Healthy Skepticism Library item: 2613

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Publication type: news

Weiss R.
Acting FDA Head Drops Other Duty
Washington Post 2005 Oct 1
http://www.washingtonpost.com/wp-dyn/content/article/2005/09/30/AR2005093001747.html

Keywords:
FDA Eschenbach

Notes:

Ralph Faggotter’s Comments:
The idea that Andrew von Eschenbach is going to avoid a conflict of interest by “…temporarily step down from his day-to-day leadership of the cancer institute.” is patently absurd.
We all know that he will be back in full control in a few months and any decisions he makes at the FDA in the interim will be informed by this understanding.

Full text:

Acting FDA Head Drops Other Duty
He Bows to Conflict-of-Interest Concerns

By Rick Weiss
Washington Post Staff Writer
Saturday, October 1, 2005; Page A03

Andrew von Eschenbach, the director of the National Cancer Institute, who last week took on the added duties of acting Food and Drug Administration commissioner after the abrupt resignation of Commissioner Lester M. Crawford, said yesterday that he will temporarily step down from his day-to-day leadership of the cancer institute.

The Bush administration came under criticism from members of Congress and others in recent days for allowing the Texas urologist and longtime Bush family friend to take the reins at the FDA while he continued to run the cancer institute, given the many conflicts of interest the dual assignment engendered.

As interim FDA commissioner, for example, von Eschenbach has final authority over requests by the cancer institute to test experimental medications in people. The NCI also has many collaborative efforts underway with pharmaceutical companies whose economic fates are intimately tied to FDA decisions.

Von Eschenbach also faces potential conflict-of-interest issues because of his ongoing role as vice chairman of the board of C-Change, a nonprofit organization headed by George H.W. and Barbara Bush, according to yesterday’s issue of the Cancer Letter, a Washington-based investigative newsletter. Others on that board include executives from Bristol-Myers Squibb Co. and Johnson & Johnson.

More generally, some watchdog groups had expressed concern that von Eschenbach — a vocal supporter of faster drug approvals — was the wrong person to take the helm of the FDA, which in the past year has suffered a crisis of confidence for its rapid approval of several drugs that subsequently had to be withdrawn from the market because of safety concerns.

In a memorandum sent to all FDA employees yesterday and later made public by the Department of Health and Human Services, von Eschenbach said HHS Secretary Mike Leavitt had asked John Niederhuber to serve as “chief operating officer to handle day-to-day management at NCI.” Von Eschenbach recently hired Niederhuber as deputy director for translational and clinical sciences at the cancer institute.

In his memo, von Eschenbach also said that “as a prudential matter,” he will not participate in certain FDA matters in which the cancer institute is a party.

“I look forward to bringing my experience on the discovery side of medicine to the delivery side of medicine,” he wrote, “making sure patients get the drugs and treatments they need as quickly and safely as possible.” Sen. Edward M. Kennedy (D-Mass.) said yesterday in a statement that von Eschenbach’s decision to reduce his duties at NCI “does not go far enough. . . . FDA deserves a Commissioner who can commit completely to this important responsibility, and the National Cancer Institute deserves a full-time Director.”

Sen. Barbara A. Mikulski (D-Md.) also expressed lingering dissatisfaction with the current state of affairs. “I look forward to the swift appointment of a full-time, permanent, competent FDA commissioner,” she said in a statement.

Mystery continues to swirl around Crawford’s sudden decision to resign as FDA commissioner. On Thursday, Kennedy and Sen. Mike Enzi (R-Wyo.) asked HHS Inspector General Daniel R. Levinson to look into Crawford’s departure, including published allegations that he had failed to disclose financial conflicts of interest before he was confirmed to the post in July.