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Supreme Court Won't Hear Experimental Drug Case. Decision Means Terminally Ill Patients Have No Right to Unapproved Drugs

Jan 15, 2008 | Parker Waichman LLP

Terminally ill patients desperate to try experimental drugs won’t be able to get them.  Yesterday, the U.S. Supreme Court refused to consider whether dying patients have the right to be treated with experimental drugs, which are not yet approved by the U.S. Food and Drug Administration (FDA).  The court—without comment or recorded dissent—let stand a ruling by the U.S. Court of Appeals for the D.C. Circuit last summer.  That ruling stated that the terminally ill have no constitutional right to unapproved drugs that the FDA only considers safe enough for additional testing.

The Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs brought forth the challenge to the original ruling.  The Abigail Alliance is headed by Frank Burroughs of Fredricksburg, Virginia and named in honor of his daughter, Abigail Burroughs.  Abigail was diagnosed at age 19 with a form of cancer that is rare in someone so young.  She died three years later at age 21 in 2001.  Steve Walker, co-founder with Burroughs of the alliance, called the court's decision not to hear the case "a tragedy."  "We have now had all three branches of government abandon our constituents, which now number in the thousands," Walker said.  The groups' petition told the court 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 group feels that too many patients cannot enter into drug trials "because they are too young, too sick, cannot qualify for the trial protocol, cannot travel, or because the trial is simply too small."  Walker said another lawsuit is a possibility; the group is also seeking a change in the law through Congress.

"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," 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," he added.  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."

In the case of Abigail Burroughs, the drug she was seeking access to in order to assist in her treatment was approved after her death.

The groups lost in the lower courts last summer when, after a pair of conflicting rulings, the full D.C. Circuit ruled eight to two 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 FDA was represented by the Bush administration; they asked the Supreme Court not to hear the case.


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