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Thursday, June 07, 2012

Kirsty Duncan MP Objects to "Bias" in the Working Group on CIHR Funding of a Clinical Trial on "Liberation Therapy"

The previous post mentioned a recently published article on "liberation therapy" that referred to it as something akin to faith healing. It criticized the decision by Canada's CIHR to fund a clinical trial on the procedure. One of the authors of that article was Barry Rubin who served on the working group that recommended the trial.

This prompted a letter from Liberal MP Kirsty Duncan to Dr. Alain Beaudet, President of CIHR [MP lists concern with CIHR expert]. This is a blatant example of political interference and it should not be tolerated. Duncan should be reprimanded in Parliament.
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,

Kirsty (Duncan)
Kirsty Duncan does not understand how science works and she does not understand that advocates of quack medicine are the ones who are "biased" against real science. It's not the scientists on the working group who caused the problem.


  1. I have MS, but the whole "liberation therapy" thing bothers me because of the unrealistic expectations that have been raised. Even the invented name smacks of "astroturfing", and the FDA are right to warn about the risks of surgical intervention. "Needs more trials" is an understatement.

    As for Gilenya (FTY720): I have been on the Phase III trial for five years now, so I've been following it out of personal interest i.e I can't claim to be perfectly objective. I'm not getting paid, and I'm no fan of "big pharma", but: not only am I not dead yet, I've had no major relapses for five years, and I can tell the difference between correlation and causation. People have died while ON the trial, but people die when they aren't on trials. In one case a man died the day after first dose, which may be related to the known temporary bradycardia (slow heart rate) after first dose, which is why they're supposed to do an EKG and screen for heart problems before starting the pills. To say that Gilenya has "killed 11 people", in contradiction of reviews by the FDA and EU, is flat-out wrong. People with MS are hardly going to expect any therapy to carry zero risk, anyway.

  2. Duncan also doesn't understand that having an opinion, or even being biased, is NOT the same as having a conflict of interest. (Is it possible Duncan is upset because Rubin's opinions conflict with her interests?)

  3. I think we should convene a committee to decide if there is any basis to relativity theory. Of course, we shouldn't allow any physicists on the committee - they've already made up their minds.

  4. Colour me unsurprised, an anti-science rant filled with scaremongering and claims of conspiracy. Pretty typical of our countries ruling party...

    ...oh, wait

  5. Ugh. This is the part that got me:
    "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. "

    Does Kirsty Duncan not understand the difference between "independent" and "lacking an opinion"? And the irony of a politician complaining about lack of independence in a scientific body... my meter is all twitchy today.

  6. Is Ms. Duncan any worse then Gary Goodyear?

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  8. thummim writes,

    Dr. Duncan is my MP ...

    You have my deepest sympathy.

    I could shed some more light on it if you desire.

    Please do. I'm anxious to find out why Kirsty Duncan seems convinced that CCSVI actually exists. Perhaps you can explain the science behind her bizarre behaviour?

    I am also not clear on your definition of science.

    I don't see why this is particularly relevant. Barry Rubin is a scientist and he has arrived at a scientifically informed opinion about CCSVI. Kirsty Duncan has some training as a scientist and she has arrived at the opposite opinion. Where does she get off calling Rubin's opinion "biased" but not her own?

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    1. I'm a proponent of the broad definition of science. Science is a way of knowing that requires evidence, rationality, and healthy skepticism.

      What definition do you prefer? I'm always anxious to hear from students of the philosophy of science although their track record on this blog isn't that great. They usually end up nitpicking over the precise meaning of every word and they usually fail to offer their own reasonable definition of science.

      Your response so far is typical. There's no reason to suspect that CCVI even exists and, therfore, it would be a waste of money to invest in an expensive clinical trial. A respected clinical scientist points this out and your MP accuses him of bias!

      Instead of focusing on the issue you choose to quibble about the meanig of "science" and "logic." This is one of the reasons why the field you're in is acquiring such a bad reputation.

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    1. thummin writes,

      You are a proponent of a definition of science that is very subjective, and many would say it is incorrect. It is clearly based on your own opinions rather than any philosophical, sociological or linguistic work

      First, as far as I know, the demarcation problem has not been solved so ALL definitions of science as based on personal opinion. That includes the opinions of philosophers.

      Second, it's simply not true that the broad definition is incorrect. There are many people, including philosophers, who prefer such a definition. They reject the idea that science has to be limited to a particular "scientific method" that only applies to disciplines like biology, chemistry, geology, and physics. What you meant to say is that, in your opinion, you prefer a different definition.

      What is most wrong about your definition is the lack of emphasis on method, although you use the frequently use the word science in a methodological sense as well.

      What you actually mean to say is that you prefer a restrictive definition of science that can, hopefully, be described by a certain methodology. I reject that definition (personal opinion, just like yours). Many philosophers also object [Is Science Restricted to Methodologial Naturalism?]. I'm sorry that your readings in the philosophy of science haven't covered anyone who disagrees with you.

      Not to devalue your definition but there are many theses written on this subject and all the information is available, As a scientist, to ignore all of this and continue to use an uninformed, opinionated, definition is disrespectful. It could also be laziness.

      Pot, kettle, black.

      I think scientists like yourself should make an attempt to learn a little about the philosophy of science before you speak about issues surrounding what makes something scientific.

      I'm not an expert but I've done a bit more research than you give me credit for. I've even been to a few meetings on the philosophy of science. I think what's really troubling you is that you are unaware of the diversity opinion in philosophy departments.

      Last thing, Philosophy of Science is not my field per se- I mainly do behavioural MS treatment research- functional electrical stimulation.

      Hmmm ....

      I would say science as a field (which is also not covered in your broad definition) is acquiring a bad reputation. One of the reasons for this is scientists have no idea about what science is about.

      Do you realize how stupid that sounds? It's like saying that philosophers have no idea what philosophy is about, or lawyers have no idea what the law is about, or musician have no idea what music is about.

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