A treatment for multiple sclerosis that upsets Big Pharma

| July 16, 2010

In a breakthrough in the treatment of multiple sclerosis, last summer Dr. Paolo Zamboni, a vascular surgeon from the University of Ferrara in Italy, made public the results of findings from his study of 65 MS patients.

Dr. Zamboni and colleagues investigated CCSVI -- Chronic Cerebrospinal Venous Insufficiency -- a condition characterized by blockages in the veins causing problems in the blood flow drainage from the brain and/or spinal cord of sufferers. This condition has been shown to contribute in a significant way to the many symptoms of multiple sclerosis. It can be relieved by angioplasty, which is a simple surgical treatment that removes the blockages.

Despite the results of Zamboni's and other significant studies, my research into the media's coverage of angioplasty as a treatment for multiple sclerosis reveals that the mainstream media, with some notable exceptions (examples of which are here, here and here) , is generally presenting arguments that are favourable to maintaining the pharmaceuticals' monopoly on treatment options (examples here, here and here). Overall, the media has failed to do its journalistic duty to research all sides of the issue. They have failed to take the numerous testimonials and positive research results seriously and are failing to take into account the costs and benefits of angioplasty versus those of MS drugs that in the end offer little to no long-term benefits.

Pharmaceuticals provide millions of dollars every year to MS Societies in the U.S. and Canada, and the MS Societies in turn advertise the drugs developed by the pharmaceuticals and encourage their members to have full confidence in these drugs, even when alternative treatments, such as diet and angioplasty, might be more effective in alleviating the symptoms of the disease. 

In fact, the MS Society of Canada claims to receive less than two per cent of its funding in pharmaceutical grants -- see Myth #2 in the link above. Additional direct assistance to the MS Societies of Canada and the US would be in the form of free education materials, speakers, and expertise, as well as paid advertising in MS Society newsletters; however, total assistance would certainly be a relatively small percentage of total budget, hundreds of thousands in Canada and millions in the U.S., but direct assistance is perhaps not the main source of influence on MS Society decision making. 

Eminent neurologists and MS research foundations also receive extensive funding from pharmaceuticals, as revealed in a full disclosure article critical of CCSVI treatment that appeared in the Annals of Neurology (Khan et al, January 2010, Annals of Neurology ).

In addition to funding their research, the pharmaceutical industry also influences through leaders -- see below -- through an educational organization known as the "Consortium of Multiple Sclerosis Centers." Page two of the report explicitly states that the CMSC is a partner with the pharmaceutical industry, other non-profit advocacy and services organizations (which would include MS Societies), and MS professional organizations.

Seven of the 11 authors of the report (including the first four, senior authors) disclosed receiving significant financial support from pharmaceuticals that produce drugs for MS. In addition, the pharmaceuticals are key players in an organization known as the "Consortium of Multiple Sclerosis Centers" whose main function is to influence MS thought leaders such as neurologists, researchers, and directors of MS Societies.

The medical establishment, in general, is hesitant to embrace a finding that would shift some of the burden of treatment for MS from neurologists to interventional radiologists, vascular surgeons, and experts in blood flow and imaging. One can only speculate about why this shift is so difficult for them.

One factor might be professional pride, but a more important factor might be the re-training that is necessary, both for doctors and technicians. As it stands now technicians lack the training to detect the blockages, even when they have the latest Doppler ultrasound equipment; and surgeons are flabbergasted at the thought of performing interventions on veins, which unlike arteries, are pliable and difficult to manipulate.

The upfront investment required to support the required changes, which would affect personnel and equipment, is also an impediment to recognition of CCSVI treatment by provincial health plans. So despite the enthusiastic support of both the Liberal and NDP health critics at the federal level, without federal financial support, changes at the provincial level may be slow in coming. In fact, the upfront cost would quickly be recovered as use of MS drugs became less common.

It is not surprising, then, that the mainstream media, when it follows the lead of the medical establishment and the MS Society, presents a biased picture that does not contribute to our understanding of the costs and benefits of CCSVI treatment. MS patients demanding the right to angioplasty for CCSVI are often depicted as a mere advocacy group attempting to badger the scientific community because of their hope for a miracle cure. The hundreds of positive reports and internet videos depicting MS patients who have benefited substantially from the treatment are dismissed as mere testimonials with no scientific merit.

