Whose Life Is It Anyway?

The FDA versus dying cancer patients.

(Page 2 of 2)

Ballenger pointed out that the American Society of Clinical Oncology (ASCO) had actually made the argument in its amicus brief in the current Abigail Alliance suit that terminal patients are desperate so they can't give informed consent, yet somehow ASCO also argues that such desperate patients can give informed consent to participate in clinical trials. Is ASCO willing to sacrifice patients who might benefit from investigational treatments in order to maintain a pool of research subjects? Ballenger said, "I do not think that this is an ethical line of argumentation."

Ballenger added, "I am more than happy to concede that the FDA has a compelling state interest to protect medical progress if the FDA can prove that expanded access to investigational drugs will imperil clinical trials. The fact is that most trials are over enrolled and that most people asking for expanded access don't qualify for the trials anyway. Standing in the way of expanded access is just perverse."

Abigail's father Frank Burroughs wrapped up the presentation for the colloquium participants. "Every drug that we've pushed for early access to over the past six years--all are now approved by the FDA." Thousands died waiting for the FDA bureaucracy to let cancer drugs that would have lengthened and perhaps even saved their lives onto the market. Perhaps finding that mentally competent terminal cancer patients do have a fundamental right to access investigational drugs will finally spur the FDA to stop clinging to an outdated mid-20th century cancer clinical trial system and embrace one more suited to the 21st century science. The millions of us who will one day develop cancer had better hope so.

Ronald Bailey is Reason's science correspondent. His book Liberation Biology: The Scientific and Moral Case for the Biotech Revolution is now available from Prometheus Books.

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