Friday, October 20, 2006

Lester Crawford and a Major Disappointment in the FDA

I actually gasped when I read this.

Lester Crawford was the previous commissioner of the Food and Drug Administration (FDA) before he abruptly and without explanation stepped down late last year after serving only two months.

His resignation at that time was puzzling as he had just weathered a difficult and lengthy confirmation process after he was appointed by President Bush. An FDA insider colleague of mine had no idea why Crawford had left at that time. Now, a logical explanation has become apparent.

Several days ago, he pleaded guilty to conflict of interest and to false reporting of financial holdings. The particular holdings involved were of companies whose products were under the aegis of his agency. Both of these offenses carry extensive fines and can lead to prison sentences of up to a year each.

The FDA is charged with the extremely complex and difficult job of insuring the safety of our food and drug supply. The commissioner of this agency is in charged of a decision process regarding the approval and licensing of most important foods, medications and devices that we as citizens consume and use.

Several factors make the FDA's mandate so difficult. Literally reams of data regarding the safety and efficacy of these products must be reviewed in making each of these complex decisions. The available evidence that can be brought to bear in any one decision is rarely clear-cut. It is virtually axiomatic that the conclusions drawn will be based on incomplete and often conflicting information subject to a multitude of interpretations.

And yet the final outcomes of these imperfect analyses affect the health and safety of millions of people. Because other countries will sometimes look to the FDA's reviews to base their decisions about these products, it is possible that billions of people may be affected. A misstep in either direction can obviously have widespread implications. When a dangerous product is wrongly approved, it can obviously injure many people. Likewise, when a safe and efficacious product is rejected, people can suffer needlessly as well.

At the same time, rejecting applications for products can result in the loss of billions of dollars in revenues for some of the most powerful companies in the world. Clearly, this can have enormous political ramifications.

The inherent subjectivity of many key controversies that the FDA must adjudicate simply reconfirms the importance of maintaining an administrative environment as free of potential bias as possible. Weighing the safety and health of our citizens against the economic concerns of massive, multinational corporations requires scrupulous transparency and integrity throughout the entire breadth of the FDA. Nowhere should this integrity be more unequivocal than in its commissioner.

Despite this, since 2002, while Crawford was working at for the agency, he filed seven incorrect reports with the government ethics office overseeing the FDA as well as to Congress (presumably as part of his confirmation hearings). The stock and options he held but did not accurately report were in a variety of companies under the jurisdiction of the agency. In effect he lied to both his agency and more importantly to Congress.

Even the appearance of impropriety can cause a devastating loss of faith in as essential and as politically sensitive an institution as the FDA. With the legion of questions that have been raised about conflicts of interest, hidden agendas and behind the scenes lobbying over the last few years, no one should better understand this than Lester M. Crawford.

His selfishness and his dishonesty was both shameful and destructive. His assertion that "Nothing that I have done, I hope, can be construed to affect the integrity of the FDA," is both self-serving and a manifestation of wishful thinking.

Crawford's cynical acts have lowered the credibility of a government agency that has at least the potential of improving countless lives. He deserves far more than a slap on the wrist.


Anonymous Anonymous said...

Sadly, it seems that more and more these days, that society's leaders operate as if the rules don't apply to them.

October 21, 2006 3:04 PM  
Blogger Kay Wotton said...

Great, comprehensive post about an important topic, especially these days. I worry that we are too concerned about the germs in food safety and not enough about the bugs in the system. It is a pleasure to read a well-written story linking up all the bits and piece.

October 24, 2006 1:51 PM  

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