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Finally, CCSVI clinical trials. So why is everyone so pissed off?

Anne Kingston takes a closer look at the federal government’s approval of $6-million, four-centre, three-province trials


 

Beatrice de Gea/The New York Times

On Friday, the Canadian government announced  approval of clinical trials into the safety and efficacy of treatment for cerebrospinal venous insufficiency, better known as CCSVI. Health Minister Leona Aglukkaq broke the news at a health ministers’ meeting more than five months after her April non-announcement announcement  that a research proposal had been selected. Back then she said she couldn’t say more until the proposal passed through ethical review boards’ approvals. Now she’s sharing details of the $6-million, four-centre, three-province trials—even though some ethical review board approvals still have to be cleared.

Anyone following the tortuous saga of CCSVI research in Canada will be forgiven if they hear the Peggy Lee chestnut Is That All There Is?  thrumming in the background. The announcement comes almost three years after Italian vascular specialist Paolo Zamboni made sensational headlines with his research linking multiple sclerosis to CCSVI, a vascular condition he identified that’s characterized by blockage in the blood flow of  neck and chest veins.  Zamboni’s claim that balloon angioplasty (or venoplasty) could improve or even arrest MS symptoms had Canadian MS patients clamouring for scanning and treatment, only to find themselves in a bizarro medical apartheid.

And it has been more than two and a half years since the Canadian Institute of Health Research (CIHR) teamed with the MS Society of Canada with the stated intent of expediting CCSVI research; together they’ve kept the issue in stasis with more flip-flopping than a bass on a boat deck.  In the interim, studies into the safety of CCSVI treatment have been published along with research linking it to other neurological conditions such as Alzheimer’s. And somehow neurologists, long-time MS caregivers, have become the go-to experts for a vascular condition—while actual vascular experts who’ve treated CCSVI have been shut out of the loop. Meanwhile, an estimated 30,000 MS patients, many of them Canadians, have travelled offshore to various clinics of varying quality for a procedure covered by provincial health plans, though not for MS. CCSVI treatment has proven effective relieving MS symptoms for some, though not all. Three people, two of them Canadians, have died following the procedure. Seeking answers, and fed up with federal inaction, Saskatchewan and the Yukon have gone rogue with a $2.2-million trial in which 86 MS patients were shipped to a phase II trial in Albany, NY.

Now we officially have “pan-Canadian” trials—provided your Canada only includes Quebec, BC and Manitoba. (Or maybe we should see this model as the test-case of Health Minister Aglukkaq’s signal August announcement about the future of Canadian health care.)  Manitoba’s presence on the list suggests last-minute scrambling. On Thursday night, the Manitoba Health Research Council (MHRC)  announced it wouldn’t sponsor in-province CCSVI trials, for which it had earmarked $5-million, because the one proposal submitted didn’t meet its criteria for a safe, ethical trial.  MHRC chairman Dr. Brian Postl also noted “other research into potential MS treatments is being identified and should be explored as well.” The next day, the province was part of the national trial, pending ethical review board approval. MHRC executive director Christina Weise told Maclean’s that approval is expected within 10 weeks, but that they don’t yet know how much they’ll be contributing to the trial. (The “potential MS treatments” Postl was referring to was stem-cell research, she said.)

The MS Society is boasting of being “partners” in the trial but the CIHR will provide $4-million of the $6 million cost, CIHR spokesman David Coloumbe told Maclean’s. How the remaining $2 million will be divvied is unclear (the MS Society of Canada didn’t respond to emails).  The randomized-controlled trial is small:  a total of 100 MS patients will be recruited for the Vancouver and Montreal centres beginning Nov. 1 (later in Quebec City and Winnipeg when those centres clear ethical review boards). At the outset, MS patients with CCSVI will be randomly selected to have either venoplasty or a “sham” procedure.  After a year, the groups will switch so everyone will receive treatment and be assessed.

