An open letter to MS patients about CCSVI treatment

March 8, 2010 10:24 by Dr. Lorne Brandes

Dear MS community,

I’ll be very frank. I did not expect that my latest posting (March 5), which injected a note of caution about current procedures to unblock neck veins, would be met with such an overwhelmingly negative reaction from you. It is clear from the scads of submitted comments that most of you now believe that someone (i.e. me) whom you regarded as supportive and open-minded about Dr. Paolo Zamboni’s CCSVI theory of MS was bought off by a drug company, somehow coerced into changing his opinion or, as one writer put it, had switched from a “fair to condescending” tone.

What also came across loud and clear, although of no surprise to me, was that many of you would go to the ends of the earth to have the procedure; that you regard any risk associated with unblocking veins to be no greater, and perhaps much less, than some of the available chemotherapy and immunosuppressive regimens; that you are fed up to the teeth with the patronizing and generally negative (or even hostile) response of neurologists to your requests that you be tested for the presence of vein abnormalities; that you passionately believe that your feelings on this matter should be respected; and that if your neurologist does not agree to assessing you for CCSVI, at least one of you is prepared to fire him or her (as one writer so very eloquently did).

On the first point, let me assure you that my position on CCSVI has not changed one iota. I am in nobody’s pocket. I have not switched sides. I continue to believe that this important concept needs to be studied seriously and funded big time (attention U.S. and Canadian MS Societies: you are being watched very closely by those whom you represent).

On the second, I fully comprehend the degree of your anger and frustration, and agree with your concern that you be tested and treated before it’s “too late”. To the saying, “Walk a mile in my shoes…..”, many of you would answer, “If only I COULD walk”. Just so you know, I had a cousin by marriage with primary progressive MS who made just that statement. Over 20 tortured years, he went from being a robust businessman to staying home because he had no energy, to walking slowly with canes, to being wheelchair-bound, to needing nursing home care, to dying in his 50s. So I get it. Always have.

Now, let’s all take a deep breath and revisit what was said in my March 5 posting.

In it, I raised a red flag for patients seeking immediate treatment for CCSVI which, despite everyone’s hopes and dreams, has yet to be proven, medically or scientifically, as an effective therapy for MS (many of you may vehemently disagree, but that is the reality).

Concerned that the difficulties or risks involved in unblocking veins (called venoplasty) may not be fully appreciated, I pointed out that the current methods have inherent and potentially serious drawbacks: a high (50%) rate of jugular (neck vein) restenosis (recurrent blockage) within 12 months, following balloon catheterization by Dr. Zamboni’s group in Italy and, in the case of stents, two serious adverse events, including one death, in 35 patients treated by Dr. Michael Dake at Stanford that had a chilling effect on his program, bringing it to a halt last December.

I also pointed out that treatment of CCSVI in Dr. Zamboni’s study failed to benefit patients with progressive forms of MS , where the accumulated nerve damage over many years is often severe and, like the effects of a bad stroke, usually irreversible. In doing so, I drew an analogy to patients with advanced cancer, where treatment that can be very effective early in the disease, is usually of much less, or no benefit late in the disease. While some took exception to that comparison, I believe that it is appropriate, and one with which few, if any, experts would disagree.

Referring specifically to Dr. Dake and the Stanford experience, I concluded that “running before we can crawl is more likely to set a good cause back than move it forward.” That statement really hit a nerve; it, along with the discussion that preceded it (including my reference to the powerful effect of placebos), apparently led many or most of you to conclude that I had reversed course and was now opposing any attempt to treat blocked veins. Not so.

In retrospect, perhaps my choice of words was poor, and open to misinterpretation. If so, I apologize. What I should have explained, but did not, was that Dr. Dake’s program was, for lack of a better term, a pilot study. It was not a fully accredited clinical trial, like the one underway in Buffalo, or being planned at UBC, each with strict Institution Review Board (IRB)-approved protocols that have all the “t”s crossed and the “i”s dotted.

