Occupational exposure and liver cancer in women: results of the Multicentre International Liver Tumour Study (MILTS)

The association of occupational variables and hepatocellular cancer (HCC) is discussed with particular reference to women, as little research has been undertaken on their behalf. This paper reports the results of an international case-control study concerning women and involves 317 cases of HCC and 1789 controls. Working in the chemical industry was shown to have only a marginally significant risk associated with HCC: adjusted odds ratio (OR) and 95% confidence interval 2.37 (1.04-5.41). Other non-significantly elevated ORs were observed in the pharmaceutical, plastics, PVC-producing, farming and butchery industries. Little consistency was found among the risk estimates for HCC, based on three different analytical approaches. None of the analyses showed a linear trend of risk with increasing duration of exposure. However, the numbers of exposed cases and controls were small for many of the occupations and therefore the study power and precision were low. We failed to find important and consistent evidence for a relationship between HCC in women and occupational variables. However, even weak evidence of occupational risk warrants careful consideration in future studies.     

Vinyl chloride: a case study of data suppression and misrepresentation

When the U.S. Environmental Protection Agency (EPA) finalized its 2000 update of the toxicological effects of vinyl chloride (VC), it was concerned with two issues: the classification of VC as a carcinogen and the numerical estimate of its potency. In this commentary we describe how the U.S. EPA review of VC toxicology, which was drafted with substantial input from the chemical industry, weakened safeguards on both points. First, the assessment down-plays risks from all cancer sites other than the liver. Second, the estimate of cancer potency was reduced 10-fold from values previously used for environmental decision making, a finding that reduces the cost and extent of pollution reduction and cleanup measures. We suggest that this assessment reflects discredited scientific practices and recommend that the U.S. EPA reverse its trend toward ever-increasing collaborations with the regulated industries when generating scientific reviews and risk assessments.     

Staff report on Medtronic’s influence on INFUSE clinical studies

Abstract

Background:

On June 21, 2011, the US Senate Finance Committee staff initiated an inquiry into whether Medtronic, Inc improperly influenced peer-reviewed studies of Medtronic′s bone-growth product InFuse, also known as bone morphogenetic protein 2 (BMP-2).

Methods:

In response to the June 21, 2011 request by Chairman Baucus and Senator Grassley, Medtronic produced more than 5000 documents pertaining to 13 studies sponsored by Medtronic where there was absolutely no reporting of adverse events associated with InFuse. Committee staff conducted a review of the documents submitted by Medtronic and other materials.

Findings:

Staff found that Medtronic was heavily involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants; that Medtronic paid a total of approximately $210 million to physician authors; and that a Medtronic employee recommended against publishing a complete list of adverse events possibly associated with InFuse; among other findings.

Conclusion:

The Committee′s investigation discovered troubling evidence that Medtronic officials influenced the content of articles in peer-reviewed scientific publications to present InFuse in the best possible light. In order to address the problem of biased research in medical literature, drug and device manufacturers and journal editors need to implement stringent disclosure policies that detail industry funding to physician authors. Medical journals should critically examine past studies that may exhibit industry bias that harms patients and misleads physicians. A company employee involved in the drafting of a scientific article should be listed as an author.     

Tobacco industry efforts at discrediting scientific knowledge of environmental tobacco smoke: a review of internal industry documents

STUDY OBJECTIVE: Using tobacco industry internal documents to investigate the use of tobacco industry consulting scientists to discredit scientific knowledge of environmental tobacco smoke (ETS). DESIGN: Basic and advanced searches were performed on the Philip Morris, Tobacco Institute, R J Reynolds, Brown and Williamson, Lorillard, and the Council for Tobacco Research document web sites, with a concentration on the years 1985-1995. Guildford depository files located on the Canadian Council on Tobacco Control website were also searched. The documents were found in searches undertaken between 1 March and 30 June 2000. MAIN RESULTS: The industry built up networks of scientists sympathetic to its position that ETS is an insignificant health risk. Industry lawyers had a large role in determining what science would be pursued. The industry funded independent organisations to produce research that appeared separate from the industry and would boost its credibility. Industry organised symposiums were used to publish non-peer reviewed research. Unfavourable research conducted or proposed by industry scientists was prevented from becoming public. CONCLUSIONS: Industry documents illustrate a deliberate strategy to use scientific consultants to discredit the science on ETS.     

