A new treatment has been making waves in the multiple sclerosis community for months now. So much so that both the U.S. National MS Society and the MS Society of Canada have announced they are offering unrestricted research grants to any country that wants to explore its viability as a treatment method.

People are very excited. We are very interested ourselves, and we want to meet the demand of our patients,” Dr. Anthony Traboulsee of the University of British Columbia’s MS Clinic told Canadian TV News at the time the grants were announced. The “Liberation Treatment” is based on something called chronic cerebrospinal venous insufficiency, the theory that people with MS have gnarled and twisted veins in their necks that impede blood from draining properly in the brain, creating blood that’s high in iron and free radicals and thought to be the source of MS lesions and symptoms.

The theory was developed by Dr. Paolo Zamboni, a neurosurgeon and researcher in Ferrara, Italy, whose wife has MS. In his initial research, he found that 95 percent of the 65 people he examined had twisted and gnarled veins. From there he developed the highly controversial treatment method of using balloon angioplasty to open the kinked veins, correct the blood flow and slow the progression of the disease and possibly reverse MS symptoms.

While some with MS have already begun to consider CCSVI the root cause of the disease, the medical and scientific communities are suspicious of its validity. Michigan neurologist Dr. Omar Khan wrote that Zamboni’s team may have failed to consider the small sample size, the lack of healthy control subjects and neurological evaluations that weren’t blind. He also pointed out that Buffalo University professor of neurology and Zamboni collaborator, Dr. Robert Zivadinov, found CCSVI in 62.4 percent of 500 subjects and 25.9 percent of controls, as well as in 45 percent of those with other diseases. Iron deposits were found in the brains of both groups, and they didn’t specifically match up with the locations of brain lesions in those with MS.

Perhaps most damaging is Zamboni’s team found less blood volume, not more, in the brains of MSers with CCSVI than controls of the same age and sex, which seems to go against the entire CCSVI theory. At the very least, all of this questions the role CCSVI actually plays in creating an MS diagnosis. “I’m optimistic, but I think we need to follow a slow, scientific approach. Media that announces a new cure for MS is totally not useful because they just create panic and frustration,” Zivadinov said.

Those with MS who do have the gnarled veins are also cautioned against turning to the Liberation Treatment for a solution. So far, the medical consensus is that the risks outweigh the benefits. Even Zamboni himself, the procedure’s creator, has urged people to realize the treatment is premature at this point unless it is part of an authorized research study. Both he and Zivadinov spoke at the American Academy of Neurology’s annual meeting in Toronto this past April, and Zivadinov was very clear: “My position is that I do not recommend open-label treatment without proper studies,” he told those in attendance. Both Zamboni and Zivadinov advised that people with MS continue their current drug regimen.

The warnings come on the heels of people with MS seeking and receiving the treatment all over the world after the groundswell of interest in the research. One such person is Jeff Beal, Emmy-winning composer of the theme from Monk, the TV series, who has the distinction of being the first American ever to receive treatment and to do it on home soil. It was his wife Joan who approached a neurologist at Stanford University with Dr. Zamboni’s research, seeing it as an opportunity to reverse the bizarre new symptoms Jeff was exhibiting — iron-colored bloodspots on the back of his legs and liver enzymes that were 10 times greater than what is considered normal. “The thinking was, if Jeff had these blockages, maybe his veins could be opened and his symptoms could be reversed or, at the very least, arrested,” said his wife.

Based on Zamboni’s paper, a radiologist scanned Beal’s head and found the characteristic CCSVI veins in his neck. At the time, Zamboni was conducting the first balloon angioplasty surgeries in Italy with a reported reduction in gad lesions after a year, a relapse-free rate of 50 percent after 18 months, and seemingly negligible complications.  “I wouldn’t say I was skeptical, but I was like, ‘Sure, I’ll try this,'” Beal said. However, Italy was too far for Beal to travel, and an early attempt with balloon angioplasty proved fruitless because his veins kept collapsing. That’s when the doctor suggested implanting stents to keep the veins open, which is done in conjunction with the angioplasty procedure. “It’s a more permanent solution, and he was only doing what any concerned doctor would do,” said Beal’s wife.

But stents, which are usually meant for arteries, can present grave risks, especially in those with MS. Zamboni condemns the practice as unsafe due to the potential for their migration up the bloodstream and a lack of understanding of their long-term effects. In fact, two people suffered adverse complications after undergoing the stenting procedure at Stanford. One died from a brain hemorrhage in August 2009, while another had to undergo open-heart surgery when a stent migrated into the left ventricle. After that, many, including Dr. Zivadinov, believed that CCSVI stenting procedures had been halted at Stanford, but Stanford’s team sent the following to their trial participants at the beginning of the year:

“Currently, we are planning to rigorously assess the risks and benefits of balloon angioplasty with or without venous stenting in the setting of multiple sclerosis. This controlled format for study will allow all patients to receive endovascular therapy if desired, but will provide a better evaluation of the risks, benefits and indications for different approaches.” The only adjustment made was to work together with the neurology department in a more controlled environment.

Even knowing all that has happened and the numerous studies that still need to take place before the Liberation Treatment or variants thereof can be widely approved, people like Joan Beal feel their loved ones can’t afford to wait. “For people that have this and are bleeding into their brains, they are going to be willing to take certain risks to stop it. It depends how far along you are in the disease and how much faith you have that this will work,” she said.

It’s not as if there aren’t benefits for those who’ve decided to take the plunge. Though the progression of his MS has yet to affect Beal’s mobility, he noticed the fog in his brain dissipated almost immediately. “I feel more awake. I still battle fatigue on a daily basis, but I feel like I have a few more good hours in my day that I didn’t have before,” he said.

Beal’s neighbor, Dana Merola, received six stents over two treatments, and she started to notice a significant improvement after only her first treatment. Her spasticity is greatly reduced, she can wave her arms above her head, she has more energy, sleeps better and can stand assisted straighter and longer than before. After seven years in a wheelchair, she can finally do outpatient physiotherapy for the first time, and she’ll testify to the virtues of this treatment all day long. “It may not look like I’m making much progress from the outside,” she said, “but if you saw where I was before now, you’d see how miraculous the benefits are.”

But there’s a $64 million question: Are these gains really enough benefit to risk the potential complications, especially when it’s still too early to say CCSVI is in direct correlation to MS? Everyone who studies this for a living advocates a “wait and see” approach — even the man who invented it, so it could be considered taking your life in your hands to do this treatment now for relatively little gain. “It’s questionable how much this treatment is going to be helpful. It may be more helpful in those who have an early onset of symptoms than those who’ve lived with it longer,” Zivadinov said.

The good news is, the grant money offered by both North American MS Societies started to be doled out to winning research applicants at the beginning of this month, so hopefully we’ll get some more definitive answers sooner rather than later.