INDIANAPOLIS - Placebos, non-therapeutic dummy substances used in research, have value in clinical studies, but restrictions placed on their use by international guidelines hinder the development of new treatments, says an internationally acclaimed medical ethicist.

The Declaration of Helsinki - originally written 1964 by the World Medical Association as a statement of ethical principles providing guidelines to physicians and other participants in medical research involving human subjects - was revised a year ago. The revamped statement asserts that using placebos is unethical whenever withholding an effective treatment would place research participants at risk of death or long-term disability. Not so, says Robert J. Levine, M.D., a professor of pharmacology at Yale University School of Medicine and director of that university's Interdisciplinary Bioethics Project.

"The truth is that placebos have played and continue to play a crucial role in evaluating the effectiveness of many new drugs," said Dr. Levine. "Forbidding the use of placebos rules out the development of new therapies. If researchers had followed such rules in the past, drugs currently used to treat high blood pressure and stomach ulcers never would have been developed because of the existence of older, yet less-effective medications."

The Yale University professor's remarks were made before a joint session of Indiana University School of Medicine's Mini Medical School and the IU School of Law-Indianapolis on Oct. 16. Dr. Levine received the McDonald-Merrill-Ketcham Award, a program co-sponsored by the schools of medicine and law that recognizes individuals who demonstrate excellence in fostering better understanding in the professions of medicine and law.

Dr. Levine emphasized the importance of explaining to research patients the need for placebo control. "In the event that any particular placebo-controlled research clinical trial can be justified, patients should be informed forthrightly of the perils of withholding active therapy," added Dr. Levine, who has been an advisor to the National Institutes of Health, Centers for Disease Control and other federal agencies on issues related to research ethics and protection of human research subjects.

While the latest Helsinki declaration is an improvement, it needs further revision, said Dr. Levine, and not only in the realm of placebo use. He described the declaration's definition of therapeutic research as an "incoherent concept" because it prohibits research components that have no treatment value; most research does.

Also, researchers and physicians around the globe do not universally follow Helsinki guidelines, and developing countries don't always reap the benefit of new treatments pioneered in clinical trials in which their citizens participated.

"There's an inherent global injustice because the distribution of wealth among the nations of the world is inequitable," said Dr. Levine. "We must avoid development of guidelines that would impede the efforts of researchers and sponsors in industrialized countries to assist poorer countries in their efforts to deliver treatments and preventions they can afford."

Dr. Levine's appearance was the second in a six-week series of the fall Mini Medical School. Participants meet each Tuesday night and hear from IU School of Medicine's leading physicians and researchers.

Mini Medical School is partly funded with an educational grant from Pfizer. IU Medical Group and Indianapolis radio station WIBC sponsor Mini Medical School, which is offered by the Indiana University School of Medicine Faculty Community Relations Committee through the IUPUI Division of Continuing Studies.

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Media Contact: Joe Stuteville
Tel: (317)274-7722
Email: jstutevi@iupui.edu