No matter that Michael Dake is a top-rated vascular interventionist whose motives are, and were, entirely noble. By offering an experimental (unproven) treatment to MS patients outside of a clinical trial, with its strict guidelines, safety precautions and treatment endpoints, he left himself open and vulnerable to all the critics and opponents (some of them, probably, for “turf” reasons) who stepped forward to stop him when he stumbled. Is that a serious setback for the study and treatment of CCSVI? You bet it is.

Those are the facts as I see them. What I do not see, dear friends, is how my raising legitimate concerns and discussing the potential limitations and drawbacks of vein procedures suddenly transforms me from a proponent of the CCSVI hypothesis into an adversary. Let us not allow raw emotion to trump rationality. I truly hope you will reflect on that.

To reiterate: my current and previous opinion on CCSVI treatment is one and the same. As I stated in an earlier (February 12) posting that garnered a great deal of positive feedback from you, “ I strongly advise that patients wishing to have their veins tested, and an unblocking procedure performed, should do so only in approved clinical trials that are properly designed to insure their safety and provide an accurate assessment of efficacy." I stick by that.

If you don’t feel that you can wait for such studies to start, and wish to have your veins treated outside of a clinical trial (most likely in another country), that is your prerogative. However, from a medical perspective, your outcome, while of utmost importance to you, will be regarded by the community of neurologists as merely “anecdotal.” Why? Because your treatment, in isolation, will not provide the answers that only can be obtained in clinical trials involving hundreds of patients, where statistical analysis will ultimately determine whether unblocking neck or chest veins is of value in the treatment of MS and, if so, for what type and under what circumstances.

Now, many of you might answer that if you benefit from an individual unblocking procedure, you don’t care what a neurologist, or, for that matter, anyone else thinks. And you would be right. Except, that your outcome would not contribute to the data needed to influence the treatment of others battling the disease.

In that regard, many of my cancer patients who enter clinical trials do so for this altruistic reason: even if the new treatment doesn’t help them, maybe what is learned will eventually benefit others. So, when seeking treatment for CCSVI, that same philosophy of doing so in a way that will help your fellow travellers is important for you to consider.

Finally, to all of you who struggle each and every day of your life with MS, I promise that I will continue to follow, and report on, all sides of the CCSVI story. I will do so honestly and objectively, and in whatever direction it leads. You deserve nothing less.

Treating CCSVI in MS patients: A reality check Why government should fund CCSVI treatment: Taking MS out of the equation An open letter to the federal health minister about CCSVI

Comments

March 8. 2010 15:02

Thanks for posting this, I have supported CTV News in there efforts on reporting about this new revolutionary medical discovery and still do.

susan

March 8. 2010 16:08

Thank you very much for your open letter. As Susan states I also support you, Avis and the CTV for your professional reporting.

Shirley

March 8. 2010 17:19

Thank You Very Much for re-itterating what you had already reported and clearing up so many of the misconceptions that people have about the whole procedure. They are the exact same reasons why I am willing to wait until something is PROVEN before I undertake such a risky procedure. I am a MS Patient in the secondary progressive stage and you could say that I like to see proven results in ANY kind of procedure that would either help or cure, even temporarily, my MS. You have been extremely proffesional in all of your reporting of the facts that have come out regarding any of this, and I commend you on not only reporting the good but the bad so that people are aware of both sides to this procedure.

Michelle

March 9. 2010 07:04

Thank you for your comments to the recent furor. Since you raise the anecdotal evidence issue it is a shame that there was no way to capture the results of many that have been treated and continue to do so in increasing numbers. Sure they do not fall under an IRB protocol however, they are experiencing positive results.
As Peter Truman always said, that's not life that's reality.

Andrew Katz

March 9. 2010 07:37

I forgot to note that there will be a march on Parliament Hill on Wednesday, May 5 at 1:00 pm to voice our concerns to our government that investigation of CCSVI is moving too slowly.

Andrew Katz

March 9. 2010 13:22

Your article is well written and your comments are open and honest. You seek to present the facts objectively and along the way you point out the risks involved. You points about studying CCSVI in a well controlled clinical trial to interpret results in a larger setting are well taken and add value to the discussion..

