Dr. Garret FitzGerald's Speech in May 2005 at Edinburgh, Scotland
Dr. Garret FitzGerald, a highly regarded medical doctor at the University of Pennsylvania, told a conference in Edinburgh, Scotland that the problems surrounding the Vioxx recall in the U.S. could happen, again, with a different unsafe drug unless the FDA makes some fundamental changes. He blamed the Vioxx problems on the FDA's failure to act in a timely manner on emerging evidence of serious side effects risk for prescription drugs with safety issues, such as Vioxx, and suggested that there was an "absence of science" in parts of the FDA. Dr. FitzGerald said that a much more sophisticated approach by the FDA as regards its drug safety oversight role is necessary in order to avoid a repeat of the Vioxx debacle. Dr. FitzGerald is one of the doctors who first raised concerns about the serious cardiovascular side effects that have been linked with Vioxx.
In more detail, Dr. FitzGerald told a medical conference convened by the Royal College of Physicians of Edinburgh in mid-May 2005 that his University of Pennsylvania research team was reporting plausible medical evidence of a Vioxx-related cardiovascular risk as early as 1998 -- a year before Vioxx was first approved by the FDA. Instead of acting on the concerns and conducting further studies, Dr. FitzGerald said that Merck Inc., the manufacturer of Vioxx, sought to dismiss his team's research findings. Ultimately, Vioxx was withdrawn by Merck in September 2004 when the company acknowledged that the drug carried "serious cardiovascular risks".
During his speech in Scotland, Dr. FitzGerald called for more rigorous studies to be conducted by pharmaceutical companies like Merck which would integrate the findings of biochemical, pharmocological, and epidemiologcal research so as to produce a more complete safety profile of new prescription drugs seeking approval by the FDA.
Dr. FitzGerald told the Edinburgh audience that he is hopeful that systemic improvements will be made at the FDA insofar that drug safety issues are now being given more priority at the federal agency since the Vioxx recall.
- Read more about the Vioxx recall and the FDA
(Posted by: Tom Lamb)