"During the last 18 months, this country’s confidence in the FDA has been shaken. It has been shaken not because of one isolated incident or one isolated whistleblower. It has been shaken because multiple drug safety concerns have been exposed by more than one courageous whistleblower.
"My oversight of the FDA leads me to the conclusion that there are cultural and systemic problems at the FDA. Unfortunately, Dr. Crawford has long been part of that same culture and system. The evidence is overwhelming that the FDA must change to better protect the American people. Dr. Crawford does not appear willing to be the man to change the FDA.
"During Dr. Crawford’s tenure, I have witnessed the suppression of the scientific process and the muzzling of scientific dissent. First, with Dr. Mosholder finding a link between anti-depressants, children and suicide. And second with Dr. Graham’s allegations regarding the FDA, Vioxx and post-marketing safety generally.
"Dr. Graham’s testimony before the Finance Committee suggests that the problems are systemic. Oversight of the FDA exposed the cozy relationship that exists between the FDA and the drug industry. It revealed that the FDA negotiated for almost two years with Merck about how to change the Vioxx label so people would know about the risk of heart attacks."
In the end, Dr Crawford did become the FDA Commissioner in July 2005, but not for long. This Lester Crawford saga gives to new meaning to the phrase of "what goes around comes around."
After less than 3 months on the job, in a September 23, 2005 letter to President Bush, Crawford announced his resignation from the FDA and said it was "effective immediately."
In public, Crawford explained his departure by saying it was time for someone else to lead the agency. On September 28, 2005, Forbes.com reported that Crawford said he decided to leave the agency because he was tiring after three years at the agency. "He denies that financial conflicts of interest had anything to do with his decision to resign," Forbes noted.
However, Senators Mike Enzi (R-Wyo) and Edward Kennedy (D-Mass) disputed that claim and asked the HHS Inspector General to investigate Crawford's resignation to see whether he left due to an undisclosed financial conflict of interest.
Less than a month later, on October 26, 2005 the Wall Street Journal reported that as late as 2004, Crawford or his wife "owned stock in companies that make or distribute products regulated by the agency.”
According to the Journal, Crawford or his wife held shares in several companies whose business is regulated by the FDA, as late as 2004, when Crawford was acting commissioner, quoting financial disclosure forms obtained by the Journal.
When Crawford began work at the FDA in 2002, the Journal said, he held stock in many companies, including Merck, Pfizer, and Johnson and Johnson. But he told ethics officials that he sold those stocks in 2002, along with stock he held in Kimberly-Clark, which makes medical devices.
Crawford also reported the sale of his stock in the company Teleflex Inc in 2002, which also makes medical devices, although "later forms show that he or his wife continued to own some shares," the Journal reports.
On the same day that the Journal's article was published, the Kaiser Daily Health Policy Report reported that the HHS Inspector General had confirmed that it had launched an investigation into Crawford's departure from the FDA.
About 3 months after that, on February 8, 2006, Crawford's new employer was revealed when the Washington Post reported that Crawford, "whose sudden resignation last fall after less than three months in office remains a mystery, has joined a lobbying firm that specializes in food and drug issues."
"Crawford is listed as "senior counsel" to the firm Policy Directions Inc." the Post said.
A few of the firm's clients listed in the article, include Merck, Altria Group Inc, formerly Philip Morris Companies, and the industry's trade group, the Pharmaceutical Research and Manufacturers of America.
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