Philip Morris involvement in the development of an air quality laboratory in El Salvador

BackgroundThe tobacco industry has organised research institutions to generate misleading data on indoor air quality, including second-hand smoke exposure and health effects.ObjectivesTo describe tobacco industry involvement in the organisation and financial support of an air quality research laboratory in El Salvador.MethodsTobacco industry documents on the internet were systematically searched from August 2007 to February 2008 for air quality studies undertaken in El Salvador, and laboratory personnel were interviewed.ResultsPhilip Morris sought to establish a network of air quality laboratories throughout Latin America. In El Salvador, in 1997, through Tabacalera de El Salvador (a subsidiary of Philip Morris) and the Salvadoran Foundation for Economic Development (FUSADES), the industry organised an air quality research laboratory. FUSADES was part of the industry's Latin American Scientific Network, which consisted of doctors hired as consultants who would send air samples from their research to FUSADES. Philip Morris Scientific Affairs personnel hired LabStat, a Canadian-based laboratory, to provide technical assistance to FUSADES (train and assist the laboratory in air quality measurements). In addition, the Washington-based HMS Group successfully implemented a plan to upgrade the laboratory and obtain international certifications. HMS Group also assisted in searching for sustainable funding for FUSADES, including seeking funds from international aid for Hurricane Mitch.ConclusionAir quality studies that have used the FUSADES laboratory should be carefully interpreted, given the support that this laboratory received from Philip Morris

Global access to affordable direct oral anticoagulants

Poor control of cardiovascular disease accounts for a substantial proportion of the disease burden in developing countries, but often essential anticoagulant medicines for preventing strokes and embolisms are not widely available. In 2019, direct oral anticoagulants were added to the World Health Organization's WHO Model list of essential medicines. The aims of this paper are to summarize the benefits of direct oral anticoagulants for patients with cardiovascular disease and to discuss ways of increasing their usage internationally. Although the cost of direct oral anticoagulants has provoked debate, the affordability of introducing these drugs into clinical practice could be increased by: price negotiation; pooled procurement; competitive tendering; the use of patent pools; and expanded use of generics. In 2017, only 14 of 137 countries that had adopted national essential medicines lists included a direct oral anticoagulant on their lists. This number could increase rapidly if problems with availability and affordability can be tackled. Once the types of patient likely to benefit from direct oral anticoagulants have been clearly defined in clinical practice guidelines, coverage can be more accurately determined and associated costs can be better managed. Government action is required to ensure that direct oral anticoagulants are covered by national budgets because the absence of reimbursement remains an impediment to achieving universal coverage. Tackling cardiovascular disease with the aid of direct oral anticoagulants is an essential component of efforts to achieve the World Health Organization's target of reducing premature deaths due to noncommunicable disease by 25% by 2025

The Tobacco Industry’s Role in the 16 Cities Study of Secondhand Tobacco Smoke: Do the Data Support the Stated Conclusions?

BACKGROUND: Since 1996, the tobacco industry has used the 16 Cities Study conclusions that workplace secondhand tobacco smoke (SHS) exposures are lower than home exposures to argue that workplace and other smoking restrictions are unnecessary. OBJECTIVES: Our goal was to determine the origins and objectives of the 16 Cities Study through analysis of internal tobacco industry documents and regulatory agency and court records, and to evaluate the validity of the study’s conclusions. RESULTS: The tobacco industry’s purpose in conducting the 16 Cities Study was to develop data showing that workplace SHS exposures were negligible, using these data to stop smoking restrictions by the U.S. Occupational Safety and Health Administration. The extensive involvement of R.J. Reynolds Tobacco Company and the tobacco industry’s Center for Indoor Air Research in controlling the study was not fully disclosed. The study’s definition of “smoking workplace” included workplaces where smoking was restricted to designated areas or where no smoking was observed. This definition substantially reduced the study’s reported average SHS concentrations in “smoking workplaces” because SHS levels in unrestricted smoking workplaces are much greater than in workplaces with designated smoking areas or where no smoking occurred. Stratifying the data by home smoking status and comparing exposures by workplace smoking status, however, indicates that smoke-free workplaces would halve the total SHS exposure of those living with smokers and virtually eliminate SHS exposure for most others. CONCLUSIONS: Data in the 16 Cities Study reveal that smoke-free workplaces would dramatically reduce total SHS exposure, providing significant worker and public health benefits

