Transparency too little, too late? Why and how Health Canada should make clinical data and regulatory decision-making open to scrutiny in the face of COVID-19

Edmonds, Sterling; MacGregor, Andrea; Doll, Agnieszka; Vural, İpek Eren; Graham, Janice E.; Fierlbeck, Katherine; Lexchin, Joel; Doshi, Peter; Herder, Matthew

doi:10.1093/jlb/lsaa083

Cited by 6 publications

(5 citation statements)

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“…Closer collaboration with Indigenous organizations would help to avoid misinterpretations and glaring policy omissions (i.e., omitting Métis people in Manitoba from COVID-19 vaccine prioritization). Additionally, health authorities must ensure that vaccine messaging is transparent about the development, testing, and approval processes of pandemic vaccines, targets and reflects communities' lived realities, and clarifies the benefit to individuals and the whole community (Edmonds et al, 2020). Where Wi-Fi/internet access may be limited (especially in northern areas of the province), those without the means to access the survey may not have been able to participate in focus groups.…”

Section: Discussionmentioning

confidence: 99%

“There's a little bit of mistrust”: Red River Métis experiences of the H1N1 and COVID‐19 pandemics

Driedger,

Maier,

Capurro

et al. 2024

Risk Analysis

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We examined the perspectives of the Red River Métis citizens in Manitoba, Canada, during the H1N1 and COVID‐19 pandemics and how they interpreted the communication of government/health authorities’ risk management decisions. For Indigenous populations, pandemic response strategies play out within the context of ongoing colonial relationships with government institutions characterized by significant distrust. A crucial difference between the two pandemics was that the Métis in Manitoba were prioritized for early vaccine access during H1N1 but not for COVID‐19. Data collection involved 17 focus groups with Métis citizens following the H1N1 outbreak and 17 focus groups during the COVID‐19 pandemic. Métis prioritization during H1N1 was met with some apprehension and fear that Indigenous Peoples were vaccine‐safety test subjects before population‐wide distribution occurred. By contrast, as one of Canada's three recognized Indigenous nations, the non‐prioritization of the Métis during COVID‐19 was viewed as an egregious sign of disrespect and indifference. Our research demonstrates that both reactions were situated within claims that the government does not care about the Métis, referencing past and ongoing colonial motivations. Government and health institutions must anticipate this overarching colonial context when making and communicating risk management decisions with Indigenous Peoples. In this vein, government authorities must work toward a praxis of decolonization in these relationships, including, for example, working in partnership with Indigenous nations to engage in collaborative risk mitigation and communication that meets the unique needs of Indigenous populations and limits the potential for less benign—though understandable—interpretations.

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Section: Discussionmentioning

confidence: 99%

“There's a little bit of mistrust”: Red River Métis experiences of the H1N1 and COVID‐19 pandemics

Driedger,

Maier,

Capurro

et al. 2024

Risk Analysis

View full text Add to dashboard Cite

show abstract

“…Given its growing volume and advantages, it is important to increase the awareness of the PRCI portal. At the same time, the value of the portal (in terms of containing evidence from the premarket phase of a drug’s development) may be limited as regulators increasingly rely on postapproval evidence 27. The data contained in the PRCI database will need to be updated and/or connected to other sources of information held by HC as evidence evolves, to ensure data contained are complete and up-to-date when researchers access the data.…”

Section: Key Challengesmentioning

confidence: 99%

How to use the regulatory data from Health Canada for secondary analyses on new drugs, biologics and vaccines

Bai,

Doshi,

Herder

2023

BMJ EBM

Self Cite

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Incorporating clinical data held by national health product regulatory authorities into secondary analyses such as systematic reviews can help combat publication bias and selective outcome reporting, in turn, supporting more evidence-based decisions regarding the prescribing of drugs, biologics and vaccines. Owing to recent changes in Canadian law, Health Canada has begun to make clinical information—whether it has been previously published or not—publicly available through its ‘Public Release of Clinical Information’ (PRCI) online database. We provide guidance about how to access and use regulatory data obtained through the PRCI database for the purpose of conducting drug and biologic secondary analyses.

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“…Building upon existing initiatives, there are steps that Health Canada can take to make its decision-making processes more transparent to enhance trust and public health. 29,30 Second, the weak evidence underlying Health Canada’s decision to approve OxyContin for chronic pain raises questions about the regulator’s close relationship with industry, which may have played a role in precipitating the overdose crisis. 31 There has been a great deal of litigation against Purdue Pharma and other entities involved in the manufacture, sale, and distribution of OxyContin.…”

Section: Gaps In Transparency and A Lack Of Accountability: Continuin...mentioning

confidence: 99%

On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data

2022

Self Cite

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The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of legal and policy attention due to the drug’s central role in the ongoing overdose crisis. However, little is known about the basis for OxyContin’s approval by regulators, such as Health Canada in 1996. Taking advantage of a recently created online database containing information pertaining to the safety and effectiveness of drugs, we conducted a retrospective analysis of Purdue Pharma’s submission to Health Canada, including both published and unpublished clinical trials. None of the trials sponsored by Purdue Pharma sought to meaningfully assess the risks of misuse or addiction associated with OxyContin. The trials were short in duration (maximum length was 24 days) and only assessed safety and efficacy of a 12-h dosing interval. Also, the two trial reports that explicitly mentioned (but did not formally evaluate) the risk of misuse were not published, making it unclear how Health Canada concluded that there was no risk of misuse. In our view, these findings underscore the need for transparency of not only of clinical trial data, but also the regulator’s interpretation of such data, which is currently lacking in Canada. Furthermore, they call into question why Health Canada’s role in precipitating the overdose crisis has not received greater scrutiny, including in the context of recent litigation surrounding OxyContin.

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Transparency too little, too late? Why and how Health Canada should make clinical data and regulatory decision-making open to scrutiny in the face of COVID-19

Cited by 6 publications

References 0 publications

“There's a little bit of mistrust”: Red River Métis experiences of the H1N1 and COVID‐19 pandemics

“There's a little bit of mistrust”: Red River Métis experiences of the H1N1 and COVID‐19 pandemics

How to use the regulatory data from Health Canada for secondary analyses on new drugs, biologics and vaccines

On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data

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