Hope - and concern - in new MS treatment

REGISTER INVESTIGATION: An experimental new treatment for multiple sclerosis patients is fiercely debated. Some patients say the treatment, in which a balloon is used to expand the veins draining from the brain and spinal cord, has sharply reduced their symptoms. But critics say there is no medical proof the treatment provides anything but a psychological effect. Patient deaths, including one in Orange County, have raised alarm further.

Canadian Michelle Walsh feared multiple sclerosis would leave her permanently bedridden when she decided to travel to Orange County and undergo a controversial vein-opening treatment that is not approved by her country's national health system.

Since the procedure in January, Walsh, 38, can graze a comb through her hair and see well enough to drive her young children to swim lessons.

"I had nothing to lose and everything to gain," she said.

Maralyn Clarke, another MS patient from Canada, felt the same sense of desperation when she scheduled her trip to Synergy Health Concepts in Costa Mesa.

At 56, she suffered from incontinence and could no longer work at a job she loved. She learned more about the experimental procedure, which uses a balloon to expand veins draining from the brain and spinal cord, after attending an "Open Mind" seminar that Synergy sponsored at a Calgary hotel.

On the morning of her April 13 procedure at Synergy's surgery center, Clarke felt excited and hopeful. Hours afterward, while napping at her hotel, she lost consciousness. Five days later, Clarke died at Hoag Hospital.

Her medical records indicate she suffered a subdural hematoma, or bleeding in the brain, following the treatment.

"This is not supposed to happen," said her husband, Frank Lamb, his voice choking, during a phone call from the couple's home in Calgary, Alberta.

Clarke is believed to be the world's third documented fatality among MS patients who underwent angioplasty, sometimes with placement of a stent, of the jugular and azygos veins. An estimated 15,000 patients have been treated in the U.S. as well as countries including Bulgaria, Poland and India.

The new hypothesis that insufficient vein drainage from the nervous system, dubbed "chronic cerebro-spinal venous insufficiency," or CCSVI, by one of its pioneers, is linked to MS is fiercely debated. Patient deaths have further raised alarm among some doctors.

"This is faith healing," said Dr. Michael Brant-Zawadzki, director of neurosciences at Hoag. "The doctors who offer it believe in it; the patients believe in it; but there's no empirical evidence that CCSVI is a medically recognized syndrome."

Stanford University stopped offering the treatment last year after an American patient died of a brain hemorrhage. Another Canadian died in 2010 after traveling to Costa Rica for the procedure, according to Canadian media reports. But other patients, including Walsh, blog about their dramatic improvements. In the last year or so, the treatment has become an Internet-driven phenomenon where patient demand, fueled by anecdotal evidence, has raced ahead of any scientifically proven data.

U.S. researchers recently have begun large-scale clinical trials and results will be several years away.

Dr. Michael Arata, the interventional radiologist who treated both Walsh and Clarke at Synergy Health, says the benefits of vein opening are too promising to dismiss.

"Some of these patients are in horrible shape," Arata said. "If we can provide some relief, then we feel like this is something we should be doing."

NEW THEORY

Experts believe MS is an autoimmune disorder that attacks the nervous system. It's a maddening, debilitating disease that's notoriously difficult to study because symptoms and intensity vary so much and come and go. MS generally strikes younger adults, and women are more susceptible than men. The disease most often afflicts people of Northern European descent living in cold climates. As a result, Canada has among the highest MS rates in the world.

There is no cure, but in late 2009, patient websites buzzed with word of an explosive discovery.

Dr. Paolo Zamboni, an Italian vascular surgeon whose wife has MS, published a study that found narrowing, twisting and blockage in the veins leading from the brain in MS patients. He also reported that when he dilated their veins, their MS symptoms improved. He speculated that CCSVI might cause the damaging inflammation found in MS.

"The Internet goes nuts because there's a bunch of understandably desperate patients out there for whom there is no perfect treatment for MS," Brant-Zawadzki said. "The patients start demanding this from their conventional doctors. Certainly in the history of medicine, there have been mavericks. The problem with this particular treatment is it has potential dangers to the patient. There's no sense to it."

Arata says he had never heard of CCSVI until a woman with MS approached him in February 2010 and asked if he would treat her. At the time, he was performing angioplasty, where a catheter directs a balloon to open veins and arteries, mostly on kidney dialysis patients.

Arata said he went online and researched Zamboni's theory. He knew from experience that the procedure was low-risk, so he agreed to try it. By fall, he and three other doctors were specializing in nothing but CCSVI treatment. Arata said some patients don't experience any improvement, but he's also seen undeniable results, like the patient who couldn't eat, speak or move her limbs.

"I had a patient within 15 minutes who was sitting up, eating in recovery and was saying, 'thank you,' '' Arata said. "The whole family was crying. I was crying."

These days, the waiting room at Synergy's Newport Boulevard office is packed with Canadians who come in for a consultation and then stroll through Fashion Island with the help of canes. The $8,000 angioplasty fee includes a four-night stay at the Hyatt Regency in Newport Beach.

The procedure, which lasts 30 minutes to an hour, is performed in the Renaissance surgical center housed in the same medical office building. Synergy also charges $2,500 for diagnostic imaging of the jugular, azygos, vertebral and lumbar veins. While most patients pay cash, Arata said a few health plans will cover the angioplasty. All of the health insurers contacted by The Register said they do not cover the procedure. Anthem Blue Cross, the largest for-profit insurer in California, describes the procedure for MS patients as "investigational and not medically necessary."

