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USA Today on Tuesday published an editorial and an opinion piece addressing a decision last week by the U.S. Court of Appeals for the District of Columbia Circuit that terminally ill patients do not have the right to obtain access to unapproved experimental drugs that potentially are lifesaving. Summaries appear below. USA Today: Supporters of increased access offer an argument that is "as powerful as it is simple: Why not let a patient and his or her doctor, rather than bureaucrats, make the final, desperate, informed decision?" a USA Today editorial states. "FDA asserts that it is responsive to such patients, that many have benefited from access to unapproved drugs" and that the agency "does not want to stand in the way of such patients," the editorial notes. However, "thousands of patients and their doctors still face daunting obstacles," according to the editorial. FDA's position is "understandable," but "why not create an 'Abigail test' that would make it easier for terminal patients who have exhausted other options to try promising drugs that are nearing final FDA approval?" the editorial asks (USA Today, 8/21). Andrew von Eschenbach, USA Today: "Over the years, thousands of patients with life-threatening diseases have been treated with drugs before FDA granted final approval," FDA Commissioner von Eschenbach writes in a USA Today opinion piece. He continues, "For example, from 1996 to 2004, while clinical trials were ongoing for eight different cancer drugs, 33,000 additional patients were permitted by FDA to be enrolled in expanded access programs." He adds, "There is, and always must be, a pathway for such options." However, von Eschenbach concludes, "allowing mass marketing and promotion of unproven therapies would have serious consequences: false hope and lack of real medical progress that could ultimately lead to control and cure of devastating illnesses" (von Eschenbach, USA Today, 8/21). "Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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