Tory senators kill proposed legislation on controversial MS treatment

By The Canadian Press - Thursday, November 22, 2012 at 2:06 PM - 0 Comments

OTTAWA – The Conservatives have used their Senate majority to kill legislation that would have authorized a national strategy to deal with a controversial therapy for multiple sclerosis.

Liberal senators say it’s shameful that Bill S-204 was squelched in committee.

They say the Conservatives refused to allow MS patients to testify about the effects of treatment for what is known as chronic cerebrospinal venous insufficiency.

The Conservative senators argue this is a matter for science and medicine, not Parliament.

The government has promised clinical trials of the therapy and a national register of patients, although neither the trials nor the registry have started.

The treatment is based on a hypothesis from Italian vascular surgeon Dr. Paolo Zamboni, who theorizes that a narrowing of veins that drain blood from the brain may be linked to MS.

Beyond Dr. Google: How social media can improve our health

By Julia Belluz - Thursday, November 15, 2012 at 4:35 PM - 0 Comments

Tetra images

This is the third part of a series of articles adapted from the 2012 Hancock Lecture, “Who Live and Who Dies, Will Social Media Decide?” delivered at the University of Toronto by Julia Belluz. This installment looks at the credibility of health information on the Web, and the pitfalls and potential of social media for health. Read parts one, two, and four.

We started the Science-ish blog because it seemed there was a widening gap between science—what is known in health research—and how it’s presented in the media by key opinion leaders, and then implemented in health policy. The question was: If we believe what’s reported about health, what politicians say about health, could we really make well-informed choices about health? This is a public health problem.

Sometimes even sources that seem credible mislead us. This year, I had an opportunity to interview Dr. Oz. when he was in Toronto and ask about his use of scientific evidence to back the claims on his show. I was prompted to do this after hearing from doctors who had patients coming into their offices on myriad supplements because Dr. Oz told them to do so.

Continue…

Controversial MS treatment will be tested in B.C. and Quebec

By The Canadian Press - Friday, September 28, 2012 at 11:02 AM - 0 Comments

TORONTO – The federal government is going ahead with a patient trial of a controversial experimental treatment for multiple sclerosis.

Health Minister Leona Aglukkaq said Friday that researchers will begin recruiting patients on Nov. 1 to study the treatment for chronic cerebrospinal venous insufficiency, or CCSVI.

That treatment involves unblocking neck veins that Italian vascular surgeon Paolo Zamboni has suggested could be a cause of MS.

About 100 patients are expected to take part in the trial to be conducted in British Columbia and Quebec.

Vancouver MS researcher Dr. Anthony Traboulsee will head the $6-million study being funded by Ottawa, the MS Society of Canada and the provinces where the trial will take place.

Traboulsee said researchers will monitor MS patients over a two-year period in order to obtain scientific evidence on the safety and efficacy of the CCSVI procedure.

The medical politics blocking CCSVI trials

By Anne Kingston - Wednesday, February 29, 2012 at 7:40 PM - 0 Comments

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. Continue…

Saskatchewan goes rogue on CCSVI clinical trials

By Anne Kingston - Friday, January 13, 2012 at 12:58 PM - 0 Comments

Yesterday Saskatchewan Premier Brad Wall left the Canadian Institute of Health Research (CIHR) and the MS Society of Canada in the dust when he announced his government has allocated $2.2 million for 86 multiple sclerosis patients in Saskatchewan to participate in Phase II clinical trials into chronic cerebrospinal venous insufficiency, or CCSVI, currently underway in Albany, NY. (Phase II trials consist of randomized treatment in a clinical setting, as opposed to Phase I trials, which research the safety and efficacy of a drug or procedure.) Applications, which will be accepted until Feb. 24 from patients who fit trial criteria, will be chosen randomly. Results from the lottery, one destined to be oversubscribed, could be announced as early as March. “It’s a good day in the province of Saskatchewan,” the premier said at a press conference, adding that very few residents of his province, which has one of the country’s highest incidence of MS per capita, have not been touched by the disease. He also noted the FDA has approved the Albany trial, the largest double-blinded study yet into the venous angioplasty treatment for MS pioneered by Italian vascular specialist Paolo Zamboni.

Anyone following the tortuous politics in the battle for CCSVI clinical trials in Canada over the past two years couldn’t help but read the comment as a not-so oblique reference to the fact the CIHR, which did an about-face on a previous decision not to fund clinical trials last year, has yet to announce its research team into Phase I trials (Phase II trials aren’t on the radar). Or that the MS Society, which allocated $700,000 into ongoing studies reviewing only the efficacy of CCSVI scanning, not treatment, has not exactly been a trailblazer on the issue, one that has dominated MS-patient activism in the past two years.

In sending Canadian MS patients to the U.S., after failing to get a home-grown trial off the ground, the premier is also debunking any myth that Canada is “a leader” in CCSVI research. Though the Albany trial is expected to take two years, Wall is already strategizing. While saying he didn’t want to get ahead of himself, the premier did allow that “if we find any symptom relief for MS, treatments that work for the many who suffer—the 3,500 plus in this province—I think it will be incumbent on the province of Saskatchewan to provide those proven and efficacious treatment to those patients.” Those are compassionate words. They’re also fighting words, suggesting that Saskatchewan, the home of once-universal Canadian health care, could also be ground zero for furthering CCSVI science—and possibly providing new treatment for a mysterious, incurable condition that afflicts so many Canadians.

