In the congressional battle over the safety of America's prescription drugs, two University of Washington experts with opposing views have been enlisted into the fray.
Dr. Bruce Psaty and Thomas Fleming appeared before a Senate committee considering potentially major changes to the Food and Drug Administration.This follows the debacle over the withdrawal of the painkiller Vioxx because of links to heart problems.
Psaty, is an outspoken advocate for setting up an independent office to handle drug-safety issues. He is co-director of the cardiovascular research unit at the UW, and told the Senate Health, Education, Labor and Pensions Committee of a "safety lag" at the FDA and that pharmaceutical companies have too much influence on the FDA.
Earlier, Fleming, chairman of the biostatistics department at the UW, told the same committee, "The FDA is not broken ", he defended the FDA and was against the creation of a separate group, outside FDA, to review safety or efficacy.
The fact that the two witnesses from a select list of 10, are from the UW speaks highly of UW Health Services in national medical issues. It also shows politically astute behaviour by dueling senators and could be the start of a congressional battle over legislation that will be opposed by the pharmaceutical industry and many FDA officials.
Psaty spoke before the Senate Finance Committee in November, and has been working with Sen. Charles Grassley, R-Iowa, and Sen. Chris Dodd, D-Conn., on a bill that is expected to be introduced in the next two weeks, to create an independent safety group to replace the existing Office of Drug Safety. Democrats Dodd and Edward Kennedy invited him to testify.
Fleming who has served on advisory committees at the FDA for 20 years wants Congress to provide more money to the FDA to better review clinical trials before new medicines are approved, and more post-marketing studies once the drugs are being used by larger segments of the population.
He testified that "the FDA proceeded in a proper manner" regarding the development of risk-benefit assessments for Vioxx and similar drugs. He has great respect for the leaders at FDA and believes them to be fair and highly effective.