October 26

The Crawford Resignation Mystery

The Crawford Resignation Mystery

Sat, 24 Sep 2005

Merrill Goozner of Center for Science in the Public Interest provides insight into what may lie behind the sudden resignation of FDA Commissioner, Lester Crawford.

Goozner surggests, “One possible clue to the administration’s thinking comes from the appointment of Andrew von Eschenbach, head of the National Cancer Institute, as acting commissioner. Von Eschenbach, who previously ran the M.D. Anderson Cancer Center at the University of Texas, has been touting the new generation of targeted cancer drugs and in recent speeches has been confidently predicting that cancer would become a manageable disease — like AIDS — by 2015.”

Former Congressman, James Greenwood, who is president of the Biotechnology Industry Organization, which represents biotech companies, described Dr. von Eschenbach as an “excellent choice” who would provide strong leadership.

If Goozner is right, and Greenwood’s endorsement of Von Eschenbachy tends provide a confirmatory hint, then the FDA is being positioned to provide rubber stamp approval for cancer drugs BEFORE they have even been shown to be effective in clinical trials.

Contact: Vera Hassner Sharav


September 24, 2005
By Merrill Goozner
The Crawford Resignation Mystery

True to form, the administration picked late Friday afternoon to announce that Food and Drug Administration commissioner Lester Crawford resigned. The veterinarian in charge of the world’s premier food and drug safety agency, who was confirmed for the job just two-and-a-half months ago, cited his age. He is 67.

The Saturday morning papers (the least read of the week; that’s why troubling announcements get released late Friday) gave no clues as to what drove the decision, although both the New York Times and the Washington Post hinted broadly that he was forced out. But why? It couldn’t have been the postponement — again — of approving Plan B, the morning after contraceptive pill. Crawford was doing the administration’s bidding on that issue.

One possible clue to the administration’s thinking comes from the appointment of Andrew von Eschenbach, head of the National Cancer Institute, as acting commissioner. Von Eschenbach, who previously ran the M.D. Anderson Cancer Center at the University of Texas, has been touting the new generation of targeted cancer drugs and in recent speeches has been confidently predicting that cancer would become a manageable disease — like AIDS — by 2015.

The Post story mentions that many oncologists have criticized von Eschenbach for overpromising, but ignores the back story. His prediction and embrace of the latest drugs has been prominently featured by the conservative Manhattan Institute, whose work on FDA and medical issues is conducted at its Center for Medical Progress. The Center is funded by the drug industry.

In the world of journalism, the Wall Street Journal’s editorial page has been touting the new cancer therapies even when the clinical trial evidence shows they don’t work or help as few as 10 percent of patients (and even then only for a few months). The Journal has been on the warpath against Richard Pazdur, who runs the FDA’s oncology bureau, claiming he has slowed the pace of drug approvals.

Paul Goldberg’s influential “Cancer Letter” pointed out in its August issue how a right wing “insurgency” is pushing for early approvals of cancer drugs. The insurgency includes Michael Milken (who has been treated for prostate cancer) and an all-star cast of conservative think tanks like the Manhattan Institute, the American Enterprise Institute, the Cato Institute, the Competitive Enterprise Institute, the Washington Legal Foundation and a cancer patient advocacy group known as the Abigail Alliance.

Grabbing a page from the AIDS activists of the early 1990s, their slogan is early access to experimental cancer drugs for the dying. If they can get the FDA to approve early access based on experimental data that suggests a new, experimental drug may affect the disease (usually based on some surrogate marker like tumor shrinkage, which can have no relationship to survival), they can then force insurance companies, Medicare and Medicaid to pay for the treatments.

That would be a godsend to the drug industry, which has invested billions in searching out cancer cures with marginal success. The new targeted therapies can cost anywhere from $4,000 to $10,000 a month. No wonder it has financially supported many of the conservative groups in the coalition.

Pazdur, who also came to the FDA from the M.D. Anderson Cancer Center, has fought to hold the line for the agency’s traditional standard that a drug be shown to be effective before getting approved. His staff has also done a good job assessing whether a new drug’s usually marginal benefits outweigh the substantial side effects and risks that are often associated with cancer therapies, including the newer targeted therapies. Just yesterday Genentech announced it had to stop a trial of its new drug Avastin for ovarian cancer after 11 percent of patients began developing holes in their stomachs and intestines.

There is a serious discussion that needs to take place at the FDA about how companies with new therapies can be encouraged to collaborate to see if in combination these drugs can have a major impact on cancer. But sophisticated scientific discussions and breaking the entrenched habits of competitive drug firms is not what the ideologues behind the anti-Pazdur campaign have in mind.

If von Eschenbach forces his former colleague out and appoint someone more malleable to run the agency’s oncology division, we’ll know the real reason why Crawford resigned.

Posted by gooznews at September 24, 2005 10:42 AM

September 24, 2005 p. A-1
Leader of the F.D.A. Steps Down After a Short, Turbulent Tenure

WASHINGTON, Sept. 23 – Lester M. Crawford, the commissioner of food and drugs, resigned abruptly on Friday, causing further upheaval at an agency that has been in turmoil for more than a year.

Dr. Crawford, who was confirmed just two months ago, on July 18, after serving as acting commissioner for more than a year, did not say why he was stepping down.

Senior officials at the Food and Drug Administration said they were stunned to learn of the resignation in an e-mail message from Dr. Crawford, who also sent a letter to President Bush stating that he was resigning “effective immediately.”