Hurry up and wait for a CCSVI strategy

By Anne Kingston - Wednesday, November 30, 2011 at 4:51 PM - 16 Comments

Update 2: The second reading of Bill C-280 is now scheduled for Thursday, December 8 at 6:30.

Update: The second reading and debate for Bill C-280 was pushed off the House of Commons schedule on Nov. 30 due to other business. It hasn’t been rescheduled. Stay tuned.

CPAC is not always recommended viewing but tonight’s programming is must-see-TV. At 5:30 pm EST (and later in endless loop) Liberal MP Kirsty Duncan’s private member’s Bill C-280 calling for a national CCSVI strategy is set for second reading and debate. (If the House of Commons vote scheduled to begin at 6:15 pm goes past 7:01 pm, private member’s business will be cancelled and rescheduled for another time at the discretion of the Speaker.)

Duncan, a Ph.D. and adjunct professor at the University of Toronto, was the Liberals’ public health critic when she initiated the 2010 sub-committee on neurological diseases, which called upon Italian vascular specialist Paolo’s Zamboni to answer questions about his hypothesis that venous malfunctions in the neck and chest are linked to multiple sclerosis—and that venous angioplasty can relieve MS symptoms dramatically. The member for Etobicoke North is calling for CCSVI clinical treatment trials as well as a national tracking program for the estimated thousands of Canadians who’ve traveled offshore for treatment—and have been denied after-care upon return. Continue…

Liberation therapy: the ‘wave of complications’ breaks

By Colby Cosh - Thursday, August 25, 2011 at 12:20 PM - 101 Comments

A group of Calgary neurologists has published a report on foreseeable complications faced by locals who have returned from going abroad and receiving trendy “liberation therapy” for multiple sclerosis. It is not clear whether the casefiles include the woman who was inadvertently liberated from the world by the treatment, but their contents sound troubling enough. “These five cases,” the authors note in their abstract, “represent the beginning of a wave of complications for which standardized care guidelines do not exist.”

They sound somewhat nervous, don’t they? It is almost as if they had not heeded the repeated reassurances of journalists and “liberation” enthusiasts that venous angioplasty and stent installation in major neck veins are routine procedures, of about as much clinical concern as having one’s shoe size measured. That tricky little distinction between veins and arteries turns out to be fairly important to the discussion: as an April letter in Clinical Neuroradiology pointed out, “Balloon dilatation and stent implantation have not primarily been developed for the venous system and are associated with a substantial risk for complications…with possible fatal outcomes.” [Emphasis mine]

Since the butcher’s bill is beginning to be drawn up, and not just in Calgary, it may be worth examining how well the “chronic cerebrospinal venous insufficiency” theory has fared over a full year of research. In April, SUNY Buffalo researcher Robert Zivadinov, a close colleague of CCSVI theorist Paolo Zamboni, delivered a controlled study of 500 patients that offered, at best, feeble confirmation of Zamboni’s original results. Zivadinov’s findings, as Colleague Anne Kingston pointed out at the time, could conceivably provide some comfort to both sides of the debate. But the one thing one could not possibly do with Zivadinov’s figures was to reconcile them with Zamboni’s original study, which claimed a perfectly sensitive, perfectly specific link between indicia of CCSVI and the presence of MS.

In the meantime, other results from preliminary studies of CCSVI and MS have been trickling out, to less fanfare. There is a cruel unrelentingness to them—a lamentable finality even to the titles of the articles. From Italy alone we have “No evidence of chronic cerebrospinal venous insufficiency at multiple sclerosis onset” (January); “Proposed chronic cerebrospinal venous insufficiency criteria do not predict multiple sclerosis risk or severity” (July); “Progressive multiple sclerosis is not associated with chronic cerebrospinal venous insufficiency” (last week).

A German team attracted some attention in January with a finding that “Intracranial venous pressure is normal in patients with multiple sclerosis”. A similar study from a VA hospital in Texas, using Zamboni’s own detection criteria to define the presence of CCSVI, was published earlier this month. The title: “No Cerebral or Cervical Venous Insufficiency in US Veterans With Multiple Sclerosis”. Meanwhile, the journal Neurology has a preprint from Greece which confirms the objectivity of the proposed CCSVI criteria—but also confirms the absence of any apparent link with MS. And for what it’s worth, a June study of animal models provides a smidgen of evidence against Zamboni’s speculation that vascular problems create autoimmune difficulties by causing localized deposits of iron to be left in the brain.

