Lawrence Diller, M.D.
Presentation before the FDA
September 13, 2004

The battle over the anti-depressants known as SSRIs and kids' depression is over no matter what specific warnings the FDA decides during the meetings on these drugs next week. This is the view from the frontline physicians who prescribe psychiatric drugs to kids -- the pediatricians, family doctors and private practice child psychiatrists. They are the silent majority of physicians who aren't intimately connected financially with the drug industry.

The ongoing publicity and negative reactions since February when the FDA held their first hearings on the SSRIs have already changed the average doctor's opinions and practices. No longer are pediatricians willy-nilly prescribing SSRIs for minor mood swings and phobias. Even child psychiatrists have become more careful to whom they prescribe. All the doctors have become aware of the agitation and restlessness that may develop in the early stages of SSRI treatment and lead to suicide or bizarre behavior. They are warning the families and following the children far more closely.

I think this is a very good development. However, many of the leaders in organized psychiatry and academia are publicly wringing their hands. ãPediatric depression is under treated,ä they say ãNow, even more families will refuse medication.ä I find this caviling worry the height of psychiatric sanctimony. For years we doctors on the frontlines were told by the experts to practice ãevidence-based medicineä and now when there is no evidence for SSRI effectiveness yet higher risks of suicidality, the leaders say ãWait, not so fast.ä My colleagues and I say ãWhere's the beef?ä

Which brings me to my major point. There's a growing credibility gap between the frontline doctors with the leadership and researchers in psychiatry. We doctors, who must decide every day in our practices who should and shouldn't get medication, simply do not know what to believe. We are increasingly bewildered, skeptical and cynical. The final blow was learning this past February about the eight negative SSRI studies on children that were never released to either doctors or the public.

This loss of credibility within the medical profession extends beyond psychiatry into all of medicine and the general public. The blame is clear. The money, power and influence of the pharmaceutical industry corrupts all. The pervasive control the drug companies have over medical research, clinical trials, publications, professional organizations, medical education, doctors' practices, and even regulatory agencies like the FDA, is the American equivalent of a Medellin drug cartel.

Some revelations seem right out of a movie script like the Manchurian Candidate. Take Representative James Greenwood's recent flip-flop. He headed a House subcommittee investigating the drug companies and the FDA over their handling of SSRIs in children. Greenwood abruptly cancelled a major hearing to announce he was becoming the head of big Pharma's major lobbying group to Congress.

It's long overdue to make changes in the way we approve and market pharmaceutical drugs in this country. One example is the suppression of the negative SSRI studies in children. The drug industry claim, that it was only protecting profits and stock holder interests, comes at the cost of children's health and highlights the amorality of an unfettered unregulated market place.

Specifically, we need true transparency in research. Recent attempts at industry self-regulation to deflect outside control fall short. A registry of clinical research should be administered by a publicly accountable agency like the National Institutes of Health. The registry should include all trials not just ones the companies want to include. The conditions of the trial should be delineated at its inception so we know if the rules were changed in order to favor one set of data. Finally, the main researchers must identify their financial ties to the companies whose drug they are studying.

Once a drug is released and marketed we also need a more organized surveillance system of follow-up by neutral third parties. We now depend on trial lawyers suing pharmaceutical companies on behalf of individuals who have experienced drug side effects. This haphazard method is costly to our society both in personal and financial terms and calls for urgent change.

Let us not lose the momentum the current concerns over children and anti-depressant medications give us. We must reform a very powerful and deceptive drug industry. We must not allow the tragedies of the families whose children suffered because of these medications, to go in vain.

Lawrence Diller, M.D., practices behavioral/developmental pediatrics in Walnut Creek, California and is the author of Should I Medicate My Child?