A recent article in a scientific journal has stimulated an interesting debate about the make up of advisory boards in health care, and what constitutes a conflict of interest.
Dr. Barry Rubin is a vascular surgeon in Toronto and a member of an Expert Panel of the Canadian Institutes of Health Research (CIHR) that is advising the federal government about a potential new treatment for multiple sclerosis (MS). Some have proposed that MS is caused by a newly described abnormality in the veins draining the brain (called chronic cerebrospinal venous insufficiency or CCSVI), and that balloon treatment of CCSVI makes people with MS feel better. The quality of the science supporting the benefit of treatment is poor, but many MS patients are convinced that the treatment is effective, based upon their own experiences and the experiences of others. In my almost 30 years in health care I have never seen a controversy about a treatment generate so much passion (on both sides), and such media and political attention.
Dr. Rubin threw a match into the smoldering embers when, in an article with the title “The “Liberation Procedure” for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand”, he and his coauthors described two patients who had severe complications shortly after treatment for CCSVI. In the discussion they stated “At this point the procedure [the treatment of CCSVI] rests in the same category of “medical” management as chelation therapy for atherosclerosis …., treatment of breast cancer with laser photodynamics, Laetrile for cancer and other unproven therapeutics found in the retail sphere.” Treatment of CCSVI was equated with faith healing.
Not surprisingly, these comments generated howls of outrage from some quarters (I suspect others are silently cheering Dr. Rubin). Kirsty Duncan, a Member of Parliament who has been a vocal pro-CCSVI advocate has asked that Dr. Rubin be removed from the panel because of conflict of interest.
Dr. Beaudet, President of the CIHR, has indicated that Dr. Rubin will remain on the panel, saying that members of the panel are “entitled to freely express their opinions.”
So, what should we make of all this?
Does Dr. Rubin have a conflict of interest that justifies removal from the CIHR panel? I don’t think so. We are usually concerned about conflict of interest if people stand to gain financially from a particular outcome. In this case, Dr, Rubin is a vascular surgeon (one of the specialties who provide CCSVI treatment), so it is actually financially counter productive for him to argue against CCSVI treatment.
I think we underestimate the importance of non-financial conflicts of interest, which relate to academic advancement and turf, rather than money. If treatment of CCSVI turns out to be beneficial, it will markedly change the way we think about the disease and the kind of research that will be done in MS in the future. There will be winners and losers in the scientific world. Is Dr Rubin likely to be a loser if treatment for CCSVI turns out to not be beneficial? Not as far as I can tell. To the best of my knowledge, Dr. Rubin has never done any research in the area of MS. I just don’t see the conflict of interest.
However, Dr. Rubin does have strong opinions about CCSVI, which he has, at least on this occasion, expressed in a rather inflammatory style. Does that justify removing him from the CIHR panel? Again I don’t think so, but with a caveat.
Although I believe members of an expert panel can hold strong views, they must commit to basing their views on evidence and to carefully considering other points of view. In this regard, the assertion in the article by Dr. Rubin and colleagues that fingolimod, a recently approved drug for multiple sclerosis, is a “documented safe pharmacological treatment” for MS does raise questions about his balance when comparing the harms of CCSVI treatment with drug treatments for MS. Fingolimod causes a transient decrease in heart rate immediately after the medication is started that is concerning enough to cause regulatory agencies to issue guidelines about the kinds of patients who can start fingolimod and how the drug must be monitored to achieve acceptable safety. The drug can also rarely cause an eye disorder called macular edema, among other side effects.
Most of us who work in health care have conflicts of interest and biases. Removing everyone with a bias from an expert panel is impossible because health care is so inter-connected.
Some people rise above their biases. For example, vascular surgeons and neurosurgeons were authors of a randomized trial that showed that an operation that they had been performing for years (extracranial-intracranial bypass surgery) was actually useless. However, many of us, often inadvertently, allow our biases to creep in to our decision making to some degree.
I agree with Dr. Beaudet that strong opinions should not disqualify someone from sitting on the CCSVI expert panel. However, the same argument would suggest that vocal proponents of CCSVI should also be added to the expert panel – at present I don’t believe there are any. I am sure some can be found who would abide by the rules of being evidence-based and balanced. It is important to have people with varying points of view around the table. This allows different opinions to be raised, and allows people to respectfully keep each others’ biases in check.
My conflicts of interest for this blog: I am a member of a Data Safety Monitoring Board for fingolimod, for which I am paid by Novartis. I am the principal investigator of a grant from the CIHR to do systematic reviews of the evidence regarding CCSVI for the CIHR Expert Panel, for which I am not paid.
The comments section is closed.
Just as a piece of information in passing:
The Yanks have probably the most complete, most unbiased, set of CCSVI information on the web.
Both sides of the CCSVI debate should read it.
http://www.ccsvi.org/index.php/advanced-topics/the-great-debate-ccsvi-and-ms
Tom
CCSVI Treatment is safe. It is far safer than some of the pharmaceutical MS treatments “approved” by all of the “approved” approvers. I cannot believe that anyone could question this fact.
CCSVI Treatment has been proven to have saved life. (I assume you are aware of the treatment of Barb Farrell who was left to die by all the “approved” approvers, but managed to get to the US where CCSVI Treatment saved her life.)
