MS Medication Breakthrough

There is new hope for the thousands of Americans suffering from M.S. A novel drug, called Tysabri, has been shown in new studies to prevent the progression of the disease. But does it come with a life-threatening side effect? For patients like, Audrey Greenfeld, who suffers from relapsing multiple sclerosis, any new treatment is a welcome one. “I was diagnosed almost fifteen years ago. I basically have no strength in my right side, and it just kept getting worse,” says Audrey.

With relapsing M.S., the symptoms come, go, and come back, and gradually worsen over time. The disorder is characterized by intermittent development of inflamed areas of the brain and spinal cord that result in plaques which destroy nerve signal transmission.

 Dr. Fred Lublin of Mt. Sinai Medical Center says, “It can produce all sorts of potential problems blindness in one eye, double vision, numbness, tingling, weakness in one arm, one leg, both legs.” The best treatments including interferon, often fall short. Audrey has tried everything…to no avail. But now, this new treatment called Tysabri may be—not a cure—but a big answer in battling relapsing M.S.

A new study shows Tysabri, when used alone, reduced relapse rates after one year of use by 68 percent. And it decreased the risk of a steady worsening of disease…by 42 percent. Dr. Lublin, who co-authored the study published in the latest New England Journal of Medicine, says, “So we know the drug is effective and we are happy with the efficacy but we don’t know what the real risk is.”

The big concern: in another study, when Tysabri was combined with interferon, there were two cases of PML—a deadly viral brain infection. The drug was withdrawn from the market voluntarily. “I stopped walking two years ago so but I figured ok ill get it when it becomes available and I got approval from my insurance company and I had one infusion and I had no side effect. So I was very excited and then two weeks after I got my infusion they took it off the market,” recalls a disappointed Audrey.

But Tysabri alone has not been shown to cause PML. So two weeks ago, the FDA once again allowed studies on the drug. And next week, an fda advisory panel will consider approval of Tysabri for relapsing M.S. “They will review the efficacy data, the safety data that has been collected since the drug was taken off the market,” states Dr. Lublin. Tysabri may be the answer for Audrey.

 “I would love to walk again, but if I cant I just don’t want it to get worse it is getting to the point where I am not going to be able to live with not doing anything so I’ve got to stop it from getting worse,” she exclaims. Tysabri may alone provide benefit for two other diseases, crohn’s disease and rheumatoid arthritis. There was, before the voluntary withdrawal of the drug by its maker, four months of open availability; during that short time span, 7,000 patients received it commercially, showing there is a huge unmet need for M.S. patients.

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