Kansas Woman Helps Gain Approval For New Crohn's Treatment

TOPEKA, Kan. (WIBW) - Melody McDowall was confident from the first treatment that she received the real deal in a clinical trial for a new therapy for Crohn's Disease.

She says she was nervous because she was due to fly out of the country for a wedding and didn't want to experience any problems. Instead, she felt better than she had in months.

McDowall lived eight years with Crohn's Disease when her medication suddenly stopped working. It left her with severe pain, plus flareups of the more embarrassing aspects the condition - frequent and sudden urges to use the restroom.

Crohn's Disease is a chronic inflammation of the gastrointestinal tract. It's thought to be a dysfunctional response of the immune system.

Concerned about side effects of traditional chemical drugs, McDowall's doctors at the Cotton-O'Neil Digestive Health Center suggested a clinical trial. It involved a new treatment from a class known as biologic agents, types of antibodies derived from plant or animal proteins.

Dr. Curtis Baum says the antibodies target the specific part of the immune system that is causing the problem in Crohn's or colitis patients. By inhibiting or blocking these isolated areas of the immune system, he says, patients can go into remission.

Baum says four of biologic agents already are on the market. Perhaps the most widely known is Humira. They're either injected or infused, given slowly through an IV over a period of hours.

But not all of them work for everyone so it's important to have more options. Baum says that's because keeping Crohns symptoms at bay requires continuing the treatment and that can't safely be done with current chemical drugs because it would cause excessive, negative side effects.

"We've always needed drugs that can keep these diseases in remission and the biologic agents are the best drugs we've ever had to do that," he said.

McDowall continues to receive a montly infusion of the treatment. She began the trial going in every two weeks. She responded so well to it that she jumped at the chance when asked to testify last December before the FDA advisory panel reviewing the drug for approval. She says it was a great experience to meet doctors and other patients who went through the same struggles she did. She said she felt so strongly that the new treatment could benefit other people that she would do whatever she could to make it available.

In fact, she says she would advocate participating in clinical trials to anyone. She says trials are how more options become available. In her case, she says she went through four different medications over the years. Without more options, she would not have the quality of life she does today.

The treatment McDowall tested won approval and will be on the market soon.

Cotton-O'Neil Digestive Health continues trials on five other biologic agents for Crohns and colitis. Anyone who would like information on participating should call 785-270-4881.


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