Stanford Report, February 9, 2005

5 Questions: Cho on conflicts of interest

An occasional feature in which a medical expert answers five questions on a science or policy topic of interest to the Stanford community

Mildred Cho

Last week, following criticism of some doctors’ paid consulting arrangements, the National Institutes of Health announced a new policy that bans its scientists from working as consultants for or having stock in pharmaceutical and biotechnology companies. (Dean Philip Pizzo, MD, serves on the panel that provided guidance on the NIH’s conflict of interest policies.) Michelle Brandt, with the Office of Communication & Public Affairs, talked with Mildred Cho, PhD, associate director of the Center for Biomedical Ethics and a leading expert in conflict of interest issues, about the new rules.

1. Congressional hearings on this matter suggest that the conflicts had become widespread among NIH employees. Have these conflicts compromised research over the last decade?

Cho: The problem with conflicts of interest is that one often cannot know whether a specific financial interest has directly affected research. This is why conflict of interest rules exist—they are supposed to limit or prohibit financial ties in situations where even a reasonable person might be unduly influenced.

2. When Elias Zerhouni, the NIH director, testified to Congress last May, he said collaboration with industry and academia is vital to advance science and to translate discoveries into medical practice. Do you think the new policy will be bad for science?

Cho: Whereas collaboration between industry and academia may be necessary for translation of some discoveries into medical practice, it might not be for other discoveries. For example, published work conducted in the academic sector might be picked up by industry researchers and lead to medical products without direct collaboration. In addition, interactions between academic and industry researchers can still exist in the absence of paid consulting relationships.

3. Could the NIH have dealt with the potential conflicts simply by requiring greater disclosure?

Cho: Greater disclosure would not be nearly as effective in mitigating conflicts. Effectiveness of disclosure depends on the appropriate people being aware of the information and knowing how to interpret it. Patients who are subjects of clinical trials or other researchers might not know what the potential effects of a disclosed conflict might be.

4. Is there any risk that this change will lead to a brain drain, with some of the best and brightest leaving government positions for the private sector?

Cho: Some brain drain is possible, but if the NIH's assertions that most NIH employees do not have large financial interests in companies is true, then the effect of the new policy is not likely to have a significant impact on most people, and thus not likely to create a stampede.

5. The new policy allows government employees to accept paid outside positions as physicians at hospitals or in other clinical settings, as well as to accept fees in some circumstances from universities for teaching or writing and editing services. Do you see any risk in allowing such activities?

Cho: These situations pose less of a risk to research integrity or safety of human subjects because they are not in conflict with research activities. That is, if these activities are unrelated to specific research projects, there is no risk of bias to research or harm to research subjects (e.g., by overlooking or underestimating the adverse effects of a drug).