Friday, September 16, 2005

Missing in Action

Well actually, Fundamentally...
If monitoring can prevent the condition from becoming fatal, then proper monitoring should have been in place. and where was the FDA when the trial was approved??
The fact is there are no "good" treatments available for ITP, and all the available treatments have potentially significant harmful side effects themselves.
It seems unlikely that monitoring alone could prevent the problems seen in the trial since the side effects from this drug were already well known - unless the trial design (or follow-through) was bad to begin with.

http://www.thestreet.com/_yahoo/stocks/robertsteyer/10243104_2.html
Among the Campath patients, three suffered from a disease, nicknamed ITP, that can cause abnormal bleeding due to low blood-platelet counts. Two of these patients received high doses of Campath, and one received a low dose. One patient died. "Investors could have flashbacks to the fatal Tysabri side effect," says Thomas Shrader of Harris Nesbitt, in a note to clients. "But we see the situation with Campath as fundamentally different in that ITP is not a fatal condition if proper monitoring is in place. Importantly, Genzyme believes that the ITP side effect can be properly managed by physicians."

http://biz.yahoo.com/bizj/050916/1165703.html?.v=1
"Campath, approved in 2001 for leukemia, already carries the FDA's toughest warning related to the risk of serious and sometimes fatal side effects. That includes a form of the condition found in the multiple sclerosis study."

http://www.campath.com/safety.html
Important Safety Information
"Hematologic Toxicity: Serious and, in rare instances fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia have occurred in patients receiving Campath therapy. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week should not be administered because these doses are associated with a higher incidence of pancytopenia."

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