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 said that between 89,000 and 139,000 people had been seriously affected by the drug. He originally provided those estimates to a congressional hearing in November.