“CCSVI Treatment has been proven to help some people some of the time.” Massive anecdotal evidence by different people over time who have nothing to gain by lying is empirical evidence of the first order. People live and die by it.
Remember good old cause and effect – the same causes having the same effects over time? The way most knowledge is acquired, as a matter of fact.
“CCSVI Treatment has been proven to help some people some of the time.” This position would seem to be in line with what Peter Liu, head of the Institute of Circulatory and Respiratory Health suggested in his June 2010 email to the CIHR. I quote: “My own interpretation of the data is that CCSVI is likely a contributing factor in a restricted subset of MS patients,”.
I assume that everyone agrees “CCSVI Treatment has been proven to help some people some of the time.” To argue that it doesn’t is like saying “I am OK, but everybody else is crazy”.
As far as Dr. Rubin is concerned, Dr. Laupacis you are wrong about Dr. Rubin benefitting from CCSVI Treatment approval. If CCSVI Treatment were to be approved, the attending surgeon would be paid what any surgeon doing a simple surgery would get paid. The only reason CCSVI Treatment is expensive is that it has been prohibited.
Take away the prohibition, and nobody has anything to gain financially from the approval of CCSVI Treatment. That is the main reason CCSVI Treatment has not been approved. When it comes to financial reward, the actors in our little play have nothing to gain, but an awful lot to lose. And money makes the world go ‘round.
Dr. Rubin values his reputation , and his place at the CIHR trough. He has had 10 years of continuous peer reviewed research funding from the CIHR, and as such does not want to bite the hand that feeds him.
He knows the CIHR in general is prejudiced towards CCSVI Treatment, and he wants to play along. He should therefore be excluded from the “expert” panel under the principles of reasonable apprehension of bias, the same as Dr. Prigent should not be on the governing council of the CIHR because of his close ties with the pharmaceutical industry. (Dr. Wosnick, you have touched on this.)
CCSVI Treatment is in itself a mole hill. The one and only reason it has become a mountain is that it scares the daylights out of a struggling pharmaceutical industry that stands to lose big time.
To sum up:
• CCSVI Treatment is safe.
• CCSVI Treatment has proven to save life.
• CCSVI Treatment has proven to help some people some of the time.
CCSVI Treatment is simple. Why not just do it? As they have in the US.
THE DOWNSIDE RISK OF CCSVI TREATMENT
The downside risk for the patient is a small incision that causes very little or no pain, I know. I have had CCSVI Treatment from Dr. Siskin.
The downside risk for the MS establishment – neurologists, the MS Society, and MS pharmaceutical companies – is the possible loss of prestige, the possible loss of employment, and the possible loss of hundreds of millions of dollars.
THE UPSIDE RISK OF CCSVI TREATMENT
The upside risk for an MS patient is the possible saving of his/her life (as it was with Barb Farrell) or the easing of MS symptoms that has been reported by thousands of people.
There is no upside risk for the MS establishment, other than immeasurable joy that a life has been saved by CCSVI Treatment.
What is your rebuttal?
Mr Peterson,
I will leave it to others more knowledgeable to decide to rebut or not. My sole comment is in response to your statement that I have somewhere touched on the appropriateness or not of Dr. Prigent to sit on the CIHR Governing Council. Please elaborate sine I do not recall ever having made any statement to that effect.
I do have an opinion o Dr. Prigent’s credentials and his appropriateness or not to sit on the GC, but have never referenced it in any public forum that I recall. To what do you refer?
I am sorry, Dr. Wosnick. I misspoke. What I meant was you touched on “the general concept of the principles of reasonable apprehension of bias”, not anything to do with Dr. Prigent in the particular.
I unreservedly apologize.
Tom
Tom,
Thanks for the clarification. Much appreciated.
Although I have not made any public pronouncements, since you did raise it, it might surprise you to know that I actually have done a an analysis of Dr. Prigent’s appointment for my former employer, the Canadian Cancer Society. It was my opinion then, as it is now, that he is very appropriate for that role and that CIHR is lucky to have him.
That might shock some people given the nature of the rest of these conversation threads etc, but one has to look at the actual CIHR ACT – the act of Parliament that created CIHR and look at its mandate etc to see that the constituency that Dr. Prigent represents (applied industry partners) is actually enshrined in the Act as being one of CIHR’s important stakeholders and consituencies.
You also have to look at Dr. Prigent’s CV and credentials. My recollection is that they were very impressive and that he was eminently qualified from both an academic and corporate perspective to be on the GC.
The very strong caveat, aside from the fact that the number of industry reps should be limited, is that Dr. Prigent represents the views of a whole stakeholder community and in no way the express interests of his employer (Pfizer as I recall). As long as he leaves all Pfizer agendas at the door, as ANY good Governor MUST do, then, in my personal opinion, he is in fact eminently well qualified to fulfil an obligatory perspective on the GC.
Michael
Hello Michael,
Not too much for now, as it is past my bedtime. lol
I kind of think of things this way.
The Expert Panel is about to make a judgment that effects the very breath a person with MS might take.
If CCSVI Treatment continues to be prohibited, the rich will continue to be rich, and some people with MS will continue to suffer and die because they cannot afford to go out of the country..
