Friday, September 25, 2009

We're "Shocked, Shocked" ...

... except that, sadly, we're not.

Today's New York Times carries a report by Gardiner Harris and David Halbfinger with this "surprising" headline: "FDA Reveals It Fell to a Push by Lawmakers". Similar articles were published in the Wall Street Journal and elsewhere (click here for WSJ article and here for Bloomberg News report).

According to the article, agency scientists who opposed approving the "Menaflex" device for sale in December of last year were overruled by agency administrators, responding to "extreme" and "unusual" (the adjectives come from the FDA's own report) pressure from New Jersey senators Robert Menendez and Frank R. Lautenberg and congressmen Frank Pallone Jr. (District 6) and Steven R. Rothman (District 9). All four are Democrats. The agency's report also accuses its former commissioner, Dr. Andrew C. von Eschenbach, of acting improperly.

The legislators and the former commissioner have all said that they acted appropriately.

Menaflex is a device designed to "guide new tissue growth" in a torn or otherwise damaged medial meniscus, the cushion between the knee bones. It is manufactured by ReGen Biologic, a Hackensack NJ-based company.

Unfortunately, clinical trials failed to show that the $3,000 Menaflex device worked any better than routine surgery. The agency is now reconsidering its decision to approve the device. According to the Times, "the agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct."

As Captain Renault (Claude Rains) told Rick (Humphrey Bogart) in 1942's Casablanca, "I'm shocked, shocked to find out that gambling is going on here!" just as the croupier hands Renault his winnings, we're "shocked, shocked" to learn that government officials are susceptible to pressure from senators and congressmen, aren't we?

2 comments:

  1. Here is more info on the Menaflex knee device: http://www.newsinferno.com/archives/12920#more-12920

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  2. Thank you, Joshua. I had not come across NewsInferno before -- but have bookmarked now!

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