MS community shocked by FDA’s rejection of drug

Harold Johnson was going downhill fast. The medication he injected three times a week for his multiple sclerosis was making him feel like a zombie, and it wasn’t helping. His vision was getting worse, and he would choke when eating or drinking, and would shake and stumble.

“The day that bothered me the most was when I went to my mom and dad’s house on Mother’s Day. I had to use a cane to walk in front of my mom,” said Johnson, 43, of Swansea. “That affected me.”

Things dramatically changed about four years ago, after Johnson began taking part in a study of the experimental drug Lemtrada.

The canes and walker he sometimes used are collecting dust in his hallway. He can ride his bike, play in the park with his dog, build robots in his basement and work full time as a computer technician at Southwestern Illinois College. Imaging of his brain shows no new damage.

“Within three weeks, I felt like Superman,” Johnson said. He even got married.

Many with the debilitating neurological disease have stories like Johnson’s. A study of nearly 1,400 patients with progressive forms of multiple sclerosis showed those taking Lemtrada had nearly 50 percent fewer new attacks than those taking the current best medication. New brain lesions were also significantly reduced. The findings have already led Canada, Australia, Mexico and the European Union to approve the drug for treatment of multiple sclerosis.

However, in late December, the U.S. Food and Drug Administration ruled the drug was not ready for approval, surprising and disappointing doctors, patients and advocates.

“The data was highly impressive to neurologists involved in treating MS,” said Dr. Barry Singer, director of the MS Center for Innovations in Care at Missouri Baptist Hospital and who is involved in the clinical studies of the drug. “It frankly came as a shock that the medication did not get approved.”

Multiple sclerosis is an unpredictable and disabling disease where the immune system attacks the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis. About 2.3 million people worldwide have MS, including 400,000 in the U.S.

FUTURE OF THERAPIES

Medical professionals are worried that the decision not only reduces much-needed treatment options but could have ramifications for future MS research. Doctors and nurses recently joined forces with advocates to send a letter to the FDA outlining their concerns.

“We’re trying through advocacy to have a fresh review of the results and a potential reversal of the decision,” Singer said.

The drugmaker, Genzyme, is appealing the ruling; and patients, friends and family members are urging citizens to sign an online petition asking the FDA to reverse its decision.

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