"The FDA has a tough job, and they do a pretty good job," added Dr. Charles Lowenstein, head of cardiology at the University of Rochester Medical Center. "This article is concerning because the results suggest that the FDA sometimes accepts studies that aren't as rigorous as possible. . . The FDA should rely on the best studies possible, not the best studies available."
According to the study authors, device safety has largely slipped through the cracks, even as attention on drug safety mounts.
Meanwhile, there has been an explosion in the number of cardiac devices out there. According to background information in the article, some 350,000 pacemakers, 140,000 implantable cardioverter-defibrillators and more than 1 million stents were implanted in the United States in 2008.
And a recent U.S. Supreme Court decision ruled that once a device is approved, consumers can no longer sue for safety or effectiveness problems.
The authors of this study reviewed 123 summaries on safety and effectiveness for 78 premarket approvals of high-risk devices (those that are life-sustaining and usually permanent) that took place between January 2000 and December 2007.
Many studies did not meet gold standards: only 27 percent were randomized and only 14 percent were blinded.
Also, some two-thirds of premarket approvals were granted on the basis of just one study, suggesting limited evidence for their safety and efficacy.
Only half of studies included control groups and 31 percent were retrospective (considered less reliable than prospective studies).
And many studies were not conducted in the United States, raising questions about how valid they are for a U.S. patient population.
But the FDA countered that it had "serious concerns" with the study's approach.
"Congress has recognized that devices are not drugs and device trials requ
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