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New York Times Reports on Medication Conundrum in Early Episode Schizophrenia Research

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

Comments on News and Primary Papers
Comment by:  Jim Botta
Submitted 24 March 2006 Posted 27 March 2006

In some of the countries where these studies of withholding medication were conducted, there are comprehensive health systems that provide organized support for the individual. The USA does not have this type of coordinated mental health support, even in our large metropolitan areas. Lacking this, it may be unethical to conduct this type of study in this country.

View all comments by Jim Botta

Comment by:  Ron Unger
Submitted 1 April 2006 Posted 3 April 2006

It seems bizarre to me to question the ethics of research utilizing non-medication interventions, when medications themselves are responsible for such incredible damage. Whether it's obesity, diabetes, movement disorders, or just general numbing of the mind, "antipsychotic" medications might best be characterized as a poisoned life raft—possibly useful in a pinch, but nothing we should be relying on if we can possibly avoid it. Jim Botta wants to use the lack of psychosocial support in the U.S. as an excuse to not even research alternatives to medication; of course, failing to do the research will only reinforce the continued over-reliance on medications and absence of alternatives. A wiser suggestion would simply be to insure that participants in such research be provided with adequate support. After all, research with good outcomes for people not utilizing medications (such as Soteria) have already been done in the U.S.; why shouldn't there be more such studies?

Long-term studies show that most people who make strong recoveries cease taking medication at some...  Read more

View all comments by Ron Unger

Primary Papers: Medication-free research in early episode schizophrenia: evidence of long-term harm?

Comment by:  Vittorio Di Michele
Submitted 17 April 2006 Posted 17 April 2006
  I recommend this paper

I read with great interest the paper by John R. Bola, which faces a major issue of whether exploratory trials should be conducted on patients at their first psychotic episode. Is it ethically justified to postpone pharmacological antipsychotic treatment for specific research purposes for such patients? The author used very stringent criteria for inclusion of trials in the meta-analysis that is depicted in table 2 of the paper. Six out of 10 studies included were conducted more than 25 years ago, when ethical criteria were not as stringent as in present years. Only two studies included DSM-IIIR diagnostic criteria, consistent with a modern conceptualization of schizophrenia, and both were conducted in European countries. The time of postponing pharmacological treatment, but not psychosocial intervention, was 6 weeks (including the Mosher study where DSM-II diagnostic criteria were used). In addition, the Finnish study allowed use of low doses of neuroleptic drugs if needed. The limitations of the studies reviewed are wisely and scrupulously summarized by the author.

My...  Read more

View all comments by Vittorio Di Michele
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