September 13, 2004

Lawrence Diller's Statement to the FDA on September 13, 2004

I have prescribed psychiatric drugs to children for twenty-six years. I've written two books on children and psychiatric drugs. I've appeared before Congress and the President's Council on Bioethics. But today I come before you as a physician in private practice with a report from the front lines -- news from the primary care pediatricians and family doctors, the private practice child psychiatrists and the families of the patients themselves.

I'm here representing the views and reactions of a silent majority of physicians who aren't intimately connected financially with the drug industry. Here's what they are saying and thinking.

The battle over the SSRIs and kids' depression is over. The ongoing publicity and negative reactions 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 problems that may develop in the early stages of SSRI treatment. 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. "Pediatric depression is under treated," they say "Now, even more families will refuse medication." I find this caviling worry the height of psychiatric sanctimony. For years we were told to practice "evidence-based medicine" and now when there is no evidence for SSRI effectiveness yet higher risks of suicidality, the leaders say "Wait, not so fast." I say "Where's the beef?"

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 simply do not know what to believe. We are increasingly bewildered, skeptical and cynical. The final blow was learning 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, publications, professional organizations, doctors' practices, Congress and yes, even regulatory agencies like the FDA, is the American equivalent of a Medellin drug cartel.

It's long overdue to make changes in the way we approve and market pharmaceutical drugs in this country. Suppression of negative studies in the name of protecting stock holder interests but at the cost of children's health, highlights the amorality of an unfettered unregulated market place. Specifically, we need true transparency in research. We also need a more organized system of follow-up by neutral third parties once a drug is released. Let us not lose the momentum to reform, this moment gives us, nor let the tragedies of the families who appear today, go in vain.

 

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