From the Wire: Cardiac pacemakers, stents and other medical devices implanted each year in hundreds of thousands of patients in the United States often are approved by government regulators based on insufficient scientific review, say researchers from the University of California at San Francisco. The US FDA often approves medical devices that have been tested in a single clinical trial, with inadequate findings
About two of three cardiovascular devices approved by the US Food and Drug Administration from 2000 to 2007 were tested in a single clinical trial rather than multiple studies, the researchers reported. Eighty-eight percent of the studies failed to include, as a primary goal, a direct clinical measure of whether patients felt better, their heart function improved or they lived longer, the researchers found.
Senator Charles Grassley, a Republican from the state of Iowa, has criticised the FDA’s device review process as too friendly to the industry. The agency said in a Sept. 24 report that its approval of a knee implant made by ReGen Biologics Inc. was flawed and needed to be re-examined. The US FDA asked the Institute of Medicine, an advisory body, to review the approval procedure used for most medical devices, though not for the majority of cardiovascular devices.
“The findings in this study raise questions about the quality of the data on which some cardiovascular device approvals are based,” wrote cardiologist Rita Redberg, a co-author of the study published in the Journal of the American Medical Association. The approvals “lack adequate strength and may be prone to bias,” Redberg wrote.
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