Approving and marketing lethal drugs, while concealing the results of studies that reveal deadly side affects, should be a jailable offense. This conduct is not due to mistakes, it is representative of, by now, an all too familiar pattern of criminal behavior by top officials within the nation's top regulatory agencies and the pharmaceutical industry.
This year Eli Lilly was made to pay nearly $700 million to settle charges that it did not warn consumers that the drug Zyprexa could cause diabetes, which resulted in grave injuries and death to hundreds of people. But nobody was charged with a crime.
Activists who are fed up with waiting for the FDA to take proper action to protect the public from dangerous psychotropic drugs are holding a three-day rally in front of White House to condemn the FDA's failure to act on the matter.
On August 24, 25, and 26, between 9 am and 5 pm, prominent activists from all over the nation will join victims and family members who have lost love ones due to these drugs to raise public awareness about their potential dangers.
They will specifically target the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which include: Paxil, Prozac, Zoloft, Wellbutrin, Luvox, Citalopram, Celexa, Lexapro, and Paroxetine.
Ellen Liversidge will be at the DC rally. She lost her son due to Lilly's crimes and she's none to happy about the fact that as part of the settlement, the plaintiff's attorneys agreed to not let the public know about the extent of Lilly's wrongdoing.
In February 2004, people may have become a bit angry when they read in the San Francisco Chronicle that top FDA officials had ordered one of its own researchers, who reviewed more than 20 trials involving 4000 children, not to disclose his findings which confirmed that SSRIs increased the risk of suicide in kids.
Another protest supporter, Vera Hassner Sharav, president of the Alliance for Human Research Protection, explains how a Harvard review of children's charts found that within three months of treatment on an SSRI antidepressant, 22% of the children suffered drug-induced adverse psychiatric effects, and overall, 74% suffered adverse events during the course of treatment.
"The FDA has known for years," she said, "but failed to reveal that antidepressants consistently fail to demonstrate a benefit in children. At least 12 of 15 trials failed."
The FDA has also known that SSRIs increase the risk of suicide and hostility in children. As far back as 1996, an FDA review showed a "7-fold greater incidence of suicidality in children treated with Zoloft than adults," Vera reports. She has accused the FDA of "foot dragging, equivocating, and tinkering with definitions while children are dying."
Dr. Donald Marks, MD, PhD is a prescribing physician, a father, and a former associate director and director for clinical research for two multinational pharmaceutical companies. He says, "SSRI manufacturing and sales is serious business with tens of millions of patients in the U.S. and a market in the tens of billions of dollars."
He contends, "that any attempt to decrease sales by increasing warnings will be met with severe organized resistance."
According to Dr. Marks, "SSRI manufacturers, such as Glaxo and Pfizer, have conducted clinical trials in depressed children, many of which show no efficacy against placebo."
"The seriousness and severe adverse event effects of SSRI drugs make their use hardly justified in the majority of cases," he added.
"My own prescribing experience with SSRI drugs," Dr. Marks said, "has revealed significant agitation and aggression, akathisia, activation of mania and hypomania, increased depression, serious dependency and withdrawal difficulties, suicidal ideation, and toxic interactions with other drugs."
The symptoms of SSRI toxicity can also be mistaken for the progression of the underlying mental state, "leading to use of more of the same and other offending SSRI drugs rather than to withdrawal of the causative SSRI agent," he warns.
While discussing the dangers of SSRIs, Rosie Carr Meysenburg, produced three handouts. The first was a personal letter from Dr. Peter S. Jensen, who at the time was the head of Child & Adolescent Disorders Research Branch of the National Institute of Mental Health, which said that research indicates that antidepressants for adolescents are not very effective.
The second document was a personal letter from Dr. Larry S. Goldman, Director of the American Medical Association, in which he wrote that physicians have known for many years the dangers of giving any antidepressants to patients with certain disorders and there is a substantial risk of precipitating mania or psychosis.