If CCSVI Treatment is approved, the rich will stay rich, (maybe a little less rich), but some people with MS may live when they might have died, or may suffer less than they ordinarily would have. The need for evidence based medicine will hardly be dealt a mortal blow.
When you consider the big picture, what harm can be done by allowing CCSVI Treatment anyway?
Not very much. If the MS medical establishment had simply allowed CCSVI Treatment in the first place, everyone would know a lot more by now about the CCSVI/MS relationship. Wouldn’t they?
Prohibition never works. All CCSVI Treatment prohibition did was to force Canadians to seek help somewhere else. If there IS a market, there WILL BE a market – it is up to legislators whether this market will be black or not.
My specialist was Dr. Ken Warren. (I live in Edmonton, by the way). He has now retired from active practice.
When news of CCSVI first broke, Dr. Warren tried (unsuccessfully) to get a trial going as soon as he could. As he said “If there is anything to this, even though I think it’s kind of batty, I want to find out (for sure) just as soon as possible.”
It makes me kind of proud to have been one of his patients. He was concerned about me – he was concerned about all his patients. He wanted to do the very best he possibly could.
He was not concerned about undermining the principles of evidence based medicine. He was not concerned about his prestige. He was concerned about me. And I very very much appreciate that.
My GP told me “Tom, don’t worry about follow up treatment. If you need help, I will give it. And you don’t have to prove you are dying first.”.
To me at least, these doctors live their Oath. And they do it proudly.
On average, more than one Canadian dies from MS each and every day.
Can you look yourself in the mirror before you go to bed and say “Today I have done everything in my power to save life. Today I have given life every chance I could, even if it seemed unlikely”?
Can you look anyone with MS in the eye and say “Tom, I believe that supporting evidence based medicine by prohibiting CCSVI Treatment is in your best interest?”
Can you?
Hello Michael,
I really do care what you have to think of my latest post. I may not always agree with you, but I highly respect and value your opinion.
As you can probably tell, what I wrote was from the heart. I truly believe that CCSVI Treatment has been proven to be safe. I truly believe that CCSVI Treatment could save more lives, given a chance.
To me at least, there is so much to be gained, and so little to be lost – why not give life a chance? Drugs that you are well aware of are on the market simply because “they do more good than harm”. Why are drugs that are KNOWN to kill and injure allowed while CCSVI Treatment is not allowed?
The only reason I can think of is money. Michael, please prove me wrong!
Tom
Hi Michael,
Sorry, I am not about to let you escape so easily without an opinion. Not if I can help it!
I, too, “know-I-know” I don’t know enough to choose about CCSVI on a strictly scientific basis.
But I believe the question about access to CCSVI Treatment has gone well beyond the strictly narrow confines of science. The question is no longer about science – it is about social justice. It is about questions that Anne Kingston commented on in her article in Macleans.
http://www2.macleans.ca/2012/06/25/the-silent-treatment-how-canada-has-failed-ms-sufferers/
Why did the CIHR just kind of take a year off and think only about itself and not those suffering and dying from MS? Where was there any sense of urgency?
The CIHR is no longer (if it ever was) a “trusted” organization when it comes to matters concerning CCSVI. It plays politics with people’s lives. Michael, I really believe you do kind of “know” that already. The evidence is too stark to just ignore.
The question of CCSVI Treatment pits neurologists, MS Society bureaucrats, and multi-billion dollar corporations (the MS “establishment”) against a small group of MS patients and their caregivers.
If Big Pharma had its marketing muscle behind CCSVI Treatment, do you think for a moment it would have been delayed?
Michael there is overwhelming evidence that CCSVI Treatment is way safer than approved MS drugs. You have got to know that. The evidence is clear even to the non-expert.
There is overwhelming evidence that CCSVI Treatment helps some people some of the time. ALL of these people are not delusional. You have got to know that. The politicians of New Brunswick and Saskatchewan have even decided against their medical counsel.
The MS establishment stands to lose big time if CCSVI Treatment is even a little successful. You have got to know that.
In England, NHS experts have called for an end to paying for MS drugs that cost so much but do so little, and have called for a public inquiry. People are beginning to wake up to the fact that they have been had.
The question of CCSVI Treatment is no longer a “medical science” problem – it is a social science problem. It is a power struggle. The autoimmune theory of MS and the vascular theory of MS had already been discussed as a sociological phenomenon BEFORE Zamboni announced his findings.
http://onlinelibrary.wiley.com/doi/10.1111/1467-9566.ep11340153/pdf
http://hsb.sagepub.com/content/51/1_suppl/S67.full
I am sorry Michael, but I will not let you hide. You can make a decision with the information you already have. If you have any questions, please, please let me know. It is people of good will like yourself that people with MS are counting on for help.
How can it make any sense to call for Stage I/II Trials when thousands of actual CCSVI Treatments have already been done in the US? These doctors are willing to share their research – I know, they have told me But they say “No Canadian doctors have asked”. How bad is that?
You have read about what I had to say about Dr. Warren. Yes, my heart is in what I say. But that does not mean by brain has gone quiescent. Dr. Warren is a brilliant man. If he can stay open minded, why can’t other doctors?
What do they have to lose?
In general terms, CCSVI Treatment is a low risk high reward procedure for MS patients.
CCSVI Treatment – a low cost non-pharmaceutical fix for MS symptoms – is a drug companies worst nightmare.
