Vita.min C lowers blo.od pre.ssure

Friday October 17 2008 (foodconsumer.org) -- A democratic fundraiser has obtained an experimental cancer-fighting drug through the Mayo Clinic although initially the drug maker refused to give it because the drug has not been approved to treat the disease he is suffering.

Fred Baron, a prominent political donor for the Democratic Party, obtained Tysabri finally after legal basis was found that he can be given the drug, his son Andrew Baron was cited as saying in an e-mail to theassociatedpress.

Baron said Tysabri is the last resort for treatment of his 61-year-old father's late-stage multiple myeloma for which the older Baron was given a few to live.

Tysabri was initiated approved by the Food and Drug Administration in November 2004 to treat multiple sclerosis or MS. It was withdrawn by the manufacturer Biogen-Idec in Feb 2005 after three patients in a trial was found to have develop progressive multifocal leukoencephalopathy (PML), a serious and rare viral infection of the brain.

The FDA approved in June 5 2006 an application for resumed marketing of Tysabri, but a special restricted distribution program is required to decrease the possibility of patients developing PML in the future.

But this drug has not been approved to treat multiple myeloma and a clinical trial is ongoing in its early stage.

Under certain circumstances, however, patients may seek to use drugs unapproved by the FDA as long as it is used as single-patient investigations, but permission should be granted by the drug maker.

Biogen Idec Inc. refused even later on Thursday to give the permission for Fred Baron to use its drug citing the high regulatory risks of giving an individual special access to Tysabri. The company resisted appeal from former president Bill Clinton and Lance Armstrong, a cancer survivor.

Andrew Baron said the Mayo Clinic found a legal ground for his father to use the drug, but Mayo Clinic spokesman John Murphy was cited as saying he was not aware of such a case.

Each year in the United States, about 15,000 people are diagnosed with multiple myeloma, a form of cancer. Doctors do not know what causes the disease.   But studies are being conducted to determine the effect of radiation, pesticide, hair dye, certain viruses, obesity and diet.