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For instance, when we say that the public has lost faith in us: I have heard that now for ten years. I'm not sure who the public is that has lost faith, because the public I see seems to have great faith in me, as well they should; but the rest ofyou, I don't know about you! I begin to worry because if you keep on saying something, you know, it will become true. The public certainly has lost some faith in us, and rightly so, because we have pulled some real boo-boos, but on balance they like us pretty well and think we are doing a good job. Perhaps it is worth reminding you that we do have methods for informing the public about physicians' problems, but I don't think we have done nearly as good ajob as we should. The AMA has tried valiantly, but I am afraid the academic community has not done much to help. The Institute of Medicine of the National Academy of Sciences has not put itself in a position to be effective; a few of the basic scientists, notably the pharmacologists, have done quite well. The truth is that as we now stand we do not have access either to Congress or to the public except via the media, and the media too often have presented the worst side of research—the hoop-de-do and the so-called breakthroughs—all of which more and more people are failing to buy. The other thing I would hope that medical people will remember is that even though we may have lost some of the shine on our halo we are still physicians. We are still people who have to console and comfort and try to cure. If we lose that, we will lose something very precious, because you cannot buy pity, you cannot buy confidence and faith very easily. The physician should be a physician, not a lawyer or a government employee in the sense that being one allows hegemony over all medical care. So I, with my antediluvian notions, still feel that doctors must be doctors because this is our heritage. We have a responsibility to our heritage: it is one of the most precious things we have, but much more important, the patients benefit by that heritage. The Future ofRegulation, and Organizing to Act: Notesfrom the Discussion Did Sonnenreich paint too bleak a picture, one participant wondered. For example, consent auditors, according to the National Commission's recommendation, are not mandatory but rather are to be appointed at the discretion of the IRB in all but one situation. Moreover, the National Commission recommended the abolition of the fictional distinction between therapeutic and nontherapeutic research: the latter is felt to be a S154 I Irvine Page ¦ The Physician's Heritage meaningless term. Third, Sonnenreich's view of the liability to which researchers and IRBs will be subject is unduly alarming. Finally, the participant concluded, the concept of the IRB as a petit FDA is something that exists only in the minds of those who write regulations for the FDA. Sonnenreich responded that if planned regulations go into effect that which is set forth as "discretionary"* will in fact become the rule: The "occasional" becomes obligatory. The difficulty about nontherapeutic research is that, although the National Commission has advised that the term be abolished, the law courts have not and do not appear likely to do so. In the end the courts will prevail unless the dialogue is changed. The courts do accept functional distinctions—as one example, that between drunkenness and alcoholism—but it takes long, concerted work and extensive background preparation to effect a regulatory or legal change. Regarding liability, Sonnenreich said that 15 years ago one would not have predicted $6.5 million settlements of medical malpractice suits. "When the situation is created where rights, responsibilities, and obligations are imposed on IRBs, their members will be sued by patients, and on behalf of patients in class action suits—because rank has its privileges and rank has its responsibilities. If you want to sit on one ofthese boards, if you want to make ajudgment as to what shall...


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pp. S154-S157
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