Experimental-drug limits upheld

The Baltimore Sun

WASHINGTON -- The Supreme Court yesterday upheld the government's authority to restrict access to experimental drugs, even if the drugs might help dying patients who have run out of other options.

In a one-line decision, the court declined to hear the appeal of terminally ill patients who argued that they had a constitutional right to try unproven but promising treatments.

"It's a tragedy," said Frank Burroughs, who has led the fight for expanded access since his 21-year-old daughter, Abigail, died while trying to get an experimental cancer treatment at Johns Hopkins Hospital in 2001. The treatment won approval in 2004.

To protect against dangerous side effects, the government generally does not allow patients to take drugs until scientific studies prove the medicines work safely. Only patients participating in the studies can get access to the unapproved drugs, as well as the few who receive special exemptions from the Food and Drug Administration.

The FDA was "pleased" with the Supreme Court ruling, said Julie Zawisza, an agency spokeswoman. "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."

In its lawsuit, the Abigail Alliance for Better Access to Developmental Drugs argued that terminally ill patients who can't get into the clinical trials still should be able to get unapproved medicines. The patients have the right to try potentially life-saving treatments recommended by their doctors that have shown promise in preliminary studies, the group asserted.

A three-judge panel of the federal appeals court in Washington initially ruled in favor of the Abigail Alliance, prompting an outcry from many in the public health field. The ruling was later reversed by the full appeals court.

Current and former drug regulators warned that the FDA's authority would be severely weakened if patients were given the right to take unapproved drugs. Many in the pharmaceutical industry said drug development would suffer if patients taking part in clinical trials of test drugs were able to simply ask for access instead.

The Supreme Court's action shifts the issue to Congress, which again could take up legislation that would allow dying patients to try promising test drugs. Such a measure was taken up during its last session.

Scott Ballenger, a Washington lawyer who represented the Abigail Alliance, predicted the federal courts would see similar lawsuits in the near future.

"This case is merely the latest in a long line of cases - both constitutional and statutory - that bubble up every few years," he said.


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