There is also the new study you might have read about which establishes that most of the gene markers statistically linked with MS are known to influence the immune system. For my money, that is actually an overhyped blow to the Zamboni hypothesis, in comparison with the lengthening train of papers finding no simple empirical connection between veins and MS at all. Most researchers agree that the CCSVI hypothesis is still worth following up with randomized controlled trials of larger size and longer duration. But they advocate this, not because there is any doubt that MS is fundamentally immunological, but because some far less radical variant of Zamboni’s idea might conceivably be, well, sort of true-ish. (See, for example, this note from neurologists in Erlangen: “…it certainly seems awkward to think of the complex disease MS solely as result of a simple venous outflow obstruction. Yet, the investigation of new vascular concepts as one variable in the pathophysiology of the autoimmune attack seems very worthwhile…”.)

Other researchers are frankly not so open to keeping up a chase that was, after all, set off by a study (Zamboni’s 100%-specific 100%-sensitive investigation) that almost certainly has to have been junk. The frustrations of a few scientists are discernible in the literature: one German group basically thumbed their noses at CCSVI by calling it the “perfect crime”—a supposed primary cause of MS that seems to leave no trace when sought in MS patients, using any means, by anyone but Zamboni or his very early supporters. Another comment in a senior journal asks whether CCSVI is “science fiction”. Either way, unfortunately, the premature enthusiasm for “liberation therapy” is cold inescapable fact.

(For those late to the party, some links to my previous discussions of CCSVI and “liberation”: I, II, III, IV. Bonus explanation of statistical specificity and sensitivity here.)

Good news, bad news: June 30 – July 7, 2011

By macleans.ca - Thursday, July 7, 2011 at 1:45 PM - 0 Comments

Good news

Taliban hostages for 18 months, two French TV journalists return home. (Gonzalo Fuentes/Reuters)

Boots on the snow

Canada is planning its biggest summer military exercise in the far North. More than ever, a grand show of force in the Arctic is vitally important. Russia recently announced that it plans to send two new military brigades to the Arctic and is boasting of plans to build a year-round port there. Tensions between Arctic nations are on the rise over the drawing of borders in this resource-rich part of the world. And while flag-planting displays may seem trivial, when it comes to Arctic sovereignty, Canada needs to use it or risk losing it.

Adult intervention

The Greek government has prevented a likely tragedy by stopping a flotilla of pro-Palestinian protesters from embarking for Gaza. An attempt to break the Israeli blockade last summer ended in a confrontation on the high seas that left nine dead. With both sides bent for a repeat showdown, the results this year could have been even worse. The Greeks are offering to work with the UN to ferry the ship’s cargo—food, medicine and building materials—to the Gaza Strip’s many needy. A bit of reasonableness that should serve as an example to the radicals on both sides.

A liberating decision

Ottawa reversed course and approved trials for a controversial procedure used to treat multiple sclerosis called “liberation therapy,” which involves opening blocked neck veins. Canada, which has among the highest rates of MS in the world, said last year it would not fund the trials due to concerns about the procedure’s efficacy and safety. Advocates, though, argue it is life-saving. The trials may finally provide some much-needed answers.

Loose connections

Cellphones don’t cause cancer after all, according to a major academic review of research by experts in Britain, the U.S. and Sweden. The report comes two months after the World Health Organization said the devices should be classified as “possibly” carcinogenic (along with pickled vegetables and coffee). Such cancer scares haven’t curbed appetite for the technology. The last wireless patents held by Nortel were bought for US$4.5 billion by a consortium including RIM, Apple, Ericsson and Microsoft.

Bad news

Ongoing efforts to fight flooding in Manitoba will cost over $550 million. (Tim Smith/Brandon Sun/CP)

Crackdown

Bashar al-Assad’s Syrian dictatorship, one of the Middle East’s most repressive regimes, continues to plumb new depths as it confronts pro-democracy protesters. This week its security forces opened fire on peaceful crowds in several towns, wounding dozens and killing at least three. With the West focused on removing Moammar Gadhafi from power in Libya, Assad seems to feel untouchable. And to our collective shame, he appears to be right.

Upper-class twit(ters)

A couple of months back, Treasury Board President Tony Clement was criticized for tweeting a comment on a CRTC decision that was effectively a change in government telecom policy. Now he’s been caught out sharing photos of Will and Kate snapped at a private reception. Clement says he’s done nothing wrong, but clearly his desire to self-publicize is getting the better of him. Facing similar aggrandizers, the BBC is reportedly considering adding a clause to its contracts with its talent to prevent tweeted leaks and spoilers. But it all pales compared to the numbskull who hacked the Fox News Twitter account on July 4 and shared the “news” that Barack Obama had been assassinated. Can’t we all find better things to do with technology?

This case has no clothes

An Ontario court this week heard arguments about whether laws preventing public nudity are unconstitutional. Lawyers for Brian Coldin, who was arrested when he showed up naked at a Tim Hortons drive-through, argue police should have discretion when enforcing nudity laws. In Coldin’s case, restaurant employees testified they felt “uncomfortable” seeing his genitals on display. If anything, this case offers an all-too-clear example why nudity laws exist and shouldn’t be fiddled with.

Social ills

Researchers writing in the American Journal of Public Health say they have calculated how many deaths may be caused by poverty each year: 133,000 in the U.S. That’s not to say money guarantees good health. A Canadian study found low-income, urban children are more likely to walk or bike to school and are therefore in better shape than their more privileged counterparts.