Please Michael do not just ignore me. Please consider what I have had to say. If you want or need more proof, let me know. If you decide that what I am saying is out-to-lunch, let me know.
Please don’t just stay quiet and go away.
Tom
Hi Tom,
Thanks for the kind words and vote of confidence. I don’t doubt that you wrote from the heart and from a place of sincerity.
Unfortunately, I am simply not an expert enough to know, or even to have an informed opinion on CCSVI. I waded into this discussion based on the conflict of interest topic and once it veered to a discussion of the pros and cons of the controversial treatment itself, I quickly got out of my depth. I am expert enough in science to know that when one doesn’t know what he is talking about, shut your pie hole :) So I shall.
What I will say is that as a person steeped in science it is always important to me to see what is the evidence. You cite many sources that say CCSVI is not only effective but safe, and other sources refute both claims. Frankly, I just don’t know.
Sorry to frustrate you but I’m afraid I will have to just leave it at that… I simply don’t have the knowledge to get any further out on that limb.
Opiniated, biased or both?
i am a 24/7 patient with myalgic encephalomyelitis, also crually know ans chronic fatigue syndrome. There are 411 000 of us in Canada (Community Health Survey 2010) , a staggering 24% more than in 2005. Yet, there is 0$ funding from the feds, 0 research from CIHR, and no answer from the Public Health Agency as of what they are doing to monitor the situation.
It is scary tothink that members of health boards are opiniated and biased to fund OR time, more care in their particular field.
The stigma and discrimination towards my disease is undeniable. If we were in 1982, my disease would be called AIDS and no one would want to care for me. Only this is 2012 and very very few physicians st want to understand, study, treat and helpcme out with my disability insurance.
Opiniated, biased, without a doubt.. What I would just like to say is, if you are a physician, a manager, a health care minister, what if you got sick with ME? It could happen to you!
Andreas, as you know I respect your opinions but just how sick do people need to become to get proper help this was just posted by a friend from Ontario:
Hi everyone. I haven’t written for a while but I wanted to let everyone that it has been almost 2 years since my Strep A coma and I am still MS symptom free. It seems that the 5 blood transfusions and the clearing of my veins definitely helped my MS. All of the work done on me was right here in Ontario under OHIP. so everyone keep positive. CCSVI treatment has to be approved. Also if any of you have had underlying conditions like cancer radiation, which I had as a baby, you can try to use other conditions to force testing and treatment.
What is wrong with this picture and these Doctors? It works, I’ve had venoplasty twice now and wouldn’t have much of a life without it!!
It seems that Peg is highlighting the need to integrate the quantifiable knowledge of science with the qualitative social sciences researchers. Although the underlying mechanisms of a disorder and the effectiveness of treatment regimes are critical areas to test and understand this tends to institutionalize the most profound personal experiences of patients and care givers who assist with their care. Unfortunately we have a tendency to stratify our knowledge into separate spheres of thinking depending on the ease of measurement – although it is great to see that Universities seem to have identified this need and structuring new program options (e.g. Arts and Sciences Undergraduate Programs) with this in mind.
It would be helpful for more qualitative researchers to become an integral part of this current discussion. This could help move beyond our current limitations in thinking and formulate some interesting hypotheses for future researchers to explore. I am not an expert in this topic but wonder if there is some research team that is looking more ‘holistically’ at MS. If not this may be a research area to consider.
Dr Laupacis there’s been a kerfuffle on Twitter recently about an ICES report on physician remuneration which you co-authored.
The study was commissioned by MOHLTC just before negotiations started. The study was overseen by a working group chaired by the head of negotiations at MOHLTC. Its results were used extensively by the Ministry in their current battle with the OMA.
Do you not agree that this is like Big Pharma paying for and running a drug trial? If the funder of ICES requests a report and guides the production of that report, to me that calls into question the results the report presents. in the same way industry-sponsored trials get asterisked.
At the very least, it calls into question the wisdom of ICES in accepting such an assignment at such a contentious time.
Any thoughts?
Hi BigDuke6. I am happy to respond, although it would be great to know to whom I am responding.
The ICES study of trends in physician income over the last 17 years was not commissioned by the Ministry of Health and Long-Term Care – it came out of a discussion David Henry and I had almost 2 years ago, in which we thought the information, particularly the comparison of income across specialties, was important information to get in the public domain.
The report actually took a long time to generate because it wasn’t straightforward to identify all of the sources of physician income, and in order to identify them, we had to work with folks in the Ministry who had those data. The role of the people in the Ministry was to provide the analysts at ICES with the data, not to determine the questions or approach to the analysis.
Before the report was released, David Henry shared the results with both the MOHTLC and the OMA. Obviously both can and will use the elements in the report that support their position.
I did not receive any compensation for working on the report. My salary comes from a combination of billings to OHIP for my work as a palliative care physician, support from the Academic Practice Plan and the research portfolio at St. Michael’s Hospital, and a Canada Research Chair that I am fortunate enough to hold. Working on this report was part of my job as a physician-researcher at St. Michael’s, and I don’t see this as a conflict of interest. As you probably know, most physicians in Ontario receive the vast majority of their funding from the Ministry. It doesn’t really make sense to talk about them all as having conflicts of interest.
