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FDA retreats over banned report

The US Food and Drug Administration has allowed previously banned trial data concerning Merck's painkiller, Vioxx, to be published.

As many as 140,000 patients in the US may have developed coronary heart disease and up to 56,000 may have died since 1999 as a result of taking Merck's Vioxx, according to previously banned trial data published this month.

The study, which is authored by Dr David Graham of the Food and Drug Administration's (FDA) Office for Drug Safety, is currently available online at the Lancet. It was previously scheduled for publication in November 2004 until the FDA put ìa gun to my headî, says Dr Graham, and banned its publication.

In January this year, however, the FDA cleared the paper for publication and also announced plans for a joint public meeting of two of its advisory committees ñ Arthritis, and Drug Safety and Risk Management ñ in February.

Dr Graham's research sought to discover the risk of suffering cardiovascular disease, such as strokes, heart disease and heart attacks, in patients taking Vioxx, Celebrex (a similar, COX-2 drug from the same class as Vioxx), ibuprofen, and naproxen.

Of the 1.4 million patient experiences researched, Dr Graham found many thousands of cases of coronary heart disease among all of the pain killer users. However, his work revealed that arthritic patients taking Vioxx for pain relief had a 34 per cent increased risk of developing coronary heart disease, compared with patients using other non-steroidal anti-inflammatory drugs (NSAIDs).

Merck is adamant that as soon as the cardiovascular side effects were confirmed, it pulled the drug from the market. Yet, Dr Graham insists that the pharmaceutical community, including regulators, should act sooner.

'In the future, when trials show that a new treatment confers a greater risk of a serious adverse effects than a standard treatment, we must be much more careful about allowing its unrestrained use,' his paper states.

Jane Tadman, of the UK's Arthritis Research Campaign, added: ìBecause of the sheer number of people affected, it is very shocking, but I don't think that anyone was overly surprised by it [Dr Graham's findings].î

She continued: ìThere had been previous trials, going back as far as 2000, that indicated that patients on Vioxx were at a higher risk than those who were not. So you have to ask why that was the case. Why did it remain on the market for a further four years? Why did it continue to be sold in vast quantities, making vast amounts of money for Merck Sharpe & Dohme for quite some time?

ìYou could suggest that it's because the regulators were insufficiently rigorous.î

Celebrex saferÖ

According to Dr Graham's paper, he identified no apparent increased risk associated with the use of Pfizer's Celebrex. Yet, US consumer watchdog, Public Citizen, has still called for Pfizer to pull the drug, along with another, Bextra, from the market because the risk is too great.

The FDA has warned doctors to limit their prescription of both Pfizer drugs, pending further advice, while Pfizer announced that it would keep Celebrex on the market but agreed to suspend all direct-to-consumer marketing for it in the US. The safety of the entire COX-2 inhibitor drug class is under investigation in the US and Europe.

30th September 2008

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