Saturday, October 18, 2008

Dallas lawyer Fred Baron allowed to use experimental drug in cancer fight

By JEFFREY WEISS - The Dallas Morning News - October 16, 2008

Dallas lawyer and Democratic Party fundraiser Fred Baron has won his fight to gain access to an experimental cancer drug, according to an e-mail sent out by his son late Thursday afternoon.
Lawyer Fred Baron in Dallas in September 2006.
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According to the e-mail from Andrew Baron, his father was given the drug, called Tysabri, in hopes that it would reverse what doctors say is an otherwise incurable case of multiple myeloma, a cancer of the bone marrow.

Tysabri has been approved to treat multiple sclerosis and Crohn’s disease but not cancer. Researchers began preliminary clinical trials testing the drug on patients with multiple myeloma only six weeks ago and don’t yet know whether it works.

The drug is not available to other cancer patients without the permission of the manufacturer, Biogen Idec. As of Wednesday night, the company was refusing to give that permission. A Biogen spokeswoman said that allowing Mr. Baron to use the drug could jeopardize its use by thousands of other people.
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Link: Son's plea to drug company

But Mr. Baron’s family enlisted some of their well-known friends to lobby the company. The list included Lance Armstrong, the bicyclist and cancer survivor; Bill and Hillary Rodham Clinton; Sen. John Kerry, D-Mass; and Sen. Edward Kennedy, D-Mass., who has brain cancer.

Andrew Baron, founder of the Web video company Rocketboom, posted a letter with details of his father’s condition on his personal blog. His plea that his father be allowed to get Tysabri was picked up by the online technology community, which posted links on several other well-known blogs.

Andrew Baron sent out a brief note late Thursday afternoon:

“Thanks to the persistence and hard work of so many friends, Frederick has received Tysabri. The Mayo Clinic working with the FDA found a legal basis for this use. We have every expectation of a positive result.”

Access to the drug was not granted by Biogen, a company spokeswoman said.

“The FDA did notify us late yesterday they were working directly with the Mayo Clinic to try and resolve the situation,” Naomi Aoki said. “It wasn’t through us.”

Mayo Clinic officials declined to comment.

Neither members of the Baron family nor representatives of the FDA were available to provide additional details about how Mr. Baron obtained the drug.

Most prescription medications can be used for “off-label” treatments without additional approval. But Tysabri was pulled from the market once because of its connection to a rare brain infection, and any off-label use must be approved by Biogen.

Biogen officials said they feared that if Mr. Baron had bad side effects from the drug, the company would have difficulty getting approval for its use by other cancer patients. It also feared that doctors would become reluctant to prescribe the drug for MS and Crohn’s.

In his letter, Andrew Baron said that Dr. Andrew von Eschenbach, head of the Food and Drug Administration, had given “special approval” for his father to get the drug. His letter also said that the FDA had agreed “that there would be no legal risk and no negative consequences” to Biogen if something went wrong.

An FDA spokesman said Biogen’s president had called Dr. Eschenbach but that no such immunity had been given to the company.

“FDA has provided no such assurance to the company,” Christopher DiFrancesco said in an e-mail. “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.”
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