“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)

Since June 27, 2007, nearly every major news outlet in the US has broadcast the story that two new studies published in the New England Journal of Medicine found a low risk of birth defects in babies born to women who took selective serotonin reuptake inhibitor antidepressants (SSRIs) during pregnancy.

SSRIs include Paxil by GlaxoSmithKline; Zoloft marketed by Pfizer; Prozac by Eli Lilly; Celexa and Lexapro from Forest Laboratories; Luvox by Solvay, and generic SSRI makers Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

On June 27, 2007, the headline that appeared in countless news outlets that run articles from the Associated Press stated: “Antidepressants Not Risky for Defects.”

ABC News reported on June 29, 2007, “Antidepressants Safer Than Believed During Pregnancy,”

“Antidepressants not linked to birth defects,” stated the internet headline for News-Medical.net, on July 5, 2007.

These headlines outraged experts knowledgeable about the true risks of birth defects, but none drew more outrage than the headline in a press release put out by the US Centers for Disease Control the day before the story broke which stated: “New Study Finds Few Risks of Birth Defects from Antidepressant Use During Pregnancy.”

“The reassuring attitude promoted in the CDC’s press release flew in the face of evidence linking SSRI exposure during pregnancy to increased birth defects, and the additional evidence of SSRI toxicity in the developing brain,” says Dr. Peter Breggin, author of The Antidepressant Fact Book and an expert on SSRIs.

“Women and their doctors who only catch the headlines created by these studies are being grossly misled,” he advises. “SSRIs should never be used during pregnancy.”

Dr. Breggin notes that the CDC instructs pregnant women to speak to their doctors about the risks and benefits of taking SSRIs, but says, “doctors will have read the headlines inspired by the CDC and imagine there is little risk.”

The paper, “Exposure to SSRI Antidepressants In Utero Causes Birth Defects, Neonatal Withdrawal Symptoms and Brain Damage,” by Dr. Breggin and Ginger Breggin, will be published in the upcoming issue of the Ethical Human Psychology and Psychiatry journal to refute the findings of the NEJM studies.

CDC Report and Media Coverage Misleading

The CDC claims the use of SSRIs during pregnancy is justified on the basis that depression has its own hazards. “But these hazards,” Dr. Breggin states, “pale in comparison to the upheaval that will befall new mothers, fathers and the extended families of the children who are born with profound birth defects.”

In addition to disputing the claim that birth defects are rare, experts say the headlines are deceptive because: (1) the studies referred to were limited to women taking SSRIs in the first 3 months of pregnancy; (2) some birth defects develop later in pregnancy; (3) stopping the drugs at the end of 3 months, or at any time, can result in a serious withdrawal syndrome; (4) infants experience a withdrawal syndrome after birth, and (5) the headlines do not mention all the other adverse effects associated with SSRIs.

The headlines dilute the findings of the many studies that have shown serious withdrawal symptoms in newborns exposed to SSRIs, including high-pitched or weak crying, tremors, irritability, convulsions, poor muscle tone, abnormal sleep patterns, feeding difficulties, rapid breathing and respiratory distress, and increased admissions to intensive care units.

In discussing a 2004 study published in the Pediatrics journal, lead author Dr. Philip Zeskind was quoted in the February 22, 2004 Sunday Telegraph as stating: “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,” he said, “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.”

Experts say the headlines are also misleading because they infer that no birth defects were found in the studies when, in fact, the CDC study further confirmed associations between SSRI use and the occurrence of craniosynostosis and omphalocele, as well as certain types of heart defects.

The study also found anencephaly, babies born without a forebrain, to be 2.4 times greater in women taking an SSRI in the first trimester. “This is a catastrophic fatal birth defect that is not correctable,” Dr. Breggin points out. In babies born with anencephaly, much of the brain does not develop, and the babies are either stillborn or die shortly after birth, according to the National Institute of Child Health and Human Development.

Babies born with omphalocele, an abnormality in which the infant’s intestine or other abdominal organs protrude from the navel, were 2.8 times higher in women taking SSRIs.

The severity of this condition varies, but can be life threatening and usually requires surgery as well as weeks to years of adapting.

Craniosynostosis, a condition in which connections among skull bones close prematurely, was 2.5 times more prevalent. “A 2.8 times greater occurrence of this condition,” Dr. Breggin explains, “will cause 2,305 more US babies to be born each year with this birth defect as a result of their mothers taking SSRIs in the first trimester of pregnancy.”

In September 2005, Glaxo sent out a “Dear Doctor” regarding a label change based on a recent study wherein women who took an SSRI were more likely to have an infant with omphalocele, in addition to craniosynostosis.

The CDC study also found that babies exposed to Zoloft had twice the risk of having a heart defect and three times the risk with Paxil. In October 2006, the journal Epidemiology reported that babies born to women who took SSRIs during the second or third month of pregnancy had nearly two times the risk of having congenital malformations, with the most common being cardiovascular in 29%, muscle and bone malformations in 31% and 14% had digestive malformations.

According to SSRI expert, Dr. Grace Jackson, “It was already known in the 1980’s and 1990’s that the administration of SSRIs to embryonic cultures of rats and mice leads to craniofacial and cardiac defects.”

The NEJM studies also showed an increased risk of neural tube defects, which are birth defects of the brain and spinal cord, with the two most common being spina bifida and anencephaly.

With spina bifida, the fetal spinal column does not close completely during the first month of pregnancy, and there is usually nerve damage that causes at least some paralysis of the legs.

A recent study conducted by the Institute of Reproductive Toxicology at the University of Ulm, Germany, and the new NEJM article noted that some women who took SSRIs throughout pregnancy had infants born with a club foot, where the foot is turned in, stiff and cannot be brought to a normal position. According to the NEJM, women who took Paxil during pregnancy were at a 5.8% increase of having a child born with this defect.

The NEJM articles also suggest that there is an association between SSRIs and anal atresia, a malformation in which the normal perforation or opening for the anus is absent where the end of the intestinal tract has not perforated the skin in the perineal area.

Industry Influenced Media

The industry’s control over the mainstream media, evidenced by the broadcast of the NEJM studies, did not happen overnight. It began in the late 1990’s when drug companies were granted permission to advertise their products to the public.

Over the last decade, the drug companies have intentionally poured so much money into advertising that the overall operating budgets of the major media outlets and television networks are now highly dependent on the pharmaceutical industry.

In addition to advertising dollars, Big Pharma has mastered the art of using the media to promote the sale of drugs and downplay their risks. Stories featured as health care news, based on rigged studies carefully planted in medical journals are promoted through reports written by PR firms and sent out to all the major media outlets in press releases.

A 2005 report by the UK Parliament found that 75% of clinical trials published in the major journals, including The Lancet, New England Journal of Medicine and the Journal of the American Medical Association, were funded by the drug industry.

Experts say medical professionals can no longer rely on what they read. “The sources of knowledge that doctors have been trained to trust have been taken over by the medical marketing community,” says Dr. John Abramson, author of the book Overdosed America.

Each year, the Prescription Access Litigation Project announces the “Bitter Pill Awards” to expose Big Pharma’s efforts to manipulate consumers through the media. For the year 2004, the group granted “The Cure for the Human Condition Award” to Paxil maker Glaxo, “For Hawking Pills to Treat the Trials of Everyday Life.”

In support of the award, PAL cited an FDA warning letter sent to Glaxo about false advertising in a Paxil TV ad, saying it wrongfully “suggests that anyone experiencing anxiety, fear, or self-consciousness in social or work situations is an appropriate candidate for Paxil CR,” when these are simply not approved uses of the drug, PAL noted.

For 2007, the Bitter Pill Award could to go to CNN for granting the most airtime to industry-paid front men to downplay the risk of birth defects, with special thanks to Dr. Sanjay Gupta.

After hearing Dr. Gupta say the use of SSRIs was ok for nursing mothers on CNN on June 12, 2007 without discussing any of the risks of drugs, Larry Bone, an avid advocate for protecting the unborn child from the birth defects linked to SSRIs, wrote this author to state that the use of the TV news segments in recent weeks to promote the sale of these drugs to pregnant women and nursing mothers was “horrifying” and must be stopped.

“The public has a right to be honestly informed about the dangers of SSRIs,” he wrote, “and the media has an ethical responsibility to see that pregnant women and nursing mothers are adequately informed about the dangers of these drugs.”

“At the very least,” he says, “media companies should carry disclaimers at the end of such news segment stating that SSRIs all carry warnings on their labels that the public should read.”

The Reported Risks

Experts say it’s a crapshoot prescribing these drugs to nursing mothers. “No one yet knows what effects SSRIs may have on nursing infants,” Dr. Jackson warns, “because no one has studied the long term consequences of administering SSRIs to infants via breast milk.”

Furthermore, she adds, no one understands how the in utero exposure to SSRIs changes the wiring of the newborn’s brain and, “it has never been proven that there is no effect of giving infants these drugs during the first months or years of post-uterine existence.”

Researchers from Columbia University published a study in the October 2004 journal Science, suggesting that exposure to Prozac in the womb and in early childhood may permanently alter the brain’s circuitry and disrupt neural development, leading to serious emotional disorders later in life.

The warnings that Mr. Bone says viewers should be instructed to read are many. On December 8, 2005, the FDA issued a Public Health Advisory and a press release to announce that the agency was asking Glaxo to change the pregnancy category from C to D, a stronger warning which means “studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus.”

The Advisory said that the FDA “has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations.”

The FDA also said that physicians who are caring for women receiving Paxil should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy.

On July 19, 2006 the FDA issued another Advisory after a study led by Dr. Christina Chambers in the February 9, 2006 New England Journal of Medicine reported a six-fold increased risk of the life-threatening lung disorder, persistent pulmonary hypertension, in babies born to mothers taking SSRIs and said, “the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN.”

