The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Weighing Benefits of SSRIs Against Suicide Risk

Evelyn Pringle December 8, 2006

Before the FDA’s Psychopharmacologic Drugs Advisory Committee begins the discussion at the December 13, 2006, public hearing on the suicide risks associated with selective serotonin inhibitor antidepressants, it should get honest with the audience and openly admit that the SSRIs do not even work.

Medical professionals maintain that in order to justify the use of a drug, its benefits are supposed to outweigh its risks and therefore, there should be a discussion of exactly what benefits result from the use of SSRIs, in any population, that would outweigh the suicide risks associated with this class of medications.

The most popular SSRIs sold in the US include Paxil, Prozac, Zoloft, Lexapro and Celexa.

As far as the benefits of the various SSRIs, an April 2002 study in the Journal of American Medical Association compared the effectiveness of Zoloft, St John’s Wort, and a placebo and found that the placebo treated patients had the highest rate of remission of symptoms at 31.9%, and Zoloft’s 24.8% was barely better than the rate of remission with St John’s Wort of 23.9%.

The FDA’s own records on Celexa (citalopram) show the agency knew the drug to be ineffective when it was approved, and the agency based its approval on 2 marginally positive studies out of a total of 17 conducted.

A March 26, 1998, memorandum by Thomas Laughren, of the FDA’s Psychiatric Drug Products, notes a total of 17 clinical trials on Celexa, including 2 uncontrolled trials, 6 active controlled trials showing no difference between treatments, and 2 placebo controlled trials that were too small to be considered studies.

Dr Laughren’s memo discusses 5 short-term trials (85A, 91206, 86141, 89303, and 89306) and 2 long-term studies (89304 and 89305). “In summary,” he wrote, “I consider studies 85A and 91206 positive support for the claim of short-term antidepressant efficacy for citalopram.”

“While 3 other placebo-controlled short-term trials (86141, 89303, and 89306) were negative, and not easily interpretable since there were no active control arms,” he stated, “I feel there were sufficient reasons to speculate about the negative outcomes and, therefore, not count these studies against citalopram.”

Dr Laughman also counted 2 relapse prevention trials as effective to support the drug’s approval. “Overall,” he wrote, “I consider these results sufficient to support claims of both short-term and long-term antidepressant effectiveness of citalopram.”

However, other FDA officials were not so eager to stretch the truth about the weak studies with medical professionals and consumers. For instance, a May 4, 1998 memo by Paul Leber, Director of the Division of Neuropharmacological Drug Projects, on the subject of “Approvable Action on Forrest Laboratories NDA 20-822 Celexa,” said the pubic had a right to know the truth about all the trials submitted to the FDA for the approval of Celexa.

He advised that the drug labeling should not only describe the trials that showed Celexa’s adequate effects; but should also describe the “well controlled clinical studies that failed to do so.”

Dr Leber specifically pointed out that Study 86141, Study 89303, and Study 89306, all failed to provide results confirming the positive findings of Studies 85 and 91206, the two clinical trials that Dr Laughman listed to support the approval of Celexa.

“I am aware that clinical studies often fail to document the efficacy of effective drugs,” Dr Leber wrote, “but I doubt the public, or even the majority of medical community, are aware of this fact,” he said.

“I believe that labeling,” he stated, “that selectively describes positive studies and excludes mention of negative ones can be viewed as being potentially “false and misleading.””

“I believe it is useful for the prescriber, patient, and 3rd party payer to know,” Dr Leber wrote, “without having to gain access to official FDA review documents, that citalopram’s antidepressants effects were not detected in every controlled clinical trial intended to demonstrate those effects.”

“I am persuaded,” he stated, “they not only have a right to know, but should know.”

When Forest Labs got Lexapro approved in 2002, it was nothing more than a chemically altered version of Celexa, and Forest Labs spent a fortune on persuading doctors to switch patients to Lexapro before its top selling drug Celexa lost its patent protection in 2004.

At the time, Forest could point to only one lone study, that the company itself paid to have published that claimed Lexapro was any better than Celexa. The paper, by Dr Jack Gorman, of the Mount Sinai School of Medicine, pooled the results of three studies and concluded that Lexapro “may have a faster onset” than Celexa, according to a report by Melody Peterson in the November 22, 2002 New York Times.

Dr Gorman’s paper was published in CNS Spectrums, a medical journal he edits, and Forest paid Medworks Media, a small medical marketing company that publishes the journal, to print the article in a special supplement.

Other researchers disagreed with the study results. “The Medical Letter, a nonprofit newsletter respected for its independence from the pharmaceutical industry,” Ms Petersen reports, “reviewed the same clinical trials as Dr. Gorman and concluded … that Lexapro had not been shown to be better than any other antidepressant, including Celexa.”

As for Paxil, in June 2004, New York State Attorney General, Eliot Spitzer, charged GlaxoSmithKline, with fraud for hiding studies that “not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo.”

According to Mr Spitzer, Glaxo published only one of 5 studies it conducted, and even that one showed mixed results.

Prozac (fluoxetine) was also known to be ineffective before it was approved for use in the US. While serving as an expert witness in a lawsuit, psychiatrist and SSRI expert, Dr Peter Breggin, author of, “Talking Back to Prozac,” reviewed a July 1985 in-house analysis by its maker, Eli Lilly, that showed Prozac had failed to demonstrate efficacy in clinical trials with patients taking Prozac verses a placebo or a tricyclic antidepressant.

“When this potential economic disaster for Eli Lilly was discovered,” Dr Beggin reports, “the FDA allowed the company to include in its efficacy data those patients who had been illegally treated with concomitant benzodiazepine tranquilizers in order to calm their over stimulation.”

“Basically, Prozac was approved in combination with addictive benzodiazepines such as Ativan, Xanax, and Valium,” he says, “but neither the FDA nor the drug company revealed this information.”

“With these patients included,” he states, “statistical manipulations enabled the FDA to find the drug marginally approvable.”

An internal Lilly document dated March 29, 1985, says, “The benefits vs. risks considerations for fluoxetine currently does not fall clearly in favor of the benefits.”

Medwatch is the reporting system by which adverse events involving prescription drugs are reported to the FDA. Within one decade of Prozac’s arrival on the market, there were 39,000 adverse event reports submitted to Medwatch and that number is said to represent only about 1% of the actual number of adverse events, according to an April 22, 2006 report by the Citizens Commission on Human Rights.

Serious questions about the possible link between suicide and SSRIs began in 1990, when Martin Teicher, of McLean Hospital in Massachusetts, reported on 6 patients who he said experienced “intense, violent suicidal thoughts” after taking Prozac.

He offered three possible theories for the increased suicidality: (1) SSRIs gave patients more energy before lifting their depression, allowing them to act on a suicidal impulse; (2) the drugs worsened depression in a small subset of patients; or (3) SSRIs caused a state of agitation and restlessness.

In a February 10, 1990, report titled, “Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment,” Dr Teicher said, “The purpose of this report is to suggest the surprising possibility that fluoxetine may induce suicidal ideation in some patients.”

“In our experience,” he wrote, “this side effect has occurred in 3.5% of patients receiving fluoxetine.”

Throughout the 1990s, Eli Lilly publicly denied that Prozac was associated with suicide or violence, but by the year 2000, the company had quietly paid an estimated $50 million to settle over 30 lawsuits, according to an Indianapolis Star investigation.

When reviewing Lilly’s studies on Prozac, Dr Breggin found that there were 12 suicide attempts in the Prozac group verses only one in the placebo group and one in the tricyclic antidepressant group, but that many of the suicide attempts were hidden under false categories.

“Even after the company winnowed out six of the suicide attempts,” Dr Breggin says, “the remaining 6:1 ratio was alarming.”

He also reviewed a November 8, 1998, study titled, “Activation and Sedation in Fluoxetine Clinical Trials,” that showed a 38% rate of stimulation in the patients taking Prozac, even though, he says, many patients were sedated and many parameters of stimulation were not counted.

Another group of documents that he examined, contained a study conducted by the FDA on increased spontaneous post marketing reports of “hostility” and “intentional injury” by patients on Prozac. “These documents,” Dr Breggin says, “were generated shortly before the 1991 FDA PDAC meeting that evaluated antidepressant-induced suicidality.”

For this study, the FDA used the antidepressant, trazodone, as a control and found a 24-fold relative increase of reports of hostility and intentional injury per prescription of Prozac when compared to patients on trazodone.

“The spike in Prozac reports,” Dr Breggins says, “occurred even before any public controversy surrounding Prozac and violence.”

The documents he reviewed also contained graphs showing a 40-fold relative increase in reports of suicide attempts, overdose, and psychotic depression, in patients on Prozac compared to patients on trazodone.

“In one memo,” Dr Breggin reports, “a Lilly employee expresses shame and regret about hiding this data.”

In the case where Dr Breggin testified, Lilly was able to have the records sealed by the court where they remained hidden for roughly 10 years.

On April 10, 2004, the British Medical Journal, citing Jurendi et al, criticized the authors of studies on SSRIs for exaggerating benefits and downplaying their harm and noted a clinical trial of 93 children on Paxil that produced 11 serious adverse events, including 7 hospitalizations, compared to only two in children in the placebo group.

