FDAnews Drug Daily Bulletin


April 13, 2006

A recent study finds that multiple sclerosis (MS) patients may prefer to choose their own drug therapy when given the option, even if that choice involves an increased risk for dangerous or possibly fatal side effects.

More than 50 percent of the 200 MS patients surveyed said they would be willing to risk the slim possibility (a one-in-1,000 chance) of suffering a fatal side effect if given the option to choose a more effective treatment for their disease, according to the study released by the American Enterprise Institute (AEI).

The study was underwritten by Biogen-Idec, which comarkets the MS treatment Tysabri with Elan, but the survey did not specifically ask respondents about the drug. The companies were forced to pull Tysabri (natalizumab) from the market in February 2005 following reports of a possible link between the product and two serious adverse events, including one patient death.

According to the survey, most MS patients may be willing to accept serious risk factors in a drug if it offers them a more effective treatment option. While they expect to rely on a thorough FDA review of drugs and adequate warnings of potential side effects, a majority of respondents indicated they would decide whether to take a drug based on consulting with their physician about viable treatment options for their particular situation.

To read the study, "A Representative Survey of M.S. Patients on Attitudes Toward the Benefits and Risks of Drug Therapy," access http://www.aei-brookings.org/publications/abstract.php?pid=1056 (http://www.aei-brookings.org/publications/abstract.php?pid=1056).