Jeff U. Wilmington, DE

March 11. 2010 12:55

I appreciate your efforts to address the greatest sea change in medicine since the polio vaccine. For myself, I am a happy anecdote of Dr Dake's, liberated 10-29-09. I contest your assertion that my treatment makes no difference to the fate of other MS patients. Doctors publish case histories on unique cases, so I did that with myself, and encouraged others treated to do the same. We now have close to 50 cases in the CCSVI forum at ThisIsMs.com that will continue to be updated with progress reports.

Yes, trials with p-values are the gold standard, but we are 2 years away from having trail results. For those running out of time, we need a new standard. Like patient-based evidence. How about a collaboration, support from the medical community on how best to gather the evidence from those that feel they can't wait on trials. That will help pave the way for others with early MS who can afford to wait. What if in a years time there were 1,000 patient cases reported, and a high percentage reported improvement? The standard of "medically meaningful" needs to be adjusted for this extraordinary moment in history. I have documented my case with MRV images at http://healingpowernow.com Perhaps you could post an article with suggestions on improving our case reports.

SammyJo Wilkinson

March 11. 2010 13:01

Hello Dr. Brandes,

I would have liked the opportunity to comment on your blog. My sister was diagnosed with MS in 2005, so this issue is very dear to my heart as I see her every day. I am sorry you watched your distant cousin deteriorate to the point of death, it must have been tremendously difficult to know even with your medical background you still had nothing to offer.

Today, right now, you do have something to offer MS patients the world over: your backing of a theory that makes more sense than anything ever before offered, based on medical knowledge of all the body's systems and all of the various pathologies that may occur. With this integration of knowledge you have the power to make better analogies than you have made so far, as you are still choosing to compare apples to oranges. The only truly important similarity between a stroke and MS is that they are vascular in origin with neurological consequences. The glaring difference is one is arterial and one is venous, and it is this difference that must be made clear to the public and medical community at large.

You stated: "I also pointed out that treatment of CCSVI in Dr. Zamboni’s study failed to benefit patients with progressive forms of MS , where the accumulated nerve damage over many years is often severe and, like the effects of a bad stroke, usually irreversible. In doing so, I drew an analogy to patients with advanced cancer, where treatment that can be very effective early in the disease, is usually of much less, or no benefit late in the disease."

We have yet to see what benefits the progressive patients will reap with their procedures, as nerve tissue regenerates slowly. I feel you are rather premature in stating they received none. These patients do not have cell death due to lack of oxygen as in a stroke situation, but cell damage due to overload of waste products due to inadequate flushing. The question of iron deposition is yet to be answered as well.

As for terminal cancer patients without options, I would encourage you to revisit the recent published story of Rick Sidoni. This father of two was told he had eight months to live after exhaustive chemotherapy and radiation treatments failed to control his throat cancer. He connected with Dr. Klimo of North Vancouver who suggested Sidoni try Erbitux, an experimental drug that might stunt the tumour's growth. But the drug cost $45,000, which extended medical care doesn't cover. His friends rallied together and raised the money, and not only was the tumor stunted, it was irradicated.

Please, refrain from telling people what their bodies can or cannot do, with the right treatment and enough time, anything is possible.

Also, in reference to the deaths attributed to Dr.Dake, please read the following:

Helen Yates, Chief Executive of the Multiple Sclerosis Resource Centre (MSRC) said: “Whilst the case of the man who had to have open heart surgery to deal with a slipped stent is accurate, the case of the woman who had a haemorrhage is less so. The lady in question had a pre-existing condition that meant she was much more susceptible to haemorrhage, in fact it has been ascertained since her death that it was nothing to do with the procedure at all and was, in fact, an adverse drug reaction to one of the blood thinning drugs exacerbating a genetic familial problem. The first case is, of course, a reminder that no procedure is without risk and with stenting, there is always a slight risk of the stent coming loose.

It is important that these two cases are viewed accurately and in perspective”

That said, I thank you from the bottom of my heart for your statement directed to the MS societies of Canada and the US. Without pressure from the medical community in regards to CCSVI, they will only continue to drag their heals in doling out the required research funding.

