Other News Dallas lawyer Fred Baron obtains unapproved cancer drug
By Ben Wasserman
Oct 17, 2008 - 12:23:32 PM
If you like the article, could you please do us a favor? Just tell Google News Services that you like foodconsumer.org included in Google News Services. Inclusion in googlenewsservices means many more people can read articles like this. Thanks.
------
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 It was withdrawn by the manufacturer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.