Please submit any comments/questions you have.
Last update Dec 2012 ! A lot has happened since then, and I hope we can look forward to a definitive update soon.
The putative relationship between MS and venous anomalies is now very doubtful (Barreto et al Ann Neurol 2013: 73, 721-8: Brod et al Mult Scler 2013: 19, 1499-1507, Comi et al Mult Scler 2013: 19, 1508-17). A small trial of venous dilatation v sham procedure in MS patients reported only in a poster (Siddiqui et al Amer Acad Neurology 20 March 2013) showed no advantage to intervention: this analysis technically precludes further recruitment to this trial. A second trial by Dr Siskin with sham controls (and financed by the Saskatchewan government) has crashed and burned (CTV News 9 Sept 2013).
A summary of the recent vascular studies is entitled “Goodbye to all that: a short history of CCSVI” (http://msj.sagepub.com/content/19/11/1425.full). This obituary could with advantage simply be repeated on this site.
“Evidence against the Involvement of Chronic Cerebrospinal Venous Abnormalities in Multiple Sclerosis. A Case-Controled Study” was recently published. They sent technician to Italy to be trained by Zamboni then altered the protocol. They changed the angle of the ultrasound probe, only looked at the upper 2/3 of the neck, required “persistent evidence of reversal of flow at different probe angles before we accepted the results as abnormal”. Is this good science or will this go down in history as how not to do research?
There have been over 275 peer reviewed articles written on CCSVI in the past three years, These studies continue and the debate rages on with no end in sight. Have you ever experienced anything else like this?
This CCSVI movement has partly been driven by patients who have experienced benefits from venous angioplasty. They want to help others and want the procedure available in their own country.
If I think back to other “controversies” such as the Laetrile, it was promoted by individuals who stood to profit and the debate abruptly ended after one or two studies were done.
As an individual with Multiple Sclerosis (MS) my life is dependent on the objectively and rationality of the doctors that treat me and the researchers that research my condition.
When reading articles and studies regarding CCSVI it is not uncommon to come across what can only be described as fear mongering and/or emotional latent language. An example would be “sacrificing science”. I don’t have the sense that this is a search for the truth but something else.
Clearly much more is going on here than “objective” science. What other factors do you think are at play Dr. Laupacis?
Ms d’Eon incorrectly characterizes the use of Laetrile to treat cancer. Amygdalin (a related form of Laetrile) was first advanced for cancer therapy in the 1920′s. It was heavily promoted in the 1950′s and it was estimated that it had been used by 70,000 subjects in the U.S. The FDA banned interstate transport of the substance in 1977, but some states still have laws permitting its use. Many clinics in Mexico currently advertise Laetrile treatment. People with cancer have been taking this substance for 90 years, even though it is ineffective. I would guess the same will be true for CCSVI therapy in the next century.
The best news in a long time.
I thank Dr. Laupacis for being forthright as a statistician, even though most on the pwMS’ side, myself included as the care-taker of an pwMS, do believe that his analyses are skewed from the start, if only from the sponsor, CIHR, but also because we strongly believe that the only aim of current studies sponsored, directly or indirectly by the government., is not so much to disprove CCSVI (even government witnesses have admitted, implicitly or explicitly that CCSVI is a fact, and the International Union of Phlebologists has classified it) but to find no benefit, hence not worthy of consideration.
But what we have to remember is that Dr. Laupacis looks at the angioplasty for CCSVI from the stand point of having the intervention paid for in Canada. THIS IS NOT WHAT THE EARLY MS PATIENTS HAVE ASKED. They only asked that they be allowed to obtain the treatment, and many who have the means have stated that they would gladly pay some extra $$$ to each IR, and his necessary colleagues, to pay for those who cannot afford the procedure, even if this were $2000 or $3000.
Granted, this would require a choice as to who would benefit first, and those charged with making this choice will not have an easy task. But this would not be an impossible task. The possibility of improvement, which can now be only guessed at, would be improved as the number of treatments grows.
I was just wondering what thoughts you might have on this statistical analysis.
Further information on a “germ” basis for MS.
This is going to take off.
Hi Dr. Laupacis
Would love your feedback on the Italian Cosmo Study that was presented at ECTRIMS. Quite a remarkable and predictable study by Dr. Comi who only found 3% of MS patients had CCSVI and therefore feels there is no need to have further studies. Would you use this study as part of your meta-analysis? And if so, would you acknowledge Dr. Zamboni’s response.
Here is Dr. Zamboni’s response to the Cosmo study. Dr. Zamboni removed himself from this study when Dr. Comi and others refused to follow his protocol and dismissed the need for proper training.
(translated to English)
“I did not expect anything different. Moreover the study Cosmo is vitiated by a defect of origin. ” Paolo Zamboni, a vascular surgeon at the University of Ferrara, which suggests a relationship between multiple sclerosis and some malformations of the veins of the neck (chronic cerebrospinal venous insufficiency, CCSVI), is not surprised by the “rejection” came from Lyon. But he adds: “Today is an important scientific journal published a study on my own and some English with biophysical data that confirm the correlation with more objective data.”
The study Cosmo negative correlation between CCSVI and multiple sclerosis. What do you think?
From this study, I went out in the design stage, because I knew that the proposed methodology would lead to this negative result. The problem is that the system easier to make a diagnosis is the Doppler, but is a method in which there is a large variability of results employees by the operator, in which judgment is derived from an interpretation of the data. We proposed to carry out the examination by a radiologist or a vascular angiologist, more experienced in the field, and conversely neurologists have wanted to claim for itself the management and they did do a training program for staff neurological, but the Doppler examination is very complex.
This explains the different result?
The presence of CCSVI in patients with multiple sclerosis has been confirmed by scientists in the area of cardiovascular disease in a proportion of between 60 and 100 per cent of cases. Conversely scholars with training neurological, in most cases, they do not find associated to patients and consider present in an amount equal in the general population. This split in the scientific world leaves completely open the dispute.
There is no way of settlement?
Last week, a consensus conference of radiologists Professor John Simonetti (University of Rome Tor Vergata) has proposed to use a built-in diagnostics with four exams: catheter venography, MRI of the veins, Doppler, cervical plethysmography. In this way you could have more reliable data.
A study of the cosmos is not valid?
I already said that if the epidemiological data is not collected properly, the result is not the real one. Can I point out that today (yesterday, ed) came out of Phlebology (leading magazine for diseases of the veins), a work that I conducted in collaboration with biophysical English, which shows – with a method that is not operator dependent – that in patients with multiple sclerosis and Ccsvi the blood that comes from the brain encounters a greater hydraulic resistance due to the blocks. Or indicate our study, carried out in collaboration with colleagues in New York and presented yesterday in Lyon, which suggests that interventions to improve cerebral veins produce. I should mention that we are talking about a disease that you do not yet know the cause nor the pathogenic process. And you want to hinder the freedom of research?
Hi Carol. We only include published studies in our systematic review, and an asbtract doesn’t qualify. Once CSMO is published, and everyone can read the detais of the methodology and results, we would definitely inlucde it in our review. Andreas
I am confused why this study would be included once it’s published, when there was no intent of actually finding CCSVI based on their methodology in testing methods. The only thing this study did was prove that inexperienced doppler operators and inexperienced neurologist interpreting the results is not a valid protocol to dispute Zamboni’s findings. It has nothing to do with scientific research that CCSVI exists or is found in a majority of MS patients. I believe Dr. Zamboni has responded to this study and even discussed it in clear detail when you were both presenting at the Senate hearing on Nov 1st. To me the Cosmo study it is the same as using a magical wand and then report that they did not find any patients with CCSVI, therefore it does not exist and no further research is required.
Also it was just my observation that when Dr. Zamboni spoke at the Senate hearing, you seemed bored (yawning) and sometimes perturbed. (Arms crossed, facial expressions and fidgeting). I get the sense that many of the medical community in this country have total disrespect and contempt for Dr. Zamboni. Is it not appropriate to talk with CCSVI experts and observe the testing and treatment before these conclusions are expressed. I know for a fact that Dr. Zamboni as well as many other CCSVI doctors have extended invites and opened their door to everyone in the medical profession, MS Societies politicians, health ministers etc, but most would rather criticize and make uninformed decisions that have delayed proper clinical trials from taking place on a timely basis.
I have not seen a published manuscript from the COSMO investigators yet, and I won’t be coming to any conslusions in my own mind until I do.
Interesting that you say I looked bored and fidgety. I wasn’t bored, but I am a natural “fidgeter” (if there is such a word). I have to say that sitting in a room by myself for 2 hours staring at a TV screen brought out the fidgeter in me.
I met Dr Zamboni in Bologna Italy in May when I met the steering committee of the Italian randomized trial. Dr Zamboni and I have corresonded by email since then, and our interactions have been cordial.
Hi Dr. Laupacis,
I posted a question a few days ago with regards to when we would be able to see the CCSVI trial protocol that has yet to surface.
It is because of malformed, badly laid out and incorrect protocol that lead to results such as this one. Dr. Zamboni has a specific protocol. The meal doesn’t turn out the same unless you follow the recipe.
p.s. no surprise this comes from the Italian MSS.
Have you heard of Dr. Dake in Stanford? He’s being sued by two MS patients for performing CCSVI treatment and harming them. http://www.marketwatch.com/story/lawsuits-against-stanford-dr-michael-dake-for-experimental-procedures-filed-by-san-francisco-firms-rouda-feder-tietjen-mcguinn-and-emison-hullverson-llp-2012-10-10
The lawsuit claims that CCSVI isn’t a recognized medical condition. Is what Dr. Dake did really that serious? Will this invalidate all his CCSVI research?
Any idea how we could get a hold of the “pan-Canadian” trials protocol that Dr. Trablousee will be heading?
Hi Anna. Good question.
I just checked http://www.clinicaltrials.gov, and I didn’t see a description of the trial protocol posted there. I’d keep an eye on that site, since it is very likely that the study protocol will be registered on that site before the first participant is enrolled.
I also found this web site: http://www.vchri.ca/s/MS-CCSVI-PII.asp, which contains general information, but no specifics.
Thank you for the links and your prompt reply, Dr. Laupacis. I would assume it would be available to the public in the very near future. Will be waiting for it.
Hi Dr. Laupacis,
Isn’t it so that so many venous angioplasty procedures are done for various ailments in Ontario, for example: for Budd Chiari syndrome, for dialysis patients, for May Thurners Syndrome, that it would be inappropriate to label it experimental? Plus, surgical procedures are very physical and invasive, often used when medications have failed. Surgery physically alters/manipulates a structure, for example hernia; removes a diseased structure, for example tonsils & appendix; or removes a blockage, for example blockages in arteries/veins. The outcome of these physical manipulations are expected or known; surgeries are not really suitable for experimentation.
Thank you for your reply and admission that the use of the term “cerebral veins” was “sloppy”–this illustrates one of my pet peeves regarding the handling of the entire CCSVI issue.
It’s frustrating when “so-called” journalists relay INACCURATE information because the public then BELIEVES the MISINFORMATION. It’s infinitely more frustrating when “so-called” EXPERTS are also relaying misinformation. I’d be willing to bet that the “so-called expert”, the federal Minister of Health, couldn’t give an ACCURATE description of the venoplasty procedure–even with advice from her advisers!
And yet people with MS in Canada remain prisoners of these bureaucrats and “experts” with conflicts of interest–Oh, Canada…heavy sigh…
Hi Dr. Laupacis,
How are you going to feel (as a Canadian physician) say in another five years from now, after it is proven and decided that YES blocked veins in CCSVI/MS patients should be opened? Another 2000 + people will have died, and many others will be permanently disabled. I cannot remember when there has ever been such a delay caused for people with other diagnosis’ in getting blocked vessels opened.
PLEASE do read this. It ties a lot of things related to MS and ties them together. And not just MS!
If this guy is right, it could be one of the biggest breakthroughs in medicine.
Referring to your reply to Judy indicating “What I have said is that I am not aware of any convincing evidence that treating the cerebral veins with venoplasty decreases the chances that someone with MS will die. “, I am just trying to confirm if you completely understand the venoplasty procedure for CCSVI. Do you understand that the Interventional Radiologists doing this procedure don’t actually go near the veins in the brain–it’s mainly jugulars and the azygos–not “cerebral” veins.
Hi Lori – yes i absolutely understand this. I agree that using “cerebral veins” was sloppy on my part and your terminology is much better (and the one we have used in our reports).
Just in case you missed it, this MIGHT be very good news for a lot of people.
Boy, do I hope so!
So, Dr. Laupacis, THANK YOU for publishing my letter.
I had bet you would.
But I await YOUR reply?
Hi Tom – sorry – which comment of yours do you want me to respond to?
Answer the questions I asked in my letter of July 18, 2012.
You have indicated several times in the past that CCSVI wouldn’t be a cause of death. However, if Dr. Zamboni and the International Union of Phlebologists are correct, CCSVI is defined as a truncular venous malformation PRECEDING MS PLAQUE. This being said, what do you think happens when the areas of the brain responsible for the heart and/or breathing functions are menaced by MS plaque activity when large, numerous, recurring plaques plague these areas of the brain?
What I have said is that I am not aware of any convincing evidence that treating the cerebral veins with venoplasty decreases the chances that someone with MS will die. Dr Zamboni himself is involved in designing a large randomized trial of venoplasty in Italy, so he clearly doesn’t think such evidence exists either.
Hi Dr. Laupacis,
Even if (and I doubt this is the case) CCSVI wouldn’t cause death; how would deoxygenated, waste material-carrying blood refluxing back into any organ, most especially the brain, be healthy for any organ? Would this not cause problems over time?
There is still lots of controversy about how much reflux of blood there is with CCSVI, or even how often it occurs.
Even if one assumes there is considerable reflux, things that make biological sense often turn out not to have the impact on patients that we think they will have. For example, some drugs that successfully treat abnormal heart rhythms turned out to kill people when tested in clinical trials. The same with some drugs that strengthen the contractility of the heart, when given to people with heart failure.
So, to me, having a plausible biological mechanism for why a treatment should work is important. Biut is isn’t enough – I want to see the results of clinical trials before i am convinced.
You may have seen some of the news coverage about the disease-modifying drugs not slowing the progression of MS:
So exorbitantly expensive “disease-modifying drugs” drugs, which have terrible side effects, and DON’T improve symptoms, and DON’T slow progression but may only POSSIBLY (nobody can really say for sure because of the unpredictability) reduce the number of attacks, are still being RECOMMENDED. But a minimally-invasive, safe, inexpensive procedure that is used regularly for other Canadians is NOT allowed for people with MS even though it has been shown to actually improve many symptoms. Something is very WRONG in this country!
Yes there is Lori … something is wrong in this country … called “LACK OF ETHICS”.
I think that it is wrong to slam any advancements made in any area of MS treatments. I was diagnosed 18 years ago when the interferons were still in clinical trials. I signed up for the Rebif trial right away. It kept me relatively well for quite a few years. When I developed antibodies and it stopped working I stopped using it and waited for something new to try. I am again in a clinical drugs trial that started 11 years ago and have been well for almost 11 years except for 1 recent attack. My doctor has never promised me that it would cure MS but my life has been greatly improved. I am hoping that one day, they will find the pill with the magic cure. If a decrease in episodes keeps me walking and higher functioning longer I am happy with that.
You should applaud any kind of advancements in the field and not slam them to make your point. I have never worked on the side that gets the trials started but I bet that they have the same obstacles in the way that the CCSVI ones have had.
I’m honestly happy that you’re doing well but I bet your neurologist is not accusing your good results as only being a “placebo effect”. If people want to take drugs and “believe” that there is some “magic” pill, I support their decision. I just think it is completely discriminatory that people with MS are being refused treatment for proper blood flow–something that I think is a basic human necessity.
I know that people tend to believe their own “results” and I believe that in my circumstances, with absolutely no other treatment available for me, I should have been allowed to try venoplasty in my own country, where I was told at a kidney dialysis treatment centre, that it is done for chronic renal conditions all the time and, is considered URGENT! My great results from treatment in the U.S. PROVED to me that my risk/benefit analysis was correct. I could either sit around and just continue to get worse or I could try a simple, safe procedure that might improve some symptoms. I can now swim for an hour every day and go out to family functions without a mobility aid–this wasn’t possible before treatment.
I would like you to see my before/after video so that you can see why I believe so strongly in treatment for CCSVI.
Walk a mile in my shoes
My Neurologist doesn’t call my good results a “placebo effect” because I have been closely monitored for the last eleven years. I had base line MRI’s, neuro exams, physicals, cognitive testing, EEG’s, blood work and ultra sounds. I was seen weekly, then bi-weekly then every six weeks. They can see what improvements I have had. They have a protocol in place that every patient who is in the trial follows. Before you had the procedure done, did you undergo baseline testing? Did they give you the imaging to show your doctors where your blocks were? A report on the procedure (OR notes)? What meds did they prescribe? Follow up recommendations? How long did they keep you after the procedure was done? These are many of the questions that our doctors face when not everyone is in a set protocol. I am sorry you had to go out of country to get the procedure done. The sad story is that it happens daily in all aspects of Health Care, and it seems to be getting worse. They are cutting back in a lot of areas.
I watched your video and I can see your improvements. I am glad that you benefited from the treatment. Hopefully it will give you long term benefit and you continue to improve over time.
My neurologist had no interest in viewing the CD of my treatment–he has no knowledge of vascular procedures. He has known me, as his patient, for 22 years, and, therefore, is very familiar with my medical condition. Even though he was not convinced that there was enough scientific evidence yet, he had to admit that I have had “significant improvements”. He allowed my husband to video record my neurological examination and seemed quite surprised that I actually had MEASURABLE improvements. It was great to not fall over when doing the “balance test” for the first time in 20 years! This is a video one year after the treatment which includes part of the neurological exam: http://www.youtube.com/watch?v=9BNL42wcFLE&feature=youtu.be
When I thought the tightness in my ribs was the “MS hug”, he suggested that I check into it further to make sure it wasn’t my heart or something else–it turned out to be gallstones. NOT EVERYTHING IS DUE TO MS! I just wanted to see if some of my symptoms might be related to the vascular condition of CCSVI–but Canada wouldn’t let me–it turns out they were! It’s been over 16 months now and I haven’t had what was assumed to be an “MS headache” (that I used to get every week) since my blood flow from my brain was restored! I guess headaches shouldn’t be assumed to be related to MS just because you’ve been diagnosed with MS!
Glad you are doing well and that your Neurologist noted your improvements. He mentioned something about a registry. Is there someone else taking notes from the improvements since the treatment. If so maybe sharing with others how do get their improvements noted might help the cause.
Yes, I am part of the BC CCSVI registry. I was interviewed in January/2012 and again in July. I was not impressed with the survey–it seemed very limited and completely ignored many of the symptoms that many people have seen an improvement in. My neurologist also told me that he has seen many patients who have had the treatment and they say they feel better but he hasn’t been able to “measure” their improvements–I was an “exception”. That really annoys me because I have never been “measured” for heat intolerance or headaches so how would he have any “measurement” to compare? Those kind of symptoms were not asked about in the Registry but I think they are EXTREMELY important when it comes to Quality of Life!
Has everyone disappeared?
I don’t know about “everyone”, but i haven’t had time to respond to your post addressed to me – will do so shortly. Andreas
Though I been follow the varied debates about CCSVI, about the intervention to try to correct the condition and about the outcome, I have never formulated an observation on these matters.
But I am getting angrier by the day when, on the one hand, I read patients who claim they had CCSVI, when they really had the angioplasty treatment, and doctors who speak of people who look for the cure through angioplasty.
MS patients, or most of them, never think of the angioplasty as even being part of a cure. They wish to subject themselves, or already subjected themselves to a minimal medical procedure to correct a vascular condition, PERIOD which, in many cases, improves their quality of life to an extent that even the most qualified MS specialist may never expect.
As for the cost of the angioplasty, and our supposedly stretched healthcare system, the MS family (includes persons with MS or pwMS, their family and friends) has a right, nay an obligation, to question why governments spend an average of $25 00 to $52 000 per year for each person with MS who is on a CRAB drug and will not even attempt to officially and fairly determine the safety (we all know the intervention is safe) and effectiveness (pwMS know it is very effective in about 35% of cases) of the procedure at an approximate cost of $1500 per person in Canada.
And please, do not bother to come back with the one case of migrated stent or the three deaths caused not by the intervention but by causes brought on by other ailments, including a broken aneurysm from post-op prescription of anticoagulants.
Just a piece of information in passing:
The Yanks have probably the most reasoned, dispassionate voice on the web. I would suggest it highly.
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.
To begin with, a gentle reminder. While we chat, people with MS continue to suffer and die. This is no idle banter.
(This following is copied here from “Healthy Debate”, Dr. Laupacis, so you may have read it before.)
The “Expert Panel” is going to be asked to make a judgment that effects the very next breath a person with MS might take.
If CCSVI Treatment continues to be prohibited, the rich will continue to be rich and no doubt get richer, 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 (what were they afraid of?), everyone would know a lot more by now about the CCSVI/MS relationship.
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 MS specialist was Dr. Ken Warren. (I live in Edmonton, by the way). He has now retired from active practice. As you no doubt are aware, when it comes to MS research, he is one of the best of the best.
When news of CCSVI first broke, Dr. Warren tried (unsuccessfully) to get a trial going as soon as he could. As he said “Tom, 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. (And by the way, Dr. Laupacis, I actually do know what your Oath says. So much for “First, do no harm”.)
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 tonight 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 me in the eye and say “Tom, I believe that supporting evidence based medicine by prohibiting CCSVI Treatment is in your best interest?”
I don’t think that compassion for the plight of patients (with MS or the many other miserable diseases pateints suffer from) is incompatible with saying that we need good evidence before paying for treatments through our publicly funded health care system. In my view, as much as possibe, the public system should only pay for treatments that we know do more good than harm, because our resources for health care are limited.
At the present time we don’t know whether that is true for the treatment of CCSVI. I note that Dr. Warren was calling for randomized trials of CCSVI treatment, not for CCSVI treatment to be offered immediately. Dr Warren was actually supporting evidence-based medicine.
If it turns out that CCSVI really does more good than harm, then we will likley look back and say that we took too long to get the randomized trials underway. On the other hand, if CCSVI turns out not to be beneficial, we will look back and say that lots of patients were given false hope, paid lots of money for an ineffective treatment, and some unnecessarily experienced serious side effects.
Finally, as i have said a few times on this site, I really think it is wrong to imply that treatment for CCSVI has been shown to save the lives of people with MS – to imply this is the case is totally misleading.
We KNOW CCSVI Treatment does more good than harm. To ignore the consistent first person evidence of hundreds of people over time is to ignore valid empirical evidence of the first order. To continue to ignore this evidence is unconscionable. I think you know better.
As I have pointed out, CCSVI Treatment is cheap cheap cheap compared to the cost of pharmaceutical interventions that kill, injure, that do not work, that are not worth what is being paid for them. Ask the Brits.
Thirty thousand dollars a year for drugs vs a one-off, maybe two-off etc. surgery that would cost $1,500 – $2,000. Do the math. If you are so worried about all the money we are spending, why are you not worried about the waste of $$$ on MS drugs that don’t work?
If CCSVI Treatment Is just a little bit successful it will save governments hundreds of millions of dollars. But some doctors (mostly neurologists), some MS Society executives, and some pharmaceutical companies will not be happy. Gee whiz!
Drugs that continue to injure and kill AS WE SPEAK have been approved by “evidence based medicine”. What evidence? Evidence provided by PROVEN organized crime – i.e. pharmaceutical corporations.
You ignore the words of hundreds of people yet cling to the notion that DBRCTs have been effective in helping people with MS. Which drugs would you like me to take? The ones that might kill me, or just the ones that don’t do anything but cost tens of thousands of dollars every year? Tell me. I am asking?
You say our health care system should only pay for treatments that we KNOW do more good than harm. So, just what evidence did all those people who approved of Tysabri consider? How much is a life worth? What is the tradeoff? Tell me. I am asking?
Double blinded randomized controlled trials. Good in theory. Too bad that is not the way life really is. At least for people with MS. Dr. Laupacis, you are a clever fellow. You know this.
LOOK AT THE REAL EVIDENCE! What you are advocating is that we should trust companies like Pftzer and GSK who have every reason to lie and no reason to tell the truth, while ignoring the testimony of hundreds of witnesses who have no reason to lie and every reason to tell the truth?
Do you have a double standard, or what? You would be laughed out of any courtroom in Canada. It is a pity that single payer health care leads to medical dictatorship as it has when it comes to MS and CCSVI. Physicians have terrific IQs, but their EQs are the same as anybody else. Power corrupts. Etc. The best medicine money can buy.
If it turns out CCSVI does more good than harm, we will look back and say “How much suffering could we have prevented? How many lives may have been saved?” CCSVI Treatment does not give false hope.
Ah, looking back – you obviously have no sense of urgency about you – you are not suffering, you are not dying – I guess you can afford to be philosophical.
If you read my letter again, you will find I did not say Dr. Warren called for CCSVI Treatment to be made available. He called for trials. Do you have problems with my use of the language? I quote “When news of CCSVI first broke, Dr. Warren tried (unsuccessfully) to get a trial going as soon as he could”. What is it you don’t understand here?
To imply CCSVI Treatment may save life is NOT misleading.
The case regarding Dr. McDonald and Barb Farrell is well documented. And publicized. Apparently you are not as aware as I thought. Look it up.
Barb was left to die by people just like you, who bathe in the crystal clear waters of reason, as defined by the reasoners, as approved by the approvers. Does that bother you at all?
“Paid lots of money”, for ineffective treatment? CCSVI Treatment in the U.S. can be had for one fifth of what it costs every year for MS drugs. Who are you trying to kid? Just how stupid do you think we are?
Side effects? You have the nerve to talk about the side effects of an CCSVI Treatment intervention? When you KNOW what side effects MS drugs can have? When you KNOW how many people have died from Gilenya – so far?
Incidently Tysabri has 10 – 20 times (depending on what you want to count) as many injury incidents as CCSVI Treatment. I have lots of other stats if you are interested.
Dr. Laupaics, talk to people IN CONTEXT when making your points. Don’t give us the gears. We know better.
Anne Kingston was right – the Canadian Health System is guilty of ignorance – guilty of ignoring what is happening in the real world, guilty of looking through rose coloured scientific glasses that only see what the MS establishment wants them to see. How coincidental that millionaires and science just happen to agree? Gee whiz!
It is true that CCSVI Treatment has not proven to be as effective as MS patients had hoped. It is true that much more research needs to be done. It is also true that CCSVI Treatment helps some people some of the time. Just like Dr. Liu hypothesized. What if you were among the “some” that might get help?
You have intelligence, but you seem to lack soul. Pity.
I will be publishing my letters and your letters. Fair warning.
This is Tom Peterson’s post taken from a pro-”liberation” FB site:
“Following is a copy of correspondence I have had with Dr. Laupacis. It consists of my original letter to Dr. Laupacis, his reply, and my rejoinder.
I believe the letters speak for themselves. (Dr. Laupacis may want to cross my name off his Christmas card list.)
As long as doctors like Andreas keep us engaged in conversation, all we do is spin our wheels. You might as well save your breath. It is people exactly like he is who constitutes our problem. He will literally “talk you to death” as he masquerades as an honest and “reasonable” broker! Don’t be fooled. He is every bit a part of the establishment as are the rest of the Health Canada related bureaucrats.
We will never find solace in the small medical minds who are dictating the fate of Canadian MS patients. Very few real doctors are behind CCSVI Treatment prohibition. The rest do not want to speak up. All they want to do is look after their patients and ignore medical politics. Can you honestly blame them? What would you do?
Comments would be appreciated.”
I hope that other pro-”liberation” supporters will keep in mind that Dr. Laupacis has been nothing but tolerant and respectful towards them (too much so, IMO). He certainly does not deserve to be attacked for simply being forthright with all of us. However, it’s clear that many of you want him to be unethical and lie or mislead you, the FDA and the Canadian health system and other MSers about CCSVI and venoplasty. If there is something to Zamboni’s theory and venoplasty as a beneficial treatment for MS symptoms, then the science will bear it out and it will be embraced by the medical establishment. If it turns out that his theory is invalid and there are no true benefits to the surgery, please realize that there is nothing Dr. Laupacis or Dr. Rubin or any other researcher can do to change that.
I have personal knowledge that this treatment works but I’m sure you don’t care about my great results. I would just like to point out that having a progressive, degenerative medical condition can be very depressing and when there is finally a bit of hope, people with this condition can’t help but get excited.
I’ll just mention that there is discrimination happening in Canada when people without MS can have this procedure (eg. chronic renal condition patients) but if you have the diagnosis of MS you cannot. Perhaps you can understand how frustrating it is that, even if there is no other treatment available for you, you can’t have a simple, safe procedure that others can.
Never mind the frustration built up when the government promised, more than a year ago, that clinical trials would be done (because there was enough evidence indicating they SHOULD be done) BUT THEY HAVEN’T STARTED YET!
It’s not that I don’t care about your great results, Lori. It’s that I also care about those MSers who had gotten the procedure done and experienced no benefits and even gotten worse afterwards: http://www.thisisms.com/forum/chronic-cerebrospinal-venous-insufficiency-ccsvi-f40/topic12342-300.html
I’d also like to point out that I have MS too , so I’m familiar with the depression it can bring. There is nothing wrong with having hope, except when it’s false hope. I have hope that there will be a real cure for all of us, not just another treatment for symptoms that affect only some of us. Unfortunately, because angioplasty was hyped as the miracle cure for MS, a lot of attention and more importantly, money, was diverted into CCSVI and venoplasty research, instead of into more promising research that will actually halt MS progression. And that’s what I truly find frustrating.
You cannot compare the use of venoplasty in chronic renal disease (CRD) patients to its use in MSers. You do know that the reason why these patients receive venoplasty is because the catheter causes trauma and scarring to the walls of the vein, which results in vein narrowing and blockage (as well as infection and thrombosis). These complications have also been seen in MSers who received venoplasty: http://www.ncbi.nlm.nih.gov/pubmed/21803799). But because CRD patients will die without kidney dialysis (within weeks at best, days at worst) venoplasty is necessary to clear the blockage caused by scar tissue. Unlike venoplasty in CRD patients however, there is no evidence that venoplasty saves the lives of MSers and as Dr. Laupacis has said, to imply so is wrong and misleading.
I do find it interesting that Canadian IRs, cardiologists and vascular specialists have not shown any interest in conducting CCSVI and venoplasty trials to the point that Canada is now sending MSers to participate in trials in the US. The government in Saskatchewan had the money and put out a call for proposals and only got one response back, which didn’t meet their criteria. What I find more interesting is that Canadian IRs and vascular specialists have not been criticized for their apathy towards CCSVI and venoplasty by the pro-liberationists.
I also questioned why there was not more interest by Canadian IR’s and vascular specialists until I found out that their interest is very strong BUT their medical licenses had been threatened by the College of Physicians and Surgeons.
I have a link to one news story, although it doesn’t seem to be available any longer. I wonder why?
I have heard this from several IR’s–I’m not making this up.
By the way, “cure” was created by the media and people who have done their research don’t call it that. Advocates simply want the right to obtain a safe procedure to restore proper blood flow from the brain, that has been shown to improve the quality of life of many people by improving some symptoms that may have mistakenly been attributed to MS.
Maria Goldberg wrote: “I do find it interesting that Canadian IRs, cardiologists and vascular specialists have not shown any interest in conducting CCSVI and venoplasty trials to the point that Canada is now sending MSers to participate in trials in the US. The government in Saskatchewan had the money and put out a call for proposals and only got one response back, which didn’t meet their criteria. What I find more interesting is that Canadian IRs and vascular specialists have not been criticized for their apathy towards CCSVI and venoplasty by the pro-liberationists.”
Actually Maria, there has been some interest, yet those interested have been shut down. There was doctor Sandy McDonald, a Cardiovascular and Thoracic Surgeon from Barrie, Ontario, who actually had his IR (Dr. Christopher Guest) perform the procedure on 6 MS patients in early 2010. This was shut down, despite attempts to continue performing the procedure.
There was also an IR (or Vascular Surgeon…not sure which one) who performed the procedure in a hospital in British Columbia. According to media reports, the neurologists had him shut down and had his operating room privileges removed.
So the information you are giving is misleading as well, saying there is no interest. There is interest, yet the doctors who are interested in it, are bullied out of the operating room by a small group of irate neurologists.
And furthermore, I think it is a “cheap blow” to copy and paste a remark made by a person on another MS “pro-liberation” site, as you refer to it.
I could bring up some of the messages that you and your friends wrote on other sites some time ago, but I’ll spare you and the other readers the details.
I have dialogued on this site with Dr. Laupacis for some time now, and I do not agree with everything he says either, but I still respect his opinion on this and understand the approach that he is using.
I agree with this.
To the person below:
Anecdotal evidence and how loud people are about a treatment does not mean that it’s incredibly successful. Never mind the fact that there hasn’t been a proper trial conducted and published, and never mind the fact that current evidence from imaging and diagnostic tests show nothing regarding CCSVI, which is a term that was recently invented itself. Most doctors are not against a life saving procedure especially if it’s good, but not practicing evidenced based medicine is unethical and can destroy the system. If there wasn’t evidence based medicine, doctors can start looking at unproven treatments and start giving them out here and there, without actual evidence that they’re not doing more harm than good. A cheap alternative treatment doesn’t mean anything. It’s also very cheap to give you worms, or place some stents in your kidneys for no apparent reason. Nothing proves it works, but because it’s cheap, we must try it?Natalizumab, or Tysabri, was put through clinical trials for many years before being approved, and it was only when there were large numbers of patients on the drug (stage 4 of the clinical trial, monitoring) when PML, caused by the JC virus, was found to be an adverse effect. If a doctor does CCSVI because of anecdotal evidence, he should not be able to keep his license. Current guidelines for the “Brits” do not say CCSVI at all. It’s an alternative treatment (akin to homeopathy) that any sane doctor should not be suggesting.
