Good morning, Madam Chair and members of the committee. Thank you again for the opportunity to speak to you.
I would like to reiterate a couple of brief points that I made the last time, but I won't dwell on those. I'm hoping that you read the transcript of comments instead.
The first point is that adverse reactions are a major public health issue, but our regulatory system does in fact prevent most unsafe drugs from being on the market. The difficulty is in heterogeneic responses to drugs, the differences in the variability in response that we all have. I believe last time I presented the example of a skin reaction in which the skin of this young baby fell off as a result of ibuprofen--Motrin, Advil. This is a product that is used repeatedly by people without any particular trouble--I use it myself without problems--but some people do have such a significant reaction. The difficulty in improving safety is that these reactions are not necessarily predictable and they don't occur in large numbers. Finding solutions to these safety problems and allowing drugs to continue to be used when they're effective and they're not unsafe is really the crux of the problem. Addressing this public health issue requires an understanding of response heterogeneity and understanding that we have different responses.
An article published in the Journal of the American Medical Association in 1998 suggests that adverse drug reactions not due to error or abuse are in fact the fifth leading cause of death in the United States. This is a very significant problem, and we need ways to address it.
How do we address a problem that occurs in some and not in all? Every drug is different. Some people have reactions to one drug and not another. I believe that a key in this is to understand the role that human genetics play in the difference in response, and that's the context in which I'm speaking to you today.
My work and the work of Dr. Michael Hayden, the geneticist I work with, is about understanding drug response and linking clinical pharmacology and human genetics. When drugs enter the body, there are four basic steps that they go through: they're absorbed, they're distributed, they're metabolized into active or inactive constituents, and they're excreted. Those four steps are controlled by genes. If we understand which biotransformation step results in a toxicity problem--in an adverse effect--we can also understand what genes might be responsible for allowing that particular occurrence. In fact, as I reported last time, Dr. Hayden and I have discovered the genes for three serious and fatal reactions.
We believe this work has tremendous value worldwide. These are drugs that have been used for many years, as my colleagues from Health Canada have stated. The drugs that are currently on the market are also a problem. It's not just the new drugs that are a problem; it's the ones we've been using in cases for 50-some-odd years. What we want to do is to use this new science of pharmacogenomics, combining clinical pharmacology and human genetics, to understand drug response, and then to use that to develop predictive tests to prevent adverse reactions in people who are most likely to experience them--or at least we should know, before we begin therapy, in whom the most serious reactions are likely to occur. If we do this properly, it will happen one drug and one patient at a time.
The technology is rapidly decreasing in cost. The research is building to show this is of value. The Food and Drug Administration in the United States is already recommending genetic testing for at least three drugs and three specific reactions, one of which was our discovery, as part of the network that was funded with Genome Canada money that developed this work, and we're very excited to move this particular area forward.
I'd like to say, finally, that all Canadians, all stakeholders in this process--from pharma, government, and industry to patients, clinicians, and academics--want safer drugs. Everybody wants that. This is an opportunity for us to move forward with a common goal, and we have the national health system to support this. I can't emphasize enough the work that I do internationally with different groups who suggest that in their countries they just can't do what we're doing. We have created an opportunity here. We've embedded our work within the health system in Canada. We've used clinicians to find reactions. By the end of this year we'll have more than 10,000 adverse drug reaction reports and controls that are critical to understanding the differences between people who respond negatively to drugs and those who don't. That work will allow us to move forward on a great many other targets to begin the development of predictive diagnostics to help clinicians make better choices for safer drugs for Canadians in the future.
Thank you very much.