Engineering behaviour change in an epidemic: the epistemology of NIH‐funded HIV prevention science

Social scientific and public health literature on National Institutes of Health‐funded HIV behavioural prevention science often assumes that this body of work has a strong biomedical epistemological orientation. We explore this assumption by conducting a systematic content analysis of all NIH‐funded HIV behavioural prevention grants for men who have sex with men between 1989 and 2012. We find that while intervention research strongly favours a biomedical orientation, research into the antecedents of HIV risk practices favours a sociological, interpretive and structural orientation. Thus, with respect to NIH‐funded HIV prevention science, there exists a major disjunct in the guiding epistemological orientations of how scientists understand HIV risk, on the one hand, and how they engineer behaviour change in behavioural interventions, on the other. Building on the extant literature, we suggest that the cause of this disjunct is probably attributable not to an NIH‐wide positivist orientation, but to the specific standards of evidence used to adjudicate HIV intervention grant awards, including randomised controlled trials and other quantitative measures of intervention efficacy.     

Air travel and venous thromboembolism

There has recently been increased publicity on the risk of venous thrombosis after long-haul flights. This paper reviews the evidence base related to the association between air travel and venous thromboembolism. The evidence consists only of case reports, clinical case-control studies and observational studies involving the use of intermediate end-points, or expert opinion. Some studies have suggested that there is no clear association, whereas others have indicated a strong relationship. On the whole it appears that there is probably a link between air travel and venous thrombosis. However, the link is likely to be weak, mainly affecting passengers with additional risk factors for venous thromboembolism. The available evidence is not adequate to allow quantification of the risk. There are insufficient scientific data on which to base specific recommendations for prevention, other than that leg exercise should be taken during travel. Further studies are urgently needed in order to identify prospectively the incidence of the condition and those at risk.     

Exposing the "myth" of ABC, "anything but chrysotile": a critique of the Canadian asbestos mining industry and McGill University chrysotile studies

BACKGROUND: Beginning in the 1930s, the Canadian asbestos industry created and advanced the idea that chrysotile asbestos is safer than asbestos of other fiber types. METHODS: We critically evaluate published and unpublished studies funded by the Quebec Asbestos Mining Association (QAMA) and performed by researchers at McGill University. RESULTS: QAMA-funded researchers put forth several myths purporting that Quebec-mined chrysotile was harmless, and contended that the contamination of chrysotile with oils, tremolite, or crocidolite was the source of occupational health risk. In addition, QAMA-funded researchers manipulated data and used unsound sampling and analysis techniques to back up their contention that chrysotile was "essentially innocuous." CONCLUSIONS: These studies were used to promote the marketing and sales of asbestos, and have had a substantial effect on policy and occupational health litigation. Asbestos manufacturing companies and the Canadian government continue to use them to promote the use of asbestos in Europe and in developing countries. Am. J. Ind. Med. 44:540-557, 2003.     

The tobacco industry's worldwide ETS consultants project: European and Asian components

BACKGROUND: The tobacco industry has formed regional environmental tobacco smoke (ETS) consultants programs in order to generate controversy on the issue of secondhand smoke (SHS) in Europe, Asia and Latin America. Only those countries in which the industry foresaw SHS restrictions were included. This paper describes the European and Asian components of the tobacco industry's worldwide ETS consultants program. METHODS: A systematic search was carried out of tobacco industry documents available on the Internet between October 2002 and February 2004. RESULTS: Beginning in 1987, Philip Morris assembled an international ETS consultants program in collaboration with other tobacco companies based on their market shares in different regions of the world. The law firm Covington & Burling contacted and hired consultants with a wide range of expertise, usually affiliated with an academic institution, in order to avoid direct contact with the industry. The objective of the program was to influence policy makers, media and the public by providing, through their consultants, 'accurate' (pro-industry) information concerning smoking regulations in public places and workplaces, indoor air quality and ventilation standards, and scientific claims regarding SHS. Consultants also conducted research related to SHS and organized and attended regional and international symposiums related to SHS without acknowledging industry funding. CONCLUSIONS: Despite evidence that the issue of smoke-free environments was close to emerging within the general public throughout the world in the late 1980s, the tobacco industry used its well-organized network of consultants to avoid SHS regulations in most of the world.     

