The mortality risks posed by Vioxx to treat arthritis and Tysabri to treat multiple sclerosis--drugs that have recently received scrutiny--are comparable to or exceed the risk of dying in a car, working as a truck driver, or rock climbing, according to a new study published in Health Affairs. Even the widespread prophylactic use of aspirin poses a fatality risk on par with the risk associated with driving a car or working as a firefighter, say study coauthors Joshua Cohen and Peter Neumann of Tufts-New England Medical Center. The study compares mortality risks posed by drugs with risks related to work, transportation, and recreation.
The authors argue that risks cannot be properly evaluated without also considering the associated benefits. They point out that some surveys of patients who take Tysabri indicate that they would tolerate considerably higher risks to alleviate their multiple sclerosis symptoms. The need for the FDA to systematically and quantitatively evaluate both the risks and benefits of drugs may soon grow. The Institute of Medicine has recommended that the FDA undertake more intensive postmarket surveillance of medications, and Congress is considering legislation in this area. Cohen and Neumann suggest that such surveillance would likely reveal that many more drugs have serious, although relatively rare, side effects. Read the abstract.
