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

Assessment of the methods used to develop vitamin d and calcium recommendations—a systematic review of bone health guidelines

Background: There are numerous guidelines developed for bone health. Yet, it is unclear whether the differences in guideline development methods explain the variability in the recommendations for vitamin D and calcium intake. The objective of this systematic review was to collate and compare recommendations for vitamin D and calcium across bone health guidelines, assess the methods used to form the recommendations, and explore which methodological factors were associated with these guideline recommendations. Methods: We searched MEDLINE, EMBASE, CINAHL, and other databases indexing guidelines to identify records in English between 2009 and 2019. Guidelines or policy statements on bone health or osteoporosis prevention for generally healthy adults aged ≥40 years were eligible for inclusion. Two reviewers independently extracted recommendations on daily vitamin D and calcium intake, supplement use, serum 25 hydroxyvitamin D [25(OH)D] level, and sunlight exposure. They assessed guideline development methods against 25 recommended criteria in the World Health Organization (WHO) handbook for guideline development. Additionally, they identified types of evidence underpinning the recommendations. Results: we included 47 eligible guidelines from 733 records: 74% of the guidelines provided vitamin D (200~600–4000 IU/day) and 70% provided calcium (600–1200 mg/day) recommendations, 96% and 88% recommended vitamin D and calcium supplements, respectively, and 70% recommended a specific 25(OH)D concentration. On average, each guideline met 10 (95% CI: 9–12) of the total of 25 methodological criteria for guideline development recommended by the WHO Handbook. There was uncertainty in the association between the methodological criteria and the proportion of guidelines that provided recommendations on daily vitamin D or calcium. Various types of evidence, including previous bone guidelines, nutrient reference reports, systematic reviews, observational studies, and perspectives/editorials were used to underpin the recommendations. Conclusions: There is considerable variability in vitamin D and calcium recommendations and in guideline development methods in bone health guidelines. Effort is required to strengthen the methodological rigor of guideline development and utilize the best available evidence to underpin nutrition recommendations in evidence-based guidelines on bone health

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