Archive
The Air That We Breathe: Addressing the Risks of Global Urbanization on Health
The Air That We Breathe: Addressing the Risks of Global Urbanization on Health
Source: PLoS Medicine
More than half of the world’s population now live in cities [1], and while urbanization has the potential to allow greater access to health care for all, huge discrepancies in how resources are allocated within cities result in major inequities in health [2]. Addressing these discrepancies and improving health require accurate assessment. To that point, earlier this month PLOS Medicine published a Policy Forum article by Jason Corburn and Alison Cohen that focused on the urbanizing planet and the need for health equity indicators to guide public health policy in cities and urban areas [2].
The major theme of Corburn and Cohen’s argument is that if societies are to ensure those living in the poorest urban slums have the same right to health as people living on the richest boulevards, health indicators must allow for the identification of where health inequities exist. For example, while indicators in Nairobi measure population access to communal toilet blocks, they give no information as to whether the toilet blocks are hygienic or safe to use and therefore mask inequity within the city. Such indicators, however, would have little value in cities like London or New York, which illustrates the need for context-specific measures.
What Is the Relationship of Medical Humanitarian Organisations with Mining and Other Extractive Industries?
What Is the Relationship of Medical Humanitarian Organisations with Mining and Other Extractive Industries?
Source: PLoS Medicine
Summary Points
- In developing countries, extractive industries (including ore mineral mining and oil extraction) have far reaching consequences on health through environmental pollution, some communicable diseases, violence, destitution, and compromised food security.
- The rapid expansion of extractive industries and the increasing frequency of environmental disasters are bound to engage medical humanitarian organisations in developing novel types of expertise.
- While humanitarian organisations might be called to intervene in areas occupied by the extractive sector, in this Essay I argue that oil and mineral exploitation reveals a fundamental clash of values between humanitarianism, the for-profit sector, and privatised global philanthropy.
Specific medical humanitarian organisations can respond to these challenges in different ways, based on their position between pragmatic or principled approaches, and their willingness to develop new technical capacities.
Challenges for HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men in the United States
Challenges for HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men in the United States
Source: PLoS Medicine
Summary Points
+ Pre-exposure prophylaxis (PrEP) with anti-retroviral (ARV) medications is partially efficacious for preventing HIV infection among men who have sex with men (MSM) and heterosexuals.
As PrEP becomes available and prescribed for use among MSM a better understanding of willingness to use PrEP and avoidance of condom use are needed so that behavioral programs and counseling may be enhanced for maximum benefit.
+ Targeted messaging will be needed about ARV prophylaxis for various at risk populations, but the general message should be that condoms continue to be the most effective way to prevent HIV transmission through sex and that PrEP is an additional biomedical intervention.
+ As new effective biomedical intervention methods, such as PrEP, become available language about “protected” and “unprotected” sex, which used to exclusively mean condom use, will need to adapt.
How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review
How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review
Source: PLoS Medicine
Background
Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings.Methods and Findings
We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys.Conclusions
Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.
PLoS Medicine Series on Big Food
PLoS Medicine Series on Big Food
Source: PLoS Medicine
The PLoS Medicine series on Big Food aims to examine and stimulate debate about the activities and influence of the food industry in global health. We define “Big Food” as the multinational food and beverage industry with huge and concentrated market power. The series adopts a multi-disciplinary approach and includes critical perspectives from around the world. It represents one of first times such issues have been examined in the general medical literature.
The PLoS Medicine Editors begin the series with an editorial discussing the rationale and process of commissioning articles for the series. As they note, industry in health has long fascinated PLoS Medicine but the journal’s focus on Big Food is new. Food, unlike tobacco and drugs, is necessary to live and is central to health and disease. And yet the big multinational food companies control what people everywhere eat, resulting in a stark and sick irony: one billion people on the planet are hungry while two billion are obese or overweight. The guest editors, Marion Nestle and David Stuckler, then lay out a background to the role of Big Food in global health, and offer three competing views of how public health professionals can respond. Subsequent articles include: a comparison of soda companies’ corporate social responsibility campaigns with those of the tobacco industry; an analysis of the rapid rise of Big Food sales in developing countries; an essay on food sovereignty and who holds power over food; views from South America and Africa on the displacement of traditional diets by the incursion of multinational food companies; and a perspective arguing against an uncritical acceptance of the food industry in health.
