21st Century Cures Act May Do More Harm Than Good - Metal Hip Implant Lawyer

21st Century Cures Act May Do More Harm Than Good

July 22nd, 2015 by Cutter Law

For anyone whose life has been affected by a failed hip implant, it’s a well-known fact that the FDA’s oversight of medical devices — both before and after they are on the market — is not as strong or effective as it should be. And unfortunately, new federal legislation passed in the House of Representatives last week actually makes this problem worse.
An article in the New York Times calls the 21st Century Cures Act “disingenuously titled”, saying it may benefit the medical devices industry but not the health of the American public.
In The F.D.A.’s Medical Device Problem, authors Rita Redberg and Sanket Dhruva (who are both cardiologists), say the law, which is expected to be examined by the Senate this fall,

“would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). In other words, anecdotal evidence, rather than the scientific studies, could be used to approve devices.

This act would also create a new, faster approval process for “breakthrough technologies” that are believed — but not necessarily proved — to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk. The legislation defines “breakthrough” loosely, creating a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick.”

The authors give a disturbing example of why postmarket clinical trials are ineffective. One clinical trial looked at patients who already had the Wingspan intracranial stent implanted with the goal of preventing recurrent strokes. The trial

“found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence, the F.D.A. did not withdraw the device (though it did narrow its recommended uses). The Wingspan continues to be marketed and implanted today, putting patients at unnecessary risk.”

Many have spoken out against the 21st Century Cures Act. Even outgoing FDA Commissioner Margaret Hamburg expressed her concerns, saying that

“There’s a misperception that you might be able to speed up innovation by lowering the standards for safety and efficacy, and I think that would be a terrible mistake that would not only just damage patients, but industry as well.”

Here are a few others’ takes on the legislation:

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