According to the FDA Advisory: “Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die.”

The risk of PPHN was first found by Dr. Chambers in a 1996 study where the researchers found two cases of PPHN, an unexpected finding since there were relatively few women in the study and both women had taken Prozac late in their pregnancies.

Warnings about the adverse effects of SSRIs in the patient information sheet on the FDA’s web site as of July 13, 2007, states: “babies delivered to mothers taking Paxil late in pregnancy have developed problems, such as difficulty breathing and feeding.”

“Babies delivered to mothers taking Paxil early in pregnancy are sometimes born with heart problems,” it states.

The Web Site Also Warns:

“Persons taking Paxil may be more likely to think about killing themselves or actually try to do so, especially when Paxil is first started or the dose is changed.”

“Paxil may cause bleeding problems,” the FDA warns, “especially if taken with aspirin, NSAID’s (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen) or other drugs that affect bleeding.”

The information sheet also advises that Paxil patients, “may become hyperactive, excitable or elated,” and, “have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire).”

Other side effects currently listed include weakness, dry mouth, constipation, yawning, infection, diarrhea, sweating, dizziness, tremor, nervousness, nausea, difficulty sleeping, decreased appetite and sleepiness.

According to Mr. Bone, CNN is not the only guilty provider of misleading information about SSRIs. “Major broadcasting companies like CBS, FOX, ABC and NBC,” he says, “are no longer worthy of trust when they shamelessly promote a class psychotropic drugs that threaten the public safety.”

“Such promotion,” he states, “constitutes a flagrant breach of basic television broadcasting ethics and fairness standards each and every time.”

Mr. Bone also says that the media should acknowledge whether the doctors featured in these segments have received grants or gratuity payments from SSRIs makers.

Risks Versus Benefits

Finally, experts point out that the headlines fail to disclose that SSRIs are ineffective. Clinical psychologist Dr. Bruce Levine, author of a new book due out this fall entitled Surviving America’s Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy, says “legitimate science shows that these antidepressants are no more helpful for depression than a placebo or no treatment at all.”

“Even the dice-loaded drug company studies show that antidepressants are, in a scientific sense, a failure,” he notes.

“For example,” Dr. Levine points out, “in 2002 the journal Prevention & Treatment analyzed 47 studies that had been sponsored by drug companies on Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone, and it reported that in the majority of the trials, the antidepressant failed to outperform a sugar pill placebo.”

Another of the world’s leading authorities on SSRIs, Dr. David Healy, also says that the effectiveness of SSRIs has been exaggerated, and the actual data reveals that only one in 10 patients on SSRIs can be shown to respond specifically to the drug rather than a nonspecific factor or a placebo.

Dr. Healy is the author of numerous books on psychiatric drugs including The Antidepressant Era and The Creation of Psychopharmacology.

He says that in prescribing SSRIs to pregnant women, he is concerned about “the benefit-harm trade-off,” because “without any benefits, the child runs all the risks including the neonatal withdrawal syndrome and birth defects.”

Dr. Healy points out that the CDC study focuses on linking particular specific defects to particular drugs, and once you do this, “you end up with very small numbers in each group and not a lot of significant findings,” he says.

Families seeking legal advice regarding SSRI birth defects can contact the Baum, Hedlund, Aristei, Goldman & Menzies Law Firm at: (800) 827-0087.

(Written as part of the Antidepressant Birth Defect Litigation Monthly Round-Up, Sponsored by Baum Hedlund’s Pharmaceutical Antidepressant Litigation Department)

The press release cited a new CDC study released in the New England Journal of Medicine and further stated, “a second study on SSRI and birth defects, also published in the June 28 issue of NEJM, did not find such an association with birth defects overall, but did find significant associations between specific SSRIs and several birth defects.”

Since the CDC put out the press release, hundreds of headlines have flooded the internet citing the new studies as proof that there is a low risk of birth defects with SSRI use during pregnancy, and the results of the studies have been reported as breaking health care news by every major media outlet in the US.

The pharmaceutical industry as a whole has spent a fortune buying influence in the media since 1997, when the government lifted restrictions on direct-to-consumer advertising.

In an article titled “Physicians and Bribery,” published by News Target on July 7, 2005, Dani Veracty says the real story about prescription drugs is not being told because the drug makers are controlling the budgets of the major media companies by pumping hundreds of millions of dollars into TV, magazine, newspaper and online advertising.

“Because of this,” he stated, “the media companies out there don’t want to say anything bad about these prescription drugs.”

In the July-August Columbia Journalism Review, contributing editor Judy Lieberman reported that at the end of 2004, drug-company ad revenue for Time magazine totaled $67 million, for Newsweek $43 million, and for the New York Times took in $13 million. By 2004, she reported, advertising revenues for the five networks including CNN and Fox news was $1.5 billion.

The drugs in the NEJM studies included Prozac by Eli Lilly, Zoloft from Pfizer; Paxil by GlaxoSmithKline, Celexa and Lexapro from Forest Labs; Luvox by Solvay, Effexor by Wyeth, and generic SSRI makers include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

Prior to the arrival SSRIs on the market, depression was estimated to affect only 100 people per million and patients with depression sought help from a medical professional trained in psychiatry and the treatment of disorder.

However, the rate of depression is now estimated to be in the range of 50,000 to 100,000 cases per million, or between a 500 to 1,000-fold increase, according to Jane Currie in the “Marketization of Depression” in the May 2005 journal Women and Health Protection.

In April 2004, the CDC reported that antidepressants topped the list of drugs prescribed to women at visits to doctor’s offices and outpatient departments, followed by estrogens and progestins, antiarthritics, and medicines for acid/peptic disorders in the Journal of Women’s Health.

By 2005, the CDC recently reported, antidepressants were the most prescribed drugs in the US during visits to doctors and hospitals and were prescribed far more often than even medications used to treat high blood pressure, cholesterol, diabetes, and headaches.

Yet, a recent analysis of studies on the efficacy of 12 second-generation antidepressants including SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs) released on January 25, 2007, by the Agency for Healthcare Research and Quality’s (AHRQ), a division of the US Department of Health and Human Services, offers little support for the wide-spread use of these medications.

The AHRQ reviewed efficacy in treating major depressive disorder, dysthymia and subsyndromal depression (including minor depression), and also evaluated comparative efficacy for maintaining remission and for treating accompanying symptoms such as anxiety or insomnia or neurovegetative symptoms.

The review included 187 studies deemed to be of good or fair quality, including 89 head-to-head randomized controlled trials, 57 placebo-controlled randomized studies, with 126 of the studies sponsored by drug companies and 17 funded by government agencies or independent sources, and analyzed the effectiveness of Cymbalta, Wellbutrin, Effexor, Celexa, Lexapro, Prozac, Luvox, Remeron, Serzone, Paxil, Zoloft, and Desyrel, many of which are now also sold in generic form.

Overall the analysis found that in controlled studies, during 6 to 12 weeks of treatment, well over a third of the patients, or 38%, saw no improvement in their condition and 54% had only partial improvement and did not achieve remission.

In light of this clear lack of efficacy, it should be noted that as early as August 2004, the FDA label for SSRIs warned that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.”

According to one of the world’s leading experts on SSRIs, Dr Peter Breggin, author of The Antidepressant Fact Book, “few physicians realize that meta-analyses have shown that antidepressants work no better than placebo at lifting depression.”

So in the case of pregnant women he says, “The risk/benefit ration weighs a placebo effect against increased parental suicide and violence, and babies with congenital defects, babies undergoing withdrawal reactions, and babies whose brains have been forever changed by being soaked in SSRIs during their development.”

Dr Breggin also notes that the NEMJ researchers failed to consider the serious withdrawal reaction in newborns and the potentially disastrous consequences of SSRI use by pregnant women. “Withdrawal reactions confirm that the brain of the fetus has been bathed in SSRIs and that it has suffered significant functional changes,” he warns.

“It should be no surprise that it is not good to bath the growing brain in toxic drugs like SSRIs,” he said, “because serotonin is intimately involved in the development of the brain in utero and SSRIs inhibit normal brain cell development.”

Experts say SSRI use creates an unnecessary risk for fetus. Dr David Healy, another leading authority on SSRIs, and the author of The Creation of Psychopharmacology, and The Antidepressant Era, said, “the overwhelming majority of women who are prescribed SSRIs are at little or no risk for suicide or other adverse outcomes from their nervous state.”

He pointed out that every pregnant woman may have symptoms of depression such as anxiety, disturbed sleep, fatigue, or a loss of interest in sex. “But having depressive symptoms and being depressed are two different things.”

Dr Healy also notes the lack of efficacy shown with SSRIs and says the risks of the neonatal withdrawal syndrome and serious birth defects to the infant far outweigh any benefits of their use by expectant mothers.

Houston Attorney, Robert S Kwok* is outraged by the new campaign to promote the use of SSRI with pregnant women. “It’s ludicrous to think a woman is at greater risk of depression during her pregnancy and should take antidepressants despite the proven risk to her developing fetus,” he stated, “yet physician ‘opinion leaders’ with industry ties are actively trying to convince doctors and patients of just that.”

Mr Kwok represents the family of Gavin Shore, a baby born with a severe cardiac defect known as Shone’s Anomaly after his mother was prescribed the SSRI Celexa during pregnancy and says Gavin’s mother was not warned that taking an SSRI could double the risk of her baby being born with a severe heart defect.

Although some of the reports citing the NEMJ studies in media mentioned that Glaxo money was involved in funding the CDC study, most neglected to mention the financial contributions of the other drug companies for the study, or the steady stream of drug money that flows to the medical facilities and researchers involved in the studies.

When combined, the named universities, hospitals and researchers involved have received money from Lilly, Pfizer, Wyeth, Glaxo, Aventis, Sanofi Pasteur, and the 3 companies that make generic versions of SSRIs.