Then there are the weasel words that are used to depict MS patients as emotional, subject to the whims of an unpredictable disease characterized by attacks and remissions, which renders them susceptible to quackery, psychological boosterism, and the much touted "placebo effect." Angioplasty itself is often referred to as "the liberation treatment," which suggests the wild and radical aims of those advocating for it. Research directors working on projects funded by pharmaceuticals and spokespersons from the MS Society are frequently quoted speaking out against the treatment without regard for the inherent bias such spokespersons would be expected to have.

The Canadian Medical Association Journal recently featured an editorial in which it argued that the medical establishment was on the side of the plain folk, guarding them against being overwhelmed by unproven therapies that had not been evaluated for safety and effectiveness, while preventing public monies from being diverted for use in untested procedures.

The truth is that despite concerted efforts to depict it otherwise, the issue here is not one of science but one of ethics. There is already ample evidence that the treatment has a high probability of being beneficial to a large number of MS patients. Detractors, however, raise the question of whether the costs outweigh the benefits. There is, in fact, ample evidence for those willing to take the time to look for it that this question has been amply answered in the positive (see here and here). Angioplasty, which is a medical procedure of long standing, can easily be adapted to treatment of CCSVI, and the treatment works. Why it works is still undetermined, but no one is arguing that it works by some mysterious energy or élan vital. There are several promising leads (such as build up of iron within the brain) that can be the subject of future scientific investigation. Patients themselves are amassing the evidence of success on the electronic bulletin boards of websites like "This Is MS." The videos are very moving, and it is hard to dismiss them as anything but overwhelming evidence for the effectiveness of the treatment.

Detractors like to point out that the benefits of the treatment cannot be considered long-term because veins are subject to collapse after stretching. However, even if the veins collapsed again and needed to be re-stretched annually, this would still be more cost effective than most MS drugs, which cost up to $30,000 per year and marginally slow the course of the disease at best.

In fact, recent studies have suggested that the so-called CRAB drugs have no statistically significant long-term effects. CRAB drugs are Copaxone, Rebif, Avonex, and Betaseron, the standard drugs used to treat MS. They are administered by injection and cost up to $30,000 per year. Because we don't have a pharmacare program in Canada, the cost of these drugs can be a considerable burden to those lucky enough to be able to afford them at all.

In addition, using vein stents (no this is not a new technology either) could eliminate the need for additional treatments.

CCSVI itself is characterized in the mainstream media as unproven and controversial. Maybe, after all, it is a fairly normal condition. However, CCSVI is not controversial. It has been unanimously recognized by an expert international body as an undesirable congenital malformation. In 2009, at a conference on venous malformations (UIP09), experts from 47 countries voted unanimously in favour of officially including the stenosing lesions found in CCSVI in the phlebology consensus document and guidelines.

How dangerous is the treatment? As of today, the treatment has been applied over 1,000 times with reports of only one death, reported by researchers to be due an aneurysm. Many MS patients, whose lives are in ruins, are willing to take the risk. And the risk can be compared with the risk of taking MS drugs, which are very unpleasant and hardly risk free. For example, a common drug for MS causes liver damage. Another recent study suggests that there are two types of MS -- similar symptoms but different diseases -- and if you treat one of the types of MS with one of the commonly prescribed CRAB drugs you may actually make the disease worse.

The medical establishment is demanding double-blind testing on the Zamboni method, which works well on drugs but is almost impossible to do with a surgical intervention. There is, of course, the questionable ethics of not correcting obvious problems once the surgical intervention has begun. In addition, given that the patients are not under general anaesthesia during the procedure, and in light of the fact that most doctors are probably lousy actors, the blind is going to be hard to maintain.

The University of Buffalo has received funding to try a double-blind test on a small sample, but any results are almost certain to be contested. The small sample size itself creates a problem because of the danger of sample bias, which is all the more likely as MS, unlike say breast cancer, is such a multi-faceted disease. Ideally you would want patients that were similar in background, venal malformations, and symptoms, except some would be given the treatment and some not. Unfortunately, this similitude is going to be impossible to achieve.

Double-blind testing does make sense for drugs, where the blind is relatively easy to maintain and ethics may be less of an issue when the benefits of the drug really are uncertain. It would seem that more usual for surgical interventions is to try it if it seems to work, and evaluate based on tracking of results over multiple treatments.

