Date of Award

9-28-2010

Document Type

Open Access Thesis

Degree Name

Medical Doctor (MD)

First Advisor

Thomas P. Duffy

Second Advisor

Robert A. Burt

Abstract

Do dying patients have a moral claim to access experimental drugs when all else has failed? This question has been the focus of an active and evolving debate concerning the rights of terminally ill patients, the nature of the drug development process, and the scope of federal regulation, with supporters arguing that seriously ill patients should be able to decide for themselves whether and when to attempt experimental therapies and opponents arguing that the resulting state of affairs would be disastrous for patient safety and for the integrity of the drug development process. This thesis concerns the ethical considerations surrounding the provision of experimental drugs for treatmentoften termed compassionate use or expanded accessand argues that compelling ethical merits on both sides of the debate complicate the formation of satisfactory public policy. Although patient autonomy is often invoked to support liberal access to experimental drugs, the paucity of known information about investigational compounds as well as the unique vulnerability of the terminally ill patient call into question the wisdom of the unfettered exercise of autonomy in this context. Although equitable distribution of experimental drugs is often felt to be a concern, the meaning of equity in this context has not been clearly defined, and in fact several working concepts of equitable access may not be achievable or desirable. Although the financial burden on drug manufacturers is frequently recognized as a barrier to expanded access, the potential for expanded access programs to constitute a marketing strategy should be recognized, and the mixing of profit motives with altruistic ones brought to light. Parsing these and other ethical nuances points to certain ways in which policies governing expanded access can be refined to allow for access while maximizing patient protection and ensuring the generation of scientific knowledge. Physicians, as frequent mediators of requests for experimental drugs, should be knowledgeable of the ethical issues inherent and should help to ensure the judicious use of experimental therapies. Finally, general misconceptions about the benefits of experimental therapy, pervasive in our culture, heighten the contentiousness of this debate. A workable legislative solution should be accompanied by a thoughtful and deliberate effort to educate patients, their advocates, and broader society about the realistic pace of drug development and the limits of modern medicine. This thesis recognizes that individuals who seek expanded access often have valid moral claims to do so, but advocates a cautious attitude toward the dissemination of experimental drugs for treatment and maintains the importance of government and physician participation in adjudicating access.

Comments

This is an Open Access Thesis.

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