September 25

Bush’s Choice for F.D.A. Chief to Keep Other Job

Bush’s Choice for F.D.A. Chief to Keep Other Job

Mon, 26 Sep 2005

President Bush proposes to appoint Dr. von Eschenbach to head the FDA while at the same time maintaining his “day job” as head of the National Cancer Institute.

Clearly the administration thinks very little about the importance of FDA’s role as watchdog over the safety of drugs.

Furthermore, either he (and his administration) don’t recognize the inherent conflict of interest in one man heading two agencies with decidedly different missions, or no one in the administration cares about the loss of public trust in the FDA!

Perhaps someone needs to inform the White House that the current credibility crisis is NOT due to impediments to “swift access to the fruits of biomedical research,” but rather to the inadequate testing and monitoring of prescription drugs. Someone ought to inform the President that FDA’s failure to ensure that drugs are properly tested before being marketed has resulted in thousands of civilian casualties to lethal drugs.

Based on the New York Times report, Dr. vo Eschenbach hasn’t a clue about the need to prevent drug-related human casualties, or about FDA’s flawed approval process.

Contact: Vera Hassner Sharav
veracare ahrp org

September 25, 2005
Bush’s Choice for F.D.A. Chief to Keep Other Job

WASHINGTON, Sept. 24 – The man chosen to run the Food and Drug Administration said Saturday that he would keep his job as director of the National Cancer Institute while serving as interim chief of the drug agency.

In an interview, the official, Dr. Andrew C. von Eschenbach, said he had a “100 percent commitment” to both jobs.

As director of the cancer institute since January 2002, Dr. von Eschenbach has worked closely with patients and their advocates. At the F.D.A., he said, he would use that experience to ensure that patients gain swift access to the fruits of biomedical research.

Promising new drugs, he said, should be made available “as rapidly as possible,” especially to patients with life-threatening diseases, who he said were often willing to accept greater risks than people with less serious illnesses.

Dr. von Eschenbach, a urologic surgeon, is a cancer survivor himself, having had melanoma, prostate cancer and basal cell carcinoma. He said his experience at the cancer institute would inform his work as the chief regulator of drugs and medical devices.

But he could find conflicts between the two roles, because the cancer institute serves as a sponsor of many applications seeking permission from the F.D.A. to test cancer drugs in humans. Moreover, a nationwide network of researchers created by the institute generates some of the data included in drug companies’ applications to sell cancer drugs.

In the interview, Dr. von Eschenbach said he would strike “an appropriate balance” in evaluating the risks and benefits of drugs.

President Bush said Friday that Dr. von Eschenbach would become the acting commissioner of food and drugs. He replaces Lester M. Crawford, who resigned on Friday, with no explanation, just two months after being confirmed by the Senate.

The resignation of Dr. Crawford left the agency adrift as it considers major changes in drug regulation, to monitor and publicize the hazards of drugs on the market. Critics inside and outside the agency said Dr. Crawford had allowed politics to trump science by repeatedly delaying a decision on whether to allow over-the-counter sales of an emergency contraceptive, the morning-after pill, known as Plan B.

Paul Goldberg, editor of The Cancer Letter, a Washington newsletter that has been critical of some of Dr. von Eschenbach’s policies, said he suspected that if given free rein, Dr. von Eschenbach would relax standards on drug approvals.

“He is revered by people who want to loosen the criteria for approval of cancer drugs,” Mr. Goldberg said.

But much of the criticism of the F.D.A. in recent years has centered on its handling of drugs for less serious ailments, like Vioxx and other painkillers.

Scientists say the selection of Dr. von Eschenbach comes at a time when the pendulum at the F.D.A. has swung toward an emphasis on drug safety. That shift has caused concern among some cancer specialists.

“The excessive emphasis on safety, particularly for patients with life-threatening diseases who have limited therapy options, could slow the whole process of drug development for these individuals,” said Dr. Richard L. Schilsky, a professor of medicine at the University of Chicago.

In an interview, Dr. Schilsky, a cancer researcher who is active in the American Society of Clinical Oncology, said he believed that Dr. von Eschenbach “would evaluate the risk-benefit ratio for drugs from his perspective as an oncologist.”

At the cancer institute, Dr. von Eschenbach has declared a goal of “eliminating suffering and death due to cancer by 2015.” The idea is that prevention, early detection and new drugs, while not curing cancer, would make it more of a chronic disease like diabetes.

Many cancer experts say such a timetable is wildly unrealistic and might undermine the credibility of the cancer program.

“A lot of people feel very uncomfortable about that,” said Dr. Otis W. Brawley, a professor and oncologist at Emory University, who was an assistant director at the cancer institute from 1996 to 2001. But if viewed as a direction for research rather than as a specific deadline, Dr. Brawley said, “the concept is not nearly as bad as it initially sounds to a lot of people.”

Gardiner Harris contributed reporting for this article.

Copyright 2005 The New York Times Company

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