Perhaps this is what Dr. Zamboni means when he says that every Canadian should be given the treatment but also that the treatment should be given in a context of scientific study. This try-and-track approach was used with the original angioplasty procedures that were performed on arteries in the 70s, for example. It has also been used with radical mastectomy for breast cancer and caesarean sections, both of which have lately been given a serious re-evaluation. One notable procedure that the try-and-track approach was used on was scoping of knees. Now, after over a million trials, it would seem that scoping is being rejected as a valuable treatment.

Blind testing of drugs seems to suffer from a problem that is the contrary of the try-and-track approach. Once a drug is approved it may readily be prescribed for conditions that don't meet the test specifications. Notably, it may also continue to be prescribed even when tracking suggests that it may be dangerous under certain conditions. This appears to be the case with one of the commonly prescribed CRAB drugs, which as mentioned before under certain conditions may actually make the disease worse.

There is also a danger that the medical establishment will dismiss the benefits by setting the bar too high. Keeping in mind that the only long-term benefit of the CRAB drugs appears to be modulation of the attacks (so that the disease progresses just as quickly but with less serious attacks and remissions), we should not expect immediate and obvious benefits from every treatment. Benefits may, after all, be both restorative and preventive. Those in the early stages of the disease might not perceive any benefits even though unblocking their veins might prevent future deterioration. Those in the middle stages of the disease are most likely to notice perceptible benefits. Those in the final stages of the disease, after their muscles have atrophied making recovery impossible, might not notice any benefits, but at least they would benefit from prevention of further deterioration.

Some patients have complained that perceived benefits are fleeting, lasting merely months. Indeed, if their veins collapse again they may need to travel once again to Europe to have the treatment redone. Unfortunately, travelling abroad can easily cost $15,000, so can't be repeated too frequently. The solution is, of course, to make the treatment locally available, then it would cost only a few thousand dollars at most. Even if this procedure needed to be repeated annually, it would be much cheaper than treatment with MS drugs, which costs tens of thousands of dollars annually.

The MS Societies of Canada and the US have tried to accommodate pressure from the medical establishment while appeasing patients by providing $2.4 million of support to seven small basic research projects over the next few years. However, the paltry amount of funding and the focus on basic research has simply further raised the ire of the MS community. Not one of the projects is focused on improving intervention techniques, and some of them, such as testing for similar conditions in the brains of Alzheimer's patients, would appear to be aimed primarily at fortifying the arguments of detractors. In addition, some of the projects appear to have been chosen because the researchers have not in the past worked with Dr. Zamboni, which might seem logical, except that part of Dr. Zamboni's contribution was precisely in the area of techniques for the detection of venal blockages.

At this point, based on the evidence of thousands of case histories and several scientific studies, the science points to a cost/benefit trade off that is wildly on the positive for providing the treatment. The benefits would accrue not only to MS patients but to society as a whole which needs otherwise to pay for their MS drugs and accommodate their incapacities. The research at this point needs to focus on refining the technique. And despite how the mainstream media tries to depict it, pressure from advocacy groups is being correctly aimed, not at short-circuiting the scientific method, but at overcoming the intransigence of the medical establishment.

Philip Lillies is a community and labour activist, secretary to the Moncton chapter of the Council of Canadians, secretary to the Moncton District Labour Council, and vice-president for the Public Service Alliance of Canada to the New Brunswick Federation of Labour. He lives in Moncton, New Brunswick, with his wife, Anne, who is afflicted with multiple sclerosis and is on a waiting list for angioplasty at a treatment centre in New York State.

 

embedded_video

Comments

Well written and well explained! Completely ridiculous that sick people must find ways to treat themselves!

From Wayne MacPhail, rabble contributor and board member:

This is one unbelievably wrong-headed and shoddy piece of work.

The Zamboni procedure is not "a treatment" for MS, as the headline
says. It is a theoretical procedure that requires a TON more study
before it can legitimately be called anything close to an MS
treatment. We do not know if it has ANY effect on MS at all.

It is certainly not "a breakthrough in the treatment of multiple sclerosis"

that is total hyperbole unsupported by evidence and is sloppy
journalism and terrible science journalism.

Calling a treatment that based on "the results of findings from his
study of 65 MS patients." is naive and sad. The small cohort size of a
study group from the guy who is advocating the treatment is in NO way
scientifically significant. That is not how science is done. It relies
on repeatability and a meta-analysis of multiple studies, which has
yet to be done in this case. A "treatment" also has to be shown as
having statistically significant benefit over doing nothing, which,
again, has not been shown in this case.

