The Health Council of Canada solicited feedback from CARP on a new report they have just published. Below is the commentary CARP provided.
Are our drugs safe? Most Canadians assume so given the multiple layers of government regulation and clinical trials and more persuasively, complaints from pharmaceutical companies that such regulation unduly impedes market entry of their drugs. But not necessarily, according to the just released Health Council of Canada Report “Keeping an Eye on Prescription Drug, Keeping Canadians Safe”
Once drugs get on the Canadian market, according to the Report, there is no systematic scrutiny of the real world experience with the drugs. Clinical trials are limited in size and scope and do not usually include people with multiple medical conditions. The Report concludes that as a result, more and more people are being exposed to unsafe drugs and cites the example of the high profile withdrawal of Vioxx and Baycol for safety reasons.
Instead, consumer safety depends on voluntary reporting of adverse drug reactions which captures only 1% – 10% of such reactions. What is needed is a system to protect the public through early detection of safety concerns – called pharmacovigilance – a systematic monitoring of drug safety once the product is released onto the market.
Pharmacovigilance is still new and evolving worldwide, and the Report canvasses and compares some international examples. None are comprehensive but Canada is barely on the grid.
A big part of the problem is that Health Canada – which has the primary responsibility for consumer safety – has limited authority to order the kind of steps necessary to monitor or uncover safety problems, to take action to prevent further use of drugs with safety problems or has failed to fully and effectively utilize the authority it does have.
The Report argues for the establishment and funding of independent research and monitoring of the safety and effectiveness of drugs after they have been put onto the market and a progressive licensing system to give Health Canada continuing authority to require compliance with drug safety measures including post –market [Phase IV] clinical trials.***
Hopeful signs include the recent creation and funding of the Drug Safety and Effectiveness Network which will research post market drug safety – but with no apparent responsibility for monitoring – and the proposed progressive licensing system which died on the order papers at the last prorogation.
Consumer safety is clearly a priority for CARP and Canadians would be appalled to think that the safety of the drugs they are taking [especially the newer ones] is not guaranteed and that there is no obvious process or responsibility to provide that guarantee. They are right to expect from the drug companies themselves a high level of integrity and good quality testing for safety and effectiveness before a drug comes onto the market. However, the limitations of the pre-market testing and the lack of systematic monitoring of post-market drug safety is a cause for concern.
The Report’s recommendations are directed at redressing this concern and action should be taken on them as soon as possible.
*** Post-market studies are referred to as Phase IV tests. Phase IV studies may be requested by regulatory authorities or may be undertaken by the sponsoring company to assess a drug’s effectiveness for a new indication or for other reasons, such as testing for interactions with other drugs, or testing in certain population groups such as the elderly. They are designed to detect rare or long-term adverse effects in a larger patient population and over a longer time than was possible during the Phase I, II and III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being removed from the market, limited to certain populations or indications, or in the issuance of safety warnings. Currently, Health Canada has no authority to require companies to undertake Phase IV studies for approved drugs once they are available on the market.