But the Paxil suicide risk does not only apply to children. An August 22, 2005, study by Norwegian researchers found that Paxil also increases suicide risk in adults. In the study of over 1,500 adults, 7 Paxil patients attempted suicide compared to only one attempt in the group of patients on a placebo. The researchers recommended that the warning not to prescribe Paxil to children should be extended to adults.

In Insight News, on October 4, 2002, investigative reporter, Kelly Patricia O’Meara, author of, “Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills That Kill (2006),” revealed a study conducted by Dr Arif Khan, medical director of the Northwest Clinical Research Center in Bellevue, Washington, that disclosed the number of suicides committed or attempted by patients in the clinical trials on SSRIs, that were kept hidden from doctors and consumers.

For the study, Dr Khan examined the official clinical drug-trial data for all SSRIs approved by the FDA between 1985 and 2000.

According to Ms O’Meara, the rate of suicides in the general public is 11 in 100,000, but the incidence rate for people participating in the SSRI trials was 718 for every 100,000. Dr Kahn’s research also revealed that nearly 4% of study participants attempted suicide within the following year.

As for weighing the benefits against the above risks, the British Medical Journal published a study on July 16, 2005, by Joanna Moncrieff, senior lecturer in psychiatry at University College London, that found SSRIs no more effective than a placebo in reducing depression.

The study also found that trials on SSRIs with negative results were less likely to be published than those with positive results, and that even in the published trials, negative outcomes were often not presented.

Dr Moncrieff said she found “no good evidence that these drugs work.”

Filed under: 2006, Celexa, Effexor, Forest, Lexapro, Paxil, Prozac, Spitzer, SSRIs, Study 329, suicide, Teicher, Zoloft

FDA Advisory Committee Schedules Hearing on SSRIs and Suicide

Evelyn Pringle December 5, 2006

The FDA’s Psychopharmacologic Drugs Advisory Committee will hold a public hearing on December 13, 2006, to review the adult selective serotonin reuptake inhibitor (SSRI) studies on the increased risk of suicide associated with the antidepressants.

The panel is expected to vote on whether the risk of suicidality in adults should be included in a Black Box warning on all SSRI labels, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.

The fact is, the FDA has known about the increased suicide risk associated with SSRIs for over 15 years as evidenced at a September 20, 1991, hearing, at which FDA official Dr Robert Temple stated:

“The discussion we heard earlier showed that people who commit suicide are highly likely to have a diagnosis of depression, which means that somebody identified them as in a high-risk category.

“But there were still a significant number of people who committed suicide without having that sort of diagnosis and I guess I would like some advice or discussion on who those people were.

“The anecdotes that one hears that are most evocative to me anyway are not the ones where people who have a 20-year history of suicidal ideation and then finally do it – that is not too surprising – it is where they assert that there has never been anything in their minds like that before and yet now they have suddenly become excessively concerned with suicide and may even do it.”

Yet here it is nearing the end of 2006, and the FDA is still refusing to provide a logical answer to explain why people who were not depressed before taking SSRIs would all of a sudden commit suicide after taking the drugs.

Top experts from all over the US and abroad will be testifying at the hearing and for many it will be a repeat performance. For instance, Baum Hedlund attorney, Karen Barth-Menzies, will be testifying again. She has been battling SSRI makers for over a decade and as a result, she has obtained internal company documents that show the SSRI makers were fully aware of the increased suicide risks associated with SSRIs but instead of warning the public, they continued to promote SSRIs as safe and effective with children and adults.

“Through our Paxil litigation,” Ms Menzies says, “we obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children.”

“That’s about as reprehensible as you can get,” Ms Menzies says.

“The manufacturers of the SSRIs,” she states, “have continuously and adamantly denied even the possibility of a causal connection between the SSRIs and suicide, and, instead, have blamed the victim and the ‘disease.’”

“This is notwithstanding clear evidence,” Ms Menzies says, “very early on in the clinical trials of these drugs that they can cause these problems.”

“We have documents,” she notes, “obtained through discovery in our litigation showing that there was an awareness of the problem as far back as the late 1970s, long before the first SSRI, Prozac, was approved for marketing in this country.”

Over the past 10 years, in addition to representing thousands of clients in SSRI lawsuits, Ms Menzies has been a tireless advocate working to increase public awareness about the host of health risks now known to be associated with SSRIs.

After listening to her testimony before the FDA Advisory Committee in 2004, a California state Senator invited Ms Menzies to work on legislation designed to inform California healthcare providers and parents about the increased risk of suicidality in children and adolescents taking SSRIs.

She also testified at a hearing in August 2004, before the California State Senate and called for better patient informed consent on the risks associated with SSRIs.

Ms Menzies has given presentations at medical conferences in the US and other countries to warn healthcare professionals about the dangers of SSRIs.

In fact, she gave one presentation that directly addressed the FDA’s mishandling of the SSRI matter titled, “Federal Preemption – How the U.S. Food & Drug Administration Has Become an Advocate for the Drug Industry Against the Consumers It Has a Duty to Protect” – SSRIs and Collisions Between Medical, Legal and Regulatory Worlds, at the 29th International Congress On Law and Mental Health, in Paris, France, on July 2-8, 2005.

Another one of the world’s most highly respected experts on SSRIs, Dr David Healy, a professor at the Department of Psychological Medicine, at Cardiff University in North Wales, will be traveling from the UK to testify. His appearance will also be a repeat performance.

Dr Healy states that he will testify about the manipulation of the scientific data on SSRIs. “We have here,” he says, “the greatest divide in medicine between the raw data on an issue on the one side and the published accounts purporting to represent those data on the other.”

“The divide,” he says, “it is important to note, only came to light as a result of the efforts of journalists and lawyers.”

“No clinician or scientist had a hand in questioning the validity of the ‘science’,” he points out.

The most famous fraudulent study involving SSRIs is GlaxoSmithKline’s study 329, involving Paxil. The study stated that Paxil was safe, well-tolerated and effective in children, but noted that some children became emotionally “labile” while taking the drug.

“In the published version of 329,” Dr Healy points out, “suicidality vanishes under a carpet of emotional lability.”

Few readers of this paper, academic or lay, he says, would have realized what lay behind this term as it appeared in the paper. “The question of what was happening to children,” Dr Healy says, “deemed to have become emotionally labile, was picked up by journalists and lawyers rather than scientists or regulators.”

As a result of Glaxo’s application for a license for the use of Paxil to treat children with nervous disorders, he explains, the raw data from clinical trials were lodged with a number of national regulators.

“Within a fortnight of seeing the raw data in May 2003,” Dr Healy says, “after the events lying behind the term emotional lability had been clarified, the regulators in the UK issued a warning against the use of Paxil for minors.”

A few weeks later, he notes, Glaxo wrote to all doctors warning that Paxil was linked to suicidality and that withdrawal from the drug was also linked to an apparent doubling of the rate of suicidality.

“This reassessment of the data does not however represent a triumph of scientific method,” Dr Healy says, “it indicates rather a crisis triggered by media concerns.”

The final nail in the coffin as far as selling SSRIs to kids in the UK, came in December 2003, when British regulators issued a position statement that said none of the SSRIs had demonstrated efficacy in treating depression in children.

By far the most damning revelations about what SSRI makers knew about the link between SSRIs and suicide came when the British Medical Journal received internal company documents from an anonymous source that left no doubt that Eli Lilly knew about the suicide risks with Prozac years before the drug was FDA approved.

After receiving the documents, the BMJ sent them to officials at the FDA, and to US Congressman, Maurice Hinchey, who in turn sent them to psychiatrist, Dr Peter Breggin, a court-certified expert on SSRIs, and author of, “Talking Back to Prozac,” and “The Anti-Depressant Fact Book.”

After examining the documents, Dr Breggin confirmed their authenticity as those that he had evaluated in the early 1990s when he served as an expert witness in Prozac litigation and discussed when testifying during a trial in 1994.

Evidence of the hidden studies showing the suicide risk can be found in a May 1984 document presented at trial which states regarding Prozac: “During the treatment with the preparation 16 suicide attempts were made, 2 of these with success.”

“As patients with a risk of suicide were excluded from the studies,” the document says, “it is probable that this high proportion can be attributed to an action of the preparation.”

In fact, a March 29, 1985 document says that the rate of suicide with Prozac was 5.6 times higher than with the other medication imipramine and went on to state:

“The benefits vs. risks considerations for fluoxetine currently does not fall clearly in favor of the benefits. Therefore, it is of the greatest importance that it be determined whether there is a particular subgroup of patients who respond better to fluoxetine than to imipramine, so that the higher incidence of suicide attempts may be tolerable.”

On November 13, 1990, a memo from a Lilly employee in Germany, Claude Bouchy, to another Lilly employee, Leigh Thompson, regarding the adverse drug event reporting of suicide and Prozac written in response to Lilly’s request that he change the event “suicidal ideation” to “depression,” Mr Bouchy writes:

“Hans (Lilly employee) has medical problems with these directions and I have great concerns about it.

“I do not think I could explain to the BGA, a judge, to a reporter or even to my family why we would do this especially on the sensitive issue of suicide and suicidal ideation.”

A second memo dated November 14, 1990, from Mr Bouchy to Leigh Thompson about adverse drug event reporting states: “I personally wonder whether we are really helping the credibility of an excellent ADE system by calling overdose what a physician reports as suicide attempt and by calling depression what a physician is reporting as suicide ideation.”