Are you aware that Chronic Venous Insufficiency has been an accepted medical condition for many, many years? It was only when Dr. Zamboni specified the cerebro-spinal veins, threatening the neurological establishment’s “hold” on Multiple Sclerosis that it became “controversial”. This procedure is performed regularly (on the jugular veins) for chronic renal condition patients to restore blood flow when occlusions occur due to repeated catheter use. I guess they deserve proper blood flow but Canadians with MS don’t!
Here is an old reference which I bet you never heard of. CCSVI deniers are good at publishing anti-CCSVI stories. But not others.
It is interesting that a brain surgeon that knows a lot about aneurysms should have had this initial take on a vascular theory of MS. He did not certainly dismiss it out-of-hand.
By the way, Dr. Weir used to be head of neurology at the University of Alberta Hospital.
Department of Surgery, University of Chicago, Illinois, USA
From the earliest pathological studies the perivenular localization of the demyelination in multiple sclerosis (MS) has been observed. It has recently been suggested that obstructions to venous flow or inadequate venous valves in the great veins in the neck, thorax and abdomen can cause damaging backflow into the cerebral and spinal cord circulations. Paolo Zamboni and colleagues have demonstrated abnormal venous circulation in some multiple sclerosis patients using non-invasive sonography and invasive venography. Furthermore, they have obtained apparent clinical improvement or stabilization by endovascular ballooning of points of obstruction in the great veins in some, at least temporarily. If non-invasive observations by others validate their initial observations of a significantly increased prevalence of venous obstructions in MS then trials of angioplasty/stenting would be justified in selected cases in view of the biological plausibility of the concept.
Dr. Weir – Order of Canada
I believe by now you have seen the recent report in Maclean’s magazine written by Anne Kingston. http://www2.macleans.ca/2012/06/25/the-silent-treatment-how-canada-has-failed-ms-sufferers/
There are many points that call into question the credibility of the CIHR and the process that was put into place to manage the CCSVI file.
How do you respond to some of the documents that are attached to this article? Do you think the CIHR has mismanaged this dossier from the beginning?
Do you feel that MS patients are justified by their outcry against the medical community, and particularly neurologists because of the way we have been berated when we dared to speak with our neurologists about CCSVI?
Is it true that you personally criticized the composition of the “Expert” panel in 2010? If so, could you provide a link to what you had to say about it?
I hadn’t seen this article – thanks for sending the link.
Art Slutsky and I wrote a commentary that was published in the Journal “Open Medicine” in 2010 in which we suggested that we thought members of the public and patients should have been on the panel (I realize that one patient was a panel member). The link is:
Thank you for this reply, and thank you for the link to the article that you wrote in 2010. I was looking for this the other day, and appreciate you providing the link.
By the way, it’s Canada Day today so hope you are resting.
Happy Canada Day to you too! I am sitting in the gazebo on our little farm in the Ottawa Valley, doing a tiny bit of work.However, I will shortly be putting the computer away for the rest of the day, and will probably drive down to Ottawa to partake in the festivities with my wife, daughter and two of her friends.
Best to you and yours.
Regarding Zamboni’s recent study, “Venous angioplasty in multiple sclerosis: neurological outcome at two years in a cohort of relapsing-remitting patients”, is there a reason why Zamboni excluded progressive MSers when he had included them in his previous studies? Also, I find the fact that 13 of the 29 participants had venoplasty more than once, 11 had it done twice and two had it done three times, very disconcerting. Do patients who recieve traditional balloon angioplasty have it done more than once in the span of two years?
Thank you for your response.
As for repeat angioplasties, I have a relative that has had 4 angioplasties (coronary) in Ontario, Canada, in the last couple of years. Stents were also placed.
In relation to MS venous angioplasty, Dr. Gianfranco Campalani, a Heart Surgeon in the U.K. has had his 3rd CCSVI treatment. He says that they are safe.
However, I do know some people who have had serious problems with venous angioplasty for MS, but the complications almost always were because of stent placement in a jugular vein.
I guess it’s a matter for a physician to determine the risk-benefit ratio with the patient. In the case of coronary angioplasty, it was a matter of life or death. In the case of MS, it was a matter of improved quality of life. Dr. Gianfranco Campalani has stated in media reports that he does not believe in taking the drugs for MS as he believes that they do not work. Since having venous angioplasty, he is able to continue his career in Belfast, Ireland where he performs heart surgery.
Hi Maria. I do not know why Dr Zamboni only reported on relapsing-remitting patients. Good question.
In terms of repeat venoplasty/angioplasty – the reason that stents are almost always inserted in someone with a narrowed coronary artery (the coronary arteries supply blood to the heart – there are 3 of them) is because the rate of re-stenosis was quite high after angioplasty without a stent (angioplasty is a procedure that involves blowing up a balloon in the coronary artery to dilate a narrowing).
I am not a cardiologist, but my understanding is that with modern stents, the chances of requiring a repeat procedure is now below 10% at one year.
As Chris Alkenbrack points out, stents are now rarely used in jugular vein venoplasty because they can migrate towards the heart, which is not good. Stents that are placed in an artery almost never migrate.
I think the important issue here is, if proper blood flow is maintained, symptom relief is possible for many MS’ers. I am hopeful once proper treatment studies are in place they will learn how to keep MS veins open on a long term basis and maybe learn who is the best candidate for CCSVI treatment success. Today it is angioplasty and possibly stents, who knows what the treatment will evolve into when proper studies are done by the proper medical disciplines. I am sure that CCSVI treatment in 10 years from now will be quite different than what we are seeing today. I am always amused why some sceptics expect a new and evolving procedure to reach excellence in it’s infancy and if it doesn’t then the opinion is to not pursue. WE have to start somewhere. The bottom line is lets get going on proper meaningful studies to correct a venous abnormality and restore proper blood flow with an safe and efficient procedure, lets figure out why some re-stenose so quickly and why some have such outstanding results and some have poor results. That is what the studies should be about . I still believe that all MS’ers with guidance from their physcian should have a choice to participate in the treatment procedure that is available today as part of a controlled medical study. They should be fully aware of the risks and consent to participate in an experimental procedure with no guarantees while the medical community learns. Some Ms’ers have no other options and no more time. CCSVI treatment may or may not help everyone but one thing that is known is the risks of where this disease eventually leads. Angioplasty is a relatively safe medical procedure whether the procedure produces long term results should not be a determining factor on whether it is a viable treatment option or determine if studies are warranted. There are very few drug or other medical procedure that guarantee long term results yet people are allowed to decide their own risk/benefit.
I have always been skeptical about using stents in the jugular veins.
They would just be exposed to too many forces: torrsion, tension, compression, extension as you move your neck, or compression from having something press on your neck (even just a seat belt in a car). It might be acceptable to place a stent in an azygos vein, where it is protected behind the ribcage, but not in the neck. Until a stent can be designed which can allow significant movement without damaging or disloging the stent it just seems too risky to me.
I would like to know where to get a copy of the observational study that was done in Newfoundland the lead investigator was Dr. William Pryse-Phillips, a professor emeritus of neurology at Newfoundland’s Memorial University. I always like to look at the actual study.
The study was looking at venous angioplasty for multiple sclerosis.
I can not find the actual study anywhere, was it published in a journal?
Thanking you in advance for any help you can give me.
(you don’t have to print this – I just want to know how to go about finding this study)
Hi Florence. I don’t think the study is published yet.
All i know can be found at the following web (a link to a video of press conference is at the bottom):
On page 26 of the Document Entitled “Systematic Reviews of the Evidence Regarding Chronic Cerebral Spinal Venous Insufficiency (CCSVI) and Multiple Sclerosis” An update for the CIHR Expert Panel, June 4, 2012 from the Canadian Chronic Cerebrospinal Systematic Review Group.
(Page 26) We read the following information: The largest planned study is a multicentre study from Italy (28), and the first patient is expected to be randomized in June 2012 (personal communication, Dr. Roberto Grilli). This study has two primary outcome measures, both assessed at one year (personal communication Dr. Graziela Filippini, Chair of the Steering Committee). The first is a composite of five validated functional measures. Patients will be considered to have improved if they improved in one or more of the five outcomes and did not worsen on any of the others. The functional outcomes assessed are walking, coordination, vision, bladder function and balance. The second primary outcome consists of MRI findings.
After observing the tables from pages 30-32, I see that this is clearly referring to the BraveDreams study in Italy. The five criteria – “walking, coordination, vision, bladder function and balance” are mentioned here.
It is written in the summary report that “Patients will be considered to have improved if they improved in one or more of the five outcomes and DID NOT WORSEN ON ANY OF THE OTHERS”. I want to know is this the criteria established by the CIHR panel or by the BraveDreams Clinical trial researchers?
The answer to this question is important because it would potentially eliminate any people who have improved in all but one of the validated functional measures. I personally would like to see these same standards applied to areas of improvement in the MS drugs that are currently available for which our government pays billions of dollars annually. If the same measures applied for the MS drugs, they would all fail pitifully.
You are right, this is the BRAVES study. Our description of the primary outcome event from that study comes from Dr Filippini, the Chair of the Steering Committee of that study, and has nothing to do with the CIHR.
To be clear, patients only need to improve in one of the five functional outcomes to be considered to have improved, as long as they don’t deteriorate in any of the other four.
This is more of a personal reflection than a question.
I can understand the necessity of having measurable outcomes, but I find it intriguing that when we talk about Multiple Sclerosis, a chronic progressive disease, that over time even if we were to improve in 4 of 5 of the functional measures but have a slight decline in one of them, that this would exclude us from the category of “improvement”.
I realize this is the way the study is designed, but it is, in my humble, non-medical opinion, a potential flaw.
I have a personal friend who had the procedure almost two years ago, and this person no longer wears diapers. There were no other real improvements, but when this person considers their own quality of life measurement, self dignity has been restored and they feel that the intervention was a total success.
Anyway, thanks for your prompt answers.
Remember that in the end, if the study goes as planned, they will have about 300 people who received treatment and 300 who didn’t. I am pretty sure they’ll cotegorize participants into those who improved, those who were the same, and those who deteriorated. With over 300 people in each group, I think that should give a pretty good sense of the impact of treatment. As I understand how they plan to proceed, your friend would be categorized as somene who improved.
I would hope that Dr Laupacis can now see the error in creating the Review Group in the first place. The government was under extreme political pressure by the Zamboni cult to publicly fund “liberation.” It made the mistake of trying to appease them by asking “experts” to review the “evidence” most of which is anecdotal with not one properly blinded study showing that “CCSVI” even existed. This “review” has only legitimized pseudo science and empowered the cult who will never be satisfied until “liberation” is funded by Medicare. The government should have said at the beginning that there was zero scientific evidence for Zamboni’s hypothesis and no more public money would be wasted on it.
I believe that any doctor who intentionally berates and insults MS patients should be banned from this site. Why are Dr. Rose’s comments about the Zamboni “cult” never filtered or monitored.
It is this type of inflammatory language that continues the divide between patients and doctors.
In the current edition of Functional Neurology http://www.functionalneurology.it/index.php?PAGE=articolo_dett&ID_ISSUE=612&id_article=5281&abstract=1&fromsearch&ultimo=1
This is a quote from the study “The annual relapse rate of MS was significantly lower post-procedure (0.45±0.62 vs 0.76±0.99; p=0.021), although it increased in four patients. The EDSS score two years after treatment was significantly lower compared to the EDSS score recorded at the examination two years before treatment (1.98±0.92 vs 2.27±0.93; p=0.037), although it was higher in four patients.”
As an MS patient, this sounds pretty positive to me. I wonder if Dr. Rose thinks the numerous physicians worldwide who have had venous angioplasty as a treatment for MS are also cultists? So sad that this type of language is used on a respectable forum.
Please see my response to Colin Rose which I just posted.
I have to say I find the rhetoric from both sides distasteful. I just looked at comments on this site from some individuals on the pro CCSVI side, and they include statements that Yves Savoie “made his first lip service”; that it is “shameful that the neurologists, MS Society Canada, won’t put their greed and pride aside….”; that “the federal government look like idiots.”; that “… a widely used tactic of your fellow doctors [is] to put a bill for an office visit without doing anything constructive”; and a comment that someone’s stance was “insane”.
so, on one side we have cults; on the other side we have insanity, greed, idiocy, lip service and unethical billing……
You may be right Chris, and I shoud now start to more aggressively edit comments from everyone.
It was not my decision to create the review group – that was made by the CIHR’s Expert Panel. Our group responded to their request for proposal.
I don’t agree with your contention that there is zero scientific evidence in favour of CCSVI, although I have repeatedly said I don’t find the evidence that currently exists convincing. Our most recent update of the literature continued to find large variations in the results of diagnostic studies of CCSVI which do not appear to be caused by differences in blinding.
I must say that the vast majority of the people with MS I have talked with who are proponents of CCSVI strike me as anything but members of a “cult”. They strike me as people who are living with a miserable disease that often hasn’t been effectively and consistently treated with currently available drugs. They, not surprisingly, are interested in potential new treatments.
Thank you Dr. L!
I don’t see how you can say that having a review group is a mistake. The general public does not have full access to Neurological publications or have the knowledge base to interpret them. Filtering genuine studies from Tom Quackery is also an issue. Not everyone living with MS knows how to tell the difference between the two. Every country around the world seems to have different standards in which they use to allow studies to occur, or even how drugs can be prescribed. It seems that Canada has one of the highest and hardest standards to meet. In a way, it protect patients from harm. I believe that the purpose of the Review Group was to gather the information and filter through it for us, and inform MS patients about what they are finding. The media coverage about the Zamboni hypothesis caused an influx of patients wanting a cure to this unpredictable, debilitating disease. I don’t think that anyone predicted how the patients would respond or the pressure it would put on both our doctors or the government. Our government is deciding to play it safe and gather as much information it can from all areas of the world. Our Healthcare budgets are stretched to the max and our OR wait times are on the rise again. I can see why they want some kind of proof that the procedure is somewhat effective before it is funded. I am not convinced that the procedure is effective for all MS it may provide some form of benefit to a certain group. Not everyone responds the same to the current medications in use to decrease the incidence of MS exacerbation. The key may be to find out what subgroup responds best to what therapy. There is so much more to learn out the nature, and course of this disease and the day we stop striving to find the answers should only be the day that we finally find the cure.
While there are those who argue in favour of publicly funded treatment now, I and the vast majority of MS patients simply would like to see effective studies of CCSVI treatment to see if it does provide benefits in a number of patients. If, and only if, it is shown to provide benefit, then it can become a standard, publicly funded procedure.
It has been immensly frustrating to hear people like youself decry the lack of quality studies, while doing everthing they can to impede such studies from taking place. Who else would you expect to fund this research other than government agencies and MS societies? Let’s get proper, scientific studies underway as soon as possibe so we can get some definitive answers!
I await the rational, science, and evidence based response from the CCSVI proponents in regard to the Newfoundland observational study of 30 MS patients plus 10 controls. A blinded analyst detected no correlation between MS and constricted neck veins, and also no OBJECTIVE improvement in patients symptoms after the liberation procedure. Oh, and please don’t resort to “big neurology” conspiracy theories. Could it be possible that the hard evidence (not anecdotal which as we all know is subject to numerous biases and errors) is mounting against Dr. Zamboni.
Hi Richard. I am looking forward to seeing the peer reviewed manuscript from this study. That is the criterion we have required for inclusion in our systematic review.
When you say peers, as in “peer reviewed” just who are you referring to?
Hi Tom. By “peer-reviewed manuscript”, i meant a detailed description of how the study was conducted and what the results were. Almost all scientific journals ask people who are independent of the authors to provide comments about what they perceive as the strengths and weaknesses of the paper. These reviews by “peers” (whose names are usually kept confidential) are considered by the editors of the journals when they decide whether or not to publish the paper. The peer reviewers are often chosen to reflect different scientific backgrounds (for example a journal might ask a neurologist, a vascular surgeon and a statistician to review an article about treatment of CCSVI). The authors of the paper are often asked to modify their paper to take into account the comments of the reviewers. Good journals receive many more articles than they can publish, and editors of journals use the reviews to help them decide which to publish and which not to publish.
It isn’t a perfect system, but better than not having peer reviewers.
Sorry. I really do know what peer reviewed is supposed to mean.
But your information to the effect that diverse mind-sets are engaged in peer review is comforting. I did not know that before. Thank you.
In response to David’s posts which describe the CIHR’s definitions of conflcit of interest, I still don’t see how these mean that Dr. Rubin is in conflict. He has strongly held opinions, but I don’t think strongly held opinions (on either side of this debate) necessarily means one has a conflict of interest. Andreas
The article entitled “The ‘Liberation Procedure’ for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand,” co-authored by Dr. Rubin is a compelling reason why he should not be on any international panel looking into research regarding Chronic Cerebral Spinal Venous Insufficiency (CCSVI). Rather than look objectively at the science he uses emotionally loaded terms such as “faith healing”.
Dr. Rubin research is in the area of molecular medicine of bioactive phospholipids. This is very interesting research however it does not make him knowledgeable about venous conditions. Dr. Rubin made up his mind prior to looking at the research – the Canadian press quotes him as being dubious of Dr. Zamboni’s research since the beginning. I agree with Dr. Duncan statement that Dr. Rubin “can longer be seen to be an independent judge of the scientific literature”. Dr. Rubin dismisses numerous peer-reviewed publications regarding CCSVI. In an emotionally manipulative and unscientific way he places the “Liberation Procedure” (more properly termed Venous Angioplasty), it in a category of unproven therapies.
The Canadian Institutes of Health Research (CIHR) needs individuals who can objectively look at research. Dr. Rubin words and actions have demonstrated that he should not be included on any panel/committee regarding CCSVI.
Individuals with Multiple Sclerosis (MS) are counting on the CIHR to evaluate research objectively and that involves choosing appropriate individuals to sit on panels/committees
Not sure if you have seen this letter from Kirsty Duncan to Alain Beaudet on the conflict of interest of Dr. Barry Rubin who as you know is a member of the Scientific advisory committee for CCSVI. I personally am very concerned with Dr. Rubins involvement and influence on CCSVI testing and treatment in Canada, when clearly he is being public with negative and fear mongering comments. What is your opinion as an advisor to the CIHR?
Letter to Dr. Alain Beaudet, President of Canadian Institute of Health and Research
The public disrespect that Dr. Rubin shows not only to his vascular peers and directly to Dr. Zamboni who not only believe in CCSVI as “faith healing” is inexcusable. I would love to know if Dr. Rubin has actually communicated with any doctors who actually study or perform CCSVI treatment. Has Dr. Rubin attended any CCSVI symposiums or conferences. I would assume before he makes these baseless accusations that he would have done everything in his power to ensure he is educated with all scientific evidence before such public statements are made.
“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?’”
Read more: http://www.ottawacitizen.com/Paolo+Zamboni/6660897/story.html#ixzz1vqoPRs00
@ Carol Prest,
You have made some excellent points here. Might I add too that Dr. Rubin is definitely in a situation of Conflict of Interest. If he is not removed from the CIHR “expert” panel because of this overt bias, many will lose faith in the scientific process in Canada. Conflict of interest in not only a financial bias, but also touches on Personal, Professional and Prejudicial biases.
Obviously, Dr. Rubin has unveiled his true colours in this. If Dr. Alain Beaudet does not react to this, he will lose the respect of the CCSVI Advocacy community, a respect that is barely hanging on a thread anyway.
I think that this committee (the CIHR expert committee) needs a little “pruning” down because I can name a few other members and give quotes that were provided to media sources that are clearly anti-Zamboni.
Patient involvement has shown to be necessary as well. There should be a couple of additions to the committee for this reason. Maybe the president of the National CCSVI Society (a newly recognized Canadian charity), for example. And then to offset the bias we of course would need Dr. Sandy McDonald and Dr. Mark Haacke on this committee, not to mention at least one or two of the Canadian doctors who have undergone CCSVI treatment themselves.
These are just a few of my thoughts on this matter.
Many interesting comments about the article in which Dr. Rubin was a coauthor.
I don’t think the inflammatory nature with which Dr. Rubin and his coauthors expressed their opinions about CCSVI is helpful.
However, do I think he has a conflict of interest? Actually – no. Dr. Rubin is a vascular surgeon. If subsequent studies establish that the benefits of treatment of CCSVI outweigh the risks, then vascular surgeons and interventional radiologists actually stand to GAIN from CCSVI treatment. So, I don’t see the conflict of interest.
Having strong opinions should not, in my opinion, preclude someone from being on an expert panel. Many folks on the pro-CCSVI side have argued that people like Sandy McDonald should be on the panel. I suspect Dr. McDonald holds positive views about CCSVI that are just as strong as Dr. Rubin’s negative views.
So, I have no problems with members of the Expert Panel holding strong views, as long as they are open minded about considering new evidence as it comes up. This applies to people on both sides of the CCSVI debate. However, I do think it is important that the CIHR expert panel membership include individuals with a variety of views about CCSVI, who commit to being open minded about the evidence as it arises.
Thanks for your response Andreas,
What I think most CCSVI advocates find offensive is that they intentionally excluded Dr. Sandy McDonald from the CIHR CCSVI committee. In my opinion Dr. McDonald has always had an open mind and took the time and energy to meet with Dr. Zamboni and learn the proper protocol before he spoke publicly about CCSVI. He observed the results of 7 procedures done in his clinic and followed the patients to learn for himself before he formed his opinion.
Unlike Dr. Rubin who came out of the blue speaking out against CCSVI from the get go. Had Dr. Rubin at least made a minimal effort to engage himself with doctors and conferences specific to CCSVI testing and treatment, then I think most of us would be more forgiving to his bold public statements. Yet this doctor who has very strong opinions is allowed to make decisions from the sidelines.
Something seems amiss to me. Why is the CIHR so afraid to have committee members that are engaged in testing and treatment and support further studies so both sides can be presented in a balanced manner. Yet Alain Beaudet ensured that the committee to determine the fate of CCSVI testing and treatment had a very strong group who are negative to CCSVI. Dr. Rubin protests to much with no scientific evidence to support his opinion and therefore the optics present themselves in such a way that he may have an agenda that will not be in the best interests of MS patients and I will say again that he has shown a public display of disrespect for his fellow peers that are interested in the truth and science relating to CCSVI. Even if there is an appearance of conflict of interest (his negative opinion of CCSVI prior to clinical trials that he apparently approved), he should remove himself from this committee. I suspect all this negative action will be a contributing factor to have an excuse to stop clinical trials before they ever get started.
You stated, “However, do I think he has a conflict of interest? Actually – no. Dr. Rubin is a vascular surgeon. If subsequent studies establish that the benefits of treatment of CCSVI outweigh the risks, then vascular surgeons and interventional radiologists actually stand to GAIN from CCSVI treatment. So, I don’t see the conflict of interest.”
This actually raises many red flags for me. Why wouldn’t a vascular surgeon be more open minded about CCSVI? Why would a vascular surgeon compare this to faith healing? Why does a vascular surgeon come across in a negative light in regards to CCSVI? What’s going on here?
I would think that a doctor, in this specialty area, would be very interested in CCSVI. If nothing else, for your own curiosity.
Something is not right here.
Hi Anna. In my opinion, the fact that Dr. Rubin is negative about CCSVI doesn’t mean he isn’t interested in CCSVI – it think it more likely means that he hasn’t found the studies of CCSVI convincing. People may disagree with him on that, but not being convinced by evidence doesn’t mean a lack of interest. Andreas
Andreas, just to clarify, Dr. McDonasld was excluded from CIHR panels BECAUSE of his potentially pro- CCSVI views, so to be fair, those with decidedly anti-CCSVI views should also be excluded.
“The third-rate mind is only happy when it is thinking with the majority. The second-rate mind is only happy when it is thinking with the minority. The first-rate mind is only happy when it is thinking.”
— A. A. Milne
Andreas, some years back, while employed with a different federal branch with a much simpler conflict of interest guideline, there were 3 main clauses an employee had to meet. After developing a new product with 100% of my own time and funds, I thought I would get pro-active and get in writing that there would be no conflict of interest if I were to sell it afterhours. The reply was a complete surprise to both me and my colleagues. They concluded that the “IDEA” of the product occurred while at work, thus was a conflict of interest even though this was not stated in the guidelines. Additionally, they would need one working prototype with all drawings and notes and I would be forbidden to sell it at anytime while employed with the government. Needless to say, it was time for a career change.
Here, there are multiple non-compliances by Dr. Rubin to the CIHRs published conflict of interest guidelines, yet you dismiss them all. Oh my, how things have changed!
Hi David. Which of the CIHR’s conflict of interest guidelines is Dr. Rubin not in complaince with?
Of course, its not for me to judge, but here is my main concern.
With regards to Mr. Rubin being one of four authors on an article, ‘The “Liberation Procedure” for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand’, in the May, 2012 Journal of the American College of Radiology, Volume 9, Issue 5 and to;
Conflict of Interest and Confidentiality Agreement for Members of Peer/Merit Review Committees (http://www.cihr-irsc.gc.ca/e/documents/committee_member_coic_form_e.pdf)
I can see the following areas where a member’s conflict of interest could be determined:
“A. Conflict of Interest: A conflict of interest is a conflict between a person’s duties and responsibilities with regard to the review process, and that person’s private, professional, business or public interests.”
2) LACK OF DISCLOSURE
Any otherwise eligible reviewer may attend a review committee unless he/she:
(i) has disclosed a potential conflict of interest in regard to the competition to be reviewed, and has been determined to be in conflict of interest in regard to the competition by CIHR’s Chief Financial Officer (CFO) or his/her delegate.
3) SCIENTIFIC DIFFERENCES
No committee member with a conflict of interest may participate in any part of the review of an application. A committee member is considered to have a conflict of interest with an application if he/she: • has had long-standing scientific or personal differences with the applicant.
When I mentioned “Oh my, how things have changed” I’m comparing to a completely different department’s policy about 20 years ago, but I’m referring to 2) above. There used to be encouragement for employees to disclose anything that could be potential conflict of interest. However here, there is absolutely NO incentive – especially when the outcome means dismissal from a review committee.
From page 2 – another area of concern:
4) LACK OF OBJECTIVITY
A committee member is considered to have a conflict of interest with an application if he/she: ” for some other reason feels that he/she cannot provide an objective review of the application.
Fabulous explanation, is there such a small video for beast cancer treatment options?
thanks! I am not aware of such a video for breast cancer treatment options. MIke Evans who helped me with this one (more than “helped” – it wouldn’t have happened without him) has done a video of similar format on the beneficial effects of moderate exercise (google “23.5 hours”) and one on concussions in hockey. i’ll ask him about breast cancer treatment options.
Hi Dr. Laupacis,
Do you know anything about the drug Prokarin?
It is hard to find Prokarin. I’m still trying to find a drug store that has it, or could get it. I think it sounds like it would be beneficial for MS. I learned that it is a cream applied to the skin, measured on a patch like nitropaste.
I noticed that a CCSVI trial: http://clinicaltrials.gov/show/NCT01089686 in the US has been terminated. Do you have any further information as to why the trial was terminated by the FDA
Hi. I noticed the same thing. It looks to me like the study was stopped after randomizing 2 people. I don’t know why. Andreas
It was on the news that the FDA stopped the study do to the risks. Strokes and deaths were mentioned. It was just a short news brief. I am sure that there will be more in depth info to follow
Here is the link to the FDA’s notice.
Correct me if I’m wrong, but I thought that all trials listed on clinicaltrials.gov site had their trial protocols approved by an IRB. It seems that the sponsor’s trial lacked this approval. Also, does the FDA’s recent statements regarding CCSVI have anything to do with this warning? The timing is rather close.
I checked with a friend of mine who knows a lot about clinicaltrials.gov and he indicated that randomized trials do NOT have to be approved by a Research Ethics Board before being posted on http://www.clinicaltrials.gov
I got the feeling that one of the things that upset the FDA about Dr Mehta’s study is that he hadn’t received permission from the FDA to do the trial . Because doing a venoplasty and possibly inserting a stent into the jugular and azygos veins isn’t an approved indication, the FDA feels that they need to approve this experimental use of the technologies. Since these technologies have been used for many years in many veins and arteries, I personally am not convinced that this makes a lot of sense, although the FDA is technically correct that use in the jugulars and azygos isn’t an approved indication. I am not sure what Health Canada’s views about this are.
I was also struck by the timing of the two releases from the FDA. I suspect they are using the Mehta example to remind people that venoplasty and stenting of the jugular and azygos veins can occasionally lead to serious complications, which is obviously true. I didn’t see any new information about the frequency of such complications in the FDA’s statement. Let me know if you did.
Thank you for your response to my comment Dr. Laupacis. I hope you don’t mind, but I sent an email to the people who run the clinicaltrials.gov site asking that since they do not require randomized clinical trials to be approved by a Research Ethics Board before being posted on their site, what can I do to ensure that my safety and rights as a trial participant are protected? This was their response:
“If an interventional trial is recruiting on our site, then it needs to be approved by a Research Ethics Board.”
I speculate that the FDA’s response to Dr. Mehta’s trial is due to the stricter stance they have taken towards the oversight of medical devices since being criticized by the Institute of Medicine for being too lax. Anyway, thanks for running this very informative blog. You have cleared up many misconceptions about CCSVI that I have come across on other sites.
The issue with Mehta is that he started his trial without IRB approval and permission to use devices for off-label applications. He just did not do the requisite paperwork.
i disagree with you profoundly when you characterize Institute Review Board approval as “paper work”. IRBs are an extremely important mechanism for trying to ensure that research is done in a manner that does not put patients at undue risk. Not submitting a research project to an IRB is not a minor oversight.
Sorry if I left the wrong impression. In this case, I was not at all upset at the FDA’a action, I felt that they did what they were supposed to do. I totallly fault Dr. Mehta for not going through the proper procedures, which of course includes the necessary “paperwork”.
ie: obtaining IRB approval.
Do you have any comments on the following?:
I also find finders fees problematic. I have been a researcher for over 25 years and have never received one, and actually have never been approached by a drug company to receive one. I am almost certain that the Research Ethics Board at St. Michael’s Hospital in Toronto where I work would not approve a study if there was a finders fee associated with the research.
This is different from paying a researcher for the time it takes him or her to evaluate a participant in a study – it is reasonable to pay for this time, just like it is reasonable to pay a radiologist or surgeon for the time taken to do a venoplasty for CCSVI.
In my opinion, the fact that some neurologists are involved with trials of drug therapy for MS does not mean that they would ignore convincing evidence that venoplasty is effective – there are lots of examples in medicine of physicians from different specialties contributing their expertise to the management of patients (such as neurologists and neurosurgeons/vascular surgeons working together in the care of people with strokes or mini strokes).
On Friday I was told by a journalist from a prominent American newspaper that she was approached by a public relations firm hired by a venoplasty clinic in the USA, in the hopes that she would write about CCSVI. I would assume that this is an attempt to increase the number of people with MS coming to their clinic. Is this substantially different from the use of finders fees that you mention? I think not.
If CCSVI treatment were to be done in Canada, MS patients wouldn’t be targets for such exploitation. Also, drug companies (and possibly our government – we are very suspicious), people who make mobility and other equiptment as needed, people who sell this equiptment, people who work in the top positions at the MS society (especially the president who makes over $250 000 anually), MS researchers/neurologists, physiotherapists, occupational therapists people involved in home care, and related work, are all making money because of us. So, if we seem really peeved, or as some prefer to say “hysterical”; it’s no wonder.
If CCSVI were to become routine care for MS/CCSVI treatment, and offered to patients upon diagnosis, money would be kept in the country, and perhaps MS patients wouldn’t be as much of an expense.
I’m very impressed by the material and comments on this site, particularly because this issue is so sensitive and controversial. Dignified debate is the best way of dealing with such situations.
In the hope that it may be of some interest, some commentators may be interested to visit http://www.testingtreatments.org, where a book written for the public is freely downloadable. Please let us have your comments and criticisms on the book.
We try to explain in the book that some treatments have really dramatic effects in everyone that receives them, while others are less universally effective and need careful evaluation. Fair tests in these circumstances need to make sure that similar patients are being compared and this will often require random allocation. In the case of CCSVI this would mean that if some people were allocated to venoplasty and others to usual care – and the results of the comparison showed a clear advantage for the venoplasty group, the usual care group could then be offer the procedure. Reliable evidence that venoplasty is helpful for a substantial proportion of people with MS will help to make the case for funding the procedure.
Please have a look at this site and share with “relevant” doctors.
This is a new online forum from Accelerated Cure. A place to share research, publications and create dialogue across disciplines. Their mission states that they want to:
“Foster communication and collaboration, especially among people in different disciplines who would benefit from knowing about one another’s work, but who do not encounter it in their normal activities.”
This is from CCSVI in Multiple Sclerosis.
Further to your comment re: Hoping double-blind study results being available soon; are they really that important? We ourselves, our families and friends, and in a lot of cases, our physicians have had and have our eyes wide open to the befores and afters of CCSVI treatment. This, as you are well aware, is a surgical procedure and not a drug. Would double-blind angioplasty for CCSVI even be ethical? You have previously commented that sometimes double-blind studies have not been required of surgical procedures that exhibit dramatic results. It can be and is argued that results from CCSVI treatment are quite often dramatic. So, is it really prudent to hold back CCSVI treatment for the sake of double-blind trials? And, you have also stated that safety studies of CCSVI treatment are not necessary.
You are right – some surgical interventions that are now routine have never been subjected to randomized trials – the one that comes most vividly to mind for me is total hip replacement for people with bad hip arthritis. In that case the benefits of hip replacement were felt to be so dramatic that a randomized trial wasn’t needed.
I agree with you that some of the reports of improvement after venoplasty have been dramatic. At the same time, I don’t think we are hearing from as many of the folks who didn’t get an improvement after treatment. And in Zamboni’s uncontrolled small study of treatment, he didn’t find much of an improvement in people with different types of MS, So, I do think that randomized trials of venoplasty for CCSVI are ethical. As a researcher, I hope that the randomized trials are well done, and the results are definitive (ie clearly positive or clearly negative), so we can stop arguing about how beneficial the procedure is. As a physician and Canadian, I hope that the results are clearly positive, so people with MS have an established treatment that they can try if they want.
