Meet MS: People negotiating the maze of of a difficult disease

By Cynthia Pegram

Published: April 5, 2008

The small form of Tammy Martin’s 15-year-old cat was as still as a sculpture, although the aged feline’s ability to nap so soundly atop the overstuffed chair sometimes results in a surprise landing.

Martin has three cats and a dog, constant and sometimes-quirky companions in her world, which multiple sclerosis (MS) has narrowed to the Amherst County home built in the 1950s by her granddad.

Martin is a former security guard, who resisted going on disability as long as she could, about four years.

“I’m stubborn.”

Now Martin is one of six area patients already among what will be more than 500 nationwide enrolling in a clinical trial of an MS drug designed to treat secondary progressive MS. The particularly relentless form of MS is suffered by about 40 percent of the 2.5 million people worldwide who have one of the disease’s four classifications.

MS damages the myelin coating on nerves. Some consider it an autoimmune disease because the body’s own immune defenses attack the myelin. Like frays in the covering of an electric wire that cause a short, the damaged myelin is scarred and impairs conduction of the nerve impulses. Depending on the location of the damage, symptoms vary and include numbness.

In this area, the trial is being run by Blue Ridge Research Center at Roanoke Neurological Associates, about an hour or so from Martin’s home.

The clinical trial of the drug MBP8298 is called MAESTRO-03. The drug is a synthetic replica of a protein component attacked by the immune system in MS.

If effective, it would be a major step forward in treating this form of MS. And that is a hope new to this group of patients.

It has been tested in Europe and Canada with some positive results, but won’t be available in the U.S. until approved by the FDA, Dr. J. Gordon Burch, a Roanoke neurologist, said in an interview.
While MBP8298 holds promise, it does not offer a cure. That will come only by solving the puzzle of what triggers MS and how to counter it, he said.

Even confirming MS can be difficult. The development of the MRI was quite helpful in discerning the presence of the disease, Burch said, “but not a definitive.”

The Blue Ridge Research Center expects to enroll 12 people in the MAESTRO-03 trial by the June 30 deadline, although more can be accepted. Referral is through a neurologist, Burch said.

The MAESTRO-03 trial is double-blind, which means neither the patient nor the researchers know until the study is complete if the patient is getting the real drug or a look-a-like but inactive compound called a placebo.

It’s hard for non-MS patients to understand the personal significance of the study.

For Campbell County resident Beata Payerhin, it means hope for her sister in Poland, an MS patient for 26 years.

Now Ewa Nowakowska has entered the clinical trial, even though it means a 20-hour trip from her home in Poland to her sister’s home here in Central Virginia.

Both learned of the trial from Medical News Today, an Internet newsletter.

Payerhin called Blue Ridge Research Center to learn the basic requirements, then went to Poland and translated her sister’s medical records. Her sister met the criteria for the study. The 18-month trial includes an injection of the trial drug every six months and an MRI evaluation every three months.

The trip from Poland to Central Virginia can be grueling for an MS patient. And with U.S. visa restrictions, Nowakowska cannot stay through the 18 months of the study and must return every three months for two years, a costly endeavor.

“The bad part is that 50 percent get a placebo — we don’t know if she is getting the drug or placebo,” said Payerhin. If, at the end of the study, the FDA OKs the drug and it’s found that Nowakowska did receive the placebo, then she will get the drug at no cost for an equivalent period.

While it was a tough call, Payerhin said, “I think you go for the hope.”

In Amherst, Martin, a voracious reader in general and about MS in particular, had an intense discussion with herself before signing up for the trial.

“I thought, ‘There’s a 50-50 chance whether or not you’ll get the drug. If you get drug, you’ll be helping yourself, plus helping the group doing the study.

“‘If I get the placebo, I’m still helping the people doing the study. They’ll take that data, compare it to the others, and more than likely, there’ll be a drug out on the market. So, you’d still help yourself, but it’s just going to take a couple of years down the road.’ ”

Her decision: “It’s for me. I’m going to do it.’”

That was last fall. Her next dose will be in April, about six months after the first. That pattern will continue into 2009.

She’d like to see more area MS patients enroll.

MS patients are usually between the ages of 20 and 50 when diagnosed. The disease can take over the person’s life.

Now 42, Martin was in her early 30s and living in Roanoke when she had the first recognizable symptom.

“I used to walk a lot,” she said. When she got overheated, her eyesight would begin to fade, and she would lose depth perception and color awareness.

One hot day, a car almost hit her. “Why are you in the middle of the road?” the driver asked. Martin thought she was safely out of the way.

The vision problems also appeared when she played basketball and got overheated. She went to her doctor, who found no reason for her symptoms, but just to be sure, referred her to a neurologist. The neurologist scheduled an MRI and some more tests.

“From the time I went to my regular doctor to the time I got the diagnosis was like two months,” said Martin.

She was pretty calm as the doctor told her she had MS. But when she got back to work that day and a concerned co-worker asked her what the doctor said, “I cried like a baby.”
That was in 1998, and she continued to work until 2002.

Her MS didn’t seem to respond to medications. Her doctor told her she had an aggressive form of the disease.

In 2004, Martin learned she had Secondary Progressive MS — but her research had already led her to that conclusion.

“I’m numb everywhere,” she said. Even on a chilly winter day, she is barefoot in her living room, her walker nearby. Socks are a hazard, because they slip.

“I lost feeling in my feet in February 1999,” she said. “Everything I lose is like a grieving process.

“The right leg is starting to give me problems. The left leg, there’s nothing there. I have no strength, no control over it.”

Before entering this trial, Martin had quit taking any disease-modifying drugs in 2005. None were doing any good, she said, and the drugs are very expensive. She stopped even though her family argued that it was a bad decision.

Martin struggled against MS, and didn’t use the wheelchair or walker until 2005, then “I got tired of falling into things.”

She has good days, and bad days.

“The bad days I call my MS days. The bad days, I can’t get anything to work right. My hand doesn’t want to work right. My leg doesn’t want to work right. I feel tired.”

It’s not another downhill slide, though, she said, because she knows that feeling.

“It’s just an MS day.”

For information about the drug trial
Contact Blue Ridge Research Associates at (540) 342-2929 to sign-up for the MAESTRO-03 drug trial for secondary progressive MS, or visit http://www.biomsmedical.com or http://www.clinicaltrials.gov for more information.