Andrew Baron, a prominent figure in the New York City technology community, has published an open letter to Biogen CEO James Mullen, demanding that he permit use of the controversial drug Tysabri to treat his father Fred Baron‘s advanced cancer.
In a blog post, Andrew Baron, CEO of Rocketboom, pleads, "Please Mr. Mullen, there is no time left. There is no justification. Just say yes."
The safety and legality of the drug is highly contested. Tysabri is also know as Natalizumab, and its FDA file details a controversial history dating back four years.
According to the FDA, Tysabri was approved in 2004, and voluntarily withdrawn by manufacturer Biogen in 2005 when patients developed deadly brain infections during trials. Tysabri was approved again in January 2008, but only for Crohn’s disease, and only as part of a strict program limiting risk of developing progressive multifocal leukoencephalopathy (PML), the deadly brain infection.
On August 26, 2008, two more cases of PML– the deadly brain infection– were uncovered in European patients using Tysabri to treat multiple sclerosis. The patients are European because use of the drug to treat multiple sclerosis is not allowed in the US.
Earlier, on March 18, 2008, James Mullen said to Reuters that he despite increasing cases of PML, he expected 100,000 people to use the drug by 2010, making it a "$1 billion plus per year drug."