A government official said the resignation was related to the fact that Dr. Crawford had not fully disclosed information about his finances to the Senate before his confirmation. The official spoke on condition of anonymity, citing Dr. Crawford’s privacy.

Michael O. Leavitt, the secretary of health and human services, accepted the resignation and thanked Dr. Crawford for his service.

Christina Pearson, a spokeswoman for Mr. Leavitt, refused to say whether Bush administration officials had asked for the resignation.

“I can’t comment,” Ms. Pearson said. “This is a personnel issue.”

In recent weeks, consumer advocates and scientists inside and outside the agency had said scientific decisions were being warped by politics.

On Thursday, a commentary in The New England Journal of Medicine titled “A Sad Day for Science at the F.D.A.” said that “recent actions of the F.D.A. leadership have made a mockery of the process of evaluating scientific evidence,” disillusioned many scientists, “squandered the public trust and tarnished the agency’s image.”

Mr. Bush said he intended to name Dr. Andrew C. von Eschenbach, director of the National Cancer Institute, to be acting commissioner of food and drugs.

Dr. Crawford, a veterinarian and expert on food safety, was named deputy commissioner of the agency in early 2002 before his tenure as acting commissioner. In that time the agency has been rocked by disputes over many issues, including the safety of painkillers like Vioxx, the regulation of heart defibrillators and other devices, and delays in deciding whether to allow over-the-counter sales of an emergency contraceptive. The director of the agency’s Office of Women’s Health, Dr. Susan F. Wood, resigned three weeks ago to protest delays in approving over-the-counter sales of the morning-after pill Plan B.

Critics, including members of Congress from both parties, say the agency has not provided the public with enough information about the risks of drugs and devices.

“In recent years the F.D.A. has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information,” said Senator Charles E. Grassley, Republican of Iowa and chairman of the Senate Finance Committee.

Senator Barbara A. Mikulski, Democrat of Maryland, said the agency had been “politicized and degraded” under Dr. Crawford, whose leadership she described as “tepid and passive.”

Before the Senate confirmed Dr. Crawford, a Senate committee looked into accusations that he was having an affair with a woman who worked in his office and that he had wasted government money by taking her on official trips when she was not needed. An anonymous letter also suggested that Dr. Crawford had helped the woman secure a promotion to a higher-paying job.

An inquiry by the inspector general of the Department of Health and Human Services found some contradictions in statements by Dr. Crawford and the woman. Investigators found a close personal relationship between them but no evidence of an extramarital affair.

The committee chairman, Senator Michael B. Enzi, Republican of Wyoming, said at the time that the inspector general had found no merit to the charges leveled at Dr. Crawford. No senator wanted to pursue the issue then.

In his message to colleagues on Friday, Dr. Crawford said that after three and a half years in top positions at the agency, “it is time, at the age of 67, to step aside.”

Senator Richard J. Durbin, Democrat of Illinois, who voted against Dr. Crawford’s nomination, said Friday: “The Food and Drug Administration is facing nothing short of a crisis in leadership. The controversy surrounding Vioxx and other pharmaceuticals has exposed weak oversight, conflict of interest and poor management at the F.D.A.”

Ira Loss, senior health analyst at Washington Analysis, which studies federal issues for investors, said he had been told by someone in the White House that Dr. Crawford had been asked to resign for a reason not yet known to the public.

“Something new has arisen that has led to this,” Mr. Loss said. It was not the controversy over the morning-after pill, he said, because Dr. Crawford “did what they wanted on Plan B.”

Under Dr. Crawford, the agency was buffeted by fierce debates over drug safety.

Critics, including many in Congress, said the agency had tried to stifle one of its own scientists who had found evidence that the use of antidepressants could cause children and teenagers to become more suicidal.

The agency was also criticized as slow to recognize that Vioxx and similar pain medicines could increase the risk of heart attacks and strokes. Merck withdrew Vioxx from the market a year ago and is facing thousands of lawsuits from people who say they were harmed by the drug.

Under pressure, Dr. Crawford and the agency have started to release more information about potential safety problems of drugs and devices, rather than waiting, as in the past, until they had a fuller picture.

“I think he started to lift the veil on how the F.D.A. does business, which was long overdue,” said Peter Pitts, a former associate commissioner under Dr. Crawford.

While many critics say drugs are approved too quickly, the F.D.A. has also come under fire from pharmaceutical companies and some patient advocates for not approving drugs quickly enough.

Pharmaceutical and biotechnology companies had generally welcomed Dr. Crawford’s appointment, partly because of his long experience at the agency, but also because they wanted a full-time commissioner. Many industry officials say that under an acting commissioner, the agency tends to put off difficult decisions.

The agency has had a full-time commissioner for only about 18 months out of the four and a half years that President Bush has been in office.

The president’s first appointee, Dr. Mark B. McClellan, did not take office until November 2002 and then left about 16 months later to run the Medicare program.

It now appears that the agency will be without a permanent commissioner for some time. Experience shows that it is difficult for any nominee to obtain broad support in the Senate, because the agency handles so many volatile issues.

Dr. von Eschenbach has been director of the National Cancer Institute, part of the National Institutes of Health, since January 2002. Before that, he had a long career as a doctor and executive at the M. D. Anderson Cancer Center in Houston.

James C. Greenwood, president of the Biotechnology Industry Organization, which represents biotech companies, described Dr. von Eschenbach as an “excellent choice” who would provide strong leadership.

Mr. Greenwood had no comment on Dr. Crawford’s resignation. Nor did the Pharmaceutical Research and Manufacturers of America, which represents big drug companies.

Copyright 2005 The New York Times Company

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