Week 8: Research issues, justice, and conflicts of interest
1. Most people's initial reaction to the Tuskegee experiment is to ask how it could have happened. What do you think? Could it happen again?
2. Some groups have a history of being exploited by medical researchers; others (e.g., women) of being left out; some of both. To what extent should research take into account differences among human beings? For instance, should they assume people are basically alike, and not actively seek out differences? Should they assume from the beginning that race and sex may be biologically relevant? Is this a scientific question, an ethical question, both?
3. Research is aimed at advancing medical knowledge (helping future patients rather than the ones in the trial). Innovative therapy is intended to benefit the patient for whom it is prescribed. Yet in practice the two intentions can be, or seem, mixed; and other factors as well will affect your decision-making. Do you need to disclose these to your patients?
Imagine, for instance, that a new drug, (X), has been approved for arthritis. Its risks and benefits are about the same as in drugs now used. Would you need to disclose the following to your patients?
|The manufacturer will pay you $100 for each patient you enroll in its study of long-term effects.|
|The HMO for which you work requires you to prescribe X, because it's cheaper.|
|You're eager to see first hand how (X) works.|
|The manufacturer sponsored a lot of "free" lunches (or gave you "free" books) during your medical training.|
4. Imagine a randomized clinical trial (RCT) is underway, comparing surgery to chemotherapy as initial treatment for advanced ovarian cancer. Surgery is the standard first treatment, although its advantages have not been conclusively established. Should you enroll your patients in the RCT? What would you say to your patients about enrolling if they asked your advice?
5. So far we have considered examples in which one may exploit or demonstrate disrespect for people in minority cultures by failing to obtain individual informed consent for research or treatment. Are there circumstances in which one could show disrespect for persons who do not identify with the "majority" U.S. middle class culture through the practice of informed consent itself? That is, are there important cultural variations in the emphasis placed on individual autonomy, and if so, how should those cultural differences be regarded? What implications does this have for which ethical standards should govern research in developing countries-- the standards of the country itself; the standards of the (presumably developed) country sponsoring the research; or some amalgam of both?
6. In your third and fourth years you will be doing procedures for the first time -- and the fifth and the tenth, until you finally feel confident about what you are doing. Should patients know that this is your first time? That you are a student? Should it depend on whether they ask, or should you volunteer the information?
7. Research shows that physicians who own labs and expensive diagnostic equipment (MRIs, etc.) prescribe more tests than physicians who have no financial interest in doing the tests. (Sometimes groups of physicians own whole diagnostic centers; the same increased referral pattern occurs.) In the policy module you will consider whether this kind of self-referral should be allowed. As long as it is allowed, however, another question arises: should patients know that you are referring them for tests from which you will personally, financially, profit?
8. Among the conflicts of interest we ask you to consider in this week's discussion are research ethics, ethics of physician gatekeeping in managed care, and physicians accepting gifts from drug manufacturers. Do you think there is a natural linkage among these ethical issues? If so, how would you characterize it? If not, why are they sufficiently different to resist being placed in the same category?
9. Do you think it is trivializing medical ethics to include accepting gifts from drug companies along with research ethics and gatekeeping? What do you think of the argument that accepting a pen, or a donut, or a free lunch from a drug detail person is essentially harmless and very unlikely to influence any physician's clinical judgment, so that the only ethical objection could come from some obsessive-compulsive, "holier than thou" or "goody two-shoes" type of person? How about the argument that it is precisely by getting medical students used to accepting these relatively minor gifts, at a time when no patient care decisions are involved, that we have evolved the various practices of physicians accepting and indeed expecting much bigger gifts from drug companies in ways that truly threaten the ethical integrity of the profession?