Multiple Sclerosis - Liberation Treatment

Miscellaneous and Personal Stuff I Must Share
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From what I understand, the procedure is unblocking blocked veins - even if there isn’t instant or noticeable improvement, isn’t having unblocked veins a Good Thing overall anyway?

This was on the local news again last night, Uzi. The lady they interviewed didn’t have spectacular results (it sounded like her big change was that she was able to curl her toes again), but she was pretty optimistic that she would keep improving (she was fairly old, too, which might have been a factor). I thought about your wife while watching, and how she seems to have had really good results.

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Hi, Uzi!

I just wanted to see if there have been any further changes now that your wife is 2 months after surgery. I’m curious about subjective observations as well, as they often have a basis (whether it is immediately recognized or not). What are the results of the other people that you had met at the hospital?

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Things keep improving. My wife is in physio at the moment. She keeps getting better every week. The physiotherapist says she’ll be able to run again (it seems to be a dream of hers). I’ve got her in the gym working on strength training and cardio. Before surgery she could only go for ten minutes on the elliptical, now she can easily do 30 minutes. Her general health has improved. Whereas before if she got sick her MS symptoms acted up. Now they don’t or to a far lesser extent.

Her right leg still gets tired quickly, but recovers within a very short period of time, but people are starting to not believe she has MS when she tells them.
She is very involved in the local CCSVI chapter in Calgary as an agitator against the health care system which still won’t treat a stenosed vein if you have MS. If you don’t have MS they’ll treat you, though. She met with the leader of the Wild Rose party and they seem to be on board and were so impressed with her that they asked her why she didn’t run for politics. She’s a US citizen so that is out here in Canada, at least.

More people are getting treatment as the practice becomes more common and the anecdotal evidence keeps increasing.
From reports of people who were at the hospital with us. The lady from California who needed two canes (the ones with the wrist brace) is now down to a hiking pole and is finding she needs that less and less.
The young fellow from Holland the last we’d heard had moved out from his parents house and was living the life of a regular 29 year old again.
I haven’t heard from the couple in the UK. I’ll write and let you know.

Some links to success stories
Chris
Another CTV article

Mcleans article about the surgery not being available in Canada.

Lots of good stuff here:
Direct MS

Some reality: When stabilization is not enough.

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Pretty cool. Continued good wishes!

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The wheels of bureaucracy turn slowly. I think if the results keep coming in so good, it will be covered in a relatively short time. I hope so, anyway - it doesn’t make any particular sense to me to not try such a low-risk procedure, even if the results aren’t spectacular.

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Hey, Uzi, I’m currently watching a debate going on in Question Period in the House of Parliament talking about liberation treatment being fast-tracked for MS sufferers. Just wanted to let you know that the politicians are aware of it and are discussing it.

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If a person is having symptoms that are connected to a vascular obstruction, then surgery may be indicated. The problem with Dr. Zamboni’s procedure is that there are serious questions about how he diagnoses “blocked veins”, no good evidence that any such blockages are producing symptoms of MS, no good evidence that the surgery is an effective treatment, the surgery is very expensive ($80,000 at one California clinic) and serious negative effects of such vascular surgery can occur).

Looking at articles, blogs and forums that have been posted online, I’m struck how quickly some people have accepted that this must be the cure they’ve sought, and how vehemently and in some cases nastily they’ve attacked physicians who are doubtful about this proposed mechanism of MS and surgery to treat it. In contrast to breathless articles of praise that have appeared in the media, here’s a more sober look at the controversy:

*"The most controversial evidence, though, is the paper (Zamboni) published last month on the actual Liberation treatment, as provided to 65 patients. The results were mixed. Dr. Zamboni reports there was significant improvement on a scale measuring certain MS symptoms such as leg function in the “relapsing/ remitting” group of patients – those with the mildest form of the disease, who normally can go into remission for months or years at a time. The more pronounced secondary and primary progressive patients had limited improvement after six months, but none at 18 months, he reported…The veins narrowed again in almost half the patients. Dr. Burks calls the outcomes “encouraging,” if tentative.

Neurologists outline a string of limitations to the study, though. There was no “control” group of patients who did not get the surgery and whose outcomes could be compared to the Liberation patients. It was not a “blinded” trial, meaning that the patients, and their doctors, all knew they had received the procedure, opening up the possibility of placebo effect. And all the patients continued to take their disease-modifying drugs, making it difficult to separate out what, if anything, improved their condition."*

An even more skeptical view can be found here from a cardiologist at McGill University.

