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White Coat, Black Hat:
Adventures on the Dark Side of Medicine

by carl elliott
beacon, 213 pages, $21.95

Warning: Reading this book may make you afraid to take your medicine. And that, of course, in many cases could be unfortunate or, even, fatal. We must, therefore, retain a little more confidence in American medicine than this book alone is likely to produce in us, but, so long as we keep that in mind, White Coat, Black Hat should force us to ask some hard questions about how best to structure the practice of medicine.

Carl Elliott, both an M.D. and a Ph.D. in philosophy, is a bioethicist (though rather different from many members of the species). To appreciate what is important (and anomalous) about the book he has written, we need to remember the early years of bioethics in this country (beginning, say, in the mid-1960s). In both clinical and research medicine autonomy was the theme of the day. Patients needed to break free, so we thought, from the heavy-handed paternalism of physicians, whom they had simply been urged to trust. And given what we had learned after World War II about abuses in research medicine, experimental subjects should be used only if they were capable of giving, and actually did give, a free and informed consent to their participation.

Quite often bioethicists were active participants in the chorus of voices calling for greater autonomy for patients and research subjects. Indeed, David J. Rothman, in Strangers at the Bedside, his fine history of the beginnings of American bioethics, depicts bioethicists as something like civil rights activists. It took no more than two decades, though, for that outsider’s perspective to be refined and reshaped, as bioethicists increasingly gained a kind of insider status, the price of which was support for keeping research science relatively free from public oversight. (The story of that shift was painstakingly told by John H. Evans in Playing God?: Human Genetic Engineering and the Rationalization of Public Bioethical Debate.)

We will best understand what Carl Elliott is doing, I suspect, if we think of him as reclaiming the outsider status of early bioethicists. He does this, however, not in order to press the claims of autonomy but in the name of an older medicine that was not a business but a profession, governed by trust and covenantal responsibilities rather than economic requirements of the market. If, as I suspect, he lays a bit too much of the blame for our ills at the feet of that all-purpose bogeyman, capitalism, the story he tells is nevertheless a sobering and instructive one.

Elliott’s chapters, any of which can also be read as a self-contained essay, treat the following players in the process by which drugs are developed and, eventually, prescribed to patients: research subjects (the guinea pigs); ghostwriters (who, rather shockingly to the layperson, write many of the articles in medical journals); sales representatives employed by pharmaceutical companies to give doctors information about new drugs (and, along the way, to give a good many other perks to the doctors and their staffs); opinion leaders (medical experts who, claiming independence and transparency, are used by drug companies to testify to the benefits of their products, especially when prescribed for off-label uses); flacks (public relations workers who increasingly market new drugs directly to “consumers,” especially by portraying some common condition as an underdiagnosed disease that can—mirabile dictu—be treated with a newly developed drug); and bioethicists (who, no longer outsiders, often prove quite willing to “partner” with pharmaceutical corporations and accept payment in return for such partnership).

All of these chapters are highly readable, laced with provocative and often saddening stories. Taken collectively, they give a sense of how research medicine has become big business, drawing all these different participants into its cash nexus. And taken together they are also likely to force many laypersons (the true outsiders) to rethink their sense of how they have come to take one or another prescribed medicine. “Many of us,” Elliott writes,

have a relatively simple, commonsense view of the way that drug development and marketing work. People get diseases; scientists develop drugs to treat those diseases; and marketers sell the drugs by showing that the drugs work better than their competitors. Sometimes, however, this pattern works in reverse. Drug company scientists develop a drug with a range of physiological effects, none of which are terribly helpful, so the marketers must identify and promote a disease for the drug to treat. . . . Once a disease has achieved a critical degree of cultural legitimacy, there is no need to convince anyone that a drug is necessary. It will come to him as his own idea.

Yet, of course, we are caught in circumstances that may be hard to untangle. The more skeptical patients become, the more inclined they will be to insist on their right to make their own medical judgments (a phenomenon for which the Internet has proved very handy). The more patients insist on this autonomy, the more trust in physicians is undermined. The more that trust is undermined, the less reason physicians have to think of themselves as having a covenantal responsibility to look out for the welfare of patients (who have now become consumers). How we are to get out of such a bind Elliott does not tell us, though for that he can hardly be blamed.

