Self-described as a science writer and the Bush Administration's worst nightmare, physician Bruce M. Psaty told CASW conference attendees what it is like to blow the whistle on the Federal Drug Administration's drug approval process.
Self-described as a science writer and the Bush Administration's worst nightmare, physician Bruce M. Psaty told CASW conference attendees what it is like to blow the whistle on the Federal Drug Administration's drug approval process. Psaty, who writes regularly for the Journal of the American Medical Association and the New England Journal of Medicine, is an epidemiologist who has gained recognition for acquiring publicly available court documents to expose flaws in the FDA system — a system which, in recent years has allowed companies to market dangerous and in some cases, life threatening drugs to the public.
In 2008, Psaty and his colleagues published findings in JAMA showing that drug maker Merck & Co. grossly underplayed the health risk of the anti-inflammatory drug Vioxx. Internal analyses showed risks were known to the company long before Vioxx was taken off the market, but that information was never submitted to the FDA or made public. "What we had was this image of Dorothy Hamill skating painlessly," said Psaty in reference to ads for Vioxx, "but you know, I could take all the Vioxx in the world and I still can't skate like Dorothy Hamill."
Psaty presented similar findings for the cholesterol medicine Baycol, a cervistatin associated with rhabdomyolysis, a condition where muscle cells break down and enzymes spill into the blood, causing renal failure and death in 10 percent of patients taking the drug. Following Psaty's findings, Baycol was taken off the market in 2001.
In conjunction with what he refers to as his "recreational activities" in uncovering drug companies' misuse of scientific data, Psaty is also exploring the genetic basis for the diseases these potentially dangerous drugs are meant to treat. The development of the Cohorts for Heart and Aging Research in Genomic Epidemiology Consortium, or CHARGE, brings together five groups from around the world to conduct a genome-wide meta-analyses to answer questions about the impact factors like age, environment, and susceptibility to cardiovascular disease at the genome level. Psaty called the meta-analysis powerful. "It's become even more complicated than when we started," he said, adding "some of the data has transformed the way we work in cardiovascular epidemiology."
Psaty said his interests were more directly aimed at trying to improve the health of the public than genetic studies, but that his work through CHARGE will continue to lead to novel biological insights that could, in turn, lead to better drug treatments.
As to changing how pharmaceutical companies market their drugs, Psaty told the audience "it's really up to you folks to persuade the public." He didn't think it would be possible with the First Amendment and a Roberts court to suppress direct consumer advertising, "but I don't think direct consumer advertising to the public benefits public health a bit." Psaty added that his next promotion is to emeritus, so that what he hopes will happen is that CHARGE will become a place for junior scientist to make better use of available genetic data to improve overall public health and more informed decisions from both drug companies and patients.
Emily Schwing is a freelancer and graduate student in Natural Resources at the University of Alaska, Fairbanks.