Thank you for your assistance in keeping this issue current and fresh in the minds of those who need to be reminded.

God bless,
Gwen Valentic-Morrison RMT CDT

Gwen Valentic

March 11. 2010 16:12

What to us was most disheartening is the strange attitude of the MS Society which we have supported for many years. Something is wrong with this picture! Hope has nothing to do with hopeless. Our son, in a sense, has become hopeless thanks to the attitude of physicians and academics. We will never do that. At least CTV keeps the door open with current news. At least some funding is possibly going to be available through UBC research. I am angry and will never give up, except on The MS Society.

Sheilagh Best

March 11. 2010 17:20

The one death at Stanford due to the procedure (stent) was sad and unfortunate but can you imagine if heart surgery stopped due to a stent coming loose? This has always been a risk in this type of surgery. It is also sad that the experimental surgery has been halted. Most likely due to the possibility of lawsuit. I have lived with migraine, hypertension and MS for too long and only now do I feel that I believe in something...Zamboni's research. It makes so much sense and it's right in our face...what more is needed? What is needed is for Western Medicine to care more about patients than profit! I never believed in the MS Drugs and I am certain they will become obsolete. I have been doing well on LDN. I know many who are doing well on LDN - which has not been embraced or researched by the medical establishment. I will risk brain aneurysm (I have had two sisters suffer from this!) in the belief that this is the answer for me if testing should prove positive. I am certain that my family has congenital vascular problems. The medical establishment unleashed potent drugs on the MS community with horrible side effects and in some cases death due to the drugs. Personally, I'll risk ballooning or stents rather than the side effects of the drugs. I am so tired of MRI's and nasty IV steroid treatments. I've signed up for 2 clinical trials and hope that I am accepted into one of them. Thank you Dr. Zamboni! Your statement that your wife's health was your greatest reward moved me to tears and trust. Thank you.

Mary Toth

March 12. 2010 11:19

Dear Dr. Brands,

Thank you for your elaborate clarification. Just like Dr. Dake, I am sure your motives are, and remain, entirely noble. Having said this, I am sure you will appriciate that nearly evry, I repeat, nearly every medical intervention is risky. Should your logic be followed, Tysabri should be taken of the market without delay and only administered in clinical trials to evaluate its safety over an extended period of usage. The unfortunate incident with Dr. Dake's patient is both the result of the inherent rist of any procedure and the price of the leaning curve. We, MS patients, should be the only judge of whether the risk is worth taking. I earned 3 degrees and was a rising star with Procter & Gamble. Had the world at my feet ad am now reduced to a shadow of who I used to be. Now tell me, should I heed your warning?

Thank you for your whole hearted support.

Asher Cohen

March 12. 2010 15:40

The death was not related to the procedure!! Please clarify this! No deaths from this procedure... many deaths from MS drugs and therapies that HAVE been through all the clinical trials and approved.

Donna

March 14. 2010 20:24

Hi Lorne,

Thank you for your very reasonable and balanced article. I am an MS Sufferer and am extremely frustrated by the MS establishments attitude towards 'patients'. Instead of sharing our enthusiasm for what hitherto has been a condition for which there is no explanation or possibility of a cure, we are motivated by the possibilities which CCSVI presents. Why are the Drs surprised? Surely they must also be moved by these new possibilities. Why does it take 10 plus years to find out if something like this works. I work in the computer industry and change happens all the time with new technologies moving from the lab to the market in weeks and months not years and decades. Innovations like Zambonis are welcomed not perceived as threatening. Yes, lets move carefully and with the necessary tests each step of the way but not at the glacial pace of the medical establishment. I don't want or need to wait until all the risks are documented, I just want to understand the odds and if I believe they are reasonable, undergo the Liberation Treatment.

James Plummer

March 15. 2010 12:16

While my neurologist would not sign the necessary referrals for the the MRV and U/S scans, my family doc looked at me (my face was a bit of a mess because of a fall two days previously) and said she would likely pursue the same thing if she were in my position; and she signed. I believe any good neurologist wants their MS patients to get better so I do respect the reluctance of mine to support the liberation procedure. What I find frustrating is the difficulty of finding information about the risks so that people with MS can make a reasonably informed decision about good ahead. I do not call myself an 'MS sufferer' by the way. Pain is inevitable, suffering is optional.

