Former FDA Chief Charged

Bulletin #692

October 22, 2006

Dear All,
As we all ponder why it is that the incredible fact that the FDA has failed ever to regulate the most commony prescribed medication used in the US (the fluoride compounds added to the public water supply) a recent article in the NY Times (October 17, printed below) reports that a former chief of this agency has been charged with “conflict of interest and lying about stock he and his wife owned in companies the agency regulates.”
While Dr. Crawford’s activities may have had no connection with the failure of the FDA to do its duty on fluoride - after all this dereliction of duty has been ongoing since the agency was formed - it does bring up yet another example of lack of integrity in high ranking officials in the agencies set up to protect our health. That lack of integrity certainly relates to the protection afforded to the fluoridation program, in one way or another, by the CDC, NIH, FDA and the EPA.
For those who wish to see an end of fluoridation it is in our interests to promote the notion that to regain the public’s trust in these huge bureaucracies they have to be seen aggressively to be upholding scientific integrity in every quarter. There would be no quicker or surer way of doing this than by removing the veil of protection each of these agences provides for this silliest of federally supported “health” programs. For example:

1) The CDC should separate those officials in its agency who promote fluoridation from those who review its safety.

2) The NIH should should stop funneling money into research on fluoride’s health effects into dental schools where the conflict of interest should be obvious to anyone (e.g. the Douglass cover up of Dr. Elise Bassin’s findings on osteosarcoma).

3) The EPA Water division should do an honest job determining (at the recommendation of the NRC) a new MCLG for fluoride. It certainly has to do a better the job than it did in 1985 when they produced the current MCLG.

4) The FDA should AT LEAST take the same hard look at fluoridating chemicals that it takes on other drugs.

At the moment one of the few bodies that have made “scientific integrity” an important goal in their operations is the union (NTEU 280) which represents the professionals working at the the EPA’s Washington DC headquarters. It is not a coincidence that one (of several) issues pertaining to scientific integrity which they continue to pursue is questioning the safety of water fluoridation. But their lonely stand for something as basic as the need for scientific integrity in government agencies is troubling. Why isn’t this at the top of the agenda of EVERY union rerepresenting federal employees?
I have said many, many times: without truth there is no science and without science public health policy will descend simply to negotiating with the highest bidders. That is what we - and millions of others - are seeing revealed nearly every day in Washington. And we are sick and tired of it. Give us some truth not only for our health’s sake but for the country’s sake!
Paul Connett
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http://www.nytimes.com/2006/10/17/washington/17fda.html?_r=1&ei=5094&en=304993&oref=slogin
Former F.D.A. Chief Is Charged With Conflict
By STEPHANIE SAUL
Published: October 17, 2006
Lester M. Crawford, former chief of the Food and Drug Administration, was charged yesterday with conflict of interest and lying about stock he and his wife owned in companies the agency regulates.

Dr. Crawford, who resigned abruptly in September 2005, just two months after his nomination had been approved by the Senate, is expected to plead guilty in federal court in Washington today, said his lawyer, Barbara Van Gelder.

Each of the two charges filed against Dr. Crawford, 68, is a misdemeanor punishable by up to a year in jail, but Ms. Van Gelder said she expected him to be fined and placed on probation.

“It’s his responsibility,” she said, “and he accepts it.”

Senior employees of the food and drug agency are prohibited from owning shares in companies the agency regulates, and when Dr. Crawford became a deputy commissioner in 2002, the government’s charging document says, ethics officials at the Department of Health and Human Services told him that he and his wife would have to sell stock in a dozen regulated companies. Those companies included several large pharmaceutical and medical device concerns, among them Johnson & Johnson, Merck, Pfizer, Medtronic and Boston Scientific.

Dr. Crawford and his wife, Catherine, sold their holdings in nine companies, the government says, but retained shares in three others: the food giants Sysco and Pepsico, and Kimberly-Clark, a maker of consumer health care and other products.

In addition, it says, Mrs. Crawford held shares in another regulated company, Wal-Mart, but her husband did not list those holdings in his 2002 financial disclosure.

Prosecutors also say that Dr. Crawford, a veterinarian and pharmacologist, owned options to buy 41,500 shares in Embrex, an F.D.A.-regulated poultry biotechnology company where he formerly served as a director. He exercised some of those options in 2003 and 2004, earning $8,150 in one transaction and $20,627 in another. He correctly reported those transaction on his federal tax returns but did not list them in disclosure filings at the time or disclose the remaining, unexecuted options he held in the company, the charges say.

The government noted that during a period when the Crawfords held shares in Pepsico, a soft drink and snack food company, he was chairman of an F.D.A. Obesity Working Group that among other tasks was reviewing calorie content labeling for soft drinks. At the time, prosecutors said, the couple held 1,400 shares of Pepsico worth at least $62,000, as well as 2,500 shares of Sysco, which specializes in supplying food to restaurants and institutions, worth at least $78,000.

When Dr. Crawford became acting commissioner of the agency in 2004, reviewers at the Department of Health and Human Services, the F.D.A.’s parent, again raised questions about his ownership of Sysco and Kimberly-Clark shares. Responding to that query, he wrote in an e-mail message to an ethics official at the department that “Sysco and Kimberly-Clark have in fact been sold.”

“In truth and in fact, as Crawford then knew, Crawford and/or his wife held shares” in both Sysco and Kimberly-Clark “throughout 2003 and 2004,” according to the charging document.

Dr. Crawford, now a senior staff member at the Washington lobbying and communications firm Policy Directions, could not be reached for comment. But his lawyer, Ms. Van Gelder, said the fact that the charges were misdemeanors reflected Dr. Crawford’s having amended his financial forms after his departure, making a full disclosure.

“One of the things I hope comes out is that he sold the Mercks and the pharmaceuticals,” Ms. Van Gelder said. “The Syscos and Kimberly-Clark, one wouldn’t ordinarily think, ‘I’ve got to divest myself.’ You wouldn’t think Wal-Mart is in the same boat as Merck.”

Dr. Crawford’s rocky 18-month tenure as acting commissioner and then commissioner was marked by a series of controversies, including the withdrawal of the painkiller Vioxx from the market and an internal battle over whether the agency would approve the emergency contraceptive Plan B for over-the-counter sale.

Though his sudden resignation last fall so soon after his confirmation appeared unusual, he offered no detailed explanation. The office of Daniel R. Levinson, inspector general of Health and Human Services, told Congress, however, that it was investigating the circumstances of the commissioner’s departure.

Records obtained through the Freedom of Information Act several weeks later revealed that the department’s ethics office had questioned Dr. Crawford’s broker in August 2005, the month before he quit.

A spokesman for Sysco said yesterday that the company had not been aware that Dr. Crawford was a shareholder.

“We were totally unaware of it, and we really didn’t have any real regulatory matters before the agency beyond routine matters,” said the spokesman, John M. Palizza.

A spokesman for Pepsico said compliance with government regulations concerning conflict of interest was clearly an individual responsibility. He referred additional questions to Dr. Crawford.