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    Friday, August 08, 2003

    Wonder Drugs No More: This must be the beginning of the end of the era of Prozac. It's no longer the darling of the media, which in the past, has portrayed it as a safe as candy, miraculous happiness pill. The New York Times has turned on it and its relations. They are, it seems, deathtraps:

    Warnings by drug regulators about the safety of Paxil, one of the world's most prescribed antidepressants, are reopening seemingly settled questions about a whole class of drugs that also includes Prozac and Zoloft.

    ...And the findings have unsettled some of the very experts who absolved S.S.R.I.'s of a link to suicide a dozen years ago. Of the 10 American specialists who, as members of an ad hoc F.D.A. panel, formally cleared the drugs of a link to suicide in 1991, seven now say that the new information would prompt them to reconsider that decision, if they were asked.

    "In 1991, we said there wasn't sufficient evidence to support a link between these drugs and suicide," said Dr. Jeffrey A. Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina and a member of the panel. "Now there is evidence, at least in children, and I wouldn't rule out that it's in adults, too."

    The furor has been set off by an analysis of unpublished studies by the British version of the FDA:

    The British regulators said that their analysis of the nine studies of Paxil found 3.2 times the likelihood of suicidal thoughts or suicide attempts among teens and children given the drug as among patients given a placebo. They also said that Paxil has not proved effective against depression in children and teenagers.

    The British regulator’s announcement is here, but it doesn’t shed any more light on the subject than the Times article. The evidence that these drugs increase the risk of suicide is sparse. In fact, it’s more than sparse. It’s unpublished and unavailable except to the regulators.

    The Medical Letter, an excellent, unbiased source of drug information, reviewed the subject last month and found the evidence wanting. According to The Letter, the FDC Reports cited a study that found among 1,134 children, “emotional lability” occurred in 3.2% of users compared to 1.5% of nonusers. “Emotional lability” was defined as “crying, mood fluctuations, thoughts of suicide and attempted suicide.” There were no completed suicides in the group. That's an important distinction. It isn't uncommon for depressed people, especially teenagers, to make a consciously feeble attempt at suicide - such as taking a drug they think is harmless, like Tylenol. Their goal isn't to kill themselves, but to gain attention.

    On the face of it, the current recommendation to avoid these drugs seems overly cautious. For one thing, compared to older anti-depressants, they are more effective and they are safer. In the old days, before SSRI’s, doctors always excercised caution with anti-depressants because the drugs themselves could be instruments of suicide. Patients would only be given a small amount of the drugs at a time, say a week or two, to avoid intentional overdoses. With the SSRI’s, that’s not a problem.

    The other suspicious aspect of the findings is that the suicide risk is highest in the first few weeks of the drug’s use. Paxil takes three or four weeks to work. Might it not be the case that the suicide risk is highest in those first few weeks not because of the drug but because the depression isn't yet fully treated?

    And Another Thing: Have you ever noticed that the New York Times has a bias against primary care physicians, especially family physicians? This is the second time in as many months that they’ve insinuated that primary care physicians - specifically family physicians - don’t know how to treat depression. The last time, their interview subject had to make a public apology, although The Times never did.

    UPDATE: Or maybe the suicide rate in the first few weeks of treatment is due to the success of the treatment, as this reader points out:

    There's an interesting theory about why SSRIs may actually lead to suicide in some cases that I, as a depression sufferer myself (treatable, thank god) find quite rational. When you are really depressed, you can barely get out of bed. Sometimes you just curl up in a ball. The very idea of leaving the house fills you with dread. In that state, you don't want to be alive but going through the motions of committing suicide is far beyond your capabilities. However, let's say you start an anti-depressant and START to feel better but insofar as recovery is slow you're far from feeling the full effect of the drug. During that short window of generally a few weeks you may get just enough recovery to kill yourself. That is, you're recovering but you don't realize it yet. You just realize that at last you have the ability to realize your fantasy of being dead. I'm sure the day will come when we have pills or some other therapy that will knock out depression in a day. But until then, I think the possibility of the occasional suicide as opposed to a lifetime of depression is a highly acceptable trade-off. Deep depression is death anyway.

    Good point.

    posted by Sydney on 8/08/2003 08:44:00 AM 0 comments


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