Joined: Wed Mar 17, 2010 4:00 pm
Location: Kanata, Ontario, Canada
Access to treatment for multiple sclerosis must be based on science, not hope
The controversial venous angioplasty procedure proposed as a novel treatment for multiple sclerosis by Zamboni and colleagues1 has generated substantial public debate. for an untested procedure first reported mere months ago. Patients and their advocates have held well-publicized demonstrations demanding access to the procedure. In Ottawa, some MPs are lobbying the federal government for millions of dollars in new funding for multiple sclerosis research and this new treatment. Desperation has even led some patients to file a lawsuit against the BC government claiming that denying access is discriminatory.2 But do we want hopeful media reports, special interest groups and political opportunism to decide which treatments we should study, provide and insure?
Yes we do. It is discriminatory. We are not so desparate as you would like us to be, or the world, including us, to believe. The reason is that we have found new hope, and therefore we do not despair. We are the most patient people you have ever met. But with this, after all the lessons in patience our disease has taught us, we at last lose our patience.
This is not an untested procedure. MPs are lobbying people who are denying this treatment of their constituents, for no other reason than that they are unfortunate enough to have MS.
MS patients have a 150 year history of being told they have no hope. That does not make us desperate. No amount of repetition by so- called experts, whether in medicine or some other field, that we are desperate, will make it so. No amount of explaining away everything we say, as if it is forgiveable, but wrong, no amount of being told over and over again that we are desperate, will convince us that we are desperate.
What we are is angry. We are angry that we are being patronized by organizations that in the past were our friends, and being told to wait.
We are angry that we have discovered we have been victims of a pseudo-scientific, commercial ill-health-care complex. This complex includes many thousands of doctors, nurses, health-care providers of varying types, drug manufacturers, and drug researchers.
The idea that multiple sclerosis is caused by chronic cerebrospinal venous insufficiency and can be treated successfully by percutaneous angioplasty of venous strictures is both novel and unexpected. To date, the published evidence is limited to a case series of 65 patients.1 The results reported by Zamboni and colleagues — greater freedom from relapse (50% v. 27%) and fewer lesions seen by magnetic resonance imaging (12% v. 50%) — seem promising but remain untested in controlled randomized trials. In addition, we are lacking a great deal of the relevant basic science, knowledge about the normal anatomy of the venous system, and links between venous anomalies and symptoms of multiple sclerosis.
There is ample evidence. There is far more evidence than we need, to start treating victims, and saving lives. More is being learned every day about how this disease works, and can be fought.
We are not lacking any of the basic science. We know how veins work. Vascular surgeons and interventional radiologists treat every other organ in the human body, with the same angioplasty procedure, even on the same veins, every single day all over the world. There are newer, better techniques, instruments, procedures, and tools being developed.
Fortunately there are brave people all over the world willing to help us now, today. None are allowed to, in Canada. 'MS'/CCSVI kills more than one person per day in Canada alone. That means, since the paper about this procedure was published last November, more than 200 people have died from CCSVI/'MS'. Only one lucky Canadian has had this procedure save her life. Several more have had a large part of their lives restored. Most of these have only happened by travelling to other countries.
Multiple sclerosis is difficult to study because most clinically relevant outcomes are subjective and because the natural history follows a waxing and waning course. These features make it challenging to ascribe benefit to treatment in the absence of a control group. No wonder that skepticism abounds in the medical and scientific communities about this treatment.
Many patients with multiple sclerosis understand these arguments; nevertheless, they insist that venous angioplasty be offered to them. They can hardly be blamed for this. Understandably, they fear ongoing loss of function and premature death. But good health policy decisions should not based on hope and desperation.
As I said, I am not desperate. I do not despair. But if good health policy decisions *can* be made based on hope (not despair), why should they not be? Is it not even better when they can be? But I think what is needed is not executive decisions, but will. The will is sadly lacking.
On the other hand, scientists and skeptics should avoid dismissing novel ideas prematurely. It is precisely the unexpected scientific discovery that often leads to major advances in care. The Nobel Prize-winning discovery that infection with Helicobacter pylori is a leading cause of peptic ulcer disease was met with widespread skepticism that delayed its translation to further research and practice. Unfortunately, for each major discovery, there are hundreds if not thousands of failures, where seemingly promising therapies prove useless and even harmful.
