The Real Defense of Right to Try

Published April 27, 2016

Advocates of the right to try argue that terminally ill patients should have access to treatments that have met the FDA’s safety requirements “but are not yet fully approved for market” (see Kurt Altman and Christina Sandefur’s “Right-To-Try Laws Fulfill The Constitution’s Promise Of Individual Liberty“). The FDA’s approval process takes years, and for thousands of terminally ill patients, those years may be the difference between life and death. Aware of the risks, many patients are nonetheless willing to try medicines and treatments that are still under investigation in clinical trials. For a significant number of these patients, the alternative is certain death.

But the right to try has no shortage of detractors, among them, Lisa Kearns, a bioethicist at New York University’s Langone Medical Center (for a representative sample of her work, see her article, “In Defense of the Nanny State“). In an interview with New Hampshire Public Radio’s Morning Edition, Kearns argued, “The whole ‘Right to Try’ movement is premised on the fact that these are life-saving, miracle drugs that are going to bring people back from the brink.” Kearns’s characterization of the rationale supporting the right to try is, of course, quite inaccurate. The critics of right to try bills deeply misunderstand them if they believe that the bills are necessarily either a statement about the quality of the pharmaceutical products at issue or an argument that pharmaceutical companies should be compelled to turn over an unfinished product against their wills.

These bills are decidedly not Panglossian endorsements of untested “miracle drugs,” premised on an unrealistic optimism. Rather the underlying argument of right to try bills takes individual sovereignty as its central premise, the whole point being that it doesn’t matter whether or not the desired treatment ultimately helps the patient — that a patient’s life and body are his own; and, therefore, no one may arbitrarily usurp the power to make important healthcare decisions for him, notwithstanding the condescending and self-assured claims that right to try advocates are dangling a false hope before patients.

A more accurate examination of the reasoning underpinning the right to try is offered by the dissenting opinion in the D.C. Circuit case of Abigail All. for Better Access to Developmental Drugs v. Eschenbach, decided in 2006. Recognizing “the historic importance of the underlying right of a person to save her own life,” Judge Rogers’s dissent in that case contended that traditional common law considerations should guide the court in its balancing the government’s interests against those of the patient. Among the common law doctrines cited were those of self-defense, necessity, and interference with rescue, all of which implicate the underlying notion that “persons in mortal peril” have a right to attempt to save their lives using means that would perhaps be off limits under ordinary circumstances. The majority had focused unduly on the exceptions to this long-established right to the detriment of the right itself and a proper constitutional analysis.

The dissent further argued that, in holding that the right to try is not a protected liberty interest under the Due Process Clause, the majority had mistakenly conflated two distinct steps in the constitutional analysis, “the inquiry as to whether a fundamental right exists at all” and that of whether the government has actually produced proof of a compelling interest sufficient to override that right. The dissent thus advanced only the very modest proposition that courts, confronted with right to try cases, ought to actually discharge their duty of judicial review, “rather than merely accepting, under the rubric of rational basis scrutiny, any assertions the FDA chooses to offer.” The Abigail Alliance case furnishes yet another opportunity to reflect on the fact that the “rational basis” test for constitutionality is a test in name only. On paper, rational basis review asks the government body whether its law or regulation is rationally related to an interest that is legitimate, which would seem to rule out arbitrary, unreasonable mandates. In reality, though, when it violates one of those sadly disfavored individual rights that rates only the rational basis tests, the government almost always wins in court.

Half-hearted champions of substantive due process might take note. For while they may believe that the right to try quite properly belongs in the constitutional no man’s land of rational basis review — the province of fanatical libertarians — they may well feel differently if rights that they favor (e.g., rights to privacy and sexual freedom) come into question. That a bioethicist can’t see the ethical problem with government paternalistically standing in the way of individual choice and potentially beneficial healthcare is a sad commentary on contemporary ideas about the proper role of government. Sick people should not have to supplicate to government bureaucrats to assume certain risks in the desperate attempt to save themselves; such intimately personal health decisions are of no concern to the meddlers in government agencies, to anyone but the patient, his doctors, and his family.