Policies to promote healthy eating in Europe: a structured review of policies and their effectiveness

This review provides a classification of public policies to promote healthier eating as well as a structured mapping of existing measures in Europe. Complete coverage of alternative policy types was ensured by complementing the review with a selection of major interventions from outside Europe. Under the auspices of the Seventh Framework Programme's Eatwell Project, funded by the European Commission, researchers from five countries reviewed a representative selection of policy actions based on scientific papers, policy documents, grey literature, government websites, other policy reviews, and interviews with policy-makers. This work resulted in a list of 129 policy interventions, 121 of which were in Europe. For each type of policy, a critical review of its effectiveness was conducted, based on the evidence currently available. The results of this review indicate a need exists for a more systematic and accurate evaluation of government-level interventions as well as for a stronger focus on actual behavioral change rather than changes in attitude or intentions alone. The currently available evidence is very heterogeneous across policy types and is often incomplete.     

Specialty differences in the association between health care climate and patient trust

Medical Education 2011: 45 : 905–912 CONTEXT Previous studies have suggested that there is a positive correlation between doctors’ emotional intelligence (EI) and patients’ trust in their attending physicians; however, there is only limited evidence of specialty differences between internists and surgeons for such an association. OBJECTIVES This study examined the association of nursing director assessments of doctors’ EI, outside observer assessments of doctors’ health care climate (HCC) in the examining room and patient‐rated trust in internists and surgeons. Health care climate refers to a key component in communication and reflects the extent to which patients perceive their health care providers as supporting patient autonomy rather than controlling the provision of treatment. METHODS In this observational study, 2702 patients seen by 110 internists and 2642 patients seen by 101 surgeons were surveyed in face‐to‐face interviews by trained nurses in two teaching hospitals in Taiwan. Using hierarchical linear modelling, we examined the association between EI and HCC as well as patient trust in doctors working in the specialties of internal medicine and surgery. RESULTS We found a significantly positive correlation between doctor EI and patient trust for all patients (p < 0.01). In addition, although HCC was positively associated with patient trust for internists (p < 0.01), it was not so for surgeons. CONCLUSIONS We conclude that doctors might benefit from training programmes aimed at improving EI and that differences in patient expectations might be considered when hospitals attempt to evaluate doctors in different specialties.     

Nutritional management of rheumatoid arthritis: a review of the evidence

Rheumatoid arthritis (RA) is a debilitating disease and is associated with increased risk of cardiovascular disease and osteoporosis. Poor nutrient status in RA patients has been reported and some drug therapies, such as nonsteroidal anti‐inflammatory drugs (NSAIDs), prescribed to alleviate RA symptoms, may increase the requirement for some nutrients and reduce their absorption. This paper reviews the scientific evidence for the role of diet and nutrient supplementation in the management of RA, by alleviating symptoms, decreasing progression of the disease or by reducing the reliance on, or combating the side‐effects of, NSAIDs. Supplementation with long‐chain n‐3 polyunsaturated fatty acids (PUFA) consistently demonstrates an improvement in symptoms and a reduction in NSAID usage. Evidence relating to other fatty acids, antioxidants, zinc, iron, folate, other B vitamins, calcium, vitamin D and fluoride are also considered. The present evidence suggests that RA patients should consume a balanced diet rich in long‐chain n‐3 PUFA and antioxidants. More randomized long‐term studies are needed to provide evidence for the benefits of specific nutritional supplementation and to determine optimum intake, particularly for n‐3 PUFA and antioxidants.     

Sugars and obesity: Is it the sugars or the calories?

Sugars containing fructose are emerging as the dominant public health targets for their role in the epidemic of overweight and obesity. This position is largely supported by ecological observations, rodent models of overfeeding and select human trials. Higher level evidence from systematic reviews and meta‐analyses of controlled dietary trials has yet to show convincingly that fructose‐containing sugars behave differently from any other forms of energy (especially refined starch and fat). Prospective cohort studies, which provide the strongest observational evidence, have shown an association between risk of overweight and obesity and fructose‐containing sugars consumed as sugar‐sweetened beverages but not as total sugars or other important sources of added sugars such as cakes, pastries and sweets. Comparative analyses show that high intakes of other highly palatable foods such as refined grains, processed meats, red meats, French fries and potato products, as well as physical inactivity may play an equal or greater role in weight gain and the risk of overweight and obesity. The contributions of these factors are also difficult to disentangle from that of sugar‐sweetened beverages owing to their collinearity with sugar‐sweetened beverages as part of a Western dietary pattern and lifestyle. Attention needs to remain focused on decreasing overconsumption of all foods associated with overweight and obesity. Sugar‐sweetened beverages and foods are certainly an important place to start but should not draw attention away from the issue of overconsumption in general.     