"This condition has been shown to contribute in a significant way to
the many symptoms of multiple sclerosis."

That statement is completely untrue. There is no conclusive evidence
to that effect. There may well only be a correlative, not a casual
relationship between blocked veins and MS.

Statements like:

"The medical establishment, in general, is hesitant to embrace a
finding that would shift some of the burden of treatment for MS from
neurologists to interventional radiologists, vascular surgeons, and
experts in blood flow and imaging. One can only speculate about why
this shift is so difficult for them."

Are speculative and lacking merit. Look, if neurologists or any doctor
or research really thought there was real hope here, they'd be all
over it. I can speculate "about why this shift is so difficult for
them". It's because they look for evidence not speculation, anecdote
and hyperbole. And despite the statement "The truth is that despite
concerted efforts to depict it otherwise, the issue here is not one of
science but one of ethics." Is is a question of science, and evidence.

BTW, the CMAJ editorial he mentions is a rational, sound and pragmatic
call for evidence, nothing more, nothing less.

The author also says that MSM is "is generally presenting arguments
that are favourable to maintaining the pharmaceuticals' monopoly on
treatment options". But, he also links to a CTV story that is exactly
the opposite. In fact, CTV STARTED the whole Zamboni bandwagon
rolling. So I guess that MSM outlet missed the Big Pharma handouts.
And I guess the laudatory articles about the treatment in the Globe
and Mail where a MSM glitch too. I would argue that the MSM have been
too soft on this story. Besides, as a former science reporter, I have
no idea how I would be in the pocket of Big Pharma.

This story and this "treatment" would be nowhere without MSM's lack of
critical thinking and boosterism.

This story is so wrong-headed and deeply flawed I am astonished we ran it.

Emailed in from Arlene Hubbard:

Thank you so much for the article on CCSVI treatment and MS vs Big Pharma. I wish more news media would have the courage and determination to take on this most important cause.


My son was diagnosed with MS in Dec.My husband, a neurology director of an fMRI facility in San Diego, and I decided we needed to get involved with the CCSVI movement.  We have been able to get our son tested and treated and now we have hospital IRB approval to conduct a study on CCSVI.  A significant number of those MSers coming for the test and treatment are from Canada. We are doing our part and thank you for doing yours!

To Wayne MacPhail and Cathryn Atkinson who helped post Wayne's response, and to Phillip Lillies author of the article:

I disagree with Wayne's assertion that this article is shoddy - it seems clear that you disagree with performing angioplasty as a treatment for stenosed viens in MS patients. Phillip thinks through his research that it is a viable and positive cost/benefit option to the MS drugs. Phillip's very well and thoughtfully written and documented article is not hyperbolic in my opinion. His points seem very reasonable to me, and your assertion that only 65 patients have been studied so far shows your lack of research in the area of CCSVI. In addition to the 65 patients Zamboni described in his published study, Dr Simka in Poland has viewed over 2000, and the University of Buffalo more than 500, with multiple other trials in progress now. This, in addition to thousands of first hand "non-scientific" videos on youtube of before and after evidence that is being ignored due to the lack of 'scientific method' (a convenient excuse for the old schoolers) in those videos.  Do your own research, and stop waiting for the establishment to put it in front of you. The Buffalo study found more than a 2 to 1 ratio of people with CCSVI and MS (using inferior scanning methods to Zambonis) to people without CCSVI and no MS. That is stastically valid. You conventiently ignore that. You also choose to ignore that Dr. Simka has found well more than 80% of his MS patients have stenosis and a great number of his patient list is easily evident for all to see on youtube.

Old school medical science is well beind the curve of modern technology. Your mind is fully closed on this issue and that is sad and unproductive.

The only error I see in Phillip's article is regarding the patient who passed away after having angioplasty. As I have read, the patient with the stent that migrated to their heart had surgery and survived. he patient who died had post-procedural issues with a blood clot in the brain and imperfect blood thinning  treatment was unable to prevent the fatality from that clot. It was not proven to be directly associated with the angioplasty. Those two patients have been recklessly used on the anti-angioplasty argument, and never are the often fatal side-effects of MS drugs mentioned by those people to balance that argument.

