Politicians; So Predictable

This story, the details of which appeared in the NY Times on September 25, 2009, describes the underside of our political system as well as anything I've read recently.

The cast of characters include Sen. Robert Menendez, Sen. Frank Lautenberg, Rep. Frank Pallone, Jr., Rep. Stephen R. Rothman, ReGen Biologics, and the FDA.

The item that precipitated this scandal is a C-shaped pad used to repair a torn or damaged meniscus. It's called a Menaflex and costs $3,000. A clinical trial of the device failed to show that it had worked any better than routine surgery. It was further alleged, according to the NY Times, that the device has often failed and when this happens patients are forced to get another operation.

The FDA's scientific reviewers repeatedly and unanimously, over many years, decided that Menaflex was unsafe. And, that's when the fan began getting hit. A report issued by the FDA claimed that they began to come under "extreme," " unusual," and persistent pressure from the four New Jersey politicians mentioned above. In response to that pressure, the FDA commissioner, Dr. Andrew C. von Eschenbach, overruled the scientists and approved Menaflex for sale in December. Dr. von Eschenbach resigned in January of '09.

In a conference call with reporters, the FDA's current principal deputy commissioner, Dr. Joshua Sharfstein said that, "The message here is that there were problems with the integrity of the FDA's decision-making process that have solutions." Indeed, a report issued by the FDA said that Dr. von Eschenbach became, as a result of political pressure, "Personally engaged in the details of a process usually coordinated" by scientific staff. One agency manager concuded that Dr. von Eschenbach "was demading not only an expedited process but also an outcome in favor of ReGen."

The politicians claimed they did no more than what they would do for any constituent. Be that as it may, the politicians collected the following from Regen:

Robert Menendez _
Oct 28, 2007 $2,000 (to the New Millennium PAC ccontrolled by Mr. Menendez)
Mar 2008 $7,100 for the Menendez campaign account

Stephen R. Rothman
Dec 4, 2007 $500
Feb 14, 2008 $8,200 for his campaign account, and $2,600 to Renewing Opportunity, Trust
& Hope, a Rothman PAC (You gotta love the names these politicians give their
PAC's)

Frank Pallone, Jr
Dec 2007 $2,300 from a ReGen executive
Oct 2008 $1,000 from a ReGen executive

Frank Lautenberg
May 2008 $2,300 from a ReGen executive

Naw, these guys didn't do it for the money. They did it to help a constituent. Believe that and I've got a bridge across the East River I'd like to sell you.

But, it's not just this ReGen thing that's so troubling. What we've got to realize is that this sort of behavior can occur when politicians decide that, for purposes of social engineering, the unskilled and unemployed should be given mortgages, or that the military should buy equipment they don't need, because constituents in their districts have factories they want to keep busy. Sure, big business needs watching. Our military needs watching. Our banking system needs watching. But more important than anything else is the need for us to keep our eyes on our politicians.