La financiación de la industria alimentaria y la investigación epidemiológica sobre nutrición y salud

The interests of the food industry to fund nutrition and health research are not limited to promoting scientific advances. Recently, several systematic reviews conducted about the effect of sugar-sweetened beverages and health outcomes have shown some biased conclusions in studies that acknowledge industry sponsorship. In this context, the Nutrition Working Group of the Spanish Epidemiology Society presented a scientific session entitled Food industry and epidemiologic research at its annual meeting. In a round table, four experts in nutrition research presented their points of view about whether the food industry should fund nutrition-related research and the related potential conflicts of interest of the food industry. All the experts agreed not only on defending independence in nutritional epidemiology regarding the design, interpretation and conclusion of their studies but also on the crucial need for guaranteed scientific rigor, scientific quality of the results and measures to protect studies against potential biases related to the conflicts of interest of funding by the food industry. Drs Pérez-Farinós and Romaguera believe that the most effective way to prevent conflicts of interest would be not to allow the food industry to fund nutrition research; Drs Marcos and Martínez-González suggested the need to establish mechanisms and strategies to prevent the potential influences of the food industry in selecting researchers or institutional sponsorship and in the analysis and results of the studies, to ensure maximum independence for researchers, as well as their professional ethics.     

Evolving the multiple roles of 'patients' in health-care research: reflections after involvement in a trial of shared decision-making

Objective This paper offers ‘consumer‐led’ reflections by steering group members of a patient‐centred research study involving consumer advocates, patients’ associations and patients, throughout the whole study, from pre‐ to post‐study phases. Original Study Design The study: ‘Shared decision making and risk communication in general practice’ incorporated systematic reviews, psychometric evaluation of outcome measures, and quantitative, qualitative and health economic analyses of a cluster randomized trial of professional skill development, all informed by consumer and patient engagement. Setting and participants The work was produced by a wide collaboration led by researchers from the Department of General Practice, University of Wales College of Medicine, Cardiff, including a consumers’ advisory group and a patients’ association. The study participants were 20 general practitioners from Gwent, their practice staff, and almost 800 patients at these practices. Discussion Consumers and patients contributed to several stages of the research from inception and design, securing of funding, implementation of the protocol, and interpretation and dissemination of the findings. ‘Patient involvement’ research initiatives that include an equally wide variety of ‘user’ participants as ‘health‐professional’ participants, accountable to a ‘Health in Partnership’ funded project, require a user‐led viewpoint to be presented and disseminated. This paper presents reflections on the processes of the research, the interpretations of study findings by the involved parties, and notes how this model is fundamental to effective research in the field of patient‐centred health care if future practice, policy and research are to change.     

Effects of soft drink consumption on nutrition and health: a systematic review and meta-analysis

In a meta-analysis of 88 studies, we examined the association between soft drink consumption and nutrition and health outcomes. We found clear associations of soft drink intake with increased energy intake and body weight. Soft drink intake also was associated with lower intakes of milk, calcium, and other nutrients and with an increased risk of several medical problems (e.g., diabetes). Study design significantly influenced results: larger effect sizes were observed in studies with stronger methods (longitudinal and experimental vs cross-sectional studies). Several other factors also moderated effect sizes (e.g., gender, age, beverage type). Finally, studies funded by the food industry reported significantly smaller effects than did non-industry-funded studies. Recommendations to reduce population soft drink consumption are strongly supported by the available science.     

Selected science: an industry campaign to undermine an OSHA hexavalent chromium standard

While exposure to hexavalent chromium (Cr(VI)) has been associated with increased lung cancer risk for more than 50 years, the chemical is not currently regulated by the U.S. Occupational Safety and Health Administration (OSHA) on the basis of its carcinogenicity. The agency was petitioned in 1993 and sued in 1997 and 2002 to lower the workplace Cr(VI) exposure limit, resulting in a court order to issue a final standard by February 2006. Faced with the threat of stronger regulation, the chromium industry initiated an effort to challenge the scientific evidence supporting a more protective standard. This effort included the use of "product defense" consultants to conduct post hoc analyses of a publicly-funded study to challenge results viewed unfavorably by the industry.     