The CDC study lists Harvard Medical School and Massachusetts General Hospital as participating and the Harvard Medical School receives nearly 25% of its funding from non-government sources, including nearly $3.5 million from Aventis Pharmaceuticals, $2.5 million from Bristol-Myers Squibb, and $2.1 million from Merck, according to an April 12, 2006 report in The Phoenix.

In addition, The Phoenix noted, SEC filings showed Harvard stock holdings of $16 million with Merck, $8 million of Bristol Myers Squibb, $34 million of Johnson & Johnson, and $33 million of Pfizer.

In one NEJM study, Dr Jan Friedman reported receiving honoraria for consulting from I3 Research, which is actually a huge conglomerate of “research” firms with names that begin with i3. The April 12, 2006 Phoenix reported that a firm called i3 Innovus, which co-authored 16 medical-journal articles in 2005, “provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle.”

The Phoenix also noted that this i3 firm had a Boston office for its vice-president of US operations, Milton Weinstein, who also happened to be a professor at Harvard Medical School and Harvard School of Public Health.

The same group of industry backed research institutions credited in the NEJM CDC study, began the disinformation campaign to boost the sale of SSRIs to pregnant women more than a year ago when “experts” at Harvard and Mass General published a study to intentionally dilute the finding of a mounting number of studies that found serious birth defects to be associated with the use of the drugs by pregnant women.

In response to a study in the February 2006 New England Journal of Medicine that showed infants exposed to SSRIs in the womb were 6 times more likely to be born with the life-threatening lung disorder, persistent pulmonary hypertension, a study appeared in the Journal of the American Medical Association the same month warning that stopping SSRIs could greatly increase the risk of pregnant women relapsing into depression.

On February 1, 2006, the Associated Press described the methods used by the Massachusetts gang when conducting the JAMA study and said researchers “followed 201 pregnant women with histories of major depression who were taking drugs such as Prozac, Zoloft, Effexor and Paxil.”

“Because of ethical concerns,” the article said, “the researchers did not randomly assign the women to either stop or continue medication.”

Instead, the AP reported, the women decided what to do and then the “researchers watched what happened.”

But the actual report on the study shows that of the 201 participants, 13 miscarried, 5 terminated their pregnancy, 12 were lost to follow-up prior to the end of pregnancy, and 8 chose to withdraw from the study.

So when reporting on the few pregnant women that remained, the study said mothers were 5 times more likely to suffer a relapse than those who continued taking the drugs.

However, a highly relevant finding rarely mentioned, in what turned out to be this wee little study, is that 26% of the women who remained on the drugs became depressed anyways.

The study authors noted that of the 82 women who continued antidepressant treatment throughout pregnancy, 21 or 26% relapsed. But there were only 65 women in the group that discontinued the drugs, so the results logically showed a higher rate of relapse when 45 became depressed.

Moreover, nearly 2 years before the study was published in JAMA, on January 13, 2004, the lead author, Dr Lee Cohen was quoted in the New York Times as saying about 75 to 80% of pregnant women who go off antidepressants will relapse during the pregnancy.

Six months after JAMA ran the study, the July 11, 2006 Wall Street Journal explained why the I3 “experts” might encourage pregnant women to keep taking SSRIs. It stated that the lead author Dr Cohen, a Harvard Medical School professor and director of the research program at Massachusetts General, was a longtime consultant to the 3 antidepressant makers, a paid speaker for 7, and his research work was funded by 4 drug companies.

In fact, the Journal reported, “the study and resulting television and newspaper reports of the research failed to note that most of the I3 authors are paid as consultants or lecturers by the makers of antidepressants,” and “the authors failed to disclose more than 60 different financial relationships with drug companies.”

And just like clock-work, the Cohen’s study was widely cited in other journals promoting the sale of SSRIs to pregnant women. “In summary, it seems clear that the risks of not receiving adequate antidepressant treatment thus far outweigh the risks of adverse events, not only in infants but in mothers as well,” wrote Dr Pierre Blier of the University of Ottawa in editorial in the Journal of Psychiatry and Neuroscience, 2006;31(4):226-8.

“The population,” he warned, “should therefore learn to fear the illness more than the antidepressant.”

But as it turns out, Dr Blier has conflicting interests included among others, being a consultant with Lilly, Forest Labs, Janssen, Wyeth and Sanofi-Aventis, and a contract employee with Forest Labs. He was also in the speaker’s bureau for Lilly, Forest Labs, and Wyeth, and received grant funding from Lilly, Forest Labs and Wyeth.

The JAMA study, along with a brief note from Dr Cohen himself, was also featured in the Spring 2006 issue of Massachusetts General Hospital’s Center for Women’s Health Newsletter, in a publication that downplayed the risk of just about all the birth defects discovered in recent years including heart birth defects and the infant withdrawal syndrome.

Since 1990, JAMA has required authors of studies to list all financial interests and has published the disclosures. In an online editorial in July 2006, JAMA editor Dr Catherine DeAngelis announced her intention to enforce the policy in part by publicizing any author’s failure to follow the rules and specifically noted that 3 consecutive nondisclosures involved authors from Harvard Medical School and included Dr Cohen’s study.

On July 11, 2006, citing material promoting the events, the Wall Street Journal reported that the Massachusetts General psychiatry academy planned to conduct Continuing Medical Education seminars in a dozen cities across the US, with Dr Cohen overseeing a segment on the treatment of pregnant women with psychiatric disorders.

One of the funding sources for the seminars was revealed less than a year later on May 1, 2007, when the Journal reported the major recipients of the $11.8 million that Eli Lilly gave out during the first three months of 2007, and said the largest single grant “was $825,000 to Massachusetts General Hospital’s psychiatry department for a year-long educational program with more than 150,000 registrants.”

It should be noted that Lilly introduced the first SSRI, Prozac, in the late 1980s and its current best-selling antidepressant Cymbalta earned the company $1.3 billion in 2006.

The financial ties between the researchers and SSRI makers was brought to the attention of the JAMA editor by Dr Adam Urato and a letter from Dr Urato was also published in JAMA, stating that since the study dealt in part with the question of stopping antidepressants during pregnancy, the readers should be aware of the potential for pro-drug bias.

However, all that being said, the Cohen study is still being cited to promote the use of SSRIs with pregnant women, as recently as April 26, 2007, in a paper by Dr Claudio Soares, director of Women’s Health Concerns Clinic, McMaster University, Ontario in Journal Watch Women’s Health, a publication put out by the NEJM.

“Results of a recent prospective study of pregnant women,” he wrote, “who were taking antidepressants at or near the time of conception demonstrated that women who opted to discontinue treatment during pregnancy were five times more likely to relapse than were those who stayed on treatment.”

“Despite the cautionary remarks commonly made by most regulatory agencies and medical societies about the use of psychotropic medications during pregnancy,” Dr Soares stated, “considerable data supporting the efficacy and reproductive safety of antidepressants have accrued.”

“Conversely,” he warned, “evidence suggests that untreated depression has negative consequences for both mother and child.”

“In summary,” Dr Soares stated, “clinicians should bear in mind the mounting evidence about the adverse effects of uncontrolled depression during pregnancy.”

But here too, Dr Urato, wrote a response to this obvious sales pitch objecting to the total lack of citations to studies that support the assertion that the risks of birth defects associated with SSRI are rare and that the benefits of SSRIs use to avoid relapse into depression outweigh the risks.

But most concerning, Dr Urato wrote, “is the complete lack of financial disclosure information to go along with the article.”

“As I was reading this piece,” he wrote, “I kept thinking to myself ‘Boy, this sounds like it was written by someone working for the antidepressant makers.’”

And sure enough, Dr Urato found that Dr Soares is on the Speaker’s Bureau for Forest Labs, Wyeth, Glaxo, and Pfizer and has received honoraria as a research consultant for Sepracor, Glaxo, Wyeth, and Neurocrine.

Mr Kwok is also highly critical of the increasingly common practice of using “opinion leaders” like Dr Soares to sell SSRIs to pregnant women. He stated, “there will come a time when the drug manufacturers will have to face the music on SSRIs causing PPHN, and that time is coming soon.”

He said his firm has an abundance of new cases that prove it’s no coincidence that pregnant mothers on SSRIs have an increased likelihood of giving birth to babies with PPHN in families where there is no history of respiratory illness.

“Just yesterday,” Mr Kwok stated, “I spoke to a mother who birthed a baby with a serious breathing disorder that requires regular use of a nebulizer, a device used to administer medication via liquid mist to the airways, commonly used in treating asthma and other respiratory diseases.”

“This young mother is now at risk of losing her job,” Mr Kwok reported, “since her infant requires full time care.”

He said doctors should be instructed to screen patients who are pregnant or planning to become pregnant and inform them of the risks of SSRIs to a developing fetus. “At least educate this “class” of women,” he said, “so they may make informed personal decisions.”

“Sure, the loss of this “class” may cost the drug manufacturers some profit,” he noted, “but it’s the right thing to do and it will save many families a lifetime of torture caring for a sick child like we see over and over again.”

The need to recapture pregnant women as customers is crucial for some SSRI makers. For instance, Forest Labs reported that Lexapro and Celexa accounted for 68% of the firm’s total sales for the year ending March 31, 2006, in its Annual Report filed with the SEC.

Back in May 2005, researchers from the University of Pittsburgh estimated that in any given year at least 80,000 pregnant women in US are prescribed SSRIs, in JAMA.

Families seeking legal advice for infants born with heart or lung birth defects to mothers who were prescribed Celexa during pregnancy may contact Robert Kwok at Robert Kwok & Associates, LLP at (888)466-5965]

* This article is written as part of a series on Celexa related litigation and is sponsored by Robert Kwok & Associates, LLP

The memo also shows that FDA reviewer Dr David Ross recommended a highlighted boxed warning for CHF, a life-threatening condition that occurs when fluid builds up in the lungs causing a severe shortness of breath that requires immediate medical attention.

