Safe drugs depend on Active Consumers

Colleen Fuller

In March 2000, 15-year old Vanessa Young died after taking a drug called cisapride (also known as prepulsid) prescribed for people with a variety of stomach disorders. Ms Young suffered from bulimia when she began taking cisapride. A coroner’s inquest into the young woman’s death held a year later criticised the federal government for not acting sooner on information it had about the risks associated with cisapride when the young woman died. This information – that patients with a number of conditions, including bulimia or anorexia, should not use the drug - was available to Canadian doctors through the medical literature but the government had failed to officially communicate that information to them, unlike in the United States which pulled the drug from the market six months before Ms Young’s death. If Health Canada was running an effective health protection system, including our country’s post market monitoring arrangements, Vanessa Young might have avoided the drug that took her life.

Vanessa Young’s death is not, unfortunately, an isolated event in Canada. That is why a group of consumers and prescription drug policy experts are set to launch a national network focused on drug safety and post market surveillance.

PharmaWatch was founded two years ago by a group of consumer advocates and drug policy experts to push for better monitoring of prescription medicine that has made its way onto drug store shelves. In July, PharmaWatch opened a national office headquartered in Vancouver, the next step towards a national network that hopes to become a powerful consumer voice advocating on safe medicine and what is called “direct from consumer” reporting of adverse drug reactions.

Each year in Canada there are 1200 applications by companies who hope to begin clinical trials so their drugs can join the 22,000 others already on the market. Of these marketed drugs, 6000 are prescription medicines, 9000 are non-prescription, 6000 are homeopathic drugs and another 1000 are controlled drugs, narcotics and biologics (for example, drugs like insulin made using genetic engineering techniques). Many argue that drugs in Canada are inadequately tested, a situation that is made worse by the poorly monitored experiences of consumers when those drugs reach the market.

Clinical trials are the first stage of Canada’s drug regulation system, followed by the drug approval stage, and promotion and post-market monitoring. Post-market monitoring (or surveillance) in Canada is the weakest stage of drug regulation, with the lowest budget. It is ineffective, underfunded and understaffed, a situation that generally suits the industry. Critics estimate that only between 1 and 3 percent of all adverse drug reactions (ADRs) are reported to Health Canada and that the government does little to encourage reporting by physicians, pharmacists and consumers. While manufacturers are required by law to report adverse reactions there is evidence that this is not being done in a rigorous way.

The goal of PharmaWatch is to encourage consumers report adverse experiences with prescription medicine. It sees this as a socially responsible act as well as a vital part of the health protection system. PharmaWatch also plans to monitor reporting of ADRs by drug manufacturers and to distribute information clinical studies and peer-reviewed reports of prescription medicines. It will provide a social, cultural, environmental and political context about different conditions and diseases, alternative medicines, and lifestyle changes that may support health.

PharmaWatch will a welcome thorn in the side of both Health Canada and the pharmaceutical industry. If you want more information contact them at 604 687 6613.