Thank you for recognizing the importance of post-market surveillance and for providing the opportunity to many groups like ours to present suggestions for improvements.
We are very gratified that you've seen fit to act on one of our previous recommendations, made when we presented our views to you during your hearings on the common drug review last year. Please accept our congratulations on your December 2007 report regarding CDR. In our view, your recommendations, if implemented, will substantially improve the cancer drug approval process in Canada.
The Cancer Advocacy Coalition of Canada is a full-time registered non-profit group, comprised of physicians, patients, and business executives from across the country, who are all unpaid volunteers. We publish the annual Report Card on Cancer in Canada, the only independent evaluation of cancer system performance in the country. In the just-released 2007 report card—which you should have in a day or two, as it's in the mail—we examined the allocation of research funds, the needs of young adults with cancer, the clinical trial research process, health human resources, access to diagnostics and drugs, and the role of nurses in supportive care. We publish these reports to identify barriers to better cancer control and to offer constructive solutions that are also realistic and implementable.
For the past three years, the articles about access to cancer drugs have recommended phase four, or post-approval, trials to confirm treatment results in the cancer population at large; and for two years in a row we have recommended increased translational research to identify the subsets of patients that benefit from these new drugs. Post-market surveillance is an appropriate portal to initiate these proposals, and it could encompass a more comprehensive system of information that is analyzed, shared, and disseminated to benefit patients.
When a new cancer drug is approved, the only obligation at present is the reporting of unexpected adverse events—and even this is not done comprehensively. From the physician's perspective, lack of effectiveness is an adverse event, when the treatment has added toxicities and other health risks to the patients, with no good result.
The information available to physicians about a new cancer drug is often not very helpful in the real world. Patients in preapproval clinical trials represent, at best, 3% of the wider population; and when patients at late stages of disease are treated in these trials, they generally achieve a response rate of 20% or less. Evidence suggests that response rates in the real world can drop to 10%. But for responders, the outcome could be a cure.
There are notable exceptions, such as Herceptin, where a tumour marker has been identified to improve patient selection. In such cases, the response rate is impressive and can include cure. However, most drugs do not have biomarkers, and for the majority of patients who do not respond, we are subjecting them to a drug with potential severe adverse effects with no hope of benefit. The objective, then, is to use every means at our disposal to identify the patients who will benefit and to spare those who will not benefit from the wasted time and avoidable adverse effects.
If post-market surveillance were formalized to capture information on positive results, as well as adverse events, then the characteristics of responders and non-responders could be captured for analysis. The immediate benefits would be remarkable. Better patient selection for the use of these expensive new drugs would save a huge amount of money that is otherwise fruitlessly spent. To accomplish that goal, post-market surveillance must collect additional reporting, and much of this must come from physicians, who can offer the important clinical detail necessary for further analysis. Reports ought to be submitted on every patient treated with a newly approved cancer drug within 12 weeks of initiating the treatment to ensure the accuracy of the information.
Physicians and others will not cooperate with an onerous paperwork exercise that produces nothing useful for their knowledge or their patients' well-being. The reporting we envisage could be done on a single computer screen; indeed, the proposal is undermined by anything more time-consuming. The information system required has to be linked to appropriate research by qualified entities, such as the National Cancer Institute of Canada, and have some assurance of timely outputs that are readily available online. Then the effort is worthwhile.
The data gathered should be readily available online and be presented in a manner that offers greater meaning than mere compilations of reported events. Indeed, if this undertaking is to serve its intended purpose, physicians and health administrators would find many other valuable uses for the data, including guideline writing and biomarker research.
In the final analysis, as this new knowledge becomes available, the true potential of each cancer drug would be realized, patient access would be increased, and treatment results improved.
A three-month increase in average survival translates into years for the 15% or so who respond to a drug. Three patients are alive well beyond three years after taking one of these new drugs and have reported their stories in our report card this year. Their written reports are very compelling stories. I would encourage you, when you get this report in a few days, to look at their proposals.
The Cancer Advocacy Coalition encourages you to focus on what is possible and needed, rather than what is already done. A robust post-market surveillance system could be an integral system providing valuable information and education, benefiting all Canadians and saving money.
I want thank you for your time and interest.