The documents also reveal how worried Lilly was about the commercial impact to the company if the truth about the Prozac-induced suicides got out. A February 7, 1990 Leigh Thompson Memo, says, “Anything that happens in the UK can threaten this drug in the US and worldwide. We are now expending enormous efforts fending off attacks because of (1) relationship to murder and (2) inducing suicidal ideation.”

On February 7, 1990, a Leigh Thompson memo also says, “I hope Patrick (a Lilly employee) realizes that Lilly can go down the tubes if we lose Prozac and just one event in the UK can cost us that.”

Dr Breggin says that after he testified in the trial in 1994, these documents seemed to just disappear, until they were handed over to the BMJ.

Filed under: 2006, Baum, Breggin, Eli Lilly, FDA, FDA hearing, Glaxo, Paxil, Prozac, SSRIs, Study 329, suicide

Big Pharma Research Racket Is Killing People

Evelyn Pringle June 23, 2006

Over the past six years, ten FDA approved drugs have been withdrawn from the market due to deaths and injuries, leading lawmakers to accuse the FDA of not doing its job in protecting the public from unsafe drugs and to call for measures of improvement.

On June 20, 2006, the New York Times reported that “two influential senators are expected within weeks to introduce a legislative proposal that could drastically change how drugs are tested and approved in the United States.”

The Senators behind the proposal are Michael Enzi (R-Wy), chairman of the Health, Education, Labor and Pensions Committee, and Ted Kennedy (D-MA), the ranking Democrat on the committee.

“In broad terms,” the Times article by Gardner Harris explains, “the bill would require that drug makers disclose the results of all large human tests of their drugs, known as Phase 3 and Phase 4 trials; create a detailed risk management plan to uncover and control any safety problems that arise after a drug is approved; and pay penalties if they fail to follow through with this plan, according to four experts who were briefed on the proposals.”

However, while lawmakers search for ways to ensure that Big Pharma does not continue to conceal adverse reactions that surface during drug trials and to sever the ties between the nation’s public health officials and Big Pharma, the Bush administration continues to promote their cozy relationships and help drug companies escape accountability for misconduct.

The best example of the administration’s efforts to protect Big Pharma was revealed recently when the FDA announced a preemption rule that would disallow lawsuits in state court against drug makers if a drug has been approved by the FDA.

“We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don’t have the same scientific knowledge,” said FDA deputy commissioner on medical and scientific affairs, Scott Gottlieb.

But in all fairness, the FDA is certainly not the only public health agency in bed with Big Pharma. Nobody can deny the fact that Big Pharma is an equal opportunity corrupter. Its obvious that drug companies have infiltrated every Federal regulatory agency in the US.

For instance, on June 14, 2006, a National Institute of Health Alzheimer’s researcher, Dr Trey Sunderland, asserted his Fifth Amendment rights, and refused to testify before the House Energy and Commerce Committee about accusations that he has profited from giving Pfizer access to spinal fluid and plasma samples collected by the NIH.

Documents presented at the hearing revealed that between 1996 an 2004, Dr Sunderland accepted consulting, speaking and advisory fees totaling about $612,000 and committee staff members estimate that about $285,000, was related to 3,245 samples taken from 538 patients who participated as volunteers at the NIH.

At a price of about $12,000 per patient, the committee estimates the cost of collecting the samples that Dr Sunderland handed to Pfizer is close to $6.5 million.

The committee also noted that he did not seek prior approval to work for Pfizer, and did not report any of the income to the agency as required by NIH rules.

In fact, at one point, when asked, Dr Sunderland said he had no outside deals. According to the December 22, 2004 LA Times, while reviewing financial disclosure reports from scientists at the NIH, in March 2000, ethics officer Olga Boikess noticed that Dr Sunderland had not declared any jobs with the industry so she sent him an e-mail that said: “You did not list any outside positions.”

To which, Dr Sunderland replied: “I do not have any outside positions to note.”

This case had been dragging on for years but the doctor has probably not been too worried because history shows that any time a Republican lawmaker get too pesky about the money trails leading to the NIH, Big Pharma simply offers enough money to induce him to jump ship.

A couple years ago, two Republicans on powerful committees switched sides shortly after they launched investigations into conflicts of interest between drug companies and employees at the NIH.

Representative, WJ “Billy” Tauzin (R-La), was chairman of the House Energy and Commerce Committee, and had cited “secret consulting fees and stock options from drug companies” as reasons to request documentation of all payments from Big Pharma to NIH scientists.

But next thing you know, Tauzin announces that he is not running for reelection, and leaves Congress to become President of the Pharmaceutical Research and Manufacturers of America, the giant trade group that represents Big Pharma, with a reported $2 million a year in salary, benefits and perks.

Next up to bat, was Representative James Greenwood (R-Pa), who led 3 hearings on NIH conflicts of interest and criticized the agency for allowing scientists to use “a swivel chair” to make decisions while taking drug company money.

But low and behold, shortly thereafter, in July 2004, Rep Greenwood announced that he was giving up his post as chairman of the Energy and Commerce subcommittee to retire, only to become President of the Biotechnology Industry Organization, a group that in the same year, urged lawmakers not to bar NIH scientists from entering into paid consulting deals.

A report by the Office of Government Ethics, released the same month that Rep Greenwood announced his “retirement,” said the NIH was beset by a “permissive culture,” and revealed that 40% of the 155 randomly selected sample payments to agency employees reviewed had not been approved or accounted for within the NIH.

The FDA remains at the top of the list for corruption simply because the FDA evaluates the safety and effectiveness of drugs and decides which drugs can be marketed in the US.

Typically, as a first step toward the approval process, a drug company will initiate laboratory testing to assess the effectiveness and safety of a drug and if the laboratory testing is successful, the company will begin testing the drug on animals. The FDA does not become involved until the drug maker seeks permission to test the drug on humans.

When the drug reaches that point, the FDA’s Center for Drug Evaluation and Research, evaluates the results of laboratory and animal testing prior to allowing any study on humans.

Once a drug is approved for testing on humans an Institutional Review Board (IRB) is appointed to review and monitor the research. An IRB is generally made up of outside scientists, doctors and other medical professionals and has the authority to approve or disapprove a study or to require modifications to secure approval of the research.

The purpose of an IRB is to assure that appropriate steps are taken to protect the rights and welfare of human subjects. To that end, an IRB uses a group process to review research protocols and materials such as informed consent documents and investigator brochures related to the research.

In recent years, serious questions have been raised regarding the impartiality of the review process due to the fact that many of the FDA advisors recommending approval of a product are at the same time employed by the drug company that developed the drug or hold some other financial interest link to the company.

Due to these conflicts of interests, critics say dangerous drugs are winning approval. For instance, nearly a third of the members of the advisory panel that reviewed the data on Vioxx, Celebrex and Bextra, and voted to allow the drugs to remain on the market, even after Vioxx had been pulled off the market, had financial ties to the makers of the drugs and had their votes not been counted, they would never have received a vote of approval.

In addition, problems continue to surface in the private research industry. Contract Research Organizations (CRO), are now hired by the industry to perform research.

Critics says the competing CROs are skewing research in favor of approval in order to win more contracts. The funding up for grabs is enormous. According to a March 24, 2006, MSNBC commentary by Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, “Private companies running studies for pharmaceutical and device companies are now a $14 billion industry in the United States alone.”

According to John Abramson, a clinical instructor at Harvard Medical School, and author of, “Overdosed America”, “When the institutional review boards were created, most medical research was conducted by universities and nonprofit institutions.”

“Similarly,” Mr Abramson says, “oversight of the safety of human volunteers in most U.S. studies is no longer done by nonprofit IRBs, but by for-profit review companies, hired directly by the for-profit research companies.”

In his opinion, he says the system lacks the appropriate checks and balances to protect human volunteers.

In the April 6, 2006 LA Times, Mr Abramson made a shocking revelation when he said, “the FDA recently approved “phase 0 studies” in which human beings can be given minuscule doses of experimental drugs even before animal studies are completed.”

A recent case in the UK demonstrates the dangers that could occur in such a study. In March 2006, six otherwise healthy men ended up in a London hospital in critical condition after participating in the trial of a new an anti-inflammatory drug, called TGN1412, to treat conditions involving the immune system, such as leukemia, multiple sclerosis and rheumatoid arthritis, conducted by the US based company, Parexel International Corp, on behalf of the German drug maker TeGenero.

The worst affected of the six men, Mohamed ‘Nino’ Abdelhady, called the Elephant Man because of the extreme swelling of his head, on April 5th, told the Daily Mail that he is plagued by nightmares.

Still recovering in the hospital at the time, he explained what he remembered. “I started to feel ill,” he said, “almost as soon as they had finished injecting me.”

“I felt as if I had rocks on my head,” he recalled, “and I must have started hallucinating.”

“Help me,” he told the newspaper that he screamed, “I’m dying.”

Ryan Wilson, the most critically ill man, begged doctors to put him to sleep because he was in such agony. His family was warned that his heart, lungs and kidneys failed.

His sister-in-law Jo Brown, recalled the horrific moment when they saw Mr Wilson in intensive care. She told reporters that his head had swollen to nearly three times its normal size, and that his neck was the same or wider than his head and that his skin had turned a dark purple.

