USA Today on Monday examined the debate over whether patients with terminal illnesses should have expanded access to experimental medications -- an issue currently under consideration in a lawsuit before the U.S. Court of Appeals for the District of Columbia.
Patient advocates -- such as the Abigail Alliance for Better Access to Developmental Drugs, which filed the lawsuit against FDA -- maintain that patients with terminal illnesses "have nothing to lose" when they take experimental medications, but agency officials and many physicians "are concerned that even terminal patients are as likely to be harmed as helped by such drugs," USA Today reports.
In addition, pharmaceutical companies and researchers have raised concerns that expanded access to experimental medications might reduce the number of patients available to participate in clinical trials.
Howard Fine, chief of brain cancer research at the National Cancer Institute, said, "Ethically speaking, who has the right to say to a patient: You have no right to try this medicine even though you're dying, even though you're well informed?"
Fine, who said that he did not speak on behalf of NCI, added, "Where are (drug makers) going to send these drugs? The local doc down the street? And who's going to educate the doctor?"
Arthur Caplan, chair of the Department of Medical Ethics and director of the Center for Bioethics at the University of Pennsylvania, said that he supports efforts to expand access to experimental medications for patients with terminal illnesses.
However, he said, "You don't want to put more weight than is appropriate" into the results of a Phase I clinical trial, which only determines the safety of experimental medications.
Caplan added that patients with terminal illnesses might extend their lives by only six months with experimental medications and also might "lose six months" (Rubin, USA Today, 4/2).