From the London Times Online:
Giving unproven drugs to terminal patients won't save lives in the end.
ABIGAIL BURROUGHS, a 21-year-old American, died from squamous-cell carcinoma of the head and neck in 2001. According to her father, Frank, she didn’t need to die. There were drugs in development that might have reined in the malignancy, but the experimental therapies were being tested on cancers in other parts of the body.
“She had the right cells in the wrong place, and she didn’t qualify for any of the clinical trials,” her father recalls. Shortly after her death, he founded the Abigail Alliance for Better Access to Experimental Drugs. This summer it scored a breathtaking victory in the courts against the Food and Drug Administration. The District of Columbia Circuit ruled, by two to one, that a patient with a terminal illness or untreatable disease had a “fundamental right” under the Constitution to experimental drugs that have passed only preliminary (Phase I) tests, and are thus a long way from approval.
The little-reported decision is already having deep repercussions in the medical world, and is likely to end up in the Supreme Court. While patients welcome the decision, regulators and clinical researchers fear that such early, wide access to experimental drugs will make it harder to obtain the clear, long-term data needed to prove efficacy. Patients may decide an unproven drug is a better gamble than ending up on a proven, but marginally effective, medication. An article in the New England Journal of Medicine this month points out that only 11 per cent of drugs — and only 6 per cent of cancer drugs — that enter clinical testing are ultimately approved; the rest are either too toxic or don’t work.
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