Again, improvements in MS patients are very difficult to attribute to any given treatment due to the relapsing and remitting nature of the disease, and the likelihood that even dramatic temporary improvements may occur by chance (or due to standard therapies in patients who are simultaneously undergoing vascular surgery).
It’s sad to think that some patients may be compromising their treatment and/or sacrificing their savings for a surgical option that, while heavily hyped, remains unproven.

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The only sure diagnosis is using a venogram. Even the doctors in Poland only used the dopler as a guide. Regular cost of an angioplasty is ~$1500-5000 in Canada. Essentially, the cost of drugs for a couple of months of ‘conventional’ treatment.

Exactly how do you do a blinded study that involves surgery? What doctor is going to fake surgery on a patient? As in run a tube up their veins and not expand any blockages they find. This is a red herring that the neurologists are putting up to criticize Zamboni. What needs to be done is a before and after analysis of the patient to determine what is placebo and what is not, and what actual benefits the patients receive, if any.

It is very interesting that those improvements just happen to coincide with the surgery. It is also interesting to note that there are no MS drugs out there that can account for the types of continued improvements people are seeing that the surgery seems to be accomplishing. There is no drug in the world for MS right now that accounts for my wife’s improvements. None. There is no placebo affect that can account for what my wife has experienced. Placebo can’t account for autonomic nervous system recovery that appeared shortly after. Her bladder spasms disappeared and she can now feel her feet. RRMS accounts for some of this, but during remission you don’t recover any more than you had before your attack. You aren’t going to recover items that went south from previous attacks.

It would be nice to think that the treatments that people are taking now actually have any benefit to them. Yet, none of them have had the anecdotal* evidence like this surgery has been having. You don’t think the drug companies would be jumping up and down if they had as much success with their drugs? Yet, their solutions are to continue to pump medicines into people that have dubious benefit and may have long term consequences.
Do you know who is driving this procedure? People who have seen the benefit first hand.

The best way to diagnose blockages is by venogram. That proves there is, or is not, a blockage. If there is a blockage, and I saw it first hand in my wife’s neck, then it should be treated as you are already there doing the venogram. Nor can I (one of the biggest skeptics and atheists out there) deny the results. It wasn’t due to her continued treatment. She had stopped taking Copaxone almost a year earlier.

*Anecdotal evidence is still evidence. Enough of it adds up to proof. People will continue to go and get the surgery because people are actually benefiting from it. And the more people who go and manage to get out of their wheel chairs (something that the drugs currently given can’t do), the more people will demand access to the surgery no matter what the neurologists and drug companies who stand to lose say in the matter.
I’m not denying that there are people with MS who don’t have blockages because Simka in Poland has not treated about 25 people in 300 where he couldn’t find the blockages. Does that mean they are not there? No, but maybe there are blockages that they can’t find yet.
Yet, this is not an experimental surgery. It is done for kidney dialysis patients. The surgery is inexpensive and safe. The reason it costs so much for MS patients is that they have to go out of the country to get it. Which also increases the risks.

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I’ll leave it to someone else to speak to how standard blinded surgery is in evaluating new procedures. But I had the functional equivalent of a fake angioplasty. In my case it was because when they injected the dye, there were no blockages. The radio-scan had been inaccurate. But if they had wanted, they could have easily let me believe that they had gone on and expanded the veins and installed the shunt. I wouldn’t have known the difference even though I was awake the whole time. In fact, I wouldn’t have known if they had just given me a stick near the femoral artery instead of actually going in.

Now, leaving blockages that need to be fixed may not be right. But I bet that in a sampling of MS patients, they’re going to find enough that have no blockages to create a control group of people who think they had the full procedure. Would you have any objection to using people with no blockages as controls? If they recovered as well as people who had the full procedure, what would be your conclusion?

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As I stated earlier, Simka has found that just about 8% of the people he has tested don’t have blockages. I don’t know where he gets the number from, was it using doppler, or venogram? Could you use these people as control? Maybe.

If they didn’t have good results after the procedure, what would be your conclusion?

I’m not trying to be snarky here, but the assumption going in is that this is snake oil. To neurologists and the pharmacy industry it is. To those that have gotten the treatment it isn’t (especially those who have actually gotten out of their wheel chairs which no drug can accomplish today). Who do we trust now to do an impartial study?

And if someone wanted to do a study, they could easily do so. The surgery is already taking place in Poland and around the world. Analyze the people before they go and follow up once they come back. Compare to current treatments. Done.