Hi Dr. Laupacis,
Thank you for your response of April 6; there are some questions inherent here. First of all, who decides what constitutes dramatic? To MS patients and their families, just stopping disease progression is great. Second, just that some people have moderate – dramatic results to some remaining apparently unchanged, is significant isn’t it? The people who feel that they didn’t have good results aren’t lessening the good results or the number of people who had them. Who decides percentages/numbers?
I agree that if treatment of CCSVI is convincingly shown to decrease disease progression, that would be important. I also agree that if some people respond to treatment, that response is important to them, even if others don’t respond.
Having said that, when people are contemplating whether or not they want to try a therapy, it is important that they be told what their likelihood of response and serious side-effects are.
To use an example from cancer, if a person with cancer is contemplating whether to take a new chemotherapy drug, it is important to know what proportion of people like her/him get a benefit, what proportion get no benefit, and what proportion suffer side-effects (and what those benefits and side-effects are).
Same story for a new drug for MS – what proportion of people respond, what proportion get no benefit, and what proportion get side-effects?
I don’t think treatment for CCSVI should be considered any differently.
As per your comment to J. Butcher I have a few questions / comments. You state: “In that case the benefits of hip replacement were felt to be so dramatic that a randomized trial wasn’t needed.”
1. If even one hip replacement was done without knowing the benefits, how than could this procedure be considered ethical ? Do you have a link to an article in a peer-reviewed journal to support this claim ? What if only the positive outcomes of this were reported ?
2. You quote from Zamboni’s orignial study, but we have come so far since then. There is a big difference between 65 patients in a pilot study, and the number of studies that have been published since then. If we are to stop “arguing about the benefits of Zamboni’s original study” maybe it would be a good idea to stop quoting from it as much research has been done since then ! This is more of an observation than a question !
I honestly don’t know whether the first people who got hip replacements many years ago were informed that they were essentially being experimented on, and had to sign informed consent forms.
I agree that there are more non-controlled, non-randomized trials than Zamboni’s – they are mentioned in our report to the CIHR. However, lots of poor quality research does not magically turn into good quality research.
Dr. Laupacis, your comment to Christopher is rather interesting in that you seem to lump all the studies done since Dr. Zamboni’s study in the poor quality research. I would agree that some studies have, indeed, been poor quality and the first one that comes to mind is the German study by Doepp. However, does “poor quality” include, for example, the Mandato et al study on the safety of angioplasty in treating CCSVI or the studies Simka et al have done on the results of CCSVI treatment?
I think the entire discussion gets mired down in maintaining the link between CCSVI and MS. CCSVI is a vascular condition and whether or not a person has MS, the person should be able to be tested and treated for this vascular condition in Canada. Instead, we have to wait for 5 to 10 years to see if treating CCSVI is beneficial for people with MS. Good blood flow is essential to good health. If there is a problem with that blood flow then the problem should be fixed.
Hi Linda. In my response to Chris, I was talking about studies of the benefits of treatment (since that’s what I thought he was referring to). I do think those studies are poor quality, since they weren’t randomized and have no non-treated control group.
I think Mandato’s study provides very useful information about the short-term risks of treatment for CCSVI, and along with other similar studies, suggests that treatment has only a small risk of serious side-effects.
You and I differ in our interpretation of what we know about CCSVI – as I understand it, the venous anatomy is very variable from person to person, so I do think it is reasonable to expect consistent results from the studies examining CCSVI in people with and without MS, before we conclude that CCSVI has an important role to play in the symptoms of MS.
Dear Dr. Laupacis, I feel very neglected, not just by the Canadian Medical System, the Canadian government, the MS Society of Canada, and other groups that pretend to care about the well-being of people with MS, but by you for not posting any response to my comment of Mar. 28, 2012 and seeing responses to others after that date.
I haven’t had a response from the MSSC either so they’ll be hearing from me again, too.
Hi Lori. Sorry about the delay in responding – I have been working in the hospital these past three weeks, so it has been busier than usual.
I don’t think I have anything to add to what I have said on this site before. I think randomized trials of venoplasty are needed and I hope the results are available soon and are definitive.
You are right that some surgical treatments are offered to patients without the results of randomized trials being available. I think CCSVI is different because there is still so much controversy about the role that venous abnormalities play in the cause and symptoms of MS.
Finally – just to be clear – I have no decision making role in this controversy.
Andreas, are we getting anywhere with this process? It seems like a lot about nothing but actually should be a lot about something ( that being people’s health & lives) I’m not sure how many bills Kirsty will have to introduce or valid results this will take but wish someone would take action NOW not in five years from now. We’ve been sent to the wrong Doctors and had the wrong tests for too many years, It has to stop!!
hope you’re having a good day:-)
This is an email I sent to the MS Society of Canada and I feel the same logic applies for you:
Shouldn’t the MSSC at least be advocating approval for venous angioplasty from Health Canada under the Special Access Program that allows practitioners to request access to procedures or drugs that are currently not otherwise approved for use in Canada? As the Health Canada web site notes: “This access is limited to patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable, or are unavailable.” I know PPMS meets those requirements. The Society has strong affiliations with many practitioners and many health care facilities.I know “enhancing quality of life” is part of your mission statement so this seems like the perfect opportunity to press for something to help those with PPMS.
The WMA Declaration of Helsinki, section 35, states: “In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.”–so this would be enhancing research as well–another part of your mission statement.
I KNOW you can appreciate the URGENCY for people with PPMS and with this evidence, http://www.sirweb.org/news/newsPDF/Release_49_Ferral_MS_final.pdf : “Endovascular treatment of CCSVI can produce significant, short-term improvement in physical and mental health-related QOL. However, improvement occurred less often in SPMS than in RRMS and PPMS, and less often in patients with >10 yrs since MS diagnosis. A prospective randomized trial is needed to rigorously evaluate the role of endovascular CCSVI treatment in MS and to understand the implications of the present study in terms of patient selection.”
I ASSUME YOU WILL BE PROCEEDING IMMEDIATELY TO USE YOUR INFLUENCE TO MAKE THIS TREATMENT AVAILABLE IMMEDIATELY FOR PEOPLE WITH PPMS.
Dearest Dr. L,
You said that the Canadian medical system would entertain studies that have been conducted throughout the world. I have finally found one as my memory skills are not up to par.
Thanks Jennifer. Please see my reply to Judy below. Andreas
Have you seen these open letters by Dr. Lorne Brandes re: study that supports Dr. Zamboni’s CCSVI theory for one?
And, a very true letter to the Federal Health Minister
Have you seen this article re: efficacy and safety of venous angioplasty for CCSVI? http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/2944
Hi Judy. I assume you are referring to the study by Dr. Sekhar from Albany, New York, which he presented as an abstract at a recent meeting.
It suggests the same promising results (although Dr. Sekhar treated more patients than Dr. Zamboni), and suffers from the same deficiencies (no control group, not a randomized trial), as Dr. Zamboni’s study. As Dr. Sekhar’s abstract says “A prospective randomized trial is needed to rigorously evaluate the role of endovascular CCSVI treatment…”. I sure hope one is completed soon.
I know that you take exception to suggesting that death could result due to not having CCSVI treatment. However, the International Union of Phlebologists have classified CCSVI as “a truncular, venous malformation preceding MS lesion”. So, taking this into account, if a lesion/lesions develop in the area of your brain that is responsible for your heart beating, or for your ability to breath for example; isn,t it true that death could occur due to not having CCSVI treatment?
I am aware of no evidence whatsoever that CCSVI causes death or that its treatment prevents death. Are you?
We know that approximately 400 Canadians succumb to MS each year (not including the ones who commit suicide). What do you think happens when say a large enough plaque, or even a number of plaques form on the part of the brain responsible for breathing or for making the heart muscle perform it’s function? CCSVI precedes MS plaque. Many physicians say that CCSVI is like having a “slow stroke”, and they refer to CCSVI as Venous Hypertension. I had my first ever good MRI showing no active lesion activity, and my condition has improved quite a lot since CCSVI treatment. There have been more positive CCSVI studies than negative CCSVI studies. Please refer to Kirsty Duncan’s response letter to the Health Minister that I sent you a copy of. I will e-mail it to you again.
Dear Dr. Laupacis
I just watched the CCSVI and MS video and can’t begin to tell you how discouraged and disappointed I am. Since when did someone involved in analyzing research take a stack of research papers and when they have a 100% at one end and a 0% at the other end discount the 100% but accept the 0%? Could it be the person doing the analyzing wants the result to be skewed towards the 0%? I could pick apart the rest of the video but it isn’t worth bothering. I have watched most of Dr. Mike’s videos and now find myself questioning whether they are all as poorly researched as this one. I doubt if I will bother watching anymore of his videos.
I know CCSVI personally because my husband was treated on Jan.15, 2011. When we came home he followed his IR’s instructions to the letter. He started physiotherapy as soon as he could and has continued to do the exercises every morning. He started eating smarter to improve his vein and brain health. On Jan. 26, 2012 we spent the day downhill skiing. He has not skied for 18 years. He used to be too fatigued, his balance was too poor, his right side too weak.
Obviously, we do not regret heading south to have his CCSVI treated. His CCSVI symptoms have improved dramatically. Every day that I look at his face and see his normal, pink complexion I know we did the right thing.
We don’t know what is going on with his MS. Because he has never been a candidate for any of the drugs he had one MRI in 30 years. Although he goes to an MS clinic every year he does not receive a full neurological exam. He receives a 5-10 minute pep talk. We sent his pre-CCSVI treatment MRI to his neuro and although his neuro acknowledged he believes there is something to CCSVI he didn’t order a follow up MRI to see if anything is worse or the same.
I have no faith in the MS Monitoring System because the information will come from the MS Clinics and it will be about the drugs. If you want to know what is really going on with MS patients you need to talk to the family doctors.
Hi Iris. I am sorry you were discouraged and disappointed.
Let me correct one error in your comment above. We absolutely did not “accept the zero”. In fact, we clearly indicated that when all the results were combined, the combined results suggesting that CCSVI is more common in people with MS than in people who do not have MS. However, because of the huge variation in the results of the different studies (as you say – from 100% to 0%), we just don’t feel that we can come to firm conclusions at this point in time. That’s why we say that “we just don’t know”. That’s a very big difference from “accepting the zero”.
What I find discouraging is that some people on the 100% side of this divide accuse us of siding with the 0%, and other folks who are on the 0% of the divide accuse us of siding with the 100%. All we are doing is reporting the results of the studies that have been published to date, which in my opinion don’t support the dogmatism on either side.
I was basing my comments on the video. At about 4:56 the video talks about the results of 10 studies showing CCSVI 13X more likely in people with MS. At about 5:07 the video talks about taking out the 100% study which then shows CCSVI 5X more likely in people with MS. The video never mentions taking out the 0% study. From your comments it sounds as though this was overlooked in the video, but I have no way of knowing that. The video also states that Dr. Zamboni used stents. I have heard him speak several times and he has always spoken against stents. So what is the truth. Did he use stents or not? Please answer that one for me.
If I can’t trust the information on your website, whose information can I trust? You’re the impartial researcher.
I want factual information. I had thought that MacLeans.ca was doing a, OK job of following the CCSVI story until they printed a report that the MS Society of Canada had participated in an information meeting between the Health Minister and MPs and it turned out that information was false. Scratch them off my list of reading material.
Why am I discouraged? What I want is to be able to go somewhere and see information that I can trust. Pro or con. Either side of the divide. I had hoped the video and your website would be part of that somewhere. The video is cute but, sorry, I don’t feel as though it is information I can trust.
On page 1353 of Dr Zamboni’s J Vascular Surgery article he refers to the insertion of a metal stent. I couldn’t tell how many were inserted. I agree not many; but not none.
One reason to exclude Dr. Zamboni’s article is to present a ‘worst case” scenario regarding the association between CCSVI and MS, to address some of the concerns of CCSVI-skeptics. The fact that CCSVI was still found 5 times more frequently in people with MS than controls without Zamboni’s study, means that it wasn’t just Zamboni who found that association. The reason we weren’t convinced that CCSVI is more common in people with MS is the huge variation in results among the 10 studies.
In terms of Dr. Doepp’s study, it in fact was not included in the main analysis. Because he found no CCSVI in anyone (whether they has MS or not), from a statistical point of view his study is treated as if it didn’t provide any information. This is described in our report to the CIHR, but one can only say so much in an 11 minute video (which is already longer than I wanted).
So we wait for the MS Society’s studies.
I am interested in the results of any high quality studies, whether they come from North America or not. Andreas
I still do not understand why the DOEPP study was ever included. It was not a CCSVI study what-so-ever. This keeps coming up and that is not right. How it managed to get published is very suspicious too. If this is how research is done then I see how CCSVI is set up to fail every time. The first Buffalo study February 2010 was the same and you all ran with that as well. This tells me that CCSVI is more certain when false information has to be injected into research.
Iris, I agree with you, completely! I know that my venous angioplasty for CCSVI gave me great improvements in many symptoms that had been attributed to MS. It is incomprehensible to me that Canadians with MS are forbidden to have their blood flow even tested when it has been demonstrated in so many people that proper blood flow can improve and even eliminate symptoms that actually may not be due to MS but are because of a vascular problem. Since I’m s/p with absolutely no treatment available and destined to just deteriorate, I felt my only option was to try this procedure and am I ever glad I did!
I am not an “expert” in meta-analysis but I do have some common sense and I could not see the logic in the cartoon demonstrating that only the “positive” results were thrown out–and even then, with the negatives being included, a demonstration that 5 times as many people with MS have vein abnormalities doesn’t strike them as an unusually high number? I have no faith in the “bean counters”.
I signed up to have the CCSVI treatment in the U.S. and told my family doctor about my intentions. She admitted that she knew nothing about the procedure (other than what she’d seen on TV), but she said she wouldn’t treat me anymore if I had it done.
So now I’ve got no family doctor to talk to about this. I’d tell my neuro (I know my neuro disapproves of the treatment) but I’m afraid I’ll end up without a specialist too.
This is the MS system for some of us: a series of failures until we have no choice but to take things into our own hands. That’s something that no study will ever be able to quantify.
Hi Jane. If you were not confrontational, and you were respectful of your family doctor’s views, and she really said she wouldn’t treat you any more; then that is pretty pathetic. A physician should not “fire” a patient just because the patient does something she disagrees with.
Like how you copied “23 1/2 hours” for this one ???
yes. Mike Evans who was the brains behind 23.5 hours produced the CCSVI video, and the same artist did the drawings. They are both acknowledged at the end. Mike works at St. Michael’s, as do I. Andreas
Dear Dr. Laupacis,
I appreciate your response: “Hi Lori. I agree with you that there isn’t effective treatment for progressive MS. I agree with you that trials of treatment for CCSVI are indicated, and I would include people with progressive MS in those trials.”
I just want to stress the URGENCY felt by people with progressive forms of MS who have ABSOLUTELY NO TREATMENT AVAILABLE. I used to think Canada was the best country in the world but now I am overcome with sadness at the abject lack of compassion displayed by it. We should be doing this procedure NOW on a compassionate basis and using the information obtained as research.
Now I hear that Australia and New Zealand are proceeding with trials and I feel embarrassed that Canada is so far behind.
How very much I appreciated your mightily creative explanation, in cartoon/sketching format.
We know you are between a rock and a hard place.
As a community, we are well aware that the MOH, CIHR, CMA, CMSS and most neurologists are unhealthily biased against us.
Thank you for admitting to healthy skepticism on your part.
May I suggest we negotiate towards a middle ground.
Perhaps an “in the meantime”scenario.
Suggesting we can be followed for bloodwork,venograms and pre and
post regular care.
We, who have our MS stabilized, cannot get our
Chronic Venous Disease looked at.
We are having slow strokes without options.
Thanks again for the brilliant mobile sketch.
Happy St Patricks Day.
Elspeth for Peg
I have participated in two long term clinical drug trials since I was diagnosed with Relapsing/Remitting MS in 1994. These trials are not cheap to run. The drug companies have to pay for all blood work, MRI’s, ECG’s, ultrasounds, produce the medication and probably pay the Neurologists to do Neuro and physical exams. Also there are trial coordinators on site and people at their end collecting the data sent in from each center. For those people who want a non-drug related trial started, they need to know that they are very expensive to run and that the money has to come from somewhere. If the Ministry of Health or taxpayers are going to be the ones to pay for it, they will want the evidence to back up the theories before the jump in. My current drug trial has been going on for the past ten years. I started in at phase 2 and it is now in phase 3. Hopefully it will get approval soon. The nature of the disease is non predicable and proving a treatment is working is even harder to show. With any type of treatment, whether it be drug or an invasive procedure, there is risk involved. It pays to be well informed about all the risks and benefits and whether the cost was worth it.
I respect your opinion but I feel the need to tell you the MAIN reason why the delay in clinical trials is so frustrating, The already proven-safe procedure of venous angioplasty is used regularly–in Canada–for many conditions. It is nothing like an unproven chemical cocktail. Just because it is not normally used to “treat” MS does not mean that it should be forbidden for people with MS. I get so tired of repeating this but CCSVI is a VASCULAR condition. I wasn’t “forbidden” to have gallbladder surgery in Canada just because I have MS so why did I have to go out of the country to have my blood flow corrected–just because I have MS? Everybody should be entitled to proper blood flow!
I understand your frustration. I would not want anyone to be denied a treatment if it is proven to be a necessary action. I had a friend who had Progressive MS and she was told that many different therapies would improve her MS, bee sting therapy, vitamin therapy etc. She tried them all, spent lots of money and guess what, it didn’t work. I learned early in my diagnosis that there are people out there who will take advantage of people in desperate situations. It pays to be cautious sometimes. I think that the delay is in getting all the information together to show that MS patients suffer from a higher incidence of blocked veins then the normal population and that by unblocking the veins that improvements will occur. It is my understanding that they had problems in the beginning reproducing the numbers in imaging that Zamboni found so that made the doctors skeptical. I think that given more time either they will be able to come up with a protocol for imaging, pre treatment and post treatment if in fact the procedure is proven to be beneficial. In some way I feel that the government is trying to protect patients from undergoing unnecessary procedures that can potentially carry a high risk eg.(stroke, embolism, death) if they are not done correctly or have a proper regime to follow. If you look back through medical history you will find that some doctors had great ideas that were proven to work and be beneficial and that there are a lot of others that were proven to be of greater harm. I applaud you for taking a risk and going out of country to have the procedure done and I hope that it will have lasting effects that improved your quality of life. The pressure is on and I hope that they will get the answers they need soon.
I have had tremendous improvements–my balance has returned after 20 years of being gone so combined with the dramatic improvement in the drop-foot in my right leg I can now walk 500 metres, unassisted, compared to requiring mobility aids for any distance outside of my apartment (where I had to hang onto the walls). I have gone from hand-held, sit-down, lukewarm showers, requiring a blast of cold water at the end, to be able to get out of the shower, to now being able to soak in hot baths–not requiring any assistance to get out of the tub–or even having a Jacuzzi!
I used to get headaches with pain behind my left eye every week or two–they might fade a bit with Ibuprofen but would not go away for a day or two. I haven’t had one since treatment (just over a year ago!) There have been other little things that have improved as well and my quality of life has not been this good in 20 years. I know many people who have had the treatment and none of them regret it and all have noticed some improvement.
Respectfully, I resent you comparing this safe, commonly used medical procedure to bee stings or supplements–that seems to be what many naysayers do because they are uninformed about this procedure or willfully try to negate the importance of proper blood flow for “mysterious” reasons. If you are so naive to think the delay is because “It pays to be cautious sometimes” then I have some swamp land to sell you!
If you want to be “cautious”, I respect your choice. The only choice I had was to continue to deteriorate or leave the country to have my blood flow restored. Even my neurologist, who has seen me for 22 years and could do absolutely nothing for me, had to admit after several tests at my first visit since having the procedure, that I am “significantly better”. I made the correct choice.
HEAR, HEAR Lori!
Now that thousands have been treated and 2/3 have had some form of relief I myself being SPMS had a couple of symptoms relieved. Which was HUGE!
I was told back in 1990 there was nothing for me so to go home and deal with it. Now that there is a make sense treatment why would this not be available on a trial basis for those who have basically nothing to lose? I bet thousands would be lining up to try in HOPES for relief of any kind. If you do not want this type of treatment … fine … your choice, not forcing you.
This topic does not belong to the MS Societies. That is where the problem is. These MS neuros do admit they know nothing about CCSVI, call it junk science, hoax and unproven that’s fine. So what is stopping them for referring us the proper experts? Lost revenue? Been busted on their unproven EAE theories and ineffective therapies? Can’t be nothing else.
“Safety for us?” That is a joke. These scripted comments are just so lame in the scheme of things.
March 14, 2012
Just a FEW of quick questions:
How many angioplasties do you know of that have had double blinded, randomized controlled trials?
Do you believe the Liberation Treatment is safe? If not, why not.
I have had the Liberation Treatment. I know how safe it is, and how simple and painless it was. Given (for the moment) that the Liberation Treatment is far safer than MS drugs that have been approved for use in Canada, why cannot trials be done at the same time as actual procedures are carried on? AT LEAST ON A COMPASSIONATE BASIS?
WHAT ARE INSTITUTIONAL MS NEUROLOGISTS AFRAID OF?
Hi Tom. Sorry about the delay in responding.
There sure aren’t as many randomized controlled trials (RCTs) of angioplasty, stents or vascular surgery as there are of drugs, but there are some – for example RCTs of cardiac stents, cardiac angioplasty and coronary artery bypass surgery. In the area of stroke prevention – randomized trials of carotid endarterectomy and endovascular treatment of cartoid stenosis. I think we need more RCTs of surgical interventions, not less. That’s why I support doing RCTs of endovascular treatment of CCSVI.
As I have said before in the comments section, our review of the literature found that the frequency of serious complications at the time of, or right after, venoplasty was about 1-2/100 (1 to 2%). Thus, I agree that venoplasty doesn’t carry a high immediate risk of complications. Unfortunately, we don’t have a good idea about the frequency of serious side effects during the days to weeks after the procedure – we do know that some major complications have been reported, including death.
Just a bit of a personal note.
I have been raised to appreciate doctors from the very beginning. I was born and raised on a farm in southern Alberta. Yet I had the care of one of the best physicians in the country, an escapee from Britain’s socialized healthcare system. Andrew Whitfield Little was his name. He gave me a tiny chessboard he had actually carried to the fields of France on D-Day. A wonderful present for a “kid”.
His two boys, James and George, were my playmates through many wonderful summers, and our families were companions on vacation trips. His wife Eileen (an RN) bought “half of the Jersey cow named Elsie”, and shared the ownership of Elsie with my mother. Eileen was a nurse by training, but unfortunately not a milkmaid! She died of a heart attack well before her time.
Andrew made house calls in the country. He had to ride horses out west of Nanton to get to some of his patients. (Remember, this was a physician from London, England who really did not know one end of a horse from another) He diagnosed my appendicitis in my bedroom, then operated on me in the hospital the same day. He taught me how to take my very first pill (penicillin, I believe) whilst sitting on the edge of my grandmother’s bed. He had to take three pills himself before I firmed up my courage. I still remember that very clearly.
Dr. Little epitomized the knowledgeable, moral and caring doctor. He made it okay for this little kid to take those first deep breaths of ice cold ether. He made me feel safe and secure. He lived his oath.
Where is Dr. Little now when I really need him the most, at the other end of my journey through life? I have used Dr. Little as a yardstick with which to measure his successors in my life. An idyllic comparison? I would like to think not. “But….?
Thanks for sharing this Tom. The practice of medicine has changed since the days of Dr. Little, as have many other professions, including the lives of the farmers who he used to visit. Although today’s doctors don’t have the breadth of skills he did, there are still many who “live their oath”. (And some who do not. However, I think that was also true of some of Dr. Little’s colleagues).
Re: MS, CCSVI, the Liberation Treatment……….
There is much to say, and to be said, about the use of venous angioplasty to treat the symptoms of MS. In my mind, there is overwhelming evidence that at the very least trials should immediately begin in Canada – stage 3 trials, that is. But so much for my mind. I am curious about yours.
From what I have read and been told, you are a willing listener. This is a good thing, because I have a lot to say – at least until you cannot stand for it anymore. lol But I would very much appreciate your opinion.
In my opinion, the present MS/CCSVI situation in Canada regarding the above speaks much more to the accidents of history than to medical science. So for the moment let me approach this problem in this way instead of playing “my research documents” against “your research documents”.
To begin with let us assume that Liberation Therapy is both safe and effective, and that the risk of “harm” pales in comparison to the possibility of “good”. If this is true, then why is good not being done?
Simply put, social constructionism. Political and economic determinism, to be a bit more precise.
Establishing the MS Troika: MS doctors – MS Pharmaceutical companies – MS Societies
Up until the 1950s the vascular theory of MS prevailed. But since then a model of MS as the result of a dysfunctional immune system has taken hold, to the extent that today dissenting voices are accused of heresy. How did this come about?
In 1952, Jean Delay (1907–1987) was the first psychiatrist to recognize the therapeutic value of chlorpromazine in the treatment of schizophrenia. A whole new world of brain changing pharmaceuticals opened up. It might not be perfect, it may have been like “working on a Switch watch with a sledgehammer”, but it was a lot better than being told to “go home and hope for the best”.
Coincidentally, the pharmaceutical industry really got underway in earnest in the 1950s, due to the development of systematic scientific approaches, increased understanding of human biology, and the implementation of sophisticated manufacturing techniques.
It was a match made in Heaven. A medical vacuum to be filled. Doctors could prove that drugs could affect neurological conditions. Drug companies learned they could mass produce these drugs, and market them to all the great unwashed that could afford them. A stock promoter’s wildest dream come true.
MS patients certainly needed help. MS doctors very much wanted to help these patients – to at least have something to give them. Pharmaceutical companies wove stories about journeys to a promised land. It was a whole new world open to possibility. Not to mention legalized snake oil.
The Canadian MS Society had got started in 1948, and started funding research in 1949. It was a good fit, along with doctors and drug companies, to bring new hope to people whose bodies had been taken over by the most evil of spirits. The MS Society did much good, and still does. But it is has rather overreached itself, becoming more caretaker to MS patients than caregiver.
Hey, there was money to be made. Careers to be built. Research to be done. Doctors, drug companies, and MS Societies had common cause – helping MS patients – so it was natural and normal that they should both cooperate and collaborate. There was nothing evil or sinister about all this; there was no “conspiracy”. There did not have to be. It was simply the market behaving the way markets do. And I am pretty sure all the actors were acting in good conscience, although after watching such programs as The Fifth Estate on OxyCcontin I begin to wonder.
So now, here we are in 2012. The MS troika has built up tremendous momentum, having spent millions of man hours and billions of dollars building up its head of steam. But what does it really have to show for itself? Nobody still knows what causes MS. There are a few marginally useful pharmaceutical treatments available for relapsing-remitting forms of the disease, but patients with primary progressive MS continue to have nothing at all. What’s been going on?
Well, a lot of people have been receiving a pretty good income from the avails of the MS malady. MS has made many people rich. Really rich. And they want to stay that way.
One of the things that has made this possible is the introduction of an interlocutor between the troika and the MS patient. The government, which is the tool used to redistribute income from the likes of you to the likes of me. Governments control the application of universal healthcare. When it’s good, it’s very very good, but even at the best of times it is a dictatorship – a benign dictatorship, to be sure, but a dictatorship nonetheless.
Governments come and go, but the bureaucracies they depend on for advice go on forever. This is particularly true in the field of healthcare. Politicians are loathe to disagree with their medical “experts”. After all, they need someone to blame if things start to go south.
With governments who ration healthcare behind them, the MS troika erected barriers that for all practical purposes eliminated competition from any entity that did not toe their line. MS creates a way of life for the people that have it. It also creates a way of life for some that don’t. This has been going on for so long now that most of the people involved cannot remember a time when things were different. Received wisdom has crowded out a past that does not fit the official truth.
Companies with MS drugs have billions of dollars to send downstream towards institutional research at hospitals and universities, and to generally support a priesthood that promotes MS autoimmune theology. The troika is much more addicted to MS drugs than are lab rat patients. As a matter of fact, many patients often just give up their medications because they work so poorly and have such toxic side effects.
Simply put, the MS troika is deeply invested in the MS status quo. God forbid that someone – anyone – should dare to rock the boat.
The Real MS/CCSVI Problem
What nobody seems to want to say, or admit to, is that the argument over MS and CCSVI really comes down to is what most arguments are about – der wille zur macht – the will to power.
In Canada there are a number of weak, marginalized, and mostly dependent people pitted against well established and entrenched organizations and other people who have nothing to win and everything to lose if CCSVI treatment proves to be useful. This of course is not a fair fight, but then again life itself is not fair.
Healthcare mandarins in hospitals, universities, and the civil service have built their own fiefdoms. Quite naturally the architecture serves its architects, and ways of thinking begin to take on a self perpetuating life of their own. Power is derived by being able to best articulate whatever is the predominate faith, and power is kept by reinforcing the status quo.
You may not agree with me, but I believe doctors are among the most powerful people in the world. They are the most trusted people in the world. And the vast, vast majority of them use their power for the good of humanity. Even after all my experience from the wrong end of healthcare, I have never had a doctor who I have not admired. You are a breed apart, and I don’t think a lot of people actually understand the nature of the burden you bear.
That being said, there are some doctors who have chosen to channel their power through institutions rather than people, and are who they are more do to der wille zur macht than any pretentions to medical brilliance. My guess is that you know some. But you will never say so, as you practice the doctor’s version of omerta, as do all your colleagues. (And you know, I can’t blame you. I would probably do the same. I can’t say it’s right – but I think I understand, at least a little bit.)
These “power doctors” are the “go to” guys when media (or the politicians of the moment) want an “expert” opinion. These doctors often wield an unearned significance in the various Associations and Colleges to which you belong. They are granted a social prestige that becomes very hard to question. Unfortunately it is to these doctors that politicians turn to when developing Medicare policy.
With the help of government, the MS troika has succeeded in the effective prohibition of vascular surgery for MS patients. So far, they have even prevented trials from starting. People with power do not like to let it go. Patient centred medicine? Why, how quaint.
Stage Three Trials Around the World
Despite the fact that tens of thousands of people with MS have been treated for CCSVI by certified doctors in clinics all over the world, the troika is holding out for Stage One trials. They are forcing people in pain to risk life, limb, and pocketbook to travel outside of Canada for a chance to relieve their pain. Members of the troika know that the prohibition of CCSVI treatment is doing harm – but they persist. It’s a pity that “First, do no harm” is not part of your oath. It should be.
South of the border, down America way, skilled and principled doctors perform hundreds (if not thousands) of liberation Treatments every day. As Dr. Sandy McDonald might say “Are they all looking at things that don’t exist”?
Is there some strange reason that Canadian MS patients can go there, get treated, and come back feeling better? To me, there is admittedly a larger placebo effect than most CCSVI enthusiasts are willing to countenance. However, there are too many people, feeling too much better, for too long, for CCSVI treatment not to be one of the ingredients of the MS stew.
Canadian doctors are just the same as American doctors. No better, no worse. Canadian doctors cannot make a claim to omniscience that their American cousins do not have. The difference between doctors in Canada and the U.S. is not medical science, but the vagaries of social construction.
Tiers and Tears
Canadians have chosen, wisely or not, for a one tier, one payer, system of medical services delivery. This model tends to centralize decision making, and leaves regulatory power in the hands of a relatively few people with wide spans of control. All too often regulators are coopted by the interests of the regulated. Human Nature 101.
Americans have chosen, wisely or not, for a two tier system in which the medical marketplace is very much in evidence. This model tends to decentralize control and allows the American medical consumer a greater number of choices than he/she would have in Canada – but at a price.
“Institutional” MS doctors in the U.S. have responded to CCSVI treatment in much the same way as their counterparts in Canada. The difference is that these American MS doctors cannot control the medical message the way they can in Canada. That is because American doctors in private clinics are not under somebody’s thumb.
When Dr. Zamboni announced his research findings, did the Canadian MS medical establishment say “You know, there is a new theory out there that sounds interesting. But we need to do a little bit of our own research before we can say we can or should make the Liberation Treatment available in Canada. Please have a little patience. We will let you know”?
No, they didn’t. They completely stonewalled, and raised fears about all the damage the Liberation Treatment could do. They could have started trials of their own. Dr. Zamboni was ready to help. Dr. Sandy McDonald was ready to help. But “oh no”, shades of “The Empire Strikes Back” – the drug pushers empire that is. The Liberation Treatment was banned in Canada so fast it made your head spin – even on compassionate grounds.
Tears could not dissuade the Government of Ontario from risking Barb Farrell’s life.
Look it up, if you don’t already know the story.
A Rose is a Rose is a ……… No By Golly, it’s a Drug
A paradigm shift from an autoimmune theory of MS to a vascular theory was not something the Canadian MS establishment was prepared to put up with. Whole empires based on an ongoing MS drug culture were at stake, threatened by a “one-off” minor surgery. OMG no more research grants. Careers threatened. What to do? Well, FUD for short. Spread fear, uncertainty, and doubt. Deny, delay, denigrate.
And make the Liberation Treatment surgery into a drug! Say, that was a good idea. The MS medical establishment knew about drugs, and trials, and that it took years and years and years for these trials to take place. Demand double blinded RCTs. (I get this vision of a blind surgeon working on a blind patient who can’t feel anything.) The fact that the Liberation Treatment usually provides immediate feedback, with no need for worries about long term effects, is of course, completely ignored.
I mean, who can argue with the need for “evidence based medicine”, especially when you get to judge what evidence will consist of? MS medical mandarins sneer about how anecdotal evidence is the least of the least. What that really means is that they just don’t give a damn about what their patients tell them. In law, first person observations (which of course can be suspect) are considered the best proof going. But oh no, the MS mandarins will tell you what you feel, how you feel, and when you feel, and you had better listen, or else.
