Trust and Integrity in Biomedical Research--The Case of Financial Conflicts of Interest (2010)
Thomas H. Murray & Josephine Johnston, Editors
The Johns Hopkins University Press, 267 pp.
In the preface, the editors make the case that biomedical research funding has changed over the past several decades. This is certainly true. Industry sponsorship of research has increased, from about 30 percent in 1980 to nearly 60 percent by early in the last decade. Academic institutions play a significant role in industry-sponsored research, where as high as one-half of biomedical companies' research budgets are used to sponsor research. Such availability of research monies (in many forms, grants, and contracts) has raised concerns in public and research circles.
The editors present several examples of either actual or perceived conflicts of interest that were observed or suspected, including at the National Institutes of Health (NIH). The editors reported that several senior NIH scientists had developed relationships with industry that included hundreds of thousands of dollars in various kinds of compensations. Such charges by newspapers and other venues led to investigations and eventually to the NIH banning its employees from accepting consulting payments from pharmaceutical companies. Concerns related to the integrity of biomedical research have drawn the attention of the Hastings Center, where a project was developed to address the ethical issues involved in the management of financial conflict of interest. This book represents contributions of members of the Center's project working group.
"Meaning and Context"
Chapters 1 to 4
In Chapter 1, Financial Conflicts of Interest in Biomedical Research, one of the editors, Josephine Johnston, a Research Scholar at The Hastings Center, asks what COI is, how it arises, who is involved with it, and how it should be managed. Medical research is grounded on the concepts of trust and the unbiased pursuit of research. Any financial interest in the research, especially by the investigators, can cast doubt on results. In a well-known case (pp. 9-10), Johnston notes that more than half the investigators involved in the Rezulin studies for type II diabetes received some form of remuneration from the sponsor. The drug was fast-tracked, but eventually removed from the market because of liver failure in some subjects. Such issues are played-up in the media and result in significant harm to research in general.
Johnston notes that management of COI is a form of risk management. There will always be conflicts of interest whenever a sponsor, an institution, the government and an investigator are involved in clinical research on an article that portends profit and provides a means of research (and personal) support. Policies are required that assist in defining the risk, what level of risk can be tolerated, and how risk might be reduced. As indicated by Johnston, some risks can never be tolerated, some that do not reach a threshold may be tolerated, and some may be ameliorated. This latter may include limited involvement in the study of the person with the COI, divestiture of the financial COI, or some other oversight of the conflicted investigator. It must be understood that research is expected to generate financial income for shareholders (p. 12). Profit from research is not "evil" but does need to be managed. As Johnston points out (p. 19)...