Wednesday, October 18, 2006

Former FDA Commissioner Pleads Guilty to Lying About Holding Stocks in Companies He Regulated

According to an Associated Press article, former FDA Commissioner Lester Crawford pleaded guilty yesterday to charges of conflict of interest - holding stocks in companies that he [FDA] regulated - and lying about that conflict of interest.

"Former FDA Commissioner Lester Crawford pleaded guilty Tuesday to conflict of interest and false reporting of information about stocks he owned in food, beverage and medical device companies he was in charge of regulating. Crawford admitted to falsely reporting that he had sold or did not own stock when he continued holding shares in the firms governed by rules of the Food and Drug Administration. Beginning in 2002, Crawford filed seven incorrect financial reports with a government ethics office and Congress, leading to the charges. ... The two charges -- conflict of interest and false reporting -- are misdemeanors and each carries a maximum penalty of one year in prison and a $100,000 fine. ... 'Nothing that I have done, I hope, can be construed to affect the integrity of the FDA,' said Crawford, adding that he had worked at the agency four times over 30 years."

The Rest of the Story

Right! In no way does this affect the integrity of the FDA. In no way can the fact that the FDA Commissioner illegally earned tens of thousands of dollars in dividends or by exercising stock options in companies that he regulated be construed to affect the integrity of the FDA. In no way is the integrity of FDA affected when its chief commits a federal misdemeanor - a crime that could be perceived as influencing the regulatory decisions made by the Agency. And in no way should we think that the integrity of FDA is affected when its chief lied about all of this.

Apparently, Crawford just doesn't get it. What he did was a crime specifically because it undermines the integrity of the FDA. It's like the chief executives of Enron pleading with the public not to interpret any of their illegal actions as a slam on the Enron corporation.

Crawford was said to be "choked up" and apologetic when he spoke to reporters outside the courthouse, but if he was really apologetic and really deserved forgiveness, he would have admitted that his actions did affect the FDA's integrity. His failure to admit that basic fact demonstrates a lack of understanding of the severity of his actions and eliminates any spirit of forgiveness that I might otherwise have felt.

The importance of this story to tobacco control is that this is the precise federal agency that the Campaign for Tobacco-Free Kids (TFK) wants to place in control of all aspects of tobacco regulation. And TFK is under the impression that the FDA will take actions that will substantially change the way that tobacco is manufactured in this country, even if such drastic changes would severely harm the profits of the tobacco companies.

For this kind of nonsense, TFK is willing to essentially give up future tobacco litigation, the ability of states to regulate tobacco, and the incentive for states to take on the tobacco issue in the first place?

And things don't seem to be much better with the current FDA Commissioner. Not in terms of illegal stocks or dishonesty, but in terms of the presence of conflict of interest that affects the integrity of the Agency.

Remember that back in October 2005, I wrote:

"To make matters much worse, The Cancer Letter reports that politics and dismissal of ethics has infested the highest level of the FDA and the HHS (Department of Health and Human Services). According to the article, Acting FDA Commissioner Andrew von Eschenbach (a family friend of President Bush) was cleared to head NCI and FDA even though heading both organizations represents a clear and unmanageable conflict of interest. While NCI "has vested interests in many compounds and works in partnership with pharmaceutical companies, FDA has the power to stop trials to protect patients from unwarranted risk. Most importantly, the agency approves drugs."

In addition, an even larger conflict of interest arises because Von Eschenbach is not only head of the FDA but also vice chairman of the board of C-Change, "a coalition of cancer groups heavily funded by pharmaceutical companies and headed by former President George Bush and his wife Barbara Bush. Peter Dolan, CEO of Bristol-Myers Squibb Co., and Gary Reedy, a vice president at Johnson & Johnson , also hold board seats."

How can Von Eschenbach possibly regulate the pharmaceutical industry and properly protect the interests of human research subjects and patients across the nation if he heads a group that is heavily funded by the pharmaceutical industry and runs that group shoulder-to-shoulder with the heads of pharmaceutical companies?

The fact that Von Eschenbach was cleared for such a role despite these inherent conflicts of interest suggests, according to the article, that politics, rather than the public's health, is now dictating policy in HHS, including at the FDA.

Perhaps the most telling quote comes from Michael Clark, a former federal prosecutor who is now a private attorney and editor of the LJN Bioethics Legal Review: "If this were a horse race, Dr. Eschenbach would be a 'trifecta' pick for conflicts of interest by adding the FDA to his NCI and C-Change affinities."

Merrill Goozmer, the director of the Integrity of Science Project at CSPI (Center for Science in the Public Interest) stated: "So here you have companies who are bringing products before FDA, and he is sitting on the board of a non-profit organization with them; what more do you have to say? It's a conflict of interest for the same reason that we don't allow the head of the Securities and Exchange Commission to own stock in the companies he is auditing."

Alan Milstein, a New Jersey health care attorney, expressed his concern that the very health of the American people is being placed in jeopardy because of the conflicts of interest that the government has waived: "Human subjects will be left without the protection of the government. When you are talking about cancer patients in trials, who are desperate for a cure, they are a vulnerable population. These are a class of subjects who need protection...This is the head of the FDA! If you need to set up a mechanism by which this guy avoids conflicts of interest, then he shouldn't be there."

The rest of the story is that the integrity of the FDA is at an all-time low. Putting regulatory authority over tobacco products into the hands of this agency at this time is about the last thing in the world that I think public health practitioners should want to do. But the insult to the injury is that the proposed FDA legislation isn't even strong public health legislation. It contains unprecedented special protections - truck-sized loopholes - for Big Tobacco. I guess being regulated by an Agency that allows financial and political interests to dominate over public health concerns is just another special protection that Big Tobacco will be able to enjoy if TFK is successful in fulfilling Philip Morris' wish.

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