There has been much debate in Canada recently about a controversial, angioplasty-like procedure for multiple sclerosis patients.

The treatment is based on the unproven theory that blocked veins in the neck or spine may be linked to MS. The surgery is not a recognized treatment in Canada, but many patients have spent thousands of dollars at foreign clinics. Some have reported dramatic improvements of their symptoms following the procedure, while others say their condition hasn't changed.

Some MS patients in Canada are calling for the federal government to fund clinical trials to make the treatment available here, but the federal health research agency says there hasn't been enough research about the procedure yet. Some Canadians who have undergone the treatment have decried what they consider a lack of medical support in this country, especially after an Ontario man, who developed complications after undergoing the procedure in Costa Rica, died in October.

CBCNews.ca contacted biomedical ethicist and McGill University Prof. Jonathan Kimmelman of Montreal to discuss some of the ethical issues surrounding this procedure.

Q: In your opinion, should Canadian health-care providers offer this vein-opening treatment for MS patients? What are the ethical issues involved?

Having close relatives with degenerative neurological conditions, I understand why patients in the MS community are so eager to see other treatment options made available. However, my understanding is that venous angioplasty, and other CCSVI treatments, have not been rigorously shown to control MS. So we have very little evidence about it being an effective treatment. It does, however, involve surgery, and like all surgical procedures, it carries risk. In general, doctors should be very wary about offering risky treatments unless they are confident that risks and burdens are amply outweighed by clinical benefits.

Another important consideration is cost, which is non-trivial for surgical procedures like venous angioplasty. The Canadian health-care system can barely cover costs of medical treatments that are well-supported by medical evidence. It is simply not good policy for health-care systems to pay for non-validated treatments at the expense of others that are validated. It's also not fair to other patients.

Having said all that, there may be a case for offering venous angioplasty in the context of clinical trials. This would enable health-care providers to determine, once and for all, whether the treatment works, and if so, whether it works well enough to justify the risks and costs of the procedure.

Q: What kind of concerns are there with proceeding to clinical trials?

Let me start by saying that the MS community, like many patient communities, is a large and diverse one. That some MS patients are lobbying hard for this procedure does not mean that all, or even most, believe it should be made available without first knowing whether it is safe and effective. So I think we need to be careful about assuming that MS patient advocates calling for coverage of this procedure necessarily speak on behalf of all MS patients and their family members.

Venous angioplasty and other CCSVI-based treatments involve surgical procedures, and unfortunately, many surgical procedures enter clinical practice before they are rigorously shown to be effective. Because these procedures carry risk, and because MS is a condition that has fluctuating symptoms, it is critical that surgical approaches to MS undergo randomized controlled trials before being taken up in practice. Unfortunately, surgical procedures often produce very large placebo effects. So to rigorously evaluate CCSVI-based treatments, trials would need to include "sham" controls in which some patients receive a pretend operation instead of the real one. Some patients may recoil at the thought of having a fake operation. But in many cases, patients receiving the fake operation end up doing better than patients receiving the real one.

Q: Could you explain the process of how a surgical procedure becomes a recognized treatment, why the steps are necessary and how long it could take?

Controlled clinical trials are only ethical if there are good reasons to believe a new treatment is as good as -- and perhaps better than -- a standard of care. That way, doctors performing these studies do not violate their duty to advance the best interests of patients who enrol. So in the case of venous angioplasty, trials would be ethical if there is solid evidence that venous insufficiency is a plausible hypothesis. We might get this from large, well-designed observational studies of MS patients. Animal experiments could also be informative. I am not a neurologist, but my understanding is the CCSVI theory is not nailed down, and cannot account for a number of features about the course of MS.

Without a doubt, good science -- and protecting patients who volunteer for clinical trials -- takes time. Controlled trials are also expensive. But it would take far longer to establish the value of these treatments if we made them available outside of trials. There are many examples in medicine where risky procedures were offered to patients before their value had been established. One example in the 1990s was the use of autologous bone marrow transplantation for the treatment of breast cancer. Many women were seriously harmed before trials made clear that the very burdensome procedure was useless for treating breast cancer.

Q: Some Canadian MS patients who have undergone the procedure and experienced complications have complained that doctors here have been unwilling to offer followup treatment. Could you explain the extent of a Canadian doctor's ethical obligation to treat these patients?

Doctors shouldn't ever judge their patients and treat them differently based on how they became injured. If someone gets injured in Mexico and returns to Canada for treatment, it shouldn't matter whether the injuries occurred from cliff diving, charity work or seeking non-validated treatments like venous angioplasty.

Q: Is a Canadian doctor obligated to redo a vein-opening procedure if the patient has complications?

No. A doctor would be obligated to treat the complications. However, if offering the procedure in the first place is ethically suspect, I don't see why a doctor would be obligated to provide the procedure once a patient suffers complications from it.

Q: There's a lot of passionate debate happening between those who want to see this vein-opening therapy available immediately in Canada and those who say it's an unproven technique that needs far more study first. What do you think is important to keep sight of in this situation?

First, I think patients and their family members should keep in mind that CCSVI is, at this point, unproven. CCSVI is a very novel theory. It may turn out to be right. But in science and medicine, most novel theories turn out to be wrong. And in medicine, people get hurt when doctors act on theories that are wrong.

Second, procedures like venous angioplasty are not without risk. I've heard patients tell me, "I have nothing to lose." But if a serious surgical complication occurs, MS patients can go from sick to sicker.

Third, many MS patients are dismissing the neurology community's skepticism of CCSVI-based treatments. Though Canada has one of the most scientifically advanced health-care systems in the world, patients are travelling to far-flung locations that are not traditional leaders in medical research in order to receive an unproven treatment. Perhaps medicine -- and the neurology community in particular -- should be thinking about why they have lost the trust of many patients.