Two prominent Stanford neurologists criticized a trial of the controversial multiple sclerosis drug Tysabri for including a patient that didn't demonstrate symptoms of MS. Dr. Annette Langer-Gould and Dr. Lawrence Steinman write in The Lancet that when a company test a drug that has a potential for harming patients, researchers need to be acutely aware of the risk-benefit balance when enrolling people for a study. One enrolled patient who died, Anita Louise Smith, had actually been diagnosed with MS but didn't have symptoms. It was subsequently determined that she did not have the disease. The neurologists say that researchers should reexamine the rationale for including a patient that had no disability, especially when other, safe drugs were available.
Tysabri was jerked from the market a year ago after two patients died from a rare brain disorder. An FDA committee is scheduled to examine whether Tysabri should be allowed back on the market. New data published this week has supported researchers' view that the drug is safe and effective in the short term.
- read this report from Forbes