http://www.healthsentinel.com/news.p...st_item&id=510
Andrew Jack, "Scientist raises estimate of Vioxx ill-effects",
Financial Times, January 2, 2005,
Link:
http://news.ft.com/cms/s/b9967e4a-5c...00e2511c8.html
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.
