A recent article in a scientific journal has stimulated an interesting debate about the make up of advisory boards in health care, and what constitutes a conflict of interest.
Dr. Barry Rubin is a vascular surgeon in Toronto and a member of an Expert Panel of the Canadian Institutes of Health Research (CIHR) that is advising the federal government about a potential new treatment for multiple sclerosis (MS). Some have proposed that MS is caused by a newly described abnormality in the veins draining the brain (called chronic cerebrospinal venous insufficiency or CCSVI), and that balloon treatment of CCSVI makes people with MS feel better. The quality of the science supporting the benefit of treatment is poor, but many MS patients are convinced that the treatment is effective, based upon their own experiences and the experiences of others. In my almost 30 years in health care I have never seen a controversy about a treatment generate so much passion (on both sides), and such media and political attention.
Dr. Rubin threw a match into the smoldering embers when, in an article with the title “The “Liberation Procedure” for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand”, he and his coauthors described two patients who had severe complications shortly after treatment for CCSVI. In the discussion they stated “At this point the procedure [the treatment of CCSVI] rests in the same category of “medical” management as chelation therapy for atherosclerosis …., treatment of breast cancer with laser photodynamics, Laetrile for cancer and other unproven therapeutics found in the retail sphere.” Treatment of CCSVI was equated with faith healing.
Not surprisingly, these comments generated howls of outrage from some quarters (I suspect others are silently cheering Dr. Rubin). Kirsty Duncan, a Member of Parliament who has been a vocal pro-CCSVI advocate has asked that Dr. Rubin be removed from the panel because of conflict of interest.
Dr. Beaudet, President of the CIHR, has indicated that Dr. Rubin will remain on the panel, saying that members of the panel are “entitled to freely express their opinions.”
So, what should we make of all this?
Does Dr. Rubin have a conflict of interest that justifies removal from the CIHR panel? I don’t think so. We are usually concerned about conflict of interest if people stand to gain financially from a particular outcome. In this case, Dr, Rubin is a vascular surgeon (one of the specialties who provide CCSVI treatment), so it is actually financially counter productive for him to argue against CCSVI treatment.
I think we underestimate the importance of non-financial conflicts of interest, which relate to academic advancement and turf, rather than money. If treatment of CCSVI turns out to be beneficial, it will markedly change the way we think about the disease and the kind of research that will be done in MS in the future. There will be winners and losers in the scientific world. Is Dr Rubin likely to be a loser if treatment for CCSVI turns out to not be beneficial? Not as far as I can tell. To the best of my knowledge, Dr. Rubin has never done any research in the area of MS. I just don’t see the conflict of interest.
However, Dr. Rubin does have strong opinions about CCSVI, which he has, at least on this occasion, expressed in a rather inflammatory style. Does that justify removing him from the CIHR panel? Again I don’t think so, but with a caveat.
Although I believe members of an expert panel can hold strong views, they must commit to basing their views on evidence and to carefully considering other points of view. In this regard, the assertion in the article by Dr. Rubin and colleagues that fingolimod, a recently approved drug for multiple sclerosis, is a “documented safe pharmacological treatment” for MS does raise questions about his balance when comparing the harms of CCSVI treatment with drug treatments for MS. Fingolimod causes a transient decrease in heart rate immediately after the medication is started that is concerning enough to cause regulatory agencies to issue guidelines about the kinds of patients who can start fingolimod and how the drug must be monitored to achieve acceptable safety. The drug can also rarely cause an eye disorder called macular edema, among other side effects.
Most of us who work in health care have conflicts of interest and biases. Removing everyone with a bias from an expert panel is impossible because health care is so inter-connected.
Some people rise above their biases. For example, vascular surgeons and neurosurgeons were authors of a randomized trial that showed that an operation that they had been performing for years (extracranial-intracranial bypass surgery) was actually useless. However, many of us, often inadvertently, allow our biases to creep in to our decision making to some degree.
I agree with Dr. Beaudet that strong opinions should not disqualify someone from sitting on the CCSVI expert panel. However, the same argument would suggest that vocal proponents of CCSVI should also be added to the expert panel – at present I don’t believe there are any. I am sure some can be found who would abide by the rules of being evidence-based and balanced. It is important to have people with varying points of view around the table. This allows different opinions to be raised, and allows people to respectfully keep each others’ biases in check.
My conflicts of interest for this blog: I am a member of a Data Safety Monitoring Board for fingolimod, for which I am paid by Novartis. I am the principal investigator of a grant from the CIHR to do systematic reviews of the evidence regarding CCSVI for the CIHR Expert Panel, for which I am not paid.