Sorry about the link being broken. I guess the Sun Times only lets you connect to their archives for a day. They don't make money that way I guess. So here's the article if anyone was interested and couldn't pull it up.
MS patients want return of drug that has serious risk: Tysabri's success hailed, but 1 in 1,000 will get brain virus
Publication: Chicago Sun-Times (IL)
Date: March 2, 2006
Author: Jim Ritter The Chicago Sun-Times
Section: News
Edition: Final
Page: 20
Word Count: 525
A $24,000-a-year drug called Tysabri looks like the best new multiple sclerosis treatment in years. Tysabri reduces the rate of MS relapses by about two-thirds, and might prove beneficial for rheumatoid arthritis and Crohn's disease.
But there's a small chance Tysabri could cause a horrible side effect. In roughly one in 1,000 patients, the drug unleashes a brain virus that can kill patients or leave them blind, paralyzed and unable to speak.
Tysabri was taken off the market last year after reports that three patients contracted the brain disease, known as PML. But now the manufacturer wants the U.S. Food and Drug Administration to bring the drug back, and three studies published today in the New England Journal of Medicine report there have been no additional cases of PML.
'BEST DRUG AVAILABLE'
MS patient Bartira Tiburtius of Arlington Heights desperately hopes the drug returns. She took Tysabri for 28 months as part of a study, and during that time she suffered no relapses.
But since the drug was pulled in February 2005, Tiburtius has suffered several MS symptoms, including balance problems and "horrible" fatigue.
The chance of getting PML, she said, "is a small risk I'm willing to take."
Tiburtius said she wants to have the right to decide her treatment, "and right now, Tysabri is the best drug available to improve my life."
Tiburtius belongs to MS Patients for Choice, which hopes to persuade the FDA to bring Tysabri back. Next week, an advisory committee to the FDA will consider the issue, and Tiburtius is among the patients scheduled to testify. If Tysabri does come back, the FDA likely would require stern warnings and perhaps occasional MRI scans to check for PML.
The largest MS advocacy group, National Multiple Sclerosis Society, has not taken a position for or against bringing Tysabri back.
About 400,000 Americans have MS. The disorder can cause a wide range of symptoms, including difficulty walking, slurred speech, tremors, bladder problems, vision loss and problems with memory, attention and problem-solving. Most patients do not become severely disabled.
MS apparently is caused when the immune system turns on the patient and attacks the protective coating of nerve fibers.
Tysabri prevents immune system cells from entering the brain and damaging the protective coatings. Unfortunately, the drug also might impair the immune system's ability to fight the virus that causes PML.
A DIFFICULT CHOICE
When Tysabri is used, "one in 1,000 patients will get a horrendous and usually fatal disease," said Dr. Larry Steinman of Stanford University, who co-discovered the drug. "The potential benefit and rare harm makes for a difficult choice that doctors and patients will have to enter into."
Steinman said he would recommend Tysabri only for patients who have had relapses and have not responded to other drugs.
Tysabri is given to patients intravenously once every four weeks. During the three months it was on the market, 5,000 patients took the drug and another 15,000 patients were waiting to begin treatment.
jritter@suntimes.com
Color Photo: Richard A. Chapman, Sun-Times / Bartira Tiburtius of Arlington Heights took the MS drug Tysabri for more than two years during a clinical trial. She says the drug's potentially deadly risk is one she's willing to accept.