Diane Martin

March 19. 2010 18:09

I think Stanford's unfortunate events will only steel medical facilities to go about this more carefully with all the proper precautions in place. I understand one of the patients had a pre-existing blood condition that was not fully taken into account when the procedure was done and the other patient's movement of the stent is a common issue with the procedure. I think it is a huge negative for Stanford, not for the issue of CCSVI's role in MS.

I do see the potential results from Stanford being the need to reject patients that have pre-existing conditions that could result in death, the need to clearly define the risks associated with the procedure by getting a release signed from all patients, as well as a possible reduction in facilities that will do the procedure openly (I say that because there are places doing the procedure on the down low - money talks).

I agree with your cautionary statements, we as MS patients need to be cautious of high-risk procedures no matter how appealing the potential results may be. It is hard for us to be patient as we watch our bodies continually decline and as we suffer with the various pains and indignities this disease gives us. On the other hand, no one can deny the results the patients who have had the treatments are experiencing (http://www.thisisms.com/ftopict-8346.html). Their experiences do show the consequences of the procedure and those notes are sobering but not entirely things that will send us running to the hills (if we could run).

The vascular theory surrounding MS may have started in the late 1800s, but it is only through of the advancement of medical technology that we are able to actually put those theories to the test, and should!

GothicRosie

April 20. 2010 19:29

A Brazilian doctor said : "If there's a problem with bloodflow from your brain, it should be corrected. Regardless of MS ". The evidences of zamboni's patient's are clear. The risk of surgery are ours...wait what? The next attack ??

Gilberto Andrade

April 25. 2010 02:10

I completely respect your open view on the subject, and also understand the reasoning for a call to calm on this. Just to clarify the safety concerns, as being involved in the CCSVI process in setting up a local trial. For all those that does not understand the safety issue involved. Looking at patient records it is clear that at least 50% of all Ms patient has a precondition for a stroke. This precondition is created by the damage to the blood brain barrier side. Please note that most of the leaks in the blood brain barrier are in the arterial side and not the venous side. The higher your Ms impact the higher the bigger your blood brain barrier breach is. Thus the more advance this precondition is. Hence this protocol should have been look at in the tragic death of Holly.
Another concern and from reading the comments above, those at the higher risk will be PPMS and SPMS. But as stated they can't wait and the claim that it needs to be done now, is certainly understandable. But he fact is the benefit for SPMS and PPMS is not great, and contrary to a statement that the repair process will take longer, this is not true. As in stroke patient and PPMS and SPMS once you have past a certain extend of damage, the body will not repair axonal damage as is normally the case with advanced MS. To certain extend Myelin only regrow up to a certain age and the myelin regrows cease. But axonal damage is not repairable.This is a sad side effect from aging. Hence the benefit that you receive from CCSVI will cease after that point is reach , if that point gets reach. Hence the benefit to SPMS and PPMS is unfortunately very minimal.
However this is when neurology comes into play , and there must be certain advancement in Myelin regrowth studies. Thus having MS will not make you a vascular patient but also neurological patient. Another sad facts is the restonis, and contrary to what CCSVI advocates make you believe that it is the cause of MS. Initial samples taken from "liberated" patient and past studies indicate rather CCSVI is caused by MS. Hence you will restenose and your Ms will symptom will return or get worse. It is not a miracle cure, but a very contraventional treatment. It would be a sad day for MS history if post CCSVi a lot does not benefit, or in 5 years down the line, the symptoms of MS that "may be mask" by the effect of a contraventional MS treatment and , it hits them like a brick wall. Please note i say "masked" as angiotensin seem to play a great roll in "liberation". Agiotension can create this feeling of well being and can mask Ms symptoms. This was clearly indicated in the 1950-60 where vasodilators was used as a treatment for MS. This treatment was stop for that exact reason and it had a very adverse effect on MS patient down the line.
Thus my understanding of call for calm on this.

