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.
FROM OVERSIGHT TO OVERKILL by Simon N. Whitney
Simon Whitney, MD, JD. opened his family practice in rural Washington state in 1982. In 1995, his career took a sharp turn when he enlisted at Stanford Law School. He wanted to study and write about medical ethics, and for this a medical degree alone might not be enough.
At Stanford, he earned a degree from the law school, and also did a fellowship at the Stanford Center for Biomedical Ethics. In order to understand the place of ethics in the world, he served on the university’s Institutional Review Board, which is charged with reviewing proposed research to make sure it does not abuse human subjects.
In 1999, Dr. Whitney accepted a faculty position at Baylor College of Medicine in Houston, Texas. He had dual responsibilities at Baylor—to see patients in the family medicine clinic, and to do original work in medical ethics. As he helped the scientists who were his new colleagues, he discovered the many problems with IRB review, and he began publishing papers proposing reform.
Whitney’s view that the IRB system needs a major overhaul was unpopular among ethicists, and he sometimes struggled to get his papers published. But scientists were grateful that someone understood their difficulties. At the end of a talk at the MD Anderson Cancer Center, when Whitney asked if there were any questions. Emil Freireich, a pioneering oncologist who had made breakthrough discoveries in the treatment of childhood cancer, asked simply “How can I help?” Other scientists have been equally enthusiastic.
In 2012, Whitney published an essay pointing out that IRB review had led, unintentionally but predictably, to lopsided enrollment in a study of the use of oxygen in the neonatal intensive care unit, leading to treatment recommendations that would apply less well to disadvantaged children. The article persuaded many scientists, but ethicists reacted with anger (one wrote that Whitney was part of a “recent wave of reactionary attacks” that is “at best ahistorical and at worse blindly hysterical”).
Over time, Whitney realized that the system would never be changed by academic debate. As a first step, in 2016 he published Balanced Ethics Review (Springer), a manual for IRB members that showed how their oversight could be less harmful to the work of scientists. Now, his new book—From Oversight to Overkill—takes the debate over the IRB system’s suppression of research into the public arena. It will enable readers with an interest in how science works, and how government action can harm the public interest, to learn the whole story and decide for themselves what should be done next.