Liberals push for CCSVI trials in Canada

By Anne Kingston - Tuesday, June 21, 2011 at 12:06 PM - 35 Comments

On Monday, a group of Liberal MPs swung the ongoing debate over CCSVI treatment for MS patients back into the federal court, metaphorically speaking. At a press conference held in the Parliament Hill foyer, Liberal MP Kirsty Duncan announced a private members bill advocating clinical treatment trials would be tabled at the earliest possible date. Liberal Senator Jane Cordy plans to introduce a similar measure in the Senate.

CCSVI has been a political hot-potato since late 2009 when research by Italian vascular surgeon Paolo Zamboni identified venous blockages in the neck and chest of MS patients; clearing them with a basic balloon angioplasty, he reported, significantly reduced symptoms, even arrested the degenerative disease’s progression in some cases. Canadian MS patients, estimated to number between 55,000 and 75,000, who clamoured for testing and treatment were told it was not available. Many neurologists—along with the Multiple Sclerosis Society of Canada– expressed concern the procedure was unproven and risky. Continue…

The Rorschach test of CCSVI research

By Anne Kingston - Monday, April 18, 2011 at 6:36 PM - 53 Comments

F. Scott Fitzgerald once famously wrote “The sign of a first-rate intelligence is the ability to hold two opposing ideas in the mind at the same time and still retain the ability to function.” That line comes to mind surveying reaction to the much buzzed-about study in the current issue of Neurology, the journal of the American Academy of Neurology, that concludes CCSVI is not a primary cause of multiple sclerosis.

The study, whose initial results were announced last year, came just as the AAN held its annual meeting in Honolulu last week. There’s a nice symmetry here. It was a year ago that Italian vascular specialist Paolo Zamboni appeared at the AAN meeting in Toronto, fresh off having rocked the medical boat with his claim that MS, long considered an autoimmune condition, had vascular roots: he theorized narrowed or blocked veins in the neck and chest of MS patients, a condition he dubbed chronic cerebrospinal venous insufficiency (CCSVI), lead to reflux of blood back to the brain. That in turn resulted in iron deposits, he posited, which caused the neural lesions that characterize MS.

Continue…

MS back in the spotlight

By Anne Kingston - Friday, March 18, 2011 at 10:32 AM - 71 Comments

Alessandro Vincenzi

Paolo Zamboni is finally relaxing in a chair in his hotel room in Bologna, Italy, reflecting on the long day of rigorous research presentations, all part of this week’s inaugural annual meeting of the International Society for Neurovascular Disease (ISNVD), of which he is the president and mobilizing force. The gathering of the new interdisciplinary group of scientists—among them vascular surgeons, interventional radiologists, physicists and a few neurologists—represents a fresh focus on the overlooked role of the vascular system in neurological conditions. It’s a timely endeavour, given the aging population. “I think we let in a little new light,” the thoughtful and mild-mannered Italian doctor says gently.

Much of that wattage, predictably, falls on chronic cerebrospinal venous insufficiency (CCSVI), a condition Zamboni identified that is characterized by blockages in the neck and chest veins. It was in this Italian city, in October 2009, that the former vascular surgeon first publicly presented his research linking CCSVI with multiple sclerosis patients. That, in itself, wasn’t groundbreaking: vascular theories of MS predate its classification as an autoimmune disorder. What made headlines, and inspired rare hope among MS patients, was Zamboni’s claim that angioplasty to restore blood flow resulted in symptoms abating, sometimes dramatically.

Eighteen months later, CCSVI is a hot, and incendiary, topic. The medical establishment has shown resistance and skepticism; many neurologists dismiss Zamboni’s hypothesis as spurious and unproven. But that hasn’t prevented an estimated 10,000 MS patients from seeking treatment at clinics springing up internationally to meet demand.

Continue…

Is there a doctor in the House?

By Aaron Wherry - Wednesday, January 5, 2011 at 5:24 PM - 42 Comments

Chris Selley questions the medical wisdom of politicians.

It took some flaming cheek for Mr. Dosanjh and Ms. Duncan to claim that “disregarding experts is a dangerous precedent” in an op-ed that involved disregarding — not to mention disrespecting — literally dozens of medical practitioners and researchers. But precious few politicians are capable of resisting the lure of emotionally charged issues, and the opportunities they afford to care out loud. From this appalling cynicism, there seems very little hope of liberation.

For the record, there are four physicians in the House of Commons: Liberals Carolyn Bennett, Hedy Fry, Keith Martin and Bernard Patry.

Looking back and forward

By Aaron Wherry - Friday, December 17, 2010 at 10:00 AM - 49 Comments

Michael Ignatieff sits for year-end interviews with the Globe, Canadian Press, Star, Sun, Postmedia, CTV and CBC. The most interesting bit might’ve resulted from a question submitted by Globe readers.

