Apologies if you cannot access this post by Merrill Goozner; I am not sure if you need to be a subscriber to reach his blog:
"Gooz," author of the excellent book, The $800 Million Pill, offers a comment on the recent NIH study showing that stents for arteries in the brain do not prevent strokes and indeed worsen the stroke risk. The good news was that Medicare-Medicaid had held off paying for these stents even with an earlier, smaller study funded by the stent company (Stryker) that was much more promising. (The definitive study, that was stopped early due to the poor outcomes, was funded by NIH.) This was billed as a success story for evidence-based medicine. Medicare-Medicaid insisted that any patient who wanted such a stent had to be enrolled in a proper clinical trial so that the evidence could be collected.
Gooz says-- not so fast. Why wasn't Stryker required to do the large-scale study right from the get-go? He even suggests that the US taxpayers ought to get a refund for the NIH study.
Gooz may be counseling perfection on some matters, but I concur with his general point that the FDA requirements for approving new devices need to be tightened up generally, as we have addressed in previous posts such as: