A prominent political donor for the Democratic party has apparently gotten his hands on an experimental drug to fight cancer over the objections of the drugmaker.
The drug, Tysabri, which is manufactured by Biogen Idec Inc., is approved only for use in patients with multiple sclerosis or Crohn's disease. Biogen refused to give permission for it to be used in a single-patient investigation on the ailing donor, Fred Baron, in spite of pleas from many high-profile figures like former President Bill Clinton and cyclist Lance Armstrong. Nonetheless, Baron received the drug at the Mayo Clinic, which apparently managed to work out a "legal basis" to give him the drug in cooperation with the FDA.
This is the latest in a number of cases in which individuals have fought to get access to drugs outside of normal group trials. Sometimes it is seen as the last chance for an ailing patient, such as in this case, in which Baron had been told he likely only had days to live without treatment.
Pharmaceutical companies, on the other hand, are often concerned that allowing end-stage patients access to trials will skew the number of deaths that show up in the final numbers, and possibly prevent the drug from passing the FDA's requirements. Time will tell whether the pharmaceutical companies or the individual patients will get the upper hand in this tough battle.
To learn more about Baron's struggle:
- Read this Chicago Tribune piece