Thirteen days after she ignited a firestorm with her announcement that the federal government does “not have the evidence to proceed” with pan-Canadian clinical trials investigating CCSVI treatment for multiple sclerosis, Health Minister Leona Aglukkaq lashed out at the press who she claims mangled her message. “We needed to clarify the misinformation that was laid out in the media,” she told the scrum assembled in St. John’s, NL, to cover this week’s meeting of federal, provincial and territorial health ministers.
The minister wanted to make clear that her government is “still open” and “never said no” to funding clinical trials on CCSVI, the controversial MS treatment pioneered by Paulo Zamboni to restore blood flow in the blocked neck and chest veins of patients via a routine balloon angioplasty. She also wanted it known the feds and provinces are in sync on the issue: “We are speaking with one voice on MS,” she said.
Aglukkaq’s statement offered a minor rewording of her Sept. 1 announcement that did say “no”—at least for now—to government funding for pan-Canadian clinical trials into CCSVI based on the recommendations of a study conducted by Canadian Institutes of Health Research (CIHR) in consultation with the MS Society of Canada. That report concluded scientific evidence didn’t support clinical trials but that the situation should be monitored via seven two-year studies into the MS-CCSVI link funded by the MS Society of Canada and the National Multiple Sclerosis Society in the U.S. The minister also announced at the time that the government would set up a consult with the study’s researchers.
Exactly how the media distorted Aglukkaq’s message isn’t clear. But it’s understandable—politic even—that she take another run at CCSVI, a topic that has polarized the medical community over the past year and sent a fault line down the health ministers’ confab. In July, Saskatchewan’s government drew a proverbial line in the sand when it announced it would fund clinical trials into CCSVI treatment. On Monday, Jerome Kennedy, health minister to Newfoundland and Labrador, kicked off the meeting with news of an observational study tracking residents before and after they left the country for CCSVI treatment (but would not provide the treatment itself). Yesterday, Alberta’s Health and Wellness Minister Gene Zwozdesky announced that he wants to speed up an “examination” study underway in his province involving patients who’ve undergone CCSVI treatment.
Aglukkaq has suffered slings and arrows of newspaper editorials that condemned the government’s wait-for-research-to-see-if-research-is-warranted position. Her office has been deluged with angry letters from MS patients who feel they can’t wait for the clinical trials required before the government green lights the procedure. Hundreds have traveled offshore to far-flung clinics, cashing into their RRSPs to pay upwards of $10,000 for the treatment. Anecdotal evidence from more than a thousand of CCSVI patients attests to varying degrees of symptom relief. Many report increased energy, improved mobility, increased sensation and improved bladder control and vision.
Zamboni’s approach contradicts entrenched thinking that MS is a neurological condition and autoimmune disorder best treated by drugs. But these drugs, with their laundry list of side effects, also pose huge risks, including fatal brain disease. Even Alain Beaudet, the president of CIHR and chair of the CIHR report, concedes the balloon angioplasty advocated by Zamboni is a “relatively low-risk” procedure. The greatest risk of venous angioplasty is veins collapsing again, he told Maclean’s.
It’s an emotional issue to be sure, one that is extending beyond the country’s estimated 75,000 MS patients to become a metaphor for its health system’s priorities. So vitriolic has been the backlash to the government’s decision that last week the MS Society of Canada was compelled to issue a letter to assure angry members it was committed to CCSVI research. Criticism of the government’s decision mounts. Yesterday, Direct MS, the country’s second largest MS charity, issued a critical analysis of the objectivity of the CIHR report.
Agluukaq said it was “important that we set the record straight for MS patients and their families.” But saying the government is “open to funding” clinical trials into CCSVI treatment does not change the fact the government is not funding clinical trials—just as saying the provinces are all “on side” doesn’t make it so. Liberal health critic Kirsty Duncan questions the government’s “double speak”: “They say we need evidence-based medicine,” she says. “But they are doing nothing to gather evidence.” She believes the government should be collecting data on the hundreds of Canadians traveling out of country for treatment: “If it did, we wouldn’t be looking at the evidence as anecdotal. The only other way to collect data is to do clinical trials, and they’re not doing that.”
Another question mark is the minister’s claim that research results from the seven studies will be available in “a few months.” Yesterday, a MS Society of Canada spokesman told Maclean’s “preliminary” findings from the seven studies are expected in “the early part of 2011”—six months from now at the earliest. (None of the seven studies involve CCSVI treatment; all explore possible links between CCSVI and MS using scanning technology.) If the government is committed to evidence-based medicine, it will have to wait until the studies are concluded two years from now. That’s the blink of an eye in research terms—but not for patients suffering from a degenerative condition in which months can mean the difference between walking and paralysis.
What many MS patients want to know is a simple question: why they’re subject to a double standard when it comes to the right to blood flow. When a non-MS patient is diagnosed with a blocked vein, it’s cleared. If someone requires surgery for a varicose veins in her legs, there isn’t a problem. So it’s perplexing that clinical trials destined to take years are required before MS patients receive similar treatment.
“Time matters,” says Duncan. “People die of this disease. And it has a terribly high rate of suicide.” Many are waiting for the minister to say ‘Yes’,” she says: “But until she actually says ‘Yes’, it’s the same result.”