Dallas, October 18: Fred Baron, the controversial political donor, has finally been successful in procuring the experimental cancerdefine-fighting drug Tysabri through the Mayo Clinic, his son revealed. This has happened despite the drug maker’s refusal to approve the treatment.
Andrew Baron, Fred Baron’s son, said that Tysabri is a “last chance effort for life” in his 61-year old father’s struggle against the life threatening multiple mylenoma. Baron is in the last stage of this disease.
Tysabri can only be given to people affected with multiple sclerosis or Crohn’s disease only if the disease is in the early clinical trial stage. The drug can also be used outside the authorized approval, i.e. what the FDA terms as single-patient investigations. But at the end of it all, the drug manufacturer has to permit the use of the drug.
Fred Baron was not permitted to be treated with Tysabri by its manufacturer Biogen Idec Inc. The company has supported its decision by saying that regulatory risks are very high in case Baron is given Tysabri.
President Bill Clinton and cyclist Lance Armstrong also tried to persuade the company but it did not budge from its decision. But Andrew Baron said that a legal basis for using Tysabri on his father has been worked out by the Mayo Clinic alongwith FDA.
However, Mayo Clinic spokesman John Murphy said that he didn’t know anything about this case. He added that no special treatment has been given to Baron.
Since 2007, 250 single-patient investigations have been given a stamp of approval by the FDA.
Biogen Idec Inc. spokeswoman Naomi Aoki said that there is no proof which shows that Tysabri can be effective in the case of Fred Baron.
She added that the drug was pulled off from the market in 2004 after it was found that three people consuming the drug got afflicted with a rare brain disease. Later, two of them died.
When Tysabri was brought back in the market, strict precautionary guidelines were issued. This included the requirement that physicians can only prescribe Tysabri for a patient suffering from multiple sclerosis or Crohn’s disease.
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