Categories
Podcast

37. Simon Whitney, MD, JD: Unethical Research, Unintended Consequences, and the Critical Need for IRB Reform

In this conversation, Daniel Belkin and Mitch Belkin interview Simon Whitney, MD, JD, about his book From Oversight to Overkill. They discuss the history of Institutional Review Boards (IRBs), including ethically questionable experiments such as Chester Southam’s cancer cell injections, the Willowbrook experiment, as well as the US Public Health Service Syphilis Study (AKA Tuskegee experiment). They then discuss Peter Buxton, Henry Beecher, James Shannon, and the congressional oversight of federally funded research. Finally, they touch on the ISIS-2 study, Pronovost’s checklist, OHRP’s crackdown in the late 1990s, and discuss whether research is too safe, IRB infallibility, autonomy in the Belmont Report, and the risks and benefits of restricting research in the name of safety.

SpotifyApple Podcasts | Google Podcasts | Youtube

Who is Simon Whitney?

Simon Whitney, MD, JD, is a family medicine physician and ethicist. He previously taught at Baylor College of Medicine for 22 years. He is currently retired from the practice of medicine but continues to publish and teach medical ethics. He is the author of the book “From Oversight to Overkill: Inside the Broken System That Blocks Medical Breakthroughs—And How We Can Fix It.”

References:

If you enjoyed this episode, be sure to check out our episode with Carl Schneider.

Categories
Podcast

34. Parker Rogers: How FDA Deregulation Promotes Medical Device Innovation & Safety

In this conversation, Daniel Belkin and Mitch Belkin interview Parker Rogers about his recent job-market paper “Regulating the Innovators: Approval Costs and Innovation in Medical Technologies” which examines the impact of FDA regulation on innovation, market structure, and product safety. They discuss the FDA’s medical device risk classification and his analysis of down-classification events (from higher to lower risk categories), which shows deregulation has a positive impact on innovation, firms producing devices, as well as product safety. They also touch on the value of regulation versus litigation, legal liability exposure of small versus large firms, and the European Medicine Agency.

Spotify | Apple Podcasts | Google Podcasts | Youtube

Who is Parker Rogers?

Parker Rogers is a Ph.D. Candidate in Economics at the University of California, San Diego. In the fall of 2023, he will be a Postdoctoral Fellow in Aging and Health Research at the National Bureau of Economic Research. In the fall of 2024, he will be joining the School of Business at Indiana University as an Assistant Professor.

References:

Categories
Podcast

26. Carl Schneider, JD: Patient Decision-Making, Questioning Informed Consent, and Why IRBs Should Be Abolished

In this colorful conversation, Daniel Belkin and Mitch Belkin speak with Carl Schneider, JD about informed consent and the problematic nature of IRBs. We discuss the difficulties of patient education and whether patients actually want medical knowledge in order to guide their decision-making. We discuss the onerousness of IRB regulation, event licensing, the costs of inhibiting knowledge generation, as well as the paternalism of IRBs. We cover how “protections” for vulnerable groups counterintuitively harms these groups by preventing both the generation of knowledge and the development of treatments. Professor Schneider argues that IRBs should be abolished and the system of informed consent ought to be reconsidered.

Spotify | Apple Podcasts | Google Podcasts | Youtube

Who is Carl Schneider?

Professor Carl Schneider is a lawyer and bioethicist. He is a Professor of Ethics, Morality, and the Practice of Law at University of Michigan. After attending University of Michigan Law School, he served as law clerk to Justice Potter Stewart of the United States Supreme Court. Schneider has authored several books, including The Censor’s Hand: The Misregulation of Human-Subject Research and The Practice of Autonomy: Patients, Doctors, and Medical Decisions.

References

If you enjoyed this episode, be sure to check out our episode with Simon Whitney.