MS Liberation treatment

[Canada 02]

Originally Posted by flamesfever

I believe this is just a token effort by the Government to appease the MS Community. They are moving at a snails pace by spending only a million dollars, and doing a 3 year observational study of those who have collectively spent many millions of dollars of their own money trying to get help.

I'll bet that the private sector comes up with the funds and initiative to conduct the trials necessary to confirm whether or not CCSVI is a key, conributing factor in MS...long before the Government do.

Then if the results are positive, you can bet the Government will jump all over it to claim credit for the results.

you don't have a clue what your talking about. A $1 million, 3 year grant is a phenomenal amount of money for an epidemiological study. almost all significant medical research in North America is government funded. The private sector is responsible for maybe 5% of medical research funding; those research dollars will often have strings attached or ulterior motives beyond knowledge discovery

[flamesfever]

Originally Posted by Canada 02

you don't have a clue what your talking about. A $1 million, 3 year grant is a phenomenal amount of money for an epidemiological study. almost all significant medical research in North America is government funded. The private sector is responsible for maybe 5% of medical research funding; those research dollars will often have strings attached or ulterior motives beyond knowledge discovery

My dear fellow. I would guess you aren't being affected, directly or indirectly by MS.

Also if what you say is correct, where have all my donations, to fund reseach by various charitable causes, been going over the years?

[puckluck]

I hope it doesn't take that long for them to approve this.

They guy I know that went over to do the procedure has had his life changed for the better.

He can now move his arms and hands more freely and can actually hold his kids for the first time in his life.

He said the difference was night and day instantly after the surgery.

[Knut]

This is a good first step. Most of the evidence that this works is anecdotal at this point. The results of this government funded study (and others like it in other jurisdictions) will open the door for everyone to have the procedure, safely performed, down the road.

You can't just approve things left and right under the health care system. Due Diligence must be done to ensure safety.

[flamesfever]

My understanding is it would take at least 5 million dollars to fund a proper clinical trial. In my mind, if you weigh the risk / reward, this thing should thing should have been started yesterday.

However, we have the MS Society spending one million, and the Alberta Government spending one million, over an extended period of time...to find out what?...if they should go ahead and spend a few extra million.

My goodness, we pay Iginla more than it would cost to fund a trial. With so many sufferers, and more and more people spending large amounts of money going abroad to have the procedure, my question is why in heavens name is it taking so long for someone or some group, or the Government to come up with the money to do the trial?

[Ashartus]

Originally Posted by flamesfever

My understanding is it would take at least 5 million dollars to fund a proper clinical trial. In my mind, if you weigh the risk / reward, this thing should thing should have been started yesterday.

However, we have the MS Society spending one million, and the Alberta Government spending one million, over an extended period of time...to find out what?...if they should go ahead and spend a few extra million.

My goodness, we pay Iginla more than it would cost to fund a trial. With so many sufferers, and more and more people spending large amounts of money going abroad to have the procedure, my question is why in heavens name is it taking so long for someone or some group, or the Government to come up with the money to do the trial?

It's probably a lot more than $5 million for a proper clinical trial. But regardless of cost, they need the observational data first to meet ethical requirements as well as to demonstrate that the clinical trial is worth conducting. If they put a bunch of people in a randomized clinical trial, and the ones that get the procedure all end up with terrible side effects a year or two down the road, whoever funded the study would end up facing lawsuits and major liabilities. A more likely outcome of the observational study could be that those getting the surgery regress within a couple of years, in which case health authorities would have to decide whether the temporary benefits outweighed the risks of the surgery before approving a clinical trial.

The process is frustrating for those suffering from a condition such as MS (or cancer, where again new treatments take many years to get approved), and there have been various debates over the years about how it could be improved, but the current system is in place for good reasons.

As to why Iginla is paid more than it costs to fund medical studies - I guess that's a symptom of our priorities as a society. Most people would rather spend money watching a hockey game than donate it to medical research.

