Thank you, Mr. Chair.
I am Dr. Michèle Brill-Edwards. Today I'm representing the Canadian Health Coalition. I'm a member of the board of the coalition. I'm replacing Mr. McBain, who could not attend today.
The Health Coalition has a mission to preserve and strengthen public medicare, and also to advocate for the protection of the health of Canadians. It is a not-for-profit, non-partisan organization dedicated to protecting and expanding Canada's public health system for the benefit of all Canadians. The CHC was founded in 1979 at the Canadian Labour Congress-sponsored SOS Medicare conference attended by Tommy Douglas, Justice Emmett Hall, and Monique Bégin, the leaders of public interest in health care in Canada.
I'll make some brief remarks.
Much of the view of the Canadian Health Coalition is already expressed in the presentation of Drug Safety Canada. I would like, however, to speak briefly to the scope of the problem, the nature of pharmacosurveillance in Canada currently and some of the problems, and then make a very few recommendations.
In essence, the scope of the problem is huge. As mentioned, the number of deaths due to the proper use of medications in Canada and the United States has been studied and is pegged at somewhere between the fourth and the sixth leading cause of death North America-wide. That tells us that we are not dealing with something rare and unusual. We're not dealing with a system that may help save the odd life here and there. We are dealing with a very major cause of mortality for Canadians.
The current system of pharmacosurveillance is in essence a passive system. In other words, input reports from health care professionals, doctors, pharmacists, nurses, and so on come into the system in a very haphazard manner, without any knowledge on the part of Health Canada as to the true number of serious adverse reactions that are really out there. The analysis that is then undertaken by Health Canada is problematic, partly because of the inherent difficulty of ascertaining a true signal of serious problem from the noise of adverse events that may or may not be related to the drug in question but may be related to the disease of the patient or other extraneous factors.
A second issue, however, is that the analysis within Health Canada of the reports received is, in essence, opaque. It is not transparent. So the messages go in, and there's no understanding on the part of physicians and pharmacists and people who need to know what analysis is done or how it's done or how valid it could be. The output of the system is often very belated and rather cryptic, and there are examples we could discuss regarding SSRIs, for example, and suicidality. SSRIs are antidepressants and have been now demonstrated, after many long years of tortured analysis, to be related to suicidality in both adults and children, but in children particularly. Recently we've learned that these drugs have no efficacy in the treatment of depression.
The belated and rather cryptic output doesn't tell doctors and other health care professionals how the drug safety analysis was really done and what supports the guidance. These outputs are largely ignored by the profession. So we have a real problem of trust in Canada with regard to the Health Canada drug safety system.
As a result of that lack of trust, there's very little reporting. Doctors and pharmacists feel there is no point in reporting to a system that doesn't give them back useful information. Another result is that heed is not taken of important messages that are put out by Health Canada, because of the perception that they are not well founded. The problem is compounded as we look to the future and ask how we could improve the system. The issue of trust comes up immediately.
It is very simple, in an academic way, to say that passive surveillance is not adequate. It certainly is not adequate. It is very easy to say we need active surveillance, better systems, targeted, focused adverse reaction reporting, and mandatory reporting, as Terence Young has discussed. It is very easy to say those things, but if we want those measures to work, we have to have trust on the part of health care workers that there's a thinking, concerned, committed Health Canada as the intermediary that acts in the public interest to reduce this burden of unnecessary deaths due to medicines.
I would like to add that in addition to active surveillance, meaning not only mandatory reporting but also focused studies that would ascertain epidemiologically the cause and effect likelihood, we also need a system for the investigation of what have been termed catastrophic drug safety failures. In lay terms, these are drug crashes, or drugs that arrive on the market and are on the market for many years, and unbeknownst to patients and their professional caregivers, there are very serious problems and many resulting deaths. Vioxx is probably the most famous example, with tens of thousands of deaths demonstrated through studies done by the FDA before the drug was removed.
My last recommendation is for an independent investigative drug safety board that is separate from the regulator and separate from the industry, and that can investigate problems arising after the industry and the regulator have made the decision to bring the drug to market. It is not acceptable for the industry and the regulator to investigate themselves behind closed doors when thousands of lives are at stake.
If the committee needs a model for such an independent board, it was proposed about a decade ago in The New England Journal of Medicine by two very prominent clinical pharmacologists with an interest in drug safety. The very handy analogy they used is that if the federal aviation authority sets the regulatory standards for flying, we automatically know we will need a separate air safety board to investigate plane crashes. That is just common sense; we don't want a conflict of interest there. Why do we not then have a similar situation where the FDA or the health products and food branch of Health Canada are the people who set the regulations, but then also have an independent, separate safety board that immediately investigates when a serious drug failure comes to light?
I would like to add on behalf of the coalition that many of the recommendations that have already been stated by Drug Safety Canada are recommendations we concur with.
Thank you.