In a live web forum entitled, "What Do We Know About CCSVI?" sponsored by the National Multiple Sclerosis Society (NMSS) and the American Academy of Neurology on April 14th, people with MS were able to join researchers and journalists in hearing about chronic cerebrospinal insufficiency (CCSVI) and multiple sclerosis straight from the people who developed the theory and conducted initial research around the MS-CCSVI link. (Read the summary from the NMSS here: Web Forum Focuses on What We Know and Don't Know About CCSVI and MS)
Dr. Robert Zivadinov, Associate Professor of Neurology at SUNY Buffalo, was the principle investigator for the first CCSVI study in the US. (Read more about preliminary results here: What Do The Results of the "Buffalo CCSVI Study" Mean, Anyway? ). While Dr. Zivadinov spent some time going over the details of what his findings were in his phase I study and what his plans were going forward, he devoted much of his time to emphasizing his concerns and approach to the ethical aspects of CCSVI research and treatment.
Dr. Zivadinov said that there was an enormous amount of international attention on this theory and that people with MS are now engaged in the conversation in a way they never could be before. However, this comes with challenges - as he mentioned, there is a classical ethical tension between rigorous scientific research and the respect for the needs and rights of patients.
To paraphrase, there are people with MS who believe in the CCSVI theory and treatment approaches that are demanding immediate evaluation for CCSVI and moving forward to get treated. Meanwhile, the scientists (including Dr. Zamboni and Dr. Zivadinov) who worked to develop this theory and figure out the best way to treat the condition are saying, "Slow down! Wait for us to work out a couple of the details!"
Among the points made by Dr. Zivadinov:
- Patients should NOT stop disease-modifying therapies at this time, even if they undergo angioplasty for CCSVI.
- At this time, patients should NOT get angioplasty for CCSVI outside of a rigorous clinical trial setting. At this point, there is not enough data - here is more safety and efficacy studies.
- There is a need to look at the impact of CCSVI treatment on MRI images and objective clinical measures.
- *The dialog between patients and researchers should be kept going.
Dr. Zamboni seems to support the cautious approach proposed by Dr. Zivadinov. He did mention that he believes there should be "compassionate grounds" for providing CCSVI treatment to people with rapidly-progressing MS under stringent guidelines and oversight. This would limit the potential harm that could be done by "unethical" doctors. However, recognizing that there were many people receiving CCSVI treatment outside of a research setting, he called for the formation of a registry that would allow people to be followed after a CCSVI procedure.
So, here are the very scientists who brought the CCSVI-MS theory into the light begging people with MS to slow down in their quests to undergo procedures to open their veins. While they realize people with MS want answers NOW, they say there is still much work to be done before this can be safely offered to all who want it (or even if it should be offered at all). What do you think?
I watched the entire panel discussion and felt it didn’t yield much new info for me, and offered precious little hope. I have had M.S. for 30 years. For the past 8 or so I have progressed from relapsing/remitting (RR) to secondary progressive(SPMS). There are no “disease modifying” drugs on the market for me. I am deteriorating daily and was a little disappointed in recommendations of the panel. Dr. Zivadinov is a dedicated researcher who has a broad interest in the wide effect of CCSVI on all neurological illnesses, the interventional radiologist seemed willing to open blocked veins if called upon to do so, though his colleague, Dake, at Stanford ran into difficulty placing stents in veins and was “asked to stop.” The neurologist on the panel was clearly the most cautious or uninformed or afraid. Only Dr. Zamboni, whose own wife suffers from M.S., and who has benefited from the “Liberation procedure” which he developed demonstrated true understanding and compassion. I would go to see him in Italy in a heartbeat,
as he seems to get it…just what my long life living with this devastating illness has been. What if I could walk again?
I also watched the entire web forum and my take-away was much different than Julie’s. I don’t think anyone was “begging” MS suffers to slow down. Instead, I think they are saying researchers need to work faster. We need to continue to aggressively study the amazing coorelations they have discovered between MS and CCSVI. I still don’t get why people are so afraid of this. Angioplasty is an extremely safe a proven procedure.
