Abigail Alliance

Glenn Cohen (guest-blogging at Prawfsblawg) has an excellent post on the significance of the upcoming en banc rehearing of the Abigail Alliance decision.  The case is extremely important for a variety of reasons, and Cohen brings considerable insight and perspective on the case (while working at DOJ, he helped draft the government's petition for rehearing).

Here is the issue: whether

the due process clause of the federal constitution provides a fundamental right that prevents the Food and Drug Administration (FDA) from blocking competent, terminally ill patients from having access to potentially lifesaving drugs that have cleared Phase 1 clinical testing but have gone no further in the drug approval process, when usage is based on the advice of doctors.

The panel opinion, authored by J. Rogers and joined by C.J. Ginsburg, concluded that such a right does exist:

The D.C. Circuit panel majority held that the due process clause creates a fundamental “right of a mentally competent, terminally ill adult patient to access potentially life-saving post–PhaseI investigational new drugs, upon a doctor’s advice, even where that medication carries risks for the patient.” The majority found this right to be “deeply rooted in this Nation’s history and tradition," as reflected in various common law doctrines (the defense of necessity, the freedom from battery, the tort of intentional interference with a rescue).

Judge Griffith dissented, arguing that he could find no compelling reason for removing the power to balance the risks and benefits of pharmaceuticals from the democratic branches of government.

Cohen suggests that the first question is "does the Constitution compel Congress and FDA to adopt a certain policy as to the regulation and approval of drugs as applied to terminally ill patients?" He argues that it does not, contra to the majority's assessment, and I happen to agree with him on this point.  This is a technical question of constitutional law, and is not equivalent to the arguably more difficult policy question: "Even if we assume Congress and FDA have the power to regulate drugs for the terminally ill in the way they are already doing, should they switch to a system with increased access?"

The entire post is eminently worth reading.  I am hesitant to stand athwart a potential door to lifesaving treatment for desperately ill patients, and yet, commentators (notably, Cassell) have explained the extreme fear and vulnerability of such patients makes it all the more important to (paternalistically, perhaps) attempt to shield them from an arguably unethical exposure to risks of pain and suffering for little benefits.  This contention, of course, is contestable for a variety of reasons, but I agree with Cohen that it is at the heart of some of the difficult policy issues presented by this case.

The sad saga of the litigation over the use of high dose chemotherapy with autologous bone marrow transplants for patients with advanced breast cancer seems quite analogous here.  These patients sued insurers and HMOs for denying coverage for the procedure; the latter argued that it was experimental.  Several of these suits were successful, but a worldwide study eventually proved -- after a significant case of research fraud in South Africa that falsified findings of efficacy -- that the study was of no benefit.  It is possible that some women suffered and even died more hastily because of the intervention (note: I intentionally did not term it "therapy" in this instance).

On the one hand, it would seem difficult to tell these desperate, suffering patients that what they perceive as their last hope ought not be made available to them, and on the other hand, to paraphrase from Wittgenstein, one must be careful of attempting to open doors that are painted on to walls, especially when doing so may carry significant risk.  These are truly difficult issues of research ethics.

Comments

[Kelly Hills]

I think, however, we often project that fear and vulnerability onto the terminally ill. While there are undoubtedly those grasping at any and all straws without thought, there are equally many terminally ill folk who have grace in the face of their illness - but still want to try. They want to live, they want to advance knowledge, they want to do something rather than just passively die.

And I'm not sure any of us have the right to tell someone no, to that. That sorry, we know better.

While some therapies do eventually end up having little to no empirical, medical benefit, I think it's much harder to quantify the placebo effect that the experimental medication might have - both in the traditional sense of placebo effect, but also because, for many people, it is the effort, the 'fight', that matters. And if they're doing something, they're fighting - tying to the earlier post on war metaphor in disease.

If ethicists can come in and judge a person competent for other medical procedures, I don't see why they can't also certify someone as competent to make the decision to undergo radical, experimental treatment, when other options have been exhausted.

For some people, passive resignation is going to generate a worse QoL than any of the pain and suffering attached to experimental treatments.