A Liberal government would launch federally-funded clinical trials of a controversial new treatment for multiple sclerosis, Michael Ignatieff said Thursday in his year-end interview with The Globe and Mail … “The question is: why can’t Canadians get a shot at getting at something that might have a therapeutic benefit?” he asked. “We say yes to that. Let’s get these trial thoroughly conducted. The federal government should take leadership here.”

MS liberation latest: Aglukkaq under fire

By Colby Cosh - Thursday, September 16, 2010 at 1:11 PM - 0 Comments

I see that Colleague Kingston is unsure why the federal Minister of Health is frustrated at media coverage of her ministry’s approach to the vein-centered Zamboni hypothesis about multiple sclerosis. One possible reason, I think, is that statements like those of Liberal health critic Kirsty Duncan are being repeated rather uncritically. Duncan told Kingston “They say we need evidence-based medicine but they are doing nothing to gather evidence.” Nothing? I wonder how else, but as “evidence-gathering”, one could possibly characterize the seven MS Society-funded preliminary studies Aglukkaq mentioned in her burst of finger-wagging at the media. These studies are designed to establish precisely what needs to be confirmed before the dream of a pan-Canadian trial of vein therapy for MS can appropriately be fulfilled: namely, whether there is any such thing at all as “chronic cerebrospinal venous insufficiency”, and whether it is really correlated with MS.

The religious conviction of some MS patients that they have a venous disorder is hard to account for, given the state of the evidence. It seems to be a by-product of natural frustration with slow progress on MS treatment, and, often, of conspiracy theories about sadistic drug companies and greedy, arrogant “neuros”. Some of these patients now reject the idea that they have multiple sclerosis at all—and, indeed, one must admit that there is something refreshingly categorical about such views. MS is not diagnosed by direct observation of demyelination, after all, but largely by means of functional criteria. The idea that CCSVI is not MS at all sidesteps the multiple logical problems with attributing MS to CCSVI. (One obvious example: why doesn’t anybody develop MS beyond middle age, even as the vascular system in most humans continues to fall into ever-worse disrepair?) I suspect it is almost easier to believe that there are some non-MS patients whose real problem might be a chronic vein blockage than it is to believe that MS, which is known to be a demyelinating disease, is caused or worsened by such blockages.

The problem with making grandiose statements about this wholly novel ontological entity, CCSVI, seems similar to the one that plagued the field of back surgery until fairly recently: patients presenting with chronic lower-back pain would be given MRIs, and a surgeon would go “Ahhh, here’s your problem”, point to some apparent lesion—a “slipped disc” or the like—and recommend an expensive, disabling operation. We now know, because people got around to checking by means of controlled investigations, that many of these lesions are indistinguishable from ones commonly found in asymptomatic individuals. Put in plain English, everybody’s back kind of looks like hell in an MRI, because we are imperfectly evolved to walk upright. Stronger criteria have thus been established for surgical interventions into chronic lower back pain, and even for mere medical imaging of bad backs. Something similar is likely to happen with tonsillectomies for children, which are increasingly thought to have been performed much too commonly in the past (although the rates at which they are done seem to be about as high as ever).

Like it or not, medicine no longer cuts first and asks questions later. We can’t presume CCSVI into existence; we have to ascertain the natural background rate of vein blockages, even ones that look dramatic in a venogram. You can see for yourself that this is the basic aim of the studies Aglukkaq points to; all seven involve vascular comparisons of MS patients with healthy controls.

For the record, I would like to politely distance myself from any suggestion that the strongly evidence-based treatments developed for vein-obstruction problems in the legs should be used, on the premise of a “right to blood flow”, to justify vaguely analogous and non-evidence-based treatments in the region of the head and neck. I would also like to observe that surgery for varicose veins does not normally involve surgical widening of the affected vessels with balloons or stents: instead, the veins are simply removed, perforated, or destroyed, precisely because a sufficient volume of blood can be counted on to return to the heart from the leg through other tissues.

Aglukkaq's message on CCSVI treatment

By Anne Kingston - Wednesday, September 15, 2010 at 11:48 PM - 0 Comments

The Honourable Leona Aglukkaq, Federal Minister of Health (left), speaks with the Honourable Jerome Kennedy, Minister of Health and Community Services for the Province of Newfoundland and Labrador, during the annual conference of federal-provincial-territorial ministers of health in St. John's, NL, Tuesday, September 14, 2010. (MARKETWIRE PHOTO/Health Canada)

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.”

MS liberation: in defence of Saskatchewan

By Colby Cosh - Thursday, September 2, 2010 at 11:05 AM - 0 Comments

You all know I’m sceptical of Paolo Zamboni’s vascular hypothesis about multiple sclerosis, so allow me to express support for Saskatchewan health minister Don McMorris, who is defending his province’s right to fund research into the idea. I didn’t like Saskatchewan’s politically-driven funding decision, but I don’t think there is any reason to believe that the funding cannot be useful even if the hypothesis is true. That seems to be what the MS Society is suggesting when it argues that Saskatchewan can’t possibly muster up a large enough sample to conduct a useful test of the hypothesis. From today’s Globe:

Yves Savoie, president of the MS Society of Canada, said a true clinical trial must be conducted at more than one institution and in more than one province. Because MS is so variable, “it will require well over 1,000 participants that will be recruited through a number of centres,” he said. “A single province or a single site would simply not be a way to get to the definitive answers that we all want.”