I think the worry and caution displayed is because of the almost ‘hysterical’ reaction of people with MS who were demanding a treatment that is not available yet.
Why is it not available, because it is entirely new and there are no testing protocols, no one trained to do the scans yet and it’s not proven yet to work, so there is no government that is going to pay for something in a universal health care plan unless it is proven. That just makes sense, otherwise every new theory for every disease would be demanded to be tried to help patients and it would bankrupt the system – not to mention- be completely unethical.
When MS patients are threatening neurologists and blaming them for being in bed with pharma companies and calling people at the MS Society’s liars and incompetent crooks — then some people get offended by that. Having worked their whole lives for the betterment of others and being slammed for “keeping”something from people with MS brings a rather sore spot into the conversation. Especially when members of your own family have MS and that’s why you do that kind of work.
Sounds like it hit home, you have to accept that the medical world went very quickly into its “protocol” mode, thisn equates to mammoth delays, asking MS sufferers to be patient is a bit pompous and calous, this is not a dangerous treatment if done properly, disease modifying drugs are toxic and leathal, you should encourage those who can, to go through liberation, dont sit back and claim ethics prevent it, ethics in this case dont prevent an early degrading death.
ms really stinks. Caretakers are overwhelmed and patients are suffering. I for one am a suffering patient. I think it is irresponsible for any Dr to not appreciate in some respect the fact that CCSVI is real and that it could every well and has very well changed lives. I would challenge that guy from wayne state that fired at Zamboni to switch bodies with me for just one day. Believe me his perspective would change.
Thanks for posting this summary, Amelie. Very interesting, and somewhat as expected with them telling us to “wait for more research”. I am.
@ Roberta – Novantrone is approved for SPMS.
I hope to see this treatment become more readily available and soon– my mother is suffering terribly and if I could afford to fly her to Dr. Zamboni personally to have this procedure believe me I would in a heartbeat. What is there to lose? She is on suicide watch, her life has deteriorated so badly from this disease.
@Jennifer: I appreciate your comments her regarding the offence you take when doctors are slammed and called “liars” etc, for “keeping treatment from their patients”, etc… I am sorry if you felt offended, but some doctors HAVE in fact lied– my mother and grandfather seem to be convinced this is all a “hoax” as this is what their doc at the MS clinic in Ottawa told them. So to be skeptical and wanting more research before approving of the procedure– that I understand– but to say this is all a “hoax”??? That is lying and misleading. Yes, one does get the idea that a doc might be “in bed with pharma companies” when one hears something like that. It is highly discouraging.
If a patient presents with blocked venous flow due to stenosis of the jugular/azygous veins, that blockage should be corrected, as would any similar venous insufficiency problem elsewhere in the body. The possible correlation of CCSVI to MS should be researched separately.
Completely wrong.
First, 100% of MS sufferers who have received the treatment testify to improvement, many improving very dramatically within hours.
Second, this is no longer a neurological issue. I have blocked veins, and refluxing, so I have a right to have them opened. Period. End of discussion.
Let’s change the doctors..out neurologists IN Inteventional Radiologists
In Ontario, a Barrie vascular surgeon has operated on a few individuals, although has now been told to stop, but is continuing testing. He says, “I know nothing about MS. I know these patients had severe problems with their veins in their neck and I fixed the problem.” I agree with the idea that CCSVI should be treated by vascular surgeons and take the neuros out of it unless they want to keep a record of their patients’ improvements.
It is true that many patients who undergo angioplasty have their veins collapse again, and not all patients have the same dramatic results. But, I think the patient should be able to make a choice as to his or her own health care. CCSVI treatment isn’t some untested drug, or a drug with a huge price tag (DMT cost a bundle) and crazy side effects (inferons) but a pretty safe operation that’s been done for a long time.
I too listened to the complete program as being on YouTube makes it very easy to listen to I was particularly interested in the part where Dr. Jock said any benefit of this vein opening procedure would be/was negated after the vein restenosed again.