I believe Dr. Rubin should be on the panel with Dr. Zamboni and then we will get to the real truths. Dr. Zamboni, I think, is a strong character to deal with the negative nay-sayers.
CCSVI is about science, and MS effects PwMS. I think that the best people to really understand this disease is “the psychologically depraved, sick MS monsters”. I did not need a doctor to tell me that I needed this procedure. What I needed was a family to support this and help me collect dollars to go to Germany.
I have had venous problems before MS, so I was truly going for the CCSVI treatment to see if my IJVs were obstructed and what proper blood flow would do for my body. Well, it is miraculous but, yes, it does not last as long as we want and this needs to be studied.
Why don’t Canadian doctor nay-sayers just admit they have other projects and they want the rest of the world to solve CCSVI.?
There truly is something to CCSVI or you may as well open up a mental hospital to throw all of us Pw MS in that believe in this treatment.
They have left the quote and removed my comment , why ? Does colin rose have the sole right to be sarcastic , i am for CCSVI TREATMENTS.
You know I respect your opinion Andreas but the infighting about whether CCSVI exists has to STOP I know from experience and am in my six month post procedure #2 and it works no-one will ever tell me any different, a healthy debate is exactly what is needed for the sake of patients and Canadian health care in general:-)
Obviously this is a sensitive subject and many have a vested interest. It just seems odd that Dr. Rubin voted against CCSVI clinical trials in May 2011, then voted in favor of CCSVI clinical trials in August 2011. This turn of events I assumed was based on the Meta Analysis presented from Dr. Laupacis’s study that the CIHR funded. Subsequent to this, Dr. Rubin continues to speak publicly in a negative and demeaning manner not only against CCSVI in general but directly to Dr. Zamboni who is a respected Vascular doctor and one of his peers. Dr. Rubin’s comments are not based on any substance that I can see, rather an emotional and angry response. I have tried to understand what this might be based on and have come to the conclusion (as a personal opinion only) that a very select group of doctors have received repeated benefit from the CIHR for their personal pet projects in past years and rely on this handout with minimum effort. If the CIHR was to fund proper Clinical Trials for CCSVI this limit the funds in the coffers for other research/studies/trials to the old inner circle club who are used to getting their repeated funding. I think this elite group feels threatened by the new kid (CCSVI) on the block and ego’s and status quo have been disrupted not to mention the amount of money that could be diverted away from their special interest projects. If Dr. Rubin really cared about the truth of CCSVI, why does he refuse to talk or listen to his peers who do believe in CCSVI. For 3 years I have witnessed the Pro CCSVI doctors willing to engage, include and take the hits from the naysayers, but the naysayers continue to stand back at a safe distance and criticize, fear monger and some out and out lie and meanwhile the person with MS is forced to fight for their own health and lives while this game of egos and turf continues.
Well said, Carol. To have a healthy discussion, the opponents have to be willing to engage the proponents in debate; to date I have only seen the opponents trying to pass judgement from their imaginary ivory tower and dismiss the intelligent, educated proponents as fanatics and cultists!
I was curious about the association of Dr. Rubin and the CIHR and discovered that Dr. Rubin has received funding from the CIHR continuously for 15 years. It certainly gives the optics that the CIHR supports Dr. Rubins projects/studies and he has come to rely on continuous funding and a very productive working relationship with Dr. Beaudet at the CIHR.
Are Rubin and Beaudet accountable to anyone.
Is there an auditing system we can look at?
To date our Clinician Group is aware of approx 78 Canadian Doctors who have had to leave the country to have their venous systems taken care of. They all have varying degrees of MS. They are keeping well below the radar with fears of retribution from colleagues.
The Medical Community has no leadership on this.
Andreas, with oxygen and retreatment I can again communicate with a clear mind.
Quality of life is not quantifiable scientifically.
I am most surely happy to talk with you again,
Warm thoughts,
Peg Johnston
If they do not remove Rubin, then in the interest of balance they must include an equally vocal proponent of CCSVI. Despite what the naysayers say about evidence, there is increasing evidence in the efficacy of CCSVI treatment in improving quality of life. After nearly two years the possibility of placebo effect has been negated. MS is not the question, CCSVI is a separate condition that for whatever reason seems to have a higher incidence in people with MS. CCSVI treatment seems to be most beneficial in alleviating fatigue and heat intolerance, which for many people with MS, like myself, are the most debilitating symptoms. Perhaps these symptoms are the result of CCSVI and have very little to do with MS….but I digress. Having a known opponent of CCSVI on the panel is not problematic if there is also a known proponent of CCSVI on the panel. We all know the truth will eventually come out regardless of the fanatical opposition or support (and yes, the opposition is just as fanatical as the support – Colin Rose’s comments can attest to that – and opposition is far ruder from what I have seen). All we ask is that it be looked at objectively and looked at sooner rather than later. Phase I tests have been sufficiently done – three published studies involving 1000 or more procedures found only around 1.6% risk of serious complication, which is safer than many ‘unnecessary’ procedures that are allowed and done in Canada. In almost any other country, we would be allowed to get this treatment provided we were willing to pay for it as an elective procedure, but in Canada we are denied the right to make our own health choices and therein lies the biggest outrage and injustice for those of us who do not have the money to travel to the United States or elsewhere for treatment. All I ask is for a balanced view to be taken of CCSVI and with Rubin on the panel it is not balanced at present. I think having both a vocal proponent and opponent on the panel will stimulate discussion and facilitate a more thorough examination of CCSVI treatment. So I, for one, say keep Rubin; but include someone else who is a proponent of CCSVI as well.
