November 1

FDA Protects Pfizer: Removes Advisory Panelist for Citing Evidence Bextra Similar to Vioxx – WSJ

FDA Protects Pfizer: Removes Advisory Panelist for Citing Evidence Bextra Similar to Vioxx – WSJ

Fri, 12 Nov 2004

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’
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

FDA Removes Panel Member From Drug Review
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 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.


Sharper teeth for medicines watchdog

Sarah 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 GlaxoSmithKline 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.

Richard 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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