Logic and experience suggest an obvious rejoinder: a single trial, however large, won’t be the way to get an answer either. Pure statistical power is a good thing, but so is experimenter diversity. If there is any merit in the Zamboni hypothesis, the scientific community is likely to arrive at a consensus about it on the basis of many different kinds of tests, some of them modest in scale, most of them performed independently. There is danger in Savoie’s apparent insistence on a One True Trial and in his gratuitous, pre-emptive criticism of what Saskatchewan is doing: he is inadvertently encouraging the Zamboni believers’ cherished conviction that they are being ganged up on by a conspiratorial clique that desires a monopoly on truth.

And if the MS Society thinks a single, giant experimentum crucis is advisable, it would be fair to ask why it isn’t advocating one, instead of funding CCSVI research in dribs and drabs. The fact is that piecemeal accumulation is the usual means of accumulating scientific knowledge. There’s no unitary global Science Court where hypotheses can be hauled in for exoneration or hanging.

We don’t really need a trial with a sample size of thousands to confidently confirm or disconfirm the most basic claim of Dr. Zamboni: that an MS diagnosis can conceivably be verified, or falsified, from nothing more than medical images of a patient’s head and neck veins. As I’ve suggested before, we could arrive at a good initial answer to that question quickly and inexpensively. There is no sense in going ahead with inquiries into causality, or into the effectiveness of any particular therapeutic regime, until we have first established that yes, there is such a thing as “chronic cerebrospinal venous insufficiency”. Trap your unicorn first, then study its anatomy.

MS liberation: the trial I'd like to see

By Colby Cosh - Wednesday, August 11, 2010 at 5:38 AM - 0 Comments

Alberta Health Services, the centralized corporate behemoth that runs the province’s healthcare system, disappointed advocates of “liberation therapy” for multiple sclerosis last week by putting out an amazing discussion paper [PDF] surveying the relationship between MS and “chronic cerebrospinal venous insufficiency”. It summarizes clinical knowledge in an accessible way and raises points that even CCSVI skeptics have overlooked. One simple example: “If proven, the association between MS and CCSVI may actually be explained by MS causing CCSVI.”

Given the logical and empirical problems with Dr. Paolo Zamboni’s theory and the special risks of venous angioplasty and stent insertion, Alberta politicians can feel comfortable in taking a hands-off attitude toward Saskatchewan Premier Brad Wall’s aggressive push for more trials of liberation therapy. If members of the Stelmach cabinet still want to pay for some risk-free research, though, I have a completely serious suggestion: why don’t we test Zamboni himself? We could do it live on cable TV. Actually, since CTV’s flagship W5 program (with synergistic assistance from the Globe & Mail) played such a large role in creating the furore over Dr. Zamboni’s theories, it’s possible the network would like first crack at the broadcast rights.

Zamboni claims to be able to tell MS sufferers apart from healthy individuals with virtually perfect accuracy just by looking at suitable medical images of the neck veins. There is no reason why the world should settle for his mere assurance that he can do so, since this ability ought to be simple to prove. And if he can do it he has no reason to be afraid to demonstrate it. It does not make much sense for the world to perform countless multi-million-dollar trials of his treatment before we check out the most basic, inexpensively verifiable element of his claims. (It certainly does not make sense to let people buy MRIs and other scans for “venous insufficiency” until we know whether that phrase has any practical meaning.)

So why not let Dr. Zamboni declare what images he requires, take 50 sets of snapshots of MS patients and 50 sets from healthy controls, and let him have at the pile of 100 file folders? Invite him to Alberta. Pay his expenses. Give him as much time as he needs. Have clinicians (and, preferably, some conjurors) present to establish proper, bulletproof double-blinding. The cost would probably come in at well under $100,000 and we would have our result instantly. Either he identifies the MS patients at a rate much better than chance or he doesn’t. If he scores close to 100%, as he has implied he can, then we would have strong reason to believe that vein structures are associated with MS. And we could justifiably move on toward establishing the proper direction of the causal arrow that those crotchety killjoys at AHS are so concerned with.

Brad goes to the Wall for MS miracle cure

By Colby Cosh - Thursday, July 29, 2010 at 5:36 AM - 103 Comments

On Tuesday, the Globe‘s Patrick White discussed Saskatchewan premier Brad Wall’s announcement that he wants to set aside cash for trials of Paolo Zamboni’s “liberation therapy” for multiple sclerosis. White says that Wall’s audible “serve[s] up an uncomfortable nudge to political leaders elsewhere who have largely avoided the emotionally charged debate” over the Zamboni technique.

This is factually true. But the wording seems hard on our “political leaders”—most of whom have, and I’m just guessing here, avoided the “emotionally charged debate” because the debate is not really their business, but that of deputy ministers, health bureaucrats, foundations, and research establishments. To be sure, there is a place for improvisational, rapid-response policymaking at the top of the pyramid of state where justifiable public demand for it exists. But “the squeaky wheel gets the grease” is a dangerous maxim, full of moral hazard, and hardly a fit foundation for a system of funding scientific research. (Surely no level of hell can possibly be hot enough for opposition politicians who abuse a scientific controversy in order to establish their emotional bona fides.)