The third was an article from the Journal of Clinical Psychiatry researched at Yale University, which stated that 11% of all psychiatric hospital admissions were from antidepressant-induced mania and psychosis. It also noted another area of research showing that Prozac and other SSRIs can simulate the effects of LSD.
"In other words," Rosie said, "this is saying for some people, taking an SSRI is the same as taking LSD."
According to Rosie, "About two million people enter a psychiatric hospital every year, 11% then is over 200,000 people a year who have an antidepressant-induced psychosis and who are hospitalized," she reported.
"Not all are hospitalized," Rosie warns. "Some of them have either committed suicide, a homicide, or a murder/suicide."
The truth is, nothing phases the greedy band of thugs involved in pushing these lethal drugs for profit. Only when they see CEOs and government officials being marched off to prison, right along side of other murderers will they knock it off.
Why are other protesters angry with the FDA and Big Pharma?
Allen Routhier is the main organizer of the August 24 DC event. Let's look at his reason.
In June 2002, Allen's wife, Diane, was suffering from abdominal pains, nausea, indigestion, migraines, and backaches, and consulted her physician. Even though she had no history of depression, the doctor attributed her problems to stress and depression.
The question remains: why?, when according to all accounts Diane was known to be a fun-loving, lively, upbeat person.
Without advising her of any side effects, her doctor sent her off with sample blister packs of Bupropion, a drug manufactured by GlaxoSmithKline also known as Wellbutrin. The packs contained no labels, no warnings, and no indication of any adverse effects or reactions that she may be experience while taking the drug.
Almost immediately after taking one pill, Diane became violently ill with diarrhea, nausea, shakes, and a fever. She also felt irritable, agitated, anxious, dizzy and nervous.
On June 20, 2003, Diane felt terrible and called in sick to work, which was highly unusual. On June 23 and 24, she was again bedridden and suffered from insomnia, nausea, headaches, toothaches, dizziness, and among other things, diarrhea.
At approximately noon on June 25, her sister, Lynn, called and Diane cried and said she did not feel well. At some point that afternoon Diane took a gun, went to a corner of the basement, laid in a fetal position, put the gun to her head and pulled the trigger.
During the autopsy, the medical examiner discovered Diane had gallstones, a condition not diagnosed by her doctor, but which fit perfectly with the symptoms she complained of.
Allen was left to explain a mother's death to their two young sons.
Jo Ann Kelly has been interested in raising awareness of the dangers of SSRIs ever since her son David died of a self inflicted gunshot wound after he was put on Lexapro for an anxiety diagnosis.
Several days before his death Jo Ann noticed increased agitation and a dryness of skin. She feared he was not metabolizing the drug and scheduled a doctor's appointment, which ended up being two days too late.
Another mother, Lisa Van Syckel, described how her daughter, Michelle, was given Paxil for a diagnosis of depression and anorexia nervosa when she actually had Lymes Disease.
While on the drug, her mother watched as Michelle self-mutilated, became psychotic, violent, and attempted suicide twice.
When she quit taking the drug she suffered severe withdrawal and was constantly ill with flu-like symptoms, vomited blood, and had rectal bleeding. On top of all that, her friends at school called her "Psycho".
Lisa maintains she was not able to make an informed consent decision on behalf of Michelle because the drug maker withheld information on Paxil's adverse effects.
Another father, Tom Woodward, described how his oldest child, Julie, hung herself while on Zoloft, when she had no history of self-harm and there was no depression or suicide in their family history as well.
The doctors said Zoloft was safe. "The possibility of violence, self-harm, or suicidal acts was never raised. The two and a half pages we received with the Zoloft never mentioned self-harm or suicide," Tom said.
Julie had been excited about college and had scored high on her SATs a few weeks before her death. However, "instead of picking out colleges with our daughter, my wife and I had to pick out a cemetery plot for her," Tom said. "Instead of looking forward to visiting Julie at school, we now visit her grave."
