Are our drugs safe? Most Canadians assume so, given the clinical trials and multiple layers of government regulation – and perhaps more persuasively, complaints from pharmaceutical companies that such regulation unduly impedes market entry of their drugs. But it may not be so, 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.
Consumer safety now depends on voluntary reporting of adverse drug reactions but this 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 or to take action to prevent further use of drugs with safety problems. The report argues it has also failed to fully and effectively utilize the authority it does have. Presumably, the technical review and modernization process now being undertaken by Health Canada will help address these gaps.
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 plus a progressive licensing system to give Health Canada continuing authority to require compliance with drug safety measures including post–market [Phase IV] clinical trials. [1]
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.
CARP is a national, non-profit, non-partisan organization with 300,000-plus members across the country which advocates for changes that improve the quality of life for all Canadians as we age. Consumer safety is clearly a priority and our members would be appalled to think that the safety of the drugs they are taking [especially the newer ones] is not monitored on a systematic basis much less guaranteed and that there is no apparent process or responsibility to provide that guarantee.
Canadians 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.
--Susan Eng is Vice President of Advocacy for CARP, the national, non-partisan, non-profit organization committed to advocating for social change that will bring financial security, equitable access to health care and freedom from discrimination for all Canadians as we age.
While it is certainly true that an effective pharmacovigilance program is important to monitor drug safety post-approval, I have seen no mention of the risks of direct-to-consumer (DTC) advertising of drugs. I have suggested on my blog, “Absorb This” (blog.absorption.com) that DTC advertising of drugs should be prohibited for the first two years after approval of a new drug.
ReplyDeleteMost of the general public is probably unaware that drugs are imperfect. Try as they might, in almost all cases pharmaceutical companies don’t know which patients are likely to respond well to a given drug, nor in which ones the same drug will be unsafe. Until such time as personalized medicine becomes a reality, the reality will be some degree of uncertainty.
The total number of people exposed to any new drug during clinical trials (prior to regulatory approval) is at most a few thousand, not enough to detect a fairly rare adverse event. It is often after a drug is approved, heavily marketed to doctors and the general public, and millions of prescriptions written, that people start to realize that there might be a problem. When patients see ads for a new drug on television, in magazines, on the internet, etc., they pressure their doctors to prescribe it with no knowledge of its safety or effectiveness. Banning DTC drug advertising for the first two years after approval of a new drug would allow regulators to monitor post-marketing reports of adverse events without exposing even more people to undue risk. If, after two years, everything looks OK, then let big pharma roll out the really big marketing and advertising guns. Maybe they could spend the money that would have gone into early DTC marketing and advertising on R&D instead, refilling their pipelines with drugs that are safer and more effective in more patients.
Banning DTC advertising for two years would also give the industry a better handle on drug-drug interactions (DDIs). Although preclinical studies can predict the risk of DDIs, which can help direct a clinical testing program, it is not yet possible to predict the magnitude of such interactions. And some of them are underpredicted or missed entirely during clinical testing.