March 10, 2006

A Conflicted FDA?

The Wall Street Journal and Bloomberg News confirm reports from earlier this week that Dr. Andrew von Eschenbach will get the Bush administration's nod to run the Food and Drug Administration. He's been interim commissioner since Lester Crawford resigned last September amid financial conflicts of interest allegations.

While the news accounts suggested Plan B, condoms and other culture war issues would dominate Senate hearings on a von Eschenbach appointment, the central issue from where I stand is his simultaneously holding the highest post at the National Cancer Institute. There were no indications in today's news reports that he plans to resign from that job.

This is a structural conflict of interest, not to mention a conflict of commitment (how can one person devote full attention to both of these complicated jobs?). As I've said in this space many times before, NCI's job is to investigate the causes of and, more importantly, develop cures for cancer. The agency's scientists file applications to the FDA to start human clinical trials, those trials are overseen by the agency, and, in some cases, it even submits new drug applications to the FDA.

In his role as head of NCI, von Eschenbach has repeatedly said that it is his personal goal to end the pain and suffering of cancer by 2015. The unrealistic assumptions behind that statement aside, it is a statement that one would expect from an advocate.

As head of FDA, he has said that streamlining the process by which drugs get brought to market will be his highest priority. The FDA does need to reevaluate the way it monitors and approves drugs. But no one on either side of the aisle on Capitol Hill, not to mention the American public, would want that streamlining and modernizing to jeopardize the agency's core mission of protecting the safety of the U.S. food and drug supply.

If the White House pursues his nomination, Congress should demand a full accounting of his actions at NCI that might present future conflicts of interest in matters that come before the FDA. What clinical trials has he had a personal hand in organizing? How many cooperative research and development agreements has the agency signed under his tenure? How many grants has he approved for companies whose products will eventually come before the FDA? Will he recuse himself from all of these matters?

There's a role in the world for advocates like von Eschenbach. It's just not as the head of the agency whose job it is to serve as policeman over companies that account for one-quarter of the U.S. economy. Someone on the Hill should inform the White House that the former cancer surgeon is not the right man for this job.

Posted by gooznews at March 10, 2006 10:08 AM