A few years ago, prescription drug safety was hot news. Newspaper editors and readers were eager to hear about the issue and journalists obliged, all largely due to one huge recall, that of the arthritis pain drug Vioxx. Interest seems to have waned lately, but a new report reminds us that problems still exist in the system of regulating and monitoring pharmaceuticals.
The Health Council of Canada, a federal-provincial body, concludes that Health Canada’s oversight of drugs is lacking in many respects and needs “vast” improvements to better protect Canadians’ safety. It notes that the percentage of drugs withdrawn from the market because of safety problems has not increased in the last 25 years, but the number of people affected has soared. Before Vioxx was pulled because of studies suggesting it doubled the risk of heart attacks, 16 million prescriptions had been written in Canada, the council notes.
The report says the testing required of manufacturers to get their new products approved is relatively minimal, and study of a drug once it gets on the market is sporadic at best. Health Canada is trying to build a new system to monitor medicines after they hit the shelves. The council calls for further action, including:
– A requirement for post-market drug studies that are unbiased, open to the public and free from conflicts of interest;
– Penalties for companies that fail to complete post-market studies; and
– Better communications of drug safety messages.
Of course, Health Canada is subject to other pressures, too. The pharmaceutical industry is constantly pushing the regulator to more rapidly approve new drugs that it says take too long to get to the patients who need them.