Thank you very much. Good morning, everybody.
Thanks for the opportunity to talk with you about the post-marketing surveillance of pharmaceuticals.
By way of introduction, I'm a patient who consumes drugs, a physician who prescribes them, a researcher who studies their benefits and side effects, and a drug policy advisor. I'm also one of the authors of the proposal to establish a real world safety and effectiveness network, which is currently being considered by Health Canada.
Let me start by saying that Canada and the rest of the world would benefit greatly from a more robust mechanism of post-marketing surveillance of pharmaceuticals, for a number of reasons.
First, some important harms are not detected in the studies that are currently conducted for licensing, either because the harms are so rare that not enough patients are studied in the initial randomized trials to be able to detect them or because the side effects occur after prolonged use.
Second, the benefits and harms of drugs in the real world can be different from the benefits and harms found in the randomized trials conducted for licensing. Those trials tend to enrol patients who are healthier and more likely to take their drugs than the average patient, and the patients are cared for by health care providers who can offer closer follow-up than is usually the case in actual practice. Thus the benefits and harms in the real world may differ from those in the trials done for a licensor.
And third, some drugs are currently licensed on the basis of so-called surrogate markers--for example, a decrease in cholesterol--with no clear evidence about their impact upon the outcomes that matter to patients, such as whether the decrease in cholesterol leads to a decrease in heart attacks or death.
Post-marketing studies have the potential to provide information about the outcomes that matter to all of us. Currently there's no systematic approach to post-marketing surveillance in this country, which is why I enthusiastically support the establishment of the real world safety and effectiveness network, which has been submitted to Health Canada.
This independent network would bring together clinicians who prescribed drugs, patients who benefit from and are harmed by drugs, Health Canada, which approves drugs, the provinces and territories that pay for them, and researchers who can analyse the databases, the forum--that basis of post-marketing surveillance. Such a network would provide important information that is not currently routinely available, particularly if it is well linked with other such networks across the world.
I've been asked to say a few words about Health Canada's proposal for progressive licensing.
As I understand it, the idea is to allow some drugs to reach the market relatively early, on the basis of promising but not conclusive evidence of an attractive benefit-to-harm ratio. This initial licensing would be conditional upon the performance of post-marketing studies to determine if the initial promising results are substantiated when the drug is used in actual practice.
The idea is attractive in one way. It would allow patients who are suffering from a severe disease for which there is no good therapy a chance to try a drug with promise. However, there are also considerable downsides to this approach. There is a reason that randomized trials are the gold standard for the evaluation of new drugs. Because of the process of randomization, in which patients essentially receive the new drug, or standard therapy based upon the flip of a coin, those who receive the new drug are virtually identical to those who receive the current best therapy. This means that one can be quite certain that any differences between the two groups, either in benefits or harms, are likely due to the drug.
Patients are rarely randomized in post-marketing studies, so that those who do and do not get the new drug in the real world are often very different in their underlying characteristics, which can make it very difficult to conclusively determine the drug's benefits and harms.
Although judicious use of progressive licensing in limited circumstances seems reasonable to me, it would be important that post-marketing studies are not used as an excuse not to do the high-quality randomized trials that we need. As well, the legal and political framework must be in place to allow Health Canada to withdraw the drug from the market or limit its prescribing on the basis of negative post-marketing results.
It's important that the committee is aware that post-marketing surveillance will not be a panacea. As I've mentioned, these studies can be difficult to interpret, and there's a relatively small group of researchers in Canada who are skilled in their execution. That is why our network proposal contains a substantial component for the training of young researchers.
I believe that inappropriately withdrawing a drug from the market because of an inaccurate result is just as bad as inappropriately allowing a drug on the market with inadequate information about its benefits and harms. Therefore, the results of post-marketing studies in one jurisdiction should be confirmed by studies in other jurisdictions. That is why the network proposal indicates that our post-marketing network must be well linked with networks around the world.
Because post-marketing studies can be expensive, decisions will need to be made about which studies need to be done and which we can do without. That is why our network proposal suggests a priority-setting committee with representation from numerous stakeholders and a strong scientific director to make the judgment calls about how our limited funds should be spent.
Every beneficial drug causes side effects. Therefore, patients and physicians will always need to weigh the benefits of a drug with its harms. I have an elevated cholesterol level, and although I am otherwise healthy, this morning I took an Aspirin and a statin, a drug to lower my cholesterol, in an attempt to decrease my chance of having a heart attack. By so doing, I realize that I am accepting the small chance of a very severe side effect, such as a major bleeding ulcer caused by the Aspirin.
Another person in precisely my situation and as aware of the same information as I am might decide that the risks of these drugs are not worth the benefit. The important point is that we should both be fully aware of the drug's risks and benefits and should make the decisions that are right for us.
There's an urgent need for all Canadians to have access to the kind of information that I'm lucky enough to have because I'm a physician. Canadians deserve complete and unbiased information about the benefits and harms of drugs, in a form that is understandable to all. Currently, this does not happen.
The information that drug companies provide to the Therapeutic Products Directorate of Health Canada is kept secret, as is Health Canada's assessment of that information. Canadians deserve access to that information, and if legislative change is needed to make that happen, so be it.
There is also a need to produce information about drugs that is written in a language and provided in formats that are accessible to all Canadians. Current warnings from Health Canada about a drug's side effects are long, technical, and difficult to understand for physicians, let alone patients.
Health Canada should borrow from the pharmaceutical industry, which excels at communicating its message clearly and succinctly. The network that we have proposed could also play a role by providing accessible independent information about the benefits and harms of drugs.
In closing, let me thank you for taking the time to consider this important issue. Establishing a more robust post-marketing surveillance system in Canada, although it will not remove all uncertainty, will be a major step forward.
I look forward to your questions, and thanks very much.