Zamboni: “Wait for trials.”

It’s encouraging to see a scientist urging caution, and citing the need for further research prior to implementation of his theories — especially when those theories are scientifically highly contentious, but yet offer a glimmer of hope to thousands of desperate people.

Here’s the story, from Adrian Morrow, writing for the Globe & Mail: ‘Liberation therapy’ doctor now warning MS patients to wait

The Italian doctor who gave multiple sclerosis sufferers hope their condition could be treated with a simple procedure – and prompted many of them to cross borders and shell out thousands of dollars to receive it – has now warned patients against receiving the treatment until further clinical trials have been conducted….

Of course, clinical trials may not happen soon. We blogged before, for instance, about Canadian recommendations against funding clinical trials: Canadian Working Group Recommends Against Funding for Controversial MS Trial.

It’s worth noting that lack of funding isn’t the only issue. A clinical trial (in any developed country, at least) would also have pass through some sort of ethical review process. In Canada, for example, any university-affiliated researcher would have to gain the approval of a Research Ethics Board in order to conduct a trial based on Zamboni’s hypothesis. And at this point, it seems unlikely such approval would be granted. Why? Well, because Zamboni’s hypothesis doesn’t have enough support among experts to warrant subjecting humans to the risks. That’s the point of the notion of clinical equipoise. We don’t test hunches on humans, even when those hunches are supported by anecdotal evidence. The anecdotes are intriguing, to be sure. But we need more than that to ethically justify a full clinical trial. We need things like:

  • strong evidence that Zamboni’s hypothesis is supported by our best understanding of the physiological basis of MS;
  • evidence from animal trials;
  • systematic analysis of individual human case-studies;
  • etc.

Someday that kind of evidence may exist. But for now (based on the expert analysis provided by the Canadian Institutes of Health Research and The MS Society of Canada), we’re just not there yet. So it’s too soon for clinical trials. Even if the risks of the procedure are not huge, neither are they trivial.

Now, advocates quoted in the G&M story suggest that patients should be allowed to judge the risks and benefits for themselves. It’s an understandable point of view, but one that doesn’t generalize very well. The role of ethics boards is to evaluate proposals to determine whether the likely social benefits of a trial are commensurate with the risks to participants. And then if approval is given, it is up to individual participants (in consultation with their own doctors) to judge whether participation in the trial makes sense for them. But that initial level of expert scrutiny is particularly important when the population being studied is desperate for a cure, as is the case here.

None of this is to say that trials won’t happen. They almost certainly will. Somewhere. But before well-justified trials can happen, a few more hurdles are going to have to be cleared.

~ by Chris MacDonald on October 17, 2010.

5 Responses to “Zamboni: “Wait for trials.””

  1. Couple of things here:
    Evidence of a vascular involvement in the set of symptoms called MS is about 140 years old. The autoimmune theory is only 40 years old and had not proved to be very useful in either understanding the disease or treating it. The first symptoms of the disease labelled MS (optical neuritis),occurs in a part of the body where there is no myelin, so it appears that myelin damage is probably not the main cause of neurological symptoms.
    The other troubling aspect of this whole situation is that the treatment for CCSVI is something which is routinely judged as necessary for people suffering from very similar conditions such as Budd Chiari or May Thurner syndromes. Additionally people on kidney dialysis programmes are routinely given this treatment when theeir jugular veins collapse… so what is the ethical problem with treating a similar condition in a patient labelled with a different disease ie MS.

  2. Thanks for clarifying things Michele; there are too many inaccurate reports flying about…some of them a touch sensationalisitic. E.g.
    the comment”…Liberation dr. has now warned patients against receiving the treatment until further clinical trials have been conducted….” This ‘observatiopn’ falis to point out that Dr Zamboni in answer to a question ‘should people get the treatment or not…’ at the International Convention on CCSVI in 2010 podcast on You Tube replied “I would only recommend the intervention be undergone as part of a clinical Study ….BUT…if a patient’s condition is so gad as to negatively impact on their quality of life, I advise dotors to carry out the procedure on copmpassionate grounds.”
    No mention in the above report of the total lack of clinical studies being insisted upon before thre the world’s first heart translplanrt work was carried out or the deliberate self infecxting with Heliobacter by Dr Barry Marshall to prove his theory which has now reed millions of the agony of stomach ulcer. I am not disputing the rational for clinical trials at all; they are clearly sensible and right. However I do expect commentators to be appropriately qualified and cautious about how they relaste information to vulnerable people:
    1) are the two Ph.D. authors medically qualified at all?
    2) Mr Mac Donald appears to to be affiliated to Neurology in someway;
    Surely any ethical argument about VASCULAR USSUES ought to involve significant input from VASCULAR spacialists…….
    Would the authors care to comment on the hundreds of thousands of venoplasty/angioplasties carried out over the last few decades as the insinuation is quite clearly that the intervention is risky.
    Also what are your comments on the fatalities from such alteratives as TYSABRI and the well documented side-effeccts of most oof the other fairly inneffective pharmaceutical interventions.
    Lastly are the authors aware of how many people have taken their own lives because of the suffering endured with MS symptoms.
    Do you know how many VASCULAR EXPERTS any of the MS Societies around the world have on their adsisorty committees?
    FIND OUT eh?

  3. After carefully reading the post and the subsequent replies… what more can I say… I have to agree wholeheartedly with the comments left by both Michele and Kevin..!

  4. Michele and Kevin have provided rational arguments in support of going ahead with the Zamboni procedure for MS people. As I understand the situation the vascular surgeons and interventional radiologists performing these procedures around the world are keen for their work to be documented as part of a large study. This is how information is collected and disseminated to practitioners and patients. I would be content to be part of that study because the procedure is commonplace in other conditions…and is a damn site less dangerous than drug therapy.

  5. I commend you for your bravery! As someone with MS who has gone from being bedridden to walking without a walking aid and NO SURGICAL INTERVENTION, I’m not convinced of Zamboni’s theory, which unfortunately has gained support in some segments of the MS community (I recognize the names of the pro-CCSVI posters here from other MS sites). I regard them as our version of the anti-vaccine activists who have the best intentions for those affected but in the end, wind up doing more harm than good. I will say however, that the whole controversy inspired me to take a Medical Ethics course (so I understand terms like “clinical equipoise” when they are used). Real patient empowerment is the opposite of desperation!

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