Thursday, June 07, 2012

Canadian Government Allocates Funds to Investigate "Liberation Treatment" for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand

The Canadian Institutes of Health Research (CIHR) is the main funding agency for health research in Canada. Most of the research in my department is funded by CIHR grants and the number and size of those grants has been shrinking, with disastrous consequences for my colleagues.

Chronic cerebrospinal venous insufficiency (CCSVI or CCVI) is the name of a condition invented by an Italian doctor named Paolo Zamboni. He claims that it is the cause of multiple sclerosis. He also claims to have developed a procedure called "liberation treatment" or "liberation therapy" that will alleviate the symptoms of MS. It involves opening up some of the veins in a patient's neck in order to improve blood flow. He has been treating patients from all over the world for the past few years.

As you might have guessed, the treatment at his clinic is not free.

There has been enormous pressure on the Canadian and provincial governments to fund this treatment for MS patients, who otherwise have no hope of a cure. So far, most provinces have refused to pay for the treatment. In August 2010, CIHR announced that it would not fund research into something that does not exist [CIHR makes recommendations on Canadian MS research priorities].
Ottawa (August 31, 2010) – On Thursday, August 26, the Canadian Institutes of Health Research (CIHR), in collaboration with the MS Society of Canada, convened a meeting of leading North American experts in multiple sclerosis (MS) to identify research priorities for Canada in this area. Today, at a press conference in Ottawa, CIHR President Dr. Alain Beaudet announced the outcomes of the discussions and shared the recommendations he has made to the Honourable Leona Aglukkaq, Minister of Health.

"There was unanimous agreement from the scientific experts that it is premature to support pan-Canadian clinical trials on the proposed "Liberation Procedure," said Dr. Beaudet. "There is an overwhelming lack of scientific evidence on the safety and efficacy of the procedure, or even that there is any link between blocked veins and MS."
This is the right decision. Money is scarce and it would be criminal to devote any of it to quackery at the expense of legitimate scientific research.

But there's a catch.

At the same time CIHR made that announcement, it also announced the formation of a "working group" to examine the result of studies currently under way—studies funded, in large part, by the MS Society of Canada.
  1. To establish a scientific expert working group made up of the principal investigators for the seven MS Society-sponsored studies (four from Canada and three from the US), scientific leadership from CIHR and the MS Societies, and a representative from the provinces and territories, to monitor and analyze preliminary and final results from these studies, as well as from related studies from around the world. The first meeting of this expert working group should take place in this calendar year.
  2. Based on the outcomes of these studies, the scientific expert working group should reach conclusions regarding (1) the association (or lack thereof) between impaired cerebral venous drainage and MS; and (2) a common standard for reliably diagnosing the condition using imaging or other techniques.
  3. Depending on these conclusions, the scientific expert working group should make recommendations on further studies including, if appropriate, a pan-Canadian interventional clinical trial.
Last year The Conservative Health Minster (Leona Aglukkaq) announced that CIHR would fund an expensive clinical trial to see if liberation treatment works [Feds to fund clinical trial of controversial MS treatment in Canada].
Canada's Health Minister Leona Aglukkaq announced Wednesday that the federal government will fund a clinical trial for "liberation treatment," an experimental vein therapy for multiple sclerosis developed by an Italian doctor.

The MS Society of Canada, a co-funding partner of the project, said it's "thrilled" by the announcement that may bring "definitive answers" about the controversial treatment developed by Dr. Paolo Zamboni.

The clinical trial for Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Canadians with multiple sclerosis seeks to determine the safety of venous angioplasty, also known as "liberation treatment" which requires the opening of blocked veins, the Canadian Institutes for Health Research said in a release about the announcement.
Barry Rubin is the medical director of the Toronto General Hospital's cardiac centre and he was a member of the working group that made the recommendation to proceed with a clinical trial. He has just published an article in the Journal of the American College of Radiology. The title is The “Liberation Procedure” for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand." (I can't access the article.) According to the press release [Canadian researcher likens controversial MS treatment to faith healing]
A member of an expert group advising the Canadian Institutes of Health Research (CIHR) about the effectiveness of a controversial treatment for multiple sclerosis has likened it to faith healing.

