Thank you, Mr. Chairman and the committee, for the opportunity to speak to you regarding my experiences both with CDR and the Ontario drug benefits program and in my role as a clinician-investigator, a clinician of patients with serious neurodegenerative diseases and an investigator in evidence-based medicine.
I'd like to disclose that I did apply for a position as a standing member of CEDAC. They didn't accept me, but I bear no hard feelings about that.
I have acted as a consultant to the Ontario drug benefits program as well as a consultant to the common drug review.
I have found that the process is very rigorous; they provide rigorous evidence-based reviews of drugs. However, I also feel there could be some improvements made to the process.
Also, I want to state that participating in drug and technology development is crucial to maintaining quality in Canadian health care and that evidence-based medicine and pragmatism are both needed in drug funding decisions.
First, my experience with the CDR is as a medical expert, not as what is known as a methodology expert. A methodology expert would be someone, typically with a PhD, who has expertise in guideline- or evidence-based medicine.
In my role, because I do have a background in writing guidelines for the American Academy of Neurology, I have been able to meet some concerns about what the appropriate designs and outcome measures of studies should be. However, I would also state that the American Academy of Neurology is very advanced in the development of critical appraisal, and other such specialties may not have experts who are similarly equipped to deal with the CDR's concerns. Therefore, studies that may have good evidence to show efficacy might be otherwise discounted.
I feel that there is a need for the CDR to take this clinical relevance into account and also to admit that often we do not know the value of quality-of-life outcomes or the appropriate outcome for studies. I think we all have to be honest and admit that even in evidence-based reviews there is some consensus contained in deciding how we are going to phrase the questions and gather the evidence, in grading the evidence, and then in interpreting the evidence.
Participation in drug and technology development is crucial in terms of maintaining and retaining the best academic physicians and scientists in medicine and science. If they are not able to participate in these activities, we will lose that great resource. In particular, I am aware that one company has closed down its neuroscience division and has stated it will not market any further neuroscience drugs in Canada. This concerns me as an investigator as well as a physician. I want to be able to provide my patients with the best possible care for a very serious illness.
Finally, there's the question of pragmatism in evidence-based medicine. Certainly, in our process at the American Academy of Neurology we have taken a strictly evidence-based approach to our guidelines. What we have heard from our members is that they would like to know, what is the clinical relevance, and what doesn't the research show? That speaks to the fact that even clinicians need to know the context they're making these decisions in. What are the potential factors that should change your interpretation of the evidence? That is something that any drug policy agency needs to take into account as well.
Because my experiences have allowed me to look at both sides of the coin, I still have a lot of faith in the common drug review. I think they do a wonderful job of evaluating the evidence, but I also feel that pragmatism needs to enter more into their decisions.
Thank you.