He is very angry. "It is clear that the FDA is a political entity and its leadership has protected the economic interests of the drug industry," he said. "Under the Bush administration, the FDA has placed the interests of the drug industry over protecting the American public."
He points out the fact that 86% of the millions of dollars in campaign contributions by drug companies went to the Bush administration and Republican candidates. He wants to know, "what did Pfizer, Eli Lilly, and GlaxoSmithKline Beecham buy?"
According to Tom, top officials in leadership positions have strong ties to the industry. For instance, "FDA's chief counsel Daniel Troy has spent his career defending the drug industry," he said. "If a study does not favor a drug, the public never hears about it."
Mark Miller and his wife Cheryl lost their 13-year-old son, Matt, after a psychiatrist gave him Zoloft. They were told that Matt had a chemical imbalance that could be helped by a new, wonderful drug called Zoloft. "It was safe, effective, only two minor side effects were cautioned with us -- insomnia, indigestion," they said.
While on the drug, Matt became agitated, could not sleep, eat or sit still. The night before they were to leave on a family vacation, Matt hung himself from a bedroom closet hook, barely higher than his height.
"To commit this unthinkable act," Tom said, "something he had never attempted before, never threatened to, never talked about, he was able to pull his legs up off the floor and hold himself that way until he lost consciousness."
Mark and Cheryl have since learned that Matt's doctor has been "a well-paid spokesman for Pfizer," maker of Zoloft.
Young Corey Baadsgaard was diagnosed with a social anxiety disorder, and was prescribed Paxil by his family doctor.
After a couple months, he started taking larger doses because it was not working. A few months later, the doctor prescribed a medication called Effexor, and abruptly discontinued Paxil. Corey was supposed to gradually increase the dose of Effexor to 300 milligrams over three weeks.
The day he took the 300-milligram dose, Corey didn't feel well so he stayed home from school and went back to sleep. That evening he woke up in a juvenile detention center.
Unaware of what he had done, Corey said, "I asked one of the members of the juvenile detention center, and I found out that I had taken my high-powered rifle that I use for hunting to my third period class, took 23 of my classmates hostage and teacher hostage."
Corey spent 14 months in jail, "not really knowing why I had been there, not really remembering anything that I had done," he said.
"These drugs are hell," his father Jay said, "look at what they have done to my son."
Joyce Storey's son, Brian, was 17-years-old when the family doctor diagnosed him with depression and gave him 14 Zoloft pills. He never warned about side effects and "even said if a person is drinking or doing drugs, that Zoloft works well with them," Joyce said.
Five days later, Brian killed a woman. After his arrest, authorities found no illegal drugs in his system, only Zoloft.
The psychiatrist that examined Brian after the event was Dr James Merkangis, a faculty member at Yale University. At the trial, he said Brian had a manic reaction to Zoloft and testified that Brian told him it was like being in a dream.
"The news media called my son the All-American boy, and he was," Joyce says. He is now serving life without parole.
Six months after Brian's arrest, another boy at his school, Jeff Franklin, took an ax to both of his parents and three of his brothers and sisters while on Prozac. Both of his parents died and Jeff is now serving two life sentences.
"This is not a coincidence," Joyce warns, "there is a common denominator, teenager, severely depressed, on an SSRI antidepressant."
"There are 13 million people on these drugs, 6 to 8 million are children," she said. "The question is why are we handing these drugs out like candy, and the answer is $17 billion a year business." Joyce noted, "It is always about money."
Jame Tierney was 14-years-old when he was prescribed Effexor for migraine headaches. After about a year, the drug lost its effectiveness and his doctor doubled the dose.
"For the next 9 months," Jame recalled, "my life as I had known it was gone. I thought daily about suicide and hurting myself. I felt void of normal emotions. I was so belligerent, agitated, and filled with hate -- hate for my family, my friends, and most of all myself. Rage consumed me. I felt trapped," he said.
Jame did things totally out of character. "I had little control and little inhibition," he said, "It was as if I was watching a movie and some villain was destroying all the relationships around me."
