January 3, 2005
Merck Pharmaceutical is bracing for some bad news at the start of the new year. A leading critic of its arthritis pain reliever Vioxx is preparing to publish a paper about the now-removed drug, and he's not expected to have many kind things to say about it.
Food and Drug Administration safety expert David Graham is putting on paper many of the things he said in person to a Senate committee in November, when he charged that as many as 138,000 people have have suffered heart attacks or strokes because they had been taking Vioxx.
Graham said his estimate of the death toll caused by Vioxx has not changed since his Senate testimony.
Two months earlier Merck abruptly pulled its popular prescription pain killer off the market, saying studies had shown a link between the drug, a COX-2 inhibitor, and increased risk of heart attack and stroke.
The appearance of a paper by Graham, a harsh critic of safety procedures used by major drug companies, is expected to further fan the flames of bad publicity and lawsuits facing Merck. The drug company already faces several class action lawsuits filed by former Vioxx users.
Graham's paper was to have been published in the prestigious British medical journal Lancet, giving it even higher impact. But Graham told Forbes its publication by Lancet was delayed due to conflicts with officials at FDA.