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My friend just got back from having this done in Germany - she looks like a million bucks. She can feel all her limbs, she can taste and smell food again, her balance is better.

Really, this may not be a cure, but it’s a hell of an effective treatment. Congrats to you and your wife Uzi!

FWIW, I beleive that Health Canada/MSSC are currently developing studies to test this as a treatment (as opposed to dismissing it outright). It will be slow (5 years) but hasn’t been ruled out (according to my co-worker who works for the MS Society).

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That and more is done in research. You often have to do that if you want to exclude a placebo effect. In my role as an Institutional Review Board member (reviewing the ethics and conduct of studies being performed on humans at the medical center I work at), I’ve helped review a study in which a brain implant study had a placebo group that had a scalp incision and a hole drilled in the skull, but no other actions performed (no incision into the dura mater, no implant).

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This is largely inaccurate. While many experts in the field of M.S. are dubious about the proposed vascular mechanism of M.S., there is considerable willingness to study the idea and conduct well-planned clinical trials. Those who suspect a strong possibility of “snake oil” are physicians and scientists who’ve seen this sort of hype before for a variety of treatments (including vascular surgery) that have failed to pan out, and who are familiar with the undeserved acclaim given to self-promoting physicians and alt med practitioners who are skilled at manipulating the news media and their patients, who see financially-motivated conspiracies everywhere aimed at denying them a hoped-for cure. The field of cancer treatment is full of such cases (for example, do a Google search on Burzynski and anti-neoplaston therapy).

Except for people like the Stanford patient who died of a cerebral hemorrhage, or the other patient whose stent migrated to his heart (that surgery program was recently closed down). And $80,000 for surgery in this country doesn’t sound all that inexpensive to me, especially when insurance doesn’t cover it.

Zamboni did not do a blinded trial, so his results are highly susceptible to placebo effect. Even so, as noted in a previous link I provided, results were mixed, with more seriously affected patients not experiencing long-term gains:

“The more pronounced secondary and primary progressive patients had limited improvement after six months, but none at 18 months, he reported…The veins narrowed again in almost half the patients.”

I do trust in the good faith efforts of researchers, who’d all love to find and/or prove a cure for MS and other chronic debilitating disorders, to design and carry out a properly blinded study of Zamboni’s surgical intervention with an adequate control group. I’d trust them much more than surgeons collecting testimonials* with which to support a highly lucrative practice.

*It’s characteristic of testimonials that they are easily presented in such a way as to maximize positive ones, while the negative outcomes get less attention (where are the testimonials from folks who failed to see improvement at 18 months? Are they still hoping their symptoms will turn around, or are they reluctant to criticize a physician who they see as having tried to help them?).

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If the control group had no improvement, or a lesser improvement, it would be evidence that the improvement of the procedure group could not be explained by the placebo effect. And if other studies duplicated the results, that would bring the prodedure closer to being an accepted medical procedure.

I’m in favor of any treatment that can be proved to work. But we really do need double blind studies and we really, really need studies done by people who aren’t promoting the procedure. Assuming that it could be snake oil is necessary.

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Except in this instance it is the patients driving this treatment because they are listening to the testimonials of other patients. It isn’t being driven by Zamboni, or any other doctor. Yet, the people who all want to see this disappear all seem to have a vested interest in keeping the status quo.

The first patient’s death was not attributed to the surgery. Only in the media was it made so.
Stents are designed for arteries. Simka claims to have resolved the issue and hasn’t had it happen in his patients.
The Dr. Mark Freedman who has been doing stem cell research for MS patients has had patients die. I’ve read that there is a 5% mortality rate for that treatment. Yet, they continue to pursue it.
Tysabri has killed at least two people. Yet, it is still on the market.
The new drug of the day is chemotherapy. And the testing done for that was?

And the cost of an angioplasty isn’t $80,000. It is less than $5000. Only if you are an MS patient was it that price. There are other places in the States now charging closer to the price I quoted. In Poland it costs ~$10000.

I agree. But, one question I have is why are no drugs ever even coming close to the ‘placebo’ effects that this surgery is having? As I’ve heard people with MS say, “Can I have some of that placebo affect, please?”

By the time these studies are done thousands of people will have had this surgery. There will be stories of no affect, to people getting out of wheel chairs. People like myself, and alice_in_wonderland will keep telling the story of people they know. They can’t keep telling people that their results aren’t real until some scientist decides it is so.

So, who should be doing the studies. You aren’t going to trust the proponents and those who believe the study are not going to trust the results of those funded, or have been funded, by the pharmaceuticals. They stand to lose tens of billions if this is proven to be true.

