Beyond Disclosure: Developing Law and Policy to Tackle Corporate Influence.

Corporate influence is one of the most pressing issues in public health. It cuts across many of our most intractable problems-from obesity to the opioid epidemic. Companies develop close relationships with public health agencies, research universities, academic medical centers, professional societies, and patient advocacy organizations-often funding medical research and public health interventions intended to address the very challenges these corporations are creating or exacerbating. How we view relationships with industry, including how these relationships are framed in ethical discourse, shapes our legal and policy responses to them. In recent years, fueled in part by the opioid epidemic, the ethical framing of industry relationships has begun to evolve in significant ways. But legal and policy responses have not yet caught up. In this article, I develop a temporal account of corporate influence, and legal and policy responses to corporate influence. This account clarifies the limitations and adverse effects of conflicts of interest disclosure, especially when implemented as the sole legal or policy response. Disclosure can illuminate corporate influence-but policymakers cannot and should not rely on disclosure to eliminate corporate influence or its effects. Nor should we allow disclosure to crowd out structural and systemic responses to corporate influence-including sequestration of and separation from private-sector entities.

Comparing the effectiveness of general dietary advice versus a very low energy diet in an obese outpatient population in Australia.

PURPOSE: Obesity is a major public health burden. Outpatient clinics are an essential resource for individuals with obesity to access advice for weight loss management. The aim of this study was to compare anthropometric and weight loss outcomes between participants receiving general dietary (GD) advice, and those on a very low energy diet (VLED) under non-trial conditions. METHODS: Data from 276 adults with obesity attending a multidisciplinary weight management clinic were analysed. Changes in anthropometry, body composition, and blood pressure (BP) over 12 months were analysed using linear mixed-effects models. RESULTS: Males on the GD demonstrated statistically greater reductions in body weight (BW), BMI, percent fat mass (FM), systolic BP, waist and hip circumference (p < 0.01). Changes in males on a VLED did not reach significance. Females showed statistically significant reductions in BW, BMI, waist and hip circumference regardless of dietary intervention (p < 0.01); those on the GD significantly reduced percent FM (p < 0.001). Females on a VLED had statistically greater reductions in BW, BMI and systolic BP compared to those on the GD. No effect of exercise physiologist was observed in this study. Participants prescribed a GD attended for significantly longer than those on a VLED (p < 0.05), irrespective of gender. At 12 months, 14.3 and 4.5% of males and females on a VLED were still attending, compared to 10.6 and 4.5% on the GD. CONCLUSIONS: In this retrospective study, females in both dietary intervention groups achieved significant changes across multiple measures. Only men receiving GD advice demonstrated significant changes. LEVEL OF EVIDENCE: Level II-2.

Adult-onset Still's disease with prominent polyserositis.

Adult-onset Still's disease is a systemic autoinflammatory disease the presentation of which can often mimic infection. As a consequence, there is often a delay in diagnosis. Serositis is a recognised but less common clinical feature that can result in complications including cardiac tamponade and constrictive pericarditis. We describe a case of adult-onset Still's disease without the hallmark rash or significant arthritis, presenting with polyserositis that showed a good response to initial steroid treatment and sustained remission with anakinra. An elevated procalcitonin level was due to active adult-onset Still's disease, not bacterial infection.

Diabetes Group Visits at the University of South Florida Morsani College of Medicine.

IN BRIEF "Quality Improvement Success Stories" are published by the American Diabetes Association in collaboration with the American College of Physicians, Inc., and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes a successful project from the Division of General Internal Medicine at the University of South Florida Morsani College of Medicine, Tampa, to improve A1C, systolic blood pressure, and weight in patients with type 2 diabetes.

Which will Trump: human rights and professional ethics, or torture redux?

Recent political developments in the United States raise concerns about the potential return of aggressive interrogation strategies, particularly in the event of another large-scale terror attack on the U.S. mainland. This essay reviews various legal, ethical and policy responses to revelations of torture during the Bush administration. It asks whether they improve the prospect that, in future, human rights will trump torture, not vice versa. The essay argues that physicians could help prevent further abuses - especially given their access, social status and expertise - but that insufficient steps have been taken to empower them to do so.

