Tuesday, June 28, 2011

Marcia Angell and Irving Kirsch – Casting Doubt on the Efficacy of Antidepressant Drugs

There is a disturbing two part article by Marcia Angell reviewing books about the use of antidepressant drugs in the June 23 and July 14 New York Review of Books.  In brief, the article argues that there is significant evidence that clinical trials of antidepressant drugs show that most of the effect of these drugs is from the placebo effect.  Also, according to one of the books reviewed, The Emperor’s New Drugs: Exploding the Antidepressant Myth by Irving Kirsch, the double blind trials may not have been that blind, since patients in the trial experiencing the side effects that these drugs often cause would surmise, as would the doctors in charge of treating them, that they were not being given a placebo but the real drug.  Kirsch hypothesizes that to the relatively small extent that these drugs were better than placebos, it might be due to this “breaking blind” or “enhanced placebo effect.”  The non-enhanced placebo effect is, in fact, quite significant.  If Angell and Kirsch are right, millions of people may have been exposed to powerful drugs which may not have conveyed much if any benefit.  

I do not have any particular expertise to assess the validity of these arguments, but those making them are well-credentialed.  Marcia Angell is a medical doctor, former editor-in-chief of the New England Journal of Medicine, and current Senior Lecturer in Social Medicine at Harvard Medical School.  Irving Kirsch, whose book I have read, is a professor of psychology at the University of Hull in England who has also taught at the University of Connecticut.  He and colleagues have conducted meta-analyses of clinical trials of antidepressant drugs, including one which included unpublished studies submitted by pharmaceutical companies to the Food and Drug Administration (“FDA”) that he and his colleagues obtained through the Freedom of Information Act.  Both he and Marcia Angell obviously have an agenda, but their arguments are not easily dismissed.

One aspect of this that is disturbing is that the FDA is portrayed by Kirsch as being too willing to approve and promote anti-depressant drugs.  In one case, the author claims that the FDA even urged drug companies in 2004 not to report “clinical-trial data that antidepressants are not better than placebos for depressed children.  If the data were made public, they cautioned, it might lead doctors to not prescribe antidepressants…Even if the clinical trials show negative results, an FDA spokesperson was reported to have said to a Washington Post reporter, it doesn’t mean that the drugs are ineffective.  The assumption seems to have been that doctors should prescribe medications that have not been shown to work, until it has been proven that they don’t work.”  If Kirsch’s account is correct, this would seem to be an example of a regulator that is more than just captured, at least on this particular subject. 

I am sure that there are respected medical professionals who strongly disagree with Angell and Kirsch, though I have not found any persuasive rebuttals.  One might even think that those with a contrary view might not want to call attention to the controversy over antidepressants.  But for people who are concerned about healthcare, the article by Marcia Angell is well worth reading.  Among other aspects of this, it is useful to ponder the economic incentives of psychiatrists, who are in competition with psychologists and clinical social workers.  Prescribing drugs is more remunerative than spending an hour with a patient, and it is something the competition cannot do.  Also, the economic incentives of the drug companies are worth considering, as well as the money they spend trying to influence the psychiatric profession.

It is interesting, though, that there does not appear to be a large black market for antidepressant drugs and, as far as I can tell, there is not a lot of spam offering a way to obtain these drugs without a prescription.  On the contrary, what one hears is that some medical professionals have difficulty convincing some patients to keep taking the drugs because of the side effects.  Other patients, though, are convinced of their effectiveness.  For example, Andrew Solomon, who suffered from severe depression, in a very well written and brutally honest book—The Noonday Demon: An Atlas of Depression —argues his belief that antidepressant drugs can be helpful.  His father, it should be noted, is Chairman and CEO of Forest Laboratories, which makes Lexapro, one of the major SSRI antidepressants.  However, given the brutal honesty of the son’s book, which often does not present the author in a very flattering way, I have no reason to doubt that he is sincere in his belief in the efficacy of antidepressant drugs.  

Anecdotal evidence is not enough when considering these drugs, which do have physical effects even if their efficacy for the conditions for which they are prescribed is in some doubt.  In any case, whatever one might believe about antidepressant drugs, Angell makes a good point when she writes:  “At the very least we need to stop thinking of psychoactive drugs as the best, and often the only, treatment for mental illness or emotional distress.  Both psychotherapy and exercise have been shown to be as effective as drugs for depression, and their effects are longer-lasting, but unfortunately, there is not industry to push these alternatives and American have come to believe that pills must be more potent.  More research is needed to study alternatives to psychoactive drugs, and the results should be included in medical education.”  

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