The memo also recommended that macular edema, a condition that causes swelling of the retina and can lead to blindness, be listed as a serious adverse event on the label. Although the recommendations were approved by Dr Rosemary Johann-Liang, the Deputy Director of the FDA’s Division of Drug Risk Evaluation, they were never added to Avandia’s label.

Instead of forcing Glaxo to post warnings to protect Americans, top FDA officials basically demoted Dr Johann-Lang for approving the warnings to begin with.

Congestive heart failure “is a very, very clear adverse reaction syndrome” with Avandia, Dr Johann-Lang told reporter, Rita Rubin, according to an article in USA Today on June 11, 2007. She also noted a concern that some patients might blame symptoms, such as shortness of breath, on the underlying diabetes and mistakenly take more of the drug.

Dr Johann-Lang has now left her position at the FDA for personal reasons, but said in her interview with USA Today, that she might have tried to figure out a way to stay “if the agency had a vision of promoting and protecting public health.”

However, her departure does not mean that the misconduct by senior FDA officials will be overlooked. On June 4, 2007, Senator Charles Grassley (R-Iowa) and the Senate Finance Committee sent a letter to the FDA Commissioner Andrew von Eschenbach demanding answers to questions by June 20, 2007, about the retaliation waged against the safety evaluators who tried to warn the public about the risks of Anvandia a year ago.

Although Glaxo downplayed the risks, according to a June 1, 2007 report by Andrea Gerlin for Bloomberg News, the FDA knew about risks associated with Avandia as far back as April 1999, when GlaxoSmithKline executives told the FDA that the drug caused “minimal” cardiovascular side effects and “mild to moderate” fluid buildup,

The agency approved Avandia on May 25, 1999, even though some FDA advisory panel members had recommended that more research should be conducted to detect potential complications.

On February 8, 2001, the FDA Web site shows the agency approved revisions to the Prescribing Information for Avandia to include a new warning regarding cardiac failure and cardiac effects.

But 3 months later, Glaxo sales representatives were “denying the existence of serious new risks associated with Avandia” in presentations at Glaxo’s promotional exhibit booth during the Annual American Association of Clinical Endocrinologists Meeting in San Antonio, Texas on May 2-6, 2001, according to a July 26, 2001 FDA letter to Glaxo.

The letter also pointed out that Glaxo had already been warned about this conduct several times. “Your promotional activities that minimize serious new risks are particularly troublesome,” it said, “because we have previously objected, in two untitled letters, to your dissemination of promotional materials for Avandia that failed to present any risk information about Avandia or minimized the hepatic risk associated with Avandia.”

The untitled letters were sent to Glaxo on June 29, 1999 and October 20, 2000. “Despite your assurance that such violative promotion of Avandia had ceased,” the July 2001 letter states, “your violative promotion of Avandia has continued.”

In a December 3, 2006 interview, diabetes researcher Rury Holman of Oxford University in the UK, an investigator in the Glaxo study known as ADOPT, told Bloomberg News that the results of that study, which were released in November 2006, were cause for concern.

“These people are early diagnosis, they haven’t got complications,” he said. “The fact that we’re seeing these cardiovascular effects in them we can’t deny that.”

The concern, he noted, was that a signal emerged in “relatively healthy patients.”

In addition, according to the FDA web site, significantly more female patients who received Avandia in the ADOPT study, “experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide.”

In an all too familiar pattern with the Bush-controlled industry friendly FDA, Americans were kept in the dark about the risks associated with a drug in what many experts are calling another Vioxx-like disaster.

On May 23, 2007, Reuter’s reported that Europe’s watchdog, the European Medicines Agency (EMEA), had taken action on the risks of Avandia last year by strengthening the warnings on the drug.

“The situation in Europe is a little bit different to the American situation because,” the agency spokeswoman said, “in Europe, Avandia is contraindicated in patients with heart failure anyway and we have warnings about ischemia.”

She also referred to a May 2007 study in the New England Journal of Medicine, conducted by Cleveland Clinic cardiologist Dr Steven Nissen, which found Avandia to be associated with a 43% increase in heart attacks and possibly a 64% increase in cardiovascular death. The EMEA spokeswoman explained that “the majority of the studies looked at in the Nissen paper have already been assessed by the (the agency’s expert) committee and, partly due to that, the SPC (summary of product characteristics) was updated in 2006.”

Only after being boxed in a corner, on June 6, 2007, the Johnny-come-lately, FDA Commissioner von Eschenbach, informed a US House Committee that the FDA is now requesting that a black box warning about CHF be added to the labels of Avandia and another diabetes drug Actos.

However, an extra year with a sleeping US watchdog paid off well for Glaxo. According to a May 21, 2007 USA Today article, doctors in the US wrote 13 million prescriptions for Avandia last year, generating more than $2 billion in sales, according to figures from the data tracking firm IMS Health. Three million prescriptions had already been sold by the end of March 2007.

Persons seeking legal advice regarding Avandia can contact Baum, Hedlund, Aristei, Goldman & Menzies Law Firm.

Experts point out that the studies analyzed for the NEJM report were not designed to look for heart risks, many were only 24 weeks long, and it may be that higher risks will appear after a longer term of use. Dr David Nathan, chief of diabetes care at Massachusetts General Hospital, who reviewed the paper for the NEJM, told the Associated Press, “This analysis is just scratching the surface of what may be there.”

Avandia (rosiglitazone) was approved by the FDA in 1999 for the treatment of type 2 diabetes, a disease that affects between 18 to 20 million Americans.

When approved, Glaxo promoted Avandia as being safer than Rezulin, a diabetes drug removed from the market in 2000 after serious cases of liver damage developed in patients taking the drug.

Avandia is currently the top selling diabetes drug with total US sales of $2.2 billion in 2006, according to IMS Health, a healthcare tracking information firm. A one-month supply sells for between $90 and $170, the Associated Press reported on May 23, 2007.

“More than 6 million people worldwide,” the Associated Press reports, “have taken the drug to control blood sugar since it came on the market eight years ago, and about 1 million Americans use it now.”

The FDA is going to have an extremely tough time wiggling out from under the rug of blame for this regulatory failure. The situation “reflects very badly on the FDA and on Glaxo,” Dr Nathan said. “It’s the FDA’s responsibility to be monitoring this stuff.”

In an editorial that accompanied the study in the NEJM, Dr Bruce Psaty of the University of Washington and Dr Furberg of Wake Forest University wrote: The drug “represents a major failure of the drug-use and drug-approval processes in the United States.”

They also state that “the rationale for prescribing rosiglitazone at this time is unclear,” because when the drug was approved its benefits were “at best mixed.”

Documents dating back seven years show the FDA knew about the risks associated with Avandia and did nothing to protect consumers. The day after the new study appeared online, on May 23, 2007, Dr Sidney Wolfe, director of Public Citizen, a non-profit health research group, sent a letter to FDA Commissioner Andrew von Eschenbach, which described a July 16, 2002 FDA memo that showed FDA scientists had recommended that the label for Avandia be amended to include post-marketing reports of heart failure among patients taking the drug.

“The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough,” Dr Wolfe said in a press release.

“As a result,” he stated further, “millions of people — to the detriment of their health — are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs.”

According to the memo, in July 2002 the FDA had 25 adverse reaction reports in which the use of Avandia resulted in hospitalization for heart failure. By the fall of 2006, the number of cases had increased to 415, Public Citizen reports.

Another memo dated May 22, 2002, submitted to the FDA by Dr. Wolfe and Larry Sasich for an FDA Hearing on Risk Management of Prescription Drugs, informed the panel that a Glaxo-employed physician had contacted Public Citizen to report that the company was concealing reports of serious problems found with the drug.

“This week,” they informed the FDA, “we received an anonymous call from a GlaxoSmithKline physician who was alarmed at the failure of his company to require a black box warning concerning heart failure caused by Avandia.”

“He maintained that the company currently has 450 reports of heart failure associated with the use of the drug and over 1200 reports of edema,” the statement said.

Nearly two years earlier, on March 15, 2000, Dr. John Buse, an Associate Professor of Medicine and Director of a Diabetes Care Center in Durham, North Carolina, sent a letter to then FDA Commissioner, Dr. Jane Henney, warning the FDA about the risks of Avandia and describing the abuse of clinical trial data by Glaxo.

“I remain concerned about the safety of rosiglitazone,” Dr. Buse wrote, “in light of its 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.”

Dr. Buse warned, “I think the FDA has to act forcefully to prevent the rampant abuse of clinical trial data by SmithKline Beecham.”

He warned Dr. Henney that Glaxo was overstating the safety of Avandia with respect to cardiovascular issues. “I have been shown glossy materials claiming that rosiglitazone has been uniquely studied in patients with preexisting cardiac disease,” he wrote, “including patients with a number of associated conditions (such as unstable angina).”

“I know for a fact,” he noted, “that such patients are excluded in clinical trials as I am a PI [Principal Investigator] in one of their trials.”

Lawmakers in both Houses of Congress reacted to the news of another FDA regulatory failure immediately. On May 21, 2007 the US House of Representatives Committee on Oversight and Government Reform announced that a hearing would be held on June 6, 2007, at 10:00 am in Room 2154, Rayburn House Office Building, to assess the FDA’s role in the evaluation of the safety of Avandia.

Committee chairman, Rep Henry Waxman (D-CA) extended an invitation to the author of the NEJMarticle, cardiologist, Dr Steven Nissen of the Cleveland Clinic, to testify at the hearing and discuss his article.

