Dare we dream?
Blaze wrote:Can any docs out there comment on whether this is acceptable or ethical?
Here's that part of the article:
However, what the federal government is proposing is a smaller-scale, two-phase trial than what was proposed by Saskatchewan. Phase 1 will involve a small number of healthy people to test the safety of the procedure while Phase 2 will involve between 20 and 300 patients to look at the effectiveness of the treatment on a limited number of people.
PCakes wrote:There must be a precedent set for this type of treatment trial? Will they really 'treat' healthy volunteers? Seems medieval. How did they test cardiac angio? or percutaneous aortic valve placement?
I'm with Cece on this one..
“It was not an easy decision,” said Dr. Alain Beaudet, president of the Canadian Institutes of Health Research, who chaired the meeting in Toronto and said that after a majority of members supported the decision, everyone voted for it.
“We always want the scientific evidence to be stronger. The question is, when will it be strong enough to get going with this thing? There are people that will tell us it’s too early. Others will tell us that it’s too late. We’re really trying here to do our best and balance science and patients, but it remains a human endeavour.”
Dr. Aaron Field, an associate professor of neuro-radiology at the University of Wisconsin, said a “key factor” in the decision was a meta-analysis of the research published so far, including a recent study by a Zamboni ally at the University of Buffalo that made headlines by suggesting CCSVI was a result, not a cause, of MS. The analysis took into account factors such as the number of subjects in research studies, and whether they used proper blinds and control groups.
“Even when you took a very conservative approach to that meta-analysis, it still came out looking like there was an association there (between CCSVI and MS),” said Field, who, like Beaudet and Rubin, stressed there is still not enough evidence to suggest cause and effect.
Research yes, still no right to treatment
CCSVI Coalition applauds announcement of clinical trials
TORONTO, June 29, 2011 /CNW/ - Today the Government of Canada on the unanimous advice of the Canadian Institutes of Health Research (CIHR) approved funding for clinical trials of CCSVI related to Multiple Sclerosis. This is a reversal of the negative position taken last fall by CIHR and the Multiple Sclerosis Society of Canada. Today's statement made no mention of participation by the MS Society in this positive decision and there is no indication that the MS Society has changed its negative view of CCSVI.
Today's announcement marks the first time that the Government of Canada has acknowledged the relationship of CCSVI to MS.
People familiar with this issue are encouraged to contact the Minster of Health, congratulate her on this decision and urge her to make a priority of having treatment for CCSVI available in Canada immediately. http://www.hc-sc.gc.ca/contact/ahc-asc/minist-eng.php As well as long-term research, treatment is what Canadians with MS, their families and friends have been asking for the right to receive treatment in their own country for a disease that slowly and unrelentingly destroys health of its victims.
The CCSVI Coalition (www.ccsvicoalition.org) will continue to fund CCSVI research in Canada and to advocate for immediate access to treatment of CCSVI.
Aglukkaq Is Right To Authorize Zamboni Trials
Canada has at last decided to be a full participant, not a bystander, in testing a potentially revolutionary treatment for multiple sclerosis devised by the Italian doctor Paolo Zamboni. It will set up clinical trials of the treatment, which until this week had been dismissed by many experts. Full participation in clinical trials is the right thing – the ethical thing – to do in a country with 75,000 people who suffer from the disease. Canada needs to see this treatment through, till the truth is uncovered.
Much has been said, of late, of a University of Buffalo study that casts doubt on Dr. Zamboni’s theory that vein blockages contribute to the disease and can be eased by surgery. But the authors of that study went on to say: “It behooves the clinical research community to carefully pursue [the theory] to its end. We should neither jump on the bandwagon as it passes through town, nor assiduously miss the parade.”
The Canadian Institutes of Health Research – this country’s main medical research funding body – has been true to its word. When it rejected clinical trials for the vein-unblocking treatment last year, it said that an expert panel would watch preliminary studies carefully. Now the expert panel has jumped in and said that early evidence of vein abnormalities is enough reason for proceeding to clinical trials.
And Health Minister Leona Aglukkaq has been true to her word, too. She said the government would support clinical trials if the CIHR gave its support.
There was always an irony in Canada’s rejection of clinical trials. The CIHR’s creation of an expert panel on the treatment was itself a recognition that Dr. Zamboni’s ideas were novel and powerful. Yet the panel rejected trials as premature and went so far as to say that they might not even win approval from ethics boards in hospitals because of the treatment’s risks. That seemed a narrow view of ethics, given the suffering of many people with the disease, which is marked by weakness, loss of muscle co-ordination and vision problems.
The CIHR says the evidence from new research isn’t clear on whether vein blockages are a cause of MS or a consequence. But there does appear to be a link between the blockages and MS, says CIHR president Alain Beaudet. That is enough to launch the first two phases of four-phase clinical trials. And so it is game on. This is not bandwagon-jumping. It is an attempt to test a new idea about an old disease, and it is in keeping with the best traditions of scientific inquiry.
http://www.theglobeandmail.com/news/opi ... ukkaq-is...
munchkin wrote:Sorry, I wasn't implying the information was wrong. I was trying to state that I hope the country acts honestly on the trials to ensure that they are done properly and without negative CCSVI bias.
Objective, fair, and appropriate trials is what I hope is true. And then the rest of the medical community can start to act like Dr's again in regards to the health issues of pwMS.
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