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21 Am. J. Bioethics 1 (2021)

handle is hein.journals/ajbio21 and id is 1 raw text is: THE AMERICAN JOURNAL OF BIOETHICS 2020, VOL 21, NO. 1, 1-3 https://doi.org/10.1080/15265161.2021.1849503 Z Taylor & Francis Taylor &Francis Group GUEST EDITORIAL Don't Blame Hippocrates for Low Enrollment in Clinical Trials John D. Lantos Children's Mercy Hospital, Kansas City and University of Missouri-Kansas City Facts don't come with their own meaning attached. Tzvetan Todorov (2003) Alex John London (2021) is frustrated by the com- monly encountered situation of doctors thinking that they know what is best for their patients even as they are aware that the evidence for their preferences is thin or flawed or non-existent. He thinks that such doctors should be more willing than they are now to enroll their patients in clinical trials in order to deter- mine which treatments are safest and most effective. London hypothesizes that such doctors' reticence to enroll their patients in clinical trials comes from the doctors' adherence to traditional codes of medical eth- ics. In particular, he focuses on the Hippocratic exhortation that a doctor must act to benefit my patients according to my greatest ability and judgment. Those codes may be part of the story, but they are clearly not the whole story. After all, doctors in other countries, who also follow Hippocratic injunctions, enroll their patients in trials (Emanuel, Zhang, and Diana 2020). Blaming Hippocrates seems like the wrong diagnosis. Looking for a solution in changes to professional codes of ethics seems like the wrong treatment. The reasons for more and better science are obvi- ous. We know that clinical judgments are often wrong. We know that conventional medical wisdom is often found out to be just plain wrong. We know that there is widespread and seemingly idiosyncratic prac- tice variation in almost every aspect of medicine (Corallo et al. 2014; Folland and Stano 1990). We want doctors to base their treatment recommenda- tions on good scientific evidence that the treatment actually works. Thus, it is important to try to figure out why it is so difficult to translate our straightfor- ward desire for better biomedical science into the actual studies that form the foundation of such science. The answer seems to be much closer at hand than Hippocrates. There are contemporary bioethicists whose views on this matter are more relevant and more troubling than the beneficence-based Hippocratic ethos. Those ethicists have an almost mystical view of the efficacy of clinical judgment. Three examples (selected from dozens of others) illus- trate the ways that today's bioethicists find research protocols risky compared to treatment based on the individualized clinical judgments of doctors. George Annas was asked, How worried are we about the loss of the physicians' individual decision when nobody really knows what the right answer is? He replied We are really worried about it ... Doctors' judgment matters. We trained them. We think that medical edu- cation means something. We put them through resi- dency and fellowship. We want their judgment (Annas 2013). Goldstein and Weijer criticize clinical trials because patients in such trials are deprived of the protection and benefit of the individualized judg- ment of their physician (Goldstein and Weijer 2020). Horn and colleagues argue that the duty of personal care requires a physician to exercise her individual judgment on behalf of the medical interests of the patient (Horn et al. 2018). These arguments by mod- ern bioethicists undergird the current system of over- sight by which research is deemed to be far riskier than treatment, even when treatment is recommended in the absence of good evidence that it is safe and effective. Sir Iain Chalmers, a pioneering clinical researcher, noted that we are far more lax in our oversight of clinical practice than in our oversight of clinical research. He criticized research ethicists for promoting double standards (Chalmers and Lindley 2000). He wry quotes William Smithells who noted, I need per- mission to give a drug to half my patients, but not to give it to all of them (Smithells 1975). CONTACT John D. Lantos ® jlantos@cmh.edu 0 Glasnapp Family Foundation Chair in Bioethics, University of Missouri, Kansas City, Missouri, USA C 2021 Taylor & Francis Group, LLC

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