FDA Protects Pfizer: Removes Advisory Panelist for Citing Evidence Bextra Similar to Vioxx_WSJ

November 12, 2004

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness and Full Disclosure

www.ahrp.org

FYI

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.

Dr. Curt Furberg was removed from FDA's advisory committee for having

analyzed the data from Pfizer's CO2 drug, Bextra, determining that the data

resemble the data from Vioxx trials.

This is a demonstration of FDA's continued pattern of obstruction and

suppression of independent scientific analysis of the safety data. FDA's

intervention on behalf of Pfizer and other manufacturers has led to the

approval of hazardous, even lethal drugs, such as Vioxx, which are widely

promoted as " safe and effective " resulting in countless preventable deaths.

The British government has announced " 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. " (see below)

In sharp contrast, the FDA 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. But the agency bans those who analyze the evidence and find the

drugs unsafe.

The FDA protects the interests of drug manufacturer by suppressing

unfavorable analyses, demonstrating a disregard for the health and safety of

public.

See: E-Mails Suggest Merck Knew Vioxx's Dangers at Early Stage As Heart-Risk

Evidence Rose,Officials Played Hardball; Internal Message: 'Dodge!' Company

Says 'Out of Context' By ANNA WILDE MATHEWS and BARBARA MARTINEZ

Staff Reporters of THE WALL STREET JOURNAL November 1, 2004; Page A1

When will Congress intervene on behalf of the public interest?

How many preventable drug-related casualties are acceptable?

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

THE WALL STREET JOURNAL

FDA Removes Panel Member From Drug Review

By ANNA WILDE MATHEWS and SCOTT HENSLEY

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.

Write to Wilde Mathews at anna.mathews@... and Hensley at

scott.hensley@...

~~~~~~~~~~~~~~~~~~~

Sharper teeth for medicines watchdog

Boseley, health editor

Friday November 12, 2004

The Guardian

The government yesterday announced 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.

Lord Warner, the health minister, said those who sat on the regulatory body

would in future have three months to sell their shares and end their

potentially lucrative consultancy agreements with drug companies.

As the Guardian revealed last month, many of the doctors and scientists who

sit on the present Committee on the Safety of Medicines (CSM), granting drug

companies licences to sell medicines, also work as paid consultants to the

industry. In 2001, 17 out of 36 members declared personal financial

interests in drug companies, while more had indirect interests. When drugs

in which they have an interest are discussed, members have to leave the

room.

Lord Warner yesterday went further than expected with a root and branch

excision of those with drug industry ties, not only from the main licensing

committee but also from the expert groups on particular diseases that will

advise it.

Even those who accept free flights, hotels and restaurant meals from drug

companies to attend bona fide educational conferences will be debarred from

the committees for six months. A Guardian investigation found this

sponsorship was widespread in the NHS.

The new rules are part of a draft revised code of practice but considerable

discussion with the industry has already taken place and it is unlikely they

will be watered down.

Another change is the recruitment of two lay members of the licensing

committee. Both the CSM and the Medicines and Healthcare Products Regulatory

Authority, which it advises, have been criticised for focusing on drug

companies rather than consumers.

The European commission and the European drug licensing agency have just

published their own proposals on conflicts of interest. " We wanted to go at

least as far and indeed we are going further, mainly because there has been

criticism of the MHRA - not altogether fairly in some cases, " said Lord

Warner. " I wanted to make sure we were going to be as transparent as

possible.

" I don't believe there is a conspiracy between the people who have worked in

drug regulation and the industry, but there is clearly a perception in some

quarters that there is a problem. We have to tackle that perception. "

Lord Warner sent a further shot across the bows of the pharmaceutical

industry yesterday in a letter to the drug companies, demanding to know why

they have not yet acted on his request to enter details of every clinical

trial they carry out on to a register.

The drug giant GlaxoKline is currently under investigation by MHRA

officials for failing to make available data from trials showing that its

antidepressant Seroxat did not work in children. When the MHRA/CSM

eventually saw the data, they banned the drug for use in children because

the side-effects outweighed the benefits.

Aware that companies do not always publish trials with negative results or

even acknowledge those that have been aborted, Lord Warner wants all trials

to be entered on a register when they begin, but only a couple of companies

have shown signs of willingness to comply. The letter was " to buck them up, "

he said.

Brook, chief executive of the charity Mind, which has been

campaigning for more openness over drug regulation, commended the government

for listening to patients. " On the other hand, it is worth asking whether

any of this would have come about without the huge amount of public pressure

and negative publicity around drugs companies' inappropriate behaviour, " he

said.

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November 12, 2004