milagros Larosa, their wife and mother, due to negligence, fraud, breach of warranty and a failure to warn about the risks of Avandia.

The lawsuit alleges that GSK over-promoted Avandia, carelessly promoted it as safe and effective and refused to adequately warn the medical community and consumers about the risks associated with the drug until the FDA finally took action.

According to the complaint, over the course of a year, Ms. Larosa was hospitalized three times for heart problems, classified as myocardial ischemic events, before she had a fatal stroke.

She suffered the first heart blockage in December of 2004 and two more occurred in January 2005 and July 2005, with each requiring a heart bypass or “coronary revascularization” to restore oxygen and nutrients to her heart.

After the last blockage, Ms. Larosa had to be placed in a nursing home where she received constant care for 6 months until a stroke killed her on December 20, 2005. She was prescribed Avandia to treat Type 2 diabetes and she had no prior heart problems before taking the drug, according to the complaint.

Baum Hedlund attorney Roger Drake reports that there are currently about 50 state and federal lawsuits filed against GSK in the US.

The Larosa lawsuit will be consolidated with all the other federal Avandia lawsuits against GSK that were joined together in October 2007 by the Judicial Panel on Multidistrict Litigation, under the title, “In re Avandia Marketing, Sales Practices & Products Liability,” with US District Judge Cynthia Rufe of the Eastern District of Pennsylvania overseeing the litigation.

According to Mr. Drake, Baum Hedlund has obtained a number of Avandia-related documents during prior litigation against GSK. In addition to Avandia cases, the firm has 23 Paxil related suicide lawsuits pending against GSK with several scheduled for jury trials in 2008. The firm also handles Paxil-related birth defects cases.

Baum Hedlund has the longest track record of any law firm in representing plaintiffs against GSK. Over the past 18 years, the firm has handled thousand of cases and served as lead counsel for the Plaintiffs’ Steering Committee in Paxil Products Liability Litigation.

Persons seeking legal advice regarding Avandia or Paxil can contact Baum Hedlund at (800) 827-0087; www.baumhedlundlaw.com/

(Written as part of GlaxoSmithKline Litigation Round-Up, Sponsored by Baum Hedlund)