Surgical interventions proceed on a basis of empirical evidence. You know, good old cause and effect observed thousands and thousands of times, with the same effects from the same causes. Drugs need the trials they do because they do not usually have immediate observable results, have side effects that vary from pain to death, and may have long term effects that nobody will ever know about.
The whole mind set of MS researchers has been built around a model of MS as a slowly progressing disease, that requires slowly progressing pharmaceutical treatments, and that requires slowly progressing trials to be able to observe slowly progressing results. The very idea of a “quick fix” is tantamount to suggesting the bludgeoning of babies in the street.
Who Will Grasp the Nettle?
If it were not for the Internet, most of us would never have heard about a rather distant Italian doctor with a cockamamie theory about MS and veins. Using the Internet, we MS patients are beginning to clump together like matter during the early stages of the universe. But it will take time to develop a coherent voice, let alone ever having the financial resources to take on the troika.
So, what can we do?
Most of us MS patients are dependent on a caring society for our very survival. And our society is caring, which is one reason we are having this conversation. But the truth is, most people do not know even what MS is, let alone how it may be treated. They care in general, but do not know how or why they should care in this particular particular.
MS patients need leverage. We need louder voices to speak up for us. We need help. We have asked those who supposedly should care, and we get a cold shoulder. Or, the typical medical answer, under their breaths “It’s not my problem”.
The only help we have had has come from politicians brave enough to buck their medical mandarins. Imagine politicians becoming more trusted than doctors. It’s happening. But the struggle for a right to CCSVI treatment remains difficult to say the least. We need to enlist the consciences of people such as yourself to shame/convince the MS medical establishment that CCSVI treatment be made available here in Canada under our supposedly superior healthcare system. We need someone to grasp the nettle, and then keep hanging on.
The Man in the Mirror
As a matter of fact, we need somebody just like you.
You can help make a difference. The only question is “Will you”?
Tomorrow morning when you look in the mirror, who will you see? Will you see somebody that knows CCSVI treatment is safe? Will you see somebody who doubts the words of thousands of people? Will you see someone who is distressed by the image of Barb Farrell getting a feeding tube? Will you see somebody who knows how many people Tysabri has killed? Will you see someone who knows that the composition of placebos in clinical trials is determined by the company supplying the drug under trial, and is not reported on?
If you don’t believe me, look it up.
Research and Reporting Methods What’s in Placebos: Who Knows? Analysis of Randomized, Controlled Trials
• Beatrice A. Golomb,
• Laura C. Erickson,
• Sabrina Koperski,
• Deanna Sack,
• Murray Enkin,
• and Jeremy Howick
Ann Intern Med October 19, 2010 153:532-535;
Will you see someone who dares to be an agent of change? Will you see someone who lives his oath? Will you see someone who will “reach out” if necessary in order to advocate for his patient? Will you see someone who knows about Article 35 of the WMA’s Helsinki Agreement?
Will you see someone that cares about the MS patients who cannot go outside the country? Will you see someone who cares that some people are suffering and dying because some of their fellow physicians are guilty of criminal negligence causing death?
Will you help?
Dr. Laupacis, sorry for posting this again, but want to make sure you are aware of this fraudulent behaviour that proves our suspicious of the actions of a few MS Neuro’s that will do anything to silence this major breakthrough of CCSVI.
I am hoping this will be brought to the attention of the CIHR expert scientific group. Luckily this abstract was removed from the AAN conference and the presentation was cancelled… due to the vigilance of CCSVI advocates that noticed the Lead investigator of the Kuwait Clinical trial name was missing on this abstract. When Dr. Sinan was contacted he was not only unaware of this abstract being published but confirmed that the results that this Neurologist stated where in fact not true based on the study results this far. The members of this study are pursuing the AAN to implement disciplinary action against this doctor.
This is why you must be careful in your reviews not only of the positive studies but especially the negative studies. There is an intentional agenda within the Neurology community to derail CCSVI at any cost. How many other studies have been altered to suit the agenda of a handful of very powerful doctors that will never acknowledge the scientific evidence no matter what get’s proven. It is not fair that the level of perfection has been applied to this very simple low risk procedure. It is time to take the Neuro’s out of this equation and let the vascular and IR doctors take ownership of this newly discovered vein disease. The fear mongering and turf war needs to stop now.
I would be interested to know what your comments are on this situation. It would seem to me that the medical community would be appalled at this situation, yet they have remained silent. Situations like this does not give one much confidence about our doctors “Doing No Harm” Please feel free to contact Dr. Sinan directly to verify everything I have written.
Please read – Kuwait CCSVI AAN Abstract – Fraudulent and immoral
Hi Carol. What a mess!
We haven’t included abstracts in our systematic review, because they don’t provide the kinds of details about the studies that readers really need, and because abstracts don’t undergo the scrutiny and checks that full manuscripts do. This example, I think, indicates that we have taken the right approach to abstracts.
I just wanted to let you know that yesterday I had my first visit with my neurologist since my venous angioplasty of March 17/11. He had last seen me March 10/11. After lots of talk and testing, he said some words that I hadn’t heard from him since I was declared secondary/progressive in 1993. “Well, you are significantly better.”
He quickly added “I must say, you are the exception…for my patients that have been going away I haven’t seen people getting better like this…most people say they ‘feel better’…but when I test them, they aren’t walking better, they aren’t stronger…but you’re better! There’s no question.”
My husband said to him “I wasn’t sure at first if you’d be able to tell the difference…” to which the doctor replied “I can tell the difference…obviously you’re walking better…that’s evident, but your strength in your right leg is better than it was the last time.”
He allowed my husband to video record the neurological testing and acknowledged measurable improvements. Of course many of my improvements, like elimination of heat intolerance and no more “MS headaches” aren’t “measurable” but he made a note of them! I know many people have felt improvements that aren’t measurable and I hope they are taken seriously because they really mean a lot!
He was very happy for me and it was a very positive visit! It was great having a neurologist acknowledge my improvements!
He also mentioned that the MS Clinic at UBC in Vancouver has put in an application to do a trial.
Have you shared with the Health Minister ” that we know enough about the immediate harms of treatment for CCSVI that it is sensible to proceed to a larger study looking at benefit.”?
Hi Judy. I have not communicated with the federal Minister on anything related to CCSVI. The Minister appears to rely mostly on the CIHR for advice about what kinds of studies should be done in CCSVI and MS. I don’t think this is a bad strategy, given that (as others have pointed out on these pages, like almost all ministers of health, the Minister is not a researcher or a scientist). As you are well aware, there is a huge breadth of views about what kinds of studies should be done in CCSVI. Some believe that it has already been conclusively established that treating CCSVI is beneficial; others aren’t yet convinced that it has even been established that CCSVI is a biological entity. Therefore, I don’t envy any group, including the CIHR, that is tasked with making policy recommendations based upon this very contentious scientific background.
As you know, I am somewhere in the middle. I am still skeptical, but I am impressed enough by the reports of patients’ experiences after treatment and some published studies, that I think it is time to do some “definitive” trials.
Hi Dr. Laupacis,
Do you think that the situation with CCSVI treatment in Canada would be better/more progressive/dealt with differently if the Health Minister had a scientific background?
One of the obstacles faced by proponents of CCSVI treatment has been the CIHR itslef. FYI I have posted the September 2010 findings of Ashton Embry, PhD. regarding the Beaudet Report. While this is a bit dated, it captures the underlying question of why we are still accepting advice from people that are prejudiced in the extreme?
An In-Depth Analysis of the “Summary Report – CIHR Full
by DIRECT-MS on Monday, September 13, 2010 at 8:19am
An In-Depth Analysis of the “Summary Report – CIHR and MS Society of Canada Joint Invitational Meeting on Multiple Sclerosis Research
Ashton Embry Phd., President,
September 10, 2010
On August 26th, the Canadian Institutes of Health Research (CIHR) and the Multiple Sclerosis Society of Canada (MSSOC) convened a meeting of a group of scientists from various disciplines “to review evidence, current international efforts, and knowledge gaps related to the etiology and treatment of MS, with a special emphasis on neurovascular issues including the recently proposed condition called chronic cerebrospinal venous insufficiency (CCSVI)”.
The chair of the committee was Dr Alain Beaudet, the current president of CIHR and the report is herein referred to as the Beaudet Report. It can be accessed at (http://www.cihr-irsc.gc.ca/e/42381.html). Because of the great importance of CCSVI research, Direct-MS, Canada’s second largest MS charity, undertook an In-Depth Analysis of the Beaudet Report to determine if the Report was scientifically acceptable and free of ethical breeches.
The committee assembled by Dr Beaudet, with help from officials from the MS Society of Canada, consisted of five CIHR executives, including Dr Beaudet, three executives from MSSOC, ten clinical/research MS neurologists, two neuro-imaging specialists, one neurosurgeon, one vascular surgeon and one interventional radiologist.
Notably, not a single committee member had any previous experience in any aspect of CCSVI research or treatment although two of the neurologists will be leading small studies on MS and CCSVI over the next two years. Notably, only two of the twenty three committee members brought critical expertise in extra-cranial vascular practice and research to the table.
The only scientific topic discussed by the Beaudet Committee was CCSVI and its relationship to MS and the only recommendations that were made related to future research directions for CCSVI and MS. There apparently was no discussion on other important topics such as “current international efforts and knowledge gaps related to the etiology and treatment of MS” and there are no recommendations regarding any MS research topic except CCSVI.
This is most surprising given that Dr Beaudet had earlier testified before the Parliamentary Subcommittee on Neurological Diseases in June that “This meeting is to be held in August and will focus on how best to accelerate research and innovation in MS…. The expected outcome will be a richer understanding of clinical research priorities regarding potential innovations related to diagnosis and treatment of MS.” There is no resemblance whatsoever between what Dr Beaudet had promised Parliament and what actually was delivered by the Beaudet Report.
Given that the meeting was dedicated to a discussion of CCSVI, it is clear from the content of the Beaudet Report that the participants did not have adequate knowledge of:
1) the origin, manifestation and detection of CCSVI,
2) the CCSVI literature,
3) the substantial international effort which is currently going on regarding CCSVI treatment.
When one considers the committee members’ lack of any expertise and experience with CCSVI and MS, this is exactly what one would have expected. Although the failure of the committee members to properly collect and analyze the available data on CCSVI is predictable and understandable, such a failure is unacceptable and it unequivocally negates the validity of the recommendations of the Beaudet Report.
Another major problem with the Beaudet Report is that a review of the committee members’ past research and/or executive activities has revealed that many have an overt conflict of interest in the regards to the potential introduction of an effective, non-drug therapy, such as CCSVI treatment, for MS. Such a potential ethical problem calls into question the objectivity of the discussions and the resulting recommendations of the Beaudet Report and provides another reason why the recommendations cannot be taken seriously.
In summary, if an important scientific issue needs discussion so as to generate recommendations to help guide government policy, it is absolutely imperative that those involved have:
• considerable expertise, knowledge, and experience in the topic at hand,
• that all sides of the topic are adequately discussed,
• that no one involved has a conflict of interest.
The Beaudet Committee fails on all three counts in that not a single participant has any expertise or experience with CCSVI, nothing positive about CCSVI was discussed, and not one, but many, participants have clear conflicts of interest.
Finally, given the importance of CCSVI research to Canadians, there is no doubt that a government-led investigation is required to determine how such a scientifically inappropriate and ethically challenged committee came into existence in the first place. Canadians, especially those with MS, deserve better than this.
Scientific Failings of the Beaudet Report
The scientific failings in the Beaudet Report range from relatively minor errors of fact to very large errors of interpretation of the relationship between CCSVI and MS. Another failing is the absence of key references and this problem is magnified by the fact that there are not many references available in the first place. Perhaps the biggest problem of the report is the complete failure to acknowledge what is happening regards to CCSVI treatment worldwide.
In the discussion of Dr Zamboni’s clinical research, the report conveys the false impression that Dr Zamboni tried to claim that CCSVI was the only cause of MS and that anyone with CCSVI will also have MS. Dr Zamboni has never made such claims and he simply drew attention to the fact that a high proportion of people with MS may well have impaired venous drainage and that such a problem could well be part of the MS disease process.
Thus statements in the report which try to discredit the CCSVI hypothesis by claiming that “patients who develop blood clots in these veins, or who have these veins removed during head and neck cancer surgery, do not develop MS” are completely inappropriate and valueless and show a lack of understanding of Dr Zamboni’s work. No one involved in CCSVI research is claiming everyone with CCSVI has or will develop MS and it is well recognized and accepted that genetic and environmental factors besides CCSVI are important factors in MS etiology and pathogenesis.
The report also tries to discredit Dr Zamboni’s clinical research (Zamboni et al, 2009a) by claiming it was not a controlled, randomized, double-blind trial. Once again, given that the Zamboni clinical trial was simply a pilot trial, and the first of its kind, it is entirely inappropriate to criticize it for not being controlled, randomized and double-blinded. No pilot trials have such rigour.
Dr Zamboni’s pilot research, like all pilot trials, was done to demonstrate the safety of the procedure and to determine if any improvements occurred in treated patients. Notably, both safety and possible efficacy were shown. Finally, Dr Zamboni concluded that the results of his pilot trial indicated that more rigorous clinical research was required.
In summary, the criticisms of the Zamboni work in the Beaudet Report have no substance and are inappropriate. No one is claiming Dr Zamboni’s initial trial is anything more than a pilot study. However, as such, its results more than justify the need for more rigourous clinical treatment research.
The most serious scientific flaws in the Beaudet Report are found in the two sections entitled “Is there such a condition as “chronic cerebrospinal venous insufficiency, or CCSVI?” and “Is “venous insufficiency” linked to MS?”
There is no doubt that both of these questions are valid and critical questions to examine when it comes to determining the need for further clinical research into the effectiveness of CCSVI treatment. The problems with the Beaudet Report lie not with the questions themselves, but with how the questions are answered.
In the first section, Is there such a condition as “chronic cerebrospinal venous insufficiency, or CCSVI?, the report points out that venous drainage of the brain is a highly flexible system. This is well accepted and is the reason why CSSVI is not an acute problem but rather is a subtle, chronic one associated with delayed drainage times and hypoperfusion. This creates problems over decades rather than days. The report completely misses this key aspect of CCSVI.
In this section, it is stated that “A proportion of the brain’s venous drainage runs through the Internal Jugular Veins when standing, however when lying down, that proportion of the venous return tends to flow through alternate venous routes.” Such a statement is completely erroneous and exactly the opposite is true. The jugular veins are important drainage paths in the supine position and are often collapsed when one is in the standing position. Such a fundamental error reflects the inexplicable and inexcusable, near absence of extra-cranial vascular expertise on the Beaudet Committee.
All other statements in this section are either irrelevant or inappropriate to the question at hand. The final statement in this section that “there is little support for the notion that venous insufficiency for the brain or spinal cord contributes to the development of MS” is a completely unsupported opinion which telegraphs the strong negative bias of the Beaudet Committee.
In the section “Is “venous insufficiency” linked to MS?, the report has missed a number of very important references, has emphasized a few, scientifically questionable, negative studies and has completely ignored what is happening in numerous CCSVI clinics throughout the world. The question of association of CCSVI and MS is an important one and must be established before clinical treatment research would be deemed necessary.
The Zamboni research (Zamboni et al 2009b) found a greater than 95% association of CCSVI with MS although less than 200 patients were tested. Most importantly, the results were checked and corroborated with selective venography, the accepted gold standard for the determination of CCSVI, and thus can be considered to be reliable. On the other hand, any scientific studies which do not include venography to corroborate the determination of CCSVI can be considered highly suspect and have to be given little weight. The reason for this is that non-invasive techniques such as Doppler and MRV have a very high rate of false negatives and can be highly operator dependent.
The subsequent University of Buffalo work demonstrated an almost 3X higher prevalence of CCSVI is persons with MS in a large study of 500 people (University of Buffalo, 2010). Notably, the person doing the determination of whether or not CCSVI was present with a Doppler technology was properly trained and had months of experience. Furthermore, the reliability of the Doppler results was checked with venography (Hojnacki et al, 2010).
It was very surprising that the Beaudet Report did not refer to other published studies of CCSVI/MS association which include Al-Omari and Rousan (2010) which found 84% of persons with MS had CCSVI (sample size 25) and no healthy controls had CCSVI (sample size 25) and Simka et al (2010) which found CCSVI in 90% of persons with MS (70 sample size). Notably, both these results were based on selective venography which leaves no doubt as to the accuracy of these data.
It is also worth noting that Dr Simka updated his findings at the June Parliamentary Subcommittee meeting which was attended by Dr Beaudet. At that time Dr Simka reported “total number of people who have been treated is now about 400. CCSVI has been found to highly correlate with multiple sclerosis. Only 3% of the multiple sclerosis patients we have seen were not diagnosed with CCSVI, using colour Doppler sonography, magnetic resonance venography, and standard venography.”
Given there are not a large number of references on CCSVI and MS, the omission of these key references, which are readily found on Pubmed, shows a definite lack of familiarity of the Beaudet Committee with the CCSVI literature.
The Beaudet Report, in keeping with its very negative bias, emphasized two small negative studies (Doepp et al, 2010; Krogias et al, 2010) which reported finding essentially no CCSVI associated with MS. Notably, both studies used only operator-dependent, non-invasive techniques and did not use any selective venography. Thus the results are very unreliable and thus contribute very little to the question of MS/CCSVI association. The Beaudet Report neglected to mention the critical lack of selective venography for the negative studies.
Perhaps one of the most important pieces of evidence regarding the association of MS and CCSVI is the fact that over 100 persons with MS are being treated for CCSVI every day (2000 a month) and well over 5000 persons with MS have already been treated for CCSVI worldwide. Notably, the daily number of CCSVI treatments is increasing every week as more and more clinics open up, especially in the USA.
Clearly, if CCSVI was not associated with MS, there would not be such a booming and ever expanding medical practice of treating persons with MS for CCSVI. If CCSVI was not highly associated with MS, the treatment of CCSVI in MS patients would never have gotten off the ground. By ignoring this major phenomenon, as well as various key references, the Beaudet Committee loses all credibility when it comes to the analysis of the association of CCSVI with MS.
The last line in this section “These recent studies have demonstrated a wide variation in the patterns of venous drainage of the brain in both MS patients and people with no evidence of MS (controls), underlining the difficulty involved in concluding that a vein that is ‘narrowed or blocked’ will cause MS.” applies only to studies which use non-invasive, detection techniques and reveals a lack of familiarity of the Beaudet committee members with how CCSVI is best detected. All studies which have used selective venography, the only reliable method for determining the presence or absence of CCSVI, have found a high association of CCSVI with MS.
The next question that the Beaudet Report asks is “Does venous angioplasty work?. The report claims that “Venous angioplasty is rarely used because the incidence of re-stenosis is so high.” However, given the obvious dearth of venous angioplasty expertise on the Beaudet Committee, such an unreferenced statement has to be questioned. In contrast to this statement, Dr Robert Maggisano, a vascular surgeon with 30 years experience, testified before the June Parliamentary Subcommittee that “We treat veins and arteries with angioplasty routinely”.
Furthermore, in a recent position statement of the Society of Interventional Radiologists, it was stated that “balloon angioplasty and stent placement of central thoracic veins have been performed safely for many years in other clinical scenarios” (Vedantham et al, 2010).
In summary, there is no doubt that venous angioplasty works because it has been used for many years and is in use today. If it didn’t work, such a procedure would have been abandoned years ago. The fact that it is currently being used for CCSVI treatment in many clinics around the world, including the prestigious Arizona Heart Institute, shows that many interventional radiologists and their review boards are satisfied that it works.
A claim that it doesn’t work by a committee dominated by neurologists and executives cannot be taken seriously, especially given the unrelenting negativity which pervades the report.
The final question of the report “Is the venous angioplasty treatment safe and efficacious?” is really two questions, one on safety and one on efficacy. Both are important and both need proper, well supported answers. By combining them, the Beaudet Report does not answer each separately and this is very misleading. For example the report states “In order to evaluate whether any treatment is efficacious and safe, it is essential to compare the treatment in a blinded fashion to a control MS population that does not receive the treatment.”
This statement is both erroneous and correct. This statement is completely wrong in terms of determining safety but is basically right in terms of determining efficacy.
So let’s look at the question of safety first and the answer to this is paramount for any recommendation of whether clinical trial research should be funded at this time. Overall, the evidence shows that venous angioplasty is very safe and this is emphasized by Dr Maggisano in his testimony “We treat veins and arteries with angioplasty routinely. It has a low-risk and a very minimally invasive component to it. Most of these treatments are outpatient treatments.”
Dr Simka in his testimony stated that “The group of 347 CCSVI patients with associated multiple sclerosis have undergone a total of over 500 endovascular procedures, including 414 balloon angioplasties and 173 stent implantations. In this group, there were only a few rather minor and occasional complications or technical problems related to the procedures.”
These data are now in a scientific paper (Ludyga et al, in press) and the failure of the Beaudet Committee to consult Dr Simka on the safety issue when they knew he had a large and reliable data base on the issue reveals a lack of initiative in obtaining important data on a key question.
In summary, there is no question, based on published work and long years of experience with venous angioplasty, that such a procedure is very safe. As Dr Beaudet testified in June, “I know of no procedure, even eating natural food, that is 100% safe.” However, the data and long years of experience indicate that venous angioplasty is about as safe as any medical procedure can be.
In terms of the question of the efficacy of venous angioplasty for MS, the Beaudet Report went back to bemoaning the lack of rigour of the Zamboni pilot trial and that the results can not be taken as proof of efficacy. Everyone agrees with this but that is not the point.
There is no doubt we do not know if venous angioplasty is effective for relieving symptoms and/or slowing disease progression. Only a proper clinical trial will determine this. The Beaudet Report presents a Catch 22 in that they cannot recommend funding a proper clinical CCSVI treatment trial until we know it works.
The absurdity of such logic needs no further elaboration.
The last line in this section contains two unsupported and completely erroneous pronouncements.
The first one claims that “there is currently no scientifically valid evidence in support of the existence of CCSVI in patients with MS”
As has been demonstrated, there is a very large and robust published data base that CCSVI is undoubtedly associated with MS and the thousands of CCSVI treatment procedures that have already been done and the over 100 CCSVI treatment procedures being done every day only reinforce this inescapable conclusion. Any claim to the contrary essentially says that fraudulent interventional radiologists are practicing in the many areas throughout the world, including the Arizona Heart Institute, which in the past has treated presidents of the United States.
The second unsupported and baseless pronouncement is that “there is currently no scientifically valid evidence to support the use of venous angioplasty in the treatment of patients with MS”.
As has been discussed, venous angioplasty is an extremely safe procedure. Secondly, a pilot trial has indicated that the procedure may well be of value for MS. Furthermore, the fact that the treatment is already in use in many countries of the world suggests that the review boards of the clinics doing such procedures are satisfied there is sufficient scientific evidence to support the use of venous angioplasty for MS.
Finally, it can be argued that the many hundreds of well documented accounts of improvements following venous angioplasty represent valid scientific observations. In his testimony Dr Simka noted that “But what I can say now about what we are seeing after one or two months of the treatment is that about 80%, 90%, of the patients experience improvement”. Although such information is usually ignored as being simply “anecdotal”, it is based on unbiased observation and should be given some weight.
In summary, there is overwhelming evidence that CCSVI is strongly associated with MS and there is ample scientific evidence and logical arguments to support the need for a clinical trial which tests the efficacy of venous angioplasty for MS. In fact, it is only common sense to agree with the sentiments of both Dr Zamboni who told the June Parliamentary Subcommittee
“I think it is irresponsible not to proceed with angioplasty treatment of CCSVI in patients with multiple sclerosis under the umbrella of controlled studies, supervised by ethical committees in tertiary hospitals, and with all the capability in interventional radiology and in vascular and endovascular surgery.”, and Dr Maggisano who passionately stated “So I would really urge the committee members, the government, and the appropriate funding agencies to look towards funding the definitive study that will answer the question, does treatment of the venous outflow obstruction improve the neurological outcome?”
There can be no doubt that we need to find out as soon as possible if venous angioplasty is an effective treatment for MS. It has been stated that “Time is Brain” when it comes to MS and, every year that the necessary treatment research is delayed, tens of thousands of Canadians may well be suffering the unnecessary loss of neurons and associated functions.
The Beaudet Report finishes with a Summary section and a Recommendations section. Each summary point and each recommendation is discussed below.
Summary Point 1 –
To date, the published evidence that venous abnormalities (i.e., CCSVI) play a role in the cause or propagation of MS is contradictory and, as such, should be treated with circumspection. This is a subject that needs prompt further study. To address this pressing need, the MS Societies of Canada and the US have funded seven studies to further determine if patients with MS have venous abnormalities that differ from age matched controls.
This summary point is very misleading because the seven studies funded by MSSOC and NMSS will NOT address the question of whether or not CCSVI is a causal factor in MS. They will simply address the question of MS/CCSVI association, a question which has already been positively and unequivocally answered by reliable, venography-based studies and the thousands of patients who have already been treated. Notably these seven studies may well not produce reliable results because they will only be using non-invasive imaging techniques for CCSVI detection. The lack of venography will substantially downgrade the results.
The question of CCSVI as a causal factor in MS was never addressed in the Beaudet Report. To answer such a question it is necessary to fulfill the key criteria of Hill (1965) for an associated factor being a causal factor. Given that:
1) CCSVI is highly associated with MS.
2) The venous malformations which cause CCSVI are congenital and thus precede the MS disease process (Lee et al, 2009: Lee et al, 2010).
3) Biologically plausible mechanisms related to CCSVI (iron deposition, hypoperfusion, upregulation of endothelial adhesion molecules) can be readily related to the MS disease process
It is reasonable to interpret that CCSVI is indeed a causal factor for MS because it fulfils the three key criteria of Hill (1965). Of course this makes the initiation of a clinical treatment trial even more urgent.
Summary Point 2 –
Seven North American studies ($2.4 million in funding by the MS Societies of Canada and USA) will carefully evaluate whether CCSVI occurs. The studies will define mechanisms of how venous drainage from the brain might be of relevance to MS, an issue that has not yet been adequately explored.
As noted above, these studies will simply add to the already overwhelming evidence that CCSVI is associated with MS. They will NOT define mechanisms of how venous drainage from the brain might be of relevance to MS.
Summary Point 3 –
In the absence of clear and convincing evidence for CCSVI, the performance of an interventional venous angioplasty trial with its attendant risk to MS patients is not appropriate at this time. It is unlikely that a proposal based on the current procedure of Doppler assessment of venous narrowing and subsequent venoplasty would pass a peer review panel (the international standard of scientific excellence and the standard for much of the funding in Canada), because evidence that CCSVI exists is currently lacking. Similarly, there are serious ethical issues associated with doing such a trial given the lack of convincing evidence for CCSVI.
There is no doubt that we have clear and convincing evidence for CCSVI if only on the basis of the 5000 venograms of MS patients who have been treated. However, there are numerous published scientific papers that clearly illustrate the presence and reality of CCSVI and it has been accepted as a recognized pathological condition by the International Union of Phebologists (Lee et al, 2009).
The performance of an interventional venous angioplasty trial is critically needed at this time because:
• CCSVI is definitely highly associated with MS,
• CCSVI is very likely a causal factor of MS
• A pilot trial established the safety of venous angioplasty for MS and indicated in may well have efficacy.
• Many hundreds of well documented experiential accounts of substantial improvement following venous angioplasty have been made available on TV, in newspapers and on the Internet.
• Thousands of Canadians will be traveling out of Canada to seek CCSVI treatment in the future and it is imperative for them to make an informed decision on whether or not to do this. Only a proper clinical treatment trial will provide the required information for such a decision.
• It is unethical for us to withhold a simple, safe, and relatively inexpensive treatment from people who are facing a devastating medical condition especially when these people may, as a consequence, assume an even greater personal and financial risk by pursuing treatment by providers of uncertain ability, in remote locations, and who do not provide follow up care (Andrews, 2010).
There is no doubt that a properly planned CCSVI treatment trial would pass an objective review committee. Notably, CCSVI treatment has been approved at numerous hospitals in the USA and they would use the same criteria for approval as any review committee in Canada.
There are NO ethical issues associated with doing such a trial just as there are no ethical issues for the many hospital review boards in the USA that have approved CCSVI treatment. The only ethical issues associated with CCSVI are associated with the question of why the neurological community, which has very large and complex financial ties to the pharmaceutical industry, is working so hard to prevent a most needed trial of a non-drug therapy from happening.
Summary Point 4 –
If a clinical treatment trial for CCSVI in MS were to be considered, one cannot expect a quick outcome given the natural course of the disease. Indeed a meaningful clinical trial could be as long as several years, with regular and repeated post-operative measurements of the key symptoms of the disease, which would add greatly to the expense of the trial. A trial of CCSVI for symptoms of MS such as fatigue or weakness would have to be compared to other available symptomatic MS therapies.
Everyone agrees that a proper trial would likely take 2 years just as drug trials do. The cost is yet unknown but cost cannot used as an argument against the clear need for such a trial. The appropriate funding can be found across Canada because the outcome of the trial will be felt countrywide.
One aspect of cost/benefit that is rarely stated is, that if CCSVI treatment is proven to be effective, it may well replace the need for expensive drug therapy for many. In this situation, there would be billions of dollars saved by provincial health departments in the future. Of course, the potential loss of such major drug revenues is of considerable concern to those that have substantial financial ties to the pharmaceutical companies that manufacture and market the current MS drugs.
Recommendation 1 –
Effective immediately, to establish a scientific expert working group made up of the principal investigators of 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 other related studies from around the world related to venous anatomy and MS. The first meeting of this expert working group should take place in this calendar year.
Such a scientific working group is not needed now or in the future, especially one that would be populated by persons who have an obvious conflict of interest. The principal investigators of the seven studies and the scientific leadership from MS societies all have financial ties to pharmaceutical companies. Furthermore, the results of these studies will add very little to what is already known about the CCSVI/MS relationship. The existence of such a group would be a waste of time and money.
Recommendation 2 –
Based on the outcomes of these studies, the scientific expert working group should reach conclusions regarding (1) a common standard for reliably diagnosing the proposed CCSVI condition using imaging or other techniques, and (2) clarity regarding a potential association between impaired cerebral venous drainage and MS.
It is already well established that selective venography is the gold standard for determining the nature and the location of the venous anomalies which cause CCSVI. In almost all cases, the seven studies funded by MSSOC and NMSS do NOT include venography and thus their results will be unreliable because of the lack of corroboration with venography. They will definitely NOT help to establish a common standard for reliably diagnosing the proposed CCSVI condition using imaging or other techniques.
There is already absolute clarity regarding the high association of CCSVI with MS. As noted above, the lack of use of selective venography in the seven studies will ensure that they add nothing to the already answered question of CCSVI/MS association. If the researchers want to verify the MS/CCSVI association for themselves, they can readily spend a week at a CCSVI treatment centre (e.g. Arizona Heart Institute) and watch the selective venography of all the treated patients. Such first hand experience should leave no doubt in their minds.
Recommendation 3 –
Depending on these conclusions, the scientific expert working group is to make recommendations on further studies including, if appropriate, a pan-Canadian interventional clinical trial that would evaluate the safety and efficacy of venous angioplasty in patients with MS.
The proposed scientific working group, made up mainly of persons with conflicts of interest when it comes to testing a non-drug therapy for MS, is the last group of people anyone would want to consult for a fair and objective evaluation of the need for a CCSVI treatment trial. This would be like asking oil company executives if we need a definitive study on climate change. Furthermore, it is very likely the results of the seven studies will be all over the map because they are using only non-invasive testing procedures which are known to not reliably detect CCSVI in many cases. The fact that the researchers are not using venography shows a lack of understanding of CCSVI detection or possibly a desire to fail.
The current data which are available and which have been discussed herein are by far enough to justify the need for a proper CCSVI treatment trial in Canada which has the highest rate of MS in the world. Dr Maggisano said it best when he testified in June that “we need to get going on this, so that within a year or two we can let our MS population know the answer.” Anyone who disagrees with such a common sense, objective conclusion would seemingly lack compassion for persons with MS and may well have a conflict of interest.
Ethical Problems Associated with the Beaudet Report
All the serious scientific flaws of the Beaudet report which are documented above are certainly very disconcerting and they essentially destroy its credibility. However, just as disconcerting are the ethical problems that are associated with the Beaudet Committee/ Report.
The first red flag when it comes to the lack of ethics of the Beaudet Committee is the fact that the committee did not include any scientists who had expertise and experience in CCSVI.
This major problem has been recently elaborated upon by Dr Lorne Brandes in an open letter to the Federal Minister of Health (http://healthblog.ctv.ca/post/An-open-letter-to-the-federal-health-minister-about-CCSVI.aspx).
As Dr Brandes notes “the problem..is that, to the last individual, these experts represented just one side of this important and complex issue. As a result, the negative answer you received was certainly predictable.” There is no doubt that such a biased selection of committee members who were charged with advising the Minister of Health on a very important health issue represents a major ethical breech.
The other major ethical issue that casts a dark shadow on the Beaudet Committee/Report is the fact that the majority of the committee members have a conflict of interest when it comes to evaluating the need for a clinical trial to test the efficacy of a non-drug therapy such as CCSVI treatment.
Such a conflict of interest takes the form of close ties, often financial, with the pharmaceutical companies that manufacture and market the drugs that are currently used for MS. Because CCSVI treatment has the potential to replace the current drugs, resulting in a major loss of revenue for the pharmaceutical companies ($10 billion in annual sales for MS drugs), anyone receiving financial benefits, including research grants, from the pharmaceutical companies would be in an obvious conflict of interest when it comes to deciding if a CCSVI clinical trial should go ahead. Clearly, it would be in their best financial interest if it did not.
As an example of such close relationships with pharmaceutical companies, Alain Beaudet appointed Dr. Bernard Prigent, vice-president of Pfizer Canada, to CIHR’s governing Council. Dr. Alain Beaudet, in the context of this appointment, emphasized the need to intensify collaboration and even to align CIHR’s “agenda” and “vision” with the pharmaceutical industry. Notably Pfizer markets the popular MS drug, Rebif.
