The right to choose

Most of the public discussion of drug safety has focused on whether FDA has imperiled public safety by allowing the marketing of dangerous products. There has been little debate about the risks associated with delaying or denying access to therapies, or about who should be empowered to make risk-benefit calculations.

The debate is likely to be quite different on March 7-8 when an FDA advisory committee hears the public's views about the merits of reintroducing Tysabri natalizumab for multiple sclerosis. The Peripheral and Central Nervous System Drugs Advisory Committee is likely to get an earful on the right of patients to make their own decisions about the trade-off between risk and benefit...