Mr Wilson remained in a coma for three weeks, and upon awakening, learned that he may lose parts of his fingers and toes, which had turned black because of his reaction to the drug.

“I’m told it’s like frostbite and my fingers will just fall off,” he told the UK’s News of the World recently.

In addition, Mr Wilson also suffered from heart, liver and kidney failure, septicemia, pneumonia and dry gangrene and is considered very luck to be alive, according to News Target on May 20, 2006.

The Parexel research was at the Phase I stage, where a drug is tested for safety with a small number of people who are given a tiny dose under careful supervision, not to determine whether the drug works, but to check for side effects, according to Q&A Drug trials by BBC News on March 16, 2006.

Experts say the recruitment of subjects for the Parexel trial left much to be desired. The web site that announced the recruitment hardly mentioned the potential risks, but elaborated at great length about the good pay, free food and “plenty of time to read or study or just relax, with digital TV, pool table, video games, DVD player and free Internet access.”

Parexel also recruits by placing ads online or in local papers, where critics say, they draw the attention of the young and poor. Once on the books, recruits often get automatic offers. “The offers keep rolling in via text message,” Tom de Castella, a former Parexel volunteer said in the March 19, 2006 Times Online. “$650 for three days here, $1,000 for a week there,” he said.

Ethicists shown the Parexel consent form, which is supposed to describe the experiment and its risks, told Bloomberg News, “the document didn’t sufficiently inform participants of the therapy’s possible dangers or properly depict the treatment as a novel drug that can disrupt the body’s immune system.”

The 13-page form also exploited the subjects’ need for money, they said, by threatening to withhold the 2,000 pound ($3,500) payment if the men left the test early.

Highly questionable research recruitment techniques are also occurring in the US. On November 29, 2005, in Texas, CBS News channel 42 reporter, Nanci Wilson, revealed records showing that staff at state mental hospitals in Texas help recruit patients into studies of experimental drugs not approved by the FDA.

At a state hospital in San Antonio, CBS News found 16 beds set aside to allow drug companies to conduct studies on mental patients under the state’s care. CBS 42 asked Austin psychiatrist, Deborah Peel, to review some of the records they obtained.

Dr Peel said the situation raised serious questions as to whether this is moral and ethical treatment. “They are essentially turning the state hospital population into research subjects,” she noted.

Texas hospital officials claim the mentally ill patients give informed consent by signing a detailed form describing the risks and benefits of participating in the study. But Dr Peel says, “I think there are real questions how informed their consent would be under those situations, because these are not people who have the means to choose to go elsewhere for treatment, and so, there’s a powerful element of pressure, of coercion that they have to feel.”

“Once again,” Dr Peel points out, “we have people who have no means, who are dependent on the state system, and the state system is working hand-in-glove with private corporations.”

In many studies, CBS news investigators determined that patients had been taken off drugs that were working and in the new study, some patients were given the experimental drug while others received a placebo.

Critics point out that for patients taking a new drug, there is no guarantee it will work, and the risks and long-term effects are not known. “To take people off medication when they have just been admitted for an inability to function and might have even been a harm to themselves or others, that raises real questions for me,” Dr Peel told CBC News.

What’s worse, she says, is that patients are not told whether they are taking a placebo or a drug even when they are discharged from the hospital during the study. They could get suicidal, she said, or could harm others.

The FDA has ignored atrocities in research involving mentally ill subjects for years. Back in 1998, a review of the data on atypical antipsychotic drugs submitted to the FDA, obtained with FOIA requests by Robert Whitaker, revealed numerous safety problems for subjects who participated in the trials.

Mr Whitaker found that among 12,176 patients from the US and abroad at the time the data was submitted, there were 88 deaths, including 38 suicides, meaning there was an overall death rate of 1 out of every 138 patients, according to his article in the November 17, 1998 Boston Globe.

The suicide rate in trials was found to be 2 to five times higher than the norm. In the medical literature, Mr Whitaker reported, suicide rates for schizophrenics ranged from two to five deaths per 1,000 per year, while the rate in trials was close to 10 per 1,000.

In addition, he found that for the three approved drugs in the study – Zyprexa, Risperdal, and Seroquel – 60% of the 7,269 patients who received the drugs dropped out before the end of the study, which typically lasted six to 8 weeks.

In the 1990s the prospect of antipsychotic drugs gaining FDA approval, promised a major market for Big Pharma and therefore, drug companies needed to recruit trial subjects quickly. And drug companies were willing to pay top dollars to researchers for each patient recruited.

In the Boston Globe article, Mr Whitaker discusses a criminal case in Georgia that reveals just how far researcher are willing to go to meet recruitment goals.

Dr Richard Borison, chairman of the psychiatry department at the Medical College of Georgia, and Bruce Diamond, a pharmacologist on the school’s faculty, were favorites for schizophrenia drugs and demonstrated a knack for rounding up psychotic patients quickly for trials funded Eli Lilly, Janssen, Zeneca, and Novartis.

As faculty members, Borison and Diamond were supposed to get approval for research and payments for trials were supposed to go the school. But according to Georgia authorities, who indicted the duo in early 1997, in 1989 they started having the drug makers send payments directly to them.

They simply opened an office across from the school, hired a commercial service to do ethical reviews of their studies, and placed their staff on the school’s payroll but kept all the money for themselves.

As unbelievable as it may seem, the scheme worked for about 7 years. From 1989 to 1996, Borison and Diamond made over $10 million including more than $4 million from schizophrenia drugs, according to the indictment and testimony during an investigation by the Augusta Veterans Affairs Hospital, where Borison was chief of psychiatry.

And these guys were slick. To recruit the mostly male patients, they hired good-looking young women, who testified that they were paid bonuses that ran into the thousands, and one staffer was even given a Honda Accord.

To find their recruits, workers looked for mentally ill patients who were stable and living in the community and offered them $150 to check into the VA so they could be in a study. Patients already in locked wards were offered cigarettes to participate.

Study coordinators, many with no medical training, determined whether a patient belonged in a study. According to an FDA investigation, untrained staff drew blood samples and adjusted doses of the drugs, and Borison and Diamond hardly ever saw the patients at all.

But the two researchers lived high off the hog, according to Georgia authorities. They socked away more than $5 million in cash and securities, spent nearly a half a million on antiques and drove Mercedes-Benz vehicles.

But as the old saying goes, all good things must end. In December, 1997, Diamond pleaded guilty to theft and bribery charges and was fined, $125,000, sentenced to 5 years in prison, and ordered to pay $1.1 million to the college.

Borison pleaded guilty to theft and racketeering charges, was sentenced to 15 years in prison, fined $125,000, and ordered to pay $4.26 million to the college.

To cover all bases, over the years, Big Pharma has also become adept at corrupting the judicial process.

For instance, Dr Bruce Levine, PhD, Clinical Psychologist and author of, World Gone Crazy, tells a story about Eli Lilly corrupting the judicial process in a case that began in 1989 when Joseph Wesbecker opened fire at his former place of employment, killing 8 people and wounding 12 more, before committing suicide, a month after he began taking Prozac. The victims of the shooting sued Eli Lilly, claiming that Prozac had pushed the guy over the edge.

It has long been known that Prozac induces violence in some patients but the FDA never required Lilly to list violence on the drug’s label. But as it turns out, five of the 9 members on the 1991 FDA advisory panel investigating the association between Prozac and violence that voted against requiring a warning label for violence, had ties to Big Pharma and two of the members had served as lead investigators for Lilly-funded Prozac studies.

The Wesbecker trial did not take place until 1994, but in the meantime, according to Dr Levine, “Eli Lilly had been settling many Prozac violence cases behind closed doors.”

In fact, he says, more than 150 Prozac lawsuits had been filed by the end of 1994, so “it was looking for a showcase trial that it could win.”

A crucial component of the victims’ legal strategy in the Wesbecker case was for the jury to hear about Lilly’s history of reckless disregard toward consumers, especially about the drug Oraflex, introduced in 1982 but taken off the market 3 months later.

“A US Justice Department investigation linked Oraflex to the deaths of more than 100 patients,” Dr Levine notes, “and concluded that Lilly had misled the FDA.”

In the end, Lilly was charged with 25 counts related to mislabeling side effects and pled guilty.

At the Wesbecker trial, Lilly attorneys argued that the Oraflex information would be too prejudicial for the jury to hear and the Judge initially agreed. However, when Lilly attorneys used witnesses to testify about it’s superb system of collecting and analyzing side effects, the Judge said that Lilly had opened the door to evidence to the contrary and so the Oraflex information would also be allowed in.

However, to Judge’s amazement,” Dr Levine says, “victims’ attorneys never presented the Oraflex evidence and Eli Lilly won the case. “

It was later learned that Lilly was successful in corrupting the judicial process in the case by cutting a secret deal with victims’ attorneys to pay them and their clients not to introduce the damaging Oraflex evidence.

However, Dr Levine says, the Judge “smelled a rat” and fought for an investigation, and in 1997, Lilly quietly agreed to the verdict being changed from a victory to “dismissed as settled.”

Legal experts are finding ways to expose and punish Big Pharma for conducting fraudulent research that requires no involvement by the nation’s compromised regulatory agencies. Barry Turner, Lecturer in Law at Leeds Law School in the UK, is a great fan of the False Claims Act legislation in the US.

