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Week 8: Research issues, justice, and conflicts of interest

Discussion Leader's Guide

1. The following probably all played a part: racism (general contempt for African Americans); the subjects' lack of power, of information, of education; the belief that researchers were their own best conscience, and the resulting lack of public and enforceable standards.  This last factor seems to have emerged at least in part from an unspoken but very deeply ingrained argument among scientists that goes something like this: "Scientific advancement is good.  Therefore a study that advances scientific knowledge is good.  My own motives, to advance knowledge, are therefore good as well.  Since my study accomplishes good things and is based on good motives, anyone who opposes my study is probably an ignorant person who does not really understand science, so I need not pay attention to people like that."  (This attitude seems no less prevalent today than in the 1930's.)  James Jonesí Bad Blood gives a detailed history of what happened and how it persisted.  See also our supplemental web page (based partly on Jones's book), Images of Tuskegee.

Many think the studies of 30 years ago could not happen today. Others are not so sanguine. In addition to far stricter professional and government regulations, most institutions have internal review boards (IRBs). In addition there is a vigorous public conversation about bioethics, in print, the classroom, and the media.

Each of these safeguards has its own problems. Professionals know their own field better than anyone else, but are subject to group-think, and to mixed motives. Financial motives often affect their stands. Government regulations can multiply and become meaningless, or the tool of tyrannical majorities. The effectiveness of IRBs has not been studied.  By late 2000, several prestigious bioethics groups were calling for a major review and overhaul of the U.S. IRB system.

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2. Patricia King ("The Dangers of Difference," Hastings Center Report 22(6):35-38, Nov-Dec 1992) considers three proposed justifications for deliberately seeking to increase the number of African Americans in research populations: first, there may be biological differences between blacks and whites, which would make the research results inapplicable to blacks. (Cf: most major cardiac research has been on males-only population, but the results serve as recommendations for women as well.) People with an ancestor from sub-Saharan Africa seem to be more susceptible to some diseases, more resistant to others; the same is true of people with some Mediterranean ancestry, of people whose ancestors came from parts of Asia, and so on. On the other hand, the very concept of race is complicated. Societies differ about which individuals are sufficiently like one another to be grouped as a "race," and about whether sets of people are sufficiently different to be called "different races." Finally history warns us that racial classifications have usually been used to punish and persecute.

She then notes that race "is a reliable index for social conditions such as poor health and nutrition, lack of adequate access to health care, and social and economic disadvantage": social, not biological factors, that might make the new interventions counter indicated. Again, however, emphasizing cultural and socioeconomic differences might encourage stigma and discrimination.

Finally, she considers the argument that the burdens and benefits of research should be shared equitably -- but notes that while the other burdens and benefits of society are so inequitably distributed, it would be unjust to put equal loads onto backs unequally bent.

Her solution: start with the defeasible presumption "that blacks and whites are biologically the same with respect to disease and treatment. . . recogniz[ing] that biological differences in some contexts are possible." Begin by "looking for social, cultural, and environmental conditions [that make a difference.] Only where possible biological differences emerge should the hypotheses that explore racial differences be considered."  What do you think of these proposals? How would they apply to other vulnerable populations who have been excluded from research?

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3.  Background: The traditional distinction between experimental research and experimental treatment has hinged upon intentions: research is intended to advance medical science, while treatment (even when innovative) is intended to help the patient. Medical research is highly regulated; innovative treatment is largely left to the discretion of the doctor. Drugs must be approved for use in human beings, but once they are approved physicians may use them for purposes other than those they were tested for.

What are we to do with the non-medical considerations that inevitably play a part in oneís treatment recommendations? The class discussion will have to focus on questions like these: Can one know whether one is being influenced by financial incentives? Are the "free" lunches (or books) provided by drug companies are ultimately paid for by patients who buy the drugs? Would drug companies spend money for books and lunches if they did not think this affected young physicians' decisions? Would any of this matter to the patient? If there's no reason to think the patient's care is compromised, is there any reason to disclose these other considerations? We ask the patient to be frank and candid; is it good, bad, or neutral to let the patient see the doctor as a full human being?

The entry of for-profit corporate interests into the field of medical research, to an unprecedented degree, may be changing the extent to which some of the post-Tuskegee reforms for protection of human subjects apply to all research in the U.S. (since current research protections for human subjects are typically required only for government-funded institutions and not for private industry, though the FDA has its own research requirements for any studies designed to lead to FDA approval of new drugs). Does this raise concerns for you? If so, what are they and what might be done?

