Updated: Friday, February 21 2014, 10:49 PM CST
The FDA has hit a new nerve with the medical community.
A drug to treat multiple sclerosis is not approved in the United States, even though it was approved in three other countries.
The controversy is whether the trials on the drug Lemtrada were done correctly.
Lemtrada was tested against another drug that was already on the market to see if it worked better. Normally, studies are done with the actual drug and placebo, but in this case, the patients and doctors knew which drugs they took.
The FDA said based on the unusual design of the trials, it does not have clear answers on if Lemtrada worked or not. However, patients and doctors involved with the study insisted it was effective.
It took 29 years before Russell McCoy's life centered on needles and medicine. To control his multiple sclerosis, Russell gives himself shots three days a week. His life now is a 180-degree difference from his life before he was diagnosed six years ago.
"The left side of my body started to deplete," McCoy said. "I couldn't keep up with doing things."
Russell faces daily debilitating symptoms. His muscles weakened and he has bad bouts of vertigo. He even struggles with small things like playing guitar.
"Something you've been playing your whole life it's kind of hard to see it wash away," McCoy said.
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