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Feds not convinced MS treatment is safe, effective
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CTV.ca News Staff
Date: Wed. Sep. 1 2010 10:19 PM ET
Despite pressure from patients to fund studies into a controversial theory on multiple sclerosis, the federal health minister says there is not enough evidence to move ahead with any more studies.
Health Minister Leona Aglukkaq said Wednesday she accepted recommendations made this week by the Canadian Institutes of Health Research not to fund further studies on the "liberation treatment."
She said the federal government will instead assemble a working group to study data from seven studies of the treatment now underway.
"To ensure that we have the evidence to support this procedure, we need to do the research," Aglukkaq said.
"And once we have that, we will proceed -- if there is enough evidence from the seven research projects already underway around this subject -- we will proceed with pan-Canadian clinical trials. We will support that.
"At this point in time, we do not have the evidence to proceed."
Many MS patients have been urging quick study on the controversial treatment and the CCSVI theory behind it, which contends that blocked neck veins contribute to MS.
The CIHR said on Tuesday that, after reviewing the research so far on CCSVI and the liberation treatment, "there was unanimous agreement from the scientific experts that it is premature to support pan-Canadian clinical trials on the proposed 'liberation procedure'."
Agency President Dr. Alain Beaudet said the team of experts they consulted wasn't convinced that the CCSVI theory was sound, nor that the liberation procedure is safe nor effective.
In response to question from reporters Wednesday, Beaudet explained that the liberation treatment, which involved threading a needle into neck veins to open them, carries risk.
"Balloon angioplasty is relatively safe -- and I think we have to insist on relatively," he said. "Any procedure where you inject a catheter in a vein, where you compress the vein, where you risk damage to the internal sheath of the vein is not without risk."
Aglukkaq said she looked forward to the outcome of studies currently underway, which are expected to take two years to complete.
"These studies will inform decisions about moving forward with any pan-Canadian clinical trials on a treatment to unblock veins. I will immediately establish a scientific expert working group to monitor and keep me informed of progress on these and other studies. More details on this working group will be available in the near future," she said.
But many MS patients and some doctors are angry with that approach. Cardiovascular thoracic surgeon Dr. Sandy McDonald, who has researched the "liberation treatment," says the federal government's decision is a disappointment.
McDonald believes that Canadian researchers would have been best positioned to answer some of the important questions about the procedure and CCSVI.
"We have a world-class health organization, we have world-class facilities, and we should be doing world-class research by people who know how to do it," McDonald told CTV's Canada AM from Barrie, Ont. Wednesday.
He conceded that there hadn't been much research so far on the treatment, but notes that more research is about to be published. He wondered: if the agency didn't think there was enough research, why didn't it want to fund studies of its own?
"What we're saying is that the research that has been done is flawed and is not good enough, and yet we're not prepared to do the research ourselves," he said.
"If the research others are doing isn't good enough, then we need to do the research here."
McDonald says while he cautions patients from going abroad for medical treatment, he understands that patients who can afford to -- and even those who can't -- will go wherever they have to, to try this treatment.
"I personally don't endorse medical tourism," he said. "But the sad part is that the stance the CIHR has taken actually puts people in the position where they're forced to look at medical tourism for a procedure that should be available in Canada, at least on a compassionate basis."
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Now we should be politically correct in paying homage to these feminists by dropping the "miss" as if that is somehow derogatory?? ..... It amazes me on how trivial the causes are that people will devote their life to. They obviously "Miss" the point to life.
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LMG
said
So Disappointed
said
Give me the treatment
said
Steve K
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Ted
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Jen B
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Patrick From North Vancouver
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Theo in NB
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mandie
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montreal49
said
Guy - Lancaster
said
firstMickey
said
awesome51
said
Gregoryd
said
Will
said
ROB
said
I for one will no longer support MS Canada in any fundraising.
How do we go about creating a grassroots campaign against the MS Society? How do we go about setting up our own organazation to fund the research we want done?
Graeme
said
kg1
said
Prakash Sinha
said
Patient in Winnipeg
said
AGAIN - no one is saying this is a cure, but it has been providing a bit of an improvement to the quality of life for many.
ross rolko
said
Bryan
said
At the same time it is not a cure, and we don't know how long the procedure will last. It is an exciting discovery, but I would like more research before I have surgery of any kind.
dave
said
Tonie Turner
said
Disgusted
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Furious in North Bay
said
JayinStoon
said
Brian
said
or 276.9 million each
Drop one plane
if MS procedure can be done for $30K
9230 people could have it done
A cheap test
malevris
said
Jay
said
Adam
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Come On People
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Richard in Ontario
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Anonymous Montreal111
said
As a researcher myself in health care, we spend 10-12 hour work days working to help solve medical problems. Meaning, we are motivated to help and really want cures. It's not just our job, we dedicate our lives to these causes. If a treatment is promising, researchers will certainly want to move forward with testing it.