And there you have it. Exactly as I predicted, and as I posted last night, once again anecdote in an environment where people are desperately seeking hope, will trump science: From CBC – MS patients not giving up on controversial procedure
http://www.cbc.ca/news/health/story/2012/06/08/nl-ms-reax-608.html?cmp=rss
Very true. But that begs the question of why those anecdotes exist at all. It was very telling that Dr. Pryse-Phillips said during the press conference that he had no idea why some patients report miraculous instantaneous improvement in symptoms after "liberation". He knows very well that these are examples of faith-healing, a phenomenon that is anathema to clinicians. The Zamboni fad in the Internet era has clearly shown that psychotherapy should be as much a part of the treatment of MS as drug and physio- therapy. If the "expert panel" really wants to help MS patients and their families who are enthralled by the those anecdotes and who pressured the government to set up the panel in the first place, it should show true professionalism in spite of the risk of unpopularity and investigate the faith-healing phenomenon and the place of psychotherapy in the treatment of the symptoms of MS in some patients.
Colin, you are always dropping terms like “faith-healing” into your comments.
What do you make of this paper from Functional Neurology:
http://www.functionalneurology.it/common/php/portiere.php?ID=1c7b4be41d76a03213e1551ead753ee5
It would seem that there is enough evidence to justify a serious treatment trial.
Dr. Laupacis, I’d appreciate your comments as well. Thanks for maintaining this forum!
Those who ridicule CCSVI dismissed Dr. Zamboni’s initial findings in his preliminary study of only 65 people who were treated because it was too small a group to be scientifically significant. Why then are they so willing to jump on this group of only 30 people who were treated from Newfoundland. Any information they think they have gleaned from this group is worse than useless. There is no consistency. They were treated using God knows what methods, by how many different doctors? Scientific information is only valid with consistency, and there is none in this group from Newfoundland. You have to look at this differently – the symptoms treatment helps most are the most subjective – the fatigue and heat intolerance among others. Did this so-called study even consider those symptoms? There was a group of neurologists who followed patients after treatment at 1, 3. and 6months and found clinically significant improvements in heat intolerance and fatigue continued after 6 months. That study was done in Poland, I believe – I know, it wasn’t done in Canada so the CIHR will say it can’t possibly be trusted, just like the study in New York that looked at 257 procedures and found it to be safe…Canada still feels the need to do it’s own safety study because apparently non-Canadian science is not science.
In reference to Joan Beal’s comment (last paragraph) and with reference to all theories relating to the cause of MS, Dr. Rubin’s work could be regarded as supplemental research to lipids and MS, i.e. “The Multiple Sclerosis Lipid Hypothesis” as published in the December 2011 issue of The Quarterly Review of Biology.
On the University of Toronto website, it mentions that Dr. Rubin Dr. Rubin has had 10 years of continuous peer reviewed research funding from the CIHR.
Dr. Rubin is also a member of the Multiple Sclerosis Expert Advisory Group for Ontario, where this group will develop recommendations and best practice guidelines on follow-up care for MS patients who undergo the CCSVI procedure.
He also represents approximately 725 physicians at Mount Sinai Hospital and University Health Network in negotiations with the Ministry of Health and Ontario Medical Association regarding the allocation of $225,000,000 per year in alternative funding plan funds to academic physicians.”
Even when ignoring opinions and bias, I still think there are too many possible/potential or real conflicts of interest here and that Dr. Rubin is a poor choice for the CIHR expert panel.
In the light of the just announced results of the observational study from NL, the current discussion is irrelevant. With negative results in a study run by a neurologist who wanted to believe the Zamboni hypothesis and who even found that in the 25% of “liberated” patients who developed clotted, obstructed veins at the site of the procedure MS symptoms didn’t worsen acutely we can say the Dr Rubin was right. Even Dr. Laupacis is quoted as saying “”It could certainly totally be a placebo effect, the fact that it [subjective symptom improvement] goes away in three months.”
http://www.680news.com/news/national/article/370775–nl-study-says-no-measurable-change-in-ms-symptoms-from-liberation-treatment
With negative results from an observational study that is consistent with other well-blinded negative imaging studies, it is highly unlikely now that anyone will ever attempt a very expensive RCT of “liberation”.
The “expert panel” can now be disbanded and no more public money should be wasted on the Zamboni hypothesis.
In future governments must resist the temptation to gain political capital by pandering to scientifically untrained medical zealots taking advantage of sympathy for patients with currently incurable diseases instead of allowing real scientists to follow the time-honoured scientific method of establishing truth.
Again, this comment from Colin Rose is off topic.
But since we have diverted, I will take the bait once.
Ironically I pretty much agree with him on the point that this whole thing has been nothing short of the poster child for public engagement shaping public policy. The internet has brought heretofore unseen power to the average person to sway his or her government via Twitter, Facebook etc. Public engagement is very good, since research serves the public, but public engagement also brings with it a responsibility and an obligation to become informed before you wield that power.
