Testing Prototype Myeloma Medication
For some people the prospect of a prototype medication can be hopeful, and testing can be done with the consent of the patient and corporations involved.
Baron has described Tysabri as a “last chance effort for life” in his 61-year-old fathers 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 Crohns 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, didnt 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 Barons case.
He was turned down for the companys 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.
Source: mibax