Access to Experimental Drugs - the Supreme Court Gets it Right

Today’s Los Angeles Times reports that the Supreme Court has turned down an appeal that claimed a right for dying patients to have access to experimental drugs not yet approved by the FDA. The appeal was brought by the Abigail Alliance, founded in memory of Abigail Burroughs, a beautiful young woman whose picture is on the website. Abigail got a rare head and neck cancer in 1999. Her Johns Hopkins physician wanted to give her an experimental medication, but was not able to. Abigail died in 2001. The drug subsequently received FDA approval. A short, powerful statement of the Abigail Alliance’s argument is in the January 11 Wall Street Journal.

The constitutional right the appeal argued for is based on the fifth amendment guarantee that no person shall “be deprived of life, liberty, or property, without due process of law.” Patients in “last chance” situations, when standard treatment offers no hope – are facing death. The Abagail Alliance argues that by not facilitating access to drugs that have passed through Phase 1 trial, the FDA is depriving them of the right to opt for to a potentially life-saving intervention.

As heartbreaking as it is to contemplate the death of 21 year old Abigail Burroughs and others like her, I think the Supreme Court got it right, for four main reasons. The court recognized the first two:

* The appeal argued for a terminally ill patient’s right to weigh the benefits and risks of taking the experimental medication and to pay for it with their own means. But Phase 1 testing does not provide the kind of information required for truly informed physician recommendation or patient consent, especially in desperate circumstances. The public, through the FDA, has a legitimate interest in the public safety implications of the FDA restrictions.

* Substantially unfettered access to experimental medications would severely undermine the ability to conduct rigorous controlled trials. Patients would be much less willing to enter a double blinded study if they could get access to the experimental agent by another route. Here too, the public has a legitimate interest in fostering rigorous testing of proposed new treatments.

* Although the appeal was limited to drugs in last chance situations and required self payment for access, there is every reason to expect that public and private insurance programs would soon be asked to cover the cost, and that patients with serious but not terminal conditions would press for the same kind of access. The cost of health care is already causing serious harms through uninsurance and job loss from diminished economic competitiveness. The public has a legitimate interest in mitigating the harms caused by runaway cost increases.

* Finally, the appellant’s argument would add to public confusion about the difference between evidence-based treatment and wishful thinking about experimental agents. Our health system is already permeated by magical thinking and denial of death. As well-intentioned as the appeal is, it would add to this unfortunate aspect of U.S. culture.

(For those with time and inclination to read a 22 page document, the decision of the District of Columbia Circuit Court, which the Supreme Court upheld by declining to hear an appeal, makes fascinating reading.)