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Did Democrats Pressure the FDA Into Approving an Unsafe Knee-Replacement Device?

September 25, 2009 - by Donny Shaw

The F.D.A. says so. On Thursday the F.D.A. issued a report admitting that they bowed to political pressure in approving a knee-replacement device, known as Menaflex and manufactured by ReGen Biologics Inc., and that the pressure came from four New Jersey Democrats.

Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman put “extreme,” “unusual,” and “persistent” pressure on the F.DA. to approve the device, which has been shown repeatedly in clinical studies to fail and require patients to have another operation to take it out.

It looks like campaign money and political connections were involved. “All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey,” the New York Times reports. Campaign finance data shows that the four of them received a total of $26,000 from the company in the last election cycle. Michael Hutton, is now a lobbyist for ReGen, and in a Wall Street Journal article from March 2009, it’s clear that he has worked specifically on the F.D.A. approval of the Menaflex device.

Of course, the four members of Congress all say that they were not influenced by the money they got from the company. The money only comes out to about $6,000 each – not much compared to the million or more it takes to run a congressional campaign. But the narrative laid out here is pretty clear. Regen gives money to Congress, Congress corrupts the F.D.A. approval process. It’s hard to see how it’s not a quid pro quo, and for purposes of maintaining a functioning democracy, the appearance of corruption is just as damaging as corruption itself.

Pictured above are Sens. Lautenberg and Menendez.

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  • oderintdummetuant 09/26/2009 10:37am

    Since this freaking blog has been on the home page, other blogs haven’t had a chance to get the same exposure. So please, check out this blog.
    Really kinda like a slap in the face to the left, but some how this isn’t getting as prominent of a placement as the “Knee-replacementgate” is getting.

  • Anonymous 09/28/2009 4:48am

    The ‘device’ was not for knee replacement but meniscal repair. The meniscus is a cushion that surrounds the joint made of cartilage and adds stability and cushioning. Menaflex is a film of collagen (same major component of cartilage) that is used to wrap that is applied surgically around the injured or torn meniscus in attempt to facilitate repair. Please get facts straight. Knee replacement devices are metal alloys and plastic that totally replace the area of the bone that forms the joint.

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