Risky MS treatment worth it: N.L. man

Cassie Aylward
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Controversial procedure linked to deaths, injuries, FDA says

Mark Lane. –Photo by The Telegram

The U.S. Food and Drug Administration (FDA) issued a warning Thursday against a controversial multiple sclerosis (MS) treatment it says has caused injuries and deaths. The treatment, called liberation therapy, was discovered by Italian doctor Paolo Zamboni.

The treatment involves unblocking veins and blood vessels in the neck and chest by inserting balloons into the veins to treat chronic cerebrospinal venous insufficiency (CCSVI).

The condition, according to Zamboni, affects the flow of blood from the nervous system to the heart. Zamboni believes this syndrome is linked to causing MS, an incurable disease affecting the nervous system. Common symptoms are fatigue and numbness or tingling in the fingers and toes.

The FDA said in its warning that there is no scientific evidence linking CCSVI and MS.

"Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly- targeted research to evaluate the relationship between CCSVI and MS," Dr. William Maisel, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, said in the FDA's statement.

The FDA received reports of one death and one stroke as a result of the procedure, performed in a handful of American clinics. The procedure is not performed in Canada.

'Guessing game'

Mark Lane decided to get the treatment in Poland in October 2010. He said the disease takes so much away from so many people that it's easy to get paranoid over treatments like these.

"Living with MS is like living in a permanent game of Russian Roulette. Every day you wake up, it's like a guessing game."

Despite the risks, Lane said he's seen his symptoms improve. Lane lost his ability to write with his right hand as a result of MS, and said he can write again thanks to the procedure.

"Myself, I feel fantastic, and I haven't lost a whole lot (to MS). I've lost it and regained it, and lost it and regained it, Lane said. And since my surgery I haven't lost anything."

The 37-year-old from St. John's was diagnosed with MS when he was in his early 30s.

The same month Lane received his treatment, Mahir Mostic, a 35- year-old man from St. Catherine's, Ont., travelled to Costa Rica for the same treatment. Mostic died after suffering complications from the procedure.

In July 2011, Marilyn Clarke, a 56-year-old Calgary woman, died from a brain hemorrhage after travelling to California for the liberation therapy.

Recognizes risk

Jessesar MacNeil, a representative for the Multiple Sclerosis Society of Canada's Atlantic division, said the MS society shares the FDA's views that the treatment is risky.

MacNeil said the society is putting millions of dollars into research to find out if there is a link between CCSVI and MS.

"People with MS deserve clarity and the hope that CCSVI (treatment) offers. It's only through rigorous research that we're going to be able to get these answers," she said.

MacNeil said the MS society is aware of both the successes and failures of liberation therapy.

"We have lots of people saying the treatment really helped them with their MS symptoms, particularly their fatigue, and their sensations in their fingers and toes, but then we've also had people who say that there was no benefit from it," she said.

Looking for evidence

In a prepared statement via email, federal Health Minister Leona Aglukkaq said Heath Canada will rely on the best scientific evidence possible before making a decision on liberation therapy.

"Before our government will give the green light to a limited clinical trial here in Canada, the proposed trial would need to receive all necessary ethical and medical approvals," Aglukkaq said. "When it comes to clinical issues, I rely on advice from doctors and scientists who are continually monitoring the latest research, and make recommendations in the best interests of patient health and safety."

Lane said the treatment is well-worth the risks.

There's risks in getting a tooth pulled, Lane said. If something happens and my health starts to deteriorate and (doctors) scan my neck and find the veins have closed again, I'm getting on a plane and going back to Poland.

Organizations: FDA, MS society, U.S. Food and Drug Administration Center for Devices Radiological Health Multiple Sclerosis Society of Canada

Geographic location: California, Canada, Poland St. John's Costa Rica Calgary

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Recent comments

  • Heather French
    May 14, 2012 - 12:24

    I was diagnosed with MS 21 years ago, I havbeen affected verty significanly with my eyesight and mobility. I keep hearing about this treatment, over and over again. It is always too great a fistance from where I live and the cost is just way beyond what I can manage. Why can't this procedure be more available in more regions aand at a loer cost. Why should I have to be stuck with this? We need more options to be available. I could be making a huge contribution to this world if I was more able. Right now I am just a drain on society.I need a lot of help at all times