[photon]

The funding is probably proportional to the likelihood of getting good results, and CCSVI is very new without a lot of data yet (26 hits on PubMed for CCSVI, a pittance). The people making the funding decisions have to decide if finite resources go to research well supported by history and evidence, or something new.

Seem to me starting out small and growing if there's evidence is the right way to go. It'll take a decade for something to go from research to a full blown treatment, the first paper on PubMed I read about CCSVI says there isn't even a gold standard way to assess CCSVI, let alone run clinical trials.

The Iginla canard is just emotional appeal and a false dilemma, it's not an either or... Iginla makes lots of money because lots of people pay money to go see the game.

It takes time for new stuff in Medicine, because it's complicated and expensive, and there's finite resources, and throwing $$ at everything that claims to be effective is impossible.

[NuclearFart]

Originally Posted by photon

The funding is probably proportional to the likelihood of getting good results, and CCSVI is very new without a lot of data yet (26 hits on PubMed for CCSVI, a pittance). The people making the funding decisions have to decide if finite resources go to research well supported by history and evidence, or something new.

Seem to me starting out small and growing if there's evidence is the right way to go. It'll take a decade for something to go from research to a full blown treatment, the first paper on PubMed I read about CCSVI says there isn't even a gold standard way to assess CCSVI, let alone run clinical trials.

The Iginla canard is just emotional appeal and a false dilemma, it's not an either or... Iginla makes lots of money because lots of people pay money to go see the game.

It takes time for new stuff in Medicine, because it's complicated and expensive, and there's finite resources, and throwing $$ at everything that claims to be effective is impossible.

Very well said. Only thing I'd add to the last paragraph is the additional step of passing ethics approval for medical research - that stuff takes months, especially with all the media scrutiny/hype.

[Canada 02]

bump

Zamboni's "disciple and ally, Buffalo-based neurologist Robert Zivadinov" no longer believes in this, and at least 6 research studies have found no validity to Zamboni's assertion that CCSVI causes or contributes to MS

Dr. Zivadinov’s findings are part of a growing body of evidence that suggests that they are wasting their time and their money – and perhaps putting their lives in danger.

But researchers trying to duplicate Dr. Zamboni’s findings could not do so, and began to poke holes in them. At least six studies published in the past year have raised serious questions.

Last August, two reports in the same issue of the Annals of Neurology found scant evidence of the condition Dr. Zamboni had dubbed chronic cerebrospinal venous insufficiency (CCSVI). In fact, none of the MS patients studied met more than one of the five criteria Dr. Zamboni said are needed to diagnose CCSVI.

A paper in February’s issue of the Journal of Neurology, Neurosurgery and Psychiatry again found no vein problems, prompting its authors to “cast serious doubt” on the concept.

Finally, Dr. Zivadinov, a specialist in MS who teaches neurology at the University of Buffalo, fanned the flames even further.

After defending the procedure to his colleagues at the Toronto conference, he went home, looked at it more closely and found blocked veins, but in just 56 per cent of patients with MS. What’s more, the veins of 23 per cent of the people he examined without the disease also had blockages.

Concluding that CCSVI does not cause MS, he largely distanced himself from the theory he’d once endorsed – and “created a lot of controversy,” he admitted in an interview. “We have been really bombarded by questions.”

partly why Zamboni's research is thought to be flawed

Ultrasound machines, which Dr. Zamboni uses to look at neck veins, are unreliable and can be wildly inaccurate, if the people operating them aren’t well trained, he explained.

Dr. Baracchini also said that he has met Dr. Zamboni and dismisses the ultrasound device he employs as a “garbage machine.”

A panel of experts convened last summer by the Canadian Institutes of Health Research also has sounded the alarm, reporting that veins are notoriously difficult to examine with ultrasound technology, which can easily compress them to seem constricted.

The panel also noted that Dr. Zamboni’s research wasn’t “blind” – researchers knew which test patients had MS, and the patients knew they were receiving treatment that might help. In such circumstances, the report noted, there is a “natural human tendency to find what one is looking for.”

