FDA OKs devices without key info, 2 studies say

Two new studies find shortfalls in the Food and Drug Administration's approval process for heart devices such as pacemakers and stents.

Safety targets often weren't clearly spelled out in the research submitted by device makers and important patient information was missing, according to one study conducted by researchers from the FDA and Boston's Beth Israel Deaconess Medical Center.

A separate analysis by researchers at the University of California, San Francisco, found heart devices frequently got the FDA's blessing based on research done outside the United States in small groups of patients. Many device studies lacked standards most scientists expect: randomization and a clear goal.

One of the new studies, published online Tuesday in the American Journal of Therapeutics, found about 40 percent of pivotal studies lacked precise targets for how safety would be measured. Studies also failed to fully account for what happened to all patients enrolled in the research and omitted important information on patients such as how many had heart disease or diabetes.

The second study appears in Wednesday's Journal of the American Medical Association. Researchers from the University of California, San Francisco, examined summaries of the research behind 78 heart and blood vessel devices. It found that many devices were approved based on small studies — 300 patients on average — and two-thirds were approved with results of just one study.