He spent most of his time alone or else fighting with his parents. "They would ask what was wrong and what had happened to me," Jame said, and "I could not answer them because I did not know or understand myself. I was terrified."
He thanks God that his parents continued to search for answers. It was the Effexor. It was not prescribed for depression and he had no history of depression prior to taking the drug.
To counter the potential withdrawal effects, Jame was given Prozac, and the same personality and behavior problems were evident. The drug affected him the same way.
"I had never had these feelings before I took Effexor," Jame said, "I have never had these feelings since I stopped taking the Effexor and Prozac."
The way Jame sees it, "Effexor took three years from me and I will never get them back."
Donna Taylor's son, Mark, was shot between 7 to 13 times at Columbine high school and nearly died.
Columbine shooter Eric Harris was on an SSRI at the time of the rampage, just like the majority of other kids who have been involved in senseless killings in recent years.
Mark Taylor points out that prior to the drastic increase in use of psychiatric on kids, "this has never happened in the history of America."
Shannon Baker does not complain about her daughter's side effects, adverse reactions, or withdrawal symptoms, because her daughter is no longer alive.
Sharon wants to be "the voice of all the other children whose voices have been silenced by these drugs," she said. She wants a ban on the use of SSRIs with children. "There needs to be no more senseless and needless deaths because of these drugs," she said.
Dawn Rider, president of ASPIRE, gave this warning: "We have been educated to believe that mental, emotional, and behavioral disorders are caused by chemical imbalances in the brain. The fact is that this is only theory, and this theory is pushed on us as if it were the absolute truth."
Many people who believe this theory have become guinea pigs. "I know this from personal experience," Dawn said. "I trusted our family doctor when he explained that depression is caused by a chemical imbalance. We trusted him when he determined that Paxil was right for my husband, and Prozac for my son."
Dawn's 14-year-old son is now dead, and when they "discovered the problems with these drugs, we decided it would be better for my husband to suffer through depression than end up dead like our son," she said, "and we found out that he could not get off of Paxil."
Her husband went through a year of hell before he was able to withdraw from the drug, and in the process, Dawn said, "it destroyed our marriage of over 20 years."
Sara Bostock's daughter, Cecily, had only been taking Paxil for two weeks when she died, during which time her condition had greatly worsened.
By the day of her death, Cecily was pale, unable to sleep, almost unable to converse, and was in a frightened, agitated state, jumping at the slightest noise.
"That night she got up and without turning on any lights, went into our kitchen only feet from where I was half asleep," Sara said, "She stabbed herself twice in the chest with a large chef's knife. The only noise was a slight yelp and a thump when she fell on the floor."
This was a young woman who had everything to live for. She had just completed applications for grad school and had received a large pay increase the month before. She had a boyfriend who loved her, scores of wonderful friends and had never been suicidal.
Her autopsy revealed a high blood level of Paxil, which reflects poor metabolization, a feature common in many SSRI suicide cases. "I believe this induced an intensely dissociative state, perhaps even sleepwalking," Sara said.
"From accounts of people under the influence of these drugs," she explained, "I believe SSRIs can alter consciousness in some mysterious and frightening way that is not normally seen even in mental illness. I am certain this is what happened to my daughter."
"Untold thousands have died because of the drug companies and the FDA's failure to heed the evidence over the past years," Sara has discovered.
Cynthia Brockman described the Zoloft-induced reactions that her son Chris had experienced, which ultimately resulted in a woman's death and a life sentence in prison for her son. She urges a ban on all SSRI use in children.
Chris described "uncontrollable fits of anger, pitches and voices setting him off, not wanting to be touched, feeling horrible all over his body, not being in reality." His reactions stopped, once he was off all SSRIs for about a year, but restarted when he was put on Zoloft again.
"Prison doctors ignored warnings, forced him to take harmful drugs, drugging him into a hallucinating, irrational, suicidal state," Cynthia said.