Feel bad for MS sufferers.

edit, forgot to post the link to the article

http://www.theglobeandmail.com/life/...articlecontent

[Cowboy89]

Originally Posted by Canada 02

Feel bad for MS sufferers.

As I understand it, MS is something that has seen leaps and bounds progress in treatments over the past 10-20 years. The shame in the Zamboni diversion is that I can only imagine that it probably slowed a lot of momentum that researchers had going for them as many of them probably had to waste time dispelling the myths of the treatment.

Saskatchewan wasted a crapload of money studying it, as politics entered the arena vs sound judgement.

[Knut]

http://www.theglobeandmail.com/life/...2014800/page3/

The Article that Canada02 posted.

“We’ve been here before,” said Yale’s Dr. Novella. “Most of the time, when enthusiasm races ahead of evidence, it’s to the detriment of everyone involved, especially patients.”

The above quote sums this debate up perfectly.

[Knut]

http://www.theglobeandmail.com/life/...rticle2014801/

Lisa Cooper, a mother of three who lives in Mount Vernon, Wash., has had the “liberation procedure” twice, and despite paying high fees and experiencing disappointing results, she is still a firm believer in Paolo Zamboni's work.

Here is the issue with this debate. Those that want the procedure are willing to believe in it, even if it does not work for them. I would hazard to guess that for every person that has the procedure done and had good results, there are multiple other people that have had it done and have had poor results.

I do think funding research into it is the right thing to do however, and there seems to be some promise to the idea.

[chemgear]

http://www.calgaryherald.com/health/...518/story.html

“I can’t explain the feeling of normalcy I had for those six weeks,” she says. Then Romanuik’s condition began a downward slide, a common experience, judging by their blogs, for most people who have the treatment.

If zero was where she was before undergoing the treatment and 10 is where she was right after it, her MS symptoms are now at three, Romanuik says, down from a seven, a month ago. She’s certain the regression means her veins have become blocked again because there was no stent put in to hold them open.

[chemgear]

http://calgary.ctv.ca/servlet/an/loc...ub=CalgaryHome

After she was discharged, her husband says she started feeling ill and had a massive headache.


She was taken to hospital and suffered massive bleeding in her brain.


Clarke was taken off life support and later died.


She is the second Canadian to die following the procedure.

[chemgear]

http://www.calgaryherald.com/health/...083/story.html

Patients with multiple sclerosis who claim they’ve benefited from the so-called “liberation therapy” say city neurologists are stirring up needless fear about the controversial treatment.

New research by University of Calgary researchers has documented serious complications among five MS sufferers who travelled abroad for angioplasty or surgical stenting of veins that drain blood from the brain.


This comment seems to be . . . a little silly. And perhaps an indication the emotion of the situation (and perhaps people getting a little ahead of themselves?):


Dr Bill Code, a board member of a national organization that advocates on behalf of MS patients who’ve received the treatment, said the peer-reviewed study is an attempt by neurologists to protect their medical turf.

“They’re trying to create a murmur in the media that this therapy is dangerous when most of the time it’s safe,” said Code, “because their egos are hurt and their research dollars are threatened.”

[chemgear]

http://www.cbc.ca/news/health/story/...sis-ccsvi.html

"It is telling us that there is likely no benefit of balloon angioplasty in patients who have MS and have CCSVI and there is a possibility that at least in the early term, because this is six months, there is evidence there may actually be increased disease activity from balloon angioplasty."

Siddiqui said he's "concerned enough to suggest that patients not receive this treatment outside rigorously controlled clinical trials. That's important because not only did we not show any benefit in a very carefully selected cohort that was most likely to show benefit, we saw none. Instead we saw potential for harm."

[CaptainCrunch]

I think that this is being presented as a cure all way before its been completely tested.

