A Victory for Coverage with Evidence Development

A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%). The $20 million study, stopped after just 451 stroke victims had been enrolled because of the alarming trend in the results, was sponsored by the National Institute of Neurological Diseases and Stroke.

A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%). The $20 million study, stopped after just 451 stroke victims had been enrolled because of the alarming trend in the results, was sponsored by the National Institute of Neurological Diseases and Stroke.

The Gateway-Wingspan system, manufactured by Stryker, was approved by the Food and Drug Administration in 2005 based on “a small, less rigorous study,” according to this morning’s Washington Post. But use has been limited by a decision by the Centers for Medicare and Medicaid Services to deny reimbursement unless patients receiving the device were enrolled in a clinical trial. This “coverage with evidence development” policy began during former CMS director Mark McClellan’s tenure during the Bush administration.

Walter Koroshetz, chief of NIHDK, told the Post, “This is an example of how to do it right.” I partially agree. The government did the right thing, given existing laws and policies. But Stryker should have done the larger trial in the first place. The potential profits from the device, if it was useful, would have far exceeded the $20 million spent by the government to prove it wasn’t.

The company should be asked to reimburse the taxpayers. And this episode shows that the FDA’s device approval process should be made more stringent to require the same kind of trials for devices that it now requires of drugs — the trials that prove with statistical significance that new products do in fact improve public health.