A few weeks ago, Health Canada recalled a herbal detox kit and a laxative promoted as safe for children because they contained dangerously high levels of heavy metals.
Testing by the manufacturer, St. Francis Herb Farm Inc., based in Combermere, Ont., found the All Seasons Detox Kit had more than twice the legal limit for lead, while the Bulklax V laxative had more than seven times the limit, as well as double the acceptable limit for arsenic.
Canadians only learned this because the manufacturer discovered it had a serious problem and went to Health Canada. For the most part, rules around the safety of herbal remedies and other natural health products in Canada are lax and poorly enforced. Many companies sell goods that are contaminated with prescription medicines or other potentially dangerous substances.
In 2013, Health Canada issued warnings about nearly 70 natural health products, including some that contained prescription substances similar to Viagra and others that were contaminated with bacteria, according to Bad Science Watch, an advocacy group. A 2013 University of Guelph study found that nearly all of the 44 herbal products they tested contained unlisted ingredients and potentially toxic contaminants.
So it seems strange that Vanessa’s Law, the much-touted new piece of legislation that is supposed to overhaul drug safety in Canada, excludes natural health products. Manufacturers will continue to prosper in an environment that is free of scrutiny and oversight, while consumers have no means to ensure what they are getting.
This is just one of several serious problems that raise questions about what, if anything, Vanessa’s Law will actually do to change the major problems with drug safety in Canada.
A commentary in the Canadian Medical Association Journal (CMAJ) published last week also questioned how the government will enforce the new requirement on health-care institutions to report all adverse reactions patients have to drugs.
Vanessa’s Law, which passed last November, was named for the teenage daughter of Conservative MP Terence Young, who died in 2000 after taking cisapride, prescribed by her doctor to treat bloating associated with her bulimia. Because she had an eating disorder, she should never have been prescribed cisapride. Her father later discovered that Health Canada had delayed in acting on the reports of heart problems linked to the drug. It was taken off the market in Canada months after she died.
On the surface, the legislation, championed by Vanessa’s father, seems like a major step forward. Companies will face fines of up to $5-million for selling unsafe products, Health Canada will have the power to force drug makers to update product warning labels and health-care institutions will need to report adverse drug reactions.
The question facing policy-makers now is how those new powers will be enforced and whether some big loopholes will be closed. Right now, the government is holding a public consultation looking for input on how the regulations that will enforce the law should be written.
Drs. Corinne Hohl and Joel Lexchin, who authored the CMAJ commentary, argue the law’s adverse event reporting requirement will be meaningless unless the regulations compel health professionals to fully document the details of each case. Currently, this type of documentation is time-consuming and laborious, which explains why only a fraction of practitioners do it. And that is unlikely to change unless institutions are incentivized to implement a system that is easy to use and efficient. Will the new law’s regulations actually compel provinces to ensure such systems are put in place?
Even if that occurs, will Health Canada dedicate enough resources to make sure every adverse event report is looked at with a careful eye so potential problems are spotted as they emerge? If the new law is to make a difference, that will be critical.
What about the exclusion of natural health products? Anyone who ingested a laxative laced with dangerous amounts of lead and arsenic would be outraged to learn the government has no plans to address the serious gaps with the safety of those products. Michael Kruse, chair of the board of directors at Bad Science Watch, is still hoping to see action in this area, but the government has so far shown no interest in increasing the scrutiny of the natural health sector.
And that is a shame.
Vanessa’s Law is destined to fail unless those regulations are crafted very carefully, spelling out with more clarity some very important issues, like what should trigger alarm bells over drug safety and how hospitals and doctor’s offices are supposed to overcome the major challenge of adverse event reporting.Vanessa lost her life after taking an unsafe drug. The day-to-day enforcement of the new legislation must ensure the government is doing everything in its power to prevent more deaths like this.Report Typo/Error