Canada's pharmaceutical drug reaction problem exacerbated by COVID-19 products

The legacy of one young woman’s tragic passing continues to impact the nation's response to adverse pharmaceutical drug reactions as the federal regulator becomes increasingly captured by its Big Pharma funders.

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Since the tragic death of 15-year-old Vanessa Young, Canada's approach to drug safety has been reshaped by a law named in her honour, following her father's pledge to ensure her life was not lost in vain after an ordinary prescription turned deadly.

In December 2019, hospitals began mandatory reporting of serious adverse drug reactions under Vanessa’s Law. This led to a significant increase in reported incidents, as reported by Blacklock’s Reporter.

According to the January 2024 Evaluation Of The Pharmaceutical Drugs Program, “Since Vanessa’s Law came into effect, hospitals across the country reported 16,520 serious ADRs [adverse drug reactions] to Health Canada, of which 678 were fatal.”

It furthers that serious adverse drug reaction reporting from hospitals was “minimal until 2019” wherein they increased from 1.3% to 9% in 2020, before decreasing to 6.5% in 2022.

“Since December 2019, reports about pediatric cases ranged between 3% and 21% of all reports submitted by provinces, according to internal program data,” the report reads.

One of the key takeaways from the report is that expectations towards the program are expected to increase in a post-COVID landscape:

[E]xpectations toward the program have increased because of its work to expedite the authorization of COVID-19 vaccines and treatments in Canada, which has added pressure on the Program to deliver its core work in a similar timeframe, in addition to implementing the identified regulatory changes.

The evaluation details that since the mid-1990s, the number of adverse drug reactions reported annually has increased from approximately 4,000 to more than 80,000, and from 1,500 to more than 60,000 for those deemed serious.

Vanessa’s Law, also known as the Protecting Canadians from Unsafe Drugs Act, made the mandatory reporting of both serious adverse drug reactions and medical device incidents.

A serious adverse drug reaction is defined as a “noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening, or results in death.”

A medical device incident (MDI) is defined as “an incident related to a failure of a medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user, or other person, or could do so were it to recur.”

This regulation covers a wide range of products including prescription and non-prescription pharmaceuticals, biologic drugs (excluding routine immunization vaccines), radiopharmaceutical drugs, disinfectants, medical devices, and drugs for urgent public health needs.

This law came about after Vanessa Young died of a heart attack in 2000 from taking the pharmaceutical drug cisapride, under the brand name Propulsid by Johnson & Johnson, as intended for acid reflux.

The drug was pulled from the Canadian market five months after her death.

Her father, then MP Terence Young initiated a “campaign for increased regulation of therapeutic products subsequently led to greater powers for Health Canada to request safety data from hospitals and industry about drugs and medical devices.”

Vanessa’s Law was enacted in 2014 and the mandatory reporting requirements came into effect on December 16, 2019.

While Vanessa Young’s death exposed gaps in Canada’s drug safety regulations, challenges persist today.

The pharmaceutical industry holds great influence over the political class and is responsible for the regulatory capture of Health Canada as its primary funder, remaining a powerful force untouched by legal consequences despite thousands of deaths linked to their products.

Today, Canada ranks among the world’s largest drug markets, with sales increasing by over 35% from 2011 to 2019, reaching nearly $30 billion.

The demand for rigorous oversight grows louder amid the backdrop of rising concerns over patient safety, especially in light of the rushed-to-market novel mRNA injections and other supposed therapeutics seen throughout the COVID era.

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