Experts Battle Over Safety and Efficacy of SSRIs
Monday, 11 December 2006, 3:23 pm
Opinion: 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?