Study on Youth Suicide Rates–Scientifically Invalid

The widely publicized specious findings of a flawed study by influential academics with copious ties to industry–which the press failed to report– claimed that reduced prescriptions of SSRI antidepressants for children resulted in increased suicide rates. 

“The most plausible explanation is a cause and effect relationship: prescription rates change, therefore suicides change,” said Dr. J. John Mann, a psychiatrist at Columbia University, the lead co-author of the study.  

Critics, among them biostatisticians scoff at this scientifically invalid study, which is but the latest effort to rehabilitate SSRI antidepressants in the wake of public disclosure that these drugs DOUBLED the risk of suicidal acts. That was documented consistently in controlled clinical trials with a  placebo comparator. 

“These kinds of studies are very important in giving us a sense of the rates of disease and death in a population and how those may correspond to other things,” said Dr. Andrew Leon, biostatistician at Cornell. “But what they don’t do is tell us whether the two trends are directly related.”

Indeed, critics note that demographics can play a role and so do economics:

"White people kill themselves about twice as frequently as African-Americans and Hispanics, so as the population becomes more diverse, the suicide rate ought to drop, all else being equal. And suicide rates also appear to be negatively correlated with economic growth, which was exceptionally strong from 1994 to 2000."

"With so many potentially confounding factors at play, interpreting the relationship between prescription rates and suicides is difficult, said Andrew Leon, a professor of biostatistics at Weill Cornell Medical College who has served on F.D.A. panels studying suicide risk and antidepressants.

This specious study, published in the official journal of the American Psychiatric Association: its lead authors have significant financial ties to drug manufacturers. This is industry’s latest effort to divert attention from high profile lawsuits and documented evidence of profound irreversible harm caused by its two most profitable psychotropic drugs–the second generation of antidepressants and antipsychotics.
 
The most profound damage caused by these toxic drugs is borne by US children for whom they are prescribed wantonly and irresponsibly at alarming rates, on the advice of psychiatry’s most influential leaders at academic centers such as Harvard (Mass. General Hospital), Columbia (Center for the Advancement of Children’s Mental Health), NYU (Child Study Center) without a shred of evidence to justify the risks. 
 
How is it that neither reporters of the New York Times nor the Washington Post see fit to inform readers about the lead psychiatrists’ substantial financial ties to these drugs’ manufacturers ?
 

Surely, reporters of the Times and Post can be expected to conceive of the fact that by publicizing a claimed–unproven–relationship between increased suicide and reduced use of antidepressants in teens ENHANCES the COMMERCIAL interests of both these drugs’ manufacturers and the academics who are also beneficiaries of increased drug sales…
 
Seasoned reporters, such as Ed Silverman who turned blogger of Pharmalot reported:
"The study, which received front-page treatment in The Washington Post, was co-authored by Robert Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago, who has served as an expert witness for Wyeth, the company that sells Effexor.

And J. John Mann, a psychiatry professor at Columbia University, has received research support from Glaxo, which sells Paxil, and served as an adviser to Eli Lilly, which peddles Prozac and Cymbalta.

How do we know? These competing interests were noted at the bottom of the study, but not in the Washington Post story. Meanwhile, as we pointed out yesterday, the American Psychiatric Association has harshly criticized the FDA for placing the warnings on product labels, saying this scares away some docs and patients. The APA publishes the medical journal, by the way, which to its credit, listed the conflicts.

These conflicts don’t necessarily suggest the data or conclusions are incorrect – that’s worthy of a separate analysis and discussion – but given the drumbeat of info coming from the psychiatric community, these should have been reported by the Post. And the medical journal should have been widely and easily accessible to the media, which it wasn’t. Full understanding requires full disclosure, from everyone."
See:Pharmalot

 
 Vera Hassner Sharav

THE NEW YORK TIMES
September 14, 2007
Experts Question Study on Youth Suicide Rates
By ALEX BERENSON  and BENEDICT CAREY

Last week, leading psychiatric researchers linked a 2004 increase in the suicide  rate for children and adolescents to a warning by the Food and Drug Administration about the use of antidepressants in minors. The F.D.A. warning, the researchers suggested, might have resulted in severely depressed teenagers going without needed treatment.

But the data in the study, which was published in The American Journal of Psychiatry and received widespread publicity, do not support that explanation, outside experts say.