Dr Nissen and statistician Kathy Wolski, MPH, evaluated 42 studies involving nearly 28,000 patients and compared the 15,560 patients who were using Avandia to the patients who were not using the drug. The study found there were 86 myocardial infarctions in the Avandia group and 72 in the control group and there were 39 deaths from cardiovascular causes in Avandia patients compared to 22 in the control group.

Rep Waxman also sent a letter to FDA Commissioner Andrew von Eschenbach requesting his testimony at the hearing. In addition, he instructed the Commissioner to provide the Committee with specific information from August 1, 2005, to the present to include: (1) A chronology of actions taken by FDA in relation to the cardiovascular safety of rosiglitazone; (2) All communications between GlaxoSmithKline and the FDA relating to cardiovascular safety of rosiglitazone; and (3) All internal FDA analyses, slide presentations, and memoranda relating to the cardiovascular safety of rosiglitazone.

“In complying with this request,” Rep Waxman advised the Commissioner, “you should produce all responsive documents in your possession, custody, or control.”

Rep Waxman also told the Commissioner, “you should submit a written certification, signed by you or your counsel, stating that: (1) a diligent search has been completed of all documents in your possession, custody, or control which reasonably could contain responsive documents; and (2) all documents located during the search that are responsive have been produced to the Committee or identified in a privilege log.”

And last but not least, Rep Waxman sent a letter to Glaxo CEO, Dr Jean-Pierre Garnier, asking him to appear. “We request that you come prepared to discuss your company’s actions with regard to the cardiovascular safety of Avandia,” the letter states.

Over in the US Senate, Senators Max Baucus and Chuck Grassley, Chairman and Ranking Member of the Senate Committee on Finance, which has jurisdiction over the Medicare and Medicaid programs, issued a public statement and sent letters to the FDA and Glaxo demanding they provide specific documents and other information to the Committee.

“What we are learning about the handling of Avandia,” Sen Baucus said in the statement, “by both GlaxoSmithKline and the FDA is appalling and unacceptable.”

“Both the drug company and the FDA,” he said, “have some major explaining to do about what they knew about Avandia, when they knew it, and why they didn’t take immediate action to protect patients.”

“We need to know if this is another Vioxx,” Senator Grassley stated, “where the FDA sat on its hands and endangered lives.”

“The FDA,” he continued, “has talked a good game about how it’s beefed up post-market
surveillance over the last two years, but a case like this undermines that claim.”

Experts say the new study findings are alarming because two-thirds of the people with type 2 diabetes die of heart problems. In a May 21, 2007 letter to Christopher Viehbacher, President, US Pharmaceuticals, GlaxoSmithKline, Senators Baucus and Grassley wrote, “It is troubling, to say the least, that by taking Avandia, diabetics may be increasing their risk of the very adverse event that they hope to prevent by controlling their blood sugar.”

“To make matters worse,” they advised, “American taxpayers have spent hundreds of millions of dollars on this drug through the Medicare and Medicaid programs.”

“One of the most immediate concerns to us,” they told Mr Viehbacher, “are reports that GSK employees silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia.”

“This allegation is very serious and warrants further investigation,” the Senators wrote.

According to plaintiffs attorney, Karen Barth Menzies of Baum Hedlund, a law firm that has been litigating drug related cases against Glaxo since 2001, “The relationship between FDA and the drug industry is disturbing. We’ve seen internal correspondence between GSK and the FDA that would cause anyone to question the objectivity and regulatory effectiveness of the FDA. Apparently the FDA has failed yet again to protect the public — to the benefit of pharmaceutical industry profits. This failure, and FDA’s derogatory attitude towards Dr. Nissen’s study, should sound an alarm to all healthcare providers, patients and legislators that the problem is systemic. Patient safety commands serious change in the agency and the industry.”

Already, legal conferences are being scheduled to discuss the legal implications of this latest drug safety scandal. Karen Barth Menzies is an invited speaker at an upcoming legal conference regarding Avandia. The conference will include Avandia’s background, the science behind the drug, its side effects as well as the FDA’s role in regulating Avandia.

Persons seeking legal advice regarding Avandia can contact Baum, Hedlund, Aristei, Goldman & Menzies .

And yesterday there was the President, whose only military experience consists of draft-dodging, going AWOL from a cushy stint in the National Guard set up by daddy, and finishing his term of duty as grounded fighter pilot, calling a press conference to inform Americans for the umpteenth time that the only way to the keep the terrorist at bay is by allowing the slaughtering in Iraq to continue; forever apparently.

Over the past month, the majority of political discussions on cable news talk shows related to Iraq funding bill were focused on how members of Congress and especially those who are presidential candidates are consumed with worry over how their votes on funding will affect the results of the next elections.

Once elected, it would be interesting to find out exactly how long it takes for politicians to lose the ability to feel and vote with their hearts when they know that a policy such as the Iraq war is terribly wrong, without thinking about how the decision will effect the vote tally in the next election.

As citizens, we have no control over our own government. Never in my 57 years on this earth have I been so ashamed to be an American knowing that every day that the war continues we are knowingly allowing our soldiers and innocent Iraqis to be killed or injured with absolutely no justification, other than because politicians believe it will be beneficial to their careers to allow Bush’s failed war policies to continue.

While political commentators discuss voter odds, myself and probably most Americans are sitting at home unable to watch the news without breaking down crying as the latest pictures flash on the screen showing the happy faces of the young soldiers who are now dead, knowing full well that the next night there will be more pictures of dead soldiers because the politicians have made it clear that the citizens paying their salaries have no right to demand that their elected officials put an end to the killing in Iraq.

It would be interesting to take a poll to see how often each politician even looks at the smiling faces of the dead soldiers and the second question in the poll should be, for those who claim that they do look at these faces every day and still vote to give Bush more funding, how many had to use drugs or alcohol to get to sleep during the 7 days following the vote.

For this poll, a high number of drugs and alcohol users would be viewed as positive because the reason for the question is to determine how many politicians still have the capacity to feel guilt.

Congress needs to get one thing straight, the war funding is not about politics, it is about more deaths and injuries every single day that ticks off the calendar all because Bush took this country into a senseless war based on lies. Every single day matters to the soldiers and their families, and to those of us who feel extremely guilty about not being able to find a away to get them out of Bush’s war.

Why is there no in-depth discussion by any members of Congress on political talk shows about where these tax dollars are actually ending up, aside from an occasional flare-up of indignation about Halliburton?

There is nothing positive in Iraq to hold up to show Americans how Iraqis have benefited from all the tax dollars already poured into a bottomless pit.

The issue of war profiteering is like the elephant in the middle of the living room, every member of Congress knows where the funding is going but Americans don’t hear them on talk shows letting people know that these kids are being killed in the name of war profits.

And the statements in speeches made by members of Congress while debating the bills don’t mean anything because 95% of Americans never hear those speeches. Honest politicians should be out screaming to any reporter who will listen to educate Americans about where the hundreds of billions of tax dollars have ended up.

This war is 100 times worse than Viet Nam. A least with Viet Nam, the war profits were not being funneled over the backs of our dead soldiers in plain sight directly into the bank accounts of current and former members of the administrations in power at the time.

Nor were they being funneled to the family bank accounts of the Presidents who were in office during the Viet Nam war.

Former Nixon administration official, John Dean, has said that the Bush administration is worse than the Nixon’s. He’s right; the Bush gang makes the Nixon administration look saintly and gives a whole new meaning to Nixon’s famous line of “I am not a crook.” In comparison to the actions of the current regime, it could indeed be said that Mr Nixon was not a crook.

Its easy to understand why most Republicans are not about to tell the world that the leader of their party is a war profiteering crook but the question remains, when are Democrats going to start addressing the issue of who is benefiting from all this war funding and start publicly naming names along with the companies they are connected with.

They have the ability to draw press coverage and give the specific names of current and former administration officials and Bush family members who have set up companies to profit off the war or steered contracts to companies they now work.

Last year, most clearly in the fall elections, Americans told Bush and Congress to get our troops out of Iraq. Democrats took control of Congress at the new year, and there was Bush in a televised address on January 10, 2007, announcing that he had ordered the deployment of five more combat brigades to serve as sitting ducks in Iraq, in addition to the 15 brigades that were already there. Since then, he has extended combat tours from 12 months to 15 months and announced the deployment of still more troops.

According to an analysis by Hearst Newspapers, when support troops are added in, the total number of soldiers in Iraq is about 162,000, and could be 200,000 by Christmas.

In the years to come, the history books will describe the Bush Presidency and the details of a grand war profiteering scheme nicknamed the “war on terror,” and with that in mind, members of Congress would be wise to start speaking out against the war profiteers to make damn sure that the historians will be able to report that that they were out there calling a spade a spade and trying to put an end to the death for profit disaster in Iraq.

One commentator on a recent cable talk show made the statement that when voting on the Iraq funding; politicians are not in lock step with how strongly Americans feel about ending this war. That comment was an understatement, because Americans are as fed up with politicians debating over the money as much as they are with the war itself.

Members of Congress and the Presidential candidates should quit trying to second guess how American will vote in the next election and think about how much longer they are going to be willing to sit at home in front of their television sets depressed and driven to tears by looking at flashes of the happy faces of soldiers who were killed that day.

As for presidential candidates, the name John Murtha should be added to the ballot, as he seems to be about the only member of Congress willing to go public and speak from the heart when trying to get the rest of Congress to recognize the need for an immediate plan to rescue our young men and women stranded in Iraq.

The candidates that are working hard to try to end the war get little credit or media coverage. Dennis Kucinich is rarely mentioned and he is working tirelessly to come up with ways to get our soldiers out of Iraq.

By the time the 2008 election rolls around, who knows, after weighing the few options available maybe Americans will decide that no candidate who is a current member of Congress and refused to listen to the people on such an important issue as the Iraq war can be trusted to serve as President.