  • Patricia Grace-Farfaglia
    May 13, 2012 - 13:24

    I had the procedure in January 2011. My hope was that I would feel less tired. But little by little I had improvements in vision, hearing, strength, pain, and heat/cold intolerance. I thought I had a re-stenosis of my right jugular in October 2012 and had another venoplasty - but didn't need treatment. Months later I learned that my gall bladder and bile duct were blocked by a diverticula and a polyp and that was creating inflammation and infection. My neurologist examined me after the surgery and felt that my MS was being fueled by chronic inflammation. I am 100% again. The BNAC study (2012) in which I was a participant identifies four major risk factors for MS/CCSVI: heart murmurs, mononucleosis (EBV), irritable bowel syndrome, and history of smoking. I have IBS, gluten-sensitivity, heart murmur, and chronic EBV. My parents were heavy smokers and I grew up in a smoke-filled house. I now exercise, get plenty of fluids, take tea and cranberry extracts as antioxidants, eat fish & vegetables, and take vitamin D3. The procedure can only do so much - the health of the endothelium that lines the veins is crucial. Healthy habits help maintain blood flow in and out of the brain.

  • Leslie
    May 13, 2012 - 12:10

    I had this procedure done at Rhode Island last year. It will be a year on the 24th. I have lost a few benefits, but I am also dealing with another illness. I think by now everyone knows this is not a cure and that it doesn't always work for some. It is far better than the side effect ridden Avonex I was on for a year, which I had to stop due to suicidal ideation. The real kicker to the story is I found out that my MS was really Lyme disease. Because some with Lyme had many benefits from CCSVI I went ahead and had it done. Glad I did. I just wish they would be honest and list the deaths from other MS medications and the dollars everyone is raking in. MS is a billion dollar disease. A cured patient is a lost patient! Just remember that!

  • Ann
    May 12, 2012 - 22:29

    I researched venous angioplasty for two years before I had the procedure and went into it with the knowledge that generally, the milder the disease, the more positive the outcome. I have what is termed 'mild' MS and have had for 30+ years, which is not to say I didn't have problems. I did, but was lucky to be very mobile. At first, I listened not so much to the people who had the procedure done but to the doctors who did or who had someone in their family who did - neurologists, vascular surgeons, anesthetists, etc. and went from there. It became a full-time job and finally, when I went to Rhode Island I felt that I was doing so with the best info out there. They don't use stents nor did I want one. I have absolutely no regrets! Huge improvements. My brief period on MS drugs did SO much more damage than the CCSVI procedure. With that in mind, why is no-one talking about the large number of people who have recently died on the new MS drug Gilenya, not to mention the Tysabri deaths. Also, since I have long ago stopped following anything the MS Society does, when did they up their measly $500,000 for CCSVI research to millions?

  • PPATEL
    May 12, 2012 - 16:39

    This treatment is not a cure for MS like some people are mistaking it as. It does help elevates the symptoms of MS. It may not work for everyone. Everyone's body is different and we cannot only rely on this treatment to cure MS. I am very happy for the patients that have gotten relief from this treatment. It has helped so many patients around the world and there haven't been any complications for the people that went to the US to get the treatment. There are many clinics in the US that offer the treatment, but it is important to pick the right place. Only a few clinics are participating in a certain protocol. I know of a clinic in Dayton, OH that are participating in a clinical study trial through the Hubbard Foundation. They are also approved by the NIH and are approved as an IRB study. It is important that they are submitting their results and following rules. I hope this information helps to anyone seeking treatment. http://www.daytonir.com/LiberationTreatmentCCSVI.aspx Thank-you!

  • Lori Batchelor
    May 12, 2012 - 15:27

    If the procedure is so "experimental", why is it used regularly as a "standard of care" for chronic renal condition patients whose veins have occluded due to repetitive catheter use in dialysis? I guess it's only really "risky" for people with MS because then it endangers the drug companies!

    • Ppatel
      May 15, 2012 - 11:09

      I completely agree with you!!

  • JJ
    May 12, 2012 - 11:41

    My wife had the CCSVI procedure done 20 months ago. The Interventional Radiologist who performed the procedure admitted to us in advance that 33% of patients see no improvement, 33% see some improvement, and 33% see amazing improvement. My wife was one of the lucky ones. From the day of the procedure, we saw immediate and dramatic improvements in her MS symptoms that continue to this day.

  • Daughter of MS
    May 12, 2012 - 10:40

    I think people need to stop toting this as the miracle cure for MS. Yes, it's a treatment that appears to have worked for many but there are just as many, if not more, that have seen little or no improvement after having the CCSVI treatment. My mother was one of them. She went to have the treatment believing that she would be "cured" of MS based on all the stories smeared across the media every day. Imagine the disappointment she felt when she didn't experience any improvement despite the high percentage of expansion in her veins. She was made to feel like a failure because all the media did was report on how wonderful this therapy is and how much everyone improves. I'm glad to see that the other side of the story is starting to be told. I'm happy for those who have seen an improvement but the story is not all one sided and people need to be aware of that.

