After several days of drama and debate over death, privilege and compassionate use, Fred Baron will receive the biologic medication to treat his multiple myeolma, according to a brief statement posted by on a blog written by his son, Andrew. The turnabout came after direct pleas by several high-profile personalities - including Hillary Clinton and Lance Armstrong - to Biogen, which sells Tysabri.
"Thanks to the persistence and hard work of so many friends, Frederick has received Tysabri," the statement reads. "The Mayo Clinic working with the FDA found a legal basis for this use. We have every expectation of a positive result. We cannot thank you enough for all of your thoughts and support!"
Fred Baron, you may recall, is a prominent Dallas trial lawyer who helped bankroll John Edwards’ presidential run and also paid for the former senator’s mistress to leave Chapel Hill, North Carolina, after the affair made national headlines. But the 61-year-old fundraiser was given only a few days to live and Biogen refused to make the med available to his Mayo Clinic doctors (back story).
A Biogen spokeswoman yesterday told us the biotech has a policy of not making Tysabri, which is approved only for treating multiple sclerosis and Crohn’s disease, available for any other treatment, even for compassionate use. That’s because the med was linked to a deadly brain infection - PML - which prompted a withdrawal in February 2005. Sales resumed in July 2006, but only under a closely controlled program that restricts access and usage.
The Biogen spokeswoman added that, given the drug’s complicated history, any inadvertent reactions Baron may experience could, theoretically, jeopardize its use for multiple sclerosis and Crohn’s patients if it would somehow cause labeling to change or spark another regulatory review. Biogen has similar concerns for the outcome of a Phase I clinical trial testing Tysabri for treating multiple myeloma.
UPDATE: On Friday morning, the Biogen spokeswoman called us to say "we didn't change our minds...The FDA notified us they would be working directly with Mayo (which is one of the site for Biogen's Phase I clinical trial)...Essentially, they cut us out of the loop. In terms of implications (for the clinical trial or any legal issues), it's too early to say." She declined to say whether Biogen was holding talks with the FDA to further clarify any of this.
This morning, an FDA spokeswoman wrote us to say the agency was in touch with Biogen and Baron's doctors, but hadn't made any promise to the biotech about implications for its clinical trial: “The FDA is working with the company and the health care professionals involved - as we would with any such request - under the provisions of FDA’s expanded access program...
“The FDA has provided no such assurance to the company. Our policy is to consider all available information when evaluating the safety and effectiveness of drugs. We recognize and appreciate that expanded access programs involve less-controlled use of experimental treatments than the well-controlled environment of a clinical trial, and thus we would consider information that might be obtained in this instance within that context.”