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result(s) for
"Gagnon, Marc-André"
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Time to improve transparency at Health Canada’s Pest Management Regulatory Agency
by
Gagnon, Marc-André
,
Bacon, Marie-Hélène
in
Access to information
,
Agricultural chemicals industry
,
Business information
2023
Last year, Health Canada's Pest Management Regulatory Agency has been criticized for not releasing information about the safety of pesticides because data are considered confidential business information. This level of secrecy contrasts with Health Canada's efforts to improve transparency related to therapeutic products. Vanessa's Law gives the federal Minister of Health discretionary powers to share confidential business information on therapeutic products when it perceives there is a serious risk to human health or the environment. The Minister of Health should be granted similar discretionary powers to make safety data for pesticides publicly available.
Journal Article
Whose shoulders is health research standing on? Determining the key actors and contents of the prevailing biomedical research agenda
by
Testoni, Federico E.
,
Gagnon, Marc-André
,
Rikap, Cecilia
in
Authorship - standards
,
Bibliometrics
,
Biomedical research
2021
Conflicts of interest in biomedical research can influence research results and drive research agendas away from public health priorities. Previous agenda-setting studies share two shortfalls: they only account for direct connections between academic institutions and firms, as well as potential bias based on researchers' personal beliefs. This paper's goal is to determine the key actors and contents of the prevailing health and biomedical sciences (HBMS) research agenda, overcoming these shortfalls.
We performed a bibliometric and lexical analysis of 95,415 scientific articles published between 1999 and 2018 in the highest impact factor journals within HBMS, using the Web of Science database and the CorText platform. HBMS's prevailing knowledge network of institutions was proxied with network maps where nodes represent affiliations and edges the most frequent co-authorships. The content of the prevailing HBMS research agenda was depicted through network maps of prevalent multi-terms found in titles, keywords, and abstracts.
The HBMS research agendas of large private firms and leading academic institutions are intertwined. The prevailing HBMS agenda is mostly based on molecular biology (40% of the most frequent multi-terms), with an inclination towards cancer and cardiovascular research (15 and 8% of the most frequent multi-terms, respectively). Studies on pathogens and biological vectors related to recent epidemics are marginal (1% of the most frequent multi-terms). Content of the prevailing HBMS research agenda prioritizes research on pharmacological intervention over research on socio-environmental factors influencing disease onset or progression and overlooks, among others, the study of infectious diseases.
Pharmaceutical corporations contribute to set HBMS's prevailing research agenda, which is mainly focused on a few diseases and research topics. A more balanced research agenda, together with epistemological approaches that consider socio-environmental factors associated with disease spreading, could contribute to being better prepared to prevent and treat more diverse pathologies and to improve overall health outcomes.
Journal Article
Prevalence and nature of manufacturer-sponsored patient support programs for prescription drugs in Canada: a cross-sectional study
by
Grundy, Quinn
,
Lexchin, Joel
,
Tadrous, Mina
in
Adalimumab
,
Biological products
,
Corporate sponsorship
2023
Globally, pharmaceutical companies offer patient support programs in tandem with their products, which aim to enhance medication adherence and patient experience through education, training, support and financial assistance. We sought to identify the proportion and characteristics of such patient support programs in Canada and to describe the nature of supports provided.
We conducted a crosssectional study to identify and characterize all marketed prescription drugs available in Canada as of Aug. 23, 2022, using the Health Canada Drug Product and CompuScript databases. To describe the nature of supports provided, we conducted a content analysis of publicly available patient support program websites and Web-based documents. Using logistic regression, we identified characteristics of drugs associated with having a patient support program including brand-name or branded generic (generic medications with a proprietary name), orphan (medications for rare diseases) or biologic drug status; estimated total cost of prescriptions dispensed at retail pharmacies; and price per unit.
Of the 2556 prescription drugs marketed by 89 companies in the study period, 256 (10.0%) had a patient support program in Canada. Many of the 89 drug manufacturers (n = 55, 61.8%) offered at least 1 patient support program, frequently relying on third-party administrators for delivery. Brandname and branded generic medications, biologic agents and drugs with orphan status were more likely to have a patient support program than generic drugs. Compared with drugs priced $1.01–$10.00 per unit, drugs priced $10.01–$100.00 per unit were nearly 8 times more likely to have a patient support program (adjusted odds ratio 7.54, 95% confidence interval 4.07– 14.64). Most sampled patient support programs included reimbursement navigation (n = 231, 90.2%) and clinical case management (n = 223, 87.1%).
About 1 in 10 drugs marketed in Canada has a manufacturersponsored patient support program, but these are concentrated around brand-name, branded generic, biologic and high-cost drugs, often for rare diseases. To understand the impact of patient support programs on health outcomes and sustainable access to cost-effective medicines, greater transparency and independent evaluation of patient support programs is necessary.
Journal Article
The role and impact of cost-sharing mechanisms for prescription drug coverage
2017
Two linked research studies discuss the impact of cost-sharing mechanisms on cost-related nonadherence to drugs by looking at the introduction of income-based deductibles for older adults in British Columbia (BC). Law and colleagues report that income-based deductibles did not significantly affect drug use or physician and hospital resource utilization among older adults, which runs counter to findings from other such studies. The authors conclude that, in some circumstances, income-based deductibles can be used to help finance drug coverage without affecting adherence to treatment. However, Canada has one of the highest rates of cost-related nonadherence, at 10.2%, and BC has one of the highest provincial rates, at 13.3%. It is possible that introducing additional deductibles in a region with an already high rate of cost-related nonadherence would make it more difficult to show statistical significance. In the other linked study, Morgan and colleagues used a more stratified analysis by focusing on health status and specific diseases.