As an academic lawyer, he has for a number of years been involved in litigation regarding the activities of the pharmaceutical industry and for the past two years, he has been involved in Qui tam litigation preparation.

“Tying Qui tam into human rights and civil liberties issues is easy,” Mr Turner says. “When President Lincoln initiated this law in 1863 it was because Union soldiers were going into battle in shoddy boots and uniforms equipped with guns and ammunition that were third rate,” he explains. “All because ‘businessmen’ saw the war as a gravy train.”

“Qui tam,” Mr Turner explains, “protects taxpayers and since tax revenue is the lifeblood of any state, any evasion of liability or deliberate defrauding of a taxpayers is an attack on all taxpayers and consequently all citizens.”

Qui tam in its long history, he says, has brought to book many crooks who stole from the US taxpayer and is based on the individual citizen being able to blow the whistle for the benefit of fellow citizens and the country.

The more recent Sarbanes-Oxley Act of 2002 (SOX), was enacted in the wake of the Enron and WorldCom scandals, and was designed to restore investor confidence in the nation’s financial markets by improving corporate responsibility through changes in corporate governance and accounting practices and by providing whistleblower protection to employees of publicly traded companies who report fraud.

SOX contains a civil and a criminal whistleblower provision. Section 806, creates a civil cause of action for employees who have been subject to retaliation for whistleblowing, and Section 1107, makes it a felony for anyone to knowingly retaliate against or take any action harmful to any person, including interfering with employment, for providing truthful information relating to the commission or possible commission of a federal offense.

According to Mr Turner, SOX is not limited to shareholders of a company. “What needs to be understood,” he says, “is that many millions of people who own no stock at all get defrauded in scams all the time.”

“Those who pay into pension funds are vulnerable to the financial shenanigans not only of fund managers but of boards of companies,” he explains, “and CEO’s that fail to police the companies activities or in some cases actively encourage fraud and reckless business practices.”

SOX came into being to prevent those financial shenanigans, he says. “The fat cats may lose a small amount of their stake in any scam,” he points out, “but the little man as ever stands to lose all.”

One of the features of SOX, he says, is the ability to bring an action against those who recklessly and fraudulently deal with stockholders money. Big Pharma, and its handmaiden psychiatry, he notes, is built on fraud.

For example, Mr Turner explains, Ritalin fraud consists of labeling millions of children as basket cases based on fraudulent research and a consensus of the vested interest.

“SSRI fraud,” he advises, “extends depression into the world of normal human experience to ever-extend the peddling of the often useless and frequently dangerous treatments.”

In other instances, he says, many poor and elderly people are starved of life saving drugs because the budgets of Medicare and Medicaid are bled dry by claims from drug companies for ‘me too’ drugs that in many cases are superfluous.

“Even where there is some justification for the use of these drugs,” he explains, “there is a drive to constantly increase the dose above the minimum effective one because a ‘minimum effective dose’ to the drug company means minimum effective profit.”

“Where money is diverted from real healthcare provisions, to a profit greedy industry that manufactures an illness to fit the drug,” he notes, “rather than provide drugs for real illnesses, then the most fundamental of constitutional rights ‘Life, Liberty and the Pursuit of Happiness’ is most at risk.”

Every unnecessary dose of Ritalin, Prozac, Paxil, and other psychiatric drugs prescribed and paid for with US tax dollars, he says, deprives patients dependant on state healthcare programs of drugs they need for cancer, diabetes, heart disease and other serious conditions.

In addition, Mr Turner points out that, “the marketing of these drugs and the ever expanding definition of psychiatric disorder that is part of this marketing strategy labels, discriminates against, and stigmatizes hundreds of thousands of American Citizens.”

“It is indeed a dramatic irony,” he says, “that in very many of these cases the US taxpayer gets to fund an industry that acts in a manner so alien to the American Constitutional ideals.”

For purposes of the litigation, “knowingly” is defined as: (1) Actual knowledge of the false information; (2) Acts in deliberate ignorance of the truth or falsity of the information; or (3) Acts in reckless disregard of the truth or falsity of the information.

Therefore, according to Mr Turner, “inducing people to invest in companies that engage in illegal and reckless activity is a violation of SOX.”

“Inducing people to take vast amounts of drugs that are known to be harmful and deliberately hiding the known dangers is a violation of SOX,” he contends.

“One day this edifice will come tumbling down,” he says, “and what will the investors in Big Pharma say then?”

In light of the Vioxx disaster, Mr Turner says, we should perhaps ask people who invested in Merck.

“Those at the top of this company,” he notes, “gambled with the lives of patients and the money of stockholders in equal bad faith when they engaged in fraudulent and dishonest behavior that allowed a dangerous drug to be marketed.”

“Those who today peddle drugs for fictitious illnesses and push dangerous and useless medications on the children,” he warns, “in our societies are doing just this.”

Merck acted with reckless disregard for the truth because it had prior knowledge of the adverse effects of Vioxx. The same goes for Eli Lilly and its prior knowledge of the lack of efficacy of Prozac and GlaxoSmithKline’s knowledge of Paxil’s suicide ideation

While suppressing negative studies, these companies placed drugs on the market that were known to be faulty in one way or another. All of these drugs have cost taxpayers dearly, not to mention the personal suffering they have inflicted in other ways

In considering other acts of fraud, Mr Turner looked at the Pharma backed charities that are based on fraudulent research to see what Federal laws they may be violating.

“Since a number of imaginative illnesses are based on this fabricated research and since a number of charities are based on the ‘imaginative illnesses’ that arose out of the imaginative research,” he says, “its just a matter of connecting the dots.”

Because charities receive tax breaks, he says, fraudulent charities defraud US taxpayers.

“The fraud in this industry is not divided into that which injures by over drugging and that which cheats taxpayers and stockholders out of their money,” he explains. “They are two sides of the same counterfeit coin.”

Mr Turner says we must tackle them together, and that lawyers in the US should be actively seeking clients who have lost money by these frauds and getting the matter before the Security and Exchange Commission now.

Filed under: 2006, antipsychotics, Eli Lilly, NIH, NIMH, Parexel, Prozac, SOX, SSRIs, whistleblower

SSRIs – Wonder Drugs From Hell

Evelyn Pringle February 7, 2006

The Glenn McIntosh family has to introduce 12-year-old Caitlin, with a photograph because that is all they has left. Caitlin committed suicide 8 weeks after being prescribed the SSRIs, Paxil and Zoloft.

“We were told that antidepressants like Paxil and Zoloft were wonder drugs, that they were safe and effective for children. We were lied to,” Caitlin’s father said.

According to Glenn, his daughter was a straight “A” student, an artist, and a talented musician who loved animals and wanted to be a veterinarian.

With the onset of puberty, Caitlin seemed to be having trouble coping, and was also having sleeping problems due to a mild seizure disorder.

“We wanted to help, of course,” her father explains, “so we took her to our family physician, who prescribed her Paxil.”

Right off the bat, Caitlin did not do well on Paxil, so the doctor took her off the drug. About a week later the family went to see a psychiatrist and Caitlin was put on Zoloft.

According to Glenn, “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.”

Once she entered the hospital, the situation got worse as Caitlin was put on more and more psychiatric drugs to treat symptoms and behaviors that Glenn says he now realizes were caused by the SSRIs to begin with.

When she was released from the hospital, the downward spiral continued until the day that Caitlin used her shoe laces to hang herself in a bathroom at school.

“Let me be very clear about something,” Glenn said, “the dramatic and severe symptoms that led to my daughter’s suicide manifested only after she started taking antidepressant drugs.”

“The pharmaceutical companies have known for years that these drugs could cause suicide in some patients,” Glenn said. “Why didn’t we?”

Grieving the loss of their 14-year-old daughter Dominique, Lorraine and Robert Slater also make the point that, “informed parental consent is only possible as long as full disclosure is made by the pharmaceutical companies, the FDA, and the medical community.”

“How can teenagers be allowed to be given antidepressants that were never approved for adolescent consumption, only for adults?” Lorraine 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?”

Shortly after she was prescribed Celexa, Dominique attempted suicide. She was treated by several mental health professionals after her initial adverse reaction to the first SSRI.

And, each time they met with professionals, her parents explained that the drugs seemed to maker Dominique’s condition worse rather than better. Unfortunately, as so often happens, the adverse reactions and behaviors caused by the SSRIs, were treated as a worsening of an underlying condition and Dominique was prescribed other drugs from the same class.

“Dominique’s mind and behavior were slowly being altered to the point that she became very agitated, irrational, ultimately suicidal,” her mother recounts, “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.”

On February 6, 2003, Dominique was switched to the SSRI Effexor, and during the two weeks that followed, her doctor doubled the dose.

The morning of February 21, 2003, Robert dropped his daughter off at school and they said goodbye as usual. Around 11 am, Dominique told her teacher she needed to go outside for some fresh air. She left classroom and never returned.

Next to nothing is known about Dominique’s activities from the time she left school on February 21, until her body was found 3 weeks later in the Delta Mendota canal in California on April 14, 2003.

Lorraine is still racked with guilt and blames herself for giving her daughter the prescribed medication. “How can you imagine I feel, knowing now that I was slowly poisoning my daughter every day as I was dispensing her antidepressant medication?” she said.