I find it sad how many people fall for quick fixes and waste their time and money, and put themselves at risk. This has happened a lot in the field of autism. Chelation therapy has killed children, but many families insist it works, despite a complete lack of evidence and theories about autism that make no sense at all. It's not clear if this therapy for MS works, but families should remain sceptical. Scientific reviews are there to protect the public from being misled and our tax dollars from being misused.
Certain practitioners see the need for a cure, and they see they can make money off of desperate families. Nevermind ethics. It is all very sad.
I hope there is a cure for MS, and I have had friends who have suffered from this too. However, I support the scientific review process. If this treatment is deemed worthy to study, the research should go forward. Until then, money should be spent on more promising treatments and studies.
AnnG
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Arun
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I'm a fan of research, but I'm not a fan of researching claims like cutting off your arm will cure cancer. The situation with Zamboni's CVI idea is disconcertingly analogous to this.
The real tragedy here is all those MS patients who have been tricked into false hope by a man looking for money and fame; especially tragic are the patients I see who had the treatment, and still have MS.
Abandoned in Canada - again
said
Albertaboy111
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Albertaboy111
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John From Southern Shore, NL
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If somebody has bee diagnosed with MS and then has a heart disease that requires the use of either one of these proceedures, does that mean the Dr. will not do the operation because of a fear of also curing the MS?
Geoffrey
said
This proposed technique may not work or may be useful in only some cases. That sounds an awful lot like a lot of drugs that are marketed to us. Drug companies benefit tremendously through tax deferrals/exemptions/grants. The MS society benefits from free-will donations from people like me.
Two to three million dollars can't seriously be a barrier to a Canada-based research study.
To me, it looks like a small bet, granted maybe on a long-shot. Maybe DND could transfer the cost of a few paint-jobs for fighter planes over to Health Canada or whoever and just give it a try...?
DiannaGrenier
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Doug # BC
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Chad
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Kevin Hooff
said
That is standard protocol. This is a case of discrimination
and criminal negligence.
Rene
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ltfrombc
said
Jan whet
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Brent
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Kevin Hooff
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That is standard protocol. This is a case of discrimination
and criminal negligence. fixccsvi.com
Prakash Sinha
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John
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It will also be my last dime to ANY research group if they deny this to MS patients, It will also be a factor in my vote this year....
Martin
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Sara
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Earthwatcher
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Al
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Albertaboy111
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malevris
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It is not a cure but a miracle none the less in that it has alleviated a substantial amount of her pain and revealed many of her symptoms.
It saddens me that pharmaceutical are extended such power as to block this FORTY-FIVE minute procedure from being widely accepted throughout our country. My mother was awake, not even an incision was made.
How arrogant of people to suggest there is a placebo effect occurring in patients. Ethically, it should be decided by patients whether they would like to accept any associated risks; none greater than an angioplasty (which is a procedure performed thousands of times a day).
Shame on our governments and the corporate control which has hindered scientific progress and availability of treatments.
SHAME.
Mars
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kg1
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Stacey
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mpb
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James T
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Henry Vandervoort
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MP
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Governments and Drug Companies are so dependant on each other one can't exist without the other.
Albertaboy111
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RCR
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Albertaboy111
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montreal kim
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kim
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James Hogan
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Jackie Barrett
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ASIFO
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It is a harsh, uncaring government that would trample on people's hope and base their decision to NOT fund research on something that sounds so promising, on a lack of research.
Who were these "so called" experts who made the decision for CIHR?
maxine David
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Prof Dis Gusted
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Carl
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Lance Penny
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Mark
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KD in Alberta
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Jim Bragg
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Will
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Sue
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MARK STEWART
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BrentK
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frustratedMSer
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T.D.
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Tom
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Wendy
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Richard in Ontario
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Jack R
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Dean in Abby
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Daveyboy
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wearestupid
said
smarten up canada email your MLA and raise hell we need to cure these poor sick people
Diane from Toronto
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ROB
said
Would someone explain to me why Canada must reinvent the wheel on medical advances.
The MS societies of Canada and the USA and CIHR herald "Over $2.4 Million Committed to Support Seven Operating Grants to Explore the Relationship of CCSVI to Multiple Sclerosis" [from the MSSociety.ca website] as their response to the demand for action by MS sufferers and the public. In fact these studies go off on their own tangent to develop new methods of imaging and to evaluate comparisons between control groups and other MS patients. All very admirable, but they are not attempting to corroborate the findings of Dr. Zamboni. In the next breath these same organization criticize the procedure and the work of Dr. Zamboni as unproven and lacking in scientific merit. CIHR President, Dr. Alain Beaudet said "There is an overwhelming lack of scientific evidence on the safety and efficacy of the procedure, or even that there is any link between blocked veins and MS." [from the cihr-irsc.gc.ca website]. Statements such as this do not inspire confidence in the public that an honest effort is being made to support Dr. Zamboni's hypothesis.