Now if we think that through he just said there was benefit from this procedure! there was benefit found, can we say that about the C.R.A.B. drugs any of them? now I believe that this means they know fully well there will be some benefit from this and for some reason, probably as Jennifer stated we will not be getting this anytime soon until our governments are convinced that this will be a benefit to them.
I feel for you Roberta just like you our symptoms are very much the same I also am secondary progressive now, was diagnosed in 1981 and now I am in a wheelchair and can’t use my left arm at all, yet my neighbor who also was in the same state as myself got this procedure done in India without a stent and she is doing better daily. the improvements for her was instantaneously noticeable in the feeling in her feet and in her hand writing. Today a week later she now has way more energy does not need her afternoon nap at all and her vision is better. I asked her about her voice and she admitted most people tell her she can talk more plainly and vocally than before.
If these aren’t benefits than what else do they want to see remember this is only a week to 10 days later, as far as safety goes I believe it’s more dangerous to drive or get driven to the clinic for this operation then it is to have the operation, and yes stents may be dangerous so why not in eight months or more just redu the angioplasty as needed?
While I am trying to get this procedure done in the near future I am also going to try to hang in there as much as I can to see if it will be done here in Alberta. I think in a few years everyone will say what were we worried about this is safe and effective and is changing people’s lives.
Julie,
An excellent summary of the recent presentation. Thank you.
This whole controversy has gotten me so riled up at times, but I was quite happy to hear of the Doctors Z urging caution and not to come off DMDs.
As a life long student of science, new discoveries are always exciting, sometimes bringing hope. As a student of human behaviour as well, I am disappointed with the accusations and conspiracy theorists.
S.
RRMS since 1998
Rx – Avonex
Just to preface, I am a public health student and I do not have MS. This is an interesting topic and I wonder if there are any other disease treatments that can be used as a template for studying and implementing this experimental procedure in a population that needs results immediately. I know there are are compassionate care programs for some experimental drugs and it seems that a registy would be a great first step until the gold standard–slow–research can be done. I think that the doctors in the panel were giving the responsible advice, but the reality is that patients are given off-label treatments all the time so it is better to capture this and follow it up than try to discourage it altogether.
My sister-in-law was diagnosed with MS in 2004. Every day is a day that we need a cure for MS. I think treatment of CCSVI shows promise as a cure, or at the very least a reversal of some symptoms (Hello??? What the heck would be wrong with THAT?!) and that further research is not only necessary, but crucial to our understanding of the link between CCSVI and MS. The research will be the foundation for future treatment. But I also think that it is unethical to prevent MS sufferers from having treatment of CCSVI if they choose it. And if the NMS Society really cares about researching CCSVI, then the money will talk. Make your voices heard! Call on the NMSS to fund all future research regarding CCSVI! And make sure your donation dollars go to CCSVI research by demanding that a separate donation pool be created specifically to fund the future CCSVI clinical trials. I for one will not be clicking the generic “Donate” button on the NMSS website anymore.
I was diagnosed with MS in the early 1980’s, and am now 53yo. I had a venogram & angioplasty on the 17th May 2010. My balance was restored within a couple of days, and I can now walk without a crutch. Not fatigued, lots of energy, warm hands & feet, plus lots more. I was SPMS and going downhill fast, looking at life in a nursing home, or suicide. After angioplasty for CCSVI, my whole life outlook changed. I am now building my muscles up so I can travel, be an active Granny one day and build a whole new life! I have the world before my feet again. To those who tell MS sufferers to WAIT, are CRUEL. Give them MS for a day, and they would be screaming for help.
I did not get a chance to see the forum. My wife has had MS for 19 years now. I have watched her go from a vibrant athletic individual, through all the stages of MS winding up leaving her in a wheel chair with cognition problems and severe pain. 2 days ago she had the liberation treatment performed. The result was nothing less than a miracle. She is walking on her own, going up and down steps with no help. She can speak coherently and for the first time in many years has smiled and laughed out loud. Say what you want and take the cautions you feel are needed, but as for my wife and I this treatment gave her back her life, and mine too. I say for MS patients with blockage of the veins, if you can have the liberation treatment done, DO NOT LET ANYONE TALK YOU OUT OF IT.
