By Steven DiJoseph
Anita Smith died from a rare, and often fatal, brain disease while participating in a late-stage clinical trial of the MS medication, Tysabri. As it turned out, a number of other patients being treated with the drug also contracted the same disease.
Although she had been diagnosed with multiple sclerosis, an autopsy revealed that Smith never had MS, thereby making her enrollment in the trial problematic at best. Moreover, the unusually high incidence of the brain disease in Tysabri patients raised a serious question as to the drug’s safety.
Although the potentially deadly side-effect caused the hastily approved drug to be pulled from the market on February 28, 2005, after only four months, the effort to have Tysabri re-approved began almost immediately. (more…)

