Thank you for your kind words.
Don't worry, I won't stop making critical comments about Biogen and Tysabri
I just won't post a comment on every Tysabri message that appears which I sometimes have been guilty of doing.
Here is the article by the WSJ reporter. She had to go digging to get info on the 7 non PML patients who died from various types of sepsis during the trial. Prior to this article, I don't think I saw anything about those deaths...not that our friends at Biogen would go out of their way to make it public!
By SYLVIA PAG.N WESTPHAL
Staff Reporter of THE WALL STREET JOURNAL
August 29, 2005; Page B3
The multiple-sclerosis drug Tysabri, which was withdrawn from the market this year, could be linked to new serious side effects, according to an analyst's report.
Through a Freedom of Information request, Steven Harr, an analyst at Morgan Stanley, obtained a list of adverse-events reports made to the Food and Drug Administration related to Tysabri.
Following an analysis of the data, he issued a note Thursday describing adverse-event reports in which a number of Tysabri patients died of rare infections. "We're not trying to put a death knell on Tysabri, but there are
signals in there that something's going on. It's important for patients and investors to know," Mr. Harr said in an interview.
A spokesman for Biogen Idec Inc., of Cambridge, Mass., which manufactures the drug along with Elan Corp., of Dublin, dismissed Mr. Harr's report. The spokesman said Biogen and Elan had performed a detailed safety analysis of the drug and found no statistically significant differences between serious adverse events with patients given Tysabri and patients given a placebo in several clinical trials.
"We have an enormous amount of information in our hands," the spokesman said. "The [adverse-events] database is a limited tool." Biogen and Elan said this month they hope to get the drug back on the market.
The FDA declined to comment on the analyst's report.
Tysabri was taken off the market on Feb. 28 after a patient contracted a rare brain infection called progressive multifocal leukoencephalopathy, or PML. Two other cases of PML subsequently have been confirmed by Biogen and Elan. Out of those three cases, there are two confirmed deaths. It is suspected that the reason patients get PML is because Tysabri suppresses the immune system.
The analyst's report describes seven non-PML deaths in patients taking Tysabri that "appear to be related to immunosuppression." One death was owing to pneumocystis pneumonia, an infection that only patients with severely debilitated immune systems get; another was because of herpes encephalitis, a rare infection of the central nervous system. Four other deaths were possibly caused by sepsis, an uncontrolled infection that spreads through the body.
The report mentioned that the FDA database contained "numerous" accounts of serious, nonfatal infections that "suggest again that the toll from Tysabri
extends beyond PML."
Despite the possible new side effects, Mr. Harr said Tysabri has a good chance of returning to the market. Its efficacy is "so compelling" in MS that doctors are likely to want to prescribe it for their sickest patients even if the risk for immune problems is higher.
Very interesting info, isn't it? It only leads to another question...if Biogen didn't make this public, what else might they be keeping under wraps?