Dear Julie:
1. I anxiously await the upcoming announcement from the NMSS regarding the awarding of research dollars for CCSVI study.
2. Ny wife has SPMS and has been diagnosed since 1984; her doctors think she began to show symptoms of MS in 1976 or 1978.
3. We are coninuing the use of Copaxone, though we have no idea as to whether it is working.
Zivadinov was the principal (not principle) investigator.
I sent my last comment off prematurely.
My wife was recently scanned per the Haacke protocol, which revealed small narrowing of the proximal internal jugular veins bilaterally.
So assuning a patient walks into your office and tells you, “Doc, I think that my brain circulation is problematic and here’e an MR study that documents how my brain circulatory anatomy looks (narrowed jugular veins), what do you do?
Steven
P.S. Zivadinov was the principal (not principle) researcher .
I am not very clear on the ethical angle of the discussion. The procedure itself is fairly standard and is very very low risk. While I understand that the hypothesized link between CCSVI and MS is not yet widely accepted by the medical community, the clinical trials to date have been consistent that this procedure – which, again, poses very little risk, no more so than a regular angioplasty – has immediate beneficial effect on MS symptoms, and that those who have had the so-called “Liberation” treatment had no recurrence of symptoms/no relapse for 3 years post-procedure.
I believe the doctor’s ethical considerations centered around ensuring the procedure is performed where there is proper medical infrastructure for potential complicaitons. The procedure should ideally be performed in a hospital setting with by a neuro-interventionist with an interventional cardiologist present. I am not an expert on MS, but I work in the medical tourism field, and one of the hospitals that I regularly visit is performing CCSVI on MS patients using the Zamboni protocol. It’s a state-of-the-art private hospital (Hospital Angeles Tijuana) that is right at the greater San Diego area border (San Ysidro). I tihnk as long as patients are having the procedure in a controlled setting like this, there is no ethical consideration at risk here.
There is historical precedent around offering treatment to patients without first completing years of research. That’s when that treatment is known to only assist and not cause harm to the patient (I think of AIDS research). This is the case with CCSVI.
Not to offer this is really a condemmnation of our medical system and the neurologists and researchers who are NOT ethical but are scrambling to save their careers – never mind how it might actually affect the every day lives of people with MS.
Shame on them and shame on our medical system for not having the strength to do what’s right.
Deb – exactly! Recently BioHeart Inc. completed adult autologus stem cell therapy on 2 chronic heart failure patients at Hospital Angeles in Mexico. The US interventional cardiologist commented at the time re: doing these procedures in Mexico vs. US (where it is not regulated or approved): “About Bioheart’s program enabling treatment to be conducted in Centers outside the US, Dr. Sherman says, “I have come to believe that valuable knowledge can be gained from small-to-moderate sized clinical studies conducted outside of the US. Depending on objectives and design, the costs and logistics of certain studies can be burdensome, or even prohibitive to conduct in the US. The two key points here are, first and foremost, to ensure the rights and safety of patients, wherever a clinical trial is done. And secondly, that data arising from the study be complete and transparent. Without both elements in-place, a study will unlikely add to our knowledge of stem cell repair, or advance the field.”
As long as the treatment program ensures that the integrity of both treatment and data collection is preserved, the scientific community is going to be in favor of them moving forward.
Hospital Angeles Tijuana is often selected to work with different US doctors, hospitals and medical device companies for innovative treatments not available in the US – CCSVI is just one of them. And in this case, the treatment is fairly standard and low risk, so I believe that MS patients should not be warned to feel any sort of reluctance to avail themselves of the opportunity, especially since it is going to be FAR more affordable in Mexico than it ever will in the US. And patients will work with Stanford trained doctors.
CCSVI is also being offered in some other top hospitals around the world, but Mexico is by far the closes location with the state of the art facilities and the right sub specialties on the medical team (neuro-interventionist and interventional cardiologist).
