Calgary Herald Column: The CMA's Evidence Deficit

This week's Calgary Herald column from yours truly looks at two controversial resolutions recently passed by delegates at the annual conference of the Canadian Medical Association:

 

In a conflict between evidence-based policy and emotion-based policy, one would expect physicians to be clearly on the side of the former.
So it is therefore disheartening to see Canadian doctors embracing policies that seem devoid of evidence and instead rely primarily on empty emotional rhetoric. If the Canadian Medical Association (CMA) cannot be counted on as a defender of evidence-based policy, then the cause will suffer immensely.
At their annual conference earlier this month, CMA delegates voted 84 per cent in favour of a ban on mixed martial arts (MMA), a sport which now commands a huge following across North America.
A press release quoted a CMA past-president as saying, “this so-called 'sport' is savage and brutal and its aim is the disability of the opponent completely.”
Words like “savage” and “brutal” might be effective in appealing to emotion, but where’s the evidence?
For so many members of such a prestigious organization to advocate the criminalization of what’s now become a major sport in North America, surely they must have some evidence to back up their position?
Well, when asked by the Vancouver Province about ring deaths in MMA, the BC doctor behind the resolution said, “I actually don’t know.”
In fact, there have been a total of two documented deaths in MMA – none at all in UFC, the main MMA promotion. UFC has taken steps to improve safety for its fighters, and it would seem much more productive for the medical profession to contribute to that, rather than pushing for a ban.
Has the CMA given any consideration whatsoever to the dangers of pushing this sport underground? What these sports need is regulation and oversight – not criminalization.
Where does it all end? The CMA is already on record in calling for a ban on boxing.
Professional wrestling, scripted though it is, certainly has its share of concussions and other head injuries – and the tragic consequences those can lead to.
Should we ban professional football? We are getting a clearer picture of just how serious the concussion problem is in that sport. Moreover, we’re learning more about the long-term impacts on the brain of such injuries.
Merits aside, the participants in MMA are consenting adults who are well aware of the risks. It is the height of arrogance for the CMA to make decisions on their behalf. 
It’s especially ironic that as the CMA scolded the news media for “singling out” the MMA policy, the CMA is guilty of the same offense: “singling out” MMA and “singling out” energy drinks.
CMA delegates also voted in favour of stricter government regulation of energy drinks, including mandatory listing of caffeine content.
However, caffeine content already is listed on the vast majority of energy drinks sold in Canada. Also included on most cans are warnings about caffeine consumption and a fairly plain warning that the product “is not recommended for children”.
This particular policy comes on the heels of a July editorial published in the prestigious Canadian Medical Association Journal (CMAJ).
The editorial correctly notes that most energy drinks contain anywhere from 80 – 140 mg of caffeine – some are slightly higher.
The editorial fails to note, however, that similar or higher caffeine levels are found in many popular offerings at the major coffee chains: iced cappuccinos, café lattes, and “Frappuccinos”, just to name a few.
You won’t find caffeine content listed on the sides of those products, nor will you find any suggestion that children avoid them.
Beyond anecdotes and assumptions, where’s the evidence on caffeine consumption amongst Canadian children? Where’s the evidence showing that energy drinks are a disproportionate part of the problem?
There’s no missing the parallel between MMA and energy drinks: both appeal largely to young men, both are relatively new phenomena, both seem strange and overly aggressive to outsiders, and therefore both are vilified by those prone to knee-jerk and visceral reactions.
If the Canadian Medical Association wishes to raise awareness about these and other potential health risks, then simply present us with the evidence. 
For a group like the CMA, the dramatics and hyperbole are most unbecoming.

