GMW: Leader of FDA quits - BIO enthuses over replacement

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GMW: Leader of FDA quits - BIO enthuses over replacement

" GM WATCH " <info

Sun, 25 Sep 2005 12:42:40 +0100

 

 

 

 

GM WATCH daily

http://www.gmwatch.org

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1.Leader of the FDA Steps Down after a Short, Turbulent Tenure - NYT

2.Friend of Bush, Andrew von Eschenbach - NATURE

 

The president of the Biotechnology Industry Organization has described

Bush's new appointment as head of the FDA as an " excellent choice " .

(item 1)

 

And no wonder. Dr. Andrew von Eschenbach is an extreme

techo-enthusiast,who has even predicted that cancer will be wiped out

in the U.S. by

2015 thanks to nanotech and similar technical fixes. Von Eschenbach is

known to favour the rapid development and " immediate application " of such

" innovative technologies " .

 

A pal of George W. Bush's (item 2), von Eschenbach was largely unknown

to the biomedical research community until his previous appointment as

director of the National Cancer Institute by Bush.

 

What impact von Eschenbach has on the currently troubled FDA remains to

be seen. " As currently configured, " the FDA senior drug safety

researcher, Dr. David Graham, recently noted, " the FDA is not able to

adequately protect the American public. It's more interested in

protecting the

interests of industry. It views industry as its client, and the client

is someone whose interest you represent. Unfortunately, that is the way

the FDA is currently structured. "

http://www.newstarget.com/011401.html

 

Given that, it hardly bodes well that while head of the NCI, von

Eschenbach was accused of seeking " to undermine the FDA's drug approval

requirements " and of " meeting behind closed doors with a

representative of

the drug industry to influence drug approval policy and to change the

product liability laws " in a direction that did not safeguard the

interests of patients.

http://www.medicalconsumers.org/pages/Letter%20To%20FDA--Approval%20of%20Cancer%\

20Prevention%20Drugs.html

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1.Leader of the FDA Steps Down after a Short, Turbulent Tenure

By Robert Pear and Andrew Pollack

The New York Times, 24 September 2005

http://www.truthout.org/docs_2005/092405D.shtml

 

Washington - 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 FDA " said that " recent actions of

the FDA 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 FDA 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 FDA. "

 

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 FDA 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 FDA 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.

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2.New NCI director appointed

Laura Bonetta

Bethesda

Nature Medicine 8, 7 (2002)

doi:10.1038/nm0102-7

http://www.nature.com/nm/journal/v8/n1/full/nm0102-7.html

 

[image caption: Friend of Bush, Andrew von Eschenbach]

 

The new year sees Andrew C. von Eschenbach begin his job as director of

the National Cancer Institute (NCI), the largest institute of the

National Institutes of Health (NIH). The head of the $3.8 billion NCI

is the

only NIH director who is chosen by the president, and George W. Bush

has selected von Eschenbach from the M.D. Anderson Cancer Center in his

home state of Texas.

 

Von Eschenbach was largely unknown to the biomedical research community

until his appointment. He is a cancer survivor himself and was the

director of the Genitourinary Cancer Center and of a prostate cancer

research program at M.D. Anderson and president-elect of the American

Cancer

Society.

 

He replaces Richard Klausner who was widely regarded as a visionary

leader credited with starting several programs to apply new molecular

technologies to the understanding and treatment of cancer. Whereas

Klausner's career has included basic research, Von Eschenbach has no

background

in bench research.

 

 

 

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