Interview with Dr. Simon Whitney, M.D.

Dr. Simon Whitney , M.D., author of "From Oversight to Overkill: Inside the Broken System That Blocks Medical Breakthroughs—And How We Can Fix It"

Dr. Simon Whitney , M.D.'s Website

Simon N. Whitney, MD, JD is supremely qualified to write about research oversight, having attained a medical degree, a law degree, and completed a fellowship in medical ethics. He therefore understands research oversight, which in the United States is conducted through Institutional Review Boards or IRBs, from a unique perspective.

Whitney’s first major publication was Balanced Ethics Review: A Guide for Institutional Review Board Members (2015). Most manuals emphasize the IRB’s role in protecting research subjects. Whitney’s contribution demonstrates the importance of a balanced approach, one that recognizes that there is moral value in both protecting research subjects from abuse and reducing the suffering and death of members of the public.

His capstone publication is From Oversight to Overkill: Inside the Broken System That Blocks Medical Breakthroughs—And How We Can Fix It, which presents the problems of excessive oversight through a series of compelling case studies. It shows how the work of scientists in fields ranging from the prevention of kidney stones to the treatment of extremely premature infants is delayed and damaged by excessive oversight. But the problem is not in the IRBs themselves; it comes from misguided federal, and ultimately Congressional, oversight. From Oversight to Overkill explains this in clear language, and paths a way forward so that we can all benefit from medical research that is freed of unnecessary burdens.

Medical research saves lives—yet all too often, it is thwarted by a review system supposed to safeguard patients that instead creates needless delays and expense. Institutional Review Boards, which exist at every hospital and medical school that conducts medical research, have ended up imposing such complex, draconian conditions that research is frequently damaged, delayed, and distorted. This is why medical miracles like the COVID-19 vaccines, which were

developed at warp speed, are far too rare. Instead, medical research in countless areas is kept at a horse-and-buggy pace. The result: unnecessary suffering and avoidable deaths.

From Oversight to Overkill vividly recounts the story behind this crisis, one that remains unknown to the general public. Family physician and ethicist Simon Whitney shows how the IRB system was launched in response to scandals like the notorious Tuskegee syphilis study—and how, in recent decades, this well-intentioned program has become increasingly bureaucratic, convoluted, and stifling.

Readers will learn how vital breakthroughs in treating conditions from kidney stones to heart attacks and premature birth have been delayed by IRB red tape, forcing doctors and patients to settle for less-effective treatments. They’ll see how ill-informed demands from Congressional leaders that regulators “get tough” on scientists have caused respected research institutions to be shut down—with no benefit to the public. And they’ll learn about a balanced, common-sense approach to reforming the system that can free scientists from pointless wheel-spinning while still protecting the public from the risks of unethical or careless experimentation.

Until now, the debate about the IRB system’s failures has been confined to specialty journals in medicine, law, and ethics. From Oversight to Overkill will finally alert citizens about this little-known crisis with America’s medical research system—and what can be done about it.

“Simon Whitney reveals a scandal that every scientist knows but none has mustered the courage to oppose: lifesaving research in the US is crippled by a mindless, Kafkaesque bureaucracy dedicated not to protecting patients but to covering its derrière and expanding its fiefdom. From Oversight to Overkill would be a whiz-bang book even if it just blew the whistle on this outrage, but it’s also as entertaining as any medical bestseller, enlivened with unforgettable stories and vigorous, witty prose.”—Steven Pinker, Johnstone Professor of Psychology, Harvard University, and the author of Enlightenment Now and Rationality

“Making the urgent case that oversight done wrong limits crucial, sometimes life-saving options for patients and doctors, Whitney calls for a new approach to how institutional review operates for medical research involving human subjects in the U.S. . . . a cogent stylist and persuasive constructor of arguments, [he offers] a convincing argument for reform to better serve patients and society.”—Publishers Weekly BookLife (Editor’s Pick)

“A carefully reasoned and disturbing portrait of potential hazards of excessive regulation.”—Kirkus Reviews

“If you’re interested in clinical research, read this book! It is not a diatribe against IRBs. It’s a call to action to make them more humane. It is highly readable and persuasive.”—Rhode Island Medical Journal.

Michael Carter, Co-Host

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