I wrote about this in my own blog about 3 months ago: http://www.michaelwosnick.com/public-engagement-in-research-the-good-the-bad-and-the-ugly/
Having said that, if one really thinks that, having tasted this power of the people (for good or ill), that a small 30 person observational study in Newfoundland is going to derail the public angst and appetite over this issue and stop the steamroller, I would like to suggest he is dreaming in technicolor.
@ Dr. Michael A. Wosnick Thank you for pointing out that Dr. Rose is once again off topic. I fail to understand why his comments get posted as they are clearly not linked to the debate at hand. Some people like to hear the sound of their own voices. I personally believe the "expert" panel is stacked against moving forward with clinical trials. With the hundreds of people who have had combined thousands of years of combined relief from this terrible disease, there must be equal forces on the expert panel. This is presently not the case. If the balance is not re-established, patient pressure will only increase, not diminish. Strong opinions are OK, but one must have both sides represented to truly have an unbiased panel. What about the Canadian doctors who have had this treatment? Why can't they be the patient voice on this panel…..they come armed with the science AND the practice behind CCSVI.
Let me justify my supposed “off topic” remarks. The ethics of conflict of interest in review committee has some meaning when considering such subjects as licensing of a drug where there exists a wealth of scientific data that must be assessed for risk/benefit in a given population. But here we are dealing with a surgical treatment of a degenerative neurological disease for which there exists no scientific data on patient outcomes only anecdotes from Zamboni and YouTube. There is total agreement among real scientists and anyone with basic knowledge of physiology and anatomy that “CCSVI” if it exists at all is highly unlikely to be a cause of MS. So the topic should be why such a committee was set up by a government agency in the first place before any real science to prove even the existence of “CCSVI” had been done.
I have always said that any number of well-blinded negative studies of will never shake the faith of hard core Zambonites in their saviour but surely we can now at least justify a refusal to further waste public money on it. “Liberation” can now join acupuncture, homeopathy and chiropractic in the medical garbage pail of unscientific treatments but for which there will always unscrupulous practitioners with no reservations about preying on desperate people.
Colin from insult to insult, you never cease to amaze me. "Zambonites", "our Saviour"? By the way…..if acupuncture, homeopathy and chiropractic medicine are such "garbage" (well, I've never personally ascribed to any of them), why does the MS Society of Canada discuss the benefits of some of these practices on their website ? http://mssociety.ca/en/treatments/cat.htm Imagine, the Society that speaks for me promotes garbage!
Colin:
Randomized controlled trials are underway (PREMiSe, BRAVE DREAMS and others).
I suggest you follow your own suggestion by allowing real scientists to follow the time-honoured scientific method of establishing truth, instead of repeatedly citing your own blog as a worthy source.
Disclaimer:
I am “a patient with a currently incurable disease” and I would like to see the research completed to either prove or disprove the theory. I enrolled in the PREMiSe study when it became apparent that it would take years to get studies underway in Canada.
Andreas,
One of the very best and well-done treatments of the controversy (albeit a couple of months old now) was your own YouTube animation. I invite everyone else to view it here: http://youtu.be/a2KRy51v3tE.
Others,
All that said, I think that many of the recent comments have actually missed the point, or have at least steered the debate away from the originally posed question. The original post was not a question of whether CCSVI is real or not, works or not, etc, it was whether Dr. Rubin stepped over a line he ought not to have stepped over by making such strongly worded comments in his role as a member of the expert panel that ostensibly is supposed to remain neutral while looking at facts and evidence .
All this talk of hoaxes and bad science etc is a totally different topic and, in my opinion, has little or no bearing on whether or not Dr. Rubin should be removed from the panel, stay on the panel, admonished not to publicly pronounce such strong opinions, or in fact be encouraged to be as vocal and outspoken as he wishes.
The question here for debate are ETHICAL and process questions, not science questions per se.Those can be for another time and place, in my view.
Thank you Dr. Laupacis for agreeing to "edit" comments. Words like CULT and HOAX are incredibly offensive to MS patients who sincerely want well-researched answers, and not simply opinions. As for the Zamboni procedure, after years on MS medications and an attempt to try to take chemotherapy, my MS continued to progress. I had the treatment more than two years ago, and have never regretted it since. A "cult" is an organized group of people who have a leader whose authority cannot be brought into question. Zamboni wanted people to question him….he wanted help with the research….he wanted more research to prove or disprove CCSVI. A "hoax" is making people believe something that is not true……in that sense, the entire autoimmune theory of MS should be classified as a hoax.
Excellent point Christopher.
We established healthydebate.ca as a venue for people to have a vigorous but respectful debate about important issues in health care. A small number of the comments about my blog have been vigorous, but not respectful. From now on, we will remove or edit comments that we feel cross the line in terms of respect (we realize that establishing that line is a judgment call). We will leave the comments that have been posted to date, because they illustrate the degree of passions on all sides, which anyone working in this area has to contend with.
This “expert panel” exists only as political appeasement of the Zamboni cult which puts immense pressure on potiticians to publicly fund “liberation”. The cult will not be satisfied with the result of any properly controlled trial; a negative result will be blamed on a Big Pharma conspiracy. To date no properly blinded trial has shown that “CCSVI” even exists as pathology. All scientists should be following the example of the courageous Dr Rubin and denounce Zamboni’s hoax.
