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FDA bowed to political pressure in approving faulty medical device

The New York Times is reporting that the Food and Drug Administration has now admitted that it approved a faulty knee device because of pressure from four New Jersey members of Congress and the device’s manufacturer, ReGen Biologics Inc.

I wish I could say that I’m surprised and shocked that the FDA would knowingly put patients at risk because of political and industry pressure. Unfortunately, it’s just another example of how the medical device industry and Pharma have corrupted the FDA’s approval process. Public Citizen’s health researchers testified before the FDA in November 2008 recommending that the FDA reject the device — which replaces damaged knee cartilage — on the grounds that a clinical trial conducted by the company conclusively proved that the device has no clinical benefit. Instead of using data from clinical trials, ReGen’s lab tests did not involve testing on humans.

According to Gardiner Harris’ story in the NYT:

Internal documents demonstrate that agency’s scientific reviewers repeatedly determined that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving inquiries from four New Jersey legislators — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

Oh, by the way, ReGen, which has its offices in Hackensack, N.J., supported all four distinguished gentleman from New Jersey during the last election cycle — or at least its chairman, Gerald Bisbee did. According to the Federal Election Commission database, Bisbee gave Menendez $4,600, Pallone $3,300, Lautenberg $2,300 and Rothman $2,300.

And that was just a quick search of only Bisbee’s name. It’s probably a safe bet that other ReGen execs gave to the campaigns, as well. So, what do a couple thousand dollars in campaign contributions get you? Well, it seems, according to the FDA’s internal review, that it might get you a free pass through any type of credible scientific review. That is if you believe there’s any quid pro quo in our political system between campaign contributions and political favors.

Peter Lurie, deputy director of Public Citizen’s Health Research Group, testified about the faulty ReGen device before an FDA panel in November 2008. He also testified before a U.S. House subcommittee about problems with the medical device approval process in June. After Thursday’s report, he said:

While this report unmasks the massive procedural irregularities in the approval of this device, the device remains on the market and patients continue to be treated with a useless device. The report recommends that the approval of the device itself be reconsidered. This would not be a moment too late. The essential fact about this device is that it doesn’t work. A gold standard, randomized, controlled trial of the product versus a placebo showed absolutely no clinical benefit from this device.