Your "certainty" that this is NOT a breakthrough is the clear hyperbole to me. If you are unable to research and write a balanced rebuttal, your board position at Rabble reflects poorly on the organization. And, why does a board member need to have someone else post their response for them? Do you lack the technical skill to create an account and post one yourself? Perhaps Phillip should replace you on the board. He researches more fully, writes much better and is much more even handed in his presentation.

 

 

 

 

 

 

Hi Tim,

I had the cause of that fatality confirmed earlier and recently corrected the story.

I'm the news editor and offered Wayne the opportunity to comment and I stand by that. I also worked with Phil on this story. This area here is a forum for comment by all opinions, and I think stating Wayne's connection to rabble is important if he wishes to comment. 

Thanks for your input!

CA

Philip, We need you to join to The Reformed Multiple Sclerosis Society to help organize our local cells.  This battle is not going to be won with logic and with heart breaking stories.  Each MS patient is worth $2 million sick, $0 when Liberated.  They are not going to be let go regardless how good the arguments are.  We need a great grass labour organizer to assemble the exploited MS patients and their caregivers so that we can move the Gucci shoed latte sipping parasites out of the way.  Write or call.  Steven Simonyi-Gindele
The Reformed Multiple Sclerosis Society, 604-771-1931 (my direct line).

To Mr. Wayne McPhail,

I'm wondering to myself if you have MS or know know someone with MS. Better yet, do you have MS? If you answer no to one or more of these questions then I don't see how you could even have an opinion from this article, unless you are one of those people that was mentioned in the article that take money from the Pharmacuetical companies that want to keep on cashing in on MS's fate of false drug dependency with hopes of getting better, when in reality the drugs only prolong the deterioration. This treatment may be a risk to people like you but to people like my wife, and hundreds and thousands of others that once were normal, everyday Americans had a blow dealt to them in the form of an extreme limitation that stops all hope of recovery. It's a damn shame how money could cloud anyones vision of human life. So the risk of getting your life back and obtaining happiness and normalcy again is definitely, as you so eloquantly(sarcasm) put it, is for damn sure worth it versus popping pills and sticking yourself for the rest of your life. Think about that. What if it were someone that you knew, or better yet, what if if was you?

And that las message was actually to Mr./Mrs. Cathryn Atkinson

Hi eyes2light

I've just spent a couple of months documenting the story of two dozen folks with MS as they move through a fitness program. Thanks for the unwarranted slam about taking money from pharmaceutical companies. 

To Tim, I'm well aware of the other research that has been done but the author writes:

"In a breakthrough in the treatment of multiple sclerosis, last summer Dr. Paolo Zamboni, a vascular surgeon from the University of Ferrara in Italy, made public the results of findings from his study of 65 MS patients."

That's what I was responding to. Despite the additional research most leading MS researchers in Canada are wary of the procedure until more evidence is in. People with MS has a rough go, giving them early potentially false hope based on hype not science is unfortunate. Advances in science aren't based on wishful thinking. 

The notion that scientists, doctors and researchers would ignore a treatment that could cure or reduce the symptoms of MS because some shadowy Big Pharma agent is fiction.

It is shoddy writing to argue that MSM has ignored this story when the Globe and Mail and CTV have been the biggest proponents of it in Canada.

If extensive research shows the procedure is actually of value then I'm certain it will adopted and used. That research isn't in yet, that's all. 

Hi eyes2light,

As I tried to explain yesterday, I am the editor who agreed to publish this opinion-editorial article by Philip in rabble. And Wayne's first comment and the comment that followed from Arlene Hubbard came to me via email. As you can see they both hold different positions. I added them here with their permission. So my role here is about free expression and non-censorship.

Hope that clears things up in terms of my role.

CA


 

To Wayne MacPhail, rabble contributor and board member AND other CCSVI detractors:

I urge you to take on, as your next field assignment, the finding and following of CCSVI patients and documenting and reporting their out comes. Do included ALL failures so they can be made public to demonstrate the lies and false hope the placebo-infested hoaxers have been spreading . . . and show the money trail that is to be the downfall of the newly publicized medical specialty Interventional Radiologists--ANYONE with such a vague title MUST be a snake oil salesman!

Go get them, all of them! Please save me and my deteriorating body from this obviously false hope that is plastering the poisonous social media sites. Then my family and friends can finally give up on me and my life and JUST MOVE ON!

I know I'll be in heaven and hope you know God loves you too! 