From a personal side, my cousin's wife is a incredible and smart and energetic lady, she wa at one time a highly acclaim athlete. Then she got Parkinson's and we've watched her degrade to the point where she's losing control over her body, she shakes and tires quickly. She's worked hard to educate herself, she's traveled to conferences, she's getting desparate and looking for anything that will help her because I thinks she's scared that this disease will impact her ability to take care of her kids.

So she goes to the states and a doctor that she see's convinces her that Liberation is a alternative treatment that not only works on MS but works on most other neurological diseases. Tells her that she has nothing to lose, and books her for the process at a cost of I think $10k.

So her and my cousin scrape up the money, borrowing where they can and she gets the surgery done. And nothing her symptoms have actually become a bit more pronounced.

So what's my point you might ask. My point is we still don't know how effective this is in terms of real full clinical trials which are ongoing. But its become an incredibly emotional debate because it offers hope, and now its prescription is spreading because its a relatively quick and easy procedure that can generate large money for specialists peddling hope.

Hey I hope that this is the right process and it relieves suffering, but I'm reading that its success rate isn't confirmed or stunningly high yet.

[flamesfever]

Originally Posted by chemgear

http://www.cbc.ca/news/health/story/...sis-ccsvi.html

"It is telling us that there is likely no benefit of balloon angioplasty in patients who have MS and have CCSVI and there is a possibility that at least in the early term, because this is six months, there is evidence there may actually be increased disease activity from balloon angioplasty."

Siddiqui said he's "concerned enough to suggest that patients not receive this treatment outside rigorously controlled clinical trials. That's important because not only did we not show any benefit in a very carefully selected cohort that was most likely to show benefit, we saw none. Instead we saw potential for harm."

This is the result of a small pilot study involving 10 MS patients, and 10 without MS. Meanwhile 30,000 people have had the procedure at a cost of say $10,000 to $20,000. each...equivalent to an expenditure of close to 1/2 a billion dollars so far.

Considering the money spent so far, and the money that is continuing to be spent on the procedure, wouldn't it make sense to spend the money to do a large phase III study to decide once and for all if the procedure works?

[onetwo_threefour]

Originally Posted by CaptainCrunch

I think that this is being presented as a cure all way before its been completely tested.

From a personal side, my cousin's wife is a incredible and smart and energetic lady, she wa at one time a highly acclaim athlete. Then she got Parkinson's and we've watched her degrade to the point where she's losing control over her body, she shakes and tires quickly. She's worked hard to educate herself, she's traveled to conferences, she's getting desparate and looking for anything that will help her because I thinks she's scared that this disease will impact her ability to take care of her kids.

So she goes to the states and a doctor that she see's convinces her that Liberation is a alternative treatment that not only works on MS but works on most other neurological diseases. Tells her that she has nothing to lose, and books her for the process at a cost of I think $10k.

So her and my cousin scrape up the money, borrowing where they can and she gets the surgery done. And nothing her symptoms have actually become a bit more pronounced.

So what's my point you might ask. My point is we still don't know how effective this is in terms of real full clinical trials which are ongoing. But its become an incredibly emotional debate because it offers hope, and now its prescription is spreading because its a relatively quick and easy procedure that can generate large money for specialists peddling hope.

Hey I hope that this is the right process and it relieves suffering, but I'm reading that its success rate isn't confirmed or stunningly high yet.

Not to be a downer, but given that Parkinsons is caused by the destruction of dopamine producing cells in the substantial nigra region of the brain, and the fact that dopamine cannot cross the blood-brain barrier, opening up blood flow makes zero-sense as a treatment for Parkinson.

Of course, given the etiology of MS, I would have said the same thing about MS and I guess the jury's still out on that, so who knows...

One would think that, with either disorder, if oxygenation of the brain or removal of waste metabolites were the issue, they would have known a long time ago, and I'm not sure what other role increased blood flow would have on the destruction of either myelin or the dopaminergic cells of the substantia nigra.

[CaptainCrunch]

No its not a downer, She ran into a doctor that was peddling miracles and it cost them a bunch of money with no results.

While he got richer, she not only got poorer, but her hopes were crushed.