October 15, 2008

Biogen Idec vs. Fred Baron

Biogen Idec has found itself in a rather unique position. It apparently has a drug that is extremely effective against certain cancers, specifically multiple myeloma which happens to afflict Fred Baron.

Here's the rub...

1) The drug, TYSABRI, is approved for treating MS and Crohn's.
2) Tysabri can cause, in a very few cases, a deadly infection in the brain
3) As a result of certain side effects in immunocompromised individuals, the drug's only available to registered patients. No offlabel uses are allowed.
4) Tysabri is already in a trial to treat multiple myeloma

Which is why it's not as easy as just getting Baron's oncologist to order treatment. Baron, to his credit, has gone to some extraordinarily lengths to get this drug including enlisting help from the FDA in letting the company know that this falls under a compassionate treatment variance. Baron has offered to sign a waiver of liability and FDA has apparently indicated that the MM trial will be unaffected by the results from this treatment which neatly punches holes in the arguments being offered by the company for refusing the request of Barron and his son (who kicked everything off with this letter) based on side effects.

This also opens a larger discussion on medicine and it's future in the United States, specifically the pharmaceutical industry which has been making some big money, especially off the Fed's prescription drug benefit. Doctors do the research and a private company benefits from that research. At what point to do ethical considerations, compassionate considerations, come into play? Simply put, at what point do we fully nationalize research that we are, to a large extent, already paying for with our tax dollars?!?!

Yeah, the vast majority of the medical research in the US is funded by ... wait for it... the United States government.

Posted by mcblogger at October 15, 2008 02:04 AM

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