After at first being refused an experimental drug that is in clinical trials, Fred Baron will be able to receive the drug, Tysabri.
Baron, 61, a prominent Democratic fundraiser, was the subject of a world-wide plea by his son Andrew. Baron is reported to be suffering from late-stage multiple myeloma, an incurable cancer of the plasma cells, which are vital to the immune system.
Doctors have reportedly given him only days to live, according to his son.
Tysabri is made by Biogen Idec Inc., which at first didn’t grant permission because citing regulatory risks. Ultimately the FDA said yes to the request after the Mayo Clinic found a legal basis for granting the use of Tysabri on Baron.
Though the drug is not yet approved for multiple myeloma treatment, clinical trials began in September. Baron did not meet the criteria for the trials.
Tysabri was approved for use with multiple sclerosis in 2004, but a company spokesperson says it was pulled after three people suffered a rare brain infection, PML.
It later returned to the market but with stricter safety guidelines.
Doctors prescribing it must sign a statement that the patient is suffering from multiple sclerosis or Crohn’s disease.
Baron, a lawyer known for lawsuits against environmental toxins including asbestos, TCE, MTBE and pesticides, was in the news recently in connection with the John Edward’s girlfriend scandal. He reportedly provided the funding that helped her to relocate to California.
He and his wife have also formed the Baron & Blue Foundation, looking for the answers to homelessness.
Former President Bill Clinton, Sen. Ted Kennedy, and cyclist Lance Armstrong all intervened on behalf of Baron.
Multiple myeloma has been seen among the first responders to the World Trade 9/11 attack, many of whom inhaled toxic dust from the site.
Thousands of sick and dying patients are keeping an eye on this case. The Wall Street Journal Health Blog cites one similar case and another where experimental drugs were sought by desperate patients and their families. #