Dr. Barry Rubin, medical director of the Toronto General Hospital's cardiac centre, and three American co-authors draw the parallel in an article entitled "The 'Liberation Procedure' for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand," in the current issue of the Journal of the American College of Radiology.

Rubin sits on the CIHR's Scientific Expert Working Group, a 23-member international panel created by CIHR in 2010 to monitor and analyse research into the link between MS and chronic cerebrospinal venous insufficiency (CCSVI), a term coined by Italian doctor Paolo Zamboni to describe blockages in the veins of the neck and spine.

Zamboni's so-called "liberation treatment" involves opening the blocked veins by inserting a balloon, a procedure known as venous angioplasty.

Health Minister Leona Aglukkaq announced last month a team of researchers has been selected to conduct a clinical trial into CCSVI in about 100 MS patients.

But the article by Rubin and his three co-authors says funding trials of a procedure "that has minimal basis in rational, empirical knowledge seems questionable." It cites two cases of Canadian MS patients who underwent venous angioplasty.

One died while the other suffered a serious stroke.

The article places Zamboni's therapy in the same category as "treatment of breast cancer with laser photodynamics, Laetrile for cancer and other unproven therapeutics found in the retail sphere. And, it asks, "When is healing 'faith healing?'"
So, it seems as though at least one member of the working group recognized that this clinical trail is a waste of money. Money that could be spent on real scientific research. This is truly a case of "sacrificing science at the altar of consumer demand."


  1. The writer's comment about quackery nullifies and invalidates this article. His title of biochemist is almost an assurance that he receives funding or benefit from the pharma corps. I've had the procedure and can testify it's remarkable improvements to me. Shameful that a person such as the writer can degrade such science and be taken serious by some.

  2. As soon as I read "He (Dr. Zamboni)has been treating patients from all over the world for the past few years. As you might have guessed, the treatment at his clinic is not free", I knew this guy writing this blog really knows nothing and is just making things up to try to get his negativity across. DR. ZAMBONI DOES NO TREATMENTS. This blog is a waste of time--I'm going to spend my time enjoying a better quality of life that this treatment has given me!

    1. Massive study disputes Zamboni theory of multiple sclerosis

      Many studies by Dr. Zamboni and his allies have found blocked veins in the majority of MS patients and few, if any, cases in healthy control subjects. They also say many patients who have had the vein-widening procedure experience a decrease in symptoms or their severity. Some scientists conducting those studies receive substantial sums from patients to conduct the vein-widening procedure.

      On the other hand, a growing body of research from a variety of academic centres has been unable to replicate the findings. For instance, this week a study published in the Archives of Neurology found no significant difference in venous abnormalities between MS patients and healthy controls.

      The results “refute that hypothesis and corroborate those of other investigators who have recently been unable to replicate the Zamboni et al observations,” the study authors wrote.

      No benefits from Zamboni “liberation” MS treatment: Sullivan

      The province refused to fund the treatment, but in September 2010 the government put up $400,000 to do an observational study on the results of the disorder.

      Sullivan said the study resulted in "no measurable, objective benefit."

      Nova Scotia Health and Wellness POSITION STATEMENT
      Venous Imaging and Venous Angioplasty in Multiple Sclerosis (MS)

      In his second study, Dr. Zamboni performed venous angioplasty on MS patients with coexistent CCSVI (as defined in his first study).

    2. I have a friend who traveled from Canada to California to have this treatment in a private clinic. She paid thousands of dollars. That was in Dec. 2011. Her M.S. symptoms were not reduced, in fact some of them increased. 24 hrs ago she had a stroke. She is only 58. Please, don't waste your money on this, until it has been proven to work by legitimate agencies.

  3. From the Free online Dictionary: "Quackery: false pretense to medical skill, knowledge, or qualification; medical charlatanry"

    Advocating an unproven treatment for an unproven condition without clearly identifying it as such easily qualifies.

    Also, it's certainly not true that all or even most biochemists are funded by big pharma (that's just not how academia works) - Larry stated in the post where most of the funding in his Dept comes from.

    By the way, Larry - there's a typo in the title of the post ("alter").