Tom and Kathy Woodward’s daughter, Julie, who had no history of suicide or self-harm, hung herself in a matter of days after being prescribed Zoloft. “Julie began experiencing akathisia almost immediately,” Tom recalls.

But he knew nothing about Zoloft’s side effect of “akathisia” at the time. The doctor had stressed that Zoloft was safe and had very few side effects. He never advised Tom and Kathy about the possibility of violence, self-harm, or suicidal acts and the information they received with the drug never mentioned self-harm or suicide either.

According to her parents, Julie was a young woman who had everything to live for. Just weeks before her death, she had scored high on her SATs and was excited about starting college.

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 added.

Like so many other cases of suicides of young people on SSRIs, Julie’s body apparently could not handle the drug. “We now know from a blood test from the coroner’s office, that she was not metabolizing the drug,” Tom said.

Tom and Kathy are angry at government officials. “The FDA has placed the interests of the drug industry over protecting the American public,” Tom said, “if the trials don’t favor a drug, the public never hears of them.”

“It is clear that the FDA is a political entity,” he continued, “and its leadership has protected the economic interests of the drug industry.”

Tom believes that suppressing unfavorable studies should be illegal, “the drug industry must be compelled to produce all of their findings and studies,” he said.

Cheryl and Mark Miller lost their 13-year-old son, Matthew to suicide, after a psychiatrist gave him Zoloft. His parents were told that Matt had a chemical imbalance that could be helped by a new, wonder 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 eat, sleep, or sit still. The night before the family was set to leave for vacation, Matt hung himself in a bedroom closet from a hook, barely higher than he was tall.

“To commit this unthinkable act,” Mark said, “he was able to pull his legs up off the floor and hold himself that way until he lost consciousness.”

His parents had no warning of their son’s plan to kill himself. Mark had never spoken about suicide or threatened to commit suicide.

Mark and Cheryle have since learned that Matt’s doctor has served as “a well-paid spokesman for Pfizer,” the maker of Zoloft.

Terri Williams’ 14-year-old son, Jacob, was an exceptional athlete and participated in both the varsity and junior varsity football teams at his school.

In September 2000, Jacob seemed to lose interest in school activities except for football, and a conflict arose with regard to his grades and school attendance. As a result, his parents attended a conference in October 2000, at which the school administrator suggested that Jacob might be depressed and recommended seeking medical help.

Terri contacted Jacob’s pediatrician and made an appointment for the same afternoon. The doctor prescribed Prozac, and three weeks later increased the dose.

Shortly after he started taking the drug, Jacob complained of having strange bad dreams and shortly after the dose was increased, his mother noticed an aggressive behavior which had not been there before. “Jacob also became destructive and destroyed some of his favorite things,” Terri said.

When questioned, Jacob told his mother, “I don’t know what is making me do this.” Terri wrote it off to normal adolescent behavior and did not pursue the issue further.

On December 5, 2000, Terri found Jacob’s body hanging from the rafter in their attic. He had hung himself with his own belt. He left a letter on the ladder leading up to the attic for his parents, thanking them for giving him 14 years of a happy life.

After her son’s death, his friends told Terri that they had noticed the same changes in Jacob, that he had become short tempered and verbally aggressive.

“Had I known that this was a potential side effect, suicide,” Terri said, “I would have never allowed my son to take the drug Prozac.”

And the sad fact is, the FDA could have warned Terri, because by 1998, according to the FDA’s adverse reaction reporting system, Prozac alone had already accumulated over 40,000 adverse reaction reports, including over 2,100 deaths, far more than any other drug in the history of the reporting system.

Filed under: 2006, Celexa, Effexor, FDA, Glaxo, Lexapro, Paxil, Pfizer, Prozac, SSRIs, suicide, Wellbutrin, Zoloft

Eli Lilly The Habitual Offender

January 27, 2007

Evelyn Pringle

The revelations that Eli Lilly concealed the side effects of Zyprexa and promoted the drug for unapproved uses is not newly discovered misconduct. It is a persistent pattern of conduct indicative of a nasty habit that needs breaking.

After the secret company documents were leaked to the press last month by attorney, Jim Gottstein, the focus has been on Zyprexa; but a year ago it was Evista, and before that it was Prozac.

In the case of Evista, approved for treating post-menopausal women with osteoporosis, Lilly concealed data that showed an increased risk of cancer. On October 24, 2002, the Cancer Prevention Coalition issued a press release that said Lilly suppressed evidence that women taking the drug were at an increased risk of developing ovarian cancer.

“There is ample scientific evidence that Evista poses risks of ovarian cancer,” said Dr Samuel Epstein, MD, Chairman of the Prevention Coalition.

The data revealed “an 8 percent increased incidence of ovarian cancer in white females over 65, those most likely to be treated with Evista, from 1997 to 1999,” he said.

“Lilly’s own study,” Dr Epstein wrote, “found that the drug was shown to induce ovarian cancer in rats and, at doses well below the therapeutic, in mice.”

He noted, “the strong scientific consensus that the induction of cancer in well-designed studies in two species creates the strong presumption of human risk.”

Dr Epstein also cited a 2001 study by the University of Southern California that found Evista increases the growth rate of ovarian cancer cells in laboratory studies, and may increase risks of recurrence of ovarian cancer.

He called Lilly’s suppression of its own evidence “reckless and threatening to women’s health and life,” and the FDA’s approval of Evista without the cancer warning “equally reckless.”

Also in 2002, the US Department of Justice began looking at Lilly’s off-label marketing of Evista, and in March 2004, the US Attorney’s office in Pennsylvania announced it was investigating the company’s marketing practices for Evista, Zyprexa and Prozac.

The DOJ’s three-year investigation found that Lilly illegally marketed Evista for the prevention of breast cancer and heart disease. The DOJ noted that sales reps sent letters to doctors to promote unapproved uses and that Lilly produced a videotape in which the company claimed Evista was “the best drug” for the prevention of osteoporosis, breast cancer and heart disease.

In December, 2005, Lilly agreed to pay $36 million to settle criminal and civil charges related to the illegal marketing of Evista. The company paid a $6 million criminal fine, a $6 million forfeiture to the federal government, and $24 million to settle a civil lawsuit.

Lilly’s settlement agreement also included the standard, but useless, permanent injunction and consent decree in which Lilly agreed not to engage in illegal marketing and promotional practices.

In the case of the antidepressant, Prozac, a selective serotonin reuptake inhibitor (SSRI), Lilly’s concealment of the increased risk of suicide and violence associated with the drug is legendary.

FDA approved in 1988, Prozac was promoted off-label for everything from shyness to eating disorders to low self esteem. Within three years, annual sales of the drug were nearly $800 million. Newsweek put a Prozac pill on its cover with a headline calling it a breakthrough drug. Even healthy people were asking for Prozac, the magazine noted.

But with the massive off-label sales, so came the less newsworthy adverse events. The reporting system for prescription drugs in the US is called Medwatch. Within 10 years of Prozac’s arrival on the US market, there were 39,000 adverse events submitted to Medwatch, a number said to represent only between 1% and 10% of the actual number.

“So, if we get 39,000 adverse event reports about Prozac, the number of people who have actually suffered such problems is estimated to be 100 times as many, or roughly four million people,” investigative journalist Robert Whitaker explained in an interview for Street Spirit in August 2005.

“This makes Prozac,” he said, “the most complained about drug in America, by far.”

“There were more adverse event reports received about Prozac in its first two years on the market than had been reported on the leading tricyclic antidepressant in 20 years,” he added.

On December 18, 2003, Lilly sent letters to healthcare professionals in the UK, saying that Prozac was not recommended for children for any use, but issued no warning to doctors in the US.

In a situation similar to the Zyprexa document case, a couple years ago, the British Medical Journal received a series of internal Lilly documents and studies on Prozac from an anonymous source. The BMJ sent the documents to authorities, including US Congressman Maurice Hinchey and the FDA.

Congressman Hinchey sent the materials to psychiatrist, Dr Peter Breggin, author of Talking Back to Prozac, and The Anti-Depressant Fact Book, who reviewed the documents and issued a January 12, 2005 report.

After examining the documents, Dr Breggin confirmed their authenticity as those that he had evaluated in the early 1990s when he served as an expert for the combined Multi-District Litigation concerning Prozac. He in fact testified about the documents during a trial in 1994 after which, he says, they seemed to just disappear.

One group of documents he examined, contained a study by the FDA on the increased post marketing reports of “hostility” and “intentional injury” by patients on Prozac. For this study, the FDA compared patients using the antidepressant, trazodone, with Prozac patients, and found a 24-fold relative increase of reports of hostility and intentional injury per prescription of Prozac compared to trazodone.

The documents Dr Breggin reviewed also contained graphs showing a 40-fold relative increase in reports of suicide attempts, overdose, and psychotic depression in patients on Prozac compared to patients on trazodone.

An August 6, 1989, Lilly document says that doctors should be warned that Prozac patients were at a higher risk of suicide unless they receive a sedative, stating: “The counterindication because of acute suicidality should become a warning whereby the physicians should be advised that in the absence of sedation, the risk of higher suicidality should be taken into account.”