Wall’s moment of inspiration will have the effect, intended or not, of encouraging sufferers of painful, intractable illnesses like MS to besiege the Saskatchewan legislature directly with appeals for the latest internet nostrum-of-the-week. Nobody’s good intentions will stem that tide: let thy voyage unto Regina begin now, O ye with lupus, ye sore afflicted with fibromyalgia! Having conjured a research project into existence in the interests of anecdote-armed Victim A, on what grounds will Wall and his successors be able to turn away B, and C, and D?

It bothers me that Wall talks of the “hope” offered to MS patients by the Zamboni theory as if it were a virtue in itself; it seems to me that this is precisely what remains to be decided—whether the hope consciously cultivated by a handful of instant medical celebrities is fully justified, or whether it is an irresponsible, tragic delusion propagated for personal gain. It could well be either: the story of Barry Marshall reminds us that weird, unanimously heckled theories sometimes turn out to be true. The patients themselves can hardly help experiencing hope, though I rather admire the stoicism, evidently informed by experience, of one CBC.ca commenter (indeed, this may be the first cogent utterance ever made by any CBC.ca commenter):

This is the third “cure” I have seen for MS in my lifetime and it wont be long before it too is relegated to the scrap heap to lay beside the hyperbaric oxygen chamber and the snake farm. I still hope to see the one that works but this isn’t it.

How could anyone be so pessimistic? Well, even leaving aside the history of MS quackery and hype, there is no shortage of circumstantial reasons. The “liberation therapy” tag is an obvious mark of heavy con-artist and/or halfwit involvement in the publicity effort. Why not go all the way and just call the Zamboni technique “super amazing unicorn magic”? In newspaper accounts (and even in our own exemplary coverage), recipients of the therapy often report renewed energy without necessarily enjoying total relief from symptoms; this may not be a sign of the placebo effect at work, but it is certainly consistent with it. And it is hard to understand how the instantaneous improvements so often described by the “liberated” can possibly be consistent with Zamboni’s actual theory of MS etiology—i.e., that poor drainage of blood from the brain encourages, over a long term, the formation of cerebral iron deposits that then lead to immunological issues and demyelination of the nerves.

These things make you go “hmm”, and when you throw in the additions to the “hmm” list provided by a March review of the Zamboni theory published in Annals of Neurology, you start sounding a little like a downed power line. Zamboni’s study claimed to be able to distinguish the intracranial veins of MS patients from those of normal people perfectly. This is not a figure of speech: they claimed literal perfection. “They reported that only MS patients and not controls met the criteria for abnormal extracranial cerebral venous outflow. This observation perfectly overlapped with the diagnosis of MS, with a reported 100% sensitivity, 100% specificity, 100% positive predictive value, and 100% negative predictive value.” Major “hmm” points there.

The authors of the review also point out that Zamboni’s proposed etiology offers no obvious explanation for why women contract MS twice as often as men, or why incidence rates around the globe get larger with greater distance from the equator. They wonder why, if MS is a vascular disorder, it almost never appears after the age of 50. They ask why retinopathy and other known consequences of poor vein drainage aren’t statistically associated with MS. Perhaps most interestingly, they point out that sufferers of head and neck cancer have, for more than a century, been receiving a (horrifying-sounding but surprisingly inconsequential) treatment known as “radical neck dissection”, which involves, among other things, the total removal of the jugular veins. If Zamboni were right, one would have expected demyelination and MS symptoms to have been noticed in these patients immediately, or at least at some point since 1906.

There might be good answers to these questions, and, indeed, Zamboni’s angioplasty/stent approach might relieve MS symptoms for reasons having nothing to do with his theoretical ideas. But his treatment will have to do significantly better than placebo in proper trials, because angioplasties and stents come with known mortality risks. And if Zamboni and his advocates are to receive the benefit of all the hypothetical “ifs”—it might work for some reason we don’t yet understand!—then common sense demands that the “ifs” whose spear-points run in the other direction be considered: everybody who’s had “liberation therapy” might drop dead at midnight on New Year’s Eve for reasons we don’t yet understand!

MS Society of Canada “a house divided,” CEO says

By Anne Kingston - Monday, June 14, 2010 at 2:07 PM - 49 Comments

Italian vascular surgeon Paulo Zamboni: the man behind the new treatment for CCSVI (CP/NATHAN DENETTE)

Tensions boiled over at the Multiple Sclerosis Society of Canada’s annual meeting on Saturday as MS patients and their advocates turned up in unprecedented numbers to demand the organization help them gain access to treatment for chronic cerebrospinal venous insufficiency, or CCSVI.

In past years the charity has had difficulty rounding up the 15 members required to achieve quorum. This year, more than 60 people showed up at a mid-town Toronto hotel, many with proxies to support Linda Molyneux and Brock Winterton, two rogue board nominees who support CCSVI treatment being made immediately available in Canada. After votes were tallied, neither came close to unseating the five board nominees on a slate proposed by the society’s governance committee.