Outdoor air pollution and lung cancer

In the 1950s evidence of an ongoing epidemic of lung cancer in the United States and Western Europe led researchers to examine the role of outdoor air pollution, which was considered by some to be a likely cause. Although epidemiologic research quickly identified the central role of cigarette smoking in this epidemic, and despite progress in reducing outdoor air pollution in Western industrialized countries, concerns that ambient air pollution is causing lung cancer have persisted to the present day. This concern is based on the fact that known carcinogens continue to be released into outdoor air from industrial sources, power plants, and motor vehicles, and on a body of epidemiologic research that provides some evidence for an association between outdoor air pollution and lung cancer. This article reviews the epidemiologic evidence for this association and discusses the limitations of current studies for estimating the lung cancer risk in the general population. It also identifies research needs and suggests possible approaches to addressing outstanding questions.     

Nasal cancer in the U.S. shoe industry: Does it exist?

Studies in England and Italy have demonstrated a striking association between employment in the shoemaking industry and cancer of the nasal cavities and sinuses. However, three recent, large-scale proportionate mortality studies of U.S. shoeworkers do not show any deaths from these tumors. This paper reviews the methodology of those studies, emphasizing the underlying data and statistical power. In addition, epidemiologic and other considerations important in assessing and interpreting the apparent absence of a nasal cancer risk in the U.S. shoe industry are discussed.     

Secret ties to industry and conflicting interests in cancer research

BACKGROUND: Recently it was reported that a Swedish professor in environmental health has for decades worked as a consultant for Philip Morris without reporting his employment to his academic employer or declaring conflicts of interest in his research. The potential for distorting the epidemiological assessments of hazard and risk through paid consultants, pretending to be independent, is not exclusive to the tobacco industry. METHODS: Documentation is drawn from peer reviewed publications, websites, documents from the Environmental Protection Agency, University reports, Wellcome Library Special Collections and the Washington Post. RESULTS: Some consulting firms employ university researchers for industry work thereby disguising industry links in the income of large departments. If the industry affiliation is concealed by the scientist, biases from conflicting interests in risk assessments cannot be evaluated and dealt with properly. Furthermore, there is reason to suspect that editors and journal staff may suppress publication of scientific results that are adverse to industry owing to internal conflict of interest between editorial integrity and business needs. CONCLUSIONS: Examples of these problems from Sweden, UK, and USA are presented. The shortfalls cited in this article illustrate the need for improved transparency, regulations that will help curb abuses as well as instruments for control and enforcement against abuses.     

Processed Meat Consumption and the Risk of Cancer: A Critical Evaluation of the Constraints of Current Evidence from Epidemiological Studies

Based on a large volume of observational scientific studies and many summary papers, a high consumption of meat and processed meat products has been suggested to have a harmful effect on human health. These results have led guideline panels worldwide to recommend to the general population a reduced consumption of processed meat and meat products, with the overarching aim of lowering disease risk, especially of cancer. We revisited and updated the evidence base, evaluating the methodological quality and the certainty of estimates in the published systematic reviews and meta-analyses that examined the association between processed meat consumption and the risk of cancer at different sites across the body, as well as the overall risk of cancer mortality. We further explored if discrepancies in study designs and risks of bias could explain the heterogeneity observed in meta-analyses. In summary, there are severe methodological limitations to the majority of the previously published systematic reviews and meta-analyses that examined the consumption of processed meat and the risk of cancer. Many lacked the proper assessment of the methodological quality of the primary studies they included, or the literature searches did not fulfill the methodological standards needed in order to be systematic and transparent. The primary studies included in the reviews had a potential risk for the misclassification of exposure, a serious risk of bias due to confounding, a moderate to serious risk of bias due to missing data, and/or a moderate to serious risk of selection of the reported results. All these factors may have potentially led to the overestimation of the risk related to processed meat intake across all cancer outcomes. Thus, with the aim of lowering the risk of cancer, the recommendation to reduce the consumption of processed meat and meat products in the general population seems to be based on evidence that is not methodologically strong.