An FDA advisory committee held a public hearing on December 13, 2006 to review drug company data that show SSRIs to be associated with suicidality in adults. The commonly prescribed SSRIs in the US include Prozac, by Eli Lilly, Paxil by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro by Forest Labs, along with various generic versions of the drugs.

Many of the world’s leading experts on psychiatric drugs traveled to Washington to appear at the hearing, some of whom have spent years investigating the adverse events associated with SSRIs, to testify about the need to extend the back box warnings about suicidality to all age groups.

Needless to say, advocates and experts alike are outraged over the limited warning, which is widely viewed as another gift to the drug makers by the FDA. “Keeping up with its support of the Psychiatric community and pharmaceutical industry the FDA has again taken the low road,” says Kelly Patricia O’Meara, author of PSYCHED OUT: How Psychiatry Sells Mental Illness and Pushes Pills That Kill.

“Not only is it continuing to minimize the adverse reactions of the antidepressants on the entire population,” she notes, “it has now become a cheerleader for the psychiatric community.” “When will the well-being of the American People,” Ms O’Meara asks, “get the protection it needs and deserves from the nation’s leading drug watchdog and when will this nation’s lawmakers stand up and be counted on this issue?”

Attorney Karen Barth Menzies is one of the nation’s most relentless advocates in the legal field when it comes to pushing the FDA to add warnings about adverse events to the labels of SSRIs. In fact, she has traveled to Washington to speak on behalf of SSRI victims numerous times.

“As I stated in my testimony before the FDA in December 2006,” Ms Menzies notes, “it is not the FDA’s job to promote the virtues of particular drugs nor is it FDA’s job to suggest what treatment people should receive for a particular medical problem.”

“Even the FDA’s Dr. Robert Temple said as much during the December hearing.”

“Yet that is what the FDA has done with its announcement of the expanded warnings on antidepressants,” she says.

“Aside from the very serious risks of these drugs,” she explains, “there is an overarching issue related to their over-prescription and drug manufacturers preying on vulnerable people by telling them they have a disease that must be treated with their medication.”

A partner in the Baum Hedlund law firm, Ms Menzies considers the FDA’s expanded warning a hollow victory. “While it appears that the FDA has finally taken the issue more seriously,” she notes, “it is 20 years and thousands of lives too late.”

In addition, in the agency’s press release and accompanying Q & A document, Ms. Menzies warns, “The FDA has made some seriously misleading statements that will lead patients and physicians into a false sense of security.”

Ms Menzies says she believes “without question” that drug makers are putting pressure on the FDA. “Despite the controversy over the failures of the FDA in the past several years,” she points out, “it appears that the FDA simply cannot muster the guts to act without industry influence.”

Critics say the nation’s regulatory agencies under the Bush administration have evolved into a protection network for drug makers, in large part, because the industry has created a revolving door where top officials move directly from their government employment into high-paying positions with drug companies.

The latest evidence of this charge appeared in the media on May 4, 2007, with a press release by Prozac-maker Eli Lilly, announcing that Alex Azar II will be joining Lilly as senior vice president, who until February 3, 2007, was the Deputy Secretary of Health and Human Services and served as the “chief operating officer of the largest civilian department in the federal government.”

“Azar supervised all operations of the HHS, including the regulation of food and drugs,” the press release said, and agencies under his direction included, among others, the FDA.

Azar follows in his former partner, Daniel Troy’s footsteps in defending the drug industry. While Troy left his position as chief counsel at the FDA to work for a law firm representing drug companies, Azar (also a lawyer) went straight to the drug industry itself.

At Lilly, Azar will be responsible for “public relations, governmental affairs, public‑policy planning and development, external and internal communications, corporate branding and community relations.”

According to the Indianapolis Star, Azar “takes over the Lilly post as seven states are suing the company, alleging that it promoted off‑label uses for Zyprexa, its top‑selling drug approved for schizophrenia and bipolar disorder.

“Like other pharmaceutical companies,” the Star points out, “Lilly also faces an array of public‑ policy challenges, including criticism that it is too cozy with doctors and regulators.”

There is one positive to be noted, at least Troy and Azar are no longer pretending to be protectors of the public health. Experts say the suicidality risk applies to all SSRI users. “The simple truth is that antidepressants cause suicide in all age groups,” according to psychiatrist, Dr Peter Breggin, a court-certified expert on SSRIs, and author of The Anti-Depressant Fact Book.

“Dragged kicking and screaming into admitting that children and now young adults are at risk for antidepressant-induced suicidality,” he says, “the FDA continues to evade reality.”

“If the relatively insensitive drug-company rigged short clinical trials pick up suicidality in any age group,” Dr Breggin says, “it’s almost a certainty that they are causing actual suicides in all ages.”

Many other experts agree that safety decisions should not be based on drug maker studies. “The fundamental problem continues to be that the FDA is basing their decisions on studies that are designed and paid for by the very companies that make these drugs,” said Dr Timothy Scott, author of America Fooled: The Truth about Antidepressants, Antipsychotics and How We’ve Been Deceived.

“It is a case,” he says, “of the fox guarding the chicken house.”

“The research designs used by these studies,” he notes, “are incredibly unfair and yet the FDA is allowing this system to continue.”

“Dishonest research designs,” Dr Scott says, “do not give an honest assessment of the physical or the psychological dangers of long-term antidepressant use.”

“Independent research investigations,” he states, “repeatedly find adverse events are much, much higher than the rates reported in the studies submitted to the FDA by the drug manufacturers.”

For over a decade and a half, Attorney Menzies points out, SSRI makers have enjoyed enormous financial benefits from their manipulations of the clinical trial data and the FDA continues to ignore all evidence aside from data provided by the drug companies. “The FDA is ignoring,” she says, “independent analyses conducted by scientists in the field, as well as historical and foreign regulatory actions dating back over 20 years.”

Ms Menzies states that clinical trial data from before SSRIs were even approved, signaled the suicidality risk. Documents obtained in litigation show that as early as 1984, Eli Lilly was aware of an increased risk of suicidality with Prozac.

Attorney Menzies calls the FDA’s statement that “scientific data does not show an increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality,” “extremely misleading.”

“Rather than accurately informing the public that suicidality can occur in some people at any age,” she notes, “this new warning gives the false perception that certain age groups are entirely safe while others are not. I know for a fact from my review of internal drug company documents that that is not true,” she says.

Critics also find this statement disturbing in light of other independent studies, including a study reported in the May 1, 2006 London Free Press, conducted at the Toronto’s Institute for Clinical Evaluative Sciences, that identified suicides among older Ontarians, 66 and up, and found that for patients who were prescribed antidepressants in the 6 months before their deaths, the risk of suicide in the first month for those taking SSRIs was nearly 5 times higher than for seniors taking older antidepressants called tricyclics such as Elavil.

Other experts also object to the piecemeal addition of SSRI warnings. “When the FDA ordered a black box warning for only those 18 and under, it defied common sense that as soon as one turned 19, one was safe,” says Dr Bruce Levine, PhD, Clinical Psychologist, author of STAR*D Wars: The Corruption of the National Institute of Mental Health and the Failure of Antidepressants.

“And now that the warning will extend until 24,” Dr Levine adds, “it defies common sense that one becomes safe on one’s 25th birthday.”

“While some people report antidepressants have benefited them,” he notes, “legitimate science shows that these antidepressants are no more helpful for depression than a placebo or no treatment at all.”

According to a study analyzing clinical trials submitted to the FDA for drug approval, the efficacy data submitted to the FDA for the six most widely prescribed antidepressants approved between 1987 and 1999, “the pharmacological effects of antidepressants are clinically negligible.” (The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration by Irving Kirsch, Thomas J. Moore, Alan Scorboria and Sarah S. Nicholls)

According to Kirsch, “[a]lthough antidepressant medication is widely regarded as efficacious, a recent meta-analysis of published clinical trials indicates that 75 percent of the response to antidepressants is duplicated by placebo.” Kirsch & Sapirstein, G. (1998). Listening to Prozac but hearing placebo: A meta analysis of antidepressant medication.

Two recent studies conducted in the UK report that exercise in a green environment may be the best remedy for depression. In response to the high cost of drugs, the rise in prescriptions and the fact that 93 percent of GPs reported that “they have prescribed antidepressants against their better judgment owing to a lack of alternatives,” the studies found that “participating in green exercise activities provides substantial benefits for health and wellbeing.”

The “green activities” included gardening, walking, running and bicycling, particularly in a “green” environment.

Another of the world’s leading experts on psychiatric drugs, Dr David Healy, author of The Creation of Pharmacology (Harvard 2002), also a frequent visitor traveling from the UK to Washington to testify at FDA hearings, says, “The clinical trial data pointing to a risk was compelling 17 years ago.”

“In between 1990 and now,” he notes, “the FDA and drug companies have argued that their assessment of risk benefit ratios has not warranted issuing warnings.”

“But if we look at the supposed benefits,” he explains, “in milder depressions — the vast majority of people who get antidepressants — the FDA analysis in December 2006 showed that only 1 in 10 people who are given antidepressants in clinical trials respond to the drug.”

“Four out of 10 respond to being seen and given sensible advice,” he notes.

“Putting this 1 in 10 response rate against a 1 in 100 rate of suicidal acts might not seem a bad bet,” Dr Healy says, “but suicidal acts are not the only risk of treatment — patients can become severely anxious, homicidal, are at increased risk of broken bones, strokes and bleeds into the gut and other organs, weight gain and its attendant risks.”

He also notes that one in two patients on antidepressants experience sexual dysfunction and that it now seems that in a proportion of these people, the problem may be permanent.

“In the case of children,” he says, “there are additional risks like failure to grow.”

