Furberg Says Bextra Similar to Vioxx - Fired From FDA Panel

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13 Nov 2004 12:56:27 -0000

 

Health Supreme Update: Furberg Says Bextra Similar to Vioxx -

Fired From FDA Panel

 

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Health Supreme Update: Furberg Says Bextra Similar to Vioxx - Fired

From FDA Panel

 

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November 13, 2004

 

Furberg Says Bextra Similar to Vioxx - Fired From FDA Panel

Pharma

 

 

According to a piece in the Wall Street Journal, Curt D. Furberg,

a professor at Wake Forest University in Winston-Salem, North

Carolina, was removed from an FDA panel reviewing the safety of COX-2

inhibitors. These are drugs of the same class as the recently

withdrawn painkiller Vioxx, which was found to be causing tens of

thousands of heart attacks.

 

Furberg looked at the data and found similarities between Vioxx

and Pfizer's Bextra. Incredibly, when he expressed his preoccupation

about the obvious similarities, he was removed from the panel as

" biased " . Now the FDA seems to have a very strange idea indeed of what

constitutes bias. While having financial and other ties to the drug

maker whose drugs are to be evaluated seems to be quite acceptable,

expressing an opinion about the drug under consideration, especially

if negative, is deemed to be bias and leads to immediate excommunication.

 

" Even as the Vioxx casualties are still being counted, even as

FDA's conduct is under Congressional investigation, the FDA office of

new drugs has taken action to obstruct evidence-based safety

evaluation of Bextra, Pfizer's CO2 drug " , comments Vera Hassner Sharav

of the Alliance for Human Research Protection, AHRP.

 

While the British government is planning to reform its own

watchdog agency, announcing " sweeping changes to the medicines

watchdog body after years of criticism and pressure, banning those who

sit on its central licensing committee from having any personal or

financial interests in pharmaceutical companies " , the FDA seems

determined to continue its cozy relationship with drug makers.

Apparently the agency cares more about the profits of pharma companies

than about the safety of the medicines they approve or about the lives

of those who rely on the the FDA to function as a watchdog.

 

Sharper teeth for medicines watchdog,

is the title of an article by Guardian health editor Sarah

Boseley. According to that report, both members of the main drug

licensing committee as well as those taking part in advisory bodies

providing expertise about specific illnesses " would in future have

three months to sell their shares and end their potentially lucrative

consultancy agreements with drug companies. "

 

Compare that with the FDA, which, according to Vera Hassner Sharav

" continues moving in the opposite direction: the FDA gives waivers

from conflict of interest regulations to advisory panel members who

have financial interests in the companies whose drugs they evaluate. "

Sharav says that " the agency bans those who analyze the evidence and

find the drugs unsafe. "

 

Here is what the Wall Street Journal reports:

 

THE WALL STREET JOURNAL

 

FDA Removes Panel Member From Drug Review

 

By ANNA WILDE MATHEWS and SCOTT HENSLEY

November 12, 2004

 

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 Cox-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 Cox-2 meeting.

 

Sandra 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 Cox-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.

 

Write to Anna Wilde Mathews at anna.mathews and Scott

Hensley at scott.hensley

 

 

See also:

 

FDA removes arthritics drugs critic from advisory panel meeting -

Medical News Today

 

Criticism upset FDA, doctor says - Boston Globe

 

FDA Bars Critic From Meeting - Washington Post

Furberg said yesterday he was concerned that " higher-ups " in the

FDA wanted to silence him. " I think they're trying to control

criticism at the committee meeting, " he said. " The fact that I've

commented on the issue should be irrelevant. I've done research and

some analysis here, and think I'm the most qualified to comment on the

data, but now they're going to take me away. It doesn't make much sense. "