Herald Column: Legalize Online Gambling

I neglected to post this over my vacation, so here it is, my Calgary Herald column on why we should legalize online gambling:

 

We are now confronted with two poor options in how best to address the issue of internet gambling.
On the one hand, we have provinces like B.C. and Ontario who have at least acknowledged the folly of prohibition. However, their response is to try and create a monopoly which cannot possibly be sustained.
B.C recently launched its own gambling website, but a litany of problems led to the site being shut down only hours after going live. Ontario, meanwhile, will launch its own website in 2012.
Given the problems in B.C., and a broader government failure in competing with the private sector, those who play at the popular and established websites are unlikely to patronize the websites run by provincial regulators.
 It would be akin to launching governmentapprovedpornography.com in the hopes of coalescing all internet porn use under a single state-run website. Connoisseurs of such content would, I’m sure, be underwhelmed by such a venture and would likely not abandon their usual sources.
When it comes to gambling we typically see government monopolies pay out far less than their private equivalents. In the US the take from state lotteries, for example, is about 30 per cent versus the five per cent take typical at most large casinos.
Here in Alberta, a 2007 Edmonton Journal investigation found that the provincially-run Sports Select paid out only about 53 per cent of the money it took in compared with the 94 per cent paid out by Las Vegas bookmakers.
If we are prepared to finally accept that consenting adults are – and should be - free to patronize gambling websites, a far better solution is regulation and oversight of what already exists.
There are many responsible and legitimate gambling websites which would be more than happy to set up shop, so to speak, in Canada and play by our rules. Rather than hoping to derive revenue from a sub-par government website, we could tax profits and individuals’ winnings from existing sites.
The misguided embraced of a provincial online gambling monopoly, though, is the least worst of the aforementioned two options.
The other is the continued embrace of prohibition.
With Alberta considering whether to follow the lead of B.C. and Ontario, voices in support of prohibition are loudly saying ‘no’.
The prohibitionists frequently pop up and trumpet ominous stats about problem gambling on the internet and then promptly place their heads back firmly in the sand. How can a problem be both real and hypothetical at the same time?
The fact that we have statistics to analyze in the first place tells us that whatever problems are associated with online gambling are problems we are already confronted with.
It’s hard to see how forcing the activity underground and relying on periodic surveys to illustrate a vague idea of its extent is an effective response.
But even the worst statistics and scenarios show that the vast majority of online gamblers to not have a serious gambling problem. And prohibition is not helping those that do.
A 2008 study from the University of Western Ontario and University of Nevada at Las Vegas recommended governments put rules in place for online gambling.
For example, losses and time played could be closely monitored. Financial limits could be enforced, as could age restrictions.
Legalizing online gambling may then be a better way to protect problem gamblers. It provides the added benefit of respecting the freedoms of responsible adults.
We should not need the state to protect us from ourselves and override our own financial decisions. Nor should it dictate what we do in the privacy of our own homes.
Bars and lounges have mandated closing times, and servers are required to ensure that patrons are not consuming more than they should. By the rationale of the internet gambling prohibitionists, we should then be forbidden to drink at home where alcohol is available around the clock and no one is there to tell you to stop.
When opponents of online gambling say Alberta should not follow the lead of B.C. and Ontario, they’re half-right: government should get out of the way altogether.

How About an Evidence-Based CCSVI Debate?

Further to previous blog posts here, here, and here, I have certainly noticed the tendency to resort to name-calling an ad-hominem attacks against those who dare question Dr. Paolo Zamboni and his as-yet-unproven theories about Multiple Scleroris.

 

Dr. Zamboni may yet be proven right - and even if his theory doesn't find a direct causal effect, he may have stumbled across something that may be useful in helping some patients with MS.

 

The fact of the matter is - a fact no amount of name-calling or ad-hominem attacks can erase - is that much of the research so far has not replicated his findings. I'm not sure why some people react so viscerally to that fact, but maybe it has something to do with the fact that so many are so hopeful that Dr. Zamboni is right that they possibility he may not be is simply too much to bear.

 

Dr. Steven Novella (who we interviewed on Aug. 4 - you can find that interview at our podcast page) has a great post at Science-Based Medicine

exploring these questions. He concludes: 

Clearly there is a need for more research so that both patients and professionals can feel comfortable that CCSVI has been given a thorough investigation and we can say with confidence what role, if any, it plays in MS. The results, also, do not have to be black and white. While it seems unlikely that Zamboni has discovered the sole and ultimate cause of MS in most or all patients, it is possible he has found a significant consequence of MS. Chronic inflammation may result in venous insufficiency in some patients. This venous insufficiency may further play a role in worsening the clinical course in a subset of those patients, who may benefit from treatment. So CCSVI may ultimately play a minor but important role in the management of MS.

