Liberation therapy for MS patients still locked away - Macleans.ca

Liberation therapy for MS patients still locked away

A closed-door meeting, accusations of a stacked panel. The fallout from the latest MS decision.

by

Beatrice de Gea/The New York Times

UPDATE: On September 13, the government of Newfoundland and Labrador kicked off its role hosting the annual meeting of the country’s provincial and territorial health ministers by announcing it will fund “observational studies” to investigate the efficacy of the “liberation” treatment that restores blood flow in the neck and chest veins of multiple sclerosis patients. Newfoundland and Labrador Health Minister Jerome Kennedy pledged $320,000—and more if required—for in-province neurologists to examine MS patients before and after they travel outside the country at their own expense for CCSVI treatment. The announcement offers a defiant response to Health Minister Leona Aglukkaq’s Sept. 1 announcement, based on the recommendations of the Canadian Institutes of Health Research, that the federal government will not fund pan-Canadian clinical trials into the treatment. It also portends a looming federal-provincial showdown on the controversial issue. In July, Saskatchewan, the province with the the highest per capita incidence of MS, announced it will fund clinical trials into the treatment.

On Aug. 26, a panel of 23 “medical specialists” and three “observers” gathered in the Ottawa offices of the Canadian Institutes of Health Research, the federal agency that distributes some $1 billion annually for health research. The eight-hour meeting yielded the unanimous decision that it would be “premature” for the federal government to fund clinical trials for a controversial multiple sclerosis treatment pioneered by Italian doctor Paolo Zamboni, formerly a vascular surgeon. Six days later, federal Health Minister Leona Aglukkaq announced that her government would accept the CIHR’s recommendation, calling it “the most prudent course of action at this time,” citing concern for patients’ safety.

Exactly what happened in the CIHR’s offices at 160 Elgin Street appears destined to stay in 160 Elgin Street. No written minutes or audio recording of the meeting are available. A spokesperson for Dan Florizone, Saskatchewan’s deputy minister of health, who was an “observer,” said Florizone is “not allowed” to speak about the meeting. (Maclean’s contacted several panel members, all of whom declined comment.)

CIHR review panels rarely summon an iota of public interest. But Zamboni’s research, which broke in Canadian media last November, has struck a chord within a patient population unfamiliar with medical hope: the vascular specialist found blockages in the veins in the necks and/or chests of 65 MS patients, a condition he dubbed “chronic cerebrospinal venous insufficiency,” or CCSVI. The notion that MS could have a vascular component is not radical; as a theory, it predates MS’s identification as a neurological condition in the late 19th century. But Zamboni was abetted by technology, able to clear blockages using a balloon angioplasty. After, he found MS symptoms abated; in a few cases, the disease’s progression halted altogether.

Already the CCSVI hypothesis has pitted neurologists, the long-time MS experts who posit that the disease is an autoimmune condition, against interventional radiologists and vascular specialists. In the middle, an estimated 55,000 to 75,000 Canadians afflicted with a degenerative disease for which there is no cure. Unwilling to wait years for the clinical trials once called for by the MS Society of Canada, hundreds of Canadians have joined the more than 2,000 MS patients travelling offshore for treatment.

Now the wait for CCSVI treatment in Canada could be much longer. “Devastating” is how Liberal MP and public health critic Kirsty Duncan describes the government’s decision, one she fears will force more patients overseas. As the vice-chair of a parliamentary subcommittee on neurological disease, Duncan has solicited testimony from CCSVI pioneers including Zamboni, Sandy McDonald, a cardio-thoracic surgeon based in Barrie, Ont., who performed six CCSVI treatments pro bono, and interventional radiologist Marian Simka, who has performed hundreds of CCSVI procedures at his clinic in Poland.

Duncan is dismayed by the lack of CCSVI expertise on the panel selected by the CIHR and the MS Society of Canada: “You want knowledgable people looking at this,” she says. CIHR president Alain Beaudet, who chaired the panel, expresses sympathy for MS patients: “I understand how devastating the disease is—how small the hopes are, and all of a sudden this new possibility for hope opens. But my role is to make public what we know of the scientific evidence.”

That evidence, to date, is scant. Zamboni himself admits his research lacks scientific rigour: his sample was small; there was no control group. Two studies in the Annals of Neurology have refuted his findings.

