Magazine article Medical Economics

Do Patients Have a Right to Experimental Drugs?

Magazine article Medical Economics

Do Patients Have a Right to Experimental Drugs?

Article excerpt

Telling a patient that he or she has a life-threatening-perhaps terminal-disease may be one of a doctor's toughest responsibilities.

If the available treatments don't help your patient, and he asks to get an experimental drug he's heard about, should he be able to have it?

This summer, the US Court of Appeals for the Distria of Columbia held that terminally ill patients do not have the constitutional right to get experimental drugs unless they're enrolled in a clinical trial or take part in other Food and Drug Administration treatment options.

This ruling was in response to a legal action, led by the Abigail Alliance for Better Access to Developmental Drugs, to enable individual patients to get drugs after Phase I of the three clinical trials phases required for FDA approval. Phase I tests only for things such as toxicity and dose, on a fairly small number of healthy patients; Phase II tests the drug's efFectiveness on a small number of ill people; and Phase III conducts larger scale trials on hundreds or thousands of people. Of the approximately 2,500 drugs in trial annually, only a small percentage make it to market. In oncology, about 6 to 1 1 percent of the proposed drugs get approved.

The Abigail Alliance was founded in 2001 when 21 -year-old Abigail Burroughs sought early stage drug treatment for head and neck cancer. One experimental drug her family sought to get was eventually approved-after she died from the cancer.

While any patient death is heart breaking allowing more patients to get early stage experimental drugs could throw a monkey wrench into the clinical trials process.

I recendy spoke with Robert J. Korst, MD, medical director of the Blumenthal Cancer Center at The Valley Hospital in Ridgewood, NJ. Valley Hospital is in the forefront of conducting cardiac and oncology clinical trials. The hospital has several clinical trials ongoing, and Dr. …

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