Another serious adverse event with SSRIs is a discontinuation syndrome. Psychiatrist Dr Grace Jackson, author of Rethinking Psychiatric Drugs: A Guide for Informed Consent, warns that some patients may not be able to return to living without the drugs, not because they develop a “craving,” but because the withdrawal effects they experience during drug cessation are intolerable and are misinterpreted by doctors as “proof” of depressive relapse, for which “lifelong therapy” is mandated.

Over the past several years, many new adverse events related to SSRI use have emerged, including life-threatening birth defects in infants born to mother’s taking SSRIs during pregnancy. But because SSRI makers have hidden negative studies for years, experts say patients and doctors were not informed of all the known risks associated with SSRIs.

“Informed consent cannot be obtained for antidepressants — or for any pharmaceutical — unless all of the drugs’ risks are known to the prescribers,” according to psychiatrist, Dr Stefan Kruszewski, Faculty, Eastern University, Department of Addictions.

“They cannot be known,” he says, “if all of the data is not made available to review or made public, as was the case with Paxil.”

According to Dr Healy, a bigger issue stems from company efforts to make billions of dollars out of these drugs by having them given to people who have little to gain from treatment and a lot to lose.”

Dr Healy says most patients with milder depression would get well if seen by a sympathetic physician or therapist and describes three side effects that have resulted from the SSRI controversy:

(1) Physicians have lost confidence in their own ability to help patients without drugs.

(2) A great deal of the problem stems from the fact that close to all of the literature physicians now read is ghostwritten and the articles overemphasize the benefits of treatment and hide the risks.

(3) Antidepressants might be useful drugs, if primarily used for those with severe disorders, but at the moment the drugs probably pose a greater risk than the illness to the lives, careers and relationships of those to whom they are being given.

Clinical pharmacologist, Andrew Herxheimer, also says doctors should be advised not to prescribe drugs, especially SSRIs, to patients with only mild or moderate depression, and if prescribing is deemed necessary, to use the lowest dose that is effective for the individual.

According to Dr Levine, the SSRI makers are not as unhappy as some might think with the warnings and negative publicity. “Patents have run out or are soon to run on all their big sellers,” he explains, “and they are preparing their next generation of worthless, dangerous but patented drugs to replace the SSRIs.”

Ms Menzies reports that there is a big push to switch people over from taking anti-depressants to anti-psychotics under the guise that people aren’t depressed after all, they actually have bipolar disorder. “It is a very cleverly orchestrated marketing scheme and it’s a continuation of the manipulation of a vulnerable population,” she says.

Vince Boehm, another persistent advocate for warnings on SSRIs, agrees, “This is all about marketing, and not about safety.”

“This latest ploy” regarding the expanded antidepressant warnings, Boehm explains, “is a delaying action on the part of the manufacturers with FDA complicity.”

“The FDA just commissioned a series of three year studies to evaluate the adult suicide problem,” he notes, “and by the time these studies are done and released, the bulk of the medications listed in this announcement will be either off or going off patent.”

For more information see:
A Paxil Lawyer Source
Anti-depressant Adverse Reactions
Paxil Birth Defects

(Written as part of the Paxil Litigation Monthly Round-Up, Sponsored by Baum Hedlund’s Pharmaceutical Antidepressant Litigation Department)

However, the massive over-prescribing of SSRIs, including Prozac, Paxil, Zoloft, Celexa, and Lexapro in combination with many other drugs now has medical experts scrambling to educate doctors about a life-threatening condition known as “serotonin syndrome.”

According to the report, “A Mix of Medicines That Can Be Lethal,” by Jane Brody in the February 27, 2007 New York Times, “with the enormous rise in the use of serotonin-enhancing antidepressants, often taken in combination with other drugs that also raise serotonin levels, emergency medicine specialists are trying to educate doctors and patients about this not-so-rare and potentially life-threatening disorder.”

According to the Times, patients at particular risk, some experts say, are those taking a combination of antidepressants and antipsychotic drugs prescribed to treat resistant depression. Ms. Brody notes that in the March 2005 New England Journal of Medicine, two specialists, Dr Edward Boyer of the University of Massachusetts Medical School and Dr Michael Shannon of Children’s Hospital Boston, found that more than 85% of doctors were “unaware of the serotonin syndrome as a clinical diagnosis.”

In a report based on calls made to poison control centers in the US in 2002, the doctors found 7,349 cases of serotonin toxicity and a total of 93 deaths. In 2004, the Toxic Exposure Surveillance System identified 48,204 exposures to SSRIs that resulted in moderate or major outcomes in 8,187 patients and death in 103 patients, according to the September 2005 American Journal of Emergency Medicine.

In 2005, the last year for which statistics are available, a total of 118 deaths were reported, according to the New York Times.

The true incidence of serotonin syndrome, experts say, may be under-reported in these figures because the syndrome may be wrongly attributed to another cause, mild cases may be dismissed or medical professionals may not suspect the condition. Studies have shown that when an expectant mother takes an SSRI, her system is flooded with extra serotonin, which then passes across the placenta into the womb, soaking the developing fetus in serotonin, according to Houston Attorney Robert Kwok. “It is this prolonged and unanticipated exposure to serotonin,” he says, “that our experts believe leads to the baby’s birth defects.”

“Studies indicate,” he explains, “that mothers who take an SSRI during pregnancy have 1.5 to 2 times the risk of giving birth to a baby with a heart defect such as an atrial septal defect or ventricular septal defect, and are 6 times more likely to give birth to a baby with a severe and life-threatening lung disorder known as persistent pulmonary hypertension (PPHN).

And the cases of birth defects are on the rise. “Our group has over 100 SSRI baby birth defect cases in medical review,” Mr Kwok states, “with most babies bearing strikingly similar heart and lung defects.”

Mr. Kwok is representing the family of Chase Steele, a baby born with severe heart defects after his mother took an SSRI during her pregnancy and the family of Gavin Shore, an infant also with severe heart defects to a mother who took the SSRI Celexa during her pregnancy. “You would think by now,” Mr Kwok says, “that the FDA would ban SSRIs for children, since the same logic applies to developing adolescents and developing babies in the womb during pregnancy.”

Serotonergic receptors are found throughout the central nervous system and are involved in the regulation of the sleep-wake cycle, behavior, appetite, temperature and muscle tone, and serotonin neurotransmission is involved with the regulation of gastrointestinal motility and vascular tone. Serotonin syndrome results from excessive stimulation or agonism at postsynaptic serotonin receptors.

According to the FDA, symptoms of the syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea. The patients often have changes in mental status, including agitation, hypervigilance and pressured speech, and in severe cases, may present with profound hypertension and tachycardia, and proceed rapidly to shock. In severe cases, patients may exhibit delirium, seizures, muscular rigidity and hypertonicity. A core temperature may exceed 40º C (104 F), and may be accompanied by metabolic acidosis, rhabdomyolysis, renal failure and disseminated intravascular coagulation.

Experts say the most important information for doctors to know when dealing with a possible case of serotonin syndrome is what drugs have been ingested, because in addition to SSRIs, there are other classes of drugs with different mechanisms that can also increase serotonin levels to differing degrees.

A greater awareness of the combinations that trigger the syndrome could lead to prevention, but a diagnostic challenge exists due to the fact that the list not only includes prescription drugs, but also over-the-counter medications and herbal supplements. The following are some of the products known to be associated with serotonin syndrome:

Monoamine oxidase inhibitors (MAOIs)
Tricyclic antidepressants (TCAs)
Selective serotonin reuptake inhibitors (Zoloft, Prozac, Paxil, Lexapro, Celexa)
Venlafaxine (Effexor)
Trazodone (Desyrel)
Nefazodone (Serzone)
Meperidine (Demerol)
Dextromethorphan (Cold Remedies)
Chlorpheniramine
Sumatriptan (Imitrex)
Atypical antipsychotic (Zyprexa, Risperdal, Seroquel)
L-dopa
Meridia
Lithium
Valproic acid (Depakene)
Linezolid (Zyvox)
St John’s Wort
Ginkgo Biloba

Many experts blame the rise in cases of serotonin syndrome on the fact that so many different drugs are being prescribed to patients at the same time in combinations, or “drug cocktails,” which have never been approved as safe and effective by the FDA for any use and without considering the over-the-counter medications that patients may be taking.

The syndrome has become more prevalent in children as the off-label use of drug cocktails with children has increased. Some experts suspect serotonin syndrome in the death of four-year-old Rebecca Riley in Massachusetts on December 13, 2006. Critics say the Riley case highlights the need to put an end to the rampant off-label prescribing of adult psychiatric drugs to children. “The general public is unaware that almost no psychiatric drugs have ever truly been tested for children,” according to David Oaks, director of MindFreedom, an international human rights organization.

“All psychiatric drugging of children,” he says, “is essentially ‘off label’ in the sense that doctors have an enormous range of discretion when prescribing psychiatric drugs to young people.”

“It’s time for society to get hands-on with the mental health system,” Mr Oaks warns, “and rein in the immense tyrannical power that doctors now have.”

The State Police investigator’s report in this case said psychiatrist Dr. Kayoko Kifuji, at the Tufts-New England Medical Center, prescribed three medications for Rebecca: 750 milligrams a day of Depakote; 200 milligrams a day of Seroquel; and .35 milligrams a day of clonidine. Rebecca was given Seroquel, for bipolar disorder, a drug only approved to treat adults with schizophrenia or bipolar, Clonidine, for attention deficit disorder, a drug approved only to treat adults with high blood pressure, and Depakote, an anti-convulsant drug approved to treat epilepsy in adults.

She was kept on this three-drug cocktail since she was two and a-half-years-old, until she was found dead on the floor of her parent’s home on December 13, 2006. At the time of her death, there were also over-the-counter cold medications in her system including Children’s Tylenol Cough and Runny Nose, which contain acetaminophen, dextromethorphan and chlorpheniramine.

