Wall Street Journal Op-Ed On Sham Surgery Gets It Wrong Reply

In an op-ed piece in the Wall Street Journal Scott Gottlieb, a former FDA official under George W. Bush, argues that the FDA should stop requiring medical device companies to use sham procedures when they test certain new products. To support his argument he uses the example of renal denervation, a once highly promising new technology for lowering blood pressure. Unfortunately, Gottlieb extracts exactly the wrong lesson from this story, because the renal denervation story is a perfect example of why sham procedures can be both necessary and more ethical than any alternative.

At first glance it’s hard to disagree with Gottlieb. The idea that patients would receive an invasive surgical procedure that could do no good appears abhorrent. “Research that introduces harm or risk with no opportunity for benefit would seem to conflict with the principles governing research on humans,” writes Gottlieb.

But the same exact words could and should be used to describe medical devices with no proven benefit. In such cases, however, instead of the relatively small number of patients potentially exposed to harm in clinical studies, the number of patients exposed to harm in the real world may be larger by many orders of magnitude.

Let’s examine this issue using the same example used by Gottlieb: renal denervation….

Click here to read the full post on Forbes.

 

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Politics and Transcatheter Aortic Valve Replacement 2

Scott Gottlieb, MD

From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears:

  1. Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people.
  2. The stampede to stake a claim in a promising, highly lucrative new territory would lead to the exploitation and mistreatment of many thousands of desperately sick people.

Remarkably, neither scenario occurred. Instead, at a very early stage, medical societies, regulators, and industry worked together to ensure the smooth introduction of TAVR in the US. The final decision earlier this week by the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement for TAVR was the latest step in a long, ongoing process that, for once, didn’t appear broken, and, in fact, represented an unusual consensus among physicians, regulators, insurers, and other involved parties.

However, in an apparent attempt to inject politics where it’s neither needed nor wanted, Scott Gottlieb, a conservative activist who is a former FDA deputy commissioner and CMS adviser, concludes that the CMS ruling means “that for costly procedures, Washington will be making more of these choices for us.” In a posting on the American Enterprise Institute’s The Enterprise BlogGottlieb writes that the decision “is a vivid example of how our healthcare is going to get reimbursed now that Washington calls more of the shots.”

Gottlieb doesn’t make a clear statement that explains his hostility to the CMS decision. Instead, he cites several facts that he thinks makes his case for him. He’s wrong.

For instance, Gottlieb writes:

CMS is also restricting the number of doctors that can perform the new procedure.

Actually, CMS has done nothing of the sort. It has insisted that doctors who perform the procedure have adequate training and that the hospitals where the procedures are performed have sufficient experience and adequate facilities. Perhaps Gottlieb would be happy to send an elderly relative for TAVR  to a local community hospital with little experience in the procedure. It was precisely to avoid this scenario that the American College of Cardiology and the Society of Thoracic Surgeons supported CMS in this coverage decision. I fail to see how anyone would benefit by widespread proliferation of TAVR by novice operators at inexperienced centers.
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