Comparative Performance of Private and Public Healthcare Systems in Low- and Middle-Income Countries: A Systematic Review
Source: PLoS Medicine
Introduction
Private sector healthcare delivery in low- and middle-income countries is sometimes argued to be more efficient, accountable, and sustainable than public sector delivery. Conversely, the public sector is often regarded as providing more equitable and evidence-based care. We performed a systematic review of research studies investigating the performance of private and public sector delivery in low- and middle-income countries.
Methods and Findings
Peer-reviewed studies including case studies, meta-analyses, reviews, and case-control analyses, as well as reports published by non-governmental organizations and international agencies, were systematically collected through large database searches, filtered through methodological inclusion criteria, and organized into six World Health Organization health system themes: accessibility and responsiveness; quality; outcomes; accountability, transparency, and regulation; fairness and equity; and efficiency. Of 1,178 potentially relevant unique citations, data were obtained from 102 articles describing studies conducted in low- and middle-income countries. Comparative cohort and cross-sectional studies suggested that providers in the private sector more frequently violated medical standards of practice and had poorer patient outcomes, but had greater reported timeliness and hospitality to patients. Reported efficiency tended to be lower in the private than in the public sector, resulting in part from perverse incentives for unnecessary testing and treatment. Public sector services experienced more limited availability of equipment, medications, and trained healthcare workers. When the definition of “private sector” included unlicensed and uncertified providers such as drug shop owners, most patients appeared to access care in the private sector; however, when unlicensed healthcare providers were excluded from the analysis, the majority of people accessed public sector care. “Competitive dynamics” for funding appeared between the two sectors, such that public funds and personnel were redirected to private sector development, followed by reductions in public sector service budgets and staff.
Conclusions
Studies evaluated in this systematic review do not support the claim that the private sector is usually more efficient, accountable, or medically effective than the public sector; however, the public sector appears frequently to lack timeliness and hospitality towards patients.
Improving Access to Mental Health Care and Psychosocial Support within a Fragile Context: A Case Study from Afghanistan
Summary Points+ After the fall of the Taliban, the rebuilding of the Afghan health care system, from scratch, provided opportunities to integrate mental health into basic health services through the use of funds that became available during this complex humanitarian emergency.+ Practice-oriented mental health trainings for general health workers and ongoing clinical supervision in the basic health care system led to substantially increased demand for and access to basic mental health care services.+ Treatment of mental disorders within the health care system needs to be accompanied by a community-based approach that focuses on psychosocial problems.+ Addressing service delivery needs in a fragile state has to be accompanied by capacity building and policy development in order to foster structural changes within the health care system.
Improving Access to Mental Health Care and Psychosocial Support within a Fragile Context: A Case Study from Afghanistan
Summary Points+ After the fall of the Taliban, the rebuilding of the Afghan health care system, from scratch, provided opportunities to integrate mental health into basic health services through the use of funds that became available during this complex humanitarian emergency.+ Practice-oriented mental health trainings for general health workers and ongoing clinical supervision in the basic health care system led to substantially increased demand for and access to basic mental health care services.+ Treatment of mental disorders within the health care system needs to be accompanied by a community-based approach that focuses on psychosocial problems.+ Addressing service delivery needs in a fragile state has to be accompanied by capacity building and policy development in order to foster structural changes within the health care system.
See: Community and health system approaches improves mental health in Afghanistan (EurekAlert!)