The thirteen Beaudet Committee members with a readily identifiable conflict of interest include: Alain Beaudet, Anthony Traboulsee, Jack Antel, Wee Yong, Paul O’Connor, Jerry Wolinsky, Aaron Miller, Douglas Arnold, Brenda Banwell, Ruth Ann Marrie, Yves Savoie, Jon Temme, and Karen Lee.
Some of the past relationships these people have had with drug companies are listed in Appendix 1. Notably, some of the remaining ten people on the committee also may be in conflict of interest but such conflicts are not as obvious and easily determined as those for the thirteen people listed above.
The fact that no conflicts of interest were declared by the contributors to the discussions which formed the basis of the Beaudet Report can be itself be considered an additional breech of ethics. Clearly they should have recused themselves when it became clear that CCSVI and the question of a CCSVI treatment clinical trial was going to be discussed by the Committee.
There can be no doubt that the reliability of the Beaudet Report is completely compromised by the fact that the majority of contributors have a clear conflict of interest. These substantial ethical problems in combination with the major scientific flaws of the Report render the Report unfit for federal government consumption, especially when it comes to a major health issue such as the need for a CCSVI treatment trial.
Furthermore, the highly biased and negative nature of the Report is readily explained by the ethical issues surrounding it. In a more circuitous manner, the unacceptable scientific content can be related to the ethical issue of the biased selection of the committee members. It would be expected that a report on the science of CCSVI and MS by a committee that did not include anyone with a solid knowledge or experience of CCSVI and MS would be hopelessly flawed, as the Beaudet Report is.
Because the Beaudet Report on CCSVI and MS is scientifically flawed and is ethically challenged, the recommendations of the Report have to be put aside and not used to influence a decision on whether or not to fund a clinical treatment trial for CCSVI. The scientific discussions and arguments in the Report ignore many important data and interpretations and are highly biased.
The report also contains clear scientific errors and most of the pronouncements are unsupported, biased opinions which are in disagreement with the current data.
The lack of a reliable and objective scientific analysis of CCSVI and MS in the Beaudet Report is due mainly to the biased selection of committee members that restricted participation to scientists having no expertise or experience with CCSVI and MS. Furthermore, most of the committee members, including the chair himself, have a conflict of interest, and such people should have been excluded from any decision making when it comes to recommendations regarding a CCSVI treatment trial.
The fact that such compromised individuals strongly influenced the recommendations further negates the reliability and acceptability of the Report and its recommendations.
Health Canada needs to convene an objective committee to properly gather and analyze the current information on CCSVI and MS so as to provide a comprehensive and balanced report which includes reliable and well supported recommendations regarding future funding of CCSVI treatment research in Canada. The committee should be populated by both scientists and practioners with expertise and experience with CCSVI and MS and scientists with experience in related topics such as venous angioplasty in other conditions, the neurovascular system, neuro-imaging and MS disease pathogenesis.
Every effort should be made to exclude individuals with a clear conflict of interest related to past and/or present relationships with the pharmaceutical industry.
Finally, Health Canada should seriously consider launching an investigation into the serious ethical breeches of the Beaudet Committee. Also the Government of Canada may want to reexamine the type of person they want leading their main health funding institution. The scientific and ethical failings of the Beaudet Committee are nothing short of shocking.
The Committee’s highly subjective and unsupportable recommendations are potentially very harmful to the many Canadians who have MS. This entire debacle provides everyone with some good lessons on how science can be perverted by ignorance and subjectivity so as to produce recommendations which potentially will serve a few professionals and harm many people afflicted with a very serious illness.
Ashton Embry, PhD
This post is in response to Chris Alkenbrach’s assertion that Kristy Duncan has won a Nobel Prize. Really? When, and for what?
Duncan is currently an adjunct professor teaching both medical geography at the University of Toronto and global environmental processes at Royal Roads University, and served on the Intergovernmental Panel on Climate Change, an organization that won the 2007 Nobel Prize with Al Gore.
Here’s a link to a bio of Kirsty Duncan.
To clear up certain misconceptions, here is a link to a FB note that I wrote about Kirsty’s contribution to the 2007 Nobel Peace prize. She was at that time a member of the Intergovernmental Panel on Climate Control, and it was a prize awarded to Al Gore and the members of this panel. There were experts from many countries who participated in this effort. https://www.facebook.com/notes/ccsvi-ivcc/who-is-kirsty-duncan-/306224122774977?ref=notif¬if_t=note_comment
Your statement “These drugs decrease the frequency of relapse in people with relapsing remitting MS” upsets me. This cannot be stated as a fact! They “may” lessen the number or severity attacks, but only for relapsing/remitting cases. I find it extremely frustrating that Progressive cases seem to be completely unimportant. THERE IS ABSOLUTELY NO APPROVED TREATMENT FOR PEOPLE WITH PROGRESSIVE FORMS OF MS! I know because I was one of the abandoned cases–left to just deteriorate. Is it any wonder why we feel an URGENT need for study of CCSVI treatment to be done as rapidly as possible? I again bring up the Declaration of Helsinki http://www.wma.net/en/30publications/10policies/b3/
and implore you to aggressively follow this Declaration! “In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.”
People with progressive forms of MS are entitled to treatment for CCSVI NOW!
Hi Lori. I agree with you that there isn’t effective treatment for progressive MS. I agree with you that trials of treatment for CCSVI are indicated, and I would include people with progressive MS in those trials.
But Dr. L,
I noticed the phase you used, Dr. Zamboni has been calling for studies for a number of years…why has this not been done. That is why people in the health “industry” are getting the MS patients/families/friends backs up. If, by magical chance, a study started today-it would take YEARS before it hit the phase Kirsty Duncan was lobbying for. Why could we not “piggy-back” information from what you guys consider a “reputable” source. People are leaving Canada by the truck loads, and with them their money…not so financially sound in my opinion. Thanks for hearing me out and I agree with Christopher, MS patients are drawing the short straw…Please help us!
I guess my point is that I am surprised that Dr Zamboni himself didn’t start a randomized trial years ago. Good quality trials conducted anywhere in the world would be relevant to Canadians with MS
Dr. Zamboni initiated a RCT in association with the MS Society of Italy back in 2010, however it soon became apparently to him that they would not support his protocol or follow his advice. Dr. Salvi and Dr. Zamboni removed themselves from that study (I can provide his press release if required) and he had to start from scratch to secure funding a proper trial…thus the Brave Dreams trial is now underway and will be done properly. So in response to your comment above…it was not due to lack of trying only intentional roadblocks and funding was standing in his way. Exactly the same situation that we are facing in Canada.
Any suggestions on how to fund a Non Drug clinical trial. Buffalo’s study, Albany’s Study are all be funded by us (private sector) When CCSVI first came on the scene and the question of funding for a Canadian trial was raised (early 2010) it was Alain Beaudet who jumped forward and said all we have to do is apply to the CIHR and funding will be available, then the MS Society submitted a request to fund in MAy 2010 asking for Clinical Trials, then in August the CIHR and executives from the MS Society met for a private meeting and it was unanimously decided to NOT fund a trial and thus we have been hanging our hat on Beaudets original advice ever since foolishly thinking that the MS Society and the MS Neuro’s would all act in the best interest of the MS patients. Instead they have been held hostage in a turf, money and poltical agenda war, while their health continues to decline. There is no interest from the Neuro’s no matter what evidence is presented, otherwise they would be consulting with the proper experts (vascular & IR), they would have shown up to the ISNVD conference, they would contact the very doctors performing this procedure and observe for themselves at least one procedure and follow up with interest the well being of those who have been treated… and they certainly would not lie to patients and give them untruthful answers and then abandon them for not following their biased advice. The longer these Neuro’s ignore the proper science and only encourage the sloppy fraudulent science, the less chance they will ever be forgiven or have any credibility in the medical community. If I was a doctor I would stand up to this bad behaviour and not let a handful of MS Neuro’s ruin the reputation that all doctors are self serving and uninformed. There has been no wrong doing from the people who suffer from this disease, however they has been intentional wrongdoing from the people who are suppose to be helping them.
Excellent question and comment Carol Prest. Thank you for speaking up for all who are asking this same thing. Maybe one day we will get a reasonable answer instead of the scripted answers we have been getting for going on to year three.
He has had problems with the Italian MS Society and government putting up roadblocks too including financial ones–but he is doing a trial!
Look forward to the results. Andreas
Here is a convenient link to CCSVI Alliance. They have updated their data base to show all the studies indicating a vascular abnormality to MS. I would think this should be presented to the non expert CCSVI committees that are currently in control of the fate of MS patients.
Also just wondering why certain posts that are clearly within the posting guidelines are taking to long to get posted from the moderator. Who is the moderator of this comment page? I posted a comment on Feb 28 and March 1 and it is still waiting for approval.
thanks for the link Carol.
I am the person who has a quick look at the submissions before they are posted. I really do try to approve them all. I have been away for a few days and got behind. My fault and my apologies.
Regarding your response to my post of Feb. 21 RE: circulation, are we to assume that you do not place much significance on circulation involving veins. Or, in other words, do you not not feel venous hypertension is of much importance; and that in your opinion, there would never be any repercussions/consequences from any degree of venous hypertension or blocked veins?
Hi Judy. I honestly don’t know about the role of venous hypertension – we haven’t looked at this in our systematic review.
Regarding the role of “blocked veins”, the results of our systematic review of 10 studies that looked at the frequency of CCSVI in people with and without MS, found that CCSVI was more common in people with MS. However, there was such a huge difference in results among studies that we concluded that more research is needed to understand why there is such a difference.
I second Sandra W. I’m so completely disenheartened by our government/healthcare regarding this vote. A person with nothing to hide, hides nothing. This decision is really making EVERYTHING look suspicious. This has to change ASAP as the only major “holdout” countries are common weath countries…things that make you go hummm….
Your thoughts, comments and ways around this corrupt situation would be appreciated. Frankly, I’m getting a little. . . . no, quite a bit fed up with the corruption that is allowed to take place and not go without any sanctions to these individuals and agencies. We are being taken for a ride and we have been sold out! Period. Where is the integrity and human compassion? Where is the investigation of this botched file?
The “Big Picture” Regarding the Rejection of Bill C-280
by Ashton Embry on Saturday, March 3, 2012 at 12:49am ·
The “Big Picture” Regarding the Rejection of Bill C-280
Ashton Embry, President of Direct-MS
Like anyone else who cares about persons with MS, I was disappointed when the Conservative government defeated Bill C-280. However, I must say I was not surprised. In fact, I would have been shocked if the bill had passed given all that has happened in the past 2 ½ years and especially what has transpired in the last two weeks before the vote.
First of all, the bill was a very positive one and was one that simply would have expedited the evaluation of the use of CCSVI treatment for persons with MS. Given the fact that for most of those with MS, disease progression and increased disability are constant, the need for CCSVI to be properly studied as soon as possible is obvious for anyone with an ounce of common sense and compassion.
The most impressive part of the defeat of Bill C-280 was the major, integrated effort exhibited by various power groups including the MS Society of Canada, MS neurologists, the Canadian Medical Association, and Conservative politicians with the Health Minister herself leading the charge. The big question becomes what was so bad about a bill that will help persons with MS by encouraging key research that all these power groups joined forces to ensure it did not pass.
Various individuals have offered their opinions on the defeat of the Bill and these include Dr Kirsty Duncan, who was the champion of the Bill (and is the champion of all persons affected by MS), Anne Kingston, a Macleans magazine writer par excellence who has written numerous insightful articles on the CCSVI issue, and Christopher Alkenbrack who gave an excellent radio interview. All of these individuals, who care passionately for persons with MS, have made good points but, for one reason or another, they did not address the big picture which looms large above the defeat of the bill.
The big picture is rather obvious and one simply has to ask what do all the groups that banded together to ensure Bill C-280 passed into oblivion have in common. The answer to this question is that every last one of them receive money in one fashion or another from the pharmaceutical companies that amass billions of dollars in profits from MS drugs every year.
It is beyond question that most MS neurologists have received money or money-in-kind (e.g. free trips) from the MS drug companies. The MS Society of Canada receives major “donations” from the MS drug companies which also “sponsor” many of their activities. Pharmaceutical companies also contribute to the Canadian Medical Association in various ways through sponsorship of activities and buying advertising. Finally, the pharmaceutical companies also make political donations to the Conservative Party. Overall, the tentacles of the cash-rich pharmaceutical companies deeply penetrate all groups that have a say in MS treatment to ensure their products are the only ones recommended to MS patients.
It is also important to realize that the drug companies need to maintain such an overwhelming influence when it comes to how MS is treated because, as the current science demonstrates, the MS drugs do nothing to stop MS progression over the long run and that, at best, they reduce the number of attacks for some. If the drugs actually were of real benefit and substantially helped persons with MS, the CCSVI issue would be of little consequence and CCSVI treatment would have been seen as simply a potential add-on to the drugs. That is, CCSVI treatment would not be of any interest to the drug companies.
However, because the drugs do not work and it appears that CCSVI treatment may well be of substantial benefit for the majority of those who undergo such a therapy, it is not hard to understand why the pharmaceutical companies see CCSVI treatment as a huge threat to their gargantuan profits from nearly worthless, MS drugs. And they are probably correct. If CCSVI treatment was readily available for persons newly diagnosed with MS, sales of MS drugs would very likely plummet and profits would evaporate. Ironically, this would greatly reduce government expenditures on MS but unfortunately drug company political donations ensure such a societal benefit will not be realized in the foreseeable future.
There can be little doubt that the pharmaceutical companies had to ensure that Bill C-280 was defeated. And this was not hard to for them to do. They simply had the various groups who enjoy the pharmaceutical largesse to do their part in beating back a bill which might help persons with MS but which unquestionably would potentially hurt the MS drug companies. So that is the “Big Picture” behind the demise of Bill C-280 and I have no doubt that future efforts to get proper CCSVI research going in Canada will meet a similar fate.
Overall, I don’t blame the drug companies for wanting to protect their profits. However I have nothing but disgust and contempt for hypocritical organizations like the MS Society of Canada and the Canadian Medical Association that pretend to want to help people with MS but are really doing everything they can to help themselves and their benefactors, the MS drug companies. I have already voiced my complete lack of respect for the self-serving, MS neurologists who have blatantly sold out persons with MS for 30 pieces of silver.
When it comes to the Conservative Government, I was hoping for more from them but politicians will be politicians. With the government’s heavy handed and callous crushing of Bill C-280, some people have gone as far as comparing the Harper Government to the Assad Government of Syria which is mercilessly slaughtering its citizens. I must clearly state that I cannot agree with such a harsh comparison even though the Harper Government’s merciless killing of Bill C-280 may possibly indirectly result in numerous deaths of various Canadian citizens with MS.
In summary, various groups that receive financial contributions in one form or another from the manufacturers of MS drugs, including the MS Society of Canada, the Canadian Medical Association, MS Neurologists and the Conservative Party, all contributed to the defeat of Bill C-280, a bill which would have potentially harmed their benefactors. As I wrote 2 ½ years ago in my essay “Hope and Elation”, “there are tens and possibly hundreds of billions of dollars at stake in the foreseeable future and the drug companies are not going to let that kind of serious cash simply disappear without a fight. It is impossible to predict how the companies will deal with this real threat to their bottom lines and stock prices but you know it is not going to be pretty.”
The killing of Bill C-280 certainly was not pretty but was perfectly predictable. Persons with MS have to accept they are basically a herd of cash cows. All those making money from this herd, by way of drug sales and a “trickle-down” of the drug money, are going to ensure the money keeps flowing. It is going to be a long time, if ever, before any serious CCSVI research is done in Canada and it will be many years, if ever, before CCSVI becomes an accepted treatment for MS in Canada. The only potential winners from such research and treatment are those with MS. Unfortunately the potential losers (e.g. MSSC, neurologists) hold all the power when it comes to deciding where MS research money goes and they will continue to ensure CCSVI treatment remains marginalized.
My personal thoughts?
Many MS docs do have links with pharma.
Some pharma companies do make a great deal of money selling drugs for patients for MS. These drugs decrease the frequency of relapse in people with relapsing remitting MS, but I agree with the writer that they sure don’t cure the disease
I agree that large randomized trials of treatment for CCSVI should have been started earlier (not only in Canada, but elsewhere)
I do not agree that the reason these trials have not gotten underway sooner is because docs, the MS Society and government is in the back pocket of pharma. I think these trials have not gotten underway because there is still a great deal of uncertainty about how exactly to diagnose CCSVI, and how much more frequently it is found in people with MS than people without MS. The folks who have been against a randomized trial feel that one needs better evidence about these issues before a trial is undertaken. I don’t agree with that point of view, but I understand it.
I also think that because the CCSVI hypothesis is such an unusual one compared to conventional scientific beliefs about the cause of MS, this makes people quite suspicious of the CCSVI hypothesis . Being skeptical of new theories isn’t necessarily a bad thing, because many of them turn out to be wrong.
I haven’t read Bill C-280, but my understanding is that it would have mandated that certain kinds of research be undertaken regarding MS and CCSVI. I can understand the concern that this would have raised in some – I don’t think we should have our politicians mandating the kind of research that is undertaken in Canada, because they don’t know much about how to do research. So, I could see that there would be concern about the precedent that such a bill would set, way beyond MS.
Thank you for your reply and thoughts on the matter, Dr. Laupacis.
I’d like to reply to a couple of your points. You said:
“I think these trials have not gotten underway because there is still a great deal of uncertainty about how exactly to diagnose CCSVI, and how much more frequently it is found in people with MS than people without MS. ”
IMO, there is still a lot of uncertainty how to diagnose CCSVI because we haven’t bothered to learn. Dr. McDonald took it upon himself to go to Italy and meet with Dr. Zamboni. Why hasn’t the medical establishment done the same or learned from treating doctors in the States?
Also, let’s drop the MS connection to CCSVI for now. CCSVI is now being found in other neurodegenerative diseases. I know it’s hard to do and I’m guilty of putting in the same pot as well but we need to start looking at it as a separate venous condition.
With regards to the Bill. You said:
“I haven’t read Bill C-280, but my understanding is that it would have mandated that certain kinds of research be undertaken regarding MS and CCSVI.”
The bill would have secured us with follow up care, trials and a qualified panel of experts that were involved with testing and treating at a much quicker and efficient manner than what we are witnessing now.
I remind you and others again, how did Dr. Rubin get the green light with his denervation procedure? It’s continuous events like these that are just reinforcing what we already know.
Almost 20 months since I was treated for CCSVI. Over 30 000 people world-wide have been treated. We’re talking a basic life necessity. . . blood flow. We’re not asking for cosmetic surgery.
Thank you for your time,
I’m disgusted with our government and this review committee. Do any of you have any idea what life is like to live with blocked veins? Six votes (the amount by which yesterday’s vote in the House of Commons was defeated) does not count in a true democratic society!!
I’m posting some links to what’s been happening regarding Kirsty Duncan’s bill C-280 and the unusual actions of the federal Health Minister.
“Health Minister Leona Aglukkaq has sparked anger by aggressively opposing a private member’s bill that would accelerate clinical trials of so-called liberation therapy for people with multiple sclerosis.”
The government of Canada missed a fantastic opportunity. When the story of CCSVI broke in Canada in Nov./09, they could have immediately sponsored a clinical treatment trial. This treatment trial could have been completed in a short time frame. If the results showed absolutely no improvements then the whole issue would have been put to rest. If the results showed even minimal improvements, the government would be touted as heroic–finally giving some hope for improved quality of life for MS sufferers.
Instead, they listened to neurological representatives of the MSSC who unfairly called it a “hoax”, ignoring the fact that these naysayers had huge conflicts of interest and it was out of their area of expertise.
Even with positive mounting evidence–both scientific and anecdotal–Canada is trying to do everything in its power to delay progress, betraying Canadians with MS by prolonging suffering and uncertainty.
Forget heroism, this government is cruel!
“Conflicts of interest affect more than research. They also directly shape the way medicine is practiced, through their influence on practice guidelines issued by professional and governmental bodies and through their effects on FDA decisions.”
I guess Leona is afraid of losing her cut? This is why she is getting all the MPs opposing Bill C-280. Pretty obvious. Certainly not because of her heart felt wishes that she fears for our safety! LOL
Hi Dr. Laupacis;
Apparently the attached letter was intentionally leaked from Leona Aglukkaq (Health Minister) office today. It appears she needed to remind her “Collegues” to be cautious in their decision to vote in support of Bill C-280 on February 29th. Clearly something is not right here. What are your thoughts on this latest tactic.
Also, would love to hear your thoughts on the findings presented at the ISNVD Conference that just took place in Florida. Will any of these abstracts be presented to the CIHR for added consideration. When might we expect the next formal meta analysis from your group?
I hope you will continue your communication with us, we do appreciate your responses.
I remember seeing a comment on-line about the rate of suicide for people with MS and whether there were any statistics showing a decline in the rate when the news of CCSVI treatment, possibly being able to relieve some MS symptoms, broke because people finally had “some” hope but then an increase when it was “forbidden” in Canada for people with MS.
This wouldn’t surprise me at all if this were true because I also remember being so happily excited to hear about the 5 people who received the treatment in Ontario with varying but mostly positive results. This turned into a crushing disbelief and horror that the 6th person in line to be treated was suddenly denied this life-line.
I’m one of the lucky ones who could afford to leave my home country for this treatment that others can receive but was suddenly denied to people with MS. This treatment WAS performed in Canada on people with MS (2 more cased in BC) with positive results but when parties with huge conflicts of interest were afraid of losing their total control over MS patients it suddenly became too “experimental”. Disgusting in this “so-called” great country.
Simka has found abnormal veins in 96.1% of patients. I’m sure you’ve already seen the study, but this might help.
Hi Dr. Laupacis. Here’s the link to “MS Wars” from the Nature of Things in case you still haven’t seen it. http://www.cbc.ca/video/#/Shows/The_Nature_of_Things/1242300217/ID=2196927676
Hi Dr. Laupacis.
Here is today’s press release from ISNVD, which offers breakthroughs in neurovascular research from this past year. I’d love to know your thoughts on these breakthroughs and their impact on the current Canadian situation.
What are your thoughts on decreased circulation? Do you agree that there are varying degrees of decreased circulation, and that there are, in turn, varying consequences to decreased circulation? For example, angina would be an example of partial decreased circulation. The transient chest/arm pain allerts the person that there is a problem with coronary circulation. If not dealt with, a more severe occlusion of the coronary arteries could, or more than likely would occur, (unless the situation is dealt with) resulting in a heart attack. The same could be said for TIAs (Transient Ischemic Attacks) as opposed to a full fledged stroke. A decubitus ulcer (bed sore) results due to a decrease in circulation, but not a total stoppage of circulation. On the other hand, I believe that gangrene would be the result of a much greater problem with circulation. Decreases in circulation to the vessels of the eyes, kidneys etc. also, I believe, have consequences to bare. I spoke with a young Canadian I.R. after returning from Egypt (from CCSVI treatment). He said that he treated jugular veins for people who had swollen faces, and shoulders from blockages in jugular veins. He tried not to be rude, but left me thinking that he believed the blockages in my jugular veins (that I had treated in Egypt) were not significant enough to warrant treatment. He pointed out that some people even had to have their jugular veins removed, but survived. I pointed to the fact that we had two kidneys, but could survive with one; had two lungs, but could survive with one. However, we evolved with two kidneys, and two lungs for reasons. Please tell me what your position is on degrees of decreased circulation, and the corresponding consequences.
Hi Judy. Sorry about the delay in responding. Decreases in circulation are clearly important in a number of diseases, and you have mentioned some of them – narrowing of the arteries supplying the heart can cause a heart attack, narrowing of the arteries supplying the brain can cause a stroke.
However, CCSVI is not an abnormality of the arteries, it is a disorder of the veins draining blood from the brain and spinal cord.
As I have said before on this site, I don’t think one can extrapolate the impact of treatment for other vascular disorders, to CCSVI and MS – we need high quality studies done in people with CCSVI and MS.
I can understand the point that you are making about the necessity of having high quality trials in Canada. Please provide a date for when you think this may happen !!!!
I’ll state my feelings on this. We know from the clinical trials in Saskatchewan (not the ones being done now, but the previous announcement from over a year ago) that a certain well-known neurologist chaired the scientific committee that said that there were no proposals that met the clinical standards, therefore that effort was shut down.
We know that the CIHR is in financial troubles from Dr. Shannon’s letter. Have you seen this ?
I “suspect” that for the proposal deadline of clinical trials Phase I / II that are in the workings as we speak, that it is possible that none of the proposals will meet the criteria put forth, whatever they be ! In that case, the trials will not move forward.
Let’s remove the white gloves and state the true intentions once and for all.
You know as well as I do that the medical profession in Canada is more and more against this all of the time, only because of the egos involved. How do you explain the number of Canadian physicians who have been treated ? Are they barking up the tree of hope-mongering ?
I suspect that some of your answers are to make people with MS think that you are being open-minded, but I think that this is not the case.
As an MS patient I am quite tired of the dirty politics around CCSVI. The Minister of Health swayed the vote and debunked Private Member’s Bill C-280. You know that to be a fact, as well as I do. If you don’t then let me know, and I will send you copies of the documents to your private e-mail that I already have. Then Doctor John Haggie wrote a letter to the MPs in order to influence them to vote against this Bill. This was confirmed to me in a telephone conversation with a Conservative MP from Nova Scotia.
Personally, I think that MS patients are getting a raw deal here, and that this is because a few neurologists with very big egos are uncomfortable with this theory.
PLEASE IF YOU THINK I’M WALKING DOWN A WRONG PATH, STATE SO…..I’M A BIG BOY AND I CAN TAKE IT ! But don’t lead us down a one-way street to a dead end. We’ve had enough of that already !
This response is my opinion alone, and not that of my other research collaborators.
Doing high quality randomized controlled trials (RCT) of venoplasty for CCSVI is not simple (lots of issues about exactly how the diagnosis is made, how to blind the treatment, how benefits will be assessed, etc). Dr. Zamboni himself has been calling for randomized trials for a number of years, and to the best of my knowledge, the RCT he is involved with in Italy is only now about to get underway.
The deadline for proposals to the CIHR for an RCT in CCSVI was March 1. I am not involved in that process in any way (I wasn’t involved in developing the request for proposals, I haven’t applied, and I am not involved in reviewing the applications). However, I would be very surprised if the CIHR doesn’t fund at least one RCT. I have no idea when they will make a decision.
I think the medical profession in Canada is split regarding CCSVI. I think most neurologists are quite skeptical. However, some now think that it is appropriate to do an RCT, which is different from a year ago (others still do not). I think most interventional radiologists and vascular surgeons would say they don’t know whether treatment for CCSVI works, but they would be open to an RCT to find out once and for all. What I just said is my gut feeling, and not based upon any survey.
Regarding Bill C-280, I have to admit I haven’t followed that too much. The Minister of Health has every right to persuade members of Parliament that her views are the right one. So does Kristy Duncan. My observation is that they both exercised their right.
I haven’t seen Dr. Haggie’s letter. Do you have a copy?
They were supposed to be allowed to be “votes of conscience” but the Minister of Health aggressively forced her own will on the “Conservatives”–and with misinformation! She should be held in contempt of parliament!
Dr. Andreas L.
YOU STATE: “Regarding Bill C-280, I have to admit I haven’t followed that too much. The Minister of Health has every right to persuade members of Parliament that her views are the right one. So does Kristy Duncan. My observation is that they both exercised their right.”
MY REPLY TO THAT IS:
- OK, they both exercised their right to influence, after all, it’s politics. The Minister of Health based her fear-mongering reply on misconceptions and misinformation.
- Kirsty (PhD and medical geographer) is a scientist, a Nobel Prize winner. I find it suspicious that we know nothing about the academic qualifications of our Minister of Health. I even contacted her office, and they were unable to tell me anything about her academic training. My observation is that our current Minister of Health is unfit/unqualified to do the job, and simply reads prepared scripts that are written by biased, uninformed individuals.
- I do have a copy of the letter that Dr. Haggie wrote ! If you look at this interview, you will see a brief excerpt of the letter. http://www.youtube.com/watch?v=-eTRTrBi_g4&list=UUbBNnR7ruD6a50h4bqPEjKg&index=1&feature=plcp
I would also invite you to read Ashton Embry’s explanation on why the vote did not go through. Very interesting perspective indeed. I personally share many like ideas with Dr. Embry (PhD). https://www.facebook.com/notes/ashton-embry/the-big-picture-regarding-the-rejection-of-bill-c-280/311308185597340
Dear Dr. A.L.
I have been off as you know
D. Sazuki’s show, I think shows that this is not a fad,
But rather a true Kuhnian shift
In my day there, ’twas a theory
Semmelweis ( sp?)
Could you comment on the Theory as I feel this is the crux of the
Tx in anticipation
Hi Peg. I haven’t seen the nature of things show yet, but i hope to see it soon.
I am not an expert in the basic science of what causes MS, and am old enough to have seen different theories of what causes various diseases come and go. That isn’t to say that I don’t think basic science is useful – it obviously is, and has been the basis of the development of all sorts of treatments for a variety of diseases that have been very beneficial.
I will start to become convinced that there is something to the CCSVI theory when we have convincing evidence from labs other than Dr Zamboni’s that CCSVI is more common in people with MS than those without MS. To date, the 10 studies that have looked at this found such different results that I don’t think we know yet.
Having said that, I am not one of those who say the CCSVI is a bunch of nonsense – I think the results of some the studies to date are sufficiently positive, and the testimonials of people who have had venoplasty are sufficiently compelling, that more research is definitely needed. I hope that that future studies definitively show that people benefit from venopasty.
Have you seen this Dr. Laupacis?
Simka M.,Latacz P.,Ludyga T.,Kazibudzki M.,Swierad M.,Janas P.,Piegza J.
Prevalence of extracranial venous abnormalities: results from a sample of 586 multiple sclerosis patients
Functional neurology 2011;26:197-203
The aim of this study was to assess the prevalence of chronic cerebrospinal venous insufficiency in an unselected cohort of multiple sclerosis (MS) patients.
A total of 586 patients with clinically defined MS underwent catheter venography of the internal jugular veins, brachiocephalic veins and azygos vein. The following findings were regarded as pathologic: no outflow, slowed outflow, reversal of flow direction, prestenotic dilation accompanied by impaired outflow, outflow through collaterals, intraluminal structures obstructing the vein, hypoplasia, agenesia or significant narrowing of the vein.
Venous abnormalities were found in 563 patients (96.1%). Lesions in one vein were found in 43.5%, in two veins in 49.5%, and in three veins in 3.1% of patients.
Venous pathologies in the right internal jugular vein were found in 64.0% of patients, in the left internal jugular vein in 81.7%, in the left brachiocephalic vein in 1.0%, and in the azygos vein in 4.9%.
Venous pathologies were found to be highly associated with MS, yet the clinical relevance of this phenomenon remains to be established.
Isn’t there something to be learned from Dr. Capalani? He’s telling it correctly. Other’s need to listen.
Dr. Gianfranco Capalani on “The Nature of Things” Feb. 9, 2012
Dr. Capalani feels that denying patients a procedure as common as angioplasty is unjustified.
“I don’t understand how they can sustain such a lie.
Angioplasty’s not the treatment for M.S.. It’s for vascular abnormality and the citizen has the right to receive for free an approved procedure. That’s all.
In my hospital, they do 1500 angioplasties a year. It’s routine, everyday work. I think that to forbid it, to take it away, not to offer it to the patient is a capital sin.”
(Dr. Capalani is a Heart Surgeon from Northern Ireland. He was treated for CCSVI in 2007, and continues to do well.)
CCSVI (not the so-called Liberation Procedure) is a measurable, treatable venous abnormality. The anecdotal evidence is too overwhelming to ignore, that is that venous angioplasty, or valvoplasty, helps some people with MS have symptom relief. It, therefore, by its’ very nature, has been shown to help other conditions, such as Parkinsons and ALS. The rammifications of this 100+year-old theory are HUGE! It has been proven (Siskin et.al, 2011) that angioplasty is indeed a safe procedure…people in Canada get it covered under OHIP for $1500-1800 every day, and it has been performed countless times since the 1970′s.
More research is coming out constantly. Studies are being published on almost a monthly basis. Doesn’t it seem a bit suspect that a simple procedure, whereby one is not even under anasthesia, that could possibly help the quality of life of those wth horrendous neurological diseases, isn’t being pursued, but actually fought?
Not enough money in it…but, if it cost a few thousand dollars a year, and was a drug, I have no doubt this “controversy” would be a thing of the past. And quickly.
The issue of clinical study is being used as a crutch. Is it ethical to perform angioplasty on one person, and not another? How do you “fake” an angioplasty? Is it common practice for the medical community to complete double-blind clinical trials on a MEDICAL PROCEDURE? Again, this is not a drug. It is a safe, ACCEPTED medical practice, which is being used in a different, novel way. This is done all the time. In fact, just recently Dr. Rubin used angioplasty to improve outcome and lessen need for medication for those with hypertention. No clinical study. He just did it, and is being praised for his new, novel use of angioplasty. The same man who is fervently against using angioplasty of any kind for CCSVI, and is wanting double-blind studies. Hypocritical? I wonder if Dr. Rubin would have been the first to treat for CCSVI in Canada, if things would be different.
Yes, I have had the procedure done. Twice. The only negative side effect I received was a bruise from the catheter. Positive effects? Hmm…from wheelchair to being able to jump. It’s not a cure…and who knows if this is a case of chicken vs. egg, or if directly related or not? WHO CARES! Let’s help people with MS, and other neurological diseases in every country improve their quality of life. In under 2 hours, in most cases.
Terrific that you improved so much after venpolasty. This is none of my business, but did you have a second procedure because you got worse again a while after the first one?
I am not aware that venoplasty has been shown to help people with Parkinson’s disease and ALS. Can you provide me with the evidence for that?