A June 13, 1990, letter to Lilly from a concerned doctor states: “There appears to be growing concern that Prozac may somehow trigger a suicidal preoccupation in a small subset of patients and that their families should be warned of this potential risk. It is certainly possible that some of the cases reported are “coincidence” in that the depressed person may have attempted suicide independently of Prozac. However, some of these cases appear to be in patients taking Prozac for reasons other than depression.”

Yet two months later, on August 31, 1990, Lilly sent out a Dear Doctor letter assuring health care professionals that there is no “causal relationship between Prozac and suicidality (ideation or acts).”

The hidden Prozac documents have come back to haunt Lilly. On January 14, 2005, a class action lawsuit was filed in Canada with claims that Lilly withheld information on the safety of Prozac. The plaintiffs contend that the reason Lilly failed to disclose the documents was because they showed a drastic increases in suicide attempts and other violent acts in patient using Prozac when compared to four other drugs.

Throughout the 1990s, while swearing publicly that Prozac did not increase the risk of suicide or violence, Lilly quietly settled lawsuits out of court and was able to keep the incriminating evidence hidden by obtaining court orders to seal the documents, just as it had been doing with Zyprexa until the latest batch of documents was leaked to the press.

Since the FDA was placed on permanent vacation when George W Bush took up residence in the White House, these days litigation appears to be about the only means available for unearthing hidden studies that show a drug’s adverse effects.

In the case of Zyprexa, Lilly has so far settled with an estimated 26,000 plaintiffs, at a cost of over $1 billion. The incriminating documents leaked to the press last month, came to light during litigation with these plaintiffs but even after the litigation was settled, they were kept under seal with a court order.

Since the documents were made public, Lilly’s legal team has spent about every other day in court trying to silence the messengers, Dr David Egilman and Jim Gottstein, and get the incriminating evidence back under seal, albeit without much success.

In a January 15, 2007, legal filing, a Lilly attorney quotes a comment by Judge Brian Cogan in a previous court hearing who said, Mr Gottstein had “deliberately and knowingly aided and abetted Dr. David Egilman’s breach of CMO-3.”

A responsive filing from Mr Gottstein should say that by issuing a protective order to suppress these documents to begin with, the court deliberately and knowingly aided and abetted Lilly in the off-label sale of Zyprexa by concealing the drug’s side effects from tens of millions of consumers and prescribing physicians.

The secret documents show that Lilly concealed information about Zyprexa’s link to severe weight gain, high blood sugar, and diabetes for a decade and because Lilly promoted Zyprexa off-label for so many uses, more than 20 million people have taken the drug. It is Lilly’s best-selling product, with sales of about $30 billion since its arrival on the market in 1996, according to the January 20, 2007, New York Times.

In the latest development in the Zyprexa saga, last week Illinois and Vermont joined a coordinated five-state investigation of Lilly’s marketing practices.

“The states are investigating whether Lilly tried to hide Zyprexa’s risk of causing weight gain and other risks associated with diabetes and whether the company promoted Zyprexa for use in patients who do not have schizophrenia or bipolar disorder,” the Times reports.

The larger question would seem to be, were the roughly 26,000 plaintiffs who entered into out-of-court settlements aware of the contents of the hidden documents and did they understand that by settling out of court Lilly would be permitted to keep the information secret knowing full well that more victims would be injured or killed by Zyprexa?

Filed under: 2007, antipsychotics, cancer, Eli Lilly, Evista, Prozac, SSRIs, suicide, Zyprexa

UpHill Battle – Warning Pharma Customers About Dangers of SSRIs

Evelyn Pringle October 5, 2006

Recent concerns about the adverse effects of selective serotonin reuptake inhibitor antidepressants (SSRIs) have focused on suicide risks. However, a new study published in the September 2006 journal, Public Library of Science (PLoS), reports that in addition to self-harm, the drugs can also cause some patients to become violent and homicidal.

Professors David Healy and David Menkes from Cardiff University in Britain, and Andrew Herxheimer from the Cochrane Centre, conducted the study to determine the risk of violent behavior in people taking SSRIs.

During their investigation, the researchers reviewed all available clinical data on SSRIs and summarized a series of what they refer to as “medico-legal” cases involving patients who became violent on SSRIs in which they have given evidence.

In addition, they analyzed 1,374 emails from patients on SSRIs sent in response to a British television program on Paxil featured on Panorama.

The authors focus mostly on Paxil because they had access to more medico-legal case material for Paxil patients than other drugs and because GlaxoSmithKline recently submitted data on the rates of “hostile” events for the review of SSRIs by the British regulatory Committee on Safety of Medicines Expert Working Group.

Dr Healy is one of the world’s leading authorities on SSRIs. He is the author of over 120 articles and 12 books, including, Let Them Eat Prozac, The Antidepressant Era, and The Creation of Psychopharmacology.

His expert testimony at the trial of a Wyoming lawsuit involving violence associated with Paxil in 2001, was a deciding factor in the return of a favorable verdict for the plaintiffs. The trial involved the tragic case where 60-year-old, Donald Schell, shot and killed his wife, daughter and granddaughter and then himself after taking Paxil for only two days.

Mr Schell’s surviving family members sued SmithKlineBeecham and won. Another decisive factor in the Wyoming case relevant to the results of the current study, is that the company’s own internal clinical trial data revealed at trial showed that Glaxo knew prior to 1998, when the deaths occurred, that Paxil had caused some patients to become violent and suicidal.

The data included an unpublished study of incidents of serious aggression in 80 patients, 25 of which involved homicide. After weighing all the evidence, the jury said that Paxil “can cause some people to become homicidal and/or suicidal,” and ordered Glaxo to pay the plaintiffs $8 million.

In the PLoS study, Dr Healy and his colleagues warn that, “The new issues highlighted by these cases need urgent examination jointly by jurists and psychiatrists in all countries where antidepressants are widely used.”

However, that might be easier said than done because according to Dr Healy, “even though PLoS is braver than most journals and less influenced by industry than most, it still took close to 18 months for this article to appear.”

“I have several articles that have taken this long,” he reports. “The hold up,” he says, “is the journal – whether PLoS or BMJ being terrified of industry and a legal action against them.”

“This stands in contrast” Dr Healy points out, “to the good news about drugs which industry manages to get out rapidly in the best quality, highest impact factor journals, apparently authored by the biggest name academics in the field.”

“But these articles,” he advises, “are based on selected data and no-one has access to the full dataset and no-one makes a judgment based on full access.”

Investigative reporter, Kelly Patricia O’Meara, author of, “Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills That Kill (2006),” is also painfully aware of the difficulties involved in getting the information published about SSRIs and violence that most experts have known about for years.

“It seems to me that the “new” study is an old issue,” she says. “I don’t believe there is anyone remotely familiar with these drugs who wouldn’t admit a strong correlation between them and violence.”

“It is an issue that must be addressed,” she warns, “given the numbers of violent acts that appear to be associated with their use.”

“The issues the doctors raise about the medical/legal aspects,” Ms O’Meara says, “are extremely pertinent.”

Specifically, she notes, in recent weeks in the Washington DC area, there have been three cases reported in the Washington Post all dealing with violence/murder associated with “mental illness.”

“While all three cases reportedly were receiving psychiatric care,” she says, “only one of the cases mentions the use of psychotropic drugs.”

“Naturally,” she points out, “any progress on this will depend largely on whether the press is informed enough to even ask the question: were they on prescription mind-altering drugs?”

Dr Healy acknowledges that, “SSRIs can be very useful and there are unquestionably people who are hugely helped, but the benefits have been over-hyped,” he says, “and the risks concealed and denied.”

It would be helpful, he notes, to have access to all the data on the violence side effect associated with SSRIs. “Based on access to all the data in this area,” he explains, “we might be able to work out if men or women are at greater risk or young or old or people being treated for anxiety rather than depression.”

“Until then,” he advises, “the key thing is that people being put on these pills need to be warned that they may not suit them and if they feel odd or more anxious they should either stop treatment or return to their doctor.”

“The worry,” Dr Healy has, “is that doctors indoctrinated by company input on this will still only see the risks from the condition being treated and faced with a patient saying they feel worse will double the dose of the treatment rather than reducing the dose or halting the treatment or switching to a different kind of treatment.”

“This would be exactly the wrong thing to do if the drug is the source of the problem,” he warns.

Other recognized experts on SSRIs share the same concerns. According to Dr John Abramson MD, author of Overdosed America, and clinical instructor at Harvard Medical School, a double standard exists in the way that information is received by physicians.

“Commercially advantageous “knowledge” travels fast and is delivered by many paths,” he says, “while commercially disadvantageous information, though available sometimes in a legalistic sense, is not communicated in the way that doctors have been formally and informally trained to receive new information.”

In the Paxil trials reviewed for the PLoS study, aggression and violence were coded under the term “hostility” which included homicide, homicidal acts, and homicidal ideation as well as aggressive events and conduct disorders, but no homicides were reported in the trials.

When combined, hostile events in both the adult and pediatric trials, during therapy and the 30-day tapering off phase, 60 out of 9,219 patients experienced hostile events.

The study found hostile events in excess in both adults and children, and across all indications. The hostility rates were highest among children with obsessive-compulsive disorder, where the rate of a events was 17 times greater.

In their submissions to the Committee on Safety of Medicines, Glaxo also reported clinical trials comparing 11,491 patients on Paxil and on other SSRIs, and there were 44 hostile events in patients on Paxil or other drugs.