Toward a systemic ethics of public-private partnerships related to food and health.

Public-private partnerships have become widespread in the pursuit of both health-related research and public health interventions--most notably, in recent measures intended to address obesity. Participants emphasize synergies between the missions or goals of the public and private partners. However, the missions usually diverge in significant ways. Consequently, these partnerships can have serious implications for the integrity of, as well as trust and confidence in, the public partners. In this article, I highlight systemic concerns presented by public-private partnerships related to food and health. These include research agenda distortion and framing effects--not least, the characterization of obesity primarily as a question of individual behavior, and the minimization or neglect of the role of food systems and other social and environmental factors on health. Prevailing analytical approaches to public-private partnerships tend to downplay or ignore these systemic effects and their ethical implications. In this article, I offer guidance intended to help actors in the public sector fulfill their mission while thinking more critically and systemically about the ethical implications of public-private partnerships.

The undocumented unwell.

Nell Toussaint is not well. In recent years, she has been diagnosed with uterine fibroids, uncontrolled hypertension, nephrotic syndrome, poorly controlled diabetes, hyperlipidemia, and a pulmonary embolism. She also suffers from decreased mobility, shortness of breath, and-perhaps not surprisingly, given her other ailments-anxiety. Toussaint is an indigent undocumented immigrant living in Canada who has been trying to secure medical coverage in the federal courts. In the process, she has sacrificed the medical confidentiality that most of us ordinarily enjoy. Toussaint first came to Canada from Grenada as a visitor in 1999 and remained after the term of her visa expired. At first, she earned enough to sustain a living, but in 2006, her health began to deteriorate, and she was no longer able to work. Although she has received some medical care since then, it has been sporadic, on an emergency basis, and at great expense. When Toussaint applied for medical health coverage under Canada's Interim Medical Health Program, which covers the cost of emergency medical care for legally admitted indigents, her application was rejected. She challenged the decision in federal court on the grounds that her right to life and security of the person under the Canadian Charter had been violated and that the denial of coverage was discriminatory.

Trust in Crises and Crises of Trust.

During times of crisis, institutions tend to focus on maintaining or restoring public trust, as well as on measures to insulate themselves (and their leadership) from potential legal liability. This is because institutions reflexively turn to lawyers, risk managers, crisis consultants, and public relations firms that focus on what they euphemistically call the "optics." In this essay, I highlight the vital importance of addressing underlying reasons for an institution's loss of public trust-in particular, the loss (or erosion) of its integrity and trustworthiness. Loss of public trust generates one kind of crisis-which I term "opsis." But there is another kind of institutional crisis that so often remains unrecognized. Just as medical sepsis in the human body is a critical condition that endangers life, the loss of an institution's integrity and trustworthiness constitutes a type of sepsis-ethical sepsis-that poses an existential threat to the institution if unaddressed.

Multinational evidence-based recommendations for pain management by pharmacotherapy in inflammatory arthritis: integrating systematic literature research and expert opinion of a broad panel of rheumatologists in the 3e Initiative.

OBJECTIVE: To develop evidence-based recommendations for pain management by pharmacotherapy in patients with inflammatory arthritis (IA). METHODS: A total of 453 rheumatologists from 17 countries participated in the 2010 3e (Evidence, Expertise, Exchange) Initiative. Using a formal voting process, 89 rheumatologists representing all 17 countries selected 10 clinical questions regarding the use of pain medications in IA. Bibliographic fellows undertook a systematic literature review for each question, using MEDLINE, EMBASE, Cochrane CENTRAL and 2008-09 European League Against Rheumatism (EULAR)/ACR abstracts. Relevant studies were retrieved for data extraction and quality assessment. Rheumatologists from each country used this evidence to develop a set of national recommendations. Multinational recommendations were then formulated and assessed for agreement and the potential impact on clinical practice. RESULTS: A total of 49,242 references were identified, from which 167 studies were included in the systematic reviews. One clinical question regarding different comorbidities was divided into two separate reviews, resulting in 11 recommendations in total. Oxford levels of evidence were applied to each recommendation. The recommendations related to the efficacy and safety of various analgesic medications, pain measurement scales and pain management in the pre-conception period, pregnancy and lactation. Finally, an algorithm for the pharmacological management of pain in IA was developed. Twenty per cent of rheumatologists reported that the algorithm would change their practice, and 75% felt the algorithm was in accordance with their current practice. CONCLUSIONS: Eleven evidence-based recommendations on the management of pain by pharmacotherapy in IA were developed. They are supported by a large panel of rheumatologists from 17 countries, thus enhancing their utility in clinical practice.

