Drug Tysabri Showed Promise - MS Sufferers Ask the Food and Drug
Administration to Bring it Back to Market
March 2nd 2006
researchers have found that the new drug natalizumab (Tysabri) can have
fatal consequences. The drug went through the U.S. Food and Drug
Administration (FDA) fast-track approval process in 2004 following
promising results seen early in two clinical trials. The drug has been
used to treat multiple sclerosis (MS).
Two patients have
contracted a rare brain infection called progressive multifocal
leukoencephalopathy (PML) last month, and two died of the disease. This
spurred the marketer, Biogen Idec and Elan Pharmaceuticals, to pull the
drug off the market until the risks can be investigated.
is an immune disorder that affects 400,000 Americans, mostly young
adults. MS is a debilitating disease that begins with numbness and
muscle weakness, often getting worse with time. The disease will cause
nervous system damage.
can lead to a loss of motor control and possible paralysis. MS damages
the nerve cells by attacking their myelin protective sheath. The
current medications are not always effective in treating MS. Tysabri
has been shown to alleviate the symptoms.
After the first
year of the two-year clinical trials, Tysabri appeared to block the
disease effects, and did not seem to cause any more infections. There
were two deaths associated with the drug’s use.
The study in the
Lancet includes the case of Anita Louise Smith, who enrolled in the
experimental drug trial in 2002 in Colorado. She had been newly
diagnosed with MS and was hoping to reduce the future symptoms
associated with the disease. Last year, she died at the age of 46 from
the PML infection linked to the drug.
prompted two Stanford University School of Medicine neurologists,
Langer-Gould MD and Lawrence Steinman MD, to evaluate the
appropriateness of testing the drug on people with no evidence of the
disease. According to the Lancet article, the two are concerned about
testing a drug on people who are not yet disabled at the time of the
trial. "We are arguing that people with no disability should probably
not enter into a clinical trial or be recruited into clinical trials,
because where is the potential benefit to them if nothing is wrong?"
Many consider the risk low and now there is a call for bringing Tysabri
back to market. According to ABC News, Tysabri is a "significant
advance" for MS patients, said Dr. Allan H. Ropper, author of an
editorial that accompanied the studies published in The New England
Journal of Medicine. He is chairman of the department of neurology at
Caritas St. Elizabeth's Medical Center and chairman and professor of
neurology at Tufts New England Medical Center in Boston.
By Dan Wilson
Best Syndication Staff Writer
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