Hope for MS patients:

Drug undergoing trials in Oklahoma

The Journal Record
January 17, 2011
By April Wilkerson
Copyright © 2011 Dolan Media Newswires

Oklahoma’s medical and research facilities continue playing a role in introducing a new drug for multiple sclerosis to those who need it.

Gelinya is the first oral treatment for MS and a relief to some people who have long relied on other drugs only administered by injection. Gelinya received approval from the Food and Drug Administration last fall, but clinical trials continue in Oklahoma to prove its efficacy and safety.

At the Lynn Institute in Oklahoma City, one person has committed to being part of a Phase 4 clinical trial, and the facility is searching for up to 10 people to participate. The Lynn Institute pays $50 a day for each patient, along with related costs, including an electrocardiogram, eye exam and other tests. About 1,000 people nationwide are being sought for this trial.

Dr. Mark Fisher, principal investigator for the trial at the Lynn Institute, said the drug brings a bit more hope to a condition that often devastates people with fatigue, weakness, dizziness, vision problems, dementia and more.

“There are a lot of patients of fairly modest means, and with the way health insurance is in this country, people may have good coverage in one respect and terrible coverage in another, such as no drug benefits,” Fisher said. “Things like this trial are good for them.

“As a neurologist, I don’t do a lot of curing,” he added. “There are a lot of conditions I see that, once the diagnosis is made, it’s permanent, including MS. You deal with an awful lot of negativity – the most you can expect in many cases is for people not to get any worse. So anything that turns the situation more positive in these chronic conditions is a good thing. ”

Such trials also are how the Lynn Institute earns its money. The drugmaker, in this case, Novartis, pays the facility for each person enrolled in the trial. Courtney Manning, manager of marketing, said the Lynn Institute has 76 clinical trials under way among its six sites in Oklahoma, Colorado and Arkansas. The money it makes from pharmaceutical companies goes into the nonprofit side of its business, which focuses on research into sleep medicine and gastroenterology, she said.

Although the Lynn Institute couldn’t say how much money it expects from the clinical trial for Gilenya, the facility often receives higher compensation the more rigorous a trial is.

Mercy Health Center in Oklahoma also has been involved with the Gilenya trial, initially in the Phase 3 trial that brought the drug to market and now in ongoing Phase 3 work. Dr. Gabriel Pardo, who leads the MS Center of Oklahoma at Mercy’s NeuroScience Institute, said the drug is a breakthrough partly because an oral medication could lead to more compliance among patients.

“Even in the most compliant of patients, after some time they can develop what we call ‘needle fatigue’ – after years of injecting, they get very tired of it,” Pardo said. “That is where an oral medication can play a significant role, especially if it has good efficacy. ”

At Mercy’s MS Center, 21 patients went through the entire Phase 3 trial, Pardo said, and he continues to monitor others who are taking Gilenya commercially. Side effects, which include cardiac arrhythmia, swelling in the back of the eye and decreased heart rate, are continually monitored.

The drug also is expensive. At its wholesale price, Gilenya costs about $48,000 per year, Pardo said. That amount is too steep for many people.

“Some insurance companies are going to a percentage program – they pay 20 percent of your medications. When you’re talking almost $50,000 a year, that’s quite a chunk of change,” Pardo said.

Novartis has an assistance program to help patients, and Mercy has a group – MS Bridge – that helps patients pay for treatment costs, Pardo said.

Mercy treats 2,000 people with MS, and Pardo estimates 4,000 Oklahomans live with the disease.