Dr. Zamboni has a hypothesis. He has conducted his research and a very limited trial. He has some very specific techniques for imaging and performing the procedure. Get away from the moniker of "The Liberation Procedure". The name is sensationalistic and implies a radical prodcedure. The procedure is in fact a straight forward venoplasty. Vascular patients have hundreds of these procedures performed every week in Canada alone !!! Their safety is not an issue. If it is, then suspend all angioplasty and venoplasty procedures immediately. From health.lifestyle.yahoo.ca: "Angioplasty is safer than bypass surgery. Less than 1% of people die from complications of angioplasty." To put this in an MS context, I am currently taking Tysabri, also known as natalizumab. People taking natalizumab have an increased risk of developing Progressive Multifocal Leukoencephalopathy (PML). PML is a potentially fatal viral brain infection. The following excerpts are from Wikipedia:
"A recent preliminary study suggests that patients on this drug for more than 12 months are at elevated risk for PML "
"The risk of developing PML was later estimated to be 1 in 1,000 (0.1%) over 18 months though the longer term risks of PML are unknown."
I am told by my neurologist that my risk is now at 1 in 500 having been on the medication for more than 2 years. The reason I stay on the drug is that it provides me with the best known results for slowing (not curing) the disease. The relative risk associated with a venoplasty is directly comparable.
The efficacy of the venoplasty with regard to MS is the real issue. I admit that there can be no definitive conclusion at this point in time. Dr. Zamboni is on record as saying that more clinical trials are needed to support his hypothesis. It is entirely possible that further research and trials will refute his hypothesis.
The seven heralded research studies all focus on imaging. Trying to find the best way to perform the imaging will not be immediately productive. It will do little if anything to prove the efficacy of the procedure. If the North Americans ( Canada and the USA ) want to corroborate or discredit Dr. Zamboni's procedure then they should duplicate his exact methodology, trying to duplicate his results.
A search of the term "scientific method" which I vaguely remember from high school science produced the following excerpt from Wikipedia:
"Scientific researchers propose hypotheses as explanations of phenomena, and design experimental studies to test these hypotheses. These steps must be repeatable in order to dependably predict any future results.”
Produce a study which exactly replicates Dr. Zamboni's steps. Prove or disprove his hypothesis and results by following the Scientific Method we were all taught in high school. Staff the research study with researchers who WANT to prove Dr. Zamboni's hypothesis to be correct, but are open minded enough to recognize that the hypothesis may be incorrect.
As an MS sufferer, I don't have the luxury of time. My disease marches on regardless of the research that is undertaken. What I need, what all MS sufferers need, are results. Tysabri gives me the hope to carry on and a little more time to wait. Dr Zamboni’s hypothesis gives all MS sufferers the hope of some if not total relief.
Don't reinvent the wheel. Work with the wheel you've got, see whether it works. IF IT DOES, then start to analyse, investigate and improve on the ORIGINAL design. Investigate whether the hypothesis works. Use Dr. Zamboni’s methods. Improve on imaging and procedural techniques if the original hypothesis is supported. Don’t waste your time. Don’t waste our time.
D Blais
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Medical research Is going nowhere in as long as we keep the Drugs maker i charge
Roli
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Someone should get his head examined
Sean
said
---
Full Disclosure: My mother died from MS related causes over 10 years ago.
As for not funding a study in Canada at this time, it actually seems to be a prudent move. Zamboni's research seems to be "sketchy at best" and there are many other studies in progress trying to replicate his results.
Why should the Canadian system spend the money on yet another attempt to replicate what Zamboni did, when the rest of these studies are going to be finished first? It doesn't make sense to me since when they finish, our study will still be in progress - so we will start off either behind, or we'll be working on a study that is useless.
I applaud the wait-for-further-results approach. If these preliminary attempts at replication of Zamboni's work are successful then I think our money will be better spent funding a next-level study.
Anne
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B. Kelley, Realist In Ontario
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Lynn Smith
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MadDog
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stevo
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William
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oddforme
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Colleen from Manitoba
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Don
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Rudy
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Disgusted
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There simply isn't a valid reason for NOT conducting clinical trials especially given the degree of improvements reported by those who get the procedure done.
Jablonski
said
Janis Maharaj
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The Health Canada refusal to fund research on this new treatment for MS is even more unconsionable than usual. It is an easy procedure, not without risks, but something that could help so many. People with MS sit helplessly by in their wheelchairs, dreaming of the day when they might experience some freedom from this terrible disease.
Health Canada officials should hang their heads in shame. This should become an issue in the House of Commons, and certainly a campaign issue for the next election campaign.
I am becoming more and more ashamed of the things this government is doing - or rather, NOT doing! Those of you with this disease, rest assured - your day will come. You and your families can speak with your votes.
Lad
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Tim from Houston
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Bob van Leeuwen
said