Planned Vaginal Birth or Elective Repeat Caesarean: Patient Preference Restricted Cohort with Nested Randomised Trial
BackgroundUncertainty exists about benefits and harms of a planned vaginal birth after caesarean (VBAC) compared with elective repeat caesarean (ERC). We conducted a prospective restricted cohort study consisting of a patient preference cohort study, and a small nested randomised trial to compare benefits and risks of a planned ERC with planned VBAC.Methods and findings2,345 women with one prior caesarean, eligible for VBAC at term, were recruited from 14 Australian maternity hospitals. Women were assigned by patient preference (n = 2,323) or randomisation (n = 22) to planned VBAC (1,225 patient preference, 12 randomised) or planned ERC (1,098 patient preference, ten randomised). The primary outcome was risk of fetal death or death of liveborn infant before discharge or serious infant outcome. Data were analysed for the 2,345 women (100%) and infants enrolled.The risk of fetal death or liveborn infant death prior to discharge or serious infant outcome was significantly lower for infants born in the planned ERC group compared with infants in the planned VBAC group (0.9% versus 2.4%; relative risk [RR] 0.39; 95% CI 0.19–0.80; number needed to treat to benefit 66; 95% CI 40–200). Fewer women in the planned ERC group compared with women in the planned VBAC had a major haemorrhage (blood loss ≥1,500 ml and/or blood transfusion), (0.8% [9/1,108] versus 2.3% [29/1,237]; RR 0.37; 95% CI 0.17–0.80).ConclusionsAmong women with one prior caesarean, planned ERC compared with planned VBAC was associated with a lower risk of fetal and infant death or serious infant outcome. The risk of major maternal haemorrhage was reduced with no increase in maternal or perinatal complications to time of hospital discharge. Women, clinicians, and policy makers can use this information to develop health advice and make decisions about care for women who have had a previous caesarean.
Where There Is No Health Research: What Can Be Done to Fill the Global Gaps in Health Research?
Summary Points+ Efforts to strengthen capacity in health research have, so far, concentrated on countries where there is existing capacity rather than those where it is almost completely lacking.+ Judged by absolute numbers of scientific papers, those with the fewest are mainly small islands and a few countries that are politically isolated.+ Judged by papers per capita, the lowest include countries in the former Soviet Union and Africa, both regions experiencing declines in life expectancy in recent years, and states experiencing conflict.+ Although there is a positive association between economic development and research output, some relatively wealthy countries seriously underperform.+ There are many examples of good practice, including regional networks and international partnerships.+ There is a strong argument for donors to look to the long term and consider how best to build health research capacity where it is virtually absent.
A Comparison of DSM-IV and DSM-5 Panel Members’ Financial Associations with Industry: A Pernicious Problem Persists
Summary Points+ The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).+ The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.+ Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.+ Gaps in APA’s disclosure policy are identified and recommendations for more stringent safeguards are offered.
Is Food Insecurity Associated with HIV Risk? Cross-Sectional Evidence from Sexually Active Women in Brazil
BackgroundUnderstanding how food insecurity among women gives rise to differential patterning in HIV risks is critical for policy and programming in resource-limited settings. This is particularly the case in Brazil, which has undergone successive changes in the gender and socio-geographic composition of its complex epidemic over the past three decades. We used data from a national survey of Brazilian women to estimate the relationship between food insecurity and HIV risk.Methods and FindingsWe used data on 12,684 sexually active women from a national survey conducted in Brazil in 2006–2007. Self-reported outcomes were (a) consistent condom use, defined as using a condom at each occasion of sexual intercourse in the previous 12 mo; (b) recent condom use, less stringently defined as using a condom with the most recent sexual partner; and (c) itchy vaginal discharge in the previous 30 d, possibly indicating presence of a sexually transmitted infection. The primary explanatory variable of interest was food insecurity, measured using the culturally adapted and validated Escala Brasiliera de Segurança Alimentar. In multivariable logistic regression models, severe food insecurity with hunger was associated with a reduced odds of consistent condom use in the past 12 mo (adjusted odds ratio [AOR] = 0.67; 95% CI, 0.48–0.92) and condom use at last sexual intercourse (AOR = 0.75; 95% CI, 0.57–0.98). Self-reported itchy vaginal discharge was associated with all categories of food insecurity (with AORs ranging from 1.46 to 1.94). In absolute terms, the effect sizes were large in magnitude across all outcomes. Underweight and/or lack of control in sexual relations did not appear to mediate the observed associations.ConclusionsSevere food insecurity with hunger was associated with reduced odds of condom use and increased odds of itchy vaginal discharge, which is potentially indicative of sexually transmitted infection, among sexually active women in Brazil. Interventions targeting food insecurity may have beneficial implications for HIV prevention in resource-limited settings.
A Comparison of DSM-IV and DSM-5 Panel Members’ Financial Associations with Industry: A Pernicious Problem Persists
Summary Points
- The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.
- Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.
