On Thursday, September 24th, the Food and Drug Administration accused four New Jersey congressmen and its own former commissioner of influencing the process that led to its decision last year to approve a patch for injured knees. This approval is now being revisited.
Apparently, the FDA’s scientific reviewers had unanimously decided years ago that the device, Menaflex, was unsafe due to device failure, causing patients to get repeat operations. But then agency managers overruled the scientists and approved the device in December after receiving “extreme,†“unusual†and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman.
Can you say, major ethical issue here? And why didn’t the scientists speak out sooner?


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