Why be against Darwin? Creationism, racism, and the roots of anthropology.

In this work, I review recent works in science studies and the history of science of relevance to biological anthropology. I will look at two rhetorical practices in human evolution--overstating our relationship with the apes and privileging ancestry over emergence--and their effects upon how human evolution and human diversity have been understood scientifically. I examine specifically the intellectual conflicts between Rudolf Virchow and Ernst Haeckel in the 19th century and G. G. Simpson and Morris Goodman a century later. This will expose some previously concealed elements of the tangled histories of anthropology, genetics, and evolution-particularly in relation to the general roles of race and heredity in conceptualizing human origins. I argue that scientific racism and unscientific creationism are both threats to the scholarly enterprise, but that scientific racism is worse.

Safety of nonsteroidal antiinflammatory drugs and/or paracetamol in people receiving methotrexate for inflammatory arthritis: a Cochrane systematic review.

OBJECTIVE: To systematically review the literature on the safety of using nonsteroidal antiinflammatory drugs (NSAID) and/or paracetamol in people receiving methotrexate (MTX) for inflammatory arthritis (IA), as an evidence base for generating clinical practice recommendations. METHODS: A systematic literature review was performed using the Cochrane Library, Medline, Embase, and conference proceedings for the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) for 2008-2009. The search aimed to identify studies describing adverse events (AE) with the concurrent use of paracetamol and/or NSAID in people taking MTX for IA. Articles fulfilling our predefined inclusion criteria were systematically reviewed and quality appraised. RESULTS: Seventeen publications out of 8681 identified studies were included in the review, all of which included people with rheumatoid arthritis (RA) using various NSAID; there were no identified studies for other forms of IA or with paracetamol. Of the studies examining concurrent use of MTX and NSAID, there were no reported adverse effects on lung, liver, or renal function, and no increase in MTX withdrawal or in major toxic reactions. However, transient thrombocytopenia was demonstrated in 1 study. Looking at specific NSAID, there were no clinically significant AE with concomitant piroxicam or etodolac, and only mild AE with celecoxib or etoricoxib. Antiinflammatory dose aspirin was demonstrated to have an adverse effect on liver and renal function. CONCLUSION: In the management of RA, concurrent use of NSAID with MTX appears to be safe, provided appropriate monitoring is performed. The use of antiinflammatory doses of aspirin should be avoided.

Pain pharmacotherapy in patients with inflammatory arthritis and concurrent cardiovascular or renal disease: a Cochrane systematic review.

BACKGROUND: Pain in inflammatory arthritis (IA) is common and often multifactorial, and many different pharmacotherapeutic agents are routinely used for pain management. There are concerns that some current pain pharmacotherapies may increase the risk of adverse events in patients with concurrent cardiovascular (CV) or renal disease. METHODS: A systematic literature review was performed searching Medline, Embase, Cochrane Central Register of Controlled Trials, DARE, and Cochrane Database of Systematic Reviews. We also hand-searched conference proceedings for the American College of Rheumatology and the European League Against Rheumatism for 2008-2009. RESULTS: Our search identified 4782 studies, of which 190 were included for detailed review, but none met the inclusion criteria for our review. We identified 1 study of etoricoxib and diclofenac in non-IA populations [osteoarthritis (OA) or mixed OA and rheumatoid arthritis]. In that study, the presence of CV disease increased the likelihood of a further CV event 3-fold. Patients with 2 or more CV risk factors showed a 2-fold increased likelihood of adverse CV events. CONCLUSION: Our review has highlighted a lack of specific evidence to guide clinicians in the management of pain in patients with IA and coexistent CV or renal disease. In the absence of this evidence, we suggest clinicians use nonsteroidal antiinflammatory drugs (NSAID) with caution in patients with preexisting CV disease or ≥ 2 CV risk factors. There is currently no evidence to advise clinicians considering other pain pharmacotherapies in the context of CV comorbidities. Current guidelines regarding the use of NSAID and opioids in moderate to severe renal impairment should also be applied to the IA population.