What would these docs do if THEY THEMSELVES, their Spouse, Son or Daughter has been suffering will ILL EFFECTS of MS for Years—??
This is a new, possibly dramatic new discovery/treatment folks. There has always been classic tension between those who practicee allopathic medicine and those who practice alternative medicine, which this is in the early phases. Be reminded of the four stages of a new idea: 1)it will never work. 2)it may work for you, but not for me. 3)I’ll try it, but I don’t expect it to work. 4) I’M SO GLAD I THOUGHT OF IT! Stay tuned. Richard Stewart
when the alternative is suicide …. what’s left to discuss.
What is the downside of opening up closed veins ? Ask kidney patients on dialysis.
I believe that several people have it right. A medical article in the WSJ only points to one conclusion. Some greedy person is trying to keep us all on very expensive medicines they make. I also found this article repeated in the LA Times. Both articles were re pleat with unsubstantiated statements and a total lack of critical think by the reporter. And do neurologist have a vested interest in our continued business from not being cured! Another perfect example of how bad newspaper reporting has become. Waiting for ten years to discover that this procedure helps (research timeline) is highly unacceptable. Patients get it MD’s don’t and never will. they have to much money invested in perpetuating the status quo.
I am sched’d for venoplasty on Sept 17. I saw a MRV of my stenosed jugulars last week. My dear friend who accompanied me is a retired nurse of over 40 years. She smiles as she tells me, all medical procedural changes that have empowered the patient over the last 40 years came from activist patients like us. It is just the natural development of things for the doctors to stand their ground until the groundswell around them makes them feel safe enough to change the dominant paradigm. So all you MSrs out there: speak with assuredness, expect that your vascular issues will be addressed, and walk and roll with your head up high. It took me a huge leap of faith on strangers’ words of mouth directions to follow the trail to a local clinical trial, and I almost gave up, but was inspired by the few MSer connections I have made who have blazed the trail for us. Let there be Love.
I did not see the panel. However, I’ve been reading up on CCSVI and Dr. Zamboni. To those who say lets wait for more research, I say “Why wait?” Taking MS drugs with adverse side effects put alot of toll on the body. Why not go through the CCSVI procedure? To those patients who cannot walk, why wait for more research on CCSVI, what do you have to lose? I have only read of positive reports on those MS patients who have gone through the procedure. The AMA and FDA are dragging their feet on approval of this procedure because the pharma industry has alot (monetary) to lose on this if they approve. We need to write to our legislators and put pressure on the medical community to approve this procedure so that many MS sufferers can lead a better quality of life.
CCSVI is currently being done in Poland, India and Spain. I am always appalled by our country to be so pompous as to think that we are the only country capable of curing its citizens. The pharmaceutical companies are of course cautioning us to be careful and go slow. They have a lot to lose. The average MS patient with good insurance spends thousands of dollars monthly for their meds. But Facebook is full of people who have had the Liberation procedure. They are now living MS free lives. And let us not forget that the venerable Dr. Zamboni who discovered the procedure did it for his wife and cured her of her MS! Just because this procedure is new, doesn’t make it bad. Ask anyone who has had it. Shame on our medical industry for keeping us doped up and stupid.
CCSVI is a way forward and is VITAL help for MS everywhere
This is a redundant statement from the NMSS and the Neurological Community. Look at the date of this article and look at the date the MS Society planned to start clinical trials.
Guess what? Those trials are yet to start and it is almost December.
We can see how fast-tracked this treatment option is being pursued by the same entity that supposedly has our best interest at heart.
A sad time for those of us who suffer from this crippling disease.
Our government (UK/2005) Health Committee wrote a report called The Influence of the Pharmaceutical Industry. Not written by conspiracy theorists but a serious committee taking evidence from the medical profession.
Worth a read to those who doubt the power of the industry to influence the medical profession away from anything that compete with Pharma.
LDN is another thing that gets rubbished as a treatment for MS.