A registry doesn't cut it

By Leslie Campbell, May 2011

BC should start clinical trials for venoplasty for MS patients.

My old friend Ernie Stigant has jumped off the fence and decided to have “liberation therapy” for his MS. He wanted to have it in Canada for both practical and political reasons, but with his granddaughter Marley reaching toddlerhood, he decided he couldn’t wait any longer, so will soon head to Seattle. “I want to be able to interact with her more, not just sit and watch,” explained Ernie.

Ernie is not a rich man. So he is lucky his daughters, along with pals at his Rotary Club, are raising money for the surgery and follow-up therapy.

Ernie’s MS was diagnosed in 1998 after eight months of tests, preceded by close to three years of wondering what the heck was wrong. 

Since the diagnosis, his ability to walk has deteriorated and one arm doesn’t work at all. Even so, he manages extremely well. He bombs around the city on a red scooter, usually tying in coffee visits with some kind of fundraising cause. He keeps in touch with friends near and far via skype and facebook. He loves to tell stories and talk politics, and he’s a doting grandfather.

He also serves on the board of the Victoria chapter of the MS Society and is one of their top fundraisers. Ernie knows a lot of retailers and restaurants in Victoria because he’s hit them up for auction and raffle prizes over the years.

But he’s been disappointed with the national MS Society in the past year for what he sees as an overly cautious approach to venoplasty, otherwise known as “liberation therapy.” Paolo Zamboni and other researchers have shown that a vein to the brain is often blocked in MS patients (chronic cerebrospinal venous insufficiency or CCSVI). Zamboni’s theory is that the blocked vein causes a reflux of blood back to the brain. This causes iron deposits which in turn cause the neural lesions that characterize MS. By inserting a tiny balloon, the vein can be opened up, restoring blood flow—and reducing at least some of the challenging symptoms of MS.

The MS Society of Canada has failed to push for clinical trials in Canada. Ernie says the foot-dragging of the Society, along with that of the federal and BC governments has been “like waving a red flag before the many people who looked upon the treatment as the first non-pharmaceutical advancement in the treatment of MS.” The internet, he says, is rife with conspiracy theories and anger towards the Society. (He is quick to point out that the local chapters of the Society are much more sympathetic to venoplasty.) 

The drugs MS patients take constitute a good argument, in and of themselves, to try a different approach. First off, they aren’t all that effective. Secondly, they are hugely expensive. Ernie took them for about a decade, paying close to $1800 a month. That’s more than $20,000 per year, mostly covered through Pharmacare (ie taxpayers). Eventually Ernie and his doctor decided to see how he did without them. No different; they weren’t helping him. 

Let’s imagine that one-third of the estimated 75,000 Canadians with MS are paying $20,000 each year. That adds up to $500 million—each year. You’d think this sum alone would motivate the government to vigourously engage in clinical trials. Given that it’s a brief procedure, with no hospital stay, and performed without any anaesthetic, it’s likely well under $5000. No wonder people are talking conspiracy. (Those pharmaceutical lobbies are powerful.)

Ernie tells me of a 75-year-old woman who reported that during the operation it was as if a light switch was turned on. Two-and-a-half hours later she was out walking and shopping (in Seattle), something she hadn’t been able to do in years. Some people have put aside their walkers and wheelchairs, but even if mobility is not regained, almost everyone reports new-found energy and the lifting of MS “brain fog.” Others have experienced dramatic improvements in their vision. Many are reducing or eliminating those expensive drugs. And one local woman told Ernie that six months after the procedure, feeling started to return to her toes—toes that had been numb for years. (She had experienced other benefits immediately.)

When I ask Ernie about the recent study that some say suggests MS actually causes the blockage, Ernie says, “It doesn’t really matter. It’s a chicken-and-egg thing. If opening the vein reduces symptoms, it’s still worthwhile doing.”

Finally, I ask what he thinks of the provincial government’s recent announcement of $700,000 in funding for a voluntary registry of patients in BC who have undergone the procedure outside the country, in order to monitor them. Says Ernie, “A registry doesn’t cut it.” People may have had their surgery in India or Scotland or Costa Rica or the US, so there’s no consistency, no controls. He also predicts many will not participate because the MS Clinics administering the registry have been so unsupportive of venoplasty. “The people who run MS Clinics,” says Ernie, “are neurologists, and they have been very defensive in this whole argument.” (Venoplasty is performed by “interventionist radiologists”—specialists in image-guided surgery.) Ernie wants BC to do what Manitoba and Saskatchewan are doing: Investing $5 million each to conduct actual clinical trials.

This morning, the Rotary Club surprised Ernie at their breakfast meeting by telling him they’d raised $8,500 for his treatment. The tests and surgery in Seattle will cost about $5800; the balance will be spent on an all-important physio and exercise program. 

I am thrilled for Ernie. But it would have been nice to keep him and that money at home.

Leslie Campbell first met Ernie in 1970 in Winnipeg, where he later became the executive director of the Manitoba Arts Council. Watch for the MS Carnation Campaign, May 6-7. Most funds support local programs for people living with MS.