She finally met with the Texas House Committee on Corrections, which ordered prison doctors to correct the crisis caused by the drugs which had triggered severe suicidal and homicidal symptoms for about two years while doctors kept starting and stopping her son's medications.
"Medical experts said Chris would not have been suicidal or homicidal had he not been reacting to SSRI drugs," Cynthia said.
Todd and Eileen Shivak's son Michael was 11 when he was given Paxil for depression. They thank God he is alive after he tried to slash his wrists in a classroom at school.
"We thought we were doing the right thing," his parents explain. "The doctors convinced us that taking these drugs was the only thing that we could do for Michael."
"How could all the doctors not recognize what was happening?" Todd asks. "Michael saw three different social workers, two different psychiatrists, and went through at least four different emergency room psychological evaluations in two different hospitals."
"It is impossible to describe the pain and utter helplessness we all felt watching Michael suffer, watch him cry, take up weapons against us, and beg us to let him die," Todd said.
"Our daughter, Catherine, was 5-years-old at the time," he noted. "She witnessed firsthand some of the most terrifying sights that I have ever had to deal with."
"Our family is finally getting back to the loving family we once were, but the fear of what happened still haunts us," he added.
Pepper Draper, a Director of the International Coalition for Drug Awareness, reports that her child was put on Ritalin, and says: "we bought into the whole serotonin theory, so we were naturally raising that serotonin, which unfortunately started causing him to become severely depressed and suicidal."
Fortunately, "we were able to finally understand the truth about serotonin, that raising serotonin and stopping the metabolism of it has caused suicide and aggression, and that is well documented," she said.
Pepper believes that "if we will teach them the right ways to take care of their bodies and cut out the things that are addictive, like these medications are, that we can help our youth learn to deal with what is going on in their lives."
Leah Harris tells how much he suffered while taking Prozac, Paxil, and Zoloft from age 12 to 18. "I went from being a shy and mildly depressed, but never suicidal kid, to being overcome with thoughts of hurting and killing myself while on the SSRI drugs, thoughts which I acted on," he said.
Since quitting SSRIs over a decade ago, he has never again self-mutilated or had suicidal thoughts. "The suicidality simply vanished," he said, and "this is clear proof that the drugs must have played a role, and I am one of the lucky ones. I have survived to tell the tale."
Leah believes that "Medical professionals and the public must be informed of the very serious risks that are associated with SSRIs." He noted that warnings may negatively effect sales and not please the industry, but said, "The FDA was created as an independent regulatory agency to serve the interests of the American public, not Big Pharma."
Grieving mother Lorraine Slater says, "informed parental consent is only possible as long as full disclosure is made by the pharmaceutical companies, the FDA, and the medical community."
Her 14-year-old daughter is dead. "Dominique's life was taken from her as a result of drug-induced psychosis and suicidal ideations, not to mention the probability of experiencing akathisia, extreme agitation," her mother said.
She is having a very difficult time with acceptance. "How can you imagine I feel as Dominique's mother knowing now that I was slowly poisoning my daughter every day as I was dispensing her antidepressant medication including Celexa and which she made her first suicide attempt after being on it for almost one month, and effects of the last medication she was on when she did commit suicide?" she asked.
She explains, "Dominique's mind and behavior were slowly being altered to the point that she became very agitated, irrational, ultimately suicidal, because none of the so-called medical professionals acknowledged the drug's role in her irrational and suicidal behavior or properly withdrew her from their suicidal effects."
"How can teenagers be allowed to be given antidepressants that were never approved for adolescent consumption, only for adults?" Larraine wants to know. "How come the medical profession doesn't fully disclose the possible harmful and fatal effects of medication as well as watch carefully for diverse effects on its adolescent population?"
Terri Williams' son, Jacob, was an exceptional athlete who participated in football on both the varsity and junior varsity football teams in school. In September 2000, Jacob lost interest in school activities except for his interest in football, but there was a conflict with his grades and his attendance.
As a result of the issue, his parents attended a school conference in October 2000 at which the school administrator suggested that Jacob may be depressed and that they should seek medical help.