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4. Again, the epidemiology segment of SCCD will treat the ways in which Randomized Clinical Trials give more reliable data than historical and other kinds of prospective studies. For this class simply assume that RCTs give significantly more reliable results. Some argue that the clinician should always base her recommendations solely on what she believes is good for the patient. Others have argued that so long as the medical community is undecided about the efficacy of a particular therapy, the doctor may (perhaps should) shelve her individual opinion about it. Some would recommend telling the patient the status of a therapy (supported strongly, weakly, or not at all; available outside of a research protocol, or available only within it). At that point, should the doctor allow/encourage the patient to make a decision? Tell her what he believes is best for her? Encourage her to enroll in a study for the good of future patients?  (How might the Emanuels' models of the physician-patient relationship from Week 1 be pertinent here?)

You might also point out the limits of the consent process in its "legalistic" forms: few people will read a six page consent form carefully, for example. It's also known that the way information is presented makes a difference: for instance, men considering prostate surgery who view a video describing various alternatives choose surgery less often than those who get the same information from surgeons,. Some critics therefore suggest that researchers should not themselves be the ones to explain risks and benefits. One more complication is that contemporary patients tend to think of "experimental" as "cutting edge" rather than "unproven."

Finally, does it make any difference that patients with advanced ovarian cancer are likely to be desperate?

(The third segment of SCCD, Health Care Policy, is relevant to the question of whether a drug -- say, AZT -- should be available without testing, or outside as well as within a research protocol. It is also possible that some small groups will choose such a topic for the final SCCD segment, the Integrative Exercise).

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5. Students should consider evidence that our concepts of autonomy and individual rights, which form the ethical as well as the legal basis of informed consent, are not universally shared. Students should see the strengths as well as the weaknesses of belief systems which emphasize communal, clan, or family decision-making over individual choice; and should be prepared to think about how patients who are members of such a culture ought to be treated in U.S. hospitals and medical facilities.

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6. The easy answer is that questions should be answered honestly, but information about one's inexperience need not volunteered. Probe that answer a bit. Wouldn't some patients want to know, and doesn't the general standard for "informed consent" demand revealing to each patient what is of individual importance to them? And aren't there many patients who appreciate the chance to work with "the young" -- with medical students who are modest and candid? Would a habit of disclosure discourage the tendency to put medical students prematurely on their own?

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7. Again there's an attractive easy answer: "I wouldn't be influenced by financial considerations." Yet the research suggests people are so influenced, whether they know it or not. Would the squeaky-clean answer be "I'll never own such a facility?" That might be a hard resolution to keep if only your own investment would make it available in some remote town or under-served district. (For optional further discussion see Lo, Chapter 33.)

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8. Here is the logic that caused us to group these topics together. Research ethics, gatekeeping in managed care, and accepting gifts from drug manufacturers all pose conflicts of interest for the physician involved in treating individual patients. As treating physician, one has an ethical obligation to do the very best he/she can for the individual patient, based on an assessment of the patient's needs and an unbiased survey of the medical evidence showing that any given treatment might or might not be of benefit. (This is often called the principle of beneficence.) In each of the topics we address this week, there is a conflict of interest tempting the physician to discount the commitment to the individual patient's well-being at least to some degree:

In research, the physician is trying to generate new knowledge to help future patients. (The physician may also be trying to advance his/her own academic career, and in some cases make more money if the research is conducted in a for-profit venue.) This might lead to a desire to recruit and retain study subjects that does not jibe with providing for each patient the best available medical care. For example, a patient who is not showing benefit from the study drug might be kept in the study to generate statistically reliable data, whereas in therapeutic practice, one would stop that drug and try a different drug.
As gatekeeper, a physician is instructed to worry about the managed care plan's bottom line and try to cut costs. There may be no conflict in many cases where good care is also low-cost care (e.g., avoiding the use of antibiotics in viral upper respiratory infections). But in at least some cases, what is best for the individual patient may be what costs an "excessive" amount from the standpoint of the plan, and the gatekeeper may feel pressure from both directions. 
One who receives a gift is psychologically programmed to want to repay the kindness. This could lead to the physician being more likely to prescribe a drug urged by the drug rep who took the physician to dinner or who keeps bringing nice freebies to the office, instead of the drug that is actually shown by unbiased evidence to be best for the patient-- or instead of the lower cost drug which would be good for the patient and also save money for the overall "system."

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9. See some of the discussion points raised under Question 3 above.  Again, we need to probe carefully the quick response, "I wouldn't be influenced by these gifts."  The data that are available suggest otherwise.  However, the question of when we are identifying real, serious ethical issues that genuinely impact on our (or the group's) moral integrity, and when we are just riding our personal hobby horses and indulging in virtue for the sake of feeling good and/or superior, remains a good question.  How can physicians (including medical students) as a group better reflect on that question to our mutual benefit?

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