By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: FDA’s Sham Regulations Impede Medical Innovation
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Devices > FDA’s Sham Regulations Impede Medical Innovation
BusinessMedical DevicesPolicy & Law

FDA’s Sham Regulations Impede Medical Innovation

John Graham
John Graham
Share
3 Min Read
fda regulations
SHARE

fda regulationsIn the Wall Street Journal this week, Dr. Scott Gottlieb discussed (gated, by subscription only) a worrying trend in the Food and Drug Administration’s regulation of medical devices.

fda regulationsIn the Wall Street Journal this week, Dr. Scott Gottlieb discussed (gated, by subscription only) a worrying trend in the Food and Drug Administration’s regulation of medical devices. Increasingly, the FDA is demanding that device makers conduct trials of new devices by randomly assigning patients to the new device…or to a sham surgery without the new device.

In the example cited by Dr. Gottlieb, patients were assigned to sham surgery instead of to a real surgery that inserted a device that ablates (destroys) small nerves in arteries, a procedure that reduces high blood pressure. At great expense, these patients’ arteries were cut open, poked, and prodded, but no functioning device was inserted. The point was to determine whether the device actually worked or whether a placebo effect caused a positive outcome.

What is especially unfortunate about this development is that the traditional clinical trial of such medical devices is a “non-inferiority study,” a study in which the new device is tested against an already approved device. If the new device is at least as good as the incumbent, it is approved.

More Read

Readmissions Revolving Door
7 Ways to Reduce ER Admissions and Readmissions
3 Ways to Improve Your Health That Have Nothing to Do With Diet and Exercise
Medicaid Expansion: How Does It Affect You?
How A Healthcare Mobile App Can Help Reduce Hospital Management Cost
Fiscal Cliff Dwellers: Don’t Forget, You Could Always Beef Up IPAB

It is hard to see how the emerging approach is ethical. Patients who would have received an older, proven device are now increasingly subjected to sham surgeries instead. I have heard anecdotes of surgeons refusing to participate in such procedures.

Patients, payers, and regulators should be thrilled that device makers are content to conduct studies that compare effective devices against each other. In contrast, pharmaceutical companies are very reluctant to conduct trials that compare safe and effective drugs against each other. In the pharmaceutical context, such trials are used not to demonstrate non-inferiority, but to show whether the new drug is superior to the old drug.

In these cases, they are called head-to-head trials, and many self-styled patient advocates have lobbied to demand that drug makers conduct such trials. A few years ago, I wrote an article explaining how head-to-head trials for the purpose of demonstrating superiority are much more expensive and difficult to interpret than placebo trials for drugs. (In the latter, patients in the control group are given a sugar pill.)

How strange then that the FDA seeks to prevent device makers from conducting trials of two competing, effective technologies, in favor of sham surgeries. It appears to be another case of regulatory overreach that puts many patients in harm’s way.

TAGGED:FDA
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

a woman walking on the hallway
6 Easy Healthcare Ways to Sit Less and Move More Every Day
Health
September 9, 2025
Clinical Expertise
Healthcare at a Crossroads: Why Leadership Matters More Than Ever
Global Healthcare
September 9, 2025
travel nurse in north carolina
Balancing Speed and Scope: Choosing the Nursing Degree That Fits Your Goals
Nursing
September 1, 2025
intimacy
How to Keep Intimacy Comfortable as You Age
Relationship and Lifestyle Senior Care
September 1, 2025

You Might also Like

Data_-_PQRS_Benefits
Health ReformPolicy & LawPublic Health

PQRS and the Benefits of Participating in 2015

December 18, 2014

Measuring Physician Quality – Bully or Just Plain Bull

May 26, 2016
Global HealthcareNewsPublic Health

The Developing World Uses Social Media to Promote Safe Sex

May 4, 2012

Tobacco Control Policies; Scaling Up Incentives

September 7, 2011
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?