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What the Doctors Didn’t Say…

by Jerry Menikoff

The recent front-page story told of a tantalizing possibility: although almost all women with breast cancer are now advised to get treated with chemotherapy, in the future more than two-thirds of them may be able to avoid that treatment. However, as the New York Times reported, the evidence supporting this change is still tentative. To get definitive proof, researchers in the U.S. have begun conducting a clinical trial, whose results are supposed to be available in about a decade.

But, there are two important parts of the story that weren’t mentioned in the Times article: first, there’s a good chance that this clinical trial won’t ever get completed in anything close to the predicted time period; second, and most importantly, if it does get completed in time, there will be reason to suspect it was conducted unethically.

Ask yourself: what woman would want to participate in this study, in which half the subjects are randomly assigned to get chemotherapy, with the other half not getting that treatment? This is the sort of decision that someone probably has a strong opinion about, one way or the other. For most women, until it is definitively proven that the chemotherapy is ineffective, the risk of not getting it would seem too great. So, participating in the study—where they would have a 50% chance of not getting chemotherapy—would be unacceptable.

As for those women who had already been looking for a reason not to be exposed to the many side effects of chemotherapy, they too should not want to participate in the study: why risk the 50% chance of being assigned to get the chemotherapy they don’t want?

The only women who should be participating in the study would either be very altruistic, or those who have no strong feelings about getting chemotherapy. That is likely to be a very small group. So if we see that a substantial percentage of women with breast cancer are agreeing to be in the study, we have reason to suspect that they weren’t given the appropriate information they needed to make an informed decision.

Surprisingly, this is far from a rare occurrence. One of the secrets of clinical trials is that although people are given a great deal of information before they enroll in a study, it often isn’t the information that they most need to make a good decision. Amazingly, almost never will the documents straightforwardly tell them why they should perhaps not enter a study—“If you want to do everything possible to make sure the cancer doesn’t come back, you shouldn’t be enrolling in this clinical trial.” The New York Times story likely provided far more useful information than is being given to the breast cancer patients who are asked to enroll in the study. Some women will no doubt cut through the obfuscation, and figure it out. But unfortunately, others—the less well educated, the most vulnerable members of our society—won’t.


Jerry Menikoff is Associate Professor of Law, Ethics & Medicine at the University of Kansas School of Medicine, where he is also Director of the Institute for Bioethics, Law & Public Policy and chair of the Human Subjects Committee. He is also Associate Professor of Law at the University of Kansas School of Law. His book, What the Doctors Didn’t Say…, is due out in July.

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