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The medical politics blocking CCSVI trials

A defeated private member’s bill shows how pitched the battle has become


 

Legislation launched by individual MPs—known as private member’s bills—rarely pass into law. So you have to wonder why Health Minister Leona Aglukkaq expended so much energy trying to quash Liberal MP Kirsty Duncan’s Bill C-280, which called for “a national strategy” for chronic cerebrospinal venous insufficiency, or CCSVI. (Duncan’s bill was defeated by six votes on Wednesday night.) Duncan, the MP for Etobicoke North, has long been a tireless advocate for scientific research into CCSVI, the condition identified by Italian vascular specialist Paolo Zamboni, who linked extracranial venous blockages to multiple sclerosis; Zamboni posited restoring blood flow with a balloon angioplasty relieved MS symptoms—and even arrested progression of the degenerative disease in some cases. Duncan’s bill had called for phase II clinical trials and follow-up care for the thousands of Canadians who have traveled for CCSVI treatment overseas.

The health minister’s aggressive opposition of the bill ramped up considerably in recent weeks. On Feb. 10, hours after a documentary about CCSVI on the CBC’s Nature of Things presented data showing one-third of MS patients significantly improve after CCSVI treatment, one-third show moderate improvement and one-third show no-to-little improvement, Aglukkaq convened an information meeting for MPs on Feb. 13*. Given that Duncan had scheduled an informational breakfast for MPs with scientists advocating CCSVI on Feb. 14, the move appeared to be a preemptive strike. Then, on February 17, the health minister sent a letter to MPs critiquing Duncan’s bill that contended CCSVI science is “indefinite.” Duncan, who holds a Ph.D. in medical geography, posted a rebuttal on her website, which of course went viral: the MP accused the federal health minister of “spreading patently false information about the current state of CCSVI research and about venous angioplasty in general.” Even the Canadian Medical Association weighed in at the last minute, sending Duncan a letter that echoed the minister’s objections two days before the vote. The MP countered its claims on her site today.

If Aglukkaq had wanted to shine spotlight on a backbencher’s bill, she couldn’t have done it more effectively. Clearly she was concerned support for Bill C-280 was gathering momentum. It’s also likely the health minister was under pressure from special-interest groups opposed to any thinking about MS that challenges the autoimmune model for the mysterious, incurable condition; though unproven, the model has given rise to a drug therapy juggernaut worth some $10-billion internationally. These drugs come with a high price tags—and side effects: This week Health Canada announced it’s investigating Gileyna, an oral MS medication approved in March 2011 that runs $30,000 per patient annually and has been linked to 11 deaths (none in Canada).

But watching the glacial pace of CCSVI research since it came to public attention in late 2009 suggests other political forces may also be at play—even the prospect that CCSVI is a trial balloon for the increasing decentralization of health care. Duncan and fellow Liberal MP Dr. Carolyn Bennett began calling for the feds to gather data and conduct research in early 2010, as Canadians with MS began traveling offshore for treatment.

Two years later, we’re still waiting, despite a lot of government busy work. In August 2010, a panel convened by the Canadian Institute of Health Research, the country’s funding arm for scientific research reviewed select CCSVI studies and declared there was not enough evidence to warrant clinical trials. Ten months later, the CIHR announced a meta-study it had commissioned provided evidence that a small-scale phase I/phase II trial (testing safety/efficacy, but not actual treatment) was warranted. There’s also been a flip-flop on tracking the tens of thousands of Canadians who’ve travelled for treatment. The CIHR said it wasn’t in their mandate, then announced it would set up a registry, but not until September 2012. The quest for rigorous data isn’t only a Canadian problem. As revealed at the five-day International Society of Neurovascular Disease (ISNVD) in Orlando last week, an estimated 30,000 CCSVI procedures have been performed worldwide, though definitive data exists on only 300 or so.

