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  • mardermj mardermj Mar 24, 2005 1:07 PM Flag

    From Miami Herald;3/22 T Backin Fall

    MS patients angry over loss of drug


    After five tough years fighting multiple sclerosis with current drugs, Carmen Chediak had just received her first infusion of a new one, Tysabri.

    She hoped it would give her more relief with fewer side effects. But three weeks ago, Tysabri was pulled from the market. One person in a 500-patient clinical trial of Tysabri, taken in combination with another drug, had died of a rare disease called PML, which attacks brain cells. Another had contracted the usually fatal disease.

    Chediak was angry the drug was pulled.

    ''It's an overreaction. I know they have to be cautious, but I wish they would hurry up and get it right.''

    She's far from alone. Tysabri was seen as a significant breakthrough for MS treatment; trials had found it nearly twice as effective in preventing relapses after two years of treatment compared with the current drugs called interferons, doctors said.

    Because of that, patients and doctors are clamoring for it to be back on the market soon. ''It's perfectly ludicrous,'' said Dr. William Sheremata, director of the MS Center at the University of Miami Miller School of Medicine, of the drug's removal. ''But with product liability attorneys hiding behind every bush, there's no alternative to pulling it.''

    MS affects 400,000 people in the United States, primarily women between ages 20 and 40. It causes loss of muscle and bladder control, blurred vision, speech and hearing problems and fatigue. Symptoms come and go; relapses sometimes worsen, in dire cases causing death.

    ''For many years we have used other, more dangerous treatments for MS,'' said Dr. Jeffrey Horstmyer, director of the MS Center at Mercy Hospital. ''Even if Tysabri has the rare side effect of PML, it's still likely safer than a lot of other things being used to treat it.''

    Still, Tysabri's problems are significant. The Food and Drug Administration approved Tysabri last November, before the end of its two-year clinical trial, because its benefits seemed so apparent. And 5,000 new patients nationwide were taking Tysabri.

    But then a patient who had been taking Tysabri for 37 months in one of the trials died of the brain infection PML, or progressive multifocal leukoencephalopathy. Another, who had been on Tysabri for 28 months, came down with PML. Both patients had been taking Tysabri in combination with Avonex, an interferon made by Biogen Idec.

    In multiple sclerosis, the body's immune system attacks the myelin, or insulation, around nerve cells in many parts of the body. When the insulation is damaged, it interferes with the brain's ability to send messages along the nerves.

    Interferons, the standard treatment for MS since the 1990s, seek to inhibit the replication of the viruses that attack the myelin sheath. Tysabri was different, developed to prevent the immune system cells from passing from the bloodstream into the brain, where they could attack the myelin sheath.

    PML is caused by activation of the JC virus, which exists in latent form in 80 percent of even healthy adults. When it is activated, it attacks the myelin sheath around the nerve cells, making it similar to multiple sclerosis -- only more dangerous, often leading to death.

    Despite the PML problems, doctors say they support Tysabri.

    ''Tysabri creates a 66 percent decrease in relapses after two years, compared with about 30 percent for the other drugs on the market,'' says Sheremata, who took part in early clinical trials of Tysabri.


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