SSRI Experts Head to Washington to Testify Before FDA Panel

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SSRI Experts Head to D.C. to Testify Before FDAWednesday, 6 December 2006, 4:11 pmOpinion: Evelyn Pringle

 

http://www.scoop.co.nz/stories/HL0612/S00107.htm

 

By Evelyn Pringle

On December 13, 2006, the FDA’s Psychopharmacologic Drugs Advisory Committee will hold a public hearing to review the suicidality data from the adult selective serotonin reuptake inhibitor (SSRI) studies. And, for what seems like the umpteenth time, SSRI experts from all over the US, and as far away as the UK, will travel to Washington to once again testify at yet another hearing on the suicide risks associated with these drugs. The committee is expected to vote on whether the risk of SSRI-induced suicidality in adults should be included in a Black Box warning on all SSRI labels, including Paxil, Prozac, Zoloft, Lexapro, and Celexa. The FDA should begin the hearing by announcing that suicide rates for adults have not declined at all in the US even with the massive wide-spread use of SSRIs. According to a Federal study, by researchers from Harvard Medical School and elsewhere, in the June 2005, Journal of the American Medical Association, despite a dramatic increase in treatment with antidepressants in 2001-2003, when compared to 1990-1992, the rates of suicidal ideation, gestures and attempts among adults have remained basically unchanged. There is probably no legal expert in the US more qualified to testify about SSRIs than Baum Hedlund attorney, Karen Barth-Menzies, and she will be at the hearing with bells on. Over the past 10 years, she has represented thousands of clients against SSRI makers. By now, the FDA knows that Ms Menzies makes no secret of the fact that she is outraged about the over-prescribing of these powerful and dangerous drugs to all age groups for nothing more than everyday problems. This will be Ms Menzies' fourth time up to bat. She has already testified three times at government hearings. She first spoke at an FDA Psychopharmacologic Drugs and Pediatric Advisory Committee hearing in February 2004, about the increased risk of suicide in children and adolescents taking SSRIs.

 

 

 

