Supreme Court Declines To Hear Case On Access To Experimental Medications For Terminally Ill Patients

Main Category: Public Health
Also Included In: Litigation / Medical Malpractice
Article Date: 16 Jan 2008 - 7:00 PDT

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The U.S. Supreme Court on Monday without comment declined to hear an appeal in a lawsuit against FDA that sought expanded access to experimental medications for terminally ill patients, the New York Times reports (Greenhouse, New York Times, 1/15).

The lawsuit, filed in 2003 by the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation, 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 U.S. Court of Appeals for the District of Columbia Circuit ruled that terminally ill patients 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." However, the full court in November 2006 reversed the decision (Kaiser Daily Health Policy Report, 8/8/07).

Arguments
In their appeal to the Supreme Court, plaintiffs' attorneys wrote that the "right of a terminally ill patient ... to take some risks ... in an effort to save her life is implicit in the concept of ordered liberty under any reasonable standard" (New York Times, 1/15).

In a brief filed with the court on behalf of FDA, Solicitor General Paul Clement (R) wrote that, although "patients who are suffering from serious diseases have an understandable interest" in experimental medications, "allowing patients to obtain and use unproven drugs carries a host of risks and potential detriments for the public health." According to Clement, FDA has found that "preliminary expectations of safety and efficacy" for experimental medications "often prove to be unfounded," and "drugs that initially appear promising are frequently found ineffective" or "dangerous" (Barnes, Washington Post, 1/15).

Reaction
FDA was "pleased" with the decision by the Supreme Court to decline to hear the appeal, according to agency spokesperson Julie Zawisza. She added, "We are committed to making effective therapies available to patients in need, and we also will continue to offer access to unproven therapies through our special access programs." The pharmaceutical industry, which has argued that expanded access to experimental medications would remove incentives for patients to participate in clinical trials, also praised the decision.

Frank Burroughs, co-founder of the Abigail Alliance, called the decision a "tragedy" (Rockoff, Baltimore Sun, 1/15). Steve Walker, also a co-founder of the Abigail Alliance, said, "We have now had all three branches of government abandon our constituents, which now number in the thousands" (Washington Post, 1/15). He added that the Abigail Alliance might seek congressional action to expand access to experimental medications for terminally ill patients (Edney, CongressDaily, 1/15).

Editorial
"Although we are sad for the outcome, we think the U.S. Supreme Court got it right Monday," according to a Contra Costa Times editorial. The editorial states that, although "we are sympathetic to the alliance's cause and believe that the FDA should go out of its way to help" terminally ill patients, "we do not believe there is a constitutional right" to access to experimental medications.

"We also agree with the appellate court's assertion that Congress could change the law to broaden such access," the editorial states, adding, "In fact, we think that Congress should do exactly that, and we encourage the Abigail Alliance to lobby Congress hard to make such a change." The editorial concludes, "It would be a far better solution than having the courts grant a nonexistent right" (Contra Costa Times, 1/15).

Reprinted with kind 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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