While suicide rates for Americans ages 19 and under rose 14 percent in 2004, the number of prescriptions for antidepressants in that group was basically unchanged and did not drop substantially, according to data from the study. Prescription rates for minors did fall sharply a year later, but the suicide rates for 2005 are not yet available from the Centers for Disease Control and Prevention

“There doesn’t seem to be any evidence of a statistically significant association between suicide rates and prescription rates provided in the paper” for the years after the F.D.A. warnings, said Thomas R. Ten Have, a professor of biostatistics at the University of Pennsylvania

In the report published last week, the authors analyzed data on suicides and antidepressant use over several years in the United States and the Netherlands. They argued that drug regulators may have created a larger problem by requiring pharmaceutical companies to place warnings on antidepressants, scaring away patients and doctors. The F.D.A. warning label says that a potential side effect in young people is an increase in suicidal thoughts and behavior.

“The most plausible explanation is a cause and effect relationship: prescription rates change, therefore suicides change,” said Dr. J. John Mann, a psychiatrist at Columbia University and a co-author of the study.

But Dr. Ten Have and other experts, while noting that it may still turn out that a reduction in prescriptions is leading to increased suicides among young people, said that the new study neither proved nor disproved this. Instead, some experts say, the study illustrates why suicide trends are so difficult to understand — and why this debate has been so polarizing and confusing.

In an interview, Robert D. Gibbons, a professor of biostatistics and psychiatry at the University of Illinois at Chicago and the lead author of the journal article, acknowledged that the data from the United States that he and his colleagues analyzed did not support a causal link between prescription rates and suicide in 2004. “We really need to see the 2005 numbers on suicide to see what happened,” he said.

But Dr. Gibbons defended the paper, saying that when taken in the context of previous studies that linked falling antidepressant use to increased suicide rates, “this study was suggestive, that’s what we’re saying.”

Other experts, however, said that the problem with such studies is precisely that they are suggestive rather than conclusive and are open to interpretation. Suicides are rare and uniquely personal events that can be driven by many factors: worsening depression or other mental illnesses, breakups or job loss, lack of drug or psychiatric treatment, even easy access to guns.

In calling for the labeling change on antidepressants, F.D.A. scientists based their decision on data from drug makers’ clinical trials, considered the gold standard in medical research. Those trials have shown that young patients who took antidepressants were about twice as likely than those on placebos to report suicidal thoughts or attempts, though the numbers in both groups were small.

Yet none of the youngsters in the trials, most of which ran for no more than a month or two, actually committed suicide. And most psychiatrists with long experience using antidepressants in children say the benefits far outweigh any risk.

In studies of data collected before 2004, Dr. Gibbons, Dr. Mann and others found clear associations between prescription patterns and suicide rates. For instance, prescription rates for patients from ages 10 to 24 rose steadily in the 1990s, while the suicide rate in that age group fell 28 percent from 1990 to 2003, according to a government report released last week.

In another study, researchers at Columbia University, analyzing data from 1990 to 2000, found that for every 20 percent increase in the use of antidepressants among adolescents, there were five fewer suicides per 100,000 people each year. Psychiatric researchers have found similar patterns among some age groups in other countries, including Sweden, Japan and Finland.

But many uncertainties remain. While the suicide rate for adolescents has fallen over the last decade, it has remained largely unchanged for the overall population, though prescriptions for psychiatric medicines have risen sharply in all age groups. Adjusted for the demographic changes, about 11 Americans per 100,000 killed themselves in 2004, the same as in 1994.

Demographics can play a role: White people kill themselves about twice as frequently as African-Americans and Hispanics, so as the population becomes more diverse, the suicide rate ought to drop, all else being equal. And suicide rates also appear to be negatively correlated with economic growth, which was exceptionally strong from 1994 to 2000. Advances in medicine also mean more lives can be saved now.

With so many potentially confounding factors at play, interpreting the relationship between prescription rates and suicides is difficult, said Andrew Leon, a professor of biostatistics at Weill Cornell Medical College who has served on F.D.A. panels studying suicide risk and antidepressants.

“These kinds of studies are very important in giving us a sense of the rates of disease and death in a population and how those may correspond to other things,” Dr. Leon said. “But what they don’t do is tell us whether the two trends are directly related.”

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