Pubdate: Wed, 03 May 2006
Source: Washington Post (DC)
Page: A09
Copyright: 2006 The Washington Post Company
Contact:  http://www.washingtonpost.com/
Details: http://www.mapinc.org/media/491
Author: Marc Kaufman, Washington Post Staff Writer
Cited: the ruling, 56 pages 
http://pacer.cadc.uscourts.gov/docs/common/opinions/200605/04-5350a.pdf
Cited: Abigail Alliance for Better Access to Developmental Drugs 
http://www.abigail-alliance.org/
Bookmark: http://www.mapinc.org/topics/Food+and+Drug+Administration

COURT BACKS EXPERIMENTAL DRUGS FOR DYING PATIENTS

Terminally ill patients have a constitutional right to obtain 
experimental drugs before the Food and Drug Administration has 
decided whether to approve them, a federal appeals court ruled yesterday.

Saying that dying patients have a basic "right of self-preservation," 
the court held that drugs that have passed the first phase of FDA 
review -- which determines whether a product is safe -- should be 
made available if they might save someone's life.

The 2 to 1 decision by the U.S. Court of Appeals for the District of 
Columbia Circuit overturned a lower court's ruling. The judges sent 
the case back to the district court for a full hearing and possibly a trial.

The case was brought by the Abigail Alliance for Better Access to 
Developmental Drugs -- which advocates making experimental drugs 
available earlier to dying patients -- and was argued by the 
Washington Legal Foundation, a public interest law firm that has 
frequently challenged regulatory agencies.

The appeals court found that "barring a terminally ill patient from 
the use of a potentially life saving treatment impinges on this right 
of self-preservation." It also agreed with the alliance that the 
Supreme Court's 1990 decision establishing a "right to die" in the 
case of Nancy Cruzan, a brain-dead Missouri woman who was ultimately 
disconnected from life support, applied in reverse in this case.

"If there is a protected liberty interest in self-determination that 
includes a right to refuse life-sustaining treatment, even though 
this will hasten death, then the same liberty interest must include 
the complementary right of access to potentially life-sustaining 
medication, in light of the explicit protection accorded 'life,' " 
Judge Judith W. Rogers wrote.

Judge Thomas B. Griffith dissented, saying that the ruling goes 
against the "expressed rule" of Congress and the president. "The 
majority's approach injects courts into unknown questions of science 
and medicine," he wrote.

In its opposition to the challenge, the FDA had said that the agency 
already has programs that make potentially lifesaving drugs available 
before final approval. In addition, it said that allowing large 
numbers of patients to take unapproved drugs could put many at 
unacceptable risk, even if they are terminally ill.

"We remain sympathetic to the desire of terminally ill patients to 
gain access to experimental treatments when they have exhausted other 
therapeutic options, and are exploring a number of new efforts to 
improve how we make investigational drugs available through expanded 
access programs," said Scott Gottlieb, deputy commissioner for 
medical and scientific affairs.

The Arlington-based Abigail Alliance was founded in 2001 by Frank 
Burroughs, whose 21-year-old daughter died of cancer. The family had 
tried to enroll her in a number of clinical trials of promising 
cancer medications but was rebuffed, and Burroughs decided to 
continue his fight to expand access to experimental drugs after her 
death. He said several of the potentially lifesaving drugs that his 
group sought to make available while they were still under regulatory 
review went on to be approved and widely used.

Burroughs said yesterday that he hopes the FDA will work with his 
group and others to make unapproved drugs more easily available to 
dying patients.

The alliance has sought access to medications that have passed Phase 
I of the FDA review, which generally involves studies of 20 to 80 
patients and results in a determination of whether the drug is safe 
enough for further human testing. Phase II trials determine whether a 
drug is effective, and Phase III studies involve larger groups and 
give a better sense of whether a drug is safe and useful. 
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MAP posted-by: Richard Lake