You aren’t the first person to say on this site that because venoplasty and/or angioplasty works for other diseases, this means that this treatment will be helpful for people with MS. I continue to find that argument totally unconvincing. It is like saying that because a chemotherapy drug works for one kind of cancer (for example breast cancer), it will work for another cancer (for example brain cancer). We know that, unfortunately, some cancer drugs that are very effective for the treatment of some cancers, are useless for the treatment of others.
Your understanding of Dr Rubin’s new study is different from mine. First of all, I am pretty sure he isn’t doing an angioplasty – he is doing a denervation procedure, which involves cutting the nerves around the renal arteries. Also, this procedure has been shown in a randomized trial to be effective (which isn’t the case with venoplasty for CCSVI), and Dr. Rubin’s study is intended to see if it works as well in the hands of surgeons here in Ontario.
Finally, you are right that randomized trials aren’t completed as frequently before the introduction of new surgical or radiological procedures as they are for drugs (where they are mandatory). However, the expectations are shifting, and we are seeing more randomized trials of non-drug treatments before they are widely used within the health care system. I personally think this is a good thing – I don’t see why non drug treatments should require a lower bar of evidence than drugs treatments.
Does this mean they’ll probably pay attention to our blood flow when we’re old?:
Rush University Medical Center
Signs of aging may be linked to undetected blocked brain blood vessels
Many common signs of aging, such as shaking hands, stooped posture and walking slower, may be due to tiny blocked vessels in the brain that can’t be detected by current technology.
In a study reported in Stroke: Journal of the American Heart Association, researchers from Rush University Medical Center, Chicago, examined brain autopsies of older people and found:
Microscopic lesions or infarcts — too small to be detected using brain imaging — were in 30 percent of the brains of people who had no diagnosed brain disease or stroke.
Those who had the most trouble walking had multiple brain lesions. Two-thirds of the people had at least one blood vessel abnormality, suggesting a possible link between the blocked vessels and the familiar signs of aging.
“This is very surprising,” said Dr. Aron S. Buchman, lead author of the study and associate professor of neurological sciences at Rush. “The public health implications are significant because we are not identifying the 30 percent who have undiagnosed small vessel disease that is not picked up by current technology. We need additional tools in order to identify this population.”
In 1994, the researchers began conducting annual exams of 1,100 older nuns and priests for signs of aging. The participants also donated their brains for examination after death. This study provides results on the first 418 brain autopsies (61 percent women, average 88 years old at death).
Although Parkinson’s disease occurs in only 5 percent of older people, at least half of people 85 and older have mild symptoms associated with the disease.
Before the study, researchers believed that something more common, such as microscopic blocked vessels, might be causing the physical decline. The study’s autopsies found the small lesions could only be seen under a microscope after participants died. The lesions couldn’t be detected by current scans.
During the annual exams of the nuns and priests, researchers used the motor skills portion of a Parkinson’s disease survey to assess their physical abilities. Researchers observed and rated the participants’:
• Ability to maintain posture
• Walking speed
• Ability to get in and out of chairs
• Ability to make turns when walking
• Sense of dizziness
“Often the mild motor symptoms are considered an expected part of aging,” said Buchman, who is also a member of the Rush Alzheimer’s Disease Center. “We should not accept this as normal aging. We should try to fix it and understand it. If there is an underlying cause, we can intervene and perhaps lessen the impact.”
Co-authors from Rush are Sue E. Leurgans, PhD; Dr. Sukriti Nag, PhD; Dr. David A. Bennett, and Dr. Julie A. Schneider, MS. The National Institutes of Health and the Illinois Department of Public Health funded the study.
Please read this detailed account of the discrimination that MS’ers are facing courtesy of CCSVI Ontario
30 January 2012
The Honourable Leona Aglukkaq, Minister of Health
The Honourable Dalton McGuinty, Premier, Ontario
The Honourable Deb Matthews, Minister, Health and Long-Term Care, Ontario
Dr. Stewart Kennedy, President, Ontario Medical Association
Dr. John Haggie, President, Canadian Medical Association
We congratulate the doctors at the Peter Munk Cardiac Centre in Toronto for successfully performing the first renal denervation procedure in Canada.
The procedure is described as minimally invasive and is used to reduce high blood pressure in patients who cannot be effectively treated by drugs. The Peter Munk Cardiac Centre received approval from Health Canada to perform the procedure under the Special Access Program. This program allows physicians to request access to drugs or procedures that are currently not approved in Canada. Health Canada’s website notes that the Special Access program “… is limited to patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable or are unavailable.”
We congratulate Dr. Rubin for planning to treat many patients in the coming months and for monitoring them after treatment to determine the safety and efficacy of the procedure.
We congratulate Dr. Rubin and Health Canada for accepting the results of renal denervation studies and clinical trials conducted in the United Kingdom, Australia and Germany.
Most of all, we congratulate Dr. Rubin, Health Canada, the Premier of Ontario and the Minister of Health for Ontario for so clearly confirming the discrimination to which Ontarians with Multiple Sclerosis (MS) are subjected.
Most people with MS also have Chronic Cerebrospinal Venous Insufficiency (CCSVI). CCSVI describes a vascular condition characterized by malformations or blockages mainly of the jugular veins and the azygous vein that results in poor drainage of blood from the brain. The treatment for CCSVI is balloon angioplasty. People with MS are denied access to testing and treatment in Ontario, and across Canada, for CCSVI because they have MS.
There is no cure and no effective treatment for MS. There are disease modifying drugs available for relapsing-remitting MS. These drugs are largely ineffective, expensive and each one causes severe side effects. Two of the newest drugs are linked to deaths: as of January 4, 2012, Tysabri has been linked to 201 cases of permanent brain infection and 42 deaths; Gilenya has been linked to 11 deaths. Clearly, conventional therapies for MS, based on an unproven theory that MS is strictly an autoimmune disease, are unsuitable and have failed people with MS.
We note that Dr. Rubin and the multi-disciplinary team at the Peter Munk Cardiac Centre
“… will treat many more patients with hypertension in the months ahead. Our focus will be directed at studying the safety and efficacy of the procedure, which could also have important secondary benefits.”
Barry Rubin, press release, January 17, 2012
Clearly, Dr. Rubin’s renal denervation program is not being held to the same standard being applied to the testing and treatment of CCSVI. Studies and clinical trials conducted in other countries have been accepted as viable evidence for performing the renal denervation procedure in Canada. Dr. Rubin will not be conducting Phase I or even Phase II double blinded clinical trials. Instead, it would appear that, based on the results of studies and clinical trials conducted in other countries, Dr. Rubin and his colleagues will conduct what amounts to a Phase III study in which patients are treated and followed to confirm the safety and efficacy of the procedure.
It also appears that this new, or should we say “experimental” procedure is being funded by the Government of Ontario. Ontarians who have been treated for CCSVI outside the country are required to pay $250.00 for a follow-up Doppler test. Follow-up care in Ontario is non-existent if a person has been treated for CCSVI.
Canadians with MS, however, must wait for the conclusion of Phase I (safety) and Phase II (efficacy) clinical trials before there can be any discussion of testing and treating CCSVI in Canada. The safety of balloon angioplasty has already been determined, for example, by Dr. Kenneth Mandato et al, Albany Medical Centre (Mandato et al, Journal of Vascular Interventional Radiology, Vol. 22, Issue 3, Supplement, Page S4, ( HYPERLINK “http://www.jvir.org/article/S1051-0443(11)00005-4/fulltext)” http://www.jvir.org/article/S1051-0443(11)00005-4/fulltext). The conclusion of this study, which involved 240 participants, is that balloon angioplasty for the treatment of CCSVI is a safe procedure with a 1.6% risk of major complications. Another study conducted by Dr. Marion Simka et al (Poland) which involved 564 angioplasty procedures concluded that the procedures appeared to be safe and well tolerated by patients (Simka et al, Phlebology, 2010 Dec;25(6): 286-95). These studies were conducted in the United States and Poland but they apparently cannot be accepted as viable evidence in Canada regarding the safety of angioplasty for the treatment of CCSVI. Balloon angioplasty has been a standard of care in Canadian hospitals for decades. It is used on a daily bases in veins and arteries.
It is estimated that 400 Canadians die each year from complications related to Multiple Sclerosis. In the past two years, some Canadians who were in hospital dying have implored doctors to treat them for CCSVI on compassionate grounds. They were refused. Dr. Rubin’s renal denervation programme is approved for use in Canada on compassionate grounds. What is the difference between Canadians suffering from chronic high blood pressure and Canadians with MS who are dying from complications associated with this disease or whose health is deteriorating every year?
We congratulate Dr. Barry Rubin, Medical Director at the Peter Munk Cardiac Centre for recognizing that the renal denervation procedure could save lives, could save the health care system countless millions of dollars in drugs, and could save the health care system millions of dollars in treating heart attacks and strokes (press release, January 17, 2012).
We can make the same argument for treating CCSVI in Ontario. The treatment for CCSVI does, indeed, improve the quality of life for people with MS; the treatment could certainly save the healthcare system countless millions of dollars in drugs; the treatment could save the healthcare system millions of dollars in emergency room visits and hospital stays which often last for weeks with very little positive results.
We think that people with MS in Ontario deserve honest answers to the following questions:
why are Ontarians with MS being discriminated against?
why are we seeing subjective favouritism with regard to the renal denervation procedure?
why are hospitals and doctors in Ontario not allowed to perform a well-established, low-risk angioplasty procedure on people with MS?
why do Ontarians who have been treated for CCSVI outside the country have to pay for a follow-up Doppler test?
why is follow-up care for Ontarians who have been treated for CCSVI not readily available in Ontario?
CCSVI Ontario (445 members)
Hi carol. Thanks for sharing this letter.
Members of our research team have different views about whether or not clinical trials of venoplasty for CCSVI are indicated at the present time, so these comments reflect my views only. I also know virtually nothing about renal denervation treatment. I also have had no involvement in the Ontario government’s decisions about renal denervation treatment.
I agree with you that we don’t need a small study looking at the safety of venoplasty for CCSVI. What we need (in my opinion) is more than one randomized trial to conclusively determine the impact of venoplasty for CCSVI on patient symptoms and the biology of MS.
There is already a randomized trial showing an impressive impact of renal denervation treatment on blood pressure. So, I would argue that because of this randomized trial, the quality of the evidence supporting the benefits of renal denervation is greater than that supporting the benefits of venoplasty for MS (for which there are no randomized trials).
What about all the procedures done in other countries? What about Drs. Sisken and Dr. McGuckin’s rule of thirds; 1/3 dramatic improvement, 1/3 moderate improvement, and 1/3 no change? Or, are we just listening to what other counties say about renal denervation and everything else, but not about CCSVI? Since when aren’t there consequences to bare, for example like gangrene, blindness, myocardial infarction, ulcers when parts of our anatomy are deprived of oxygen? Isn’t the right to have oxygen to our whole being our inherited right? How is it decided, or who decides about who gets to have oxygen and who doesn’t get to have oxygen. It appears that everyone has a right to oxygen to their whole beings except MS patients. I thought the right to oxygen was a basic human right, especially here in good Canada.
On January 27, you wrote to Christopher Alkenbrack and said:
“I am almost certain that they are not denying that patients are reporting improvements in symptoms like fatigue, fewer problems with cold extremities, etc. What I think they mean is that when they do a neurological examination , they usually don’t see an “objective” improvement in things like balance, strength, etc.”
I know that many of us face adverse reactions and opinions from our MS neurologists upon having been treated for CCSVI. Christopher is quite correct that their objectivity is quite skewed.
I will briefly share with you my personal experience. I am 18+ months post-treatment. I am lucky enough to have still maintained all of my improvements. My neurologist said that I claim to be better but upon examining me, he found me worse. He went on to tell me that at this stage of my disease, only chemo could help me.
A more incorrect diagnosis could not have been given to me! My improvements have restored quality of life and I walk without my cane for 2-3 blocks. I am totally independent. Why and how he can come to this conclusion totally baffled me and upset me because I had respected him up until that point.
Most of our MS neurologists are biased and are not looking at the history of MS to lead us into the future. Please be aware of this and don’t underestimate the biases and mistreatment that many of us have faced post-treatment.
Bottom line is that it’s our body and we know it best. We also should have every right to treat any venous anomaly that we may have regardless of our MS.
I’m replying to my own comment to add something that I forgot to state and that is that my improvements were NOT recorded in my medical file by my neurologist.
Yesterday I was reading a paper on a topic different from MS. It was about people with urinary incontinence (a very common and distressing problem, for which (like MS) there isn’t great treatment). The study was comparing the outcomes that researchers focused on when studying treatments for urinary incontinence – they were things like diaries in which people recorded the number of episodes of incontinence a day, and the number of incontinence pads used per day. These measures were felt to be the most “objective” as possible in this difficult to study disorder.
However, when patients with urinary incontinence were asked what outcomes were most important to them, they chose quality of life measures.
There is obviously a correlation between the number of incontinence pads used and quality of life. However, I think this example illustrates that people with a disease sometimes have different opinions about what measures of the benefits and harms of a treatment are the most important, compared with researchers.
I personally think that researchers should pay more attention to patient symptoms and quality of life, but all my colleagues don’t agree with me.
I would like to comment on urinary incontinence which is a common MS symptom. I was a little disappointed that my CCSVI treatment did not improve my bladder frequency/urgency problem. However, the improvements in my balance and mobility have made it so much easier to get to the bathroom quickly that it is definitely not as much of a problem as it used to be and that can be measured both objectively and as a quality of life issue!
Dr. McDonald has done a wonderful job in this video to outline why some of the negative CCSVI studies do not support Dr. Zamboni’s study. Why do these studies continue to be included in Canada’s decision and muddle results. Why does the CIHR continue to ignore Dr. McDonald who is one of the few doctors in Canada that has Zamboni training and experience with CCSVI testing and treatment and follow up care. Has your committee ever contacted him directly or is Dr. Rubin the only vascular doctor that all the expert committees will listen to. (FYI Dr. Rubin as far as I know has only seen a few CCSVI patients due to complications post procedure) but has not direct experience with testing and treatment. Please explain why the CIHR cherry picks doctors that have no expertise in this condition.
Why do the MS Neuro’s in Canada not want to discuss CCSVI with Dr. McDonald, what are they afraid of learning? The CIHR should be encouraging all the disciplines of doctors to work together for the benefit of the MS patients. Why is this still not happening?
(I hope this video will link for your review, if not just visit any of the CCSVI sites and you can access it)
Thanks for sending the link. I watched the video. Dr McDonald appropriately points out the need to standardize the ultrasound technique, and the need to understand why different sites get different results.
Some of the variation may be because some studies don’t use Dr. Zamboni’s protocol. However, Dr. McDonald also pointed out how Dr Zivadinov’s results, although definitely finding more CCSVI in people with MS than those without MS, weren’t nearly as dramatic as Dr Zamboni’s, while presumably using the same protocol. As well, the study Dr. McDonald was involved in by Dr. Bastianello, showed marked differences in the frequency with which CCSVI was diagnosed among the 6 centres, all of whom were presumably using Zamboni’s protocol. I agree with Dr McDonald that we still have lots to learn.
Hi Dr. Laupacis, with all due respect the following statement (response) that you posted above is not accurate
” Dr. McDonald also pointed out how Dr Zivadinov’s results, although definitely finding more CCSVI in people with MS than those without MS, weren’t nearly as dramatic as Dr Zamboni’s, while presumably using the same protocol”
Please ensure your fellow members and the CIHR are made aware of the facts. The National MS Society can provide the transcript and video to confirm the following;
Back On April 14, 2010 the National MS Society sponsored a CCSVI Live Web forum with Dr. Zamboni, Dr. Zivadinov and Dr. Miller (may have been a few more Neuro’s as well) At this forum Dr. Zivadinov himself said that his CCSVI study did not have the proper ultrasound equipment and he did not follow the full Zamboni protocol. He was quoted as saying “this could explain the difference in results. He also stated that in his second phase trials he would be using the proper equipment and protocol.
Unfortunately these significant details always get lost and buried when the CCSVI so called experts committee’s (MS Neuro’s that have no true knowledge of CCSVI testing or treatment) present their sanitized findings to cause doubt and further confusion. Again why is CCSVI being held to a standard of perfection and why are the MS Neuro’s and the MS Society the only voice/opinion that the medical community and the government will listen to. They are not acting in the best interests of MS patients anymore. Dr. Zivadinovs results although lower than Zamboni’s are still very compelling, yet they have been portrayed as evidence of non support. Just another fact that you may not be aware of regarding the normal control subjects in Zivadinov’s trial. Many were family members, again this has been verified by Dr. Zivadinov himself and an email I personally received directly from the Buffalo study coordinator.
Many of us have been following every detail of CCSVI since late 2009 and all I ask is that if your committee is representing all the facts of CCSVI in an unbiased way…please learn all you can and question not only the doctors supporting CCSVI, but question the motives and information provided by the naysayers as well.
Hi Dr. Laupacis.
During this video from the 2011 New York Symposium, Dr. Sandy McDonald addresses the discrepancies between positive and negative studies on CCSVI. He does an excellent job of explaining some of the problems with the studies.
I strongly encourage your team, Dr. David Butler Jones, Dr. Alain Beaudet and all others making decisions on “CCSVI in Canada”, to attend these international conferences. It is essential that the doctors who are actively testing and treating CCSVI are included in discussions related to “CCSVI in Canada”, for the benefit of everyone. Attending these conferences and including doctors using angioplasty to treat CCSVI in key Canadian discussions would go a long way towards making patients believe Canada is even trying to treat this issue fairly. ~Amy
Hi Dr. Laupacis,
I don’t have the link for this important news, so I will just copy and paste it below:
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New Data Challenge Theories Of Multiple Sclerosis
ScienceDaily (Feb. 23, 2004) — A new view of multiple sclerosis (MS) may arise from the first extensive study of brain tissue from the earliest hours during a bout of the disease. The results, published February 23, 2004, in the advance on-line edition of the Annals of Neurology, suggest that the earliest event is not, as previously believed, a misguided immune system attack on a brain substance called myelin.
Health & Medicine
• Multiple Sclerosis Research
• Immune System
• Nervous System
Mind & Brain
• Multiple Sclerosis
• Disorders and Syndromes
• Brain Injury
• Multiple sclerosis
• Gate control theory of pain
Instead, the first event appears to be the death of the brain cells that produce myelin, triggering a subsequent immune system mop-up operation to clean up the cells and the myelin, said author John W. Prineas, MBBS, of the University of Sydney in Australia.
Multiple sclerosis is an enigmatic disorder of the nerve fibers of the brain and spinal cord. Scarring (sclerosis) replaces myelin, which normally insulates the nerves from damage and speeds electrical conduction through the fibers.
Depending on which nerve fibers are hindered, patients can experience problems ranging from weakness and clumsiness to numbness, visual disturbances, and even emotional and intellectual alterations. In some patients, MS manifests itself in cycles of relapse and remission; in other patients, the disease may progress to a stage of severe debilitation, either slowly or rapidly.
According to Prineas, the study he conducted with coauthor Michael H. Barnett, MBBS, began several years ago while he was working at the New Jersey Medical School in Newark. A fellow neuropathologist in Manhattan asked whether Prineas and his colleagues would be interested in examining brain tissue from a 14-year-old girl who died unexpectedly 17 hours into a relapse.
Sudden death can occur in MS if the damage (or lesion) occurs in parts of the brain that control vital functions such as breathing and blood circulation.
“This patient proved to be unique in the history of multiple sclerosis in that there was lesion available for study that was less than a day old,” said Prineas.
According to the dominant theory of MS, when the researchers examined the hours-old lesion, they should have found the beginnings of an immune system attack.
But Prineas and Barnett noticed that the myelin in the lesion was still intact, and there was no evidence that the typical armada of immune system cells and molecules had moved into the area yet. Instead, oligodendrocytes cells, which produce the myelin, were dying. Myelin is, in fact, an extension of oligodendrocytes that wraps itself around nearby nerve fibers.
“This encouraged us to re-examine other early MS cases in our brain bank,” said Prineas. “Similar lesions, albeit extremely rare, were identified in a number of other early MS cases, which allowed us to conclude that the changes observed probably occur at the onset of any typical new lesion.”
The results could have significant consequences for MS research, much of which is focused on understanding why the immune system attacks myelin. The focus may have to shift to understanding why the myelin-producing cells begin to die.
“The important point, at this stage of our investigation, seems to be that we have no laboratory model for this sort of pathology,” said Prineas.
The Annals of Neurology, the preeminent neurological journal worldwide, is published by the American Neurological Association, the world’s oldest and most prestigious neurological association. The 1,400 members of the ANA–selected from among the most respected academic neurologists and neuroscientists in North America and other countries–are devoted to furthering the understanding and treatment of nervous system disorders. For more information, visit http://www.aneuroa.org.
Dr. Laupacis, A few days ago you made the following response to a comment about conflict of interest regarding pharmaceutical companies:
Also, it seem to me that some of the proponents of CCSVI have even greater conflicts of interest because many of them stand to make considerable personal income testing for CCSVI and performing the procedure, if it becomes routine care. Why is this very real conflict of interest almost never acknowledged by the proponents of CCSVI?
I speak only for myself, but if doctors in Canada could perform the testing and procedure for CCSVI they would be paid according to provincial rates, assuming that the testing and procedure would be funded. Even if testing and treatment were not funded by the provinces, the doctors who would deal with CCSVI would actually be helping people and that is the difference – a huge difference – between those who appear to be quite happy with the status quo for Canadians with MS and those who would make any money from testing and treating CCSVI.
Frankly, I would like to exercise my right to choose to follow a medical treatment and not be denied that right because I have the MS label.
Hi Linda. I was in no way suggesting that doctors who do a procedure or test shouldn’t be appropriately paid for doing them – of course they should.
However, if that increases their own personal income, or (as is almost certainly the case in the USA) the income of the institution they work at, then that to me is a clear conflict of interest when testing the benefits of a treatment for CCSVI. As I have said many times, that doesn’t mean that such doctors can’t do high quality studies of these interventions. They just need to declare their conflicts of interest, as do neurologists who participate in clinical trials of drugs.
Thank you for your response Dr. Laupacis. I am somewhat confused though. What conflict of interest should a physician in the United States who is treating CCSVI declare?
I’m not sure that all the physicians in the US who treat CCSVI are testing the benefits of the procedure or publishing the results of the procedures they perform. Some in the US and in Europe have done what I think are observational studies on the safety of balloon angioplasty; so they should declare any income they make or that their institution makes as a conflict of interest?
That is an interesting concept, especially since those of us who have been treated outside the country know that the doctors and/or their institutions are making money. I have just never thought of that as a conflict of interest. I simply thought of it as a professional charging for professional services.
One thing that I find very offensive as an MS patient is the reaction of certain neurologists. I know you can not speak for others, but when I hear medical professionals state things like: “I’ve had 100 patients treated for CCSVI and not one of them has seen any improvement”. Really ? When I hear this, I immediately question their objectivity.
I have personally met more than 100 patients who have been treated, and I asked them all the same question…..”Did you find improvement (even little improvement), and do you regret having the treatment ?” Only 1 person so far has regretted having the treatment, and that person had a stent placed in their jugular.
I’ve had some improvements that have stood the test of time, and others that have not. But to be treated by a neurologist like I’m a total idiot (and yes, this happened to me), I’ve lost faith in this profession, as have many others.
Can you personally recall any other field where one set of experts have taken over the research in a field that is not their specialty? (ex. neurologists leading the reserach in a vascular issue ?). If so, please cite this example for us.
Hi Christopher. A very interesting (and in my opinion valid) point about neurologists’ reaction to the improvements reported by many patients after treatment for CCSVI. I am almost certain that they are not denying that patients are reporting improvements in symptoms like fatigue, fewer problems with cold extremities, etc. What I think they mean is that when they do a neurological examination , they usually don’t see an “objective” improvement in things like balance, strength, etc.
I think this reflects researchers’ general tendency to place more emphasis on biological measures (in the case of MS, changes in MRI lesions, for example) than on patient reported outcomes. This is partly because MRI results are unlikely to respond to the so-called “placebo effect” (the desire all of us have to believe that a treatment that we really WANT to work, WILL work). On the other hand, a symptom like fatigue can be affected by many variables including how well we slept last night, which may have nothing to do with our underlying disease.
However, in the end, what we are trying to do with any treatment is make people feel and function better, so I agree with you that patient-reported outcomes are exceptionally important, and should not be dismissed.
Regarding your question about battles between specialties – I am afraid I am not a medical historian. I do know that historically, cardiologists and nuclear medicine physicians used to battle over who should be performing and reading various cardiac nuclear medicine tests. In the last three decades or so, coronary angioplasty (performed by cardiologists) has substantially replaced coronary artery bypass surgery (performed by cardiac surgeons) – so much so that there isn’t nearly the job market for cardiac surgeons there used to be. However, I can’t tell you whether this switch in technique was done with collegiality or with hostility.
I do know that neurologists and vascular surgeons seem to work very well together when managing patients with stroke, where some patients clearly benefit from a procedure called carotid endarterectomy.
I have heard some people say that they think neurologists are anti-CCSVI because they are afraid of losing patients. I don’t think this is true. Even if high quality trails show that venoplasty is effective in many patients, this is not going to be a cure for MS, and MS neurologists will not “go out of business”.
From what I hear from many MS’ers that are patients at the MS Clinic’s is that most cannot even get a follow up MRI done if they have disclosed they have received CCSVI treatment. In fact most cannot even get an appointment. Their Neuro’s are not interest in seeing them or hearing of improvements. They dismiss them and further encourage with fear that they need to get on the drugs or there is nothing they can do for them. The misinformation about CCSVI and the fear mongering is still taking place in the MS Clinics. There is still no good followup care and referrals from GP’s to vascular doctors are being cancelled once the vascular doc finds out they have MS. They do not want to get involved with the turf war and get in trouble by the College of Physcians and Surgeons. (this has happened) Many MS’ers are not telling their Neuro’s the truth, many have stopped their medication but their doctors don’t know so they can still get an MRI done. Most MS’ers have lost faith and no longer respect the Neuro’s at these MS Clinics but are afraid that speaking out that the Neuro’s might jeopardize their disability or insurance coverage and many have no choice to change doctors depending where they live. This has become a very sad situation and until the Neuro’s start reaching out in a geniune way the trust for all doctors will continue to decline.
People have also told me that they haven’t told their neurologist that they had a procedure for CCSVI. I agree that it is very sad that we have reached the stage where, in some instances, communication is that poor and there is so little trust.
Dear Dr Laupacis, re getting follow-up MRI – my wife received her CCSVI treatment Oct 2010, had her annual MS Clinic check-up June 2011: Neuro said she looked and checked out very well, we asked about getting follow-up MRI to see any differences from pre-procedure MRI (at Mexican Clinic) which we had with us but which he was not interested in looking at, his response was seeing one MRI picture was not going to do any good in this issue, it wouldn’t prove anything. Seemed to me he didn’t want to see any possible proof of the benefits of CCSVI treatment. Any thoughts / comments, thanks, Malcolm.
I am responding to Malcolm’s note from february 14, where he wonders why his wife’s neurologist didn’t order an MRI scan a few months after her venoplasty.
Malcolm – I am not a neurologist and obviously can’t speak for your wife’s neurologist. However, my understanding is that MS plaques can come and go even without treatment, so if her MRI scan looked better than the previous scan, one really wouldn’t know whether the plaques got better spontaneously or because of the venoplasty. Similarly, if the plaques had gotten worse, this wouldn’t mean that the venoplasty was useless; without the venoplasty the plaques might have deteriorated even further.
Although MRI is a useful measure of disease activity in MS, because plaques change spontaneously over time, one can only use MRI to assess the benefit of a treatment for MS by comparing the scans of a number of patients who had a particular treatment with the scans of a number of people who didn’t get the treatment.
I am glad your wife is doing well.
Dear Dr. Laupacis
Back in the dark ages, when I was growing up we trusted our doctors implicitly here in Canada. When they worked on research, that information was usually available, not hidden away. Drugs were discovered and put together in labs where biology was king, not chemistry. Doctors back then were heroes when you were fixed. Nowadays, they are heroes to a few when what is wrong with them can be strung out for years and turned into a money maker for unethical and money hungry doctors – sort of like the one who was on t.v. almost before the news about CCSVI was out there in the public domain calling it a hoax. Ethics used to be a huge strong point for doctors. Now, it appears to be a stumbling block. And strange as it may appear, this only seems to occur where two types of doctors are involved – neurologists and psychiatrists.(two out of every three kids these days has some sort of psychiatric problem and are prescribed go nowhere, do nothing good drugs). Of course the other types, being a part of the ‘Old Boys Club, get walked all over. For example, my G.P. should be able to advise tests for CCSVI, arrange them and see that this is followed up on but cannot – his/her license would be pulled on the say so of a bunch of people who know precious little about MS or CCSVI. To take this insane stance that is prevalent here in Canada is just that – insane, particularly when the proof of it’s safety are out there throughout the world. We did not demand this type of trial for heart or kidney transplants. We did not demand it of people getting limbs re-attached. We did not demand it of any procedure before – only drugs. So what I want to know is why is venopasty for MSers different from every other procedure? It isn’t cost because it is cheaper per person than these useless drugs that do nothing good and lots of things not so good. It is cruel and inhumane to do this to MSers who have already suffered the criticism of doctors and laypeople for years because they have no real understanding of MS symptoms. Where are the ethics?? How are you and your fellow doctors ever going to turn the tide on the loss of trust that is becoming rampant? I’m into my golden years and with this MS it does not appear they are ever going to be golden and MY neuro will sit on his fanny and let me die when there is a possible relief to my symptoms.. Some doctor!
Lots to potentially respond to! I will only make a few comments.
I don’t at all agree with your sweeping negative generalizations about neurologists and psychiatrists. In my view, that kind of unjustified rhetoric makes this controversy unnecessarily polarized. Having said that, I have been disturbed by the condescending reaction I personally have received from some neurologists when I have suggested that a randomized trial of CCSVI is indicated, so I can imagine what some patients have experienced.
All drugs used for MS are not useless. However, in my opinion, none of them are dramatically effective, all have serious side effects, and the price charged for some of them is unjustifiably high.
You are right that the “system” demands randomized trials of drugs, but not always of non-drug treatments. You are also right that some surgical treatments are so dramatically effective that we have not demanded randomized trials before introducing them into routine care (for example solid organ transplantation and hip and knee replacement). However, it is increasingly common to demand randomized trials of devices or surgeries – for example implantable cardiac defibrillators.
Finally, you imply that treatment for CCSVI will decrease your chance of dying. As I mentioned in a previous comment, there is no evidence that treating CCSVI decreases the risk of death, and I think it raises unjustified hope to suggest that it does.
As a CCSVI advocate, I really appreciate your response to Karen above. I think that it is a fair response, though some of the things I may not agree with 100%. You have nevertheless pinpointed a couple of issues; first that fact that some neurologists have reacted negatively to your suggestion that trials move forward.
Second, you question the efficacy of the MS medications and their high price.
One point that I strongly agree with you about is that this entire controversy has polarized the medical community and has strained relationships between MS patients and their neurologists. However, I may add here that MANY family doctors have spoken favorably about the improvements of their MS patients.
As for the last point (CCSVI being a life-saving treatment). I think that what Karen was referring to is that this treatment MAY bring her a quality of life that no other MS treatment can offer. In that sense it is ‘life saving’ as sometimes dignity can be restored, even if only in certain symptoms.
I personally know people who have had CCSVI treatment who no longer suffer from chronic bladder issues. In that sense, this is a ‘life-saving’ treatment.
I have grown to know hundreds of MS patients through this ‘movement’, and for the first time I’ve seen rays of hope.
I’ll post another question above, as I don’t want it to get lost in the heart of this message.
Hi Christopher. Good point about the potentially different interpretations of the term “life saying”. andreas
Dear Dr. Laupacis
I am in my mid 60s. I do not expect to live forever. BUT both sides of my family have longevity on their side- the kind of longevity that would give me about another 30 years of life. This past week I have been laid low with fatigue that never lets up, legs that won’t hold me up (I used to walk to work -7 kms and home every day just because I like walking. Now just going the 6′ from my computer to the door leaves me exhausted for hours). When I have to urinate, I require a catheter which comes with it’s own set of problems, many of them stemming from the fact that I have relatively no feeling in my hands which makes it difficult to hold it in the right place with the right amount of pressure to keep it there without puncturing my bladder.
Standing at the stove to cook a decent meal for myself is often impossible as I tend to fold up at the waist. The temporary aid that helps – strapping my back – is no longer done though it works for me when I can find someone to do it.
I see in your response that you are offended by my sweeping statements. I have accomplished something!! Now at least one doctor knows how I feel when every little thing wrong with me is cavalierly written off as being my MS – a widely used tactic of your fellow doctors to put in a bill for an office visit without doing anything constructive. My experience with doctors in Canada has covered a large area – from Nova Scotia to Vancouver and almost everything in between. And the habit of doing this has had a long history in medicine. Indeed, instead of carry Dr. Penfield’s (and others) studies further, there seems to be a backward slide into studying the likes of Charcot (Gee! Another doctor who dealt with something generally regarded as a predominantly female illness where sweeping diagnosis were made for decades and where all problems were swept into the same bin – you might check out Lyme Disease. Several patients with Lyme Disease have not been diagnosed with it but with MS and have been spoon fed drugs derived from chemicals that have done them more harm than good)
The other reason for the sweeping generalities is that those few doctors who do not buy into this insanity are pretty much in the same boat with us – shut out, ostracized by the vast majority of doctors who deal or dabble in brain diseases and by our government who listens to them.
Regarding the trials – the procedure you mentioned involved the implanting of a foreign body. CCSVI treatment does not require that though it has been done. Angioplasty has been a routine treatment in Canadian Hospitals since the 70s I think. Do trials for people who need stents perhaps but there is no intelligent reason for doing trials for those who do not need them. Emergency rooms are often called upon to do procedures that are not trialed first. And I cannot find one procedure that doesn’t need an outside piece of equipment implanted that has ever been trialed.