Terri contacted Jacob's pediatrician and made an appointment for that afternoon. The doctor prescribed Prozac, and subsequently increased the dosage three weeks later.
Shortly after starting Prozac, "Jacob began to complain of having strange dreams, which he had said were bad," Terri said. "Shortly after the dosage was increased, I began to notice an aggressive behavior, which had not been there before. Jacob also became destructive and destroyed some of his favorite things," she noted.
His friends later told Terri that they had noticed the same behavioral change; that he had become short tempered and showed a verbal aggression that had not been present before.
When questioned by Terri, Jacob stated, "I don't know what is making me do this." Terri wrote it off as adolescent behavior and did not pursue the matter further.
On December 5th 2000, she discovered Jacob's body hanging from the rafter in their attic where he had hung himself with his own belt. He had left a letter on the ladder leading up to our attic thanking his parents for giving him 14 years of a happy life.
"Had I know that this was a potential side effect, suicide," Terri said, "I would have never allowed my son to take the drug Prozac."
And the fact is, the FDA could have warned Terri about the drug because by 1998, Prozac alone had already accumulated over 40,000 adverse reaction reports, including more than 2,100 deaths, under the FDA's adverse reaction reporting system, more than any other drug in history.
Glenn McIntosh introduces his 12-year-old daughter Caitlin with a photo because it is all he has left. Caitlin committed suicide eight weeks after being prescribed Paxil and Zoloft.
She was a straight-A student, a talented musician, artist, and poet, who loved animals and wanted to be a veterinarian.
With the onset of puberty, this bright, sensitive girl who had once loved going to school, started having trouble coping, as many kids do. She was also having problems sleeping due to a mild seizure disorder, her father said. "We wanted to help, of course, so we took her to our family physician, who prescribed her Paxil."
Caitlin didn't do well on Paxil, so the doctor took her off it. A week later they saw a psychiatrist and he put her on Zoloft. "She then started having strong suicidal ideations, along with severe agitation known as akathisia and hallucinations, and she was put in the adolescent ward of a mental hospital to "balance her meds," Glenn said.
There, things got worse as she was put on other psychotropic drugs to treat the symptoms that Glenn now knows were caused by the SSRIs.
"Let me be very clear about something," he said, "the dramatic and severe symptoms that led to my daughter's suicide manifested only after she started taking antidepressant drugs."
The downward spiral continued until Caitlin hung herself with her shoelaces in the school bathroom. "We were told that antidepressants like Paxil and Zoloft were wonder drugs, that they were safe and effective for children. We were lied to," Glenn said.
"The pharmaceutical companies have known for years that these drugs could cause suicide in some patients. Why didn't we?" he wants to know.
Delnora Duprey is a grandmother who described how it had been over two years since she had seen her grandson Chris play ball, ride a bike, talk on the phone, or run in to say, "Hey, grandma, what's for dinner?"
Chris is a tall, thin boy, quiet and well liked and respectful to everyone, "who loved his family dearly, and had hopes and dreams for a future," Delnora said.
The family's nightmare began when Chris was diagnosed with depression, and "placed on medication that was never tested on children and never meant for their use," she said. He was first put on Paxil, but was switched to Zoloft a short time later.
The doctor increased the dosage to 200 milligrams and within 48 hours, Chris had shot and killed his other grandparents while they slept and burned their house down.
Today Christopher is sitting in prison facing incarceration for life, "a child that does not even know what has happened to him," his grandma said.
According to Delnora, he was a sweet boy who never hurt himself or anyone else before.
Many readers might want to advise these people to go to government officials with these horror stories, the people who can punish drug companies for hiding adverse reactions and not warning people about the dangers associated with drugs.
The problem is they already have. The tragic stories above were relayed to officials during a February 2, 2004, FDA hearing.
Itís now 18 months later, and needless to say, nobody has been punished.
Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption in government. She can be reached at: email@example.com.
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