Mandatory Disclosure of Pharmaceutical Industry-Funded Events for Health Professionals

David Henry and colleagues examine compliance with new disclosure requirements of Medicines Australia, the pharmaceutical industry representative body, and argue that they fall short and instead more comprehensive reporting standards are needed

Compromise or Capitulation? US Food and Drug Administration Jurisdiction Over Tobacco Products

Stanton Glantz and colleagues critique the recent policy decision in the United States to grant the FDA regulatory authority over tobacco products, a decision that has broad but not unanimous support among health care professionals

Ensuring the quality and specificity of preregistrations

Researchers face many, often seemingly arbitrary, choices in formulating hypotheses, designing protocols, collecting data, analyzing data, and reporting results. Opportunistic use of “researcher degrees of freedom” aimed at obtaining statistical significance increases the likelihood of obtaining and publishing false-positive results and overestimated effect sizes. Preregistration is a mechanism for reducing such degrees of freedom by specifying designs and analysis plans before observing the research outcomes. The effectiveness of preregistration may depend, in part, on whether the process facilitates sufficiently specific articulation of such plans. In this preregistered study, we compared 2 formats of preregistration available on the OSF: Standard Pre-Data Collection Registration and Prereg Challenge Registration (now called “OSF Preregistration,” http://osf.io/prereg/). The Prereg Challenge format was a “structured” workflow with detailed instructions and an independent review to confirm completeness; the “Standard” format was “unstructured” with minimal direct guidance to give researchers flexibility for what to prespecify. Results of comparing random samples of 53 preregistrations from each format indicate that the “structured” format restricted the opportunistic use of researcher degrees of freedom better (Cliff’s Delta = 0.49) than the “unstructured” format, but neither eliminated all researcher degrees of freedom. We also observed very low concordance among coders about the number of hypotheses (14%), indicating that they are often not clearly stated. We conclude that effective preregistration is challenging, and registration formats that provide effective guidance may improve the quality of research

Looking inside the black box : a theory-based process evaluation alongside a randomised controlled trial of printed educational materials (the Ontario printed educational message, OPEM) to improve referral and prescribing practices in primary care in Ontario, Canada

Background: Randomised controlled trials of implementation strategies tell us whether (or not) an intervention results in changes in professional behaviour but little about the causal mechanisms that produce any change. Theory-based process evaluations collect data on theoretical constructs alongside randomised trials to explore possible causal mechanisms and effect modifiers. This is similar to measuring intermediate endpoints in clinical trials to further understand the biological basis of any observed effects (for example, measuring lipid profiles alongside trials of lipid lowering drugs where the primary endpoint could be reduction in vascular related deaths). This study protocol describes a theory-based process evaluation alongside the Ontario Printed Educational Message (OPEM) trial. We hypothesize that the OPEM interventions are most likely to operate through changes in physicians' behavioural intentions due to improved attitudes or subjective norms with little or no change in perceived behavioural control. We will test this hypothesis using a well-validated social cognition model, the theory of planned behaviour (TPB) that incorporates these constructs. Methods/design: We will develop theory-based surveys using standard methods based upon the TPB for the second and third replications, and survey a subsample of Ontario family physicians from each arm of the trial two months before and six months after the dissemination of the index edition of informed, the evidence based newsletter used for the interventions. In the third replication, our study will converge with the "TRY-ME" protocol (a second study conducted alongside the OPEM trial), in which the content of educational messages was constructed using both standard methods and methods informed by psychological theory. We will modify Dillman's total design method to maximise response rates. Preliminary analyses will initially assess the internal reliability of the measures and use regression to explore the relationships between predictor and dependent variable (intention to advise diabetic patients to have annual retinopathy screening and to prescribe thiazide diuretics for first line treatment of uncomplicated hypertension). We will then compare groups using methods appropriate for comparing independent samples to determine whether there have been changes in the predicted constructs (attitudes, subjective norms, or intentions) across the study groups as hypothesised, and will assess the convergence between the process evaluation results and the main trial results.The OPEM trial and OPEM process evaluation are funded by the Canadian Institute of Health Research (CIHR). The OPEM process evaluation study was developed as part of the CIHR funded interdisciplinary capacity enhancement team KT-ICEBeRG. Gaston Godin, Jeremy Grimshaw and France Légaré hold Canada Research Chairs. Louise Lemyre holds an R.S. McLaughlin Research Chair