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8/8/2004
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Youth risk of suicide, medication revisited Antidepressants, suicidal thoughts, actions may be related, FDA analysis suggests.
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This article appeared first on the front page of the Wall Street Journal. The following day was another article, this one discussed the discrepancies between the actual results of a study on children using Zoloft and how Pfizer presented the results of that study. This second article appeared on the front page of the second section of the Wall Street Journal.
And media attention is growing. Tom Woodward, our PA director, appeared on Good Morning America Friday morning and did a wonderful job of presenting this issue in spite of his jet lag from our trip to Sacramento where we testified to the CA Senate on Wednesday.
Then that evening on ABC Evening News with Peter Jennings Tom appeared again with Jennifer Tierney and her daugher Jamie who had suicidal thoughts and became hostile after taking Effexor for headaches.
Clearly the warnings are on their way!!! FINALLY! After all these years! With this confirmation of the original warning sounded by Dr. Mosholder from the FDA, it should be clear the warnings must come.
The extent of those warnings remains to be seen.
From those who have seen the internal company documents we know that there is NO DISTINCTION in age groups with these suicidal reactions. These reactions are the same across the board, no matter the age. Last March the FDA issued its advisory for all age groups, so it will be interesting to see how the warnings are issued after this hearing.
Will the warnings come only for children or for all age groups, as they recently did in Canada, with their strong warnings of "harm to self or harm to others" being added to the cautions for those of any age? Surely this coming month will prove to be very interesting as these meetings convene.
Ann Blake Tracy, Ph.D
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A new Food and Drug Administration analysis of clinical-trial data shows evidence of a link between antidepressant drugs and suicidal tendencies among young people. The finding is likely to reignite debate over the issue and the agency's handling of it.
The new analysis, which focused on 25 studies of nine drugs, found that children and teenagers who took the medicines were more likely to have behavior or thoughts that appeared suicidal, compared with those who got placebo pills.
When the analysis used a far broader category of incidents that might possibly reflect suicidal intent -- some of them classified as "not enough information" -- the young people who took the drugs were twice as likely to engage in the behavior.
What makes the issue so controversial is how the FDA has dealt with an internal debate on the matter. Congressional investigators have been examining the agency's decision to block a staffer from revealing this past February his finding of a tie between antidepressants and suicidal tendencies in young people, which drew on many of the same trials.
FDA officials said his conclusion was premature and based on ambiguous data. The new FDA analysis relies on an in-depth review of the data by outside researchers led by reviewers from Columbia University.
The new findings are likely to intensify pressure on the agency to consider stronger action to limit use of the drugs by young people. The FDA is scheduled to present a final version of the analysis to an advisory committee in September, asking for its recommendations on what safety steps it needs to take.
The FDA's new analysis, which hasn't been made public, was contained in a draft document reviewed by The Wall Street Journal. An FDA spokeswoman said the agency was still reviewing the data and couldn't comment before the committee meeting.
The new analysis by an FDA medical reviewer tabulates the results of an outside re-examination, requested by the agency, of the clinical-trial data. The document, dated July 19, focuses on an array of antidepressant drugs, including Pfizer's Zoloft, Forest Laboratories' Celexa, Wyeth's Effexor, GlaxoSmithKline's Wellbutrin and Paxil, and Prozac, made by Eli Lilly & Co. and available generically.
The results varied sharply from drug to drug, and even multiple trials of the same drugs sometimes found differing levels of possible risk. Also, some of the results weren't strong enough to achieve statistical significance. No trial participants actually completed a suicide attempt.
Nevertheless, the document's findings appear to be consistent with a controversial earlier analysis by an FDA epidemiologist, Andrew Mosholder. He wasn't allowed to publicly present his conclusions at an advisory-committee meeting in February. He shared his views with agency officials as early as last December.
Two congressional committees are examining the FDA's handling of the epidemiologist's report. Mosholder declined to comment.
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