The title of your blog is “Healthy Debate: Unbiased facts, informed opinions”. Please keep this debate healthy and erase any comments that use inflammatory language or unfriendly comments.
I strongly object to Dr. Colin Rose’s comment. Inflammatory language such as he has used will only fire up both sides of the debate.
How would Dr. Rose qualify the Canadian neurologist who has received treatment for CCSVI? How would he qualify the fact that more than two dozen Canadian physicians who have received treatment for CCSVI? Actually, that was a rhetorical question and I really don’t require an answer because I truly don’t care about his opinion.
The only thing he does constructively is refer people to his blog where he criticizes everything that he finds objectionable. Seriously…..what kind of Dr. attempts such lame self-promotion? If he is such an amazing researcher and former retired professor of McGill University, where is all the research he has published?
Please, Dr. Laupacis, you are a respectable person and though I don’t agree with all of your opinions, you have never used such inflammatory language. You honestly state your conflicts of interest, and for that you should be commended!
Don’t let this blog become a battle ground for unreasonable argumentation on either side of the battle ground, especially people like of C. Rose.
Dr. Rubin is an expert in “lipid mediators” or “bioactive lipids”. Many diseases, such as arthritis, cardiovascular disease, MS and diabetes are associated with chronic inflammation. An important step in finding an effective treatment is to understand the basics of an inflammatory response, including the role of bioactive lipids. Understanding how bioactive lipids regulate the disease processes will lead to the development of drugs that have more specific targets and less adverse side effects.
http://vascularsurgery.utoronto.ca/faculty/rubin.htm
One of the biolipids he is actively researching has an application for MS:
Anti-inflammatory role of microsomal prostaglandin E synthase-1 in a model of neuroinflammation–(for the Institute of Clinical Pharmacology in Frankfurt- This work was supported by Deutsche Forschungsgemeinschaft Grant GE695 and the LOEWE Lipid Signaling Forschungszentrum Frankfurt.)
http://www.ncbi.nlm.nih.gov/pubmed/21075851
I believe this is a continuing turf war between vascular doctors and IRs looking for mechanical solutions, and molecular researchers looking for pharmacological solutions. Although Dr. Rubin has experience in mechanics, his research focus is molecular–and his grant and research money, as well as recent comments, reflect this bias.
Thank you Joan for bringing forth this information. I was unaware of this.
Now that’s “Healthy Debating” – stating facts in a non judgemental way, and using appropriate language to do so.
I think others could learn from this (me included).
I agree that Dr. Rubin exercised poor judgement in publishing his opinion while at the same time sitting on the panel.
Your comment: “I agree with Dr. Beaudet that strong opinions should not disqualify someone from sitting on the CCSVI expert panel. However, the same argument would suggest that vocal proponents of CCSVI should also be added to the expert panel – at present I don’t believe there are any” is realy the gist of the argument. When the CHIR expert panel was created, people with CCSVI felt that there should be an “expert” on that panel; that is, someone who had hands on experience with diagnosis and treatment of CCSVI. But we were told that Dr. McDonald was excluded BECAUSE of his bias.
In order to be viewed as a valid panel, both opinions should be represented. Proponents and detractors can each argue against the evidence from the other side. We get the best concensus when both sides are at least present to be able to present their views. Stacking the panel with skeptics will not achieve a balenced viewpoint.
Very well stated, Jim. Now that’s “healthy debating!”
No one sitting on any similar group is without some conflict of interest or bias. Some are more self evident or self proclaimed than others. The real task in such a setting is to clearly set out rules and manage the conflict rather than try to eliminate conflict entirely.
When I was responsible for the peer review process of a major national grant funder (the National Cancer Institute of Canada) we revised our old “conflict of interest” regulations into two situations, much as Andreas has outlined. We classified true “conflicts of interest” in the narrower sense of demonstrating financial gain, or the possibility of financial gain for the reviewer or his/her immediate family. Those tended to be fairly straightforward, as long as declarations were honest and forthright.
We also had a category of bias, or the “perception” of bias. While the first category of conflict was more of a legal precept, the category of bias was more of a non-legal precept of optics and the appearance of being fair and equitable to all applicants. This one was, not surprisingly, far more difficult to enforce, especially since bias can often be in the eye of the beholder.
But in the long run, we made our expectations very clear upfront. We wanted intelligent, informed debate and discussion among experts. Strong opinions if based on evidence was part of the reason we collected these experts together in the first place. But strong opinions that had no evidence to support them are just personal opinions and personal biases and had no place in the peer review process, doing it overall more harm than good.
From what has been presented here, my take is that Dr. Rubin may have exercised poor judgment and lack of respect for the process more so that any conflict of interest per se.
Dr. Rubin is exactly correct. “CCSVI” was always junk science and “liberation therapy” is just high-tech faith healing. Zambon’s original paper on the subject was so flawed it should never have been published. See blog for details.
http://medicalmyths.wordpress.com/2009/11/24/the-zamboni-myth-ccsvi-surreal/
The problem is not in having a strong opinion, but in a team setting, using it to subdue others’ voices. Surgeons are especially notorious generally for thinking of themselves as ‘above others’ to begin with and when their opinions are disagreed with, they tend to be inflammatory to deal with. Therefore he can say his opinions out loud in public, but my personal opinion thinks he should not be on the panel.