I will apologize to all the neuros who do not deal with MS for including them in my sweeping statements. That should have been specified and I didn’t do that. My own experience with MS neuros however, stays pretty much the way I wrote it. With a few exceptions, the ones I have had the misfortune to see have been pontificating, pill pushing Puff balls in love with their own voices – they never shut up long enough to hear yours (or mine).
About those MS drugs. Exactly what benefit and in how many people have they had?? DO not come back and tell me they prevent relapses. That is nothing more than guess work. Relapses in MS come and go at their own speed and without drugs an MSer can go years between relapses. I can find nothing on the Internet nor in the library that says there is any proof of that theory or even how one could scientifically know when a relapse was about to take place or how one would know it had been stopped by these drugs. It is not logical. It smells like a marketer type spin being put on an expensive, useless drug and we see those marketers spins every time we tune into an American TV channel that accepts advertising from pharmaceutical companies.
Gotta go – my catheter is calling )
Hi Dr. Laupacis.
Please help us understand this one.
How can this move forward without double blind clinical trials, but here we sit with impaired blood flow? I’m at a loss. ~Amy
“Toronto doctors first in Canada to perform surgery treating hypertension
Read it on Global News: Global News | Toronto doctors first in Canada to perform surgery treating hypertension ”
I just can’t understand Dr why can patients who have arterial hypertension get this treatment and those with venous hypertension can’t? Its very discriminatory I feel because any form of hypertension is bad for a person no?
First of all, I don’t know anything about renal denervation surgery for hard-to-treat high blood pressure. However, a quick literature search I have just done has found what appears to be a well conducted randomized trial of the surgery which shows dramatic differences in blood pressure between those who got the surgery and those who didn’t (see http://www.ncbi.nlm.nih.gov/pubmed/21093036).
I also notice that there is an editorial in the Lancet accompanying the article entitled “The jury is still out”. i can’t access that editorial from my home computer, but I wouldn’t be surprised if the editorialist is asking for others to replicate the findings in other randomized trials before the surgery is routinely used – precisely the kind of information I think we need about the treatment of CCSVI.
I could not find that this procedure was ever subjected to a phase I trial and i also could not find that any trials on this procedure have been done in Canada. Dr. Rubin has been approved to perform this treatment while Phase III studies care currently underway based on international results to date. This Dr. Rubin who also sits on the CIHR expert committee for CCSVI has been very vocal about the dangers of CCSVI and was also a member who originally voted against studies in Canada. We are all aware of his close association with Dr. Beaudet and the CIHR and it seems the procedures that he supports are subject to different rules and standards. This is the stuff we get very frustrated on. If you could correct me if I am wrong to prove that this procedure that Amy is referring to has been held to the same standards and timing that CCSVI has been held to then we can move on from this point.
Hi Dr. Laupacis.
A friend recently drew this to my attention, and it discusses some of the things that are disturbing to the CCSVI advocates. I have a few questions and I’m interested in hearing your opinion. From Professor Joel Lexchin: ” What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials.”
1. How will this be prevented from happening with CCSVI studies?
2. How will the studies that are biased be eliminated?
3. How will the conflicts of interest be elimianted/regulated?
“The Health Law, Ethics & Policy Seminar Series presents Joel Lexchin – Professor, School of Health Policy and Management, York University
“Those Who Have the Gold Make the Evidence: The Pharmaceutical Industry and Clinical Trials”
Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship.
This talk will discuss the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in industry-funded research is not likely to account for the biases seen.
Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of “seeding” trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries.
There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it’s not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs.
The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials.
Joel Lexchin received his MD from the University of Toronto in 1977 and for the past 24 years has been an emergency physician at the University Health Network. He is currently a Professor in the School of Health Policy and Management at York University. He has been a consultant on pharmaceutical issues for the province of Ontario, various arms of the Canadian federal government, the World Health Organization, the government of New Zealand and the Australian National Prescribing Service. He is the author or co-author of over 100 peer-reviewed articles on topics such as physician prescribing behaviour, pharmaceutical patent issues, the drug approval process and prescription drug promotion.
University of Toronto – Faculty of Law
University of Toronto Faculty of Law: Visitors..”
Most people would agree with Joel that pharmaceutical company funding can introduce biases into the conduct, analysis and reporting of their studies. On the other hand, the pharmaceutical industry DOES design and pay for some high quality clinical trials that provide unbiased information about their drugs.
AN-Wen Chan, a young researcher at the University of Toronto, has published about the disturbing frequency with which researchers have a tendency to publish the positive findings from their studies, and not publish the negative ones – see http://www.ncbi.nlm.nih.gov/pubmed/15161896 for one example.
Interestingly, An-Wen found that biased and incomplete reporting was very common in studies that were NOT sponsored by industry; not only those that were industry sponsored.
That is why people like myself who are long in the tooth and have watched many supposedly fantastic and safe treatments come and go, tend only to be convinced if different researchers studying different populations consistently come up with the same results. That’s why I find the huge variation in the results of studies of CCSVI to date bothersome.
You and others frequently raise questions about the conflicts of interest that some (?many) of the critics of CCSVI in the neurology community have because of their relationships with the pharmaceutical industry. I think that is a legitimate issue to raise, but I don’t think that means that their views should be ignored.
Having raised this, I would still be convinced by positive high quality studies conducted by such individuals, especially if the results are replicated by others.
Dear Dr. Andreas Laupacis,
I really hope we can get trials started at a phase2/3 start with the CIHR because starting at a phase 1 is not only not necessary but a waste of tax payers money and time that MS patients do not have the luxury of.
I was so proud I have had a Premier and Health Minister in Saskatchewan who have heard & read everything I have sent them and really cared to help get this underway sooner than later. In March our first patients from Saskatchewan will be sent down to Albany Medical Center to take part in the FDA approved largest double blind controlled trial. I would hope that if Saskatchewan has the science come back (showing what many of us allready know) that Canada as a whole can start doing this vascular procedure as a treatment for MS.
I want to thank you for taking the time to respond to all of our questions we have had on here. We all really appreciate this open type of communication with you sir.
Agree that what we need is trials focused on determining the benefits of treatment for CCSVI, as well as careful follow up to assess for the frequency of side-effects days to months after the procedure (which have not been well reported).
Here is a paper from Dr. Zamboni outlining the testing procedure for CCSVI. If studies are intended to dispute Dr. Zamboni’s findings then they should be held to this protocol.
MS is caused by a vascular deficiency. It’s time for all provincial governments to step up to the plate and allow angioplasty for all.
Saskatchewan Premier Wall announcment for CCSVI clinical trial partnership with Albany New York. Patients will be sent as early as March 2012 to participate in this double blind treatment study.
Mr. Wall and his government have now made the federal government look like idiots. While they are wasting time assessing trials 1&2 and the safety of this simple procedure that has already been proven safe, they will have documented proof of the results we all know. The feds better learn to get with the program and stop being so arrogant in there way of thinking. I as an Canadian MS patient who has had the procedure done twice by 2 brilliant US doctors want to thank you for your leadership and GUTS that the rest of the country has not shown!
I was treated for CCSVI in Albany NY November 30th 2010. I have been symptom free this whole year and feeling better than I have in my WHOLE LIFE! Everyone that has MS deserves to be treated fairly to find out if they really do have MS/CCSVI or both! Honestly, if we had a broken leg it would be fixed..RIGHT? So many people could have such an improved quality of life, or even be like me, symptom free! The procedure is so simple really…compared to living a whole life in constant suffering! WHERE IS THE LOVE!
Come on Canada!!
I’ve had two CCSVI procedures done in the states, each a year apart. For my second one the person in the bed beside me was having venoplasty done and a stent put in for a blocked vein due to dialysis for diabetes. This same procedure is done for other diseases why on earth can it not be a treatment choice for MS’ers. November 2010 I was told by my neurologist there was nothing more Canada could do for me. I was barely able to use a cane, should of been using a walker, and would of been in a wheel chair by the spring of 2011. I did the only logical choice and had the CCSVI procedure done. As I mentioned I just recently had my second procedure as my veins restenosed. I am now the proud owner of two stents in my Azagos vein. I can’t afford to do this again in the states costing thousands of dollars. I have a right as a Canadian citizen to the best health care.
The above is a polite and factual description of how Canadians with MS must endure many shameless policies and behaviors from its government officals. Any patient in need of medical care has a right to recieve that care. That cruelty is also compounded by denying a MS patient a common and relatively safe procedure to treat a health condition, which also happens to often relieve some MS symptoms. With no objections for patients without MS to have the same treatment, where is the medical justification for this policy? Further research is needed but not at the cost of a patient with MS to keep progressing.
Dear to who is monitoring this page.
I have red it every day.
Dr L has not been in touch since Dec 21 at noon.
Today, I think, is Monday , and the 9th.
It is about 20 days.
Could please, you, let me know if he is coming back.
I am odder but still young to like information.
Happy News Years
Hi Peg. I am just back in the saddle after some time off. I have to go saw my wife’s new hockey stick she got for Christmas so it fits her, but I will then respond to some of the comments posted in the last 3 weeks.
Happy new year.
I have an MS story..but to be honest with you, and trying to be as respectful as the gov’t is being to us, I grow weary of repeating myself…We, my fellow MSers, have been treated with disrespect, disdain and discrimination…I could list all the scientific reasons as to why CCSVI should be accepted by Canada, but that isn’t necessary. For every year we are forced to wait, that’s one step closer to a cane, then the walker, then a wheelchair..AND if one makes it that far, there is that final step to suicide. Just what don’t you get? I wouldn’t wish MS upon my worst enemy, not even those who deny us our God given right to treat OUR bodies as we see fit.
Peace of mind and heart be with you
While I have made the step from a cane, to a walker, and then to a wheelchair when I go outside my home, I can assure you that my next step will NOT be suicide! I think it is ridiculous for anyone to think that all people with MS will resort to suicide or even think about it! I am angry that our government will not allow us the CCSVI treatment in our own country, but suicide is not a viable alternative!
As a patient with MS who had CCSVI treatment, I have four concerns about your conclusions.
1) Studies are subject to non-scientific bias more often than not. Regarless of study size, their subjective data and results still confirm a tendency of CCSVI in pts with MS does overwhelm a tendency of CCSVI presence in other pts. Continuing to study equalivent results but with further scientific data, is less imperative. It is a delay in obtaining relevant data which promotes progression in studies which will directly effect MS pts in a safe and timely manner. Data to date, allows for studys beyond the initial phases.
2) Existing scientific data and research present qualified new conclusions on the state of MS research. To permit a scienific study with incorrect data used to identify which type of disease MS is, can only produce incorrect reults. To correlate research with corrected information allows for more correct results.
3) Adding data from MS pts treated for their CCSVI, adds vital data. The results pts experience from relieving their CCSVI, at any point during recovery, does correlate. It is less scientific and more observational data, but it enforces the tendency of CCSVI to exist in MS pts with a higher frequency than other types of pts. This data correlates with initial data and promotes the need to progress the study.
4) To include anyone with conflicts of interest as a member of the study, in any phases of study processes, removes credibility from the study results. There are no assurances the data can be assured as scientific without bias.
I travelled to Sophia Bulgaria Nov 2011 had Venogram with Balloon Venoplasty of Azygos and both internal jugular veins, it gave me great relief from many symptoms, such as MS hug, breathlessness, choking on food and drinks,. No daytime Fatique nightime insomnia. My walking was a little better for around six months, not so good now I struggle to hobble around.
Dear Dr. Laupacis;
With all due respect, I have receieved information that you are a lobbyist for the Pharmaceutical industry. Can you confirm if that is true. If so how can you be unbiased on this committee.
Could you explain exactly what your involvement is with certain Pharmeceutical companies and how much financial benefit you have received to date.
I hope you understand how very important that CCSVI testing and treatment is for so many waiting and sufferring. We cannot afford anymore intentional roadblocks or political agenda’s to interfere. So we have to question motives and ask questions so we understand what we are up against.
I’m sorry if this seems harsh but MS’ers in this country have been treated with disrespect and poor medical treatment from the MS Clinics for the last two years, they have been ignored unless they agree to drug treatments. They are still being denied follow up care for CCSVI and most Vascular doctors and IR’s will not even take a referral if they hear the word CCSVI and MS because of all the intentional controversy that the MS Neuro’s initiated. These Neuro’s think they own the disease and this is wrong. For over 2 years all we have heard is empty promises and how a new committee will be formed to address CCSVI concerns. Always more delays and starting from scratch, and always with experts that know nothing about CCSVI and no desire to learn.
MS patients have lost trust with their Neuro’s, the College of Physian and Surgeons, their health ministers and the Canadian MS Society.
Canadian MS’ers deserve to have this treatment option in Canada with proper followup care even if they have to pay for it until the proper studies are completed. The decision should be between their physican and themselves to make an informed decision based on the information to date. Dr. Sandy McDonald said it would cost approx $1500.00 for testing and treatment. Some people cannot wait another 5 to 10 years to have a chance of symptom improvements and a chance for improved quality of life. They know their risk of waiting and many have paid the price already. Apparently in Canada we will not provide compassionate care when no other options are available.
This procedure has been held to a level of perfection and processes that have not been applied to other medical procedures. This has become a political and self serving turf war and PWMS have been caught in the middle to fight for their own lives. We need to know that you will be fair and if push comes to shove, you will put the interests of the MS’er above your own.
We need to know that you will call out and dismiss the negative studies that were done incorrectly. If certain studies (like Doepp’s) were intended to disprove Zamboni’s results, would it not be appropriate that he should have followed Zamboni’s exact protocol. There has been 2 official responses refuting Doepp’s study, were these taken into consideration in your summary. In my opinion studies like this were only intended to muddy the waters and cause questions to further delay proper studies.
I look forward to your response.
Thank you Carol for your question asking about conflict of interest concerning our plight of discrimination and denials by those who have no experience or right to dismiss people pw/MS. I once again am very upset to read this and I stand by my comment I made December 10 and Jayden Pall you obviously do not have MS and work alongside with those who have conflict of interest in this matter. I now consider your comment made to me December 15 mute.
This is why I am so angry people who have no business to be in our businessss have no business to make comments. PERIOD.
Please prove us wrong. Please.
The suggestion that I am a lobbyist for the pharmaceutical industry is kind of ironic, because for many years I suspect I was one of the least popular Canadians as far as the Canadian pharmaceutical industry was concerned. From 2003-2006, I was the first Chair of the Canadian Expert Drug Advisory Committee (CEDAC). CEDAC is a committee that recommends to most of Canada’s publicly funded drug plans which drugs should be paid for from the public purse. We based our recommendations on our interpretation of the cost-effectiveness of new drugs, and about half of the time we recommended that the new drugs not be paid for because we did not think they were good value for money. This reflects my strong belief that it is important that we have good evidence about the benefits and cost-effectiveness of new therapies before they are paid for by the public system (I believe that about new drugs and I believe that about treatment for CCSVI).
Having said that, I feel that pharmaceutical companies have produced many drugs that are excellent value for money (I myself take a statin drug to lower my high cholesterol level), and I do interact and work with the pharmaceutical industry on a limited basis. Related to MS, I am a member of two Data Safety Monitoring Boards for Novartis, for which I get paid for my time – one for fingolimod and the other for a drug for MS that has not yet been licensed. The role of the Data Safety Monitoring Board is to independently monitor the results of the trials while they are underway, and to recommend changes to the studies should there be concerns about patient safety.
So,… do I interact with pharmaceutical companies, technology companies and governments? Absolutely.
Do I also interact with patients, health care workers, hospitals and the public? Yes.
Are my views influenced by these interactions? Undoubtedly.
Do these interactions mean that my views should be discounted? No.
Do I think that the views of physicians who are paid for treating patients with CCSVI should be ignored because they are paid for providing the treatment? No.
It is impossible to be involved in health care without interactions with all of the various players involved in health care.
Thank you for responding Dr. Laupacis. As you can see we are a tough crowd and just want answers and action. We appreciate any opportunity to talk with medical professionals both for and against CCSVI. I can see you do not scare away easily and for that I do appreciate your willingness to answer questions and provide us with current updates and suggestions.
Dr. Laupacis, Are you aware of this following information re: stents being used for brain aneurisms , or the Pediatic MS study that finds that: in MS, demyelination is first, followed by inflammation, contrary to the autoimmune theory? So much for those $1300+/month MS meds. The evidence is overwhelming for MS being a vascular problem as opposed to an autoimmune disease.
Global National Promising brain aneurysm treatment
Wed, Dec 28: A procedure is helping aneurysm patients avoid risky brain surgery thanks to some Canadian research. Crystal Goomansingh reports.
Are you aware of this research? : http://www.facebook.com/#!/notes/ccsvi-in-multi
“Dr. Zamboni was the first to suggest that MS lesions looked alot like venous ulcers because of the fibrin cuffs found in both sites of injury. And researchers have noted that fibin deposition comes FIRST, before demylination.”
What’s blood got to do with it?
Researchers are honing in on fibrinogen as a mediator in vascular disease, and they are also finding a link in MS. Fibrinogen is a protein which is made in our livers. It’s the sigaling protein for fibrin, which allows our blood to clot. …
By: CCSVI in Multiple Sclerosis
This is the article re: Pediatric MS: http://www.facebook.com/#!/notes/ashton-embry
Latest Key Finding in Pediatric MS
Studies of pediatric MS have the advantage of determining the factors which cause MS onset because of the small amount of time between the onset of the disease process and its diagnosis…
By: Ashton Embry
I find myself thinking of rust, and how quietly it just comes. There is no explosion, or anything big; it’s quiet but it is the resulting damage of a chemical reaction. Couldn’t this be what the iron is doing to our myelin sheath?
The clock continues to tick.
Hi Judy. I just looked at the news story on the treatment of brain aneurysms with a stent. Very interesting, but I brain aneurysm and MS are such different diseases that I don’t think one can extrapolate treatment from one disorder to the other.
.I AM NOT SCREAMING IT IS JUST I AM A ONE FINGER TYPER LOL..THANK-YOU ..I WANT TO TELL YOU ABOUT MY M.S. STORY…I WAS DIAGNOSED IN 2000 HOWEVER THEY WERE TREATING ME FOR A EAR INFECTION FOR 11 YEARS PRIOR SO NOW THEY FIGURED I HAD M.S IN 1989…I WORKED UNTIL 2006 AND FINALLY COULD NOT DO IT ANYMORE..MY SWEETIE AND I MOVED TO SAKATCHEWAN ,CANADA FOR CHEAPER LIVING WE CAME FROM ALBERTA,CANADA I WAS ON ALL THE SO-CALLED M.S. DRUGS EVEN CHEMO AND THEY JUST MADE ME WORSE & SICK WE WENT ON HOKLIDAYS TO CUBA NOV/09 AND WHILE WE WERE THERE A T.V PROGRAM FROM CANADA CAME ON W5 WAS SAYING THEY FOUND A CURE FOR M.S BUT WE ALL NO IT IS NOT A PROVEN CURE[CCSVI TREATMENT] WE GOT BACK TO CANADA AND I WAS GOING DOWNHILL FAST SO MY SWEETIE GOT ON THE INTERNET TO DO RESEARCH ON CCSVI TREATMENT…SHE GOT ME INTO A STUDY IN MEXICO AND MY FEWELING WAS “WHAT DO I HAVE TO LOSE’ SO WE WENT IN JUNE/10 AND GOT THE TREATMENT…IWAS THE FIRST MALE DONE IN MEXICO..AFTER WE WERE SITTING BY THE OCEAN DRINKING CORONAS AND I SAID TO MY SWEETIE,,,I DO NOT THINK IT HELPS SHE JUST SMILED AND SAID ‘YOU REALIZE HOW HOT IT IS IT IS 110* F” BEFORE TREATMENT THERE IS NO WAY I WOULD HAVE HANDLED THAT..THE NEXT DAY I NOTICED NO FATIGUE AND THE COLOR WAS COMING BACK TO MY LEFT SIDE…WOW,SO WE WENT BACK TO CANADA PEOPLE WERE NOTICING BIG IMPROVMENTS IN MY SPEECH,I COULD CONTROL MY BLADDER AND BOWELS AGAIN..MY WALKING INPROVED SLIGHTLY HOWEVER I DO NOT USE MY CANE ANYMORE OR MY SCOOTER AND MY EYESITE IMPROVED EENOUGH TO GET MY DRIVING LICENSE
AND MY GENERAL DOCTOR NOTICED BIG IMPROVMENTS…MY NEURO SAID ”
YOU ARE THE SAME NO IMPROVMENTS ?? SO I QUIT TAKING ALL M.S. DRUGS MUCH TO HIS DISMAY.. THE TREATMENT GAVE ME MY LIFE BACK..I AM VERY BITTER WITH MY NEURO AND THE M,S. SOCIETY FOR STOPPING THIS I KNOW IT WORKS..FOR SOME PEOPLE THEY GET LITTLE IMPROVEMENT BUT THE TECHNOLEGY IS GETTING BETTER NOW THEY AREE USING BIGGER BALLONS SO LESS RESTENOSIS ALSO THEY ARE TREATING THE VALVES IN YOUR JUGULARS WHICH BEFORE WAS USALLY WHAT CAUSED THE RESTENOSIS THEY ARE CHECKING FOR OTHER THINGS LIKE MAY THURBERS,LYME AND THEY ARE NOW TREATING OTHER VEINS LIKE SINUS IT HAS COME ALONG WAY IN A YEAR PLEASE FEEL FREE TO PRIVATE MESSAGE ME FOR ANY OTHER QUESTIONS WE HAVE TO TAKE CARE FOR US
UPDATE: IN MARCH 2011 MY HEARING CAME BASCK IN MY LEFT EAR IT WAS ABOUT 50 % NOW IT IS 100% I GOT MY HEARING TESTED AND NOW THEY ARE SAYING MY RIGHT[WHICH WAS MY GOOD EAR] IS WORSE THAN MY LEFT
I would like to know why we must go through such a long proceedure to get treatment trials underway. There are several trial already in process.
Why can we not just add Canadian centers to existing trials? It would increase the size of those existing trials, making them multicenter, and thus improving the quality of the results. Since theses trials are already IRB approved, it should shorten the time to get underway.
I did not want to wait any longer, so I am a subject in the PREMiSe study by the University at Buffalo. It seems to do everything we want, comparing diagnostic modalities (Doppler US, MRV, CTV, IVUS, OCT), with a double blinded treatment /sham group, who undergo extensive evaluations as to physical and cognitive function.Plus there are blood draws for other tests.
When I asked why we couldn’t have other centers replicate this trial, it was suggested that it might be a matter of EGO… researchers wouldn’t want to do it unless they are principal investigators.
I hope this isn’t the only reason….
I have a feeling this is the reason Jim. It is a sad state when EGO come into play.
This is a world wide problem and those who have no expertise in CCSVI are the ones who seem to have the same script in their negative thinking or trying road bocks to prolong the results we have already seen and have been part of.
In some instances it may be preferable to have different trials with slightly different designs, because if they all show the same result, that increases one’s confidence in the results. That said, it would be very important to try to ensure that at least some of the outcome measures used in the various trials are the same, so the results of the various trials can be carefully compared, and combined when possible.
The fact that a study is IRB approved in a country outside of Canada won’t shorten the time it takes for it to get approved by Canadian IRBs, because each IRB looks at the study that comes before it independently.
There are MANY people who have been misdiagnosed with MS, who have Lyme disease.
The Western Blot test is the test they NEED as the first offense. If they have this test and test negative, they should be tested for CCSVI and treated to correct it. The many people who have been treated for CCSVI and show little to no improvement, could very well have Lyme disease (they could have BOTH).
As someone who has been horribly misdiagnosed for over 10 years, I know the proper diagnosis and coinciding treatment is paramount to recovery.
I had this treatment in Albany/Latham, NY on June 8, 2010, and I have had amazing improvements. I was first misdiagnosed with a brain tumour in 1997, which was in fact, my first MS attack. I was finally diagnosed with MS in 2008. Even some things I didn’t attribute to MS have improved, and I have had improvements on my improvements.
I can now swallow and cough properly (which I hadn’t done in years). Facebook is where I met all of these wonderful people who commented, and it saved my life. My biological father died of MS on May 6, 2004, and I watched him die. It was a devastating experience for me. It was all because he couldn’t swallow or cough (he aspirated on a breakfast drink). We are not “desperate”, we are sensible and intelligent people who give our informed consent to have this treatment; repeatedly, if necessary, because feeling normal is terribly addicting. We follow VERY closely, every bit of information that emerges, so please never underestimate us; we are a fiercely determined bunch.
To deny this simple, minimally invasive treatment to the many of us in Canada, is like signing their death warrant needlessly. Give it a fighting chance. We do hear from the people that this unfortunately isn’t successful for, but they still stand in total belief that this can possibly stop MS if caught early enough. The damage that has been done may be too extensive for them, but may show improvements over time and be wonderful surprises.
I am now in college trying to get a new career going, because my former one would take many years to develop again. We’re keeping on, keeping on, and we have hopes and dreams just as you do.
I’m sure you already know about this, but just in case you’ve missed it, I’m including the link to the ISNVD 2nd Annual meeting in Orlando, Florida in February. I was treated for CCSVI almost 18 months ago and had many symptoms relieved.
Thanks. Dr Dueck is presenting the results of our systematic review at that meeting. Andreas
Dear Dr AL
What benefits for private clinics here in Canada?
Does the CIHR consider this.
How can we help you?
It is fine to after Season Greeting Respond.
Marry Chritmas to you and your family.
Best warm thoughts, Peg
Was it the heart attack that caused the build-up of plaque in the arteries??
How possibly would having MS which is an interruption in routine messages cause the jugular and azygus veins to develop malformations (which can include webbing or other such inteference) ??
There is simply too much evidence to ignore any further. For 180 years, the vascular connection to MS, which is well-documented in the MS literature, has been brought up by different physicians; nobody knew what to do with this information until Dr. Zamboni. So this information just got swept under th rug so to speak. I know that you don’t like comparing MS to a leg ulcer; but that’s exactly what’s happening, only not as dramatic. The formation of MS plaques along the path of the veins, the directionality of these plaques away from these plaques, the iron deposits, the perivenous cuffing being evident in MS plaques being similar to a variety of perivenous tissue reaction observed in a variety of anotomic territories where there is chronic obstruction of a venous bed, and the multitude of copy variations that the immune system in, and the vascular malformations of CCSVI share. Also, CCSVI being found in 60 % of pediatric MS would suggest a causal relationship to MS. I don’t want to seem like I’m over-simplifying things too much; but it really isn’t that complicated. One could even compare this to a dot-dot picture in a child’s coloring book: the lines being veins, and the dots being the MS plaques.
In an article by Julie Stachowiak, PhD, she explains why the difficulty of replicating CCSVI research and why the varied results; relating these variances to structures found in the veins of autopsied MS patients. (http:www.msabout.com/b/2011/10/25/a-ccsvi-breakthrough-i-so.htm?r=facebook). Would you please speak to Dr. Stachowiak? Dr. Ashton Embry, PhD from Alberta, and Dr. Kirsty Duncan PhD, MP Etobicoke North are research scientists who are also certainly well worth consulting. It would be a monstrous shame not to begin CCSVI research trials in Phase III at least.
I’m sorry I didn’t get this in with the first comments I posted for you.
I would like to thank you for giving us the chance to communicate with you.
And, I would like to wish you a Very Merry Christmas.
In November 2009, when W5 aired their program re: Dr. Paolo Zamboni (a Vascular Surgeon of 30 years and a University Professor), and his wonderful research, many, many countries rose to the occasion and embraced this wonderful, exciting research; but not Canada. Canadian MS researchers were heard loud and clear, denouncing CCSVI treatment as a “hoax“.
The International Union of Phlebology has classified CCSVI as a truncular, venous malformation preceding MS lesion. Some of the physicians treating CCSVI, consider it to be a `hemodynamic condition which results in venous microhemorrhage, cerebral hypertension and cerebral atrophy. (Brain shrinkage occurs in MS). The fact that venous insufficiency can cause“ acute neurological disturbances was convincingly demonstrated in a case reported about a patient with a patent arm arteriovenous shunt who developed headaches, gait disturbance, and cognitive dysfunction that significantly improved after litigation of that shunt.“ Some of the physicians feel that it is“ quite possible that some of the protean manifestations of MS, including fatigue and lethargy, headaches, and cognitive dysfunction may actually represent symptoms of CCSVI itself.“ At first my neurologist was supportive enough to order a Doppler Ultrasound to be done in Port Perry which was covered by OHIP at that time; I was positive for 3 out of 5 criteria for CCSVI. My neurologist was going to complete the paper work for me to have the CCSVI treatment out of country covered by OHIP, but then declined after listening to “other neurologists.“ After numerous attempts, I finally found a GP in Brockville who was supportive enough to complete this paperwork. I had CCSVI treatment on March 5, 2011 in Alexandria, Egypt. I have had many good improvement since then as evidenced by my warm extremeties, better color, decreased spasticity, improved strength, flexibility, endurance (as evidenced by 3 physiotherapy reports), my first ever good MRI scan, my managing to get my driver`s license back, my not needing air-conditioning in the summer etc.
It seems that the government does not cover anything that is any good at all for our MS, such as LDN (low dose naltresone) about $40 per month, CCSVI treatment that if done in Canada has been estimated to cost approx. $1500, or supplements. I have gone through the process, and am scheduled to have my in person hearing with OHIP, and the Health Services and Appeal & Review Board on Feb. 7.
Some day if somebody ( who Stephen Harper trusts) could get through to him that this whole situation ( the mishandling of CCSVI and MS) is so bad economically in every way, as well as terrible for these Canadian patients, he may straighten things out.
It`s just sad that in the meantime, over 30 people each month are going to die.
Not all Canadian MS patients can afford to go out of the country for treatment. It has mainly because of these people that this has been almost like a full time job to advocate for this treatment to be done in Canada. If, this surgical procedure has to undergo studies; it should start at phase III. I repeat, again, that I do not feel this procedure can be shammed. I cannot believe that we are really just being denied oxygen here in Canada.
Thanks Judy. I know of absolutely no evidence that CCSVI decreases the likelihood of death in patients with CCSVI. Are you implying that you are aware of such evidence?
I agree with you that we know enough about the immediate harms of treatment for CCSVI that it is sensible to proceed to a larger study looking at benefit.
Dr. Laupacis, I don’t understand the first couple of sentences of your response. The only statistic that I am familiar with is that 400 MS/CCSVI patients succumb to their disease each year in Canada.
I am glad that you are in favor of the larger study.
Hi Judy. Sorry that I wasn’t clear.
I interpreted your comment “It`s just sad that in the meantime, over 30 people each month are going to die” as implying that some of those people wouldn’t have died if they had access to treatment for CCSVI. My point was that there is absolutely no evidence that CCSVI decreases the risk of dying in people with MS (that I am aware of), and it is important not to imply that it does.
I made this point because it is quite common for those advocating for a new treatment (for example, drug companies) to point out how bad a particular disease is, but to downplay the really important issue, which is how much the new treatment actually improves the disease.
To use an example outside of MS, those suggesting that the government should pay for new drugs to treat dementia often point out how devastating dementia is to patients and their families. My reaction to that information is that I totally get that (my dad died of dementia, and I had a front row seat view of how it affected him, my mom, and his ability to interact with his young grandchildren). However, the fact that dementia is a bad disease is almost irrelevant if we are discussing whether a new drug treatment for dementia should be paid for by the health care system. What is most relevant for that decision is how much the new drug would improve my dad’s mental status, and whether it would decrease the burden on my mom who was looking after him. The reality is that, although drugs for dementia have some benefit, the benefit is small and comes at the expense of some drug-related side-effects (so we decided not to treat my dad with those drugs).
Dr. Laupacis, I appreciate what you’re saying here; I really do. But what comes to my mind here are two things: the International results to CCSVI treatment. (for example,as reported by M.P. Dr. Kirsty Duncan) 1/3 of those treated seem to have dramatic results, 1/3 those treated seem to experience more moderate results, while 1/3 seem to just remain unchanged. My question for you then is: Wouldn’t just stopping this wretched disease in it’s tracks be valuable enough?
The second thing that comes to mind is this; and I will use my father as an example. My father had experienced heart problems for a number of years. In 1985, he had emergency bypass surgery: a triple bypass. He lived until 1990. Was it worth it? Believe me; any amount of extra time we got with that man was way worth it. Who decides? I think even stopping a relentless disease in it’s tracks is worth it.
thank you for this opportunity! I am one of the patients that this procedure did not work for me, but I still believe I this 100% and I proudly advocate this. I find it wrong that no doctor is willing to follow up on me because I have MS! I am truly disappointed. After my California treatment last may (I got it done the first time in Bulgaria, on october of 2010). Anyhow, the doctor that treated me in california now told me that my valves are too small for my veins making it nearly impossible to have proper blood flow (in my opinion, this is a birth defect and I should be able to get some type of treatment. The doctor said until they invent prosthetic valves, then there could be some hope for me. Are we close? I hope so . Being refused treatment because I have MS is wrong and criminal. Research, research, research!
CVI (Chronic Venous Insufficiency) has been an accepted medical condition for many years. Angioplasty as a treatment procedure has also been accepted for many years. Now that “cerebrospinal” has been added to specify particular veins and angioplasty is now used as a treatment to possibly improve symptoms that have been attributed to Multiple Sclerosis, it is now considered “controversial”. This really does not make sense to me.
I lived for more than 20 years with absolutely no hope for improvement. I risked my life for pharmaceutical science by being a guinea pig for an experimental drug (Lanercept). The trial had to be halted after 7 months because patients on the drug (including myself on the low-dose) were getting worse. I am still haunted by the extreme hallucinations I had. When some drugs were finally approved that MIGHT reduce the number of attacks or POSSIBLY decrease the severity of attacks, I wasn’t qualified to take them because I was now secondary/progressive and they were only for relapsing/remitting.
