Liberation Therapy, Controversial MS Treatment To Get Government Funding: Leona Aglukkaq

Ms Liberation Therapy

First Posted: 06/29/11 05:17 PM ET Updated: 08/29/11 06:12 AM ET

THE CANADIAN PRESS — OTTAWA - The federal government will fund a clinical trial of a controversial treatment for multiple sclerosis patients but it could be years before so-called liberation therapy is widely available in Canada.

Health Minister Leona Aglukkaq announced the move Wednesday in spite of recent studies that have cast doubt on narrowed neck veins as the primary cause of the debilitating illness.

She said a scientific working group established by the federal government last August has agreed unanimously that a preliminary clinical trial into a controversial vein-widening procedure should proceed.

"Our government has been clear that we were prepared to fund a clinical trial, but only when there was sufficient medical scientific information to support proceeding safely," said Aglukkaq.

She said the team, sponsored by the Canadian Institutes of Health Research, reviewed scientific reports on the procedure and deemed it safe enough to go ahead.

"There is unanimous agreement that a clinical trial should proceed at the Phase 1 and Phase 2 level."

Aglukkaq attached no dollar figure on the federal funding. She said that will depend on the proposal that's ultimately accepted by the CIHR for conducting clinical tests on liberation therapy.

Narrowed neck veins — or chronic cerebrospinal venous insufficiency — became the subject of numerous studies after Dr. Paolo Zamboni of Italy theorized it could be a factor in the development of MS.

Zamboni surmised that reduced blood flow leaves iron deposits in the brain, leading to the neural lesions typical of MS. He contends that reversing the condition by unblocking neck veins using balloon angioplasty could help alleviate symptoms.

Many hopeful Canadian MS patients have gone abroad seeking the procedure, which isn't offered in this country, while the MS community has been leaning on Ottawa to proceed with trials.

In the absence of action from Ottawa, Saskatchewan and Manitoba have committed funding for clinical trials. Earlier this month, New Brunswick announced it will provide public funding to help cover the costs of receiving liberation therapy abroad.

Some clinical studies — most recently by a team at the University of Buffalo — have indicated that the vascular condition does not have a primary role in causing MS and have cast doubt on the efficacy of liberation therapy.

But CIHR president Dr. Alain Beaudet said the evidence reviewed so far suggests "a trend to an association between the greater prevalence" of blocked neck veins in patients with MS than in healthy people.

"More studies will be needed, and particularly the results of the seven ongoing studies will be needed, to strengthen this conclusion. But, nonetheless, the committee felt that, on the basis of this preliminary evidence and what's published so far, that we should in parallel start already with a Phase 1-2 trial."

Beaudet said it's hoped the preliminary trials , which involve only small sample groups, will begin early in 2012. Realistically, he said it will be at least a year before any results are known.

Should preliminary results warrant, a phase 3 trial, involving hundreds of patients, would then be undertaken. Beaudet conceded it could take years before determining whether liberation therapy works and should be widely available in Canada.

"Clinical research takes time but you don't want to subject patients to a treatment that has not been proven and you don't want to carry out a trial on patients without having the necessary scientific evidence to do so," he said.

"I believe that we are proceeding in the way that science tells us we should be proceeding."

The MS Society of Canada, which has committed $1 million toward the cost of a clinical trial and has been lobbying hard for federal funding, welcomed Aglukkaq's announcement.

"We are pleased to see that the federal government and CIHR have kept MS at the top of their health care agendas," the society said in a written statement.

Opposition parties also welcomed the announcement but criticized the federal government for taking so long and expressed concern about how long the trials will now take.

"I think there'll be continuing, very strong pressure on the government to move as quickly as possible," said New Democrat MP Libby Davies.

"It's going to come from us politically but it's also going to come from the (MS) community because this is now a well-organized community and I think they do have legitimate expectations that they want the government to act with the greatest speed and efficiency to get this under way."

Liberal MP Kirsty Duncan said Canadians with MS have been calling for clinical trials since November 2009 when news of liberation therapy first emerged. Fifty other countries have already launched clinical trials.

With some 55,000 to 75,000 Canadians afflicted with multiple sclerosis and 400 a year dying from the illness, Duncan said: "If (liberation therapy) improves quality of life, it's incumbent on us to do the science and do it as quickly as possible."

Duncan has been keeping close contact with 300 Canadians who've undergone the vein-widening procedure and she said there've been "some very exciting results." She knows of wheelchair-bound patients who've been able to walk again and home-bound patients who've been able to return to work.

Aglukkaq maintained the government has acted swiftly but prudently.

"What we've been able to accomplish since the time the issue was raised and today has been significant," she said, adding that she's asked Beaudet to move as quickly as possible on launching the trials.

"We agreed to move forward with clinical trials once the evidence was there ... The evidence is now here."