Arata, who is scheduled to speak at a patient seminar in Nova Scotia later this month, stresses that the procedure is not a treatment for MS, but rather a treatment for obstructed blood flow. He said angioplasty can improve the symptoms of a number of neurological conditions and that he has also opened the veins of patients with Lou Gehrig's and Parkinson's diseases.

"My way of understanding it is we're improving the environment the brain functions in," he said.

Arata declined to comment on Clarke's death. He said Synergy's rate of serious complications is less than 1 percent after more than 1,000 CCSVI procedures.

While most patients and publicity have come from Canada, CCSVI is about to find a bigger U.S. audience. Talk show host Montel Williams, who has MS, said he underwent the vein procedure and plans to discuss his experience on "The Dr. Oz Show" this fall.

"I have some really serious maladies in the veins in my body," Williams said during an interview with Fox News. "I had some corrections done. I've had some incredible results."

Such anecdotal reports haven't won over the neurologists who treat MS patients. They note that many people with vein obstructions don't have MS or any problematic symptoms. There are also MS patients whose veins look normal.

"The venous system in the brain is very forgiving," said Dr. Ellen Marder, a Dallas neurologist who recently published a study comparing the veins of MS patients to those without the disease. "There are a number of people who are missing veins or have them on only one side. These are people who don't have multiple sclerosis. There are people who lack certain large veins and they drain their blood just fine through other veins."

Marder said she doesn't believe the theory merits further study or that there's scientific evidence to support the existence of CCSVI, which she called an "anatomic variation."

"I think the whole thing is just not very good science," Marder said. "I don't see really any indication that this can be regarded as a treatment for MS."

Dr. Gary Siskin, an interventional radiologist who is conducting a comprehensive double-blind CCSVI clinical trial in Albany, NY, said he understands the skepticism yet he believes the vein blockages may contribute to the symptoms of MS.

"A lot of it is very theoretical," Siskin said. "If you're someone with the culture of 'produce proof before any therapy is initiated,' this isn't going to sit well with you. The proof isn't there."

What is there, Siskin said, are patients who feel more energetic and think more clearly after angioplasty. He also acknowledged that improvements are generally reported in the more subjective symptoms of MS.

"There certainly have been enough anecdotal reports to warrant further study," Siskin said. "It's hard for me to just dismiss a patient that says they're feeling better."

The Synergy consent form mentions the possibility of complications including stroke or death. An excerpt also reads that "any improvement in Multiple Sclerosis symptoms from this procedure is still being investigated and outcomes are not guaranteed...The benefits of this procedure and the risk of recurrence is unknown and has not been proven by in depth medical studies."

That's exactly the concern of Dr. Barry Rubin, a Toronto vascular surgeon who serves on a Canadian panel that recently decided to fund upcoming clinical trials on the procedure, which is otherwise not available in the government-run health system. Rubin also worries about patient follow-up when procedures are done out of the country.

"Do no harm. Those are the magic words in medicine," Rubin said. "Some people have been harmed by this procedure. I think it's important that MS patients know about the risk. Unfortunately, there's not enough data out."

NO TIME

But MS patients like Ian Hubbert, 39, weren't willing to wait around for years of study. Hubbert, who lives in Long Beach, underwent the procedure by Arata in November against the advice of his neurologist.

"I can sum it up real quick: Pharmaceutical companies run the show," he said. "A lot of people are having it done and they're not taking the medicine anymore."

Hubbert says immediately afterward he realized he could feel sensation in his hands, which had gone numb 15 years before. He's stopped using a wheelchair and has gone off medications for spasticity, fatigue and bladder control.

Brant-Zawadzki from Hoag said the problem with anecdotal evidence about MS is that symptoms often fluctuate and can improve for no apparent reason. He also said patients have a strong desire to believe the procedure will help.

"The placebo effect is very powerful," he said. "If you have a strong enough belief that your headache will go away by hitting your thumb with a hammer, your headache will go away, but you don't want to hit your thumb with a hammer because that will cause damage."

In the case of Clarke, the woman who died, she was diagnosed with MS in her late 30s. She hoped the vein opening would allow her to return to work as an X-ray technician. She chose Orange County rather than travel to a more distant country where she couldn't speak the language, her husband said.

Lamb said that after his wife's hour-long procedure, her blood pressure spiked and a nurse gave her an injection to lower it. Clarke took Tylenol for a splitting headache, which is one of the possible side effects.

Back at the hotel, she snored throughout the afternoon. When Lamb couldn't rouse her, he called 911. In the hospital, Clarke remained unconscious, but Lamb did notice that her normally cold feet and hands were warm. He's not sure if that was a result of her vein procedure.

Lamb released Clarke's medical records, which include examination notes. Hoag neurosurgeon Dr. Richard B. Kim says the cause "of the subdural hematoma remains unclear, but seems temporally and physiologically related to the internal jugular vein dilation procedure." An autopsy was not performed.

When doctors told Lamb his wife would never recover, he and their son made the painful decision to remove her from life support. Lamb said he misses everything about his spirited, active wife.

"Her presence; the camaraderie we had. The love we had for each other," Lamb said. "There's a big empty house. It's pretty lonely."

He said he hopes his wife's death will help other MS patients make an informed choice, although he's not sure anything would have dissuaded his wife.

"She was so determined to have that done," said Lamb, a retired electrician. "If we would have had to mortgage the house, she would have done it. To her, it was her life-saver."

Contact the writer: 714-796-3686 or cperkes@ocregister.com

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