Multiple Sclerosis Drug Back On Market

Tom Durante - tdurante@longislandpress.com 06/29/2006 12:29 pm

Pamela Mastrota of the National Multiple Sclerosis Society says Tysabri needs to be monitored. After more than a year of uncertainty and doubt, patients are relieved at the possible re-emergence of a treatment to relieve the symptoms of multiple sclerosis, an incurable neurological disease affecting more than 300,000 Americans. After the deaths of two MS patients taking Tysabri, Biogen Idec Inc. and its partner, Elan, had taken the drug off pharmacy shelves in February 2005. Its removal was met with frustration from MS patients, including those on LI, where there are 7,000 confirmed cases. "There was a lot of disappointment when it came off the market," says Pamela Mastrota, president and CEO of the Long Island chapter of the National Multiple Sclerosis Society. Tysabri (pronounced Tie-SAH-bree) reduced the number of flare-ups of MS in patients with relapsing forms of the disease, which can cause blurry vision and slurred speech, tremors, numbness, paralysis and blindness. The drug, taken by intravenous injection every four weeks, keeps inflammatory cells from entering the brain. In two separate clinical trials at Stony Brook University Hospital in 2003, about 15 to 20 patients were treated with the drug. Researchers were encouraged by the results. "The drug was very well-tolerated," says Stony Brook neurologist Dr. Patricia K. Coyle. "And the patients did very well." Then in November 2004, the U.S. Food and Drug Administration (FDA) initially approved the drug for clinical trials in patients with MS, Crohn's disease and rheumatoid arthritis. But three patients out of the 3,000 participants nationwide developed progressive multifocal leukoencephalopathy (PML), a rare brain infection. PML is commonly associated with diseases such as cancer and AIDS. Two of the patients with PML died. The manufacturer withdrew Tysabri in February 2005, the same month the FDA put trials of the drug on hold. A year later, the FDA approved resumption of a clinical trial of the drug, and in March, dozens of MS patients testified at an FDA hearing on Tysabri. The drug will be back on the market in July, but with a mandatory registration and monitoring program for patients and their doctors. Tysabri will also carry a "black box" warning describing the types of risks associated with the drug. "It can be effective, but it needs to be monitored properly," says Mastrota. "We need to be aware of both the benefits and the potential risks." According to Biogen's website, patients are instructed to take Tysabri only after finding limited success with other MS treatments. One patient, 48-year-old James Blog of Huntington, was in the process of receiving the drug when it was pulled off shelves in February 2004. Blog, a New York City accountant, has had a mild case of MS for 15 years. Blog began taking Tysabri in October 2003 as dual therapy with Avonex, another MS drug. He was a part of the clinical trial at Stony Brook Hospital and felt the treatment was effective. "I was feeling good," he says. While Blog's diagnosis may not be as serious, he sometimes experiences relapses which cause disorientation, stiff legs and a lack of coordination. During his last episode, which happened six months after discontinuing Tysabri and Avonex, he needed steroids to help him bounce back. The decision to take or switch to Tysabri hinges on the opinion of the patient's neurologist. In July, Blog will be meeting with his neurologist at Stony Brook to determine if his future will include Tysabri. Speaking from experience, he hopes he's a candidate. "It works great," Blog says. "But in three weeks, I'll know if I can get back on it. I would trust my doctor."