FDA’s Sham Regulations Impede Medical Innovation

In 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.

In 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.

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.