Beaudet says he kept the panel small: “I wanted a frank and open in-depth discussion, not one of those theatre-panel types where everyone presents and there’s no discussion.” Physicians who weren’t “bona fide clinical scientists, i.e., researchers and recognized as such,” he says, were excluded. Most on the panel were neurologists; two vascular experts made the cut, though neither specializes in the venous system beyond the brain.

The absence of hands-on CCSVI expertise was intentional, says Beaudet: “We didn’t ask people who had been extremely vocal for or against the procedure,” he says. “I didn’t want it ending up as a bullfight—that ‘I’m right, you’re wrong.’ I wanted people who could take a higher ground and in an unbiased fashion review the science and make an unbiased recommendation.”

Yet panellist Paul O’Connor, a neurologist at Toronto’s St. Michael’s Hospital, has been a vocal CCSVI critic. In February, he told the National Post that MS patients shouldn’t get tested for CCSVI: “There is not a shred of real evidence anywhere that messing around with these veins does anything to help MS patients,” he said. Beaudet, a former neuroscientist, is himself a skeptic: “We have to be open-minded in science,” he says. “But [CCSVI] makes very little sense. It doesn’t fit with the epidemiology; it doesn’t fit with the prevalence in women; it doesn’t fit with geographic representation; it doesn’t fit with the pattern of veins in the neck.”

As Duncan points out, the current model for MS research is focused almost exclusively on drug therapies, an $8-billion global industry. And that, in turn, could raise questions about conflict of interest given that several of the CIHR panellists receive research grants and honorariums from pharmaceutical companies, a common practice in medical research.

The MS Society of Canada appears to have reasserted itself through the whole process. In May, the organization called for $10 million from the feds for CCSVI research: “It is obvious that the relationship between CCSVI and MS requires further investigation,” it announced in a press release. In June, it announced it was contributing $700,000 to a $2.4-million joint two-year research initiative with the National MS Society in the U.S. to fund seven studies investigating CCSVI-MS linkage through scanning. Three of the CIHR panellists—Anthony Traboulsee, Jerry Wolinsky and Brenda Banwell—are principal investigators in these studies, which now, according to a CIHR recommendation, should form an “expert working group” that provides regular CCSVI updates to the minister of health.

Panellist Ruth Ann Marrie, the director of the MS Clinic at Winnipeg’s Health Sciences Centre, presents another enigma: Marrie co-authored “Vascular comorbidity is associated with more rapid disability progression in multiple sclerosis,” a study published in March 2010, which concluded the subject “deserves investigation.” But that paper was not among the nine studies reviewed by the panel. Nor did they cast eyes on the abstract for a paper Simka will present later this month based on 381 cases that found 97.1 per cent had venous blockages.

The CIHR decision has summoned inevitable blowback. MS patient Ted Warren immediately resigned as chairman of the MS Society’s St. John’s-Mount Pearl chapter. Christopher Alkenbrack, a former high school principal in Wolfville, N.S., wrote minister Aglukkaq a blistering letter impugning the “integrity” of the CIHR decision-making process. The 43-year-old, who was diagnosed with MS 17 years ago, had CCSVI treatment in Poland in May. Since then, he has seen continual improvement. He now hopes to return to work. “The future is full of possibility for me. That’s something most MS patients can’t say.”

If anything, the government’s decision not to fund CCSVI trials has steeled rogue resolve.

Sandy McDonald, for one, hopes to set up a treatment trial at the University of Toronto. Last week, the San Diego-based Hubbard Foundation received national institutional research board approval, or IRB, for a multi-centre registry of CCSVI testing and treatment. Neurologist David Hubbard founded the organization this year after his 27-year-old son Devin was diagnosed with MS. After receiving CCSVI treatment in the U.S., Devin’s symptoms vanished, says Hubbard.

Forty years and billions of dollars of research into MS has yielded nothing; viral and autoimmune theories of MS remain unproven: “But that’s not what neurologists are telling patients,” he says. As he sees it, there’s no way around studying CCSVI but to do the procedure. Currently, he’s investigating whether his IRB can be extended to Canada. “I’ve never been so embarrassed to be a neurologist,” he admits. “We’re supposed to be the smart ones.”