Joan Bryden, The Canadian Press

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10:03 AM on 06/30/2011
""paying for hope"""" is a demeaning headline ----and it is an insult to those with MS -----
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09:49 AM on 06/30/2011
sdfdsfs
09:44 AM on 06/30/2011
most of the "controversy" in my opinion is generated by big pharma ---a cure for any disease means lost revenue -----MS drugs for symptomatic relief cost 25,000 to 50,0000 dollars per year

sure the liberation thing is new and untested but needless delays wont get to the answer any faster ----the government seems to think the answer will be better if you wait ten years ---

you can flip a coin a thousand times in one day or you can do a coin a month for ten years --the likely result will be the same ---same is true of this treatment --so get on with it ---sick people need relief now ---not after they are gone
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Midnight Toker
08:40 AM on 06/30/2011
my beautiful wife..

gone now five years this july..

had stenosis of her left carotid artery and ms symptoms on her right side.

i don't know if she had stenosis on the drain side.. the mri we received didn't say.

she smoked Cannabis for the spasms, pain and depression.. and that was the best med.

it sounds like this ''liberation therapy'' might have helped her.. but we'll never know.

the criminalization of Cannabis though is in itself criminal.. SO LEGALIZE IT.
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westcoastkid
09:28 AM on 06/30/2011
Completelt agree with your comments RE: medical cannabis. My father who also has MS uses medical MJ to quite remakable results. This therapy is supported by more than one high-quality clinical trial. It is considered an acceptable adjunct therapy in both MS with spasticity and several chronic pain syndromes.

However, the current Gov't is just about to quash the access to medical MJ for many Canadians such as my father. Not only that, their legislation will make many medical MJ users criminals who could be subject to jail time. That is sick, cruel, and WRONG. Write your MP a letter describing your wife's story. I've already written mine.
10:51 AM on 06/30/2011
If we could just find proof that Jesus smoked a joint to recover after miracles it's likely we could get it legalized by harperites.
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Clay4bc
06:29 AM on 06/30/2011
This therapy is not 'controversial". I have a friend who suffers from rather advanced MS, and she had the treatment. Improvement was immediate, and continuous.
The only thing 'controversial' about this is that she had to travel to San Diego to get it, and pay
$15 000 out of pocket for a safe and easy treatment that is actually available in Canada - but is somehow not available for MS patients.
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westcoastkid
09:24 AM on 06/30/2011
I'm not sure if you know what 'contraversial' means.

Just because you know somebody who went internationally and paid out of pocket for an unproven therapy does not mean it is not contraversial. Rather, that would be almost the definition of contraversial.

When the overwhelming majority of specialists in this area do not support a treatment, combined with the FACT that there is no reputable medical evidence demonstrating positive results or safety, I think most would agree that is a contraversial therapy.

If I know somebody who went to mexico and had an IV infusion of taco sauce to treat their cancer, would that also be "not contraversial"? After all, I know somebody who did it.....
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westcoastkid
09:33 AM on 06/30/2011
Sorry about the typos and spelling, btw. Happens when you are typing on a smart phone...
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Clay4bc
10:05 AM on 06/30/2011
I understand very well what it means.
And to say that there is no "reputable medical evidence demonstrat­ing positive results or safety" is laughable. There happens to be mounds of evidence.
The problem is that this treatment doesn't involve taking a lifetime of drug therapy to alleviate the symptoms, and thus big-pharma can't get behind it.
I'm not sure why you feel the need to question this treatment, but you wouldn't even think of questioning it if you saw a loved one slowly dying of MS, and then saw this treatment.bring them back, after all of the failures of current 'non-controversial' treatments. I have to seriously question your motivation on this one...
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westcoastkid
07:45 PM on 06/29/2011
Why are they enacting legislation to severely limit access to medical marijuana - even make criminals out of those who use it or produce it?

Medical marijuana is supported by numerous reputable and high-quality medical studies and is accepted as a standard of care in many pain clinics as well as MS centres (ironically).

CCSVI/Liberation therapy have been heavily criticized in the medical literature and there are numerous high-quality publications who's results cast serious doubt on the merit of this "therapy". Yet the Gov't is supportive to the degree of providing federal money to it. Cannabis? Not so much. Doesn't sit well with the base....

Sad that politics trump evidence and data in todays health care dollar allocation decisions. And scary that despite good evidence to support medical marijuana, it will be more or less eradicated by pending legislation.

(Just to be clear, I support medical research of CCSVI/liberation. I just want to point out the hypocrisy of this ruling....)
05:46 PM on 06/29/2011
MS --------does not mean More Study --------

as far as the buffalo study goes ----if blocked veins do not cause MS ,it is neither here nor there --blocked veins are not an asset --when blood flow to the heart is blocked, it is fixed ----when blood flow from the brain is blocked, it too, needs to be fixed --if only to relieve the oppressive fatigue ms patients deal with

in ontario ----big brother is running wild ---patients cant get the treatment -not even on their own nickle --doctors are prevented from doing it ----so jobs and money are sent to regions(foreign countries) where there are no restrictions -----usually doubling the cost due to travel and accomodartion expense ---this is wrong and should be stopped immediately

as far as the feds study goes ----if the drug companies or their paid hands are involved i tend to believe the results will be skewed -----this trial needs to be totally independent of both government and big pharma to have any credibility

and one last point ----for the price of 3 of those F35'S THE ENTIRE 75,000 patients in canada with MS could have the liberation treatment done and paid for -------one large trial and the answer would be definitive --does it work yes or no -----?------will the 65 fighter jets do the job --we have to wait and see - but that does not hinder the purchase of the planes -yet the same question hinders treating sick people---that is wrong and should be
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stanschurman
05:23 PM on 06/29/2011
Well, we know one thing. Asbestos doesn't cause MS. The Harper government seems to believe that asbestos is about as harmful as green leafy vegetables, so why would we expect them to have a clue about any other medical research?
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ethrop
micro-bio-tic
04:51 PM on 06/29/2011
This is insane. More of this sort of thing is to be expected from the Harper crowd: uninformed, irrational and kneejerk policy-making