WSJ.com - FDA Removes Panel Member From Drug Review

[Guest guest]

Can't have any traitors.

Sheri

>Date: Fri, 12 Nov 2004 17:01:43 -0800

>From: Belkin

http://online.wsj.com/article/0,,SB110022560578272312,00.html?mod=todays_us_

page_one

FDA Removes

Panel Member

From Drug Review

By ANNA WILDE MATHEWS and SCOTT HENSLEY

Staff Reporters of THE WALL STREET JOURNAL

November 12, 2004; Page A8

A researcher who publicly questioned the safety of Pfizer Inc.'s painkiller

Bextra was removed from a Food and Drug Administration advisory panel that

will review it and similar products next year.

Curt D. Furberg, a professor at Wake Forest University, Winston-Salem,

N.C., said he was informed by the agency that he no longer will participate

in the meeting in which the committee will examine the safety of -2

inhibitors, the class of drugs that includes both Bextra and Vioxx, a

painkiller that Merck & Co. recently withdrew from the market. Dr. Furberg

said he was told by the FDA that his invitation was rescinded because he

was quoted in the New York Times as saying Bextra appeared similar to Vioxx

and that Pfizer sought to suppress that information.

" They'd said because I had taken a public position, I was disinvited, " Dr.

Furberg said. He added that he felt he wasn't biased, and he was " trying to

be evidence-based " in making findings about Bextra from an analysis of

data. " I collected the information to get evidence to contribute to the

debate, I drew a conclusion, and I'm off, " he said. Dr. Furberg said he

still is on the FDA's drug safety and risk management advisory committee,

but won't be part of the February -2 meeting.

Kweder, acting director of the FDA's office of new drugs, said the

agency routinely screens advisory committees for possible conflicts,

including intellectual as well as financial interests. " If he's already

expressed a particular point of view, and especially written a paper on it,

it would be difficult to expect him to come to such a meeting and be

objective about the subject, " she said. Dr. Furberg still could speak

before the panel as part of the public-comment period, she said.

The panel is set to review the safety of Bextra and Celebrex, another

Pfizer drug, as part of an examination of -2 inhibitors. Vioxx was

withdrawn from the market in September by Merck following a clinical trial

showing that after 18 months, patients taking it had a higher risk of heart

attacks and strokes.

Dr. Furberg was quoted in coverage of an analysis he helped to do that

found that patients taking Bextra might be at higher risk for heart attack

or stroke.

Pfizer called the findings " unsubstantiated. " A Pfizer spokeswoman said the

company had nothing to do with Dr. Furberg's departure from the panel.

" Pfizer would never intervene in any way with the FDA's regulatory

process, " she said.

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Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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