- Gaps in APA’s disclosure policy are identified and recommendations for more stringent safeguards are offered.
Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database
BackgroundPublication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy.Methods and FindingsFDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant.ConclusionsThe magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs.
Planned Vaginal Birth or Elective Repeat Caesarean: Patient Preference Restricted Cohort with Nested Randomised Trial
Planned Vaginal Birth or Elective Repeat Caesarean: Patient Preference Restricted Cohort with Nested Randomised Trial
Source: PLoS Medicine
Background
Uncertainty exists about benefits and harms of a planned vaginal birth after caesarean (VBAC) compared with elective repeat caesarean (ERC). We conducted a prospective restricted cohort study consisting of a patient preference cohort study, and a small nested randomised trial to compare benefits and risks of a planned ERC with planned VBAC.
Methods and findings
2,345 women with one prior caesarean, eligible for VBAC at term, were recruited from 14 Australian maternity hospitals. Women were assigned by patient preference (n = 2,323) or randomisation (n = 22) to planned VBAC (1,225 patient preference, 12 randomised) or planned ERC (1,098 patient preference, ten randomised). The primary outcome was risk of fetal death or death of liveborn infant before discharge or serious infant outcome. Data were analysed for the 2,345 women (100%) and infants enrolled.
The risk of fetal death or liveborn infant death prior to discharge or serious infant outcome was significantly lower for infants born in the planned ERC group compared with infants in the planned VBAC group (0.9% versus 2.4%; relative risk [RR] 0.39; 95% CI 0.19–0.80; number needed to treat to benefit 66; 95% CI 40–200). Fewer women in the planned ERC group compared with women in the planned VBAC had a major haemorrhage (blood loss ≥1,500 ml and/or blood transfusion), (0.8% [9/1,108] versus 2.3% [29/1,237]; RR 0.37; 95% CI 0.17–0.80).
Conclusions
Among women with one prior caesarean, planned ERC compared with planned VBAC was associated with a lower risk of fetal and infant death or serious infant outcome. The risk of major maternal haemorrhage was reduced with no increase in maternal or perinatal complications to time of hospital discharge. Women, clinicians, and policy makers can use this information to develop health advice and make decisions about care for women who have had a previous caesarean.
Complexity in Non-Pharmacological Caregiving Activities at the End of Life: An International Qualitative Study
BackgroundIn late-stage palliative cancer care, relief of distress and optimized well-being become primary treatment goals. Great strides have been made in improving and researching pharmacological treatments for symptom relief; however, little systematic knowledge exists about the range of non-pharmacological caregiving activities (NPCAs) staff use in the last days of a patient’s life.Methods and FindingsWithin a European Commission Seventh Framework Programme project to optimize research and clinical care in the last days of life for patients with cancer, OPCARE9, we used a free-listing technique to identify the variety of NPCAs performed in the last days of life. Palliative care staff at 16 units in nine countries listed in detail NPCAs they performed over several weeks. In total, 914 statements were analyzed in relation to (a) the character of the statement and (b) the recipient of the NPCA. A substantial portion of NPCAs addressed bodily care and contact with patients and family members, with refraining from bodily care also described as a purposeful caregiving activity. Several forms for communication were described; information and advice was at one end of a continuum, and communicating through nonverbal presence and bodily contact at the other. Rituals surrounding death and dying included not only spiritual/religious issues, but also more subtle existential, legal, and professional rituals. An unexpected and hitherto under-researched area of focus was on creating an aesthetic, safe, and pleasing environment, both at home and in institutional care settings.ConclusionsBased on these data, we argue that palliative care in the last days of life is multifaceted, with physical, psychological, social, spiritual, and existential care interwoven in caregiving activities. Providing for fundamental human needs close to death appears complex and sophisticated; it is necessary to better distinguish nuances in such caregiving to acknowledge, respect, and further develop end-of-life care.
Challenging Medical Ghostwriting in US Courts
Summary Points
+ Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.+ In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.+ For example, when an injured patient’s physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.+ In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.+ Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.+ Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.
Rotating Night Shift Work and Risk of Type 2 Diabetes: Two Prospective Cohort Studies in Women
These findings show that in these women, there is a positive association between rotating night shift work and the risk of developing type 2 diabetes. