On December 6th, Health Canada announced the Protecting Canadians from Unsafe Drugs Act giving powers to the Minister of Health to force companies to recall or stop the sale of any therapeutic drug product or device marketed in Canada. The tabled legislation comes hot on the heels of an investigative report in the Toronto Star outlining Health Canada’s inability to unilaterally withdraw Diane–35 from the Canadian market despite an elevated risk of blood clots that resulted in the death of Marit McKenzie. It also hearkens back to the thalidomide tragedy from the 1960’s, where Health Canada failed to react quickly to reports that the antinauseant medication marketed for pregnant women was causing birth defects.
Bill C–17 overall is a laudable step in the direction of improving patient safety and improving Health Canada’s dearth of authority over prescription drugs. One of the more toothier powers is the ability to fine or jail corporate executives of pharmaceutical companies who “knowingly or recklessly” act in a way which may jeopardize patient health.
The legislation should improve communication times — a problem highlighted by the recent Apotex recall of Alysena which wasn’t communicated to Health Canada until 2 weeks after the faulty product was detected.
It also properly requires full disclosure of relevant information of harm and safety to Health Canada. If that legislation had been in place previously, it may have helped discover the safety information Merck hid with respect to Vioxx before it was ultimately recalled for causing sudden cardiac deaths. In theory, then, Health Canada should have better and more timely access to safety information.
But there are other gaps in prescription drug regulation that the bill does not attempt to solve. For one, Health Canada continues to operate under a “culture of secrecy”, with data and decisions for drug approval being protected for the sake of protecting commercially sensitive information. Therefore, prescribers continue to utilize drugs like Tamiflu and Aricept without having access to important clinical trial information that could impact patient care, and companies balk at releasing the information voluntarily in order not to compromise the value of their patent monopolies.
Similarily, the legislation doesn’t address the thorny issue of off-label marketing (when a company markets one of its products for a purpose other than was it was approved for). While we know it shouldn’t happen, it does. Health Canada relies on the industry to self-regulate itself and has allocated minimal resources to ensure compliance with current regulations. Moreover, the Food and Drug Act limits the penalty of off-label marketing to a fine of $500 and three-months of jail time. In contrast, the FDA has been actively prosecuting pharmaceutical companies for promoting off-label usages, with GSK settling one of the largest cases in FDA history for $3 billion for the improper marketing of off-label use of Paxil in children, among other infractions.
The importance of pharmaceutical company marketing influences over physician prescribing habits and consumer behaviour cannot be overstated. Many clinicians have already opted not to meet with drug representatives in order to limit the amount of biased evidence they are exposed to. In 2004, Barbara Mintzes described how Diane–35 was being heavily marketed for the off-label use as an oral contraceptive, largely unchecked.
Health Minister Rona Ambrose has also announced the Plain Language Labelling Initiative, which aims to improve the labeling of OTC products to help improve patient self-selection of medications. Yet the information supplied with prescription products is also obtuse and not very patient-friendly. This is an especially odd omission from Bill C–17, co-named “Vanessa’s Law”.
Vanessa Young, the daughter of MP Terence Young, suffered a cardiac arrhythmia after being prescribed cisapride. In the Veridict of the Coroner’s Jury into Vanessa’s death, one of the recommendations made to Health Canada was to improve patient information leaflets that are handed out by pharmacies and package inserts that are commonly distributed with medications. Among the recommendations was that information leaflets ought to conform to a standard template, use plain language, and be approved by Health Canada before distribution to patients. Given the effort to standardize OTC labelling and the clear connection of Bill C–17 to Vanessa Young’s case, it’s unfortunate that the opportunity to address this problem was not siezed. It would have marked at least one area where Health Canada was ahead of the FDA in patient safety.
We could also bemoan the ongoing issues with prescription drug abuse and the inability for Health Canada to block the entry drugs or withdraw them from the market for larger public health issues, such as an uptick in the abuse of the more tamper-susceptible generic oxycodone formulations. But it’s fanciful to think that a single bill could overhaul the pharmaceutical regulatory regime in one fell swoop. It’s fair to conclude that the bill is a positive step to improving prescription drug safety in Canada. With the increase in the number of drugs recalled voluntarily in recent years — a trend which some researchers say is associated with the fast track approval that many companies have sought for their products — the new bill may increase that number further still.
My hope is that the new legislation marks the beginning of a new trend at Health Canada to improve the quality, effectiveness and safety of our drugs on the whole in Canada.
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Patients are only as safe as the weakest link in the healthcare chain. It is well established that a shocking number of hospitals underreport medical incidents and adverse events. Too many of these episodes lead to serious patient harm and death. Indeed, medical harm in hospitals is the third leading cause of death in Canada and the United States.
Some hospitals, as Patient Protection Canada has discovered from its own patient and family incident reporting program (www.patientprotection.ca), actually attempt to cover-up the harm they cause by not disclosing it to anyone. I am among those families.
Until legislation also makes deliberate non-reporting or cover-up of adverse events by hospitals a criminal offence, patients will continue to be placed at unacceptable risk in the Canadian healthcare system.