They told me I’d just get worse–no hope for me! Until CCSVI was found to be related to MS–maybe I had some hope! But it didn’t matter that I had previously risked my life to try to find something to help MS–Canada didn’t believe they had any responsibility to possibly ease my suffering even though other Canadians who hadn’t been labeled with the MS curse could receive venous angioplasty for other conditions. I lost my trust that the Canadian government wants the best for Canadians. They refused to allow a minimally invasive procedure even though there was absolutely no other treatment available for me–so much for the Declaration of Helsinki!
I agree with ALL the below statements. It would be reduntant for me to re-type the same opinions. I’ve had the treatment twice as well and found it to be “a life changer”! I feel everyone should be entitiled to the choice of this, do not discriminate based upon MS. They really do not know a whole lot about this disease, I have many articles that say, “Unknown etiology.” Please give us a chance to live because by stalling this, you (the government, the society, and the medical professionals) effectively are killing us! I thought the first philosophy of the hyppocratic oath was do no harm. By stalling this treatment, that is exactally what is happening. Please re-consider the position, we would be most eternally grateful.
Thank you and I look forward to faster change on the horizon,
First thank you Dr. Laupacis for your interest and allowing us to comment.
Second, I have been treated for CCSVI twice in Albany at a cost of close to 18000. It has improved my quality of life 100%. I have SPMS and been battling this disease for over 21 years and the veinoplasty/ angioplasty is the ONLY treatment that has helped my symptoms. It has helped get rid of my cog fog, tinnitus,depression , spasms and mobility are better, I have my balance back, no fatigue, bladder,bowel,sleep, all improved. I am myself again and my husband and kids have their wife and mom back. I still have mobility issues but that’s it. I don’t feel sick at all and enjoy living life again.
It is shameful that the neurologists, ms society, Canada, won’t put their greed and pride aside and allow us this simple angioplasty here in Canada.
Hi Maria. Your experience, as well as the experience of others, is compelling. However, people who have not responded to venoplasty are much less likely to publicly talk about their experience than those who feel better. Therefore, I do feel that we need complete information from a large number of patients who have undergone venoplasty, compared with others who have not had venoplasty, before the procedure is funded by the public system. It is too bad that high quality studies have not yet been done by the proponents of the procedure.
I agree with you that the controversy about this issue, and the passions felt on both sides, has led to an unfortunate split among some patients and neurologists.
I agree we need both good and bad and or no results but no one wants to follow us. Nothing is 100% per cent effective and also huge depends on the individual’s disease progression. But either way we should be allowed to try it here in Canada. People without ms get this procedure done daily here ,in their arteries, legs, renal veins. There is no mystery in this procedure and the vascular doctors are ready and willing and able to do this ,if given the go ahead. It makes no sense that this has to be 100% proven effective and they don’t do trials on procedures for goodness sake. Drugs are fast tracked at an alarming rate and deaths are numerous but that is okay! Gilenya was must approved and there is already a death! Tysabri was recalled because of the pml and deaths but then approved again and the deaths and pml are increasing again. I don’t understand the rationale behind not allowing us a simple angioplasty. Proper blood flow to all parts of your body is vital no matter if you have ms or not! Thank you for taking the time to read this.
My spin on the MSSC letter for caregivers to write our government to have another drug covered for PWMS.
This simple procedure gave me the love of my life back.
This is how I would like to see the MSSC supporting my wife and the thousands of other PWMS fight for this procedure that has helped so many.
For MS Patients and Caregivers/Care Partners, though it is the holiday season and you are likely busy preparing for upcoming festivities, we hope that you will take a few minutes to review this message and respond.
Starting December 15, 2011, Patients, Caregivers and Patient Groups can provide input into BC’s Medicare’s Procedure review process for:
Generic name: Angioplasty
Brand name: Venous Angioplasty
Procedure used for: To treat CCSVI (Chronic cerebrospinal venous insufficiency) this is the first non pharmaceutical approach in treating MS symptoms. If you would like to see this non-invasive procedure covered by BC Medicare. Please complete the patient and caregiver input process on the link below. The opportunity for input closes on January 12, 2012.
The BC and Yukon Division of the MS Society of Canada along with the BC chapters will provide input as patient groups however it is critically important that the Ministry of Health also hears from many people living with CCSVI / MS and their caregivers/family. This is your opportunity to help determine which non drug therapies are available for people with CCSVI / MS in BC.
To provide input, please visit the Ministry of Health website at
The input process is simple and asks just a few questions such as:
• How does CCSVI / MS affect your day to day life or the day to day life of someone you care for?
• Have you had Venous Angioplasty to treat CCSVI? If so, what effects did you experience?
• What Drug treatments have you used and have any ever helped?
• What do you expect from a procedure that is preformed daily for Canadians’ without the label of MS?
• Are there additional factors that should be considered in reviewing this procedure, ie better quality of life, less side effects, reduced days off work, etc?
IMPORTANT: Input for the procedure listed above must be received by the Ministry of Health no later than MIDNIGHT on January 12, 2012.
IT HAS BEEN 18 MONTHS SINCE MY CCSVI PROCEDURE AND NOW I AM DRUG FREE AND DOING GREAT….THE SO=CALLED EXPERTS CAN NOT SAY 18 MONTHS IS A “PLACEBO” IT WORKS AND THEIR IS 1000′S OF MSER’S WHO HAVE GOT IT DONE AND GOT THEIR LIFES BACK….JUST ASK THE EXPERTS …WHO LIVE WITH IT DAILY…
I have had vein issues before I ever had MS. They were supposedly just varicose but no one had any problems removing them. I have seen a phlebologist that wanted another vein pulled to prevent thrombosis of the leg. Why are we only concerned with the blood that flows through arteries and not concerned with the blood that provides the body with oxygen. Oxygen helps the body stay agile and keeps the brain healthy. I am tired of MS supporting health aide stores. I believe PWMS would much rather help society. My CCSVI treatment was not poor. Canada buys Siemens equipment from Germany so why is their equipment okay but their studies are poor. It is time for Canada to create a federal budget. Pront0!
Please watch this 6 minute video taped by Dr David Hubbard from San Diego CA. He is a Neurologist who is very well versed in the topic of CCSVI. He is currently doing research on the hypothesis and is about to publish results in the New Year. I am one of the anecdotal evidence patients treated in 2010. I am still realizing huge gains from this after 2 years, but I understand my testimonial does not stand up in the eyes of science, so I would appreciate if you would hear it from a scientist.
Please follow the link below.
Thanks Tami. Carol Prest also forwarded a link to Dr. Hubbard’s video.
I have to say, with all respect to Dr. Hubbard, that I found the video unimpressive and misleading.
First of all, he doesn’t acknowledge the huge difference in the results of various studies that have attempted to diagnose CCSVI, with some studies finding CCSVI in all patients with MS and other studies finding CCSVI in no patients with MS.
I find this omission particularly surprising since Dr Hubbard is a coauthor on a paper suggesting a research agenda in CCSVI – see http://download.journals.elsevierhealth.com/pdfs/journals/1051-0443/PIIS1051044311007597.pdf
To quote from this paper: “Much discussion was centered on the understanding that much work needs to be done to better define, explore and prove the concept of venous outflow obstruction playing a role in the pathogenesis of MS. Although others have raised this issue in the past, it remains, at best, poorly understood. Therefore, much investigation needs to be done in this area.”
Another quote from the article: “There was near universal agreement that randomized trials would be required to confirm the role of venous interventions in MS.”
I agree with these quotes from Dr. Hubbard and his colleagues. Therefore, I find it exceptionally odd that in his video, Dr Hubbard makes it sound like we absolutely know that CCSVI causes MS, and that venoplasty works.
What does Dr. Hubbard really believe?
It also strikes me as totally inappropriate to equate treating varicose veins in the leg with treating neck veins in people with MS. Is Dr. Hubbard saying that if a drug is found to improve varicose veins, that it will for sure improve the symptoms of people with MS? I sure wouldn’t say that. The brain is an incredibly complex, fragile organ, and one needs to do specific studies in patients with MS. One can’t extrapolate from studies done in other diseases, in other parts of the body.
Thank you Tami and Dr Laupacis,
As you know the Science Board of the CCSVI Coalition has requested a panel discussion of CCSVI with CIHR. Dr Hubbard would love to debate these issues with Dr Laupacis or any neurologist in his CIHR review group.
Dr. Laupacis, In an article by Julie Stachowiak, Ph.D., the difficulty replicating CCSVI research is explained. It explains why the varied results to CCSVI treatment; relating these variances to structures found in the veins of autopsied MS patients and healthy controls. (http://www.msabout.com/b/2011/10/25/a-ccsvi-breakthrough-i-think-so.htm?r=facebook).
Hi Dr. Laupacis, I am attaching a video that Dr. David Hubbard posted a few day ago. He is an American Neurologist who son Devan has been diagnosed with MS. Dr. Hubbard then decided to research all the studies past and present and hooked up with Dr. Zamboni and has been collaborating with him and Dr. Haacke on a regular basis. Dr. Hubbard also came to Canada to do a presentation to many of our members of parliament (arranged by Kirsty Duncan) on his own dime I might add in support of CCSVI testing and treatment. His family started the Hubbard foundation and is currently doing an observational study. This was all based on the improvements that his son received from CCSVI treatment.
I thought you might be interested in his video which he tries to explain his findings and the obstacles that he and many are facing in getting proper studies completed. I know that Dr. Hubbard, Dr. Sandy McDonald and others who are familiar with this procedure would be more than happy to discuss or further clarify any points that may still be of concern. I would encourage such a discussion.
As you can tell, we are very passionate about getting CCSVI treatment available in Canada as soon as possible. We recognize that proper followup care is essential for it’s success and no matter what any politician or MS Society member is saying, this is still not happening due to the fact that IR’s and vascular specialists are afraid to even talk to a MS patient (even with a referral from their GP). The MS Clinics are continuing to fear monger and mislead their patients and in some cases refuse to see an MS’er if they have been treated for CCSVI. They are withholding MRI’s post procedure and cancelling appointments. They are counting on dragging this out for many years to preserve their turf. If CCSVI wasn’t working do you not think the MS’ers themselves would be the ones shutting this down.
I truly appreciate that you are trying to help and look forward to your next update.
All we want is honesty, transparency, respect and a bit of compassion. Canadian MS survivors and their families are entitled to this.
Another study for you to review
This study was done in 2006
“In conclusion, MS deﬁnitely shows many of the characteristics associated with vascular inﬂammatory phenomena, underscoring signiﬁcant roles of the
cerebral vascular system, cerebral vascular inﬂammation and defects with the blood–brain barrier in active MS. The well documented immune components of MS must interact with the vascular system in introducing and maintaining the cells which drive the inﬂammatory response and involve the expression of adhesive determinants (under the control of unbalanced cytokines), their penetration and destruction of the BBB and the development of the MS lesion, all of which may be future targets with immunomodulating drugs and regulatory cytokines.”
Please see my response to Tami McGregor’s post. Andreas
Thank-you for your previous reponse, Dr. Laupacis. In light of the fact that your “Canadian CCSVI Systematic Review Group” is being funded by the CIHR, how much direction is your group being given by the CIHR? How much involvement does the CIHR have with your group, your decisions and your statements?
The CIHR funding came through an initiative called “Evidence-on Tap – Expedited Knowledge Synthesis” , which was first established in 2008 Basically, the CIHR selected a number of groups across the country who were felt to have the capacity to do high quality systematic reviews of the evidence regarding almost any health-related topic. A group at St. Michael’s Hospital that I led was selected to be one of these groups.
The main purpose of these review groups is to have them available to rapidly conduct policy relevant systematic reviews at the request of Ministries of Health and health care institutions across the country (see http://www.cihr-irsc.gc.ca/e/43989.html) . For example, at the request of the Ontario Ministry of Health our group did a systematic review about what is known about successful “Health in All Policies” across the world (HIAP is a fancy way of saying that a government’s health policy should not only focus on health care, but policies about housing, public transit, the environment, etc. affect health as well).
In the case of the CCSVI systematic review, the CIHR itself requested the review, in order to provide its Working Group with up to date evidence from the scientific literature.
In terms of how we have interacted with the CIHR, we have done our work entirely independently. Prior to each report (we have done 2 to date), I have asked all members of the CIHR Working Group if they know of any studies that they think should be included in our review (to date they haven’t identified any we weren’t already aware of). I presented the results of our first review to the Working Group at a face-to-face meeting they had in June 2011, and answered their questions. The second review was emailed to the Chair of the Working Group a week before we posted it on our web site, but there was no communication about it.
In summary, the CIHR identified the topic for our systematic review, but we have conducted the review independently from the CIHR.
I was diagnosed in April of 2004. I was immediately started on the Disease Modifying Drugs. They are not supposed to help you feel better but are supposed to reduce the number and severity of relapses. They made me worse and each year I had more and more attacks (I was having 5-6 a year). The only thing left for me was Tysabri which almost 2 in 1000 people will get PML or Chemo. Neither of these drugs are safe and yet they are readily prescribed. In March 2011 I went to the United States for venoplasty. Not only did my relapses stop, I also had improvements in my symptoms, something the drugs never offered. Venoplasty is safe. As a Canadian, I should be allowed to have this treatment in my own Country! I would even pay for it to be done here. How many complications arise from Breast Augmentation or Tonsillectomies? About the same as venoplasty? We already know it’s a safe procedure and the stall tactics that are being done are incomprehensibe. I believe, as many other’s do that the Pharmaceutical companies are playiing a big role in the Neuro’s and MSSC decision to drag their feet. No other treatment has undergone such rigorous testing. Quit stalling Canada and let us have what every other Canadian can have (unless you have MS too).
Some of the comments posted on this site over the weekend have made me wonder the following. Since the provinces don’t fund venoplasty for CCSVI, there is nothing to stop physicians from doing the procedure outside of the health care system (if the provinces paid for the procedure it would be illegal to do so, because one can’t charge patients for something that is covered by the publicly funded system). Why don’t Canadian clinics offer the procedure privately?
I was involved in a project that asked a group of Toronto citizens outside the health care system to deliberate about the CCSVI issue. They were not unanimous in their views, but many of them felt that Canadian MS patients should be offered the option of treatment for CCSVI in Canada – see http://healthydebate.ca/wordpress/wp-content/uploads/2010/12/Multiple_Sclerosis_Citizens_Council_Report.pdf for the full report.
Hello Dr. Laupacis, I fnd this very interesting I will be booking an appointment with my vascular surgeon for January at St. Mikes I would be thrilled if this could be paid and treated here should I need it again, hoping not but 2012 will tell, obviously we’d all prefer not to pay but I’d still rather my money stay in Canada. Thank you Sandra
When you say “there is nothing to stop physicians from doing the procedure outside of the health care system” I am reminded that I was at a meeting in Nov./2010 where a private interventional radiologist advised their private clinic had been informed by the College of Physicians and Surgeons of BC that anybody performing treatment for CCSVI would be reprimanded and could lose their license to practice medicine. That might answer your question “Why don’t Canadian clinics offer the procedure privately?” See what we’re up against?
Just to update you my treatment in California on Dec 21 was as successful as my first in Egypt, so it’s now proven to me twice CCSVI is the real deal, vision returned immediately and right arm is no longer numb too many people can’t afford to wait any longer. We deserve a chance to live productive lives!!
Apparently if you have heart disease in Canada, experimental treatment can be done with out clinical trials to treat valve issues and anyone can receive this experimental treatment within 5 months, but if you have MS getting your valves treated in veins will take a 4 phase clinical trial and a 10 year wait.
CCSVI Treatment Double Standard – First Experimental Heart Valve June 2011 to 50,000 treated by November 2011
by CCSVI in MS Toronto on Tuesday, November 29, 2011 at 6:03pm
“June 7 2011 St. Jude Medical Announces First Implant of Portico Transcatheter Heart Valve: St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first human implant of its Portico™ transcatheter aortic heart valve. The procedure was performed by Dr. John Webb, director of cardiac catheterization and interventional cardiology at St. Paul’s Hospital in Vancouver, British Columbia.” – BusinessWire
BC doctor makes open heart surgery, history: A BC doctor invents a cutting-edge medical procedure that could help patients avoid open heart surgery. – Global National TV November 28 2011
Global TV Video:
So they did this first treatment on humans on June 2011 in Vancouver BC, and already this experimental treatment is being done at over 10-centres across Canada, 5-months later. In the Global TV video Dr. John Webb says that this new experimental treatment has been offered to 50,000 patients in Canada and around the globe already”
This is the frustration Canadian MS’er are dealing with, the standard of perfection that CCSVI testing and treatment has been held to is like none other. This is not a drug trial. Progressive MS patients have no options except for angioplasty for any chance of improved quality of life. They should at the very least be accepted for treatment on compassionate basis. Doctors and patients should be free to discuss and have options to try experimentals treatments. They know the risks and trust me they also know the risks of no treatment and where they will end up. Phase I trials are redundant and are only being used as another stall tactic to benefit MS Neuro’s not the MS patient.
Sir, You have opened the door to discussion. My daughter was diagnosed with an unproven autoimmune disease MS 9 years ago, she was given drugs that seemed to make her worse. Her neurologists walked out on us at her last appointment, my daughter had received the procedure for a proven vascular disease and was doing great.
How I ask can you be doing trials on a proven vascular procedure, using angioplasy when you have not proven what you call MS an auto immune disease.
Can you or any neurologist say with certainty that my daughter or all the thousands like her in Canada actually have MS an auto immune disease? which drugs are prescribed freely for. Or have many been misdiagnosed, which I believe my daughter has been, and actually has a proven vascular disease, which there is a proven vascular procedure to help them (angioplasty). A very simple procedure that I have been witness too, and also have been witness to 100′s of people like my daughter find such wonderful results from, including people getting out of wheelchairs, drugs have never had such results.
Why sir should they be fighting for their lives paying thousands of dollars out to go across the border to receive this procedure?. When the only hope you can give them is 10-12 years of trials for something hundreds of doctors are already doing
around the world.
I feel if Canada had joined in the procedure for CCSVI you would have found the most important thing right now is finding the answer to how to stop the restonosing. This will come because we know these doctors are on their side and are fighting for the answers and they will get there!
Of course research and standerizing are very important but this is also being dealt with by many of these doctors, the only difference is they are doing it along side the procedure and the patients input.
Of course this is not proper protocol as far as the neurologists and MS Society. Who would want to prove the procedure for CCSVI works when they have not proven their own theory an auto immune disease as MS. I guess all of you in the medical service are Ok with this but not Ok with a procedure that is done every day in Canada.
If this is the case maybe all angioplasty should be stopped while you prove it is safe.
Hi Candy. I obviously can’t comment on the specifics of your daughter’s medical condition. I am glad that it sounds like she is getting better.
Lori Batchelor also suggested that because angioplasty has been shown to be effective for the management of heart disease and venoplasty is used for some conditions (actually, not that many) , specific studies do not need to be done of venoplasty of the jugular veins in people with MS.
I, respectfully, disagree. The fact that dilating the ARTERIES of people with heart disease has been shown to be beneficial (after many, many randomized trials were conducted) does not mean that dilating the VEINS of people with MS will do more good than harm. These diseases are so different that almost all physicians would say that separate studies need to be done for these different populations.
A couple of decades ago, neurosurgeons undertook two procedures to treat narrowing of the arteries supplying blood to the brain in people who had suffered a mini stroke. One was called a carotid endarterectomy (CE) and the other extracranial-intracranial artery bypass (ECIC). After randomized trials of these two procedures, both of which improved blood flow to the brain were done, it was found that CE was extremely beneficial, but ECIC bypass did more harm than good. Because of those well done studies, ECIC bypass is almost never done now, and CE is done routinely. That’s the kind of information we need, in my opinion, about treatment of CCSVI.
Thank you for the opportunity to comment, however I do feel we have been totally ignored and let down by our government and the group supposed to be advocating for us the MSSC. I had venoplasty in Dec 2010 and am heading back for round two in one week, as I had awesome results 95% relief of symptoms from proper blood flow I will now make sure my blood is flowing properly so I can continue living my life with some quality, keeping us sick is only a drain on society. Proper blood flow should be available to all Canadians all of the time, not something that requires travel outside of our country and could eventually bankrupt us!!
Hi Sandra. I hope your second procedure goes well.
I don’t mean to sound callous when I say this, but I understand why Canada’s provincial Ministries of Health aren’t paying for endovascular treatment for MS at the present time as part of routine care. There are still great uncertainties about how to diagnose CCSVI. For example, a study from six centres, one of which was Dr. McDonald’s lab in Barrie, found huge variations in the frequency with which the various components that need to be evaluated to diagnose CCSVI were positive – reflux in the intracranial veins was positive in 26% of patients in one centre and 91% in another centre (reference 38 in our November 2011 report). It seems that different labs do not agree with each other about how to diagnose CCSVI, which I think is a major problem
In terms of treatment, even Dr Zamboni says that there need to be randomized trials of endovascular therapy in order for us to truly understand its benefits (reference 12 in our report).
If there is convincing evidence from high quality randomized trials that endovascular therapy provides benefit to patients, then I agree with you that our governments should pay for the treatment.
I just feel a need to say that “money” isn’t/shouldn’t be the deciding factor in whether a medical treatment is “allowed”. You might be surprised how many people would be happy to pay for this treatment themselves if they could just have it in a convenient place, close to home.
I also want to point out, there is absolutely no treatment available for people with progressive forms of MS. They are just left to get worse until they die.
I want to point out that Canada is a member of this organization–WMA Declaration of Helsinki–and should follow its ethical practices! Please note:
“35. In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.”
There is no acceptable excuse not to give people a chance at a better quality of life!
Sorry, I forgot to post the link:
I feel that treatments that have definitively been shown to be effective should be made available within our health care system to people, without patients having to pay for them (assuming the price charged isn’t exorbitant).
Unfortunately, in my opinion, the studies of CCSVI have in general been of such poor quality that we still don’t know whether treatment is effective, and we aren’t even sure how to diagnose CCSVI. This afternoon I was reading a “Special communication” from a group of physicians working in the area of CCSVI, and what they basically said is that the method of diagnosing CCSVI is still not agreed upon, and that different groups perform venoplasty in such a variable way, that they don’t think it is yet possible to do a randomized study of venoplasty (although they think a randomized trial should be done). And this is from a group of physicians who diagnose and treat CCSVI! See:
I find it disappointing that so many people have been treated for CCSVI, yet the quality of the studies done on how to diagnose and treat the disorder are so poor.
Thanks for raising the Declaration of Helsinki. It is certainly true that physicians not infrequently try unproven treatments when they feel their patients have no other options.
Thank you for your reply, I will have a Haacke protocol MRV this time, there are other ways of testing I’ve spoken with Dr. Haacke and have sent his protocol to a local lab closer to my home, but I will never understand why the government needs proof of an association with MS all I know is improper blood flow makes me sick. I have been off all DMDs since June 2010 and have felt so much better, correcting my blood flow was the best thing that happened to me in 9 years, a long time to be left wasting away!!
Does the Scientific Expert group also have other endovascular specialist such as Cardiologist and Phelbologist? If not I strongly feel you should.
Having Venoplast twice now has helped with some symptom relief, greatly increased the quality of my life and most importantly helped slow down my secondary progressive ms.
Start doing the right trials at a phase 2/3 level because why do we need phase 1 when venous angioplasty is allready performed on patients in Canada and has for decades?
We have a vascular surgeon, a neuroradiologist and a neurosurgeon on our panel who have experience with ultrasound, MRI and vascular interventions.
Venoplasty HAS been performed for decades in Canada, but not many in the jugular or vertebral veins. However, I agree with you that the reports to date in about 1150 patients who have undergone venopasty for CCSVI provide us a pretty good sense of the side-effects that occur at the time of venoplasty (see my reply to Carol Prest earlier today).
I again feel a need to make a point. I have it in writing from the BC Ombudsperson that venoplasty is performed regularly in Canada for people with chronic renal conditions–it is a “standard practice of care”–and is routinely performed in the jugular veins to relieve stenoses caused by repetitive catheter insertions.
I will NEVER understand why renal patients require proper blood flow but people with MS do not!
I, too, had my CCSVI treated on June 8, 2010 (over 18 months ago) in Albany, New York, by Dr. Gary Siskin, and have only had improvements on my improvements since then, with absolutely NO RELAPSES. I know my improvements are anecdotal, but the improvements I’ve had enabled me to enroll in college, taking Mechanical Engineering Technology; something that definitely wouldn’t have been possible pre-treatment.
Before I was treated, I had difficulty swallowing, and I couldn’t cough for years (both are life saving functions), which were the two things that took my father’s life on May 6, 2004. He had MS for over 35 years, and he was only 68. I coughed on the table during my treatment, and looked up at the nurse, who was stroking my hair, and said, “I don’t do that”. Needless to say, I was jubilant and cheer each time I cough. Swallowing more than once in a row still amazes me, because I didn’t realize it was a part of being ill; I thought everyone had the difficulty swallowing.
My blog, if you would like to read about me, is at desidi.blogspot.com. I haven’t updated it since June, because of being in college and being very busy studying for final exams. If you would like to contact me to discuss this further, please feel free to do so. I am at email@example.com.
Everyone has the right to feel as great as I do, and this treatment should be allowed in Canada instead of being forced to go outside of our country, if they choose to do so. Many can’t afford to do it, but they see the improvements of people like me, and crave it for themselves. It is informed consent we are giving, because we KNOW the risks of angioplasty, which has been done for over 30 years (without ever having a trial; they just did it to start saving lives). We talk to people in the medical profession, ask questions, and receive answers.
Thank you for this opportunity.
Would your group be willing to disclose previous research they were part of?
In addition, disclose any connections to any companies, or funding from same, which would perhaps be perceived as conflict of interest.
Who funds you.?
Do you have a knowledgable client or two on your panel who have had this procedure?
Why did you put this team together?
Will you be open and transparent with us through Carol Prest?
Thank you in anticipation,
We mention the funding for this current project on CCSVI and our conflicts of interest at the bottom of the “About us” section of this web site.
I indicated how and why our group got together in my reply to Amy Preston on December 1 (see below in this “comments” section of the web site).
Space doesn’t allow me to list all of the research that the whole team has done. A link to my publications can be found here:
We do not have anyone on the study team who has undergone endovascular therapy.
Are you familiar with this recent study published on the safety of CCSVI treatment
“Safety of Endovascular Treatment of Chronic Cerebrospinal Venous Insufficiency: A Report of 240 Pati
Journal of Vascular and Interventional Radiology, Volume null, Issue null, Pages null, null, Authors:Kenneth D. Mandato, MD; Paul F. Hegener, MD; Gary P. Siskin, MD; Ziv J Haskal, MD; Meridith J. Englander, MD; Sreenivas Garla, MD; Nancy Mitchell, NP; Laura Reutzel, NP; Christopher Doti, NP”
It would seem to me that this would qualify for a Phase I clinical trial. I would hope that the CIHR would reconsider and start the Clinical Trial at an adaptive Phase II/III. Not sure why Canada has to recreate the wheel, unless it is an intentional stall tactic once again. Venous angioplasty is no more dangerous than angioplasty on arteries. It is inconceivable to me that our medical expects cannot come to that conclusion with out doing a 2 year study.
I would ask that common sense needs to be part of this equation for the sake of thousands of MS suffers waiting for the Canadian health system to help them in Canada with a safe procedure that may improve many of their symptoms and quality of life. We all know what the end result is with MS (that is certain) and many progressive MS’ers have no medical treatment available to them and no time to wait for political posturing.
There is enough evidence to start at a Phase II at minimum and hopefully a Phase III would be adopted. I trust your ongoing meta-analysis will concur.
Yes, we did include the results from this study in our report to the CIHR last month – see the “Our findings” section of this web site.
I agree with you that there is now quite a bit of information about the side-effects that occur at the time of a venoplasty or stent insertion. Specifically, we found 6 studies that reported on almost 1150 patients. The most common serious side-effect was a heart rhythm abnormality that required treatment or hospitalization in about 1-2% of patients.
What we don’t know is the proportion of patients who suffer a serious side-effect such as a blood clot or serious bleed during the weeks to months after the procedure. I agree with you that this won’t be sorted out with a small Phase I/II trial, but will need careful and complete follow-up of many patients.
Would it not be reasonable to contact the doctors currently doing the procedure and collaborate with them on any serious side effects such as blood clots. The Hubbard foundation is currently doing a multi centre registry study and also has a global centric registry for patients.
Dr. Siskan in Albany is currently doing a clinical treatment study and has been treating MS patients for 2 years now.
I believe Dr. Simka in Poland has also been tracking his patients.
Anything that can be done to accelerate the Canadian trials to Phase III should be done. So many MS survivors cannot wait for 4 years to get to the treatment part of the trials.
Hi Carol. We included the results of Dr Simka’s and Dr Siskin’s studies in our most recent review. I agree with you that we have a pretty good estimate of the side-effects that occur at the time of venoplasty or immediately thereafter. Serious harms do occur, but they occur rarely. I also agree with you that a small randomized trial like the Canadian Institutes of Health Research is proposing to fund won’t provide much more information about immediate harms than what we already know.
I was treated for CCSVI January 2011 and have had dramatic results since then. I was diagnosed with RR MS in 1998 and experienced Optic Neuritis, weakness, loss of balance, paralysis, loss of bowel and bladder control, pain, numbness, extreme overheating and fatigue, cognitive disfunction, and lots more ugly stuff over the past twelve years. I walked with a cane and had a handicap parking pass. On January 27 after having both jugulars and azygous vein unblocked through simple angioplasty, I felt my lower legs and feet for the first time in twelve years. Over the course of the next few months all sensations returned to my body. The heavy sensation of weight I had been carrying was lifted. I received peripheral vision and my eyes turned green. My facial paralysis left and I could smile fully again. I started sweating. I started walking around the block every day. I got full return of my bladder and bowel function. I went off all my medications. I was just re-tested at the ten month mark at Dr. McDonald’s office in Barrie Ontario and have full 100% blood flow returned. My brain is healing and cog fog is gone. I can go to church and prayer group meetings again THANK GOD! I can grocery shop by myself and recently drove a round trip 100KM by myself. There is lots more to tell and you can see my blog for more. It worked for me and I hope you can help find out why and who it works best for in your research. My two previous experiences with surgery were much more dangerous and risky and had more complications than this one simple procedure.
I appreciate that this group has made an effort to reach out. I see that Dr. Dueck is a vascular surgeon, but why is there only one vascular person in this group, when CCSVI is a vascular issue? How and why did the people in this group assemble?
Hi Amy. When the Canadian Institutes of Health Research announced a competition to choose a group to undertake a review of the scientific literature regarding CCSVI and MS, I was keen to apply. I have a long standing interest in evaluating various medical technologies, and the controversy about CCSVI and MS was an area where I thought a careful review of the science would be helpful. I approached people I knew and asked them to be part of the research group. We have a team that has lots of experience reviewing the scientific literature, but we also cover the clinical bases. Andrew Dueck is not the only person on the team with expertise in vascular disease – Julian Spears is a neurosurgeon who does vascular surgery and Richard Aviv is a neuroradiologist with lots of experience with imaging the neurovascular system.
With all due respect, isn’t Dr. Julian Spears part of the CIHR expert panel that originally refused funding for CCSVI Pan Canadian Trials. Is this not considered a conflict of interest for Dr. Spears to be part of this committee and the CIHR expert panel?
Are any of the doctors on this panel associated with the MS Society of Canada advisory committees?
I am hopeful this committee will be fair and unbiased and focus on the integrity of all studies coming forward to ensure all Canadian MS’ers will get honest and proper results.
Julian Spears was a member of the first CIHR panel that reported in the summer of 2010, but has not been a member since then. Our group received our grant from the CIHR in February 2011.
None of us are on MS Society advisory committees; Dr. Burton is on its Biomedical Grant Review Committee.
Until I see something in writing ‘WITH TRUTH’ I will NOT respect any organization who just gives LIP SERVICE AND PRESENTS NO ACTION.
The CCSVI issue has been road blocked since Yves Savoie made his first LIP SERVICE November 23/09. Until this VERY DAY … NOTHING has been accomplished except LIP SERVICE and money being dished out in the millions on a silver platter … ALL to the MSSC.
This has been biased at every turn and until we get answers … your group will NOT be looked as credible by many who sit suffering while you all devise further unnecessary road blocks.
STOP PATRONIZING those who have been discriminated against from receiving proper Health Care because you all have something to prove … which will be of no worth in the end. It is too bad none of these so called EXPERTS do not have the misdiagnosed label of MS. No doubt we would not be here two years later fighting for our rights.
I look forward to the ‘TRUE’ answers others have asked here.
With due respect, Ms. Renshaw, your tone could be nicer. For your information, all caps often means shouting. I’m sure you know that since I see you on social media everyday.
Dr. Laupacis, I thank you for answering even the tough questions by these posters. It speaks very loudly about your respect for good, honest dialogue with readers.
Thanks for pointing this out to me Jayden … you are correct!
My frustration is genuine and as these two years have passed I have not seen any movement by anyone. Like I said Lip Service is not action. I want to see some action now! People are suffering and we just do not have time to listen. There are thousands of posting with valuable information out on the web that have just cause for me to scream.
I am sorry Dr. L. for coming across in this manner and over the past month I do see you want to help. I am just tired reading the same thing over and over. With respect I Thank You for giving CCSVI attention that it deserves and I HOPE soon we will be able to move forward.
Jayden … if you see me on FB … why have you never expressed yourself to me before? Is it because you agree with me? Hmmmmm …
Treatment for CCSVI has improved my quality of life immensely. I was diagnosed with relapsing/remitting MS in 1990 with several severe attacks and lingering symptoms and then labeled secondary/progressive before any of the approved drugs were available and, therefore, never qualified for any treatment. I have been unable to work since 1992. Neurologists insisted I had MS and that I would just continue to get worse, which I did, assuming they knew what they were talking about.
Imagine my surprise when many of my symptoms suddenly improved after a venous angioplasty on March 17, 2011 and I could stand up without hanging onto anything for the first time in about 20 years! I have also had my heat intolerance disappear and my “weekly” headaches have not made an appearance since my treatment–it’s been over 8 months now!
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