March 8, 2006 at 09:39:55

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Genentech and Biogen Legal Troubles - When It Rains It Pours

By Evelyn Pringle (about the author)     Page 4 of 4 page(s)

opednews.com     Permalink

"The condition is caused by a virus that destroys the sheath that covers the nerves," WebMed says. "Symptoms include mental deterioration, vision loss, speech disturbances, and movement abnormities or paralysis."

According to the FDA, in the general population, PML is extremely rare, and virtually never occurs in individuals with normal immune systems. Even in patients with AIDS, only 1 – 5% are diagnosed with the disease during their lifetime.

After Anita Smith died of PML, her husband filed a lawsuit against the drug makers. On February 25, 2006, News Inferno reported a major ruling in the case that ordered Biogen to produce all medical records immediately for Anita Smith.

The lawsuit claims an autopsy determined that she never had MS.

In recent years, drug companies have been trying out MS medications on people with mild symptoms or none at all at the time of treatment, several experts say, including some who, like Smith, might not have the disease, according to the February 18, 2006 LA Times.

These trials broadened the market for MS drugs but, critics say, put patients who don't need powerful new medicines at risk, the Times wrote.

"People with no active disease — in other words, people who are doing fine — shouldn't be given an experimental drug with unknown risks," said Stanford University neurology professor Lawrence Steinman, a co-inventor of Tysabri who has previously spoken out about the drug's dangers.

Steinman and another Stanford neurologist, Annette Langer-Gould, urged the FDA to tighten criteria for selecting patients in MS drug trials, according to the Times. "We are concerned that not only were patients put at risk by Tysabri, but we feel that the risk was absolutely unnecessary to assume," they said in an e-mail to the agency.

The drug makers are losing mega buck every day the drug remains off the market. Despite an annual price tag of $23,500, by the time the Tysabri was withdrawn after a mere 4 months on the market, 5,000 patients were on the drug and 15,000 more were awaiting insurance verification for the first dose, according to the February 18, 2006 LA Times.

Biogen and Elan want their money maker back on the market. The FDA has hearings on the drug scheduled for March 7 and 8, 2006. and is expected to determine whether the Tysabri can return to the market by the end of March.

It remains to be seen how many more people will turn up injured by Genentech and Biogen through illegal marketing schemes perpetrated on unsuspecting patients.

Information for injured parties can be found at Lawyers and Settlements.com

http://www.lawyersandsettlements.com/articles/rituxan.html

By Evelyn Pringle

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