  • Michele Findlay
    May 12, 2012 - 04:59

    Much is made of two aspects of CCSVI treatment, the first being the risks attached to the procedure and secondly the scientific evidence required. Let me address risk as it is the one most commonly used to frighten people... The figures of complications and deaths compare most favourably with deaths and complications from MS prescribed deaths. There have been 5x less deaths as a result of angioplasty for CCSVI than there have been fromTysabri caused PML. To be generous to Tysabri/PML 1 in 2000 have died, whereas with CCSVI treatment only 1 in 10,000 have died. Additionally in terms of benefits the surgical treatment is at least as successful as tysabri. Very little research reveals that tysabri is not universally effective. (see risk sharing schemes) Secondly let us examine the need for scientific proof. Only about 20% of currently prescribed treatment is the result of scientific proof. The fact is that medicine is not a precise science. Things work for some and not for others... I do believe that there is a rule of thirds in medicine: 1 third get better, 1 third will get some benefit and one third will not benefit at all and may get worse. The value of clinical trials in respect to this treatment in MS is uncertain being that people with MS symptoms get worse in time and at an unpredictable rate. So let us use a bit of common sense here and assess, treat, review, record patients and the outcomes of a procedure considered safe for the general population and treat people with MS for venous insufficiency without all the hype and bunkum which is flung about with great abandon by people who ought to know better.

  • Carletta
    May 11, 2012 - 19:17

    I personally went through the treatment of CCSVI and it truly saved my life! I have a 2nd chance at life. It's so frustrating to hear these things when I personally went through the treatment almost a year ago (May 24, 2011) and the results are still holding strong! I am a productive citizen... I can do things for myself now. YEs it is a guessing game when you wake up when you have MS... after CCSVI I wake up with a HUGE smile everyday!! I thank God for Dr Zamboni in caring to find an alternative way to ease these symptoms with MS! Without it I wouldn't know where I would be today! Maybe it has something to do with the stage you are in with MS if the procedure will work for a particular person.. its better going through this procedure than injecting myself with drugs that there isn't proof that it actaully works! The drugs made me want to die with crazy depression that set in (check the side effects!) With CCSVI what is the risk? having a gluten free diet (oh no watch out to the companies that lose revenue that are high in carbs!) seriously the MS Society needs to really help people with MS instead of giving SO much funds to drug companies why don't they take some of those profits and help others with MS that doesn't have help to afford their meds or health insurance! Personally living everyday with a dark cloud over my head was torture! after CCSVI all I can say I have never felt so great in all my life!!

  • Susan
    May 11, 2012 - 15:51

    Even with the prescription drugs out there they have risk also. Some have caused brain infection and death some get good results some see no difference. Just as in the CCSVI treatments some regain so much from the treatment some haven't. In other health related problems if people have blockage they have them cleared to keep from having strokes or other problems. Look at shots we give our children to stay healthy some die from the shots. There will always be risk. The biggest deal is not knowing which treatment will work for each person and which one is well worth the risk for them.

  • Lori Batchelor
    May 11, 2012 - 15:17

    I was told I had to have my gallbladder removed--under general anaesthetic--but was told it was very safe. 2 months after, I collapsed from pain and vomiting--because they hadn't removed all the gallstones so I had to go in for another procedure. No surgical procedure is 100% without risk or possibility of complications . After 21 years, my MS had reached a point where I couldn't stand without hanging onto something because of poor balance. I couldn't walk more than a few feet because of poor balance and right-sided weakness with drop-foot. I became very experienced at falling and was extremely lucky not to seriously injure myself like friends of mine have. There was absolutely no treatment for my secondary/progressive condition so I was "supposed to" just accept that I was going to just deteriorate and become even more disabled. After lots of research, the minimally invasive procedure of venous angioplasty seemed a lot less risky than my gallbladder surgery and just getting worse and possibly doing severe damage to myself with another fall. I am so glad I took the "risk" because now my balance is 99% and I can walk several yards without assistance. My risk/benefit analysis was correct!

  • JHughes
    May 11, 2012 - 12:36

    I think it is important to hear about the risks just as much as we hear about the good news people share about CCSVI treatment. I personally know 2 people who have gone outside of Canada to have their veins unblocked. One of my friends feels good, my other friend got worse after treatment, to the point that she is thinking about taking a leave of absence from work. These facts NEED to be told. Both sides of the story.