FT.com / Industries / Drugs & healthcare - Scientist raises estimate of Vioxx ill-effects

FT.com / Industries / Drugs & healthcare - Scientist raises estimate of Vioxx ill-effects: "
Scientist raises estimate of Vioxx ill-effects
By Andrew Jack in London
Published: January 2 2005 21:54 | Last updated: January 2 2005 21:54

The scientist at the centre of a dispute over the safety of the anti-inflammatory Vioxx has vowed to publish research that suggests up to 139,000 Americans have died or have been seriously injured as a result of taking the drug.

The likely appearance in the Lancet of a revised version of a paper by Dr David Graham, an employee of the Food and Drugs Administration, will fuel debate over the effectiveness of the US drug regulatory system and may spur additional litigation against Merck, the manufacturer of Vioxx.
Dr Graham originally estimated in August that 28,000 Americans had died or suffered debilitating heart attacks as a result of taking Vioxx since it was first approved in 1999. His research sparked a debate that has since forced regulators to call into doubt the safety of the entire cox-2 inhibitor class of drugs to which Vioxx belongs.
In an interview with the FT, Dr Graham said he was determined to go ahead with publication of his updated analysis, even though he had been threatened with dismissal by the FDA if he wrote and published the paper.
'The FDA has suppressed the paper and maligned me in the media but never responded. The proper place for scientific information is in a peer-reviewed scientific journal,' he said.
The FDA only allowed him to present the data in his personal capacity and banned him from publishing it in the Lancet. A few weeks later, Merck withdrew Vioxx, claiming it had done so voluntarily and identified health risks in its own study.
Re-analysing the data, including recent information from Merck's study, Dr Graham sa"

The National Institutes of Health: Public Servant or Private Marketer?

The National Institutes of Health: Public Servant or Private Marketer?: "
December 22, 2004E-mail story Print

The National Institutes of Health: Public Servant or Private Marketer?
Doctors have long relied on the NIH to set medical standards. But with its researchers accepting fees and stock from drug companies, will that change? A continuing examination by The Times shows an unabashed mingling of science and commerce.

CELEBREX & Heart Attacks

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The New York Times > Health > Regulation Redefined: At F.D.A., Strong Drug Ties and Less Monitoring

The New York Times > Health > Regulation Redefined: At F.D.A., Strong Drug Ties and Less Monitoring: "At F.D.A., Strong Drug Ties and Less Monitoring
By GARDINER HARRIS

Published: December 6, 2004


hen federal drug officials suspected in 1992 that a popular allergy pill might cause heart problems, they turned to their own scientists. Their trial confirmed the danger, and the drug was pulled from the market.
Eight years later, similar worries surrounded the arthritis pill Vioxx. But by then, the Food and Drug Administration had shifted gears, slashing its laboratories and network of independent drug safety experts in favor of hiring more people to approve drugs, changes that arose under an unusual agreement that has left the agency increasingly reliant on and bound by drug company money. Discovering Vioxx's dangers would take four more years.
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That delay has led to a firestorm of criticism. Members of Congress, an internal F.D.A. whistleblower and prominent medical journals have said the agency is incapable of uncovering the perils of drugs that have been approved and are in wide distribution. Some have accused it of being cozy with drug makers"

VIOXX FDA Whistleblower

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Opinion | Editorials, Opinion Pieces Examine Recent FDA Safety Issues With Flu Vaccine, Vioxx Withdrawal -

Opinion | Editorials, Opinion Pieces Examine Recent FDA Safety Issues With Flu Vaccine, Vioxx Withdrawal - Kaisernetwork.org

The FDA Failed with Bextra

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@wsj.com1 and Scott Hensley at scott.hensley@wsj.com
Story is from the Wall Street Journal

Bayer Held Back on Drug Dangers of Baycol

Report: Bayer Held Back on Drug Dangers

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The Journal of the American Medical Assn. argues that Bayer hid important information regarding the safety of their drug Baycol. They also criticize the FDA for not taking appropriate steps to monitor the drug, which showed signs of danger as far back as 1998. This allegedly resulted in tens of thousands of people being hurt by the statin. Alan Zarembo, LA Times 11/23/2004

Read Article: LA Times

Wilentztv.com Media Center - Lawsuits, Litigation, Class Actions - New Jersey, New York, Philadelphia

Wilentztv.com Media Center - Lawsuits, Litigation, Class Actions - New Jersey, New York, Philadelphia

The FDA is Broken

Doctor David Graham the FDA research scientist is a hero who had the character to stand up the FDA officials that tried to intimidate him and silence him.