At that particular hearing, the famous SSRI litigator concluded her testimony by telling the panel: "Put me out of business for the right reasons. Warn about these drugs." Many of Baum Hedlund's clients who have suffered tragedies caused by SSRIs will be also be attending the hearing and some will be speaking. However, a number of clients who wanted to testify were not selected by the FDA's new "lottery" system, and will not be permitted to speak. But Ms Menzies says she plans to speak on their behalf. She has first-hand knowledge of how the drug companies hid the evidence about the suicide risks. The documents that have been unearthed in litigation reveal that the risk was known in the mid-1980's before the first SSRI, Prozac, was approved for use in the US. Because of Baum Hedlund's work in the Prozac litigation, Ms Menzies has the ability to provide the committee with the historical background on SSRIs, including internal company documents that show how and why the SSRI suicide risk with adults was obfuscated fifteen years ago during the first FDA advisory committee hearings on the suicide issue. She will explain exactly how the clinical trial data was manipulated by SSRI makers to skew the statistical analyses of suicidality. "Civil lawsuits," she says, "have uncovered internal company documents to which not even the FDA has access." And she maintain that the drug makers have purposely failed to conduct studies on the risk of suicidality because they already knew such trials would produce negative results. In August 2004, Ms Menzies testified before the California State Senate and called for better patient informed consent about the risks associated with SSRIs. Next, she testified at the September 2004, FDA Advisory Committee's follow-up hearings and discussed the lack of efficacy in SSRI treatment of children, as documented in pediatric clinical trials that had surfaced during litigation. In between the February and September 2004 hearings, Ms Menzies met with members of Congress to discuss SSRI related suicidality and the FDA's failure to alert the public about the dangers of SSRIs, and provided documentary evidence to show that the risks posed were real. She also provided information to investigators in two separate Congressional investigations that resulted in two hearings in 2004, at which drug company executives and FDA officials were interrogated and chastised by members of Congress. In addition to Ms Menzies, one of the world's most highly regarded SSRI experts, Dr David Healy, a professor at North Wales Department of Psychological Medicine, at Cardiff University, will be flying in from the UK to testify at the hearing. He too will give a repeat performance. Dr Healy has authored 12 books including, Let Them Eat Prozac, The Antidepressant Era, and The Creation of Psychopharmacology, and is known to be outspoken when he believes it is necessary. During his testimony at this hearing, Dr Healy says he plans to draw attention to the manipulation of the clinical trial data on SSRIs. For over a decade, he has been trying to raise awareness about the link between SSRIs and suicide. Back in August 1991, Dr Healy authored the paper, "Antidepressant Induced Suicidal Ideation," in which he said that the cases of two patient "suggest that the emergence of suicidal ideation on antidepressants cannot always be attributed to a lifting of psychomotor retardation but rather that the ideas may in some instances be produced by antidepressants." Three years later in 1994, he authored the paper, "The Fluoxetine and Suicide Controversy," and stated, "In the opinion of this author, the volume of case reports and other studies is sufficient to demonstrate that antidepressants and antipsychotics may induce suicidal ideation in certain individuals under certain conditions." After the February 2004 advisory committee hearings, Dr Healy analyzed the data from the pediatric SSRI trials on suicidality and hostility, including those kept hidden for years, and sent his analysis to the FDA on February 19, 2004. To distinguish the difference between suicide possibly caused by SSRIs verses suicide caused by an underlying illness of depression, Dr Healy broke down the studies into a group of children being treated for depression and a group of anxious children who were being treated for obsessive compulsive disorder or social phobia. From a pool of 931 depressed patients taking SSRIs versus 811 depressed patients taking placebo, Dr Healy determined that there were 52 suicidal acts by patients on SSRI versus 18 in the placebo group. In a pool of 638 anxious patients taking SSRIs versus 562 anxious patients taking a placebo, there were 10 suicidal acts in the SSRI group versus 1 in the placebo group. When these data sets were combined, in the 1569 patients on SSRIs there were 62 episodes of suicidality versus only 19 episodes in 1373 patients on a placebo. This analysis clearly shows that SSRIs can cause some children who were not depressed to begin with to become suicidal. Dr Healy believes the FDA should do more about the industry's practice of paying medical professionals to publish fraudulent research papers ghostwritten by PR firms. "While it is not FDA's brief to regulate the academic literature," he states, "the possibilities of a close to fraudulent representation of data and of extensive ghostwriting does set up an argument that these apparently scientific articles are in fact infomercials rather than the real thing.If these articles are essentially advertisements," Dr Healy says, "it is much less clear that FDA can throw their hands up and plead an inability to do anything about the production of such materials." Former Federal fraud investigator, Allen Jones, will also be testifying at the hearing and he too has testified before about the over-promotion and marketing of psychiatric drugs. "The pervasive manipulation of clinical trials, the non-reporting of negative trials and the cover-up of debilitating and deadly side effects," Mr Jones says, "makes it impossible to prescribe, or take, these drugs with any level of meaningful informed consent.Doctors and patients alike," he states, "have been betrayed by the governmental entities and officials who are supposed to protect them." During an investigation in Pennsylvania, Mr Jones learned all about Big Pharma's methods promoting the sale of psychiatric drugs by corrupting public officials and says, "conflicts of interest permeate the testing, approval and marketing of drugs in America.Academic researchers with industry ties," he explains, "put favorable spin on dubious clinical trial results and then the embellished results are presented to FDA Advisory Boards peopled with Pharma consultants, grantees and advisors.These results," he reports, "are further embellished in medical journals by still more academics on drug company payrolls." From there, he says, this body of misleading research becomes institutionalized by "expert panels" in treatment guidelines generated by additional academics and researchers with financial ties to the industry. As a fraud investigator, he discovered a hidden account in Pennsylvania where drug companies were funneling money to the state employees who were in charge of deciding which psychiatric drugs could be included in the treatment guidelines for the official list of drugs covered by public health plans like Medicaid and prescribed to people in all state institutions and programs. According to Mr Jones, the employees "were given unrestricted educational grants that were deposited into an off-the-books account, unregistered, unmonitored, literally operated out of a drawer." Mr Jones also found that the drug makers were paying these same state employees honorariums of up to $2,000 to speak at industry events and giving them perks such as lavish meals and trips. After the SSRIs and atypical antipsychotics were successfully added to the state formulary list, Mr Jones reports, Pennsylvania spent a combined total of $139 million in 2003, for those 2 classes of drugs alone. Last month, the former Pennsylvania Chief Pharmacist, identified as being on the take by Mr Jones during his investigation, was indicted on felony and misdemeanor conflicts of interest charges involving accepting money from drug companies while a state employee with great influence over the drugs that would added to the state formularies to be prescribed to patients in Pennsylvania. "I predict we will be seeing many more prosecutions of this type," Mr Jones says, "as the extent of drug company corruption of government officials becomes known." Another prominent SSRI expert making a return visit to testify once again is Dr Joe Glenmullen, a psychiatrist and clinical instructor in psychiatry at Harvard Medical School, and the author of the book, "Prozac Backlash," which describes his experiences of watching patients become suicidal while taking SSRIs. He has testified previously about a specific side effect of SSRIs called akathisia, that he and many other experts say, can make some patients so agitated that they feel death would be a welcome relief. "This side effect is so well established," Dr Glenmullen told a previous panel, "that it is clearly described with SSRIs in the Diagnostic and Statistical Manual, the DSM, the American Psychiatric Association's official diagnostic manual.If you look at the transcript of the FDA hearing on this very side effect 10 years ago," he stated, "you will see the FDA saying repeatedly we don't know what to do, we need more research.It is a tragedy," he added, "to be here 10 years later and hear the FDA saying the same thing.The industry's response to this side effect," he continued, "has been to blame the underlying psychiatric conditions of patients, to dismiss legitimate medical case reports as anecdotes, and to scare the media away from the subject, claiming that it would frighten patients away from treatment.Well, I prescribe SSRIs and I warn patients," he told the panel, "and they are not frightened away from treatment." In conclusion, Dr Glenmullen clearly stated that the suicidality in SSRI patients was not caused by an underlying psychiatric condition, that it was caused by akathisia. "Let's stop blaming the victims," he said, "and deal with this very real side effect."

