Research Ethics Blog

Zamboni: “Wait for trials.”

It’s encouraging to see a scientist urging caution, and citing the need for further research prior to implementation of his theories — especially when those theories are scientifically highly contentious, but yet offer a glimmer of hope to thousands of desperate people.

Here’s the story, from Adrian Morrow, writing for the Globe & Mail: ‘Liberation therapy’ doctor now warning MS patients to wait

The Italian doctor who gave multiple sclerosis sufferers hope their condition could be treated with a simple procedure – and prompted many of them to cross borders and shell out thousands of dollars to receive it – has now warned patients against receiving the treatment until further clinical trials have been conducted….

Of course, clinical trials may not happen soon. We blogged before, for instance, about Canadian recommendations against funding clinical trials: Canadian Working Group Recommends Against Funding for Controversial MS Trial.

It’s worth noting that lack of funding isn’t the only issue. A clinical trial (in any developed country, at least) would also have pass through some sort of ethical review process. In Canada, for example, any university-affiliated researcher would have to gain the approval of a Research Ethics Board in order to conduct a trial based on Zamboni’s hypothesis. And at this point, it seems unlikely such approval would be granted. Why? Well, because Zamboni’s hypothesis doesn’t have enough support among experts to warrant subjecting humans to the risks. That’s the point of the notion of clinical equipoise. We don’t test hunches on humans, even when those hunches are supported by anecdotal evidence. The anecdotes are intriguing, to be sure. But we need more than that to ethically justify a full clinical trial. We need things like:

Someday that kind of evidence may exist. But for now (based on the expert analysis provided by the Canadian Institutes of Health Research and The MS Society of Canada), we’re just not there yet. So it’s too soon for clinical trials. Even if the risks of the procedure are not huge, neither are they trivial.

Now, advocates quoted in the G&M story suggest that patients should be allowed to judge the risks and benefits for themselves. It’s an understandable point of view, but one that doesn’t generalize very well. The role of ethics boards is to evaluate proposals to determine whether the likely social benefits of a trial are commensurate with the risks to participants. And then if approval is given, it is up to individual participants (in consultation with their own doctors) to judge whether participation in the trial makes sense for them. But that initial level of expert scrutiny is particularly important when the population being studied is desperate for a cure, as is the case here.

None of this is to say that trials won’t happen. They almost certainly will. Somewhere. But before well-justified trials can happen, a few more hurdles are going to have to be cleared.