21 March 2006. A feature article in the March 21 New York Times Science Tuesday section, by reporter Benedict Carey, focuses on a forthcoming review of studies of the long-term effects of withholding medication in early episode schizophrenia. The review, by John Bola of the University of Southern California specifically addresses the vexing question of when it is ethically defensible to include placebo groups in research studies. It will appear in the April print issue of Schizophrenia Bulletin, accompanied by several commentaries, and was published online October 27, 2005 (access limited to subscribers).
Bola's study is a meta-analysis of six studies from 1959 to 2003, including 623 people with symptoms of psychosis. He found no significant difference in long-term outcomes between patients who were given medication and those who were not medicated in early episode schizophrenia. Bola's conclusion is that a categorical prohibition against medication-free research in early episode schizophrenia should be reconsidered.
According to the Times article, this analysis "exposes deep divisions in the field that are rarely discussed in public," and the article features viewpoints from different sides of these divisions, both from psychiatrists and people with schizophrenia. William Carpenter of the Maryland Psychiatric Research Institute and editor of Schizophrenia Bulletin (and an SRF advisor) is quoted as saying, "The pendulum has swung too far, and there's this knee-jerk reaction out there that says that any period off medication, even for research, is on the face of it unethical."
Jeffrey Lieberman of Columbia University appears to disagree. "If the diagnosis is clear, not treating with medication is a huge mistake that risks the person's best chance of recovery. It's just flat-out nuts," Lieberman is quoted as saying.
Although Bola hypothesizes in the Times article that a subset of patients may in fact be better off without medication, the focus of his Schizophrenia Bulletin article, as well as the accompanying commentaries, is very circumscribed, dealing only with the ethics of drug-free arms of research studies (see Rothman and Michels, 1992 for the article that sparked this debate). And on that point, Bola writes, "The most striking observation in this review is the dearth of evidence that addresses the long-term effects of initial treatment."—Alden Bumstead and Hakon Heimer.
Carey B. Revisiting Schizophrenia: Are Drugs Always Needed? New York Times, March 21, 2006. Feature Article
Bola JR. Medication-free research in early episode schizophrenia: evidence of long-term harm?
Schizophr Bull. 2006 Apr;32(2):288-96. Epub 2005 Oct 27. Abstract