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Cancer Agency Post Raises Questions About New FDA Chief

Times Staff Writer

President Bush’s new Food and Drug Administration chief could face a built-in conflict of interest if he follows through with his plan to keep his position as head of the National Cancer Institute while also taking over the FDA, some leading physicians and consumer activists caution.

Dr. Andrew C. von Eschenbach expressed confidence Monday that he could do both jobs well. But because the FDA has an oversight role in the cancer institute’s drug development research, some experts foresee problems -- especially since he is publicly committed to accelerating approval of some anti-cancer drugs. Other experts said each job was so demanding that it would be nearly impossible to do justice to both at the same time.

Von Eschenbach raised further questions by suggesting Monday that his FDA role might be temporary. In an e-mail to advocates for cancer research, he called his FDA appointment “an interim role.” He wrote that he would “work to ensure an orderly transition of a new, permanent commissioner at the FDA.”

The main pharmaceutical trade group applauded his appointment as FDA chief. “The administration has moved quickly and placed the Food and Drug Administration in good hands, allowing the FDA to move forward on a number of important issues,” the Pharmaceutical Research and Manufacturers of America said in a statement.

Critics suggested that the proposed arrangement could make it more difficult for the FDA to avoid controversy and move forward.

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“It is very hard for him to be in both positions and deal with requests regarding cancer drugs,” said Dr. Curt Furberg, a professor at Wake Forest University who has advised the FDA on safety issues. “I really see a potential conflict. As head of NCI, he may be very eager to get drugs approved by FDA, particularly drugs that have been developed and tested by NCI.”

Dr. Jeffrey Drazen, editor in chief of the New England Journal of Medicine, said: “These are agencies with big budgets that make a lot of decisions that influence the health of individual Americans. What we really need are two highly qualified, motivated individual leaders.”

Dr. Paul D. Stolley, a former chairman of the University of Maryland’s Department of Epidemiology and Preventive Medicine had similar concerns. “I think it’s alarming that he’s going to run both jobs at the same time,” said Stolley, who worked from 2000 to 2001 as a visiting scientist at the FDA. “It’s hard enough to run the FDA, alone. Almost nobody’s done it well, for years and years.”

Von Eschenbach’s appointment as acting commissioner was announced Friday after the unexplained resignation of Lester M. Crawford, who won Senate confirmation two months ago. Crawford had gotten off to a rocky start after he delayed a promised decision on whether to allow over-the-counter sales of the so-called morning-after contraceptive. Health and Human Services Deputy Secretary Alex Michael Azar II told senior officials Monday that Crawford’s departure involved a personal matter, an administration official said.

Crawford’s resignation came at a delicate time because the agency had been criticized about its oversight of drug safety.

Von Eschenbach, a urologic surgeon who has set a goal of turning cancer into a manageable disease in the next decade, is committed to expediting approval of new treatments.

“I believe it’s still important to ask the question: ‘How can we accelerate the timeline? How can we make certain we are getting these interventions to patients as quickly as possible?’ ” he told Associated Press.

The FDA must approve institute-sponsored clinical trials involving humans. Once a drug has been approved, physicians have broad latitude in prescribing it, even for conditions not authorized by the FDA.

Von Eschenbach “is talking about getting drugs to terminally ill patients faster, and that’s a laudable goal,” said Diana Zuckerman, president of the National Research Center for Women and Families. “But you can’t approve a drug and assume it will only be used for terminally ill patients. Everything he has been quoted as saying suggests he doesn’t understand how the FDA works.”

Times staff writer David Willman contributed to this report.


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