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Evelyn Pringleevelyn-pringle (Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)

 

 

 

 

Experts Battle Over Safety and Efficacy of SSRIs Monday, 11 December 2006, 3:23 pmOpinion: Evelyn Pringle

 

Experts Battle Over Safety and Efficacy of SSRIsBy Evelyn Pringle

Every time the FDA is even thinking about taking measures to protect the public from the increased risk of suicide associated with SSRIs, Big Pharma sends out the hired guns to publish some half-baked study to dispute the suicide risk. An FDA advisory committee is holding a public meeting on December 13, 2006 to once again review the data that experts say show SSRIs to be associated with suicide in adults and is expected to vote on whether to add a Black Box label to SSRIs, including Paxil, Prozac, Zoloft, Lexapro, and Celexa, about on the risk. So true to form, last month Big Pharma's hired guns attempted to pass off a bogus study as science that claims suicide risks do not increase in children taking SSRIs. The so-called "research," was published in the American Journal of Psychiatry. In the study, the researchers contend that if no prescriptions for SSRIs were written, there would be 253 more suicides each year among children and adolescents in the US. To reach their conclusions, the researchers say they looked at county by county suicide data across the US for children aged 5 to 14, for the 2-year period of 1996 through 1998, and found that the counties with the highest prescription rates for SSRIs had the lowest suicide rates in this age groups. According to Dr Stefan Kruszewski, MD, a Psychiatrist and Addictionologist, from Harrisburg, Pennsylvania, studies such as this are fiction. "These retrospective data analysis," he says, "generally cherry-pick the suicide statistics that the authors wish to use to attempt to transform an association of facts to something that it is not.For several decades," he notes, "reports have appeared periodically in the psychiatric and mental health literature that suggest or infer a casual relationship between the enormous rise in prescriptions written for antidepressants and apparent changes in the numbers of completed suicides."

 

 