At the helm is an CCSVI naysayer: neurologist Anthony Traboulsee, director of the UBC Hospital MS Clinic, who has voiced skepticism about CCSVI in the past. On the 2012 CBC’s MS Wars: Hope, Science and the Internet, Traboulsee expressed disappointment that CCSVI research has pushed funding for stem cell research, which he called “one of the greatest futures of treating all neurological diseases,” back by five years.  Traboulsee was also a member of the CIHR’s  Scientific Expert Working Group formed to oversee research into CCSVI clinical trials. CIHR spokesman Coloumbe says there’s no conflict of interest in Traboulsee now overseeing the shebang, and promised a full explanation as to why on Monday. (This post will be updated when it arrives.)

In an email, Traboulsee confirmed each site will have a “vascular specialist and MS specialist” though it’s unclear who the vascular specialist are. He’ll be working with interventional radiologist Lindsay Machan. The Montreal tranche will be run by doctors Marc Girard, president of the Québec Association of Neurologists, and Jean Raymond, an interventional neuro-radiologist who sat on the the August 2010 CIHR panel that decided against funding clinical trials into CCSVI treatment. The fact Quebec’s on board  is surprising given the province’s resistance to CCSVI. As Maclean’s reported in in 2010, the Collège des médecins du Québec, which polices the province’s doctors,  demanded Montreal’s Westmount Square Medical Imaging, one of  two private clinics then agreeing to scan MS patients for CCSVI, stop doing so.

Dr. Michael Shannon, head of the scientific advisory board for advocacy group  CCSVI Coalition,  applauds the CIHR and MS Society for taking this first step. “I think it has the potential of providing very useful information that can be integrated into the bigger CCSVI research picture,” he says.  Shannon, a former deputy surgeon general of Canada with expertise setting up clinical trials, says the study’s design must be bulletproof to be credible. “If the phase II trial is properly designed so the data is unassailable and compelling in terms of benefits over risks, CCSVI treatment should be be adopted as a standard of care,” he says, pointing out Health Canada has already approved balloon angioplasty to treat other venous blockages. But he also raises a big concern: that doctors performing CCSVI treatment in the Canadian clinical trial won’t have prior hands-on experience. Interventional radiologists say it takes upwards of 60 procedures to achieve proficiency; Salvatore Scalfani, a veteran interventional radiologist in Brooklyn NY, has reported it took him 200 procedures to feel comfortable.  Traloubsee told Maclean’s the technologist and radiologist involved in the trial spent a week with Zamboni and his team in Italy.  The vascular team has had “extensive conversations with many international colleagues who’ve performed the procedure,” he says, including Dr. Gary Siskin who’s running the Albany trials.

Linda Hume-Sastre, president of patient advocacy group  CCSVI Ontario, criticizes Friday’s announcement for what was left out: no mention of where the interventional radiologists performing the procedure have been trained or who trained them; no mention of how clinical improvement will be measured or by whom; no mention of the participation of vascular specialists, especially those with experience treating CCSVI. Hume-Sastre wants CCSVI to be unbundled from MS. Though diagnosed with MS, when she was treated for CCSVI 14 months ago it was for a a venous abnormality, she says:  “I had a vascular conditon that, when treated, meant that certain symptoms that MS neurologists define as MS symptoms were eliminated and remain at bay.”

Hume-Sastre questions of the timing of the clinical trials announcement only days before an Oct. 4 Senate committee begins consideration of (Lib.) Senator Jane Cordy’s Bill S-204 calling for a national CCSVI strategy: clinical trials, providing aftercare Canadians who travel out of country for treatment and a system to track patients.  It won’t be the first time politics reared its head in this issue.

For her part, Cordy is pleased clinical trials are finally happening, but maintains her bill remains relevant. She too has concerns about the annoucement, including the failure to mention vascular specialists and Traboulsee’s opposition to CCSVI treatment: “One has to question whether or not Health Canada and CIHR are truly interested in fair and objective trials,” Cordy says. It’s a damning indictment, one that rests with the feds to prove wrong.


 
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