  4. I see the kooks struck early.

    While I generally agree with you Larry, I'm not quite as strong in my criticism. There are a lot of questions in regards to the "liberation therapy"; it seems to function via a mechanism unrelated to the known basis of MS (i.e. autoimmunity), its unclear if blocked veins are diagnostic in MS patients [blockage rates vary greatly in trials - from 100% (zamboni) to ~50% (various other trials), with non-MS patients having these blockages from 0% (zamboni) to ~35% (other studies)], and zamboni's result has not yet been replicated.

    None of that means it doesn't work - but conversely - the data in hand is also doesn't tell us if it does work. While it seems unlikely that this treatment has the potential to cure MS, if it alleviates the symptoms it may still be a useful tool in the MD's toolbox. Trials are needed to determine the efficacy (if any) of the procedure.

    The thing is, those trials are underway, and on a scale much larger than the approved 100-person trial. IMO, the proposed trial is merely playing politics - its existence was due to the pressure of politicians, its size is insufficient to provide robust data, and by the sounds of it, it isn't even well designed (unblinded + uncontrolled).

    Clinical trials should only occur where there is a valid reason for doing so, and when the trial itself is designed in a way to provide meaningful results. This trial appears to meet neither of those conditions - far larger trials are in progress, and the design of the trial is quite poor.

    Patients shouldn't be experimented on, just to make politicians look good.

  5. On the contrary, there are several very credible studies which had been undertaken which show a positive correlation between MS and deformed veins. Unfortunately, there have been some studies showing no correlation. However, ultrasound was used in these studies and, in the case of the ultrasound studies, the wide variance in outcomes simply shows that ultrasound is operator dependent and that knowledge of veins is needed. Venopgraphy is the gold standard of detecting stenosis and none of the negative studies used these. The negative studies were done by neurologists, who are not specialists in vein function and anatomy. In fact, one study by the National MS Society, done on cadavers, with direct physical observation, showed that people with MS often have abnormalities which cannot be detected by ultrasound, namely, webbing and other artifacts.

    1. On the contrary, there are several very credible studies which had been undertaken which show a positive correlation between MS and deformed veins. Unfortunately, there have been some studies showing no correlation
      Biased, much? Its not "unfortunate" that some studies see no correlation, its reality. Its only unfortunate, as those studies run counter to your pre-derived conclusions - as witnessed by your attempts to demonize those studies which run contrary to your beliefs.

      Real scientists - i.e. Larry & I - don't have the luxury of simply rejecting studies we find inconvenient to our pet theories.

      And whether or not their are vein abnormalities is only relevant if they are either causative to MS (i.e. it is the presence of the abnormal veins that causes MS), or if "fixing" the veins reverses symptoms or slows their progression. The former is almost certainly untrue - no biological mechanism by which reduced blood flow could lead to lesions typical of MS has ever been posited; indeed, the very concept runs contrary to what is known of MS. The later remains an open question, which is why properly designed trials are needed.

      And there is one last issue which Larry touched on - angioplasty is not without risk. Even if it reverses symptoms, the risk of the surgery may far exceed its benefits. Once again, properly designed trials will provide a clear assessment of costs and benefits.

      The politician-created Canadian trial is too small and too poorly designed to meet any of those goals.

    2. I am a subject in a well designed treatment trial (PREMiSe, by the University at Buffalo NeuroSurgery department). While I expect this study to give us some answers, it is too small, and should be replicated at several sites to get a true picture.

      I felt that as long as the Interventional Radiologist (in my case, a Neurosurgeon) doing the procedure has a proven track record, the risks were so small that it has been well worth my while to be a participant in this study, regardless of whether I was in the treatment or placebo arms.

      With MS, ANY positive change is worth some risk, because the alternative is continous deterioration.

  6. I realize this is a late reply, but there is new news on the "liberation" front. Zamboni's followed up on his original results and found only a weak positive effect at two years post-treatment (PMID 22687168); quite the drop from the 100% "success" he originally reported.

    A Canadian study (by William Pryse-Phillips; I've only found news reports of the study), following up on MS patients who went overseas for treatment, showed no significant effect.

    I guess I need to change my original post - there is some good evidence now that it doesn't work - makes you wonder what purpose the proposed Canadian trial could possibly have...