Ailing Democratic donor obtains experimental drug

DALLAS (AP) _ An ailing Democratic fundraiser has obtained an experimental cancer-fighting drug through the Mayo Clinic, according to his son, despite the drug maker's refusal to sanction the treatment.

Fred Baron, a prominent political donor linked to the John Edwards mistress scandal, received the drug Tysabri after a "legal basis" for its use was found, his son Andrew Baron said in an e-mail to The Associated Press. He didn't elaborate.

Baron has described Tysabri as a "last chance effort for life" in his 61-year-old father's battle with late-stage multiple myeloma. Doctors last week gave Fred Baron only days to live, his son said.

Tysabri is approved for people with multiple sclerosis or Crohn's disease, but is only in the early clinical trial stage for multiple myeloma.

Patients can seek to use drugs outside the authorized use under what the Food and Drug Administration calls single-patient investigations. But permission must ultimately come from the drug manufacturer, said Judy Leon, an FDA spokeswoman.

Biogen Idec Inc., which manufactures Tysabri, didn't grant permission to treat Fred Baron with the drug, company spokeswoman Naomi Aoki said late Thursday. Biogen has maintained the regulatory risks of giving him special access to Tysabri are too great.

The company stood by its decision despite appeals from such prominent figures as former President Bill Clinton and cyclist Lance Armstrong.

Andrew Baron said the Mayo Clinic, working with the FDA, found a legal basis for using Tysabri on his father.

Mayo Clinic spokesman John Murphy said he had no information about the case. Leon said the FDA could not comment on individual cases, but said no preferential treatment had been given to Baron.

The FDA approved about 250 single-patient investigations in 2007, Leon said.

Fred Baron has bankrolled millions for Democrats in Texas. He made headlines this summer when he acknowledged sending money to Edwards' former mistress. Baron has said Edwards had no involvement with the payments, which were used to resettle Rielle Hunter, Edwards' former mistress, in California.

Aoki has said there is no data showing Tysabri would work in Fred Baron's case. He was turned down for the company's clinical trial, but Aoki said she could not say why.

Aoki said Tysabri was first approved for multiple sclerosis in 2004, then pulled from the market after three people taking the drug suffered a rare brain infection. Two died, she said.

It later returned to the market but with strict safety guidelines, including a requirement that physicians who prescribe Tysabri sign a form stating the drug is for someone with multiple sclerosis or Crohn's disease.

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