Book Review

What the Doctor Didn't Say: The Hidden Truth about Medical Research

N Engl J Med 2007; 356:877-878February 22, 2007

Article

What the Doctor Didn't Say: The Hidden Truth about Medical Research
By Jerry Menikoff, with Edward P. Richards. 321 pp. New York, Oxford University Press, 2006. $29.95. ISBN: 978-0-19-514797-1

This book begins in the spirit of a muckraker, with the stated mission of exposing “the hidden truth” about medical research or, more precisely, medical research with human subjects. Each year, millions of people enroll as subjects in medical research — and very often, it appears, with little understanding of the implications of their decision (if indeed the decision was theirs), the risks entailed, or the availability of other options that might better serve their goals.

The first part of the book clarifies the distinction between being a medical patient and being a medical research subject — a distinction that in theory is well understood but in practice, evidently, is not. The increasing number of physicians who recruit their own patients for research trials no doubt contributes to the failure of patients to understand that becoming a research subject will not necessarily be in their own best interests. Menikoff argues that part of the reason for this misunderstanding lies in consent forms, which he believes are often deceptive. Patients may enroll in studies as their “last, best hope,” not realizing that the treatment being tested could be available outside the study. Consent forms, he argues, are designed to obtain consent, not to facilitate informed choice. He asks, “To what extent are we willing to be less than fully truthful to subjects to get them to enroll in studies?”

Several chapters of the book are devoted to discussion of the laws and regulations, or the lack of such, pertaining to the enrollment of persons who are not fully capable of providing consent, including incompetent adults, children, and patients who are unconscious. Studies involving such subjects present some of the most difficult ethical dilemmas in medical research. In these chapters, Menikoff begins to switch gears. His focus shifts from a concern that patients get truthful and complete information about studies in which they might enroll to a concern that society find ways to encourage or even require greater participation in research.

For example, with respect to research involving children, Menikoff argues that the current federal regulations are unduly restrictive and that research that involves more than a minor increase over minimal risk is often carried out in violation of these regulations — such as studies that “alter a child's medications or even require [children] to stop taking them.” In his view, we should loosen the regulations rather than try to alter or prevent such investigations. His somewhat curious argument is that since parents are legally free to expose their children to substantial risks, medical researchers, with the parents' permission, should be free to do so as well. If this recommendation were combined with another of Menikoff's recommendations — namely, that research subjects in studies that involve significant risk should be paid substantial sums to compensate them for taking the risk — one can imagine the unfortunate consequences for some children.

Whether or not Menikoff advocates substantial payments in cases where the research subject is not the party providing consent, it is clear that he favors such payments to competent adults. He argues that the payments are not “coercive” (or, as some might say, “bribery”) but simply appropriate compensation for assuming a risk. He does not, however, explore the questions of how much compensation would be appropriate in various circumstances, whether the degree of risk can be calculated in advance, or what the results might be if pharmaceutical companies started competing for subjects with one another or with governmental research entities by significantly increasing their payments for participation in studies.

Menikoff suggests another means of increasing participation in research — restricting the availability of alternative (experimental) treatments outside a research setting. He believes that this step is morally defensible because of the importance to society of medical research (though he does little to differentiate among the many kinds of endeavors that fall under this rubric). Apart from the ethical issues here, there are practical ones. It would seem extremely difficult to restrict patients' access to medications already approved by the Food and Drug Administration in cases in which a physician or physicians decided to use the medications off label in clinical investigations.

Menikoff's book tells us that if we believe in the research enterprise, then we must accept that persons, consenting and not consenting, will be exposed to risks — sometimes very substantial risks. We should be honest about this, but we should not be afraid to use the carrot and the stick or to alter our laws and ethical guidelines in order to facilitate medical progress.

In our current circumstances, however, as medicine becomes ever more commercialized and industrialized, it is not clear how the advancement of knowledge can be separated from the advancement of power, profit, and prestige and the incentives they provide for misbehavior and the erosion of patient protections. For some of us, the often-quoted warning of the philosopher Hans Jonas is still relevant:

Let us not forget that progress is an optional goal, not an unconditional commitment. . . . Let us also remember that a slower progress in the conquest of disease would not threaten society, grievous as it is to those who have to deplore that their particular disease be not conquered, but that society would indeed be threatened by the erosion of those moral values whose loss, possibly caused by too ruthless a pursuit of scientific progress, would make its most dazzling triumphs not worth having.

Beverly A. Woodward, Ph.D.
Brandeis University, Waltham, MA 02454

Citing Articles (1)

Citing Articles

1. 1

   T. Bogardus. (2008) Should We Be Alarmed by Medical Research?. Journal of Medicine and Philosophy 33:5, 524-532
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