Joel Lexchin

The influence of pharmaceutical company promotion on prescribing and its impacts have been subject to extensive debate. This review helps to clarify whether and how interactions between clinicians and the pharmaceutical industry influence prescribing. Main objective: to assess the effects, using evidence from randomised trials, and the associations, using evidence from non-randomised studies, of pharmaceutical industry promotional interactions with prescribers (including provision of information, payments, gifts, and samples), compared to no interactions, on the appropriateness, quantity, and cost of prescribed medicines, and on formulary requests. We searched CENTRAL, MEDLINE, Embase, one other database, and two trial registers to January 2025. We included randomised trials, non-randomised trials, controlled before-after studies with at least two intervention sites and at least two control sites, interrupted time series studies with a clearly defined intervention time point and at least three data points both before and after the intervention time, and cross-sectional studies comparing exposure levels and outcomes at a single time point. We also included controlled cohort studies comparing outcomes over time, and case-control studies assessing the effects of past exposures. We included cross-sectional, cohort, and case-control studies if the data covered an entire population or a random sample of a defined population, with a response rate of at least 60%. The critical outcomes were prescribing appropriateness, quantity, and cost, and formulary requests by clinicians exposed to interactions with pharmaceutical companies compared to clinicians not exposed or with less exposure. We used Cochrane's RoB 2 tool to assess bias in randomised controlled trials (RCTs), and the Joanna Briggs Institute tool for cross-sectional studies to assess bias in cross-sectional, cohort, and nested case-control studies. We used study design-specific criteria developed by the Cochrane Effective Practice and Organisation of Care (EPOC) Group to assess bias in controlled before-after studies and interrupted time series studies. We grouped studies into four groups based on exposure type - advertising and education; gifts and payments; free samples; and conflict-of-interest policies - to analyse outcomes. We presented the data in harvest plots and narratively summarised the results. Due to heterogeneity, we were unable to conduct any meta-analyses. We used GRADE to assess the certainty of evidence. We included 93 studies. Most studies (82/93, 88%) were conducted in the USA; 11 were conducted in the European Union or the UK. Sixty of 93 studies (65%) were cross-sectional, along with 23 controlled cohort studies, four controlled before-after studies, four interrupted time series, one nested case-control, and one RCT. Sixty-two studies examined payments, gifts, or other transfers of value; 16 examined advertising or educational activities (primarily delivered through pharmaceutical industry sales representative visits); seven examined free drug samples; and eight examined conflict-of-interest policies, such as restrictions on sales representative visits or the acceptance of gifts and samples. Exposure to pharmaceutical company advertising or education may be associated with decreased prescribing appropriateness (6 studies; 1335 prescribers) and increased prescribing costs (2 studies; 986 prescribers), and is probably associated with an increased quantity of prescriptions (7 studies; 151,399 prescribers), compared to no or less exposure. Prescribers' receipt of gifts and payments from pharmaceutical companies is associated with decreased prescribing appropriateness (10 studies; 2,941,948 prescribers), an increased quantity of prescriptions (39 studies; 3,858,871 prescribers), and is probably associated with increased prescribing costs (25 studies; 2,505,292 prescribers), compared to receiving no or fewer gifts and payments. Evidence on associations between receipt of free samples and prescribing appropriateness (1 study; 10 practices), quantity (4 studies; 150,050 prescribers), and costs (4 studies; 2508 prescribers) is very uncertain. Institutional conflict-of-interest policies are probably associated with improved prescribing appropriateness (2 studies; 3065 prescribers), may be associated with a decreased quantity of prescriptions (6 studies; 110,470 prescribers), and have uncertain effects on costs (2 studies; 33,975 participants), compared to no or more lenient conflict-of-interest policies. There was little evidence examining formulary requests (1 study; 105 prescribers). Prescribers' exposure to pharmaceutical industry advertising and education and their receipt of gifts and payments may be associated with increased formulary requests, but the evidence is very uncertain. We rated two outcomes from the one included RCT as having an overall high risk of bias. The principal risk-of-bias concerns for the cross-sectional and cohort studies related to the identification of confounding factors. For controlled before-after studies, the main concerns were baseline comparability and incomplete outcome data. We judged most domains for interrupted time series studies to be at low risk of bias. Overall, we downgraded the certainty of the evidence for risk of bias and imprecision, and upgraded it for dose-response effects and large effect sizes. Overall, we found that promotional interactions clinicians have with pharmaceutical companies are probably associated with harmful outcomes: less appropriate prescribing, greater quantity of medicines prescribed or provided, higher prescribing costs, and a greater likelihood of recommending hospital formulary additions of the company's drugs. Conversely, in most analyses of organisational conflict-of-interest policies restricting the pharmaceutical industry's promotional interactions with clinicians, restrictions are associated with beneficial outcomes on prescribing...

This review provides a comprehensive overview of how to maintain integrity in all aspects of clinical trials, but there are some further issues that the author needs to comment on: * A 2017 Cochrane review by Lundh et al found that clinical trials...

