Legal News

Faced With Father?s Illness, Fred Baron?s Son Pleads With Pharma CEO

By Dan Slater

UPDATE: We heard back from Naomi Aoki, a spokeswoman for Biogen. “The FDA notified us yesterday afternoon that they’re going to be working directly with the Mayo Clinic to address this situation,” she told the Law Blog. Aoki went on to explain that the Biogen drug, Tysabri, was approved for multiple sclerosis in 2004. But then Biogen, according to Aoki, voluntarily withdrew Tysabri from the market because it had caused a brain infection, known as PML, in three patients.

“We did a safety review, consulted with experts on PML, and worked closely with FDA to come up with a risk management program that allowed us to bring it back on the market in a way that limited its use,” says Aoki. Tysabri, she says, is now one of the most regulated drugs on the market and the risk management program prohibits its off-label use. She says Biogen is currently conducting a phase-one safety trial testing Tysabri on multiple myeloma — the type of cancer that Fred Baron was reportedly diagnosed with last week.
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Fred Baron, a pioneer of asbestos litigation and big Democratic fundraiser who found himself in the spotlight recently when news broke that he moved John Edwards’ mistress across the country, has final stage multiple myeloma, a terminal form of cancer, according to a post on his son’s blog, Dembot.

In a letter that cc’s Lance Armstrong, Bill Clinton, John Kerry, Ted Kennedy and the head of the FDA, among others, Baron’s son, Andrew Baron, pleads with James Mullen, the CEO of Biogen, to allow his father to use a Biogen drug, Tysabri, in a way it’s “never been used before.” He writes:

In what can only be defined as a miracle in timing, a few days ago, one of his doctors who has been studying his tumor cells in the lab for years found an antibody with an exact match: Tysabri which is manufactured by your company, Biogen Idec. In the test tube, it attached to the antigens on the surface of the tumor 100%.

Though the drug has never been used before in this way, and because time is running out, the head of the FDA, Dr. Andrew von Eschenbach has granted special approval for use of the drug for this purpose but you have personally decided “no”.

According to the letter, last Thursday Baron’s doctors at the Mayo Clinic determined that he may only have about 24-48 hours to live. On his blog, Baron’s son writes that Armstrong, Clinton, Kerry, Kennedy, Senator John Harkin and Dr. von Eschenbach have all asked Mullen to say “yes.”

We placed a call to Biogen and will update the post when he hear back.

Full post as published by Law Blog - WSJ.com on October 16, 2008 (boomark / email).