Some food for thought for Trenton City politicians and those currently seeking office – please keep donor money and campaign contributions out of public decision-making:
September 29, 2009
The curious case of the Food and Drug Administration, the knee implant and four New Jersey congressmen raises serious concerns about how politics can influence decisions that affect Americans’ health. It also raises hopes that the FDA is cleaning up its act.
The agency is taking a second look at its approval for Menaflex, a patch designed to replace torn cartilage in the knee. The FDA’s scientific reviewers had recommended against approving the device, based on studies showing it was prone to failure with the result that patients had to undergo more surgery.
Yet it was approved for the market in late 2008. How did that happen? The FDA, to its credit, is now looking into that.
Its preliminary investigation found FDA’s own processes at fault – some of the agency’s rules were confusing, and other times procedures simply weren’t followed.
But it also said unusual pressure was brought on the agency by Reps. Steve Rothman and Frank Pallone and Sens. Frank Lautenberg and Robert Menendez, all New Jersey Democrats.
Fair enough, but the FDA report said the congressmen were involved in the process to a “highly unusual” degree. It noted their persistence and their interest in “specific, substantive aspects of the device’s review.” It said they spoke directly with then-commissioner Andrew von Eschenbach, even trying to arrange a meeting with the commissioner, company officials and members of Congress all present – which would have violated FDA policy. The report stopped short of saying that political pressure was the most significant factor that got the device through the process.
Yes, the congressmen were responding to a constituent’s complaint of unfair treatment by a federal agency. It also happens to be a company whose executives gave a total of $28,000 in political contributions to the four politicians. Not every constituent has the wherewithal to contribute thousand of dollars and get special attention. Even when there isn’t a direct quid-pro-quo it has the aroma of pay-to-play.
Money has infected our politics for so long, there is the temptation to look away and say “So, what else is new?” But when it comes to a medical product which, if defective or inferior, may lead to more pain and expense for patients, there is no excuse for allowing politics to get in the way of scientific review.