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    Clinical Trials: Are They Safe? Look for the Stamp

    By
    WebMD Health News

    April 17, 2001 (Washington) --The headlines on failed experiments are frightening, and members of a blue ribbon committee hope they can prevent more unnecessary deaths by applying a new recommendation from the Institute of Medicine (IOM). It calls for a 'seal of approval' -- or accreditation -- on human trials, as well as other basic reforms.

    "[Accreditation] does, indeed, possess strong potential as a mechanism to strengthen the participant process protection system. We recommend that this approach be pursued as soon as possible -- in a thorough and deliberate manner," says Daniel Federman, MD, the IOM panel chair and distinguished professor of medicine and medical education at the Harvard Medical School.

    Consider just a few incidents from the last three years:

    The Fred Hutchinson Cancer Research Center in Seattle, one of the top cancer research centers in the country, is accused of violating ethical standards in a study of experimental leukemia drugs where 20 patients died. The renowned hospital staunchly denies any wrongdoing.

    Two years ago, the University of Oklahoma at Tulsa was hit by accusations that researchers there treated patients with a contaminated skin cancer vaccine. Following the incident, the institution overhauled its approach to medical research and replaced key staffers.

    And in the most sensational case of a human experiment turned tragic, 18-year-old Jesse Gelsinger became the first patient to die as a result of gene therapy in 1999. His father Paul has become a crusader to reform the oversight system.

    "They need to get philosophers and spiritual leaders and all segments of academia and the general public involved in determining the ethics of what they're doing. ... The money's the thing that's putting pressure on everything, and that's why these researchers lose their perspective," Gelsinger tells WebMD.

    The IOM analysis took six months and is the first step in a review of clinical trial safety that will be concluded in 2002.

    Ultimately, the accreditation would not be a specific set of guidelines but a "standard of standards" that focuses on performance, not just rules and regulations. Hopefully, that would inspire new confidence on the patient's part.

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