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.