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Published on: 12/13/2006
Last Visited: 3/14/2007
Ethical Considerations in Medication-Free Research with Schizophrenia Patients: An Expert Interview with William T. Carpenter, Jr., M.D.NARSAD: News & Events: For the Media: News Article
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with William T. Carpenter, Jr., M.D.
(Great Neck, NY - >) , In a recent article, posted on October 25, 2006, in Schizophrenia Bulletin, John R. Bola, PhD, of the University of Southern California, Los Angeles, asserted that there is insufficient evidence to conclude that short-term postponement of medication in early episodes results in long-term harm, and suggested reconsidering the categorical prohibition against medication-free research.
On behalf of Medscape, Jessica E. Gould, B.A., interviewed William T. Carpenter, Jr., M.D., Editor-in-Chief, Schizophrenia Bulletin, Professor of Psychiatry and Pharmacology, University of Maryland School of Medicine, Baltimore, MD, and member of the Scientific Council of NARSAD: The Mental Health Research Association, about the ethical issues surrounding medication-free research.
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Dr. Carpenter: The Bola article in Schizophrenia Bulletin was a meta-analysis evaluating how subjects in research studies do when they are off medication.
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Dr. Carpenter: In general, the considerations include, first of all, how long they are going to be off medication.If they have a problem being off medication, how rapidly could medication be restored and is it likely to be effective?Will there be appropriate clinical observation?
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Dr. Carpenter: The first step toward safety, again, is excluding people at greatest risk.
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Dr. Carpenter: The ethics and principles for medication-free research would be the same as that which guides ethical oversight of any human subject research.
If research is deemed justified by the scientific merit, you must ensure that it is also justified by having adequate safeguards to minimize risk.That risk should be comparable in proportion to the importance of the experiment.
Medscape: Tell us about the issue of biological toxicity.
Dr. Carpenter: There was a hypothesis that Richard Wyatt put forward some years ago that psychosis might, in and of itself, be neurotoxic.[2,3] If true, the implication would be that the more you experience psychosis, the worse it is for your brain tissue.
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Dr. Carpenter: There are many interesting hypotheses that require off-medication study designs.
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Dr. Carpenter: Many institutional review boards have a strongly negative approach toward off-medication research in schizophrenia.The cost of doing business has gotten extraordinarily high without there being any evidence that people are actually being harmed by participating in off-medication studies.
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Dr. Carpenter: The response from the field has been interesting.
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Dr. Carpenter: The basic issues would be the same.
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Dr. Carpenter: There is extensive non-adherence to medication.
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Interviewee affiliation: William T. Carpenter, Jr., M.D., Editor-in-Chief, Schizophrenia Bulletin; Professor, Psychiatry and Pharmacology, University of Maryland School of Medicine, Baltimore, Maryland; founding member of the Scientific Council of NARSAD: The Mental Health Association
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Disclosure: William T. Carpenter, Jr., M.D., has disclosed no relevant financial relationships.