Federal Appeals Court To Rehear In March Case Involving Terminally Ill Patients' Access To Experimental Treatments

Main Category: Medical Malpractice / Litigation
Also Included In: Public Health
Article Date: 01 Feb 2007 - 5:00 PDT

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The U.S. Court of Appeals for the District of Columbia on March 1 will hear an appeal filed by FDA in a lawsuit that seeks to provide terminally ill patients with expanded access to experimental medications, the Washington Times reports (Lopes, Washington Times, 1/30). In the case, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation in 2003 filed a lawsuit against FDA to obtain access to experimental medications for terminally ill cancer patients. The lawsuit asked FDA to provide a special initial approval of experimental medications that appear effective and allow their sale and distribution to terminally ill patients who have no other approved treatment options. FDA argued that programs currently exist to provide experimental medications to terminally ill patients and that increased access to such treatments would lead to unacceptable risk. In May 2006, a three-judge panel of the court ruled that terminally ill patients have a "right of self-preservation" and should have access to experimental medications that have not reached Phase II clinical trials. According to the 2-1 decision, which reversed the dismissal of the lawsuit by a lower court, "barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on this right of self-preservation." FDA appealed the decision and asked the full court to rehear the case. In November 2006, the court vacated the decision and agreed to rehear the case (Kaiser Daily Health Policy Report, 11/22/06). FDA in December 2006 proposed rules that would expand access to experimental medications for certain patients and would allow pharmaceutical companies to charge patients for the treatments in some cases (Kaiser Daily Health Policy Report, 12/12/06).

'Ethical Dilemma'
According to the Times, the "issue poses an ethical dilemma: Whether to consider an individual's need to have access to medications expected to help a condition or to give priority to the government's responsibility to ensure public safety." Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said, "This is a classic ethics stand-off case," adding, "There is evidence that first generation drugs will make people sicker. The history of drug development is littered with failures. A patient's hope is not grounded in experience." Scott Ballenger -- an attorney for the law firm Latham & Watkins, which represents the Abigail Alliance in the case -- said, "These are drugs that FDA has already approved for substantial human testing in a number of clinical trials," adding, "We are asking for a transaction between a willing drug company and patient to be decriminalized." However, Lawrence Gostin, a Georgetown University Law Center professor who specializes in bioethics and health policy law, said that he expects FDA to win the case. "Despite the emotional aspect of the case," FDA has the responsibility to protect patients, he said, adding, "I can't see an abandonment of these rules." Michael Levin-Epstein of the Food and Drug Law Institute added that the rules proposed by FDA would expand access to experimental medications. He said, "In effect, FDA is telling doctors that if you have patients that might need an unapproved drug, 'Here is the form, here is how to fill it out.' They are being proactive; right now, they are not reaching out to physicians" (Washington Times, 1/30).

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