Professor Mary Wiktorowicz addressed the Canadian Senate Committee on Social Affairs, Science & Technology Thursday morning where she emphasized that “the adverse effects of drugs are one of the top 10 leading causes of death, and a new governance process is needed to study and act on the risks” in this country.
The Senate committee began examining the process to approve prescription pharmaceuticals in Canada last year with a particular focus on clinical trials, post-approval monitoring, off-label use, as well as the nature of unintended consequences in the use of prescription pharmaceuticals
In her presentation – “Addressing the Risks of Medicine: A New Governance Strategy for Pharmacovigilance” – to the committee, Wiktorowicz stressed the erosion of public confidence in Health Canada, the country’s drug regulator following the Auditor General’s 2011 report which found it is not fulfilling its responsibilities, its lack of transparency and lack of public representation in the regulatory process.
“Canada is currently without a systematic approach to monitoring drug safety in the real-world and that has put patients at an increased risk at being exposed to the harms of medicines,” says Wiktorowicz, chair of York’s School of Health Policy & Management in the Faculty of Health. A new, more open and inclusive strategy with more clout is needed.
“Activesurveillance should be arm’s length from pharmaceutical companies, whose research results frequently overstate the effectiveness and obscure the harmful effects of their pharmaceuticals,” she says. This according to a 2008 study that re-analyzed the data pharmaceutical companies submitted to the FDA to support new product applications.
“Markets for ‘blockbuster’ drugs are so large that even risks that occur infrequently can lead to thousands of injuries,” says Wiktorowicz. For example, the Food & Drug Administration received about 82 adverse drug reaction reports a year for digoxin (1990s), which did not seem to be a big problem at the time. However, a “systematic survey of United States’ medicare records over same time period revealed 202,211 hospitalizations for adverse drug reactions related to digoxin,” she says.
Wiktorowicz proposes the new pharmacovigilance governing process be similar to the Food & Drug Administration’s Drug Safety Board in the US. It should include representatives from the Drug Safety & Effectiveness Network (DSEN) and provincial government drug plans, including experts with access to health-care data bases to actively study the effects of drugs in the real world. In addition, the DSEN should receive increased funding to conduct independent studies.
Health Canada should have the authority to require post-market studies without lowering pre-market safety requirements, request and re-analyse clinical trial data, and have the skills and resources to act on adverse drug reaction reports. “The safety of Canadians should be the priority of Health Canada over the proprietary commercial interests of industry,” says Wiktorowicz.
Wiktorowicz is first author on the paper, “Pharmacovigilance in Europe and North America: Divergent Approaches,” that was published in the July issue of Social Science and Medicine earlier this year, and first author of a 2010 report commissioned by the Health Council of Canada on the safety of medicines in Canada – “Keeping an Eye on Prescription Drugs, Keeping Canadian Safe: Active Monitoring Systems for Drug Safety and Effectiveness in Canada and Internationally.”
To view a copy of Wiktorowicz’s presentation to the Senate Committee on Social Affairs, Science & Technology, click here. A webcast of the proceedings can be accessed here – scroll to 30:14 on the video.