Supreme Court Rejects Appeal Seeking Experimental Drug Access

By Anna Boyd
12:01, January 15th 2008
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Supreme Court Rejects Appeal Seeking Experimental Drug Access

The U.S. Supreme Court announced Monday that it turned away an appeal that sought to give terminally ill people greater access to experimental drugs that might save their lives.

The request belonged to the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation, which accused the Food and Drug Administration in 2003 of depriving patients a chance for recovery, after exhausting all ways of conventional treatment.

“Huge numbers of Americans die each year after being denied to developmental drugs that might have prolonged their lives, drugs that, in many instances, later received FDA marketing approval. A terminally ill patients 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,” said the argument.

The alliance is leaded by Frank Burroughs of Fredericksburg and named after his daughter, Abigail who died in 2001 at age 21 of a form of cancer rare in someone her age. The girl needed Erbitux, and ImClone Systems Inc. cancer drug that was undergoing clinical testing and had been recommended by her oncologist. The FDA approved the drug in 2004.

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 disease have an understandable interest in trying potentially effective investigational drugs, particularly when patient’s illness is life-threatening,” said in a brief filed with the court Solicitor General Paul D. Clement. “On the other hand, allowing patients to obtain and use unproven drugs carries a host of risks and potential detriments for the public health.”

J. Scott Ballenger, an attorney for the two advocacy groups, said in the Supreme Court appeal that the case was of great national importance, especially to terminally ill patients and their families. He based his argument on statistics, which reported, “approximately half of million Americans will die this year of cancer alone and a substantial proportion will find themselves at some point without any remaining treatment alternatives.”

He added that the two advocacy groups want this decision to be approved only for dying patients “with no remaining treatment options to fight for their lives.”



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