MSPat

May 3. 2010 18:39

Well, here at least, Dr. Brandes attempts to present the side against CCSVI with science and not just dismissing the idea grandly from his perch as a different kind of specialist.
I would love to join a clinical trial, but try getting into one.
The one death at Stanford was unrelated to the procedure so I'm tired of the 'someone died, you know' line being given to us as proof that treatment for CCSVI is dangerous.
Zamboni himself didn't use stents. It may be that stents for CCSVI need to be developed.
Consider this: If a person has balloon angioplasty and experiences a rollback of symptoms -- not a miracle, but maybe a functioning bladder and lessened fatigue, for example -- even if for only a few weeks or months, that may be anecdotal, but it's good enough for me.

Diane Martin

May 3. 2010 18:46

Woops, forgot to ask: where is it written that Zamboni had little success with progressive forms of the illness? I have read everything I can find about his work with angioplasty for MS patients and have not seen that caveat. Have I just not absorbed the bad news? I suppose it's possible (I have PPMS), but I've looked and looked and haven't seen it. Maybe it's in one of those journals where you have to be a medical specialist or pay money to read it.

Diane Martin

May 20. 2010 20:03

I saw my nuerologist today at the M.S. clinic, University of B.C. , Canada.

He told me that the Univeristy of Buffalo decided to modify Dr. Zamboni's procedure for evaluating the veins of M.S. and control subjects. That this may be a real issue in them not reproducing the excellent results that Dr. Zamboni got.

UBC sent interventional radiologists to review the procedure with Dr. Zamboni. They were impresed with the research Dr . Zamboni had done and the techniques he had developed to evaluate the veins.

Dr . Zamboni let them do the evaluation on several patient themselves and they came up with 100% narrowed veins in M.S. patients. , not the %65 that the university of Buffalo found.

This also extends to the actual treatment and selection of the optimum veins for treatment as it is not possible to widen all of the narrowed veins.

Let's put pressure on our researchers , funded by M.S. societies of Canada and the United States , to do the procedure the way Dr. Zamboni did it. If it is not done that way, then results may not be as good and funding may be discontinued.

Doctors in Poland, India and other locations doing the evaluation and procedure who have not been trained or approved by Dr. Zamboni probable give people sub-optimal results when vein selection for treatment is not optimal.

Apparently, the publication from the University of Buffalo did not bother to mention that the vein evaluation procedure had been modified from Dr. Zamboni's. They thought they had a better way of doing it.

Maybe they didn't.

Maybe if this continues, results will be unfavorable, and funding will dry up.

Let's keep the researchers feet to the fire on this. The funding is for us M.S. patients, not really for researchers.. isn't it? Hopefully they will be willing to un-modify. Zamboni created this. He's the expert. Let's do it this way and not mess this up!

Thanks,
Karen

Karen Walker

June 16. 2010 08:03

Dear Dr. Brands,
I am travelling to Costa Rica at the end of June for the Liberation Treatment. Judge as you will...your cousin would probably have wanted to do the same if he could have. No, my results will not used to determine the benefits of this treatment in any study...I am not one of the lucky few chosen to be part of a study...I live in Northern Ontario...they tell me it's impracticle, and they have enough of "their own" patients to fill the study numbers. So be it. Then I will do my own research and my own study on myself. I refuse to feel quilty that I am going ahead with this because my results will be more meaningful when they can be assessed by Canada's health care system. You can bet they will be extrememly meaningful to me, my family, and all of my friends and acquaintances who love someone who has MS.
Della

Della

June 18. 2010 09:18

ELECTORNIC CIGARETTE

October 31. 2010 01:54

http://www.facebook.com/notes/ccsvi-in-ms-toronto/compassion-denied/482254624918

Please investigate if this was a needless death. We are not talking about Micheal Dake's mishaps here. If this happened it is criminal negligence to bolster arguments against venoplasty treatment. 'I told you so' is a very un-Canadian way of treating illness.

Chris Sullivan

November 12. 2011 01:05

SO cute!!!!! I love how it turned out!!!! Beautiful work!!

Vito Gloden

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