WASHINGTON, Jan 3 (AFP) - A US Food and Drug Administration (FDA) expert has said he is determined to publish a study linking the anti-inflammatory drug Vioxx to deaths and illness of up to 139,000 patients, media reports said Monday.
Shares in Merck, the maker of the drug withdrawn around the world last September, took a new battering following reports that David Graham, associate director of the Office of Drug Safety with the FDA, has vowed to publish his study.
He told the Financial Times his report would appear in the British medical journal The Lancet.
Graham said last year that 28,000 people had suffered sometimes fatal heart attacks or strokes after taking Vioxx. In testimony to Congress in November, Graham revised this to 139,000.
Graham told the Forbes.com news website however that publication of the paper had been delayed because of a dispute with his bosses at the FDA.
"The FDA has suppressed the paper and maligned me in the media, but never responded" to study's conclusions suggesting that Vioxx is an even more dangerous drug than believed when it was pulled off the market in September, he told the Financial Times.
The study updates results of research he conducted which said some 28,000 patients had died or suffered debilitating symptoms after taking Vioxx.
Before Congress, Graham called the drug "a terrible tragedy and a profound regulatory failure."
Merck withdrew Vioxx from the market saying its own company-sponsored trial found patients who took the medication for more than 18 months doubled their risk of heart attack or stroke.
Vioxx was approved by the FDA in 1999 and when it was withdrawn from the market, millions of people around the world were taking it.
Graham testified however that there were signs of problems in company studies as early as November 2000.
Merck's shares were down 2.7 per cent at 31.27 dollars in late trading Monday. The share lost about 25 percent in the weeks after the withdrawal.
01/03/2005 19:43 GMT - AFP