According to a report by investigators, Rebecca’s teachers and a school nurse repeatedly complained about the child’s extreme lethargy and how she seemed better when the drugs wore off, and the nurse also pointed out that Rebecca did not exhibit the kind of behavior that might justify prescribing these types of drugs.

A therapist who treated the children also told investigators she was concerned about the medications prescribed to Rebecca because she never noticed symptoms of attention deficit or bipolar disorder.

A state trooper’s affidavit said a Walgreen’s pharmacy filled a number of clonidine prescriptions for the Rileys when they should have had an ample supply and that Dr. Kifuji approved extra pills several times because Carolyn Riley said she had run out or lost her supply. Carolyn Riley told investigators that Dr. Kifuji had authorized the extra doses to help Rebecca get to sleep, the affidavit said. The trooper also reported that Dr. Kifuji received calls from a therapist and a nurse at Elden Johnson Early Childhood Center, where Rebecca was a student, saying they were concerned about her medication.

The affidavit shows that no testing was conducted on Rebecca in making the diagnosis of attention deficit or bipolar disorder and that Dr. Kifuji said she diagnosed Rebecca based on the parents’ statements and “brief visits” in her office as frequently as twice a month and as seldom as once every two months.

In July 2006, a social worker treating Rebecca filed a complaint with the agency reporting that Carolyn Riley was “neglecting her children” and “appeared heavily drugged and unable to respond” on one of her visits to the family home. The social worker said that during one visit, Carolyn told her that urine on the floor was from when Rebecca had taken a nap on the floor, according to an affidavit from investigators, and the social worker said she had to tell Carolyn to clean the floor.

When checking out the social worker’s complaint, the DSS Commissioner said all the doctors and a psychiatric hospital caring for one of the children in July 2006 said the medications were appropriate and there was no one else to consult, so the department did not substantiate the complaint.

The medical examiner’s office determined that Rebecca died from “intoxication due to the combined effects” of the drugs clonidine, Depakote, dextromethorphan, and chlorpheniramine, the district attorney’s office said in a statement.

The official autopsy report states that Rebecca died of the “combined effects” of the drugs and that her lungs and heart were damaged by “prolonged abuse of these prescription drugs, rather than one incident.” Those findings have some experts wondering whether the medical examiner may be a member of the 85% of doctors identified by the New England Journal of Medicine study who are unaware of the serotonin syndrome as a clinical diagnosis.

The statement released by the DA states, “This occurred as a result of the intentional overdose of Rebecca with clonidine,” and the manner of death “was determined to be homicide.”

Rebecca’s parents have both been charged with murdering their daughter.

However, psychiatrist Dr. Grace Jackson, a leading authority on psychotropic drugs, takes issue with the claim of the manner of death being homicide.

“I’d put my money on serotonin syndrome as the cause of death,” she says, “a potentially lethal condition of serotonin excess, leading to signs and symptoms which include autonomic instability, heart dysrhythmias (sudden death), hyperthermia (high fever), changes in mental status (including possible coma), hyperreflexia, and myoclonus.”

“In this case,” D. Jackson says, “the primary culprits were dextromethorphan and chlorpheniramine, an antihistamine which also boosts serotonin levels.”

“It is probably quite likely,” she explains, “that the family had not been warned by any doctor or pharmacist that this combination of medications could cause death — particularly, in a toddler.”

“It is also possible,” she adds, “that the psychiatrist did not realize that the family was administering dextromethorphan to the child — it might have been given from an over-the-counter cough remedy by unsuspecting parents.”

Dr. Jackson also notes that Depakote has been shown to increase levels of serotonin in many brain regions, “hence,” she says, “it was factor #3 in the serotonin syndrome which presumably killed this child.”

“This toddler,” she explains, “may have been receiving tiny doses of the medications prescribed, but that did not protect her from serotonin syndrome.” Reports by investigators, based on interviews of relatives in the home who observed Rebecca in the days before she died, describe symptoms typical of serotonin syndrome. They said she became restless, disorientated, incoherent, would not respond to her name and that she appeared dazed and “out of it.” She was lethargic at school and at home, and a neighbor described her as zombie-like, according to interviews in an affidavit filed in Plymouth District Court.

The day before she died, Rebecca developed a fever and was coughing uncontrollably, so her parents went to Wal-Mart to buy cold and flu medicine. While at Wal-Mart, Rebecca began to vomit, so Carolyn Riley purchased Pedialyte and a plastic bowl for Rebecca to vomit in during the ride home, and she reportedly vomited about five times over the course of that day.

Rebecca’s grandmother told reporters that the doctor never told the parents not to give her the over-the-counter cold medications now listed as contributing to her death because of the prescription drugs she was on.

Dr Jackson suspects that Rebecca -– like so many patients -– was the unwitting victim of “Evidence Based Psychiatry,” which means drugs, drugs, and more drugs, because “somebody, somewhere, published a study that showed a three year old responded to five or six or seven drugs in combination,” she states.

Dr. Jackson is the author of, Rethinking Psychiatric Drugs: A Guide for Informed Consent, a book that provides a critical appraisal of three classes of psychiatric drugs that an estimated 20% of Americans consume on a regular basis, including antidepressants, antipsychotics and stimulants.

According to Harvard Instructor Dr. John Abramson, author of, Overdosed America, this “gruesome story” seems to have two separate and distinct components. “First,” he says, “is the question of whether or not the child was being given medication as it was prescribed. And the second is the question of why such medicines were prescribed for such a young child.”

Dr. Abraham points out that there has been a progressive medicalization of other than desirable behaviors in children. “We have seen this in the enormous proliferation of stimulant medication use,” he notes, “far out of proportion to use in other countries.”

Now, he says, the diagnosis of bipolar disorder in children is rising in parallel and, clearly, it is the drug industry driving this medicalization to sell more products. In what can only be described as assembly-line customer recruitment, Rebecca’s psychiatrist, Dr. Kifuji, also prescribed the same powerful drug cocktail to Rebecca’s older brother and sister when they were diagnosed with the same illnesses several years earlier.

The Rileys’ attorneys say the parents are unsophisticated people who did not question the doctor. Michael Riley’s lawyer, John Darrell, told the Boston Globe on February 7, 2007, that neither parent knew enough treatment to have challenged Kifuji. “You’ve got two poor parents here of minor means financially, of minor education,” he said.

A reading of all the official reports and court documents in this case definitely indicate that be true.

As so often happens with families like the Riley’s, who are covered by public health care programs, and with the great assistance of Dr. Kifuji, the entire Riley family become a cash cow for the psychiatric-pharmaceutical industry, including the mother and father.

Another incentive certainly worth noting is the potential monthly income Dr Kifuji generated for herself by the legal pill-pushing to the Riley family. A 2003 study by the American Psychiatric Association found doctors could earn about $263 an hour for holding three 15-minute medication management sessions per hour, compared to about $156 for a single therapy session. That represents an hourly pay cut of 41% for doctors doing therapy only, the APA study said.

Critics say more blame should be focused on the prescribing doctors. “While the pharmaceutical companies certainly are getting rich providing mind-altering drugs for psychiatry’s made-up mental disorders, the fault lies with the psychiatric community,” says Kelly Patricia O’Meara, author of PSYCHED OUT: How Psychiatry Sells Mental Illness and Pushes Pills That Kill.

“Until the fraud of psychiatric diagnosing is exposed,” Ms. O’Meara warns, “the American people will continue to hear about more and more of these tragic outcomes.”

And it always goes back to the chicken and the egg theory. Was there an epidemic in this family where all five family members were so severely mentally ill? Or did the psychiatric-pharmaceutical industry convert them into life-long disabled customers through the administration of a powerful drug cocktail for years on end?

According to Dr Ann Blake Tracy, Director of International Coalition for Drug Awareness, and author of Prozac: Panacea or Pandora?, she expects a person placed on one of these drug cocktails to be on disability within a three- to five-year window of time. “And for a decade and a half,” she says, “she has been trying to figure out how our economy will survive the skyrocketing disability rates.”

The chicken and the egg theory arises a second time in this case when reviewing the allegations lodged against the parents. Were the bizarre behaviors of the parents cited in official reports and the media the result of ignorance, bad parenting or a wish to harm Rebecca? Or were the behaviors in fact brought on by the combination of drugs the parents were ingesting?

“Naturally,” Ms. O’Meara notes, “one has to wonder that if the entire family was being ‘treated’ for their alleged mental illnesses, why then didn’t the drugs work?”

Dr. Tracy says, “Is it absolutely possible that some of the alleged behaviors of the parents in this family could have been caused by the prescribed drugs they were taking.”

She explains that the hypothesis behind these psychiatric drugs is backwards, meaning they often end up causing the conditions that they were prescribed to treat.

Leonard Frank, author of Zyprexa: A Prescription for Diabetes, Disease and Early Death, concurs. “Psychiatrists and other physicians,” he explains, “prescribe drugs in attempt to suppress objectionable conduct but the drugs often make the conduct even more objectionable, in which event the prescription is changed.”

Then he explains, one drug may be substituted for another, or one or more drugs may be added to the mix, or the dosage may be decreased, or more likely increased, and this process may go on endlessly, he says.

Following Rebecca’s death, the Department of Social Services placed the other two Riley children — Kaitlynne, 6 and Gerald, 11 — in foster care and sought an independent opinion on their medical care, and doctors determined that their medication needed to be changed.

Persons injured by Serotonin Syndrome and seeking legal advice can contact the Robert Kwok & Associates Law Firm, at (713) 773-3380.

*This article is written as part of a series on emerging issues involving the pharmaceutical industry and is sponsored by Robert Kwok & Associated, LLP.