In an attempt to avoid the inequitable outcome of the COVID-19 pandemic whereby High-Income Countries received the overwhelming majority of vaccine doses after they became available, the World Health Organization initiated negotiations in December 2021 on a legally binding Pandemic Agreement. This paper uses a variety of documents and personal experience to examine how the Canadian government communicated with its domestic stakeholders about the stances that Canada was taking during the negotiations and to illustrate what positions Canada was advancing at the negotiations table in Geneva. This article argues that the government lacked transparency in its communications and gave no indication that it was listening to the feedback it was receiving. During the negotiations, aside from advancing a progressive position of gender equality, the government pushed to weaken the obligations of countries and the commercial sector to ensure that vaccines, treatments and technology would be available on an equitable basis globally in any future pandemic. Now that the Pandemic Agreement has been adopted by the World Health Assembly, there is still the task of agreeing on an annex on pathogen access and benefit sharing. Past experience suggests that during these negotiations Canada will favor commercial over public health interests.

Background: Medical societies shape clinical standards, develop practice guidelines, and provide continuing education to physicians. Many receive funding from pharmaceutical and medical device companies, creating conflicts of interest (COI); however, organizational-level COI governance in medical societies remains largely unexamined. We developed what is, to our knowledge, the first comprehensive tool to assess medical society COI policies and applied it to Canadian medical societies. Methods and findings: We identified 68 Canadian medical societies meeting our inclusion criteria and systematically searched the publicly accessible sections of their websites for COI policies. Two researchers independently analyzed policies using our 51-item tool covering nine domains: continuing medical education/continuing professional development (CME/CPD), leadership COI, clinical practice guidelines, industry relationships, research funding, external funding, annual general meetings, staff COI, and society journals. Only 33 societies (48.5%) had any publicly available COI policy, and those with policies addressed an average of only 1.85 domains (20.5% of possible domain coverage). The most frequently addressed domain was CME/CPD (22 societies, 32.4%), followed by leadership COI (12 societies, 17.6%). Within domains where policies existed, societies covered an average of only 32.5% of relevant items. The most common policy item was speakers’ declaration of COI in CME/CPD activities (16 societies, 23.5%). Policies addressing research funding, external funding, annual meetings, and staff COI were rare (1.5–5.9% of societies). Where present, policies were generally restrictive but narrow in scope. Conclusions: Most Canadian medical societies lack comprehensive COI governance, and existing policies are fragmented and reactive. More transparent, comprehensive, and enforceable frameworks are needed to protect institutional independence and public trust. The assessment tool may be adaptable for use in other jurisdictions to support international standardization and best-practice development.

Objectives: This study looks at the number of cancellations by companies and refusals by Health Canada of new drug applications from 1 June 2019 to 1 July 2025 and the amount of information given for the decisions taken. Design: Cross-sectional. Setting: Canada. Participants: New drug applications. Main outcome measures: Number of applications cancelled or refused and reasons for decisions. Results: There were 270 regulatory decisions of which 33 (12.2%) were either cancelled by the company (30) or refused by Health Canada (3). In 10 of the 30 cases where the submission was cancelled, there was no information about the reason for the company's decision. In the remaining 20 cases, the website just said that a decision had been made by the company. Two of the three refusals by Health Canada were because of concerns about safety and efficacy and quality-related issues. The third refusal was due to deficiencies and/or significant omissions in the clinical and non-clinical information. In the 30 submissions cancelled by the company, there was no information about what Health Canada thought in 6 cases. In 16 cases, Health Canada had not completed its evaluation, and in the remaining 8, the evaluation was completed. Conclusion: Over 12% of new drug submissions to Health Canada are either cancelled or refused. Health Canada does not always fully communicate the information that it has regarding the reasons for these decisions and needs to be much more transparent about its decision-making.

As characterised by the Association of the British Pharmaceutical Industry (ABPI), the association representing UK research-based pharmaceutical companies, joint working has a narrower focus than collaborative working.3 Examples of joint working projects appear on the ABPI website,4 and there have been a number of recent evaluations of NHS–industry partnerships.5 6 These arrangements have a long history7–9 but at the same time, concerns over them such as details of the partnerships being kept from the public and having staff supplied by a third party that might gain from the switch have also been previously expressed.10 11

Conflict-of-interest (COI) between doctors and the pharmaceutical industry is widespread and is present in the majority of practitioners. The effects of COI on how doctors prescribe and hence on the health of their patients is negative. This article first summarizes the widespread nature of COI and then examines what forms it takes and how doctors view COI. It next looks at the two ways that have been used to try and limit its influence – managing COI and avoiding COI – and shows that managing COI by limiting gifts to small amounts and relying on declaring COI are based on false assumptions and have little chance of producing any positive results. It then goes on to review the measures that have been shown to be beneficial, particularly policies and legislation restricting or prohibiting certain types of COI among medical students, residents and practicing doctors. Finally, this article looks at how to build upon the successes that have occurred and what more could be done.