Burroughs Wellcome And Azt Case Study

To the Editor:

A front-page article April 12 contained references to the Burroughs Wellcome Company that incorrectly implied that vital AIDS research on acquired immune deficiency syndrome was proceeding slowly because of our refusal to supply our AIDS drug Retrovir (formerly known as AZT), for clinical trials sponsored by the Federal Government.

Our company has a long, well-established history of ethical, efficient and rapid antiviral drug development. We initiated the pivotal study that proved the safety and efficacy of Retrovir in February 1986 entirely at our expense. It began four months before contracts were awarded for the Government's AIDS treatment evaluation units, and yielded important results before the first patient entered a unit.

During the period you refer to, September 1986 to March 1987, Retrovir was in extremely short supply. We made a commitment to supply Retrovir free, on a compassionate-plea basis, to the 5,000 to 6,000 patients who had been shown potentially to benefit from it. We supplied Retrovir to all the patients who applied and met eligibility criteria. We believe we saved lives and improved the quality of life for thousands of patients with this deadly disease.

We are not, and never were, as you say, ''thrust into a conflict of interest dilemma'' trying to ''decide whether to sell the drug, for up to $10,000 a year per patient, or provide it free'' to additional clinical trial patients. It would have been difficult to sell Retrovir at any price before Food and Drug Administration approval March 19, and we never made any attempt to do so. Our dilemma was determining how much of the drug to supply free to thousands of sick and dying patients, and how much to provide, also free, to the National Institutes of Health and others to test in patients who were less critically ill. We chose to supply $10 million worth (the major portion of the available supply) to compassionate-plea patients. We had an obligation to use the remaining supply in studies to provide critically needed information at the earliest possible moment.

The events you describe occurred when we were faced with a large number of requests, from the treatment evaluation units program and others, to test Retrovir in other patients, disease conditions and in combination with other potential therapies. Discussions surrounding the study of Retrovir in combination with interferon provide a good example of the difficulties encountered in cooperative AIDS research involving many parties with different perspectives.

An improving Retrovir supply has now permitted us to dedicate additional amounts of the drug for clinical studies in more than 2,500 patients.

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Case | HBS Case Collection | September 1991 (Revised February 1993)

Burroughs Wellcome and AZT (A)

by Willis M. Emmons III

Abstract

Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S. government. In spite of repeated demands over the previous two years to lower the price of AZT (trademarked Retrovie), Burroughs Wellcome and its parent company, London-based Wellcome PLC, have refused, claiming that the $6,300 annual (wholesale) cost of the drug per person is justified, based on high research, development, production, and other costs associated with the drug. The firm's opponents accuse it of using an existing chemical compound, ample government research assistance, and a cooperative regulatory system to gain a monopoly on the only approved treatment available for people with AIDS. The case gives students the opportunity to explore the economics and regulation of the pharmaceutical industry, wrestle with the ethics of drug pricing, and analyze the formulation of public relations strategies on the part of both private companies and activist groups in the age of AIDS.

Keywords: Governing Rules, Regulations, and Reforms; Ethics; Business and Government Relations; Communication Strategy; Health Care and Treatment; Monopoly; Intellectual Property; Research and Development; Price; Pharmaceutical Industry; London;

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