Safety of non-steroidal anti-inflammatory drugs, including aspirin and paracetamol (acetaminophen) in people receiving methotrexate for inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, other spondyloarthritis).

BACKGROUND: Methotrexate is routinely used in the treatment of inflammatory arthritis. There have been concerns regarding the safety of using concurrent non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin, or paracetamol (acetaminophen), or both, in these people. OBJECTIVES: To systematically appraise and summarise the scientific evidence on the safety of using NSAIDs, including aspirin, or paracetamol, or both, with methotrexate in inflammatory arthritis; and to identify gaps in the current evidence, assess the implications of those gaps and to make recommendations for future research to address these deficiencies. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, second quarter 2010); MEDLINE (from 1950); EMBASE (from 1980); the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effects (DARE). We also handsearched the conference proceedings for the American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) (2008 to 2009) and checked the websites of regulatory agencies for reported adverse events, labels and warnings. SELECTION CRITERIA: Randomised controlled trials and non-randomised studies comparing the safety of methotrexate alone to methotrexate with concurrent NSAIDs, including aspirin, or paracetamol, or both, in people with inflammatory arthritis. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the search results, extracted data and assessed the risk of bias of the included studies. MAIN RESULTS: Seventeen publications out of 8681 identified studies were included in the review, all of which included people with rheumatoid arthritis using various NSAIDs, including aspirin. There were no identified studies for other forms of inflammatory arthritis.For NSAIDs, 13 studies were included that used concurrent NSAIDs, of which nine studies examined unspecified NSAIDs. The mean number of participants was 150.4 (range 19 to 315), mean duration 2182.9 (range 183 to 5490) days, although the study duration was not always clearly defined, and the studies were mainly of low to moderate quality. Two of these studies reported no evidence for increased risk of methotrexate-induced pulmonary disease; one study assessed the effect of concurrent NSAIDs on renal function and found no adverse effect; one study identified no adverse effect on liver function; three studies demonstrated no increase in methotrexate withdrawal; and one study showed no increase in all adverse events, including major toxic reactions. However, transient thrombocytopenia was demonstrated in one study, specifically when NSAIDs were taken on the same week day as methotrexate. This study was a retrospective review that involved small numbers only and was of moderate quality; these finding have not been replicated since.Four studies looked at specific NSAIDs (etodolac, piroxicam, celecoxib and etoricoxib), with a mean number of participants of 25.8 (range 14 to 50) and mean study duration of 16.8 (range 14 to 23) days. These studies were mainly of moderate quality. The studies were primarily pharmacokinetic studies but also reported adverse events as secondary outcomes. There were no clinically significant adverse effects with concomitant piroxicam or etodolac; and only mild adverse events with celecoxib or etoricoxib, such as nausea and vomiting, and headaches.For aspirin, seven studies provided data on adverse events with the use of aspirin and methotrexate. These studies included a mean number of participants of 100 (range 11 to 232), had a mean duration of 1325 (range 8 to 2928) days and were mainly of low to moderate quality. Two of the studies reported no evidence for increased risk of methotrexate-induced pulmonary disease and two studies showed no increase in all adverse events including major toxic reactions; however, none of these studies specified the dose of aspirin that was used. One study demonstrated that concurrent aspirin adversely affected liver function at a mean dose of 6.84 tablets of aspirin per day, which is a possible daily dose of 2.1 g presuming that 300 mg aspirin tablets were given. A further study described a partially reversible decline in renal function with 2 g daily of aspirin. One study reported no increase in adverse events with 975 g aspirin daily, however the study duration was only one week.For paracetamol, no studies were identified for inclusion. AUTHORS' CONCLUSIONS: In the management of rheumatoid arthritis, the concurrent use of NSAIDs with methotrexate appears to be safe provided appropriate monitoring is performed. The use of anti-inflammatory doses of aspirin should be avoided.