Bioethics in Brief is a newsletter of the Center for Bioethics and Humanities, committed to promoting clinical health care and health policy which is patient-centered, compassionate, and just. Opinions expressed in the newsletter are those of the authors and do not represent the position of the Center.
Ms. W has colon cancer and is not expected to live beyond six more months. Treatments used thus far have been ineffective and her disease continues to progress. She has heard about an investigational new drug (IND), but human trials to test the drug's safety (Phase I) have only just begun. In the ordinary course, before the drug becomes available it must also be studied for efficacy (Phase II) and then past muster for safety, efficacy and its overall benefits and risks in expanded clinical trials (Phase III)...
Also: the FDA, Unproven drugs, The costs of health insurance.