May 1, 2004

The FDA Conference on Children and Anti-depressant Medication

I've been a doctor for twenty-seven years and thought I was pretty accustomed to the sad and difficult stories I heard about kids in my practice of behavioral pediatrics. Still I wasn't prepared for the tales of devastation and woe as I listened to parents and children speak earlier this week at the Food and Drug Administration meeting on the adverse effects of the anti-depressant drugs on children.

This public hearing was called by the FDA to review a decision by the agency's British equivalent, the Medicines and Healthcare Products Regulatory Agency (MHRA), to no longer recommend the selective serotonin drugs (SSRIs) like Zoloft, Paxil or Effexor to children for the treatment of depression. The public was invited by the FDA to share their experiences and opinions with a panel of doctors who were then to advise the FDA on the use of these drugs in children.

Because of the large number wishing to speak, everyone was strictly limited to only two minutes. Nonetheless, speaker after speaker shared harrowing tragic stories of children suddenly becoming suicidal and taking their own lives or going berserk, killing someone and spending their next twenty years in jail.

The stories were compelling and relentless, almost overwhelming. I recall two. One was a thirteen year old boy was acting perfectly normal with his family one evening. He was found dead fifteen minutes later hanging with his belt around his neck on a hook in his room closet. Then there was the woman who in a daze put a revolver under her chin but survived the bullet wound which destroyed her face in the process. She said she felt the reason she survived was to warn others about the dangers of these drugs.

The problem facing the FDA, though, is that many of these extreme acts could have been the product of the disorders these drugs were meant to treat. Yet only two parents of about forty personal witnesses spoke of the value of the medications. They also happen to be representatives of the National Alliance for the Mentally Ill (NAMI) which has close ties to the psychiatric establishment and drug industry.

Western Europe uses far less medication for psychiatric disorders in children compared to the U.S. In fact, this hearing would never have taken place but for the MHRA interpretation of American data on the SSRIs that was never disclosed to either doctors or patients. It turns out that only three of fifteen studies have ever shown a benefit for the SSRIs over placebo in the treatment of childhood depression. However, seven of the "negative" studies, all funded by drug companies, were never published (there is no legal mandate to do so). The FDA had kept them in their "back files." The MHRA had access to these studies. They weighed the lack of clear benefits using the drugs against the apparent higher rate of suicidality in children given the real drug versus placebo, and came down against their use in kids. Prozac was exempted because there was one study that showed it was helpful for depression in kids.

The FDA officials at the meeting acknowledged these same adverse "signals" in the studies but still weren't ready to issue a warning on this class of drugs. Psychiatrists, in general, despite the lack of solid evidence feel these medications can be very helpful to depressed children. Many families agree, though it may be the benefits could also be achieved with a sugar pill.

But by the end of the day, the medical panel consisting of pediatricians, not psychiatrists, were insistent the FDA issue some temporary warning to physicians and patients -- that these drugs meant to treat depression could also cause agitation , restlessness and increased suicidality especially in the first days and weeks of treatment. If depressive symptoms worsen or new symptoms appear, rather than raising the dose or adding another drug (which is a common practice now), first stopping all medication may be the most prudent choice.

To those families whose horror included the possibility that their tragedies may have been made worse by these medications, the FDA's reluctant decision to add a warning represents validation, albeit a much delayed bitter pill. And were it not for vigilant foreigners whose treatment culture does not automatically mean "popping a pill," new stories of this kind of tragedy would likely continue.


2099 Mt. Diablo Blvd., Suite 208
Walnut Creek, CA 94596