The recent CTV -W5 documentary “The Problem with Pills” illustrates in horrific detail, what happens when whistleblowers – often experts in their fields - are ignored and not protected, laws to protect the public are not upheld and policies are diverted from the public interest towards a specific interest. These actions have led us to a place where 22,000 or more innocent Canadians die a year from adverse reactions to legally prescribed drugs.
One W5 participant noted Health Canada had “backed down” from enforcing the many extra powers the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) gave it. The Food and Drugs Act and Vanessa’s Law are part of criminal law in Canada. And Health Canada does not uphold it? The main message from the participants was – do not trust Health Canada to protect you from unsafe drugs. How have we arrived at such a dark place?
Here’s how. In 1996 the top medical regulator from Health Canada, Dr. Michele Brill-Edwards, tried to warn us that not enforcing the law, deregulation and shifts in priorities taking place at the Department were leading to more deaths from unsafe drugs. She sacrificed her career to speak out in the interest of public safety but her message went unheeded. Many knowledgeable others have also tried to warn us:
- The Auditor General - warned us and Parliament a number of times about the deficiencies in the regulatory body – Health Canada- which included funding and staff cuts among many others.
- Researchers - starting in 2000 with Wiktorowicz’s work , Shifting priorities at the Health Protection Branch: challenges to the regulatory process. Also, there is the work of 16 researchers in the Fall 2013 issue of The Journal of Law, Medicine and Ethics on the topic of Institutional Corruption and the Pharmaceutical Policy. They clarify how certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety and Regulatory oversight of pharmaceutical marketing.
- The Media – alerted us over the years with stories of unsafe drugs.
Almost 25 years later, the media and W5 are warning us again, about needless Canadian deaths from unsafe drugs.
The reasons for this are:
- Health Canada’s failure to uphold the law. This started long before the 2014 Vanessa’s Law which according to some really gave the regulator no new powers it didn’t already have. The problem was not the law but the failure to enforce it – a problem of dysfunctional culture. The only real reform was to increase the penalties to drug companies for non-compliance.
- The “shift in priorities”. With deregulation, came a shift in priorities that undermined the intent of the Food and Drugs Act – “to protect the public from health hazard” - and the role of Health Canada for regulating public safety under the Act. Roles and responsibilities shifted from an approach where Health Canada had comprehensive responsibility for public health protection, to one where responsibilities were now dispersed among government, industry, academia, and consumers themselves. The pharmaceutical industry was now the main client especially after Health Canada introduced fees to review drugs for marketing approval.
- The development of a systemic dependency and the policy of deregulation. All of the above flowed from the development of a systemic dependency that undermined our political and regulatory institutions and diverted them from their purpose and their ability to achieve their purpose – otherwise known as “institutional corruption” or “policy capture”. Political pressures to ensure a thriving economy, create jobs and to secure their sources of political and financial support in industry were part of the picture. This malfunction was evidenced by “regulation” becoming a bad word, cutting “red tape” a governing imperative and “partnerships” with the private sector an objective. The conflict of interest inherent in a regulator being a partner with the regulated was not considered.
Unfortunately authorities did not inform Canadians they were changing the role of Health Canada from guardian of public safety to guardian of the pharmaceutical industry.
To repair this damage, we must
- Reverse deregulation in the context of public health and safety
- Re-regulate appropriately and enforce the regulations
- Provide effective Whistleblower protection
This is a minimum requirement to convince the public that government and Health Canada deserve our trust.
Canadians should not have to fear for their lives from taking medications.
And neither should Canadians ever again have to watch the heartbreaking scene of two still grieving parents feeling compelled to travel across the country to warn us about unsafe medications and untrustworthy governments and regulators as in W5's documentary. If all systems were working as they should, it never would have gotten to this. So not acceptable.