Or it may all turn out to be a figment of Zamboni’s imagination, spawned by the sincere hope of finding a cure for MS. Time and research will tell.

My open plea to the MS community, especially those who are going down the rabbit hole of conspiracy theories, is to keep this discussion about the scientific evidence. This is not the place for cheap conspiracy theories. I fear my plea will fall on deaf ears, but it never hurts to ask.

 

 

In terms of finding answers and testing the evidence, Maclean's magazine columnist Colby Cosh has a brilliant idea: 

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.

 

(...)

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.

UPDATE: I've often said that anecdotes are not evidence, but since so many anecdotes are being presented as such, it seems appropriate to include this: 

Neil Pierce, president of the Alberta division of the MS Society of Canada, said he knows other patients who don't want to publicly share their stories of disappointment, after the liberation procedure failed them, because of the backlash they expect to face from people within the MS community. "It's been so divisive," he said.

(...)

 

For six weeks after undergoing the controversial therapy for her MS, May Feitsma said she felt immense relief, energy and hope. But the degenerative disease ultimately again chained her breath, hands, feet and head.

 

Warning from Alberta Health Services CCSVI-MS Theory

Further to the story discussed at length at this blog here and here, Alberta Health Services has weighed in on the controversy surrounding Dr. Paolo Zamboni's controversial theory about MS and his proposed "liberation treatment". While some politicians are irresponsibly jumping the gun, Alberta Health Services is sounding a note of caution: 

Patients with multiple sclerosis considering heading overseas for the much-hyped liberation treatment should speak with medical experts instead of relying on positive anecdotal evidence from fellow sufferers since the unproven procedure could cause severe medical problems, Alberta Health Services says.

 

“People with MS should be wary about getting information solely from media stories and reports or from patients’ blogs,” the provincial health authority says in a strongly worded position paper on the subject, posted to its website. “Be careful about where you get information and where you go for treatment.”

The information sheet can be accessed directly here (PDF). Some highlights:

...Current information from Buffalo suggests that people with MS have a 56.4% chance of having CCSVI, and that those without MS have a 22.4% chance. In addition, over 40% of people with other neurological diseases have vascular changes consistent with CCSVI. However, other groups (Doepp et al, 2010 Annals of Neurology) have not found an increased rate of CCSVI in British and German people with MS as compared to “control” persons without MS. In contrast, Dr. Zamboni reported that 100% of the MS patients he studied had MS but none of his controls had CCSVI.

 

(...)

 

Generally speaking, and based on current evidence, neurologists and neuroscientists who are up-to-date about the biology of MS and vascular diseases of the brain do not believe that CCSVI will be proven to be a cause of MS. Nor do these experts believe there is likely to be any merit in venous angioplasty for CCSVI. They know that brain injury in MS is caused by the immune system and they are also familiar with vascular diseases that affect the brain (most
commonly stroke and conditions such as cerebral venous sinus thrombosis where the veins that drain the brain are blocked). Thus, neurologists care for people with MS and for people with neurological diseases caused or related to abnormal blood vessels, so they have the expertise to understand the association between the brain and its blood supply and venous drainage, and they are aware of the
consequences of blocked veins within the brain and/or the neck. They also know that MS or an MS-like condition has never been shown to be a result of blocked or sluggish veins.

If poor venous drainage from the brain were to cause MS, then people with blocked or absent jugular or vertebral veins should develop MS or an MS-like condition. There are many people with true venous insufficiency but they never get MS. In fact, neck surgeons commonly tie off one or both jugular veins during surgery to treat head and neck cancer; this has no medical consequence because the venous drainage of the head and brain is designed to have alternative routes of drainage.

 

(...)

 

Because arteries are thick walled and are designed to deal with high pressure, they can tolerate angioplasty. Because arteries carry blood away from the heart and get smaller as they get farther from the heart, a stent will only get properly secured into an artery by its high pressure blood flow.

Veins, on the other hand, are thin walled, collapse when not filled with blood, and do not tolerate injury well. Veins clot off permanently if repeatedly or severely injured.

Angioplasty purposely causes the veins to be stretched by a balloon. The veins commonly react by clotting and then
often become completely blocked. Similarly, stents will often clot, especially in the low pressure
flow seen in veins.

 

(...)