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Geez, work in Transylvania?

People are already getting treatment. You can compare it to other groups who take drugs or don’t take anything. Why put people through surgery, no matter how minor, if you don’t need to?

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The price of anything medical in the US isn’t much of a good reference, you know. Specially given that the same procedure, done by the same medical team in the same location and in exactly the same way, will change price depending on who’s paying.

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Placebo effect. If people think you’re doing something to them, a certain, significant percentage will show improvement. The treatment has to be proven to not only have a positive effect but also be better than placebo.

Some surgery trials are compared against medication or no treatment or a different surgery, but often a “sham” surgical group is required, depending on the situation. Subjects are fully informed of what research “treatment arms” (options) are involved before participating in the research.

In this particular study, this was a neurological illness in which there (to the best of my recollection) was no other effective treatment available. Obviously an implant in the brain is a very dramatic step to take, and researchers had to make absolutely sure that - even though the implant showed positive effects in earlier cases where only the implant was offered - there was an actual benefit of having the implant in place, versus the participant just thinking they’d gotten the implant. After all, the treatment also obviously had certain risks, and you need to establish that the risk is worth it.

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Oh, and who should be doing the research? The way it’s usually done is that an independent monitoring group is contracted as a go-between. They monitor the involved study sites that are carrying out the research, and collect the data, making sure it is “de-identified” and “blinded” before going to the company, so that the company does not know which study participant got which treatment. The data is analyzed, looking for differences in response to treatment, frequency/severity of problems/side effects, and so on. Only after this is the treatment type revealed.

Really, you wouldn’t believe how many cases I’ve seen where treatments were thought or hoped to work, and only later it turned out they didn’t. The majority of medical research starts out with animal testing to look for anything glaringly wrong in terms of safety, then is tested in healthy humans to again check for overall safety. Then the treatment is tested by itself, under a controlled study with all side effects closely monitored and noted, and finally if that seems to work, it goes on to a test versus a placebo, often with another treatment being used at the same time in both groups (or as a “rescue” backup only) to see if the new treatment helps even more.

The last phase (called phase III testing) is where things tend to not work out so well, where researchers find out that it’s not any better than placebo, or that the side effects are so awful that - unless the disease is fatal or something and there are few other options - the treatment is not considered worth the risk.

Here’s one example. I was working at my current workplace, but not directly on the study in question. It was for a treatment (that also involved surgery in the process) that was hoped to help give back at least a little bit of light/dark perception and maybe more, in a particular disease that pretty much inevitably led to blindness, and there were no effective treatments out there. As you might guess, there was a lot of excitement about it. A doctor had come up with the idea originally, and raised money to test it. First it was tested on a small number of people with the disease and some encouraging positive results were seen, possibly some improved light/dark perception and similar things, so a new study (testing it versus placebo) was done at various hospitals. It was also talked about on one of those “new medical miracles” shows on the Discovery Channel or something like that, and I think it’s from there that it went crazy - somehow it got picked up by a big radio show (the sponsor of the study wasn’t involved in this; we think it was maybe an excited participant from the first study) and the host hyped it as being a miracle cure for this incurable disease, and talked about where the study was being done. Meanwhile I come into work on Monday and boom, all of our office’s voicemails are full with messages from all over the US and the world. It was crazy! People were begging to get into this closed study, and all we could do is refer them to the company to get on a waiting list for the next study. It was years ago that this happened and I still get calls to this day asking about the treatment.

What happened? The people who’d actually received the treatment didn’t do any better than placebo. In fact, none of them did that well at all in the long run, and with more people involved, they were better able to see various side effects - sometimes side effects are so rare that they might show up only 1 in 1,000 cases, 1 in 10,000, etc. No miracle cure, not even a passable treatment.

Listen, I don’t have a dog in this fight, or if I do, it’s actually on your side. When I was a little kid, I had an aunt with MS. My sister had a MS scare herself, with some possible brain lesions turning up that had her nervous until it was ruled out, and I understand what a nasty bitch of a disease this is. I’m just talking about how research is done in the US and around the world. Surgical treatments are put through rigorous testing every day; it’s not something that’s done only for medications. It would be a benefit to those affected by MS if this could be similarly tested.

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65 patients is not a very big sample. To understand why this matters, click here for a brief lesson in statistics; after reading that page, click the link at the end (“You Be the Research Scientist”) to see how those concepts apply to research on the causes and cures of MS.

BTW, that site - www.multiplesclerosissucks.com - is pretty good in general.