Make the evidence on drug safety and effectiveness public
THUNDER BAY – HEATH – Recently federal and provincial health ministers agreed to create a working group to explore how to improve Canadians’ access to pharmaceutical drugs. In the wake of this, there is new optimism that pharmacare, publicly funded and universally available to Canadians, might one day come to pass.
I support pharmacare. Many Canadians cannot afford the drugs they’re prescribed and that’s unjust. Yet, if Canada is to implement national pharmacare, surely we want to know more about the drugs we’ll be paying for. To this end, we must tackle a pre-existing challenge: we must open up the evidence our drug regulator houses concerning drug safety and effectiveness.
For decades Health Canada has kept that information confidential at the behest of drug manufacturers. This practice limits the ongoing evaluation of a drug’s safety and effectiveness and, in turn, provincial and territorial governments’ decision-making about which drugs to pay for, not to mention physicians and patients who make decisions about which drugs to prescribe and take.
In some cases, disclosing this evidence might prevent serious harm. Consider Vioxx. Approved in 1999 for treating arthritis, it was withdrawn from markets in 2004 after thousands are estimated to have suffered cardiac arrest and death. Regulatory officials knew of this risk but kept it secret on the grounds it was company property. This practice has to stop.
And so, we must reframe the “pharmacare question” from one of access to one of access to what, exactly. Our gaze must turn upstream to the producers of pharmaceutical knowledge — companies that have long insisted that unpublished information about drug safety and effectiveness must be held in confidence by the regulator.
Yet, the problems with the way that private corporations decide which pharmaceutical interventions to develop and how run even deeper. Industry has a well-documented tendency to tweak the formulation of existing drugs in order to extend their financial rewards. There is insufficient research comparing the effectiveness of competing drug treatments because drug-makers have weak incentives to demonstrate the real value of their products.
Meanwhile, drug firms are shifting their focus to rare diseases. This shift may be driven less by concerns that those diseases have been traditionally marginalized, and more by the fact that the path to market for rare disease drugs tends be faster and cheaper, while the price of many of these drugs is exceptionally high.
In addition, Canada’s public funding for research has, over several years, been increasingly aligned with industry’s goals and practices. A slew of policy initiatives from every level of government emphasize commercializing research. In this environment, the ability of publicly funded science to advance valuable pharmaceutical interventions instead of product line extensions, or independently scrutinize the evidence base behind such interventions, may be compromised.
Pharmacare is not a fake fix; it represents major reform with the potential to positively influence pharmaceutical manufacturers by forcing them to provide stronger evidence of the therapeutic value of their products relative to existing ones. But absent fundamental changes in the way pharmaceutical research is rewarded, shared, and scrutinized, any new formulary will be a half measure.
Those working on pharmacare need to think bigger: not only in terms of how federal, provincial and territorial governments can cooperate to create a national formulary, but also in terms of how such an institution can be designed in parallel with changes in pharmaceutical regulation and research.
Health Canada now has the power share unpublished pharmaceutical information with researchers and other governmental bodies, including a national formulary if it’s created. The regulator can also attach real, enforceable post-market monitoring conditions to drug company product licenses, which is especially important for informing formulary evaluations of those interventions as real world evidence about the benefits and harms of a drug accumulates. In practice, neither is happening adequately.
In pharmaceutical research, a wholesale rethink of the incentives, criteria, and processes for rewarding and carrying out drug research is needed. We need to hit the reset button so that universities are not in the business of recklessly promoting research and funding support for investigator-led and controlled drug trials and essential groups like Cochrane Canada is restored.
To improve access not just to drugs, but better drugs, pharmacare has to help drive these additional, but interconnected, institutional changes.
Matthew Herder is an advisor with EvidenceNetwork.ca and Associate Professor, Health Law Institute, Faculties of Medicine and Law, Dalhousie University, Twitter: @cmrherder
