Acting FDA Head Temporarily Drops NCI Duty_WashPost

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Acting FDA Head Temporarily Drops NCI Duty_WashPost

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and

Accountability

http://www.ahrp.org

FYI

Who is kidding who?

The appointment of a long time Bush friend, Dr.

Eschenbach, head of

the National Cancer Institue, as acting

commissioner of the Food and Drug

Adminsitration reeks of conflicts of

interest--not just one conflict.

The Washington Post reports that not only is

Eschenbach an outspoken

advocate for faster drug approvals--which is what

Big Pharma wants--but

there is his close relationship with Bib Pharma

as the vice-chairman of the

board of directors of C-Change, a " non-profit "

headed by H.W and

Barbara Bush, whose board includes

BristolMyersSquibb and & .

Members of C-Change include: Chiron Corp,

AstraZeneca Pharmaceuticals,

GlaxoKline, OSI Pharmaceuticals. The fact

that Eschenbach is now

reported to be only temporarily giving up the top

job at NCI only reinforces

the perception that he is not committed to devote

quality time to attending

to drug safety issues.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

Acting FDA Head Drops Other Duty

By Rick Weiss

von Eschenbach, the director of the

National Cancer Institute, who

last week took on the added duties of acting Food

and Drug Administration

commissioner after the abrupt resignation of

Commissioner Lester M.

Crawford, said yesterday that he will temporarily

step down from his

day-to-day leadership of the cancer institute.

The Bush administration came under criticism

from members of Congress and

others in recent days for allowing the Texas

urologist and longtime Bush

family friend to take the reins at the FDA while

he continued to run the

cancer institute, given the many conflicts of

interest the dual assignment

engendered.

As interim FDA commissioner, for example, von

Eschenbach has final

authority over requests by the cancer institute

to test experimental

medications in people. The NCI also has many

collaborative efforts underway

with pharmaceutical companies whose economic

fates are intimately tied to

FDA decisions.

Von Eschenbach also faces potential

conflict-of-interest issues because of

his ongoing role as vice chairman of the board of

C-Change, a nonprofit

organization headed by H.W. and Barbara

Bush, according to

yesterday's issue of the Cancer Letter, a

Washington-based investigative

newsletter. Others on that board include

executives from Bristol-Myers

Squibb Co. and & .

More generally, some watchdog groups had

expressed concern that von

Eschenbach -- a vocal supporter of faster drug

approvals -- was the wrong

person to take the helm of the FDA, which in the

past year has suffered a

crisis of confidence for its rapid approval of

several drugs that

subsequently had to be withdrawn from the market

because of safety concerns.

In a memorandum sent to all FDA employees

yesterday and later made public

by the Department of Health and Human Services,

von Eschenbach said HHS

Secretary Mike Leavitt had asked Niederhuber

to serve as " chief

operating officer to handle day-to-day management

at NCI. " Von Eschenbach

recently hired Niederhuber as deputy director for

translational and clinical

sciences at the cancer institute.

In his memo, von Eschenbach also said that " as a

prudential matter, " he

will not participate in certain FDA matters in

which the cancer institute is

a party.

" I look forward to bringing my experience on the

discovery side of medicine

to the delivery side of medicine, " he wrote,

" making sure patients get the

drugs and treatments they need as quickly and

safely as possible. " Sen.

M. Kennedy (D-Mass.) said yesterday in a

statement that von

Eschenbach's decision to reduce his duties at NCI

" does not go far enough. .

.. . FDA deserves a Commissioner who can commit

completely to this important

responsibility, and the National Cancer Institute

deserves a full-time

Director. "

Sen. Barbara A. Mikulski (D-Md.) also expressed

lingering dissatisfaction

with the current state of affairs. " I look

forward to the swift appointment

of a full-time, permanent, competent FDA

commissioner, " she said in a

statement.

Mystery continues to swirl around Crawford's

sudden decision to resign as

FDA commissioner. On Thursday, Kennedy and Sen.

Mike Enzi (R-Wyo.) asked HHS

Inspector General R. Levinson to look into

Crawford's departure,

including published allegations that he had

failed to disclose financial

conflicts of interest before he was confirmed to

the post in July.

C 2004 The Washington Post Company

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