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MS Patients Want More Treatment Options
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.
MS is an auto-immune disease that attacks the brain and spinal cord, and specifically the lining of nerve cells. The grim reality is that there is no cure.
"You have to sit there and smile and act like everything is okay, but really it's just a bunch of acting," McCoy said. "I'm screaming on the inside most of the time."
Treatment is different for each patient. MS symptoms can range from mild to severe. Currently there are only 10 different drug options available on the market.
Dr. Edward Fox is a Board Certified Neurologist at Central Texas Neurology Consultants, P.A. He said he feels there should be more options when it comes to MS drug treatments. He played a part in the Lemtrada study, and said its effectiveness should outweigh how the trials were handled.
"The greatest difficulty we have is pairing the patient to the correct treatment," Fox said. "We felt this was a valid option, because there were a number of clinical trials that did show efficacy and showed safety that would be manageable for us."
If approved, Lemtrada would be most aggressive MS drug on the market. It would require only eight doses of medicine compared to McCoy's 152 shots a year.
And, until more medical advances come to fruition, McCoy is taking it one day at a time.
"In a sad sense some of us are lab rats in a way," McCoy said. "I just try to live life. I'm tired of being held back. I don't want to hold myself back anymore."
In Central Texas there are thousands of people living with MS, and in the country there are about 450,000.
If you would like to voice your opinion about the FDA's decision to not approve Lemtrada click on this link: http://petitions.moveon.org/sign/thousands-of-multiple