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Saturday, May 19, 2012 1:30 AM | Ken Torbert Volg link

Dear Alain,



Hello and warm wishes.



I am writing to you in order to bring an urgent issue to your attention. As you know, Dr. Barry Rubin is a member of CIHR’s expert working group to study CCSVI. According to CIHR’s website, the working group’s mandate is:  “The scientific expert working group will make  recommendations on further studies including, if appropriate, a  pan-Canadian interventional clinical trial that would evaluate the  safety and efficacy of venous angioplasty in patients with MS, and  will provide advice on the protocols to expedite such a trial (e.g.  inclusion/exclusion criteria).”



Dr. Rubin is the fourth author on an article, ‘The “Liberation  Procedure” for Multiple Sclerosis: Sacrificing Science at the Altar of  Consumer Demand’, in the May, 2012 Journal of the American College of  Radiology, Volume 9, Issue 5 , Pages 305-308.



Alain, you and I have discussed conflict of interest numerous times before-both at committee and in correspondence. Surely, a member of the scientific expert working group publishing such a paper  questioning clinical trials is in conflict with the group’s mandate.



It is absolutely imperative that all members of the expert working group be independent, but equally important, be seen as independent, and not to have taken a position. Dr. Rubin can no longer be seen to be an independent judge of the scientific literature, as demonstrated by the conclusion of the paper.



Let me quote from the article, “Although some would agree that a randomized, blinded clinical trial is necessary to settle the issues raised in the controversy surrounding this procedure, others would agree that not all controversial procedures require such an expensive approach. Funding trials of a procedure that has minimal basis in rational, empirical knowledge seems questionable. At this point, the procedure rests in the same category of “medical” management as chelation therapy for atherosclerosis (which failed just such a trial), treatment of breast cancer with laser photodynamics, Laetrile for cancer, and other unproven therapeutics found in the retail sphere. When consumerism and patient advocacy groups pressure the scientific and political establishment, reasonable accommodation is warranted. The question is, What is reasonable? It may be that the operators believe in the therapy as much as the understandably desperate patients. The subsidiary question is, When is healing ‘faith healing’?



I will not comment on the science-or lack thereof-of the above.



It is extremely important to note that the first author of the paper, Dr. Michael Brant-Zawadzki of Hoag Memorial Hospital is being credited with prompting the FDA warning this past week.



There are important questions that need investigation. How did Dr.  Brant-Zawadski and Dr. Rubin make contact? Were you apprised that Dr. Rubin was writing the article? Did you read the article pre-publication? When was the article accepted for publication? Were you or other officials at Health Canada and CIHR apprised of the FDA alert, and if so, when? Does CIHR support Dr. Rubin’s behaviour? Are you concerned that the FDA alert-and this article-will  prejudice/affect the ethical board reviews for CCSVI clinical trials?  What action will be taken, as clearly this is a conflict of interest?



There is real concern amongst the CCSVI community that while the government fast-tracked Tysabri–a drug which was known to cause PML, and has now infected 232 people and killed 49 people–, and Gilenya, a drug which has now killed 11 people, and is currently under review in  Canada (by the way, I am still waiting to hear from Paul Glover about the process for Health Canada’s review of Gilenya)–, the government has been reticent about clinical trials for venous angioplasty, which is performed for Budd-Chiari syndrome, May-Thurner syndrome etc.  across this country. Now a key panellist has not only come forward, but also published a paper with tremendous hyperbole, “sacrificing science at the altar”, and members of the CCSVI community are concerned that a parallel process is being created-one in which the government says it will undertake clinical trials, while a key player appears to work actively to prevent this.



In closing, Dr. Haacke, Dr. McDonald, and Dr. Zamboni were not included in the August 26th, 2010 joint CIHR-MS Society meeting. The explanation given for their not being included in the meeting was that their work would be discussed, and including them might bias the discussion. Now, we have a member of CIHR’s expert working group publishing and questioning clinical trials. Clearly, his position may bias the discussion.



Alain, this is extremely serious, and so, I look forward to hearing from you at the earliest time possible regarding Dr. Rubin’s inclusion in the scientific expert working group.



Yours very truly,


Kirstya (by the way, I am still waiting to hear from Paul Glover about the process for Health Canada’s review of Gilenya)–, the government has been reticent about clinical trials for venous angioplasty, which is performed for Budd-Chiari syndrome, May-Thurner syndrome etc.  across this country. Now a key panellist has not only come forward, but also published a paper with tremendous hyperbole, “sacrificing science at the altar”, and members of the CCSVI community are concerned that a parallel process is being created-one in which the government says it will undertake clinical trials, while a key player appears to work actively to prevent this.



In closing, Dr. Haacke, Dr. McDonald, and Dr. Zamboni were not included in the August 26th, 2010 joint CIHR-MS Society meeting. The explanation given for their not being included in the meeting was that their work would be discussed, and including them might bias the discussion. Now, we have a member of CIHR’s expert working group publishing and questioning clinical trials. Clearly, his position may bias the discussion.



Alain, this is extremely serious, and so, I look forward to hearing from you at the earliest time possible regarding Dr. Rubin’s inclusion in the scientific expert working group.



Yours very truly,



 Kirsty



http://www.facebook.com/notes/ccsvi-ontario/kirsty-duncan-writes-to-dr-alain-beaudet-president-cihr/334428676628043