Journal Article
Analyzing the impact of trade and investment agreements on pharmaceutical policy: provisions, pathways and potential impacts
2019
Background
Trade and investment agreements negotiated after the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which other provisions in trade agreements can affect pharmaceutical policy and, in turn, access to medicines have been little studied. There is a need for an analytical framework covering the full range of provisions, pathways, and potential impacts, on which to base future health and human rights impact assessment and research. A framework exploring the ways in which trade and investment agreements may affect pharmaceutical policy was developed, based on an analysis of four recently negotiated regional trade agreements. First a set of core pharmaceutical policy objectives based on international consensus was identified. A systematic comparative analysis of the publicly available legal texts of the four agreements was undertaken, and the potential impacts of the provisions in these agreements on the core pharmaceutical policy objectives were traced through an analysis of possible pathways.
Results
An analytical framework is presented, linking ten types of provisions in the four trade agreements to potential impacts on four core pharmaceutical policy objectives (access and affordability; safety, efficacy, and quality; rational use of medicines; and local production capacity and health security) via various pathways.
Conclusions
The analytical framework highlights provisions in trade and investment agreements that need to be examined, pathways that should be explored, and potential impacts that should be taken into consideration with respect to pharmaceutical policy. This may serve as a useful checklist or template for health and human rights impact assessments and research on the implications of trade agreements for pharmaceuticals.
Journal Article
What did the scientific literature learn from internal company documents in the pharmaceutical industry? A scoping review
2023
Objective To identify all scientific papers that used internal industry documents in the pharmaceutical sector and analyze what and how the scientific literature learned about corporate influence in the pharmaceutical sector through these internal documents. Design Scoping review. Methods Using different series of keywords, we searched six databases, PubMed, Scopus, Web of Science, CINAHL, Business Source Complete, and PAIS, for peer‐reviewed journal articles analyzing pharmaceutical corporations' internal documents. We completed the scoping review using a purposive snowball sampling method to extract relevant case studies and peer‐reviewed journal articles from relevant articles' reference lists when our search keywords failed to capture them. To analyze the content of the literature and better categorize the types of corporate strategies at play in the pharmaceutical sector, we used categories of ghost‐management previously developed in the literature. Results We identified 37 peer‐reviewed papers in the final results. All the articles included in the final results are published in English. Almost all articles obtained most of their internal document data through legal proceedings. All 37 articles unveil dynamic ghost‐management strategies that pharmaceutical corporations employ to safeguard their corporate interest. The strategies identified relate to scientific capture (n = 28), professional capture (n = 16), regulatory capture (n = 6), media capture (n = 3), market capture (n = 4), technological capture (n = 2), civil society capture (n = 4), and others (n = 2). Conclusion The scientific literature using internal documents confirmed widespread corporate influence in the pharmaceutical sector. While the academic literature used internal documents related to only a handful of products, our research results, based on ghost‐management categories, demonstrate the extent of corporate influence in every interstice of pharmaceutical markets, particularly in clinical research and clinical practice. It also allows us to better refine the conceptual categories of ghost‐management to better map corporate influence and conflict of interest.
Journal Article
Validation of Plasma Free Hemoglobin Testing for Extracorporeal Membrane Oxygenation (ECMO) Patients
2026
Abstract
Background
Circuit-induced hemolysis is relatively common in extracorporeal membrane oxygenation (ECMO) patients. Intravascular release of cell-free hemoglobin can lead to complications and requires timely recognition. Validation of plasma free hemoglobin (PFH) measurement using a direct spectrophotometric method is presented.
Methodology
We evaluated a method modified from Kahn et al. (Ann Clin Lab Sci 1981;11:126–31) on a stand-alone spectrophotometer (Cary 60) and compared its performance to the semiquantitative H-index on an Abbott Alinity c, including precision, linearity, recovery, reference interval verification, interference, and stability. Method comparison was performed relative to the H-index and the same method on a different spectrophotometer (Beckman DU 720). Lipemia interference was performed on the Cary 60, Cary 3500, and Beckman DU 720. Surrogate biomarkers for hemolysis detection were also investigated in ECMO patients.
Results
The PFH method on the Cary 60 demonstrated imprecision ranging from 1% (96.0 mg/dL) to 4% (3.0 mg/dL), linearity to 100 mg/dL, and recovery >80% for values >2 mg/dL hemoglobin-spiked plasma. Dilution expanded the reportable range to the maximum dilution tested (1000 mg/dL). Lipemia interfered with PFH measurement by the direct method, but the same method on the Cary 3500 was resistant to lipemia. Bilirubin did not cause significant interference. Direct and H-index methods were comparable with a mean difference of 5.03 mg/dL (95% CI −1.38, 11.44). Lactate dehydrogenase was the most reliable surrogate biomarker for hemolysis. with AUC of 0.921 (0.894, 0.949) at >50 mg/dL.
Conclusion
PFH measurement by a direct spectrophotometric method is more precise and sensitive compared to the H-index; however, PFH measurement is susceptible to lipemia unless performed on a high-end spectrophotometer.
Journal Article