"However," he reports, "there is no evidence that there is a causal relationship." Who are these guys? One of the study’s co-authors, John Mann, is a member of the, American College of Neuropsychopharmacology Task Force on SSRIs and Suicidal Behavior in Youth. ACNP has served as a major shill for Big Pharma for years. This same gang issued a report complete with a press conference, ten days in in advance of the scheduled February 2, 2004, FDA advisory committee hearings on SSRI use with children, that said after reviewing the evidence it was the task force’s view that SSRIs were safe and effective and well-tolerated by children. At the time the ACNP report was called a thinly veiled attempt by the drug companies to preempt the FDA by making a public announcement in favor of SSRI use with children. Mr Mann himself has served as a paid speaker, consultant, and expert witness for SSRI makers and has received tens of millions of dollars in grants from the same companies to fund his research over the years - resulting in studies that always just happen to favor the drug makers' position. While testifying in a jury trial in Cheyenne, Wyoming, on May 21, 2006, Mr Mann served as an expert witness for Paxil maker, GlaxoSmithKline, and the now famous Houston attorney, Andy Vickery, asked Dr Mann about how much money he had received from drug companies to conduct his research. According to the trial transcript, Mr Vickery said, "we've looked at it just straight from your CV from 1990 or '91 to the present, and it looks like the total amount of grants was $31,520,124." He asked Mr Mann whether that sounded about right and Mr Mann flippantly said, "I've never added it up." Mr Vickery then asked whether it sounded like the amount was in the right ballpark, "over $30 million?" and Mr Mann said, "It is possible." In addition to fraudulent studies, thirty million apparently buys a lot of publicity because news of Mr Mann's latest research was pumped out and accepted by just about every major media outlet in the US and Canada. One headline by the Austin American-Statesmen and CBC News Canada, read: "Antidepressants Lower Kids' Suicide Risk, New Research Finds" Another CBS News headline read: "Child Suicide: No Antidepressant Link?" Reuters, News Max, Dominican Republic, and Scientific American all ran the headline: "Antidepressants Tied to Lower Suicide Rates in Kids" However, conspicuously missing in a google news search are any headlines disputing this unscientific study. Dr David Healy, a professor at North Wales Department of Psychological Medicine, at Cardiff University, in the UK, will be testifying at the December 13, FDA hearing. He says there is little difference in the research on the suicidality risks associated with SSRIs with adults verses with children. "There is a striking overlap between the results in trials from adults and pediatric trials," he notes. "While the rate of suicidal acts is higher in pediatric trials of depression," he explains, "the relationship between active treatment and placebo is the same in both adult and pediatric groups." Dr Healy has authored 12 books on psychiatric drugs, including, "The Creation of Psychopharmacology," and "The Antidepressant Era," and he plans to testify about the manipulation of data from clinical trials on SSRIs. According to Dr Healy, "There is probably no other area of medicine in which the academic literature is so at odds with the raw data." A possible explanation, he explains, is that the literature has had a significant ghostwriting input, a possibility that the ACNP Report, he says, that was published 10 days before the February 2004, hearing, did nothing to dispel. "The Task Force," Dr Healy says, "reported SSRIs to be effective, safe and well-tolerated, but the authors claimed that they might be mistaken in that they had not seen the raw data." Yet the some of authors of the report, he points out, including Graham Emslie and Karen Wagner, were also authors on almost all of the randomized trials on SSRIs, so Dr Healy questions how these people can claim that they have not seen the raw data. "Science depends on access to, or a fair representation of, all of the data," he says. "Portraying positive only results as science," he points out, "in other settings, has been called fraud." Along with Dr Mann, Dr Healy also testified as an expert in the Paxil trial in Wyoming but on behalf of the plaintiff. He told the jury that all SSRIs can trigger suicidal and violent behavior in some patients. On the stand, he described his own studies that showed that SSRIs could even cause one in four "healthy volunteers" to become agitated, and in some cases suicidal. Healthy volunteers, he explains, means the subjects were not mentally ill or depressed to begin with. To support his testimony, Dr Healy used data from the drug company's own clinical trials and presented a summary of a study involving more than 2,000 healthy volunteers in which hundreds of people on Paxil had experienced adverse reactions, ranging from insomnia or anxiety to attempted suicide, that doctors in the study coded as "possibly,probably" or "definitely" caused by Paxil. For the record, in the battle of the experts in the Wyoming trial, Mr Vickery and his chosen expert, Dr David Healy, won the day and obtained the first guilty verdict by a jury in a Paxil-related suicide case. Mr Vickery is expected to be at the FDA's December 13, hearing, as are most well-recognized experts on SSRIs, including Dr Joseph Glenmullen, Dr Ann Blake-Tracy, and Dr Peter Breggin. A review of all of the studies that led to the ban on SSRI use with children in the UK, by Tim Kendall, deputy director of the Royal College of Psychiatrists' Research Unit in London, and colleagues, was discussed in the April 23, 2004, New Scientist journal. After he learned that there were hidden pediatric studies, Mr Kendall contacted the SSRI makers directly and asked for the unpublished studies and when none of the companies supplied the data, he contacted a government agency and obtained 6 unpublished studies on three SSRIs. After the researchers added the unpublished pediatric studies to those that were published, the risk benefit balance completely changed. "When we got the unpublished data and put it in with the published data, something happened," Mr Kendal told New Scientist. "Instead of being safe and effective, the risk-benefit reversed." In fact, the unpublished studies on Zoloft, New Scientist said, "suggested the drug increased suicide-related events such as suicidal thoughts or attempts by 14 times compared with placebo." An editorial accompanying the study in the journal, Lancet, said the research on SSRI use with children is marked by "confusion, manipulation, and institutional failure." Analyses of published studies that governments rely on to set regulations, the editorial stated, are "made entirely redundant if results are so easily manipulated by those with potentially massive financial gains." The review of all the SSRI studies also showed the drugs to be practically useless with children and adults. "This data confirms what we found in adults with mild to moderate depression: SSRIs are no better than placebo," Mr Kendall said, "and there is no point in using something that increases the risk of suicide." With all that said, the FDA has set up another advisory committee meeting, at great expense to the tax payers, to re-re-re-review exactly what about SSRIs?

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Evelyn Pringleevelyn-pringle