FDA head's dual role worries some

Dispute over `Plan B' drug leaves cancer institute head doing 2 jobs


WASHINGTON -- The government's principal cancer-fighting agency has been without full-time presidentially appointed leadership for almost eight months, aggravating oncologists and advocate groups who say the country needs strong management to combat, treat and prevent a disease that kills more than half a million people every year.

Dr. Andrew von Eschenbach, 64, a urologist and close Bush family friend from Texas, has served as director of the National Cancer Institute since 2002. But in an unusual arrangement, von Eschenbach has been straddling leadership posts there and at the Food and Drug Administration since September when the then-FDA commissioner abruptly resigned.

In March, President Bush nominated von Eschenbach to run the FDA permanently, and von Eschenbach said then that he intended to quit the cancer institute post.

But his FDA nomination is languishing in the Senate with no confirmation hearings planned because of a dispute over the morning-after contraceptive pill. The FDA has delayed a final decision, pending for about three years, on over-the-counter sales of the so-called Plan B pill, and Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington are blocking the nomination until the FDA acts on the pill.

For now, von Eschenbach appears to be continuing to lead both the FDA and the cancer institute.

Institute spokeswoman Nicole Saiontz couldn't provide a date that von Eschenbach's resignation would take effect.

The FDA, meanwhile, has been without full-time leadership for at least two-thirds of Bush's presidency.

Dr. Vincent DeVita Jr., who led the National Cancer Institute for eight years during the Carter and Reagan administrations, said, "There are probably decisions that need to be made that are not being made because they require the sign-off of the director, and the director's preoccupied running back and forth between the Food and Drug Administration and the National Cancer Institute."

Bush's proposed federal budget for 2007 calls for cuts of almost $40 million in funding for the cancer institute, leaving spending at about $4.75 billion.

"When budgets are being cut, you need leaders," said DeVita, a professor of medicine at Yale University.

While saying he personally likes von Eschenbach and Bush, DeVita said he is additionally troubled that von Eschenbach has been leading the institute that champions the development of cancer drugs and the agency that regulates the development process of those drugs.

"I think it's inherently a conflict of interest and it's just not possible to do both jobs right," DeVita said.

The White House said Dr. John Niederhuber, von Eschenbach's deputy, has day-to-day control of the cancer institute.

Christina Pearson, a spokeswoman for the Department of Health and Human Services, said Niederhuber is managing the institute with an interim senior leadership team.

"We have great confidence in them," she said.

But critics say the imprimatur of a presidential appointment and the mantle of permanency that comes along with it help drive progress.

"If you don't know whether the leader's going to be there permanently, trying to develop relationships and trying to make long-term plans are difficult for the person that's the deputy," said Donna E. Shalala, President Bill Clinton's secretary of Health and Human Services, the umbrella Cabinet department for the NCI and the FDA. She is now president of the University of Miami.

"There's just no organization that should go without a leader for a long period of time," she said.

DeVita added, "You need somebody you can blame everything on or pat him on the back, whatever it is."

Through a spokeswoman, Niederhuber declined to be interviewed, and von Eschenbach didn't return a call seeking comment.

Dr. H. Shelton Earp, who leads the Association of American Cancer Institutes, a consortium of cancer centers, gave credit to the deputies who have led the cancer institute - "It's not that people aren't trying," he said, but he said lasting decisions on the institute's future should come from only a permanent director.

"I think everyone would feel better with a permanent appointment in that position," said Earp, who is also the director of the Lineberger Comprehensive Cancer Center at the University of North Carolina.

Also, the institute could face a crisis if it continues without presidentially appointed leadership, said Ellen Sigal, chairwoman of Friends of Cancer Research, a Washington nonprofit organization.

Sigal, whose sister died of breast cancer, said the status of Niederhuber is "a little like being engaged or being the girlfriend. It's not the same as being the spouse. It's just different."

As for what happens next, spokeswoman Erin Healy said the White House doesn't speculate on forthcoming appointments.

Matthew Chayes writes for the Chicago Tribune.

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