Biogen Idec said no, but the FDA said yes. We told you yesterday about the case of Fred Baron, a generous Democratic donor who's dying of multiple myeloma. The Clintons, Ted Kennedy and several other prominent politicians, as well as Lance Armstrong, were lobbying Biogen for Tysabri. Well, now Baron will get the drug, even though it's not yet approved for multiple myeloma treatment.
Biogen didn't cave, however; Baron's doctors at the Mayor Clinic worked with the FDA to find a "legal basis" for Tysabri use, the Associated Press reports. You'll recall that Tysabri is sold under a restrictive risk management program because of its links to a potentially fatal brain infection, PML. That program usually prohibits off-label use, and as you know, Tysabri is only approved to treat multiple sclerosis and Crohn's disease in the U.S. Clinical trials for multiple myeloma began in September.
You can be sure that the media will be following Baron's case, so we'll find out how he fares on Tysabri. One of the reasons his illness has attracted so much attention: Baron was the donor who acknowledged sending money to former presidential candidate John Edwards' ex-mistress. That adultery-and-payoff scandal hit the tabloids, of course. So it's no wonder that the money man is now making headlines.
- read the Washington Post story