Vioxx safety data approved
The U.S. Food and Drug
Administration has given a whistle-blower scientist permission to publish
data indicating that as many as 139,000 people had heart attacks that may be
linked to Vioxx, the scientist's lawyer said Monday.
Dr. David Graham, who
works in the FDA's office of drug safety, has said he was not allowed to
publish his data questioning the safety of Vioxx, a pain medication
principally used to treat
Additionally, an FDA official sent e-mail messages to the medical journal
Lancet trying to persuade the journal not to publish the data.
Citing its own safety
concerns, manufacturer Merck & Co. voluntarily pulled Vioxx from the
market in late September.
Graham testified in
November before a U.S. Senate committee that the FDA fumbled in its handling
of safety concerns around Vioxx and had mishandled concerns about five other
widely used drugs. He contended that the FDA has an inherent conflict of
interest that triggers "denial, rejection and heat" when safety
questions emerge about products it has approved.
The FDA denies the
allegations, and controversy over the agency's role continues.
But the question of
publication of the Vioxx data appears to be settled.
The FDA told Graham on
Monday that he could go ahead and publish his research, which shows that
88,000 to 139,000 people have had heart attacks that could be linked to
Vioxx, with 30 per cent to 40 per cent of them fatal, said Graham's lawyer,
The report will be
resubmitted to the Lancet, a British medical journal, which is expected to
publish it, Devine said.
Calgary Herald 2005
Copyright (c) 2005
Interactive, a division of
. All rights reserved.