In the trials comparing Paxil with another SSRI, there were 16 hostile events in a group of 2,418 patients. These SSRI comparator trials may be confounded by indication, the researchers note. They might, for instance, have included a higher proportion of OCD patients.

However, most noteworthy in this review, the researchers found that in healthy volunteer clinical trials that took place in the late 1980s or early 1990s, hostile events occurred in three of the 271 healthy volunteers taking Paxil, while none occurred in the 138 volunteers taking a placebo.

“Although not statistically significant,” the authors point out, “this finding is striking because hostile events are unusual in healthy volunteer trials, and this figure was higher than the rate reported in clinical populations above.”

Glaxo attributed these events to the fact that the volunteers were confined, although the study authors note that both the Paxil and placebo volunteers were confined.

But here again, Dr Healy acknowledged the significance of the findings in the healthy volunteer trials 6 years ago. “We can make healthy volunteers belligerent, fearful, suicidal and even pose a risk to others,” he wrote in the June 2000, Primary Care Psychiatry.

“People don’t care about the normal consequences as you might expect,” he stated. “They’re not bothered about contemplating something they would usually be scared of.”

Four years later, on September 21, 2004, Dr Healy is sounding the alarm again and quoted by The Guardian, as saying, “I think there is very clear evidence for all of the SSRI group of drugs that in addition to making people suicidal, they can make people homicidal or seriously aggressive and the data have been sitting in the MHRA’s files on this issue.”

“It is there for children across a range of different problems,” he said, “it is there for healthy volunteers and a range of adults and the MHRA has paid no heed to this.”

Another recognized expert on SSRIs, Ann Blake Tracy, PhD, Executive Director, International Coalition For Drug Awareness, and author of, “Prozac: Panacea or Pandor?” has been investigating the adverse events associated with SSRIs for the better part of two decades and says that, “This study confirms all of the previous data we have on increased levels of serotonin and violence.”

Ms Tracy has been working to make her findings public for the past 16 years. “This understanding that increased levels of serotonin – the exact so called “therapeutic” effect that antidepressants are designed to have,” she states, “has long been associated with psychosis, mania, suicide, violent crime (including rape, arson, murder), and could have saved many, many lives in the past two decades that these drugs have been in such widespread use worldwide.”

According to Ms Tracy, research has shown that impairing serotonin metabolism will produce tension and anxiety which appear from out of nowhere, depression, suicide – especially very violent suicide, hostility, violent crime, impulsive behavior with no concern for punishment, and argumentative behavior.

“How anyone ever thought it would be “therapeutic” to chemically induce these reactions is beyond me,” she states. “Yet, these reactions are exactly what we have witnessed in our society over the past decade and a half as a result of the widespread use of these drugs.“

She makes a very good point when she poses a thought provoking question. “Can you remember two decades ago,” she asks, “when depressed people used to slip away quietly to kill themselves rather than killing everyone around them and then themselves as they do while taking SSRI antidepressants?”

In the PLoS violence study, the authors provide an excellent example of the bizarre violent murders and suicides that Ms Tracy refers to, when they discuss the 1989 case of Joseph Wesbecker who shot and killed eight people, and injured 12 others, before killing himself at his place of employment in Kentucky after taking Prozac for about four weeks.

This incident also led to a lawsuit against Prozac maker Eli Lilly. The case was tried and settled in 1994, and a number of documents about drug-induced activation were made public back then.

The cases of out of character acts of violence by persons taking SSRIs are not isolated incidents or limited to certain age groups. Delnora Duprey has observed first hand the horror that can result from prescribing SSRIs to children. She is the maternal grandmother of Christopher Pittman, who at 12-years-old was placed on Paxil and Zoloft simultaneously, and subsequently murdered his paternal grandparents by shooting them as they lay sleeping and then burning the house down.

The following morning, two hunters found young Christopher hysterical in the woods yelling and waving a loaded shotgun over his head.

Ms Duprey says that she would like to stress as a family member who has gone through a terrible tragedy due to these drugs, that she knows how they can change people. “Our Christopher went from a sweet shy good kid,” she recalls, “to an angry hyper aggressive person in a very short time period.”

“This was not a normal change in a personality,” she states, “it was the medication.”

Ms Duprey, along with every other relative, blames the SSRIs, and says that Christopher would never have murdered his grandparents because he adored them both.

“While off the medication our Chris is back,” she says, “he has gotten his GED and has done very well under some rough conditions.”

Christopher has remained in jail ever since the night he killed his grandparents in 2001.

He was tried as an adult, found guilty and sentenced to 30 years in prison.

At a sentencing hearing his aunt, Melinda, the daughter of the slain grandparents, begged the court to show mercy toward her nephew, stating that her parents would want the court to show mercy toward Christopher.

The South Carolina Supreme Court has opted to hear an appeal and the case is set for a hearing in October 2006.

Through their review of adverse event records in the UK, Dr Healy and his collegues found that by 2003, there were already 121 cases of aggression in patients on Paxil reported to the Medicines and Healthcare Products Regulatory Agency, and furthermore, by January 2006 that number had risen to 211.

The authors specifically point out that such reporting systems estimate that doctors only report between one and ten percent of adverse effects.

The data reviewed for the study that was submitted by Pfizer on Zoloft’s pediatric trials showed aggression to be the most common cause for discontinuation in the two Zoloft placebo-controlled trials in depressed children.

In the Pfizer trials, eight of 189 patients in the Zoloft group discontinued for aggression, agitation, or hyperkinesis (a coding term for akathisia), compared to no dropouts for these reasons in the group of 184 patients on a placebo.

When discontinuations were considered for any treatment-induced activation including suicidal ideation or attempts, aggression, agitation, hyperkinesis, or aggravated depression, there were 15 drop outs by patients on Zoloft and only two in the placebo group.

In the only other placebo-controlled Zoloft pediatric trial, of children with OCD, out of 92 patients on Zoloft, there were ten dropouts. Five for behavioral activation, two for agitation, one for aggression, one for nervousness, and one for emotional lability.

In comparison, in the group of 95 children taking placebos, there was one discontinuation for hyperkinesis out of two dropouts overall.

In addition, in one healthy volunteer trial on Zoloft run by Dr Healy, one of twenty volunteers reported aggressive behavior. This is not the only Zoloft healthy volunteer trial to show hostility after Zoloft intake, Dr Healy says, but the other data remain unpublished.

Finally, in pediatric trials of Wyeth’s Effexor, 2% of the children dropped out because of hostility, more than double the rate of children on a placebo.

The researchers also analyzed the 1,374 emails that were received by the BBC television following a program on Paxil and found that many people described emotional storms and thoughts and acts of violence or self-harm.

The analysis, they said, indicated a clear link between severe mood changes when Paxil treatment began, or later when the dosage was increased, decreased, or withdrawn.

Remarkably, the analysis found reports of violence in patients with no prior history of violent behavior. The results, the authors note, were also consistent with an analysis of reports by people on Paxil submitted to the MHRA by doctors between 1991 and 2002.

The authors say the strength of the current study showing an association between violence and SSRIs is that the data are unselected, but consistent even though it comes from a variety of sources.

“A weakness of the study,” they note, “is that we have been able to include only a subset of existing data in the analysis.”

“Data on aggression on other antidepressants will necessarily have been collected as part of the development programmes for these drugs,” they state, “but these data are not in the public domain.”

“Earlier reports have linked antidepressants to violence,” they note, “but this is the first independent study to offer a quantitative analysis of the issue; no other studies exist with which our results can be compared.”

By now many experts are questioning whether it can be said that the benefits of SSRIs outweigh their risks or whether they have any benefits at all. According to Dr Peter Breggin, another well-known expert on SSRIs, and author of, The Antidepressant Factbook, “study after study has confirmed that antidepressants typically perform only a little better than sugar pills.”

“In some studies,” he notes, “antidepressants actually turn out to be less effective than the lowly sugar pill.”

He also points out that “if depression is a product of our conflicts, stressful life experiences, and stifled choices, a drug would have no direct effect on treating it.”

Another expert in the field, and author of, The ADHD Fraud, Dr Fred Baughman, says, “we have the “disease-ing” of emotional and behavioral problems—of life’s problems with never a mention that the causes can be found in every-day life difficulties—things people can and must be helped with.”

He says when people get help in solving their work problems or marital and family problems or financial problems their “mental illness” is often gone in a day.

“The drugging psychiatry-pharmaceutical cartel,” Dr Baughman warns, “is too anxious to “disease” and “disable” those with real-life problems and the emotional symptoms they beget.”

Dr Healy has said that most patients diagnosed with mild or moderate depression would be better characterized as suffering from “community nervousness.” And although he views the condition as a real disorder, he says that it “could be due to a host of different factors such as overwork, stress, and constitutional deficits. But clinicians everywhere are diagnosing depression because that’s what they have a treatment for.”

“The Prozac story,” he writes in the book, ”Let Them Eat Prozac,” is one of a “wholesale creation of depression on so extraordinary and unwarranted a scale as to raise grave questions about whether pharmaceutical and other health care companies are more wedded to making profits from health than contributing to it.”

Filed under: 2006, Effexor, Glaxo, Paxil, Pfizer, Pittman, Prozac, SSRIs, Zoloft

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