Meanwhile, Saskatchewan has gone rogue,  spending $2.5 million on a CCSVI treatment trial in Albany, NY this spring: 670 MS patients applied for 86 slots. Angela Lagace, a technician at Barrie Vascular Imagining in Barrie, Ont. trained in Zamboni scanning protocol, will travel to Saskatchewan to teach technicians follow-up scanning. Kenneth Mandato, an interventional radiologist the Albany Clinic, told Maclean’s they’ve performed the CCSVI procedure on more than 2,000 patients; he estimates 80 per cent of them were Canadian. Mandato presented a preliminary study of 240 patients at the ISNVD meeting that revealed a 1.6 per cent risk of major complication during treatment and concluded it is safe—and added he has seen remarkable improvements in patient quality of life. According to buzz at the conference, other provinces are planning treatment trials.

In her letter to Duncan, Aglukkaq called for “the independence of our scientific process and the safety of our fellow Canadians,” adding “However difficult the decision is, as parliamentarians we have an ethical obligation to put patients’ safety first.” Yet Health Canada  permits experimental procedures that haven’t passed clinical trials under its Special Access Program which are “limited to patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable, or are unavailable,” according to its website.

A high-profile recent example that has not gone unnoticed by CCSVI advocates is renal denervation, a treatment for drug-resistant hypertension performed for the first time in Canada at Toronto’s Peter Munk Cardiac Centre in January. The technique to lower blood pressure pioneered by Australian researchers entails snaking a specialized catheter through the groin, then applying a heat source to deactivate nerves on the artery that feeds blood to the kidney. The first treatment study involving 106 patients was published in the December 2010 issue of the Lancet: it found blood pressure in 84 per cent of subjects declined (as it did in 35 percent of controls) after six months. “The results [of the study] are not enough for me to be confident,” says Dr. Barry Rubin, the medical director of the Munk Centre who sat on the CIHR panel assessing the need for CCSVI trials. “But it’s enough for me to be interested.” One concern, he notes, is long-term effects on renal nerves as well as the need to repeat the procedure.

Sandy Logan, a nephrologist at Toronto’s Mount Sinai sees promise in the renal denervation procedure but questions the rigor of the science: the study wasn’t double-blinded nor was there a placebo group, he says, adding it was bankrolled by Adrian Inc., the American company that developed the catheter used in the procedure—which cost US$6,000 each. (Clearly, there’s money to be made: in November 2010, a month before the renal denervation study was published in the Lancet, Minneapolis-based Medtronic Inc., the world’s largest medical device company, announced it was buying Adrian for US$800 million cash up front and cash payments equaling revenue growth until 2015.) Logan is currently participating in an independent Belgium-based randomized control trial. Results won’t be available for several years. Until then, Canadians should have access to renal denervation, he says, drawing an analogy to CCSVI: “You have to do properly done studies to know if it’s going to work or not. You can’t just say we’re not going to do it in Canada until we know, because nobody in Canada will have any experience.”

As CCSVI is floated as a trial balloon, the pins are coming out. In a letter posted on CCSVI Coalition yesterday, Dr. Michael Shannon, a former deputy surgeon general and former co-chair of the FPT Steering Committee on Blood Governance, likens the federal stall on CCSVI research to the tainted blood scandal. “It would seem that we have learned nothing from The Krever Commission which very clearly placed the blame for both the HIV and Hepatitis C misadventures of the 80s on the shoulders of the Red Cross and Health Canada,” Shannon writes, claiming the federal government’s “inability and unwillingness to protect the Canadian public” in the blood scandal, which cost thousands of lives and billions of taxpayer dollars in health care costs and lawsuits, was driven in part by financial considerations. He suggests financial constraints are also behind the reluctance to fund CCSVI treatment trials: “I suspect that there is significant budgetary pressure within CIHR,” writes Shannon, who calls for a full disclosure of the CIHR’s deficit situation this year and next. “The lack of definitive action on the part of governments, government agencies such as the CIHR and NGO’s such as the Canadian MS Society is disgraceful unconscionable,” he says, a response that suggests fallout from a private member’s bill—even a defeated one—thrust into the spotlight is just beginning.

*An earlier version of the story stated that the Multiple Sclerosis Society of Canada was at the Minister of Health’s MP briefing meeting. This is incorrect.


 
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