The attempted putsch reflected frustration among its 31,000 members over the society’s resistance to supporting treatment for CCSVI, a condition identified by Italian vascular surgeon Paulo Zamboni that made headlines after a CTV broadcast last November. Zamboni had discovered blockages in the neck and thorax veins of MS patients. After they received balloon angioplasties to restore blood flow, a routine procedure in cardiac medicine, many saw their symptoms improve; some saw the disease’s progression halt.

The MS Society has taken the position that CCSVI treatment is “experimental,” that Zamboni’s research is yet to be scientifically tested, and that the results of clinical trials, which could take years, are necessary before CCSVI treatment be given the green light.

“It’s an exciting time in MS research,” Linda Lumsden, chair of the national board of directors for the MS Society, told the crowd, noting “CCSVI has consumed the interest of the membership.” On Friday the Canadian and U.S. MS societies announced $2.4 million for four research studies in the U.S. and three in Canada; all will research CCSVI but not test possible treatment. The society has also requested $10 million for CCSVI research from the federal government, Lumsden said. She was particularly buoyed by the charity’s recent partnering with A&W expected to net some $400,000: “Go out and buy a hamburger on August 26,” she instructed the crowd.

But she couldn’t ignore the anger percolating in the room: “I know there is a level of frustration but we are working aggressively to get scientific evidence,” she said. “Then we can advocate.”

The stance infuriated many. “People with MS don’t have the luxury of time,” said Brock Winterton, a Toronto financial analyst who spoke of the “growing sense of despair” watching the disease weaken his wife, Janet Heisey. “There was nothing until we found out about Dr. Zamboni’s work,” he said. “And we had something and it was called hope.” After the meeting, the couple flew to Bulgaria where Heisey was booked for CCSVI treatment. People with MS “don’t understand why something so low-risk should be denied to them,” Winterton said, criticizing the “modest” $350,000 the society has allocated annually for each CCSVI study, noting it’s a mere 2 per cent of its total research funding.

Linda Molyneux, whose 22-year-old son received CCSVI treatment in Bulgaria earlier this week, blasted the society for being unresponsive to its constituency: “It has become clear MS societies have lost touch with their membership,” she said. “Are they here to serve neurologists and drug companies? Or are they here to serve people with MS?” she asked, noting: “Patients feel the single greatest impediment that stands between them and this treatment is the MS Society.” She spoke of the toll the disease took on her son, such as the crushing fatigue that caused him to drop out of university. Days after his CCSVI procedure, she added, he was out sight-seeing with his father.

The ‘miracle cure’

By Anne Kingston and Cathy Gulli - Monday, April 19, 2010 at 4:21 PM - 100 Comments

Photographs by Andrew Tolson

Last week, in a traditionally appointed Vancouver living room, Dr. Mark Godley made an announcement that could change the face of Canadian medicine. Addressing a multiple sclerosis support group that had formed on Facebook, the anesthesiologist and medical director of False Creek Healthcare Centre shared “very, very good news”: “A patient in B.C. had the procedure done here in B.C. today,” he said as the dozen people gathered erupted in claps, cheers and enthusiastic calls for details. The group here knows the lingo: “the procedure” is the radical and game-changing “liberation treatment” pioneered and named by Italian vascular surgeon Paolo Zamboni that has dominated MS chat rooms and academic research since it was first reported by media last November. The MS patient in B.C. showed results consistent with Zamboni’s, Godley reports: “He has warmth in his hands, the numbness has gone from his fingers, and for the first time [in years] he’s able to lie flat on his back.”

What’s stunning about Godley’s announcement is that, until now, the “liberation” treatment—a simple surgery that sends a tiny balloon to clear a clogged jugular vein—has been almost entirely unavailable in Canada, where it’s considered “experimental” by health officials. Provincial health care plans won’t fund it; doctors won’t perform it. Instead, Canadians have been flying to private clinics in Poland, Kuwait and India, paying upward of $10,000 for the surgery. In fact, the procedure that Godley describes was performed under the radar in an unnamed B.C. hospital, billed as a routine angioplasty. It was done “very quietly without the hospital knowing what he was really there for,” he says. Soon, though, such stealth will be unnecessary: in May, Godley said, his private clinic will be the first in Canada to openly offer the day surgery. “Wow!” cried out one member of the support group. “What’s the cost?” asked someone else, to which another replied, laughing, “Who cares?”

Such excitement has greeted Zamboni’s research among MS patients, who a year ago couldn’t have imagined a possible cure for the degenerative disease that affects 2.5 million people worldwide. Most are diagnosed at a young age—between age 15 and 40—more of them women than men, and most of Northern European descent. Canada has among the highest incidence of the disease—between 55,000 and 75,000 people, with 1,000 new cases every year. Not only is there no cure, researchers have not found a cause. All that’s known for certain is that the symptoms, which include numbness, loss of mobility, bladder malfunction and paralysis, are devastating.

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