By the way, IF CCSVI doesn't work it will be a shame, but a bigger shame will be NOT LOOKING into it diligently . . . even if it is to prove it doesn't work! Just use the protocols Dr. Zamboni used and prove him wrong. MS'ers are willing to self-fund such studies--look how much we're paying to travel to be Liberated!!!

God's speed, Grace, and Mercy to all--

--Roy

 

 

Hi Roy:

I support your call for CCSVI to be looked into diligently if it is a call for evidence over emotion. I am less on side with your sarcasm. The hope about CCSCI seems to me to be out of scale to the evidence, hope that has been spurred by MSM, not dampened by it. In fact, there is lots of evidence that MSM promoted the story. For example, the Globe and Mail story that kicked this all off in Canada is titled:

"Researcher's labour of love leads to MS breakthrough"

And despite the headline of this piece:

"A Treatment for Multiple Sclerosis That Upsets Big Pharma"

I see no quotes from pharmaceutical spokespeople, no evidence in any way that Big Pharma is upset and no one with any authority saying so. So the two key premises of the piece 1) that MSM is not giving the procedure its due and 2) Big Pharma is upset lacks evidence, as does, for the most part, the procedure itself.

So, yes, evidence would be good.

Wayne,

I would like to direct you to some hard evidence and some very compelling anecdotal evidence.

The "TIMS" (this is ms) message boards contain many links to before and after video's from people that have been found to have  congenital venous malformations and subsequently have had corrective angioplasty to those veins.

 What is startling is that these people  have  also been diagnosed with MS. After correcting their venous disorder , many of the symptoms that have previously been attributed to  MS have been relieved. Please take a look at these before and after videos.

 http://www.thisisms.com/ftopic-12172-days0-orderasc-0.html

There is a great web site based in Switzerland  that has complied 100's of scientific publications including the  consensus document of the International Union of Plebology  who  studied the evidence and unanimously voted in favour of officially including the stenosing lesions found in CCSVI in their  new Consensus document and Guidelines.

 http://csvi-ms.net/en/content/publications-venous-multiple-sclerosis

What I find most startling is that the charity group that our Canadian  Medical Establishment looks to for facts and data regarding MS have not been aware of, nor have recognized much of the scientific data already established.  This charity group  has also not funded  the current scientific treatment studies in CCSVI related to MS, even though our provincial medical establishment (Quebec) has stated that these studies will be relied on to establish Canadian guidelines. 

 

http://www.neurology.org/cgi/content/abstract/74/13/1041

Here is evidence from nearly 9000 MS patients that shows (as researched by neurologists) that vascular problems are highly correlated to MS and increased disease progression by a whopping amount in MS patients when present.

CCSVI is a vascular problem. People with MS should have vascular problems fixed. Case closed.

It may not cure anything, but it will fix your vascular problems, and 9000 people in this study just proved it will help slow disease progression. When does 'science' begin to count?

Given the various studies and the number of people now actually treated with angioplasty, I think it is likely nearing 15000 people showing in one way or another that MS and vascular issues _are_ related and it is idiotic to me that these issues aren't allowed to be treated.  Think about it. If your jugular viens were pinched off with a clothespin, wouldn't you think it  would make sense to open them up? This isn't rocket science, it's basic household plumbing. Unfortunately, this plumbing course is being taught mostly by electricians (neurologists).

Wayne, if you were aware of the other studies (as you now mentioned), why did you insist on making a point of the 65 people being the only ones studied? Just to try to prove Phillip wrong because he didn't mention all the other people being scanned and treated and studied in trials, you think it is ok to ignore what you know that helps to prove Phillips point? And you wonder why people make up conspiracy theories about big pharma and MS societies? 

Go find me three youtube videos where people who have been treated for CCSVI and have NOT seen some improvement. Then I'll find you 300 who did. Is it really _just_ hopeful thinking?

How many doctors did double-blind trials with sham surgeries on heart bypasses, or liver transplants or burst appendix removals? Would that make sense? I wish people would stop using "good science" as an excuse to inhibit forward progress here. Doctors are supposed to 'do no harm'. By not being allowed to do this angioplasty, it is clear that they are to do more harm than by fixing people's viens. My mother explained it to me as a 'sin of omission'.

