Fassler testified at FDA hearings on antidepressants during 2003 and 2004 and urged caution about implementing black box warnings. The agency ordered the warnings in October 2004 and they began to appear on drug labels about six months later.
[Let's see, that would be April 2005. Hummm. How could those black box warnings in April '05 have effected a decrease in prescriptions and consequently, an increase in suicides in '04? Makes one wonder, doesn't it?]
http://www.bestsyndication.com/?q=09200 ... atment.htmPharma Hand Seen Behind Alarmist Suicide Statistics
Submitted by Martha Rosenberg on September 19, 2007 - 3:37pm.
Long before the New York Times reported this month that youth suicides were up 8% from 2003 to 2004 and experts blamed an "antidepressant deficiency" big pharma was trying to plant the story.
There's too much money in diagnosing children with major psychiatric illnesses and keeping them on psychotropic drugs their whole lives to let a little thing like the black box warnings the FDA imposed on antidepressants for children in 2004 ruin sales.
After all this is a nation that believes that children are born with a Ritalin deficiency, insomnia is Ambien deficiency and old age is hormone deficiency. Why shouldn't pharmacology trump biology with suicide statistics as well?
Last year an article in the June issue of PLoS Medicine set the stage.
Lead author Dr. Julio Licinio, a consultant to Prozac-maker Eli Lilly, found the U.S. suicide rate "dropped steadily over 14 years as sales of the antidepressant [Prozac] rose."
It was followed by an article in April in the Archives of General Psychiatry by four representatives of a private "drug development services" company called Quintiles Transnational and four other authors expressing concerns that "the number of children and teenagers who were prescribed antidepressants has decreased significantly" underlining "the importance of presenting a fair balance within the media." ("Impact of Publicity Concerning Pediatric Suicidality Data on Physician Practice Patterns in the United States")
And in February a MedPage Today article actually scooped the New York Times with the headline, "Teen Suicide Spike Linked to SSRI Black Box."
Black box warnings create a barrier to treatment "by scaring young people and parents away from care," said David Shern, Ph.D., president of Mental Health America, reported to have accepted $3.8 million from pharmaceutical companies in 2005, in a statement when the article broke.
Charles Nemeroff, M.D., Ph.D., of Emory University School of Medicine took it a step further.
"The concerns about antidepressant use in children and adolescents have paradoxically resulted in a reduction in their use, and this has contributed to increased suicide rates," he told reporters. Dr. Nemeroff has links to Eli Lilly, Pfizer, Wyeth-Ayerst, Pharmacia-Upjohn and five other drug makers according to published reports.
Unfortunately for pharma, when the New York Times broke the story it had a short shelf life.
The rise in suicides among ages 10 to 24 in 2003 to 2004 stood. But the charge that the rise was due to a drop-off in antidepressant prescriptions, especially selective serotonin reuptake inhibitors (SSRIs) like Prozac, which came from an article in the September American Journal of Psychiatry, promptly fell on its head.
It turned out the drop in SSRI prescriptions that "caused" the suicide rise occurred the following year. In most of the year cited, SSRI prescriptions actually "rose an average of just over 10 percent" for those 18 and under according to Psychiatric News and "the number of prescriptions peaked in March 2004."Meanwhile preliminary Centers for Disease Control and Prevention statistics from the year that would have been influenced by a drop in SSRI prescription that occurred--2005--do not show deaths up, though they have not been broken into category.
Asked about the 180% turnaround in facts which meant the suicide rise was not caused by SSRI prescription drop-offs and possibly caused by SSRIs themselves, vindicating the FDA's black boxes, the article's lead author Robert D. Gibbons, Ph.D., a professor of biostatistics and psychiatry at the University of Illinois at Chicago, did not sound the statistician.
"
This study was suggestive, that's what we're saying," Dr. Gibbons told the Times in a follow-up story--"Early Evidence on the Effects of Regulators' Suicidality Warnings on SSRI Prescriptions and Suicide in Children and Adolescents" is suggestive? try conclusive--and should piggyback off previous studies that showed the links. better.
Then why publish it?There were other question marks about the American Journal of Psychiatry article too--not counting Pfizer's financial contribution and Dr. Gibbons link to Wyeth Pharmaceuticals.
What if the suicides aren't about SSRIs at all but the growing popularity of treating children with antipsychotic drugs?
"I would be absolutely certain that the increase is not because kids are not being treated," says David Healy, M.D., a psychiatrist at the University of Cardiff and early critic of SSRIs. "They may not be getting SSRIs, but they are getting psychotropics," he says and,
"the antipsychotic 'mood stabilizers' have just as great an increase in suicide risk as antidepressants-- if not greater."Pharma is probably working on a new round of articles on the topic right now.
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Martha Rosenberg is a nationally known columnist who frequently writes about health care.
