2006_10_01_archive

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.