Debate Questions Experimental Drug Use by Terminally Ill

BY ORAMEL III

A look into the rights of the terminally ill to have access to experimental drugs was the focus of debate Monday night in an event co-sponsored by The Journal of Law and Technology, The Federalist Society, The American Constitution Society, and The HLS Ethics, Law, & Biotechnology Group.

Centering on the current case of Abigail Alliance v. Eschenbach, the participants included Richard Samp from the Washington Legal Foundation, lead counsel for plaintiffs, and I. Glenn Cohen, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. The two guests’ debate was moderated by Visiting Professor Russell Korobkin and followed by a question and answer session with the audience of over forty students.

Abigail Alliance v. Eschenbach was recently decided by the D.C. Circuit Court of Appeals en banc, finding against the Abigail Alliance, but with the expectation that it may go up on appeal to the Supreme Court. The case involved a suit by the Abigail Alliance for Better Access to Developmental Drugs against the FDA for access by terminally ill patients to experimental cancer drugs that have passed through Phase I testing.

The debate did not remain tightly cabined, since the right to experimental drugs for the terminally ill involves a discussion of other fundamental health rights such as abortion and physician assisted suicide, and raises questions about the regulatory system currently in place for drugs and what its future should be. The parties to the debate actually spent much of their allotted time attempting to frame the discussion in ways that favored their side.

Richard Samp, in a quiet measured tone, spent much of his time focusing on the question at issue in Abigail Alliance v. Eschenbach, whether the terminally ill have a right to access drugs that have passed through Phase I testing. In arguing his case, Samp focused on a comparison between the claimed right of access and other rights that courts have found, such as the right to an abortion, the unanimously found health exception to abortion laws, the right to self-defense, and the right to freedom from interference in saving a life. Samp repeatedly focused on the idea of an individual right to attempt to protect oneself and the concept that the government cannot mandate that you die for the good of society as a whole.

Cohen alternated his argument time between legal critiques of the concept of a fundamental right to access, and policy critiques of how a decision that such a right existed would lead to large negative changes in the current regulatory system. In his basic framing of the debate, Mr. Cohen, with great aggressiveness, attempted to draw the debate in terms of larger issues, and especially in terms of the consequential effects that would result from a decision for the Abigail Alliance. He began by introducing the idea that the debate currently is “not about there being no access” as he described the current process for requesting experimental drugs.

After then addressing the legal issues of rational basis analysis and standards for a constitutional claim of a right, Cohen vehemently attacked the idea that a new standard of access to drugs at Phase I would be beneficial to terminally ill patients or the population as a whole.

In making this claim he spent much of his time arguing that the current process of making a request to the FDA for experimental drugs in extreme situations was valid and that an alteration of this system would lead to deleterious results for the nation. He noted that the drugs in question are not assured of being successful or of being harmless to even terminally ill patients, as after passing Type I testing, “only 5% of the drugs make it to approval.”

Cohen then argued that the debate was really about “a libertarian or consequentialist view” of how to deal with drugs. He argued that a lowering of the threshold of access to Type I approval of drugs would destroy the current approval and testing process, as it would disincentivize patients from taking part in the later stages of the trial and approval process, thus weakening our testing regime for all new drugs and hurting the nation.In the end the debate centered on Samp arguing in relation to other rights the Supreme Court has upheld and claiming that the request in the case was merely for a cabined off right for the terminally ill who were simply trying to “get a foot in the door” at the FDA, while Cohen set the debate in the larger framework of the regulatory state and the effect any decision would have on the rest of the population and their access to safe and well tested drugs.

The debate may not have produced a clear winner in the eyes of the audience, but the discussion made clear that the issue of terminally ill patients’ access to potentially life saving experimental drugs draws on legal and policy questions which go well beyond the issue at hand in the case. Any decision by the Supreme Court in Abigail Alliance v. Eschenbach could have an effect on issues as broad or narrow as the various arguments heard in Monday’s debate.

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