How insoluble are some of the difficulties that accompany the process by which a drug is first developed and eventually comes to be prescribed to us is, in some ways, most evident in Elliott’s very first chapter. It tells the story of “the guinea pigs”—the people most likely to be research subjects in Phase I trials, which test the safety of a drug under development by giving it to healthy subjects and examining any side effects they experience. It turns out that many of these guinea pigs are now professionals—“people who need money and have a lot of time to spare: the unemployed, college students, contract workers, ex-cons, or young people living on the margins who have decided that testing drugs is better than punching a clock with the wage slaves.” In some large urban areas “a community of semiprofessional research subjects who enroll in one study after another” has sprung up.

While it was once true that most testing of potential new drugs took place in medical schools and teaching hospitals, that is no longer the case, and in Elliott’s view the change has given rise to serious problems and abuses. Pharmaceutical companies have needed to test more and more potential drugs, the tests (and the regulations that govern them) have become increasingly complicated, and the companies, whose research costs are enormous, have required a faster pace than the academy can provide. Hence, the need for professional guinea pigs. “The relationship between testers and test subjects has become, more nakedly than ever, a business transaction.”

Is this all bad? Academicians—who have increasingly ceded control over their institutions to an ever growing bevy of administrators, who in turn use more and more marketing techniques to draw students, now thought of as consumers—are hardly in a position to cast stones. Moreover, contractual relationships give the research guinea pigs a certain amount of control and protection—perhaps at least as much protection as the standard requirement of free and informed consent has provided. Nevertheless, when one reads, for instance, of how the Eli Lilly company used homeless alcoholics for testing experimental drugs, it is hard not to believe that such guinea pigs are being exploited, even if they may welcome their improved living conditions during the course of the research.

But is it simply a drug company that exploits them, if indeed they are exploited? All of us live parasitically off them. “Drug testing,” as Elliott notes, “has always involved a kind of moral trade-off in which subjects are asked to take risks for the good of other people.” As long ago as 1970, in The Patient as Person, one of the truly important books at the dawn of bioethics, Paul Ramsey argued that, in a healthy society dedicated to research aimed at the conquest of disease, we would all regard ourselves as “joint adventurers” in the cause of medical progress.

Something like that has, for the most part, been our ideal. Research subjects were to participate freely, neither being coerced nor even induced through offer of payment. The ideal, though, has not been realized. “Not many people,” Elliott notes, “feel a moral duty to take part in these studies”—though, of course, we are more than happy to reap the benefits brought by new drugs. And, unsurprisingly, the guinea pigs—for whom participation becomes not a “joint adventure” with the rest of us, but a job—believe they should be paid well for doing what the rest of us do not really want to do.

The result is an uneasy compromise: Guinea pigs are paid to test drugs, but everyone pretends that guinea-pigging is not really a job. IRBs [Institutional Review Boards] allow sponsors to pay guinea pigs but, consistent with FDA guidelines, insist on their keeping the amount low. Sponsors refer to the money as “compensation” rather than “wages,” but guinea pigs must pay taxes, and they are given no retirement benefits, disability insurance, workers’ compensation, or overtime pay. And because so many guinea pigs are uninsured, they are testing the safety of drugs that they will probably not be able to afford once the drugs have been approved.

How we are to untangle this web of pretense is far from clear. Perhaps the deepest problem is one that Elliott does not quite reach. We have learned to think of continuing medical progress as sacred and are prepared to offer quite a few sacrifices on its altar.

What Elliott tells is essentially a story of the loss of trust. Once lost, it cannot easily be restored. And once it has been lost, contractual and market practices are bound to seem sensible. We cannot ask pharmaceutical companies or hard-pressed physicians to forgo profit unless we potential patients are prepared to accept a slower pace of medical “progress.” Hence, the most basic prescription that follows from this very fine book is an old one: “Physician, heal thyself.”

Gilbert Meilaender holds the Phyllis and Richard Duesenberg Chair in Theological Ethics at Valparaiso University.

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