Supreme Court Declines to Hear Experimental Drug Case

Supreme Court Declines to Hear Experimental Drug Case
Petitioners Argue Terminally Ill Should Have Right to Drugs Not Yet Approved by FDA

By Robert Barnes
Washington Post Staff Writer
Monday, January 14, 2008; 4:36 PM

The Supreme Court today declined to consider whether dying patients have a right to be treated with experimental drugs not yet approved by the Food and Drug Administration.

The court, without comment or recorded dissent, let stand a ruling by the U.S. Court of Appeals for the D.C. Circuit, which said the terminally ill have no constitutional right to drugs the agency had considered safe enough for additional testing.

The challenge was brought by the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs. The latter organization is headed by Frank Burroughs of Fredericksburg, and named in honor of his daughter, Abigail Burroughs, who was diagnosed at 19 and died at 21 of a form of cancer rare in someone her age.

The young woman died in 2001, and the drug she was seeking was later approved.

“Petitioners contend that a terminally ill patient with no approved treatment options has a right to decide for himself, in consultation with his own doctor, whether to take a drug that the FDA concedes is safe and promising enough to be tested in substantial numbers of human subjects,” the two groups told the court.

“This case is about the patients who cannot get into the trials — because they are too young, too sick, cannot qualify for the trial protocol, cannot travel, or because the trial is simply too small.”

The groups lost in the lower courts last summer when, after a pair of conflicting rulings, the full D.C. Circuit ruled 8-2 that “there is no fundamental right deeply rooted in this nation’s history and tradition of access to experimental drugs for the terminally ill.”

The Bush administration, representing the FDA, asked the Supreme Court not to hear the case.

“On the one hand, when existing treatments have been tried and have proven ineffective, patients who are suffering from serious diseases have an understandable interest in trying potentially effective investigational drugs, particularly when the patient’s illness is life-threatening,” U.S. Solicitor General Paul D. Clement said in a brief filed with the court.

“On the other hand, allowing patients to obtain and use unproven drugs carries a host of risks and potential detriments for the public health.”

Clement said FDA studies have shown that “preliminary expectations of safety and efficacy often prove to be unfounded, and drugs that initially appear promising are frequently found ineffective or even affirmatively dangerous to life and health.

“Worse still, the drug may be affirmatively unsafe, and taking it may sicken the patient or even kill him.”

Clement also argued on the agency’s behalf that “unfettered access to investigational drugs for treatment uses may harm society at large by undermining the clinical trial process itself.”

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