Newspaper article The Florida Times Union

Denied Relief; FDA Veto of Drug Miffs Doctors, MS Patients

Newspaper article The Florida Times Union

Denied Relief; FDA Veto of Drug Miffs Doctors, MS Patients

Article excerpt

Byline: Charlie Patton

Before Harold Johnson enrolled in a clinical trial of the drug Lemtrada, multiple sclerosis was ruining his life.

"Things were pretty bad," said Johnson, 43, who was diagnosed with multiple sclerosis in 2009. "I had optic neuritis in my right eye. I had problems talking and would sound like I was drunk. My memory went out to lunch. The worst thing was when I'd take a drink of water it would go down the wrong pipe. I had to get on my knees because I felt like I was about to pass out. Many times I thought I was going to die."

All that changed dramatically in 2009 when Johnson, who lives in Swansea, Ill., received his first infusion of Lemtrada.

"It 100 percent changed," said Johnson, who got married soon after he enrolled in the clinical trial.

He called Lemtrada "the best thing that has ever happened to me besides my wife."

So Johnson, like a lot of people, was shocked when the Food and Drug Administration announced last November it would not approve the use of Lemtrada in treating relapsing multiple sclerosis.

"Lemtrada was a quantum leap forward in treating multiple sclerosis," said Jacksonville physician Daniel Kantor, medical director of Neurologique and president-elect of the Duval County Medical Society.

The FDA's decision "was a great disappointment not only for patients, but doctors and investigators," said Kantor, who was involved in the clinical trial. "It's clear this medication is effective."

Multiple sclerosis, also known as MS, is a potentially debilitating disease in which the body's immune system eats away at the protective sheath that covers nerves, according to the Mayo Clinic's website, www.mayoclinic.org. That damage causes interference in the communication between the brain, spinal cord and other parts of the body. Symptoms vary widely, depending on the amount of damage and the nerves that are affected. …

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