Terminally Ill Win Access To Trial Drugs

Terminally ill patients have a right to get access to potentially life-saving new drugs that haven’t received full government safety approval, a U.S. appeals court ruled today.An advocacy group for the terminally ill sued the Food and Drug Administration after the agency refused to give them new drugs that had passed the first of three FDA testing phases. A lower court upheld the FDA’s refusal and dismissed the suit.A federal appeals court in Washington, overturning the lower court’s decision, said American law recognizes a right to control over one’s own body, including a right to self-preservation.“As recognized throughout Anglo-American history and law, when a person is faced with death, necessity often warrants extraordinary measures not otherwise justified,” U.S. Circuit Judge Ann Rogers wrote for the divided three-judge panel. “Barring a terminally ill patient from the use of a potentially life saving treatment impinges on this right of self-preservation.”Drugs must pass three phases of testing before they can be marketed to the public, the court said, citing FDA regulations. In phase I, drugs are tested for their side effects on a group of 20 to 80 patients. In the subsequent two phases, drugs are tested on larger groups for effectiveness and safety.The Abigail Alliance for Better Access to Developmental Drugs, which is based in Arlington, Virginia, told the appeals court the whole process takes an average of seven years. They want terminally ill patients to be able to try so-called investigational new drugs after phase I. Under current FDA rules, only participants in phase II and II trials have access to such treatments.In its ruling, the appeals court said that government regulation of new drugs was recent compared with the “ancient principles” of self-preservation. The court further cited earlier court decisions holding that an informed, competent person can refuse potentially life saving medical treatment.“The logical corollary is that an individual must also be free to decide for herself whether to assume any known or unknown risks of taking a medication that might prolong her life,” Judge Rogers wrote.The appeals court sent the case back to the lower court to determine whether the existing FDA rule serves a compelling government interest that warrants trumping the right to access to the drugs after phase I testing.Susan Cruzan, an FDA spokeswoman, didn’t immediately return a call seeking the agency’s response.“We are very happy with the court’s agreement that our members have a fundamental right of self-preservation,” said Frank Burroughs, president of Abigail Alliance, which was founded to help patients get access to developmental drugs to treat cancer, including Erbitux and Gleevec.

Terminally Ill Win Access To Trial Drugs

Terminally Ill Win Access To Trial Drugs

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