 

For this reason, there are no situations where venous angioplasty is an accepted and satisfactory treatment. This is very different than arterial angioplasty which is known to be useful. Therefore, the claims that venous angioplasty
is a “routinely done procedure” are not true.

Venous angioplasty is a procedure that needs to be properly evaluated in well designed clinical trials that determine both the risks and the benefits. However, given that we can be confident that many people will sustain completely occluded veins from the procedure, we must be very sure that there is enough evidence to suggest that CCSVI actually contributes to ongoing brain injury in MS before we undertake such trials. Patients considering leaving the country for this purported treatment should also consider this.

 

(...)

 

As of today, no Canadian neurologist has found significant or sustained improvement upon examination of patients
who had had venous angioplasty performed, despite the fact that most returning patients report feeling better and sometimes note improvement in sensation or walking.

 

(...)

 

People with MS should be wary about getting information solely from media stories and reports or from patient’s “blogs.” They should seek out expert advice from knowledgeable MS caregivers and experts, and should carefully determine the credentials of any centre offering “liberation” treatment. 

 

Herald Column: Is Paolo Zamboni the new Andrew Wakefield?

Further to this post, this week's Calgary Herald column from yours truly looks at the hype surrounding the CCSVI theory and "liberation treatment" for MS, and whether all the attention is deserved: 

Canada’s premiers will certainly have much to discuss when they meet this week in Winnipeg, so it’s most curious that an unproven medical theory will find its way onto the agenda.

Alongside the discourse on the economy and health care, discussions will take place on the so-called “liberation treatment” for multiple sclerosis (MS).

There is, of course, promising research on treatments for all sorts of diseases. Why should this proposed treatment warrant the immediate and specific attention of Canada’s provincial heads of government?

Such, I suppose, is the Italian doctor’s rock-star status at the moment, that politicians are lining up to associate themselves with the hype surrounding him.

(...)

Saskatchewan Premier Brad Wall has called for clinical testing, to be paid for by the Saskatchewan government.

Alberta’s has announced a new working group which will examine whether to follow Saskatchewan’s lead.

Nova Scotia Premier Darrell Dexter, though, has warned his fellow premiers to “make sure that our decisions are made on the basis of the best evidence."

So what does the “best evidence” tell us?

To begin with, Zamboni`s own research has been called into question. An article in The Lancet argued that his study ``falls short of the standards and quality that are acceptable in clinical research."

That would be a moot point, however, if his original findings could be replicated. So far, though, that is not happening.

A University of Buffalo study released in February found CCSVI in 56 percent of MS patients, but also in nearly a quarter of healthy patients. A German study from last month found CCSVI in only 20 per cent of MS patients.

A Dutch study from last month is even more damaging to Zamboni’s theory. Researchers studied 20 MS patients and 20 healthy subjects; blockages were found in ten MS patients and eight healthy subjects. Additionally, the size and direction of blood flow in the brain was normal in all participants.

Furthermore, two separate papers from Germany and Sweden published this week in the Annals of Neurology both report finding no trend of blockages in MS patients.

Other studies are still proposed or already underway. But until and unless they confirm Zamboni`s findings, far more prudence and skepticism is needed.

Unfortunately, much of the media coverage of Zambonis theory omits some or all of the contradictory research. In its place are emotional anecdotes from MS sufferers and those who have undergone the surgery.

It’s all a little too reminiscent of the Andrew Wakefield debacle. Wakefield, of course, is the now-discredited British researcher who claimed that the MMR vaccine was linked to autism.

Like MS, autism represents a frustrating medical mystery we all yearn to see unlocked.

Like Zamboni, Wakefield`s findings threatened to turn conventional medical wisdom on its head. Like Zamboni, Wakefield`s defenders presented the conspiracy theory of their hero struggling against an arrogant and intransigent medical establishment backed by a greedy and unscrupulous pharmaceutical industry.

Much like today, the radical and controversial research made for sexier headlines than the boring research which merely confirmed the status quo.

This may turn out to be a grossly unfair comparison. My fear, though, is that it won`t.

As of now, the sort of attention Zamboni has received is enormously out proportion with the status of his theory. And until much more research is done, this would not seem to be the sort of thing that should be the purview of Canada’s premiers.