Bioethics for Breakfast: Experimental Medicine and the FDA

Who should have the final say regarding access to experimental medicines: the doctor, the patient or the FDA? This question was addressed on October 24th at a well-attended Bioethics for Breakfast session on Access to Experimental Treatments and the Indiana Courts. Rafat Abonour, MD, Director of the IU Simon Cancer Center Adult Clinical Research Office and the Associate Dean of Clinical Research at the IU School of Medicine, addressed the history and process of clinical drug trials, and the challenging ethical issues that arise when patients demand access. Judge Nancy Vaidik from the Indiana Court of Appeals discussed the role that the courts have traditionally played in mitigating such access and the options that exist under current law. Jennifer Girod, JD, PhD, an attorney at Taft Stettinius & Hollister LLP and Faculty Investigator at the IU Center for Bioethics, led the audience of community leaders in a discussion of the important policy and ethical issues involved. This seminar was part of the Bioethics for Breakfast: Seminars in Medicine, Law and Society series that is jointly convened by the IU Center for Bioethics and Taft Stettinius & Hollister, LLP. – Amy Lewis Gilbert

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