Sunday, August 12, 2007


Aug. 12, 2007 (McClatchy-Tribune Regional News delivered by Newstex) --
The U.S. Court of Appeals for the District of Columbia Circuit apparently believes that bureaucracies can and do have power so absolute that they trump the traditional right of free people to control their own bodies and try to protect their own lives. If that's not the case, it's difficult to see how the court arrived at the 8-2 decision in Abigail Alliance v. Eschenbach, which denies terminal patients and their doctors access to medications that have passed safety tests required by the Food and Drug Administration but not the full battery of tests to prove efficacy.

The best course would be for the FDA to loosen up its restrictions on access to partially tested drugs, which lead to 'thousands of people dying because of the FDA's bureaucratic know-it-all attitudes,' as Paul Kamenar of the Washington Legal Foundation, which was co-plaintiff in the case, explained it to Appeal-Democrat sister paper The Orange County Register.

The next-best course (because it would take longer) would be for the U.S. Supreme Court to reverse this misguided ruling. Kamenar assured OCR an appeal will be filed before the end of the month.

The Abigail Alliance for Better Access to Developmental Drugs was founded in 2001 by Frank Burroughs after his daughter, Abigail, a University of Virginia honors student, died of cancer after being denied a new cancer drug her oncologist believed could save her life. The drug was later approved and is saving lives now, but it's too late for Abigail Burroughs.

The Abigail Alliance was not requesting access to experimental drugs that have not undergone any clinical testing. It wanted to establish a right for terminal patients to have access to new drugs that have passed Phase I of the FDA's required battery of clinical trials, which establishes that a drug does not pose undue safety risks. Subsequent trials establish whether drugs are effective for the diseases for which they were developed.

Since those subsequent trials may take years, and many of the Abigail Alliance's members have been told they have six months or so to live, waiting for the full trials amounts to a death sentence.

If we had our way, the FDA would be able to keep drugs off the market only if they failed to pass safety tests. Efficacy tests could be required to provide valuable information to doctors and patients but would not be grounds to ban the use of medications. Even if that reform is not politically feasible, however, surely there should be a different standard for terminally ill patients than for patients seeking a new treatment for corns or bad breath. We don't know if that's a constitutionally guaranteed right or not, but it's simple compassion and common sense.

As Judge Judith Rogers put it in a powerful dissent, 'Denying a terminally ill patient her only chance to survive without even a strict showing of government necessity (for denying access to the drugs) presupposes a dangerous brand of paternalism.' You might even call it cruel and unusual punishment.

The Supreme Court should take up this case and reverse it as quickly as possible.

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