The delay due to unwarranted skepticism was unnecessary. Why do we have to keep making the same harmful mistakes over and over, when we know that that is the very definition of insanity? I am not speaking of 'MS'/CCSVI, or of stomach ulcers, but of what is referred to in engineering as the NIH, or 'Not Invented Here' syndrome. I think it is more troublesome among those doctors who have an exceedingly high opinion of themselves.
This controversy over access to novel treatment illustrates how quickly news of promising scientific discoveries can create unrealistic expectations. In contrast to novel medications, all Other health interventions have few regulations to help manage expectations with proper evaluation. As a consequence, unproven therapies can be rapidly introduced into practice, overwhelming our ability to evaluate their safety and effectiveness. Regulating the complex process of developing and testing procedures won’t work. Rather, we need to build a new and ongoing capacity to initiate clinical studies in response to promising therapeutic discoveries.
I think we have a very mature capacity for clinical studies. I think clinical studies, randomized, blinded, placebo-controlled or not, are very beneficial things. Certainly if Dr. Zamboni had not done enough clinical studies we would not even have got this far. However when we have the opportunity, by basic medicine, to repair and restore so much, I think it is very sinful not to, whether or not it is also a violation of my human rights to life and freedom. I do believe it is.
A major part of this approach involves limiting access to experimental procedures to well-designed clinical studies or research programs. Doing so will ensure access to innovative care for all patients while ensuring that the procedures are introduced safely into practice with appropriate evaluation. Hospital staff and clinicians have a duty to keep unproven therapies from premature use. Similarly, provincial governments should prevent public funds from being diverted to the use of drugs or procedures that lack evidence of safety and effectiveness.
No wonder we keep making that mistake again. We somehow cannot learn well enough how not to use the business of science, of learning, as an excuse to drag our feet. So we continue to make the h. pylori mistake again and again. Is that sanity?
Patients should insist on evidence. They should also insist on having their views represented when decisions about where to spend research dollars are made. With other diseases, such as breast cancer, patient advocates have successfully provided an important perspective in the decision-making process. It is only with patients that can research priorities can be set, implemented and tested so that we find better treatments.
I think what you meant to say was that it is only with patience that etc., etc. One thing former 'M.S.' patients have, is patience. I have waved a sign that said "Patients without patience." It makes a good sign. But to be frank, I and many, many other CCSVI patients, are past patience. That is why lawyers are becoming involved.
The federal government should refrain from allotting funds for specific projects because (a) provinces may be incapable of dealing with the repercussions in clinical care; (b) we may not have organized clinical research networks able to design and execute a study; and (c) the project may not be feasible or the best one to take forward, once examined by experts and peer reviewers, given other promising alternatives.
I think it is up to the leaders of provinces and federations to decide whether they can deal with the repercussions. If the research dollars are not forthcoming, well times are tough all over. I have my own ideas about what is promising, and others may have better information about feasibility and merit. We should be improving the wheel, not re-inventing it.
Our tax dollars and charitable contributions should target research programs, networks and infrastructures that will leave long-lasting legacies, including a means to safely access innovations. Public funds should also address major questions that will improve care and health while promoting excellence. Failure to do so will leave our academic institutions and research community repeatedly at the mercy of advocacy campaigns and decisions based on political expediency and opportunism.
Or worse. I have seen mostly CCSVI patients who are willing to take the more realistic risks with their personal money and their own veins. I have also seen charities, medical associations unwilling to concede anything, to their own detriment, on this foolish altar. CCSVI kills. Let physicians who can, save lives.
Matthew B. Stanbrook MD PhD Deputy Editor, Scientific Paul C. Hébert MD MHSc Editor-in-Chief
With the editorial advisory team: Ken Flegel MDCM MSc and Noni MacDonald MD MSc
Competing interests: See www.cmaj.ca/misc/edboard.shtml CMAJ 2010. DOI:10.1503/cmaj.100835
1. Zamboni P, Galeotti R, Menegatti E, et al. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg 2009;50:1348-58.
2. Feds urged to fund MS trial. CBC News. 2010 June 1. Available: www.cbc.ca /health /story/2010/06/01/ms-ccsvi-trial-funding.html (accessed 2010 June 14). DOI:10.1503/cmaj.100835
All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Can adian Medical Association.
CMAJ © 2010 Canadian Medical Association or its licensors 1 Early release, published at www.cmaj.ca on June 28, 2010. Subject to revision.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
Last edited by 1eye on Tue Jul 27, 2010 4:47 pm, edited 1 time in total.