FDA Admits Politics Trumped Science on Knee Device

Sciencemag.ort ^ | 9/25/09 | Sam Kean

[Nachum]

For the first time, the U.S. Food and Drug Administration has publicly admitted that politics has trumped science. The agency acknowledged yesterday that it approved a device to help with knee-replacement surgeries—a device the agency’s own scientists said often failed—only after it received pressure from a cohort of Democratic congressmen from New Jersey, where the device’s manufacturer is located.

The $3000 device was known as the Menaflex, a “collagen scaffold” that supported a damaged meniscus in the knee. It failed its initial reviews but received approval in December of last year anyway, during the waning days of the Bush Administration. In a new report, FDA cited pressure from senators Robert Menendez and Frank R. Lautenberg and representatives Frank Pallone Jr. and Steven R. Rothman as a decisive factor in gaining approval: “The Director of FDA’s Office of Legislation described the pressure from the [Capitol] Hill as the most extreme he had seen and the agency’s acquiescence to the Company’s demands for access to the Commissioner and other officials in the Commissioner’s office as unprecedented in his experience.”

[NonValueAdded]

Let’s look at the timeline. December: as the article says “the waning days of the Bush Administration” but what it doesn’t say is “the transition period of the Obama administration.” How could democRAT Congresscritters exert that much pressure? Easy to do if the FDA folk feared for their jobs under the incoming administration. A Bush guy on the way out would have told them to go pound sand. No, this one was not “Bush’s Fault.”

[IrishCatholic]

bookmark.

[SaraJohnson]

“This won’t happen any more now that Omaba has cleaned the lobbyists out of DeeCee.”

I know that what you are sayin’ is true cause I saw it on Tee Vee. : )

[Sacajaweau]

Ah....Government Healthcare