If your car was driving toward a cliff, and you weren't positive that your new antilock brakes would actually stop the car (but many people showed that they worked for them), would you step on the brakes or let the car drive off the cliff because it wasn't proven? Maybe they won't work, and you'll go off the cliff anyway. Maybe they will work. In any event, what harm is there in trying?

 

 

 

Hi Tim:

The conclusion of the study you cite is "The impact of treating vascular comorbidities on disease progression deserves investigation."

I have no argument with that. Yes, let's investigate it to the extent that it is worthy of research. We also need to research other aspects of the situtation, for example: What percentage of the general population has vascular problems without MS. Is the amount of vascular problems in the MS population actually higher than in the general population? Does the Zamboni process actually make any real, measureable and repeatable difference? 

 

Let's not jump on a "it works" bandwagon too soon, as have MSM (despite this story's claim to the contrary). As for the You Tube videos, or thisisms.com video . They are subject to "selection bias". Just because say, 300 'it works" videos are posted vs. three "doesn't work" means nothing in the broader scheme of things. It is a self-selected sample that is hopelessly skewed and entirely unscientific. 

The brake analogy isn't valid. It's not a brake or no-brake scenario here. First off, if brakes weren't proven to work, the car wouldn't be on the road) Also, research costs money. Research dollars directed in one way don't get used in another way. The danger is that uninformed public sentiment may skew the spending of limited research dollars in an unfortunate way. What if a very promising treatment fails to get proper funding because public attention is so focussed on this procedure. I think a lot of scientists and MS officials worry about just that.


I find it a peculiar assertion by the author that the mainstream media "is generally presenting arguments that are favorable to maintaining the pharmaceuticals' monopoly on treatment options." Indeed, were one to systematically filter out and peruse all articles in the popular media to date on CCSVI--Google Alerts is particuarly apt at this task--it would become patently evident that the overwhelming majority of publications paint a rather glowing picture of CCSVI. It is, in fact, not uncommon to see terms like "breakthrough" and "miracle" used liberally in the context of this new treatment modality. 

The author makes some specious omissions when presenting the pivotal data to support the purported efficacy of this treatment. In Zamboni's paper (Zamboni et al., J. Vasc. Surg. 2009) reporting on the benefits of the "liberation method" on 65 patients, one must be mindful of several critical aspects of the study that seriously undermine its scientific validity: 1. The study was open-label, meaning that neither the patients nor assessing clinicians were blinded to treatment; 2. The study did not employ controls, which precludes any meaningful comparisons to the baseline; 3. The sample size was very small, and in fact only numbered 35 when counting only the relapsing-remitting MS patients, to whom positive outcomes were largely confined. Taken together, these factors are obfuscate the validity of the study's conclusions.

The evidence required to implement this procedure in the standard of care for MS patients in Canada is presently absent. Notwithstanding the myriad of moving and undeniably compelling testimonials on public fora like Youtube, it would be irresponsible to put great stock into evidence that is susceptible to considerable sampling bias. Think, for instance, how disinclined one would be to post a video lamenting an angioplasty treatment failure; it would be demoralizing and even humiliating to admit to the world that you just gave $15,000 to some charlatan peddling an unproven surgery.

The fact is, there is a real potential for harm by bypassing the regular (and admittedly slow) cadence of the clinical trial process of testing a new therapeutic. While, persons with MS may not have the luxury of time (as is often vocalized by patients and their families--and understandably so), the duty of their healthcare providers to heal through evidence-based medicine, while reasonably minimzing risks, supersedes the desire for a "quick fix." Remarkably, the author seems to malign the MS Society by implying that it is actively attempting to stifle research on CCSVI when in fact, the MS Society of Canada accelerated the application process for grants investigating CCSVI and MS; this had never previously been done for any of the previous (and countless!) "breakthroughs" that have also been touted as cures for MS. Here, the old adage cautioning us to "not put all of our eggs into one basket" is apropos, since diverting a disproportionate amount of resources to research any one theory--especially one with considerable flaws (see Khan et al. Ann. Neurol. 2010)--has the potential to stop other promising research leads in their tracks. Donors to funding agencies like the MS Society of Canada expect prudent use of their valuable research funding to investigate hypotheses that are built upon established findings, and employ scientifically rigorous methods. 

As a person who sees the hardship of MS everyday (a close friend of mine has MS), I sincerely hope that the liberation method is truly the long-awaited miracle cure. However, one must resolve that "hope" and "evidence" are not the same thing.

 

Login or register to post comments