Tuesday, August 22, 2006

Experimental treatments: a constitutional right?

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.

To read on, click here.


Anonymous said...

Phase I drugs haven't had the same testing as drugs that have made it to Phase III studies. The safety and efficacy studies are needed to ensure that drugs which ultimately receive FDA approval are indeed "safe". The guidelines in place that control drug research are there for a purpose. I realize that patients with an essentially terminal illness may wish to try anything in hopes of a "cure" or simply "buying more time" with loved ones, but what about the quality of that life as they deal with unknown medications with unknown side effects that may not even work. Research guidelines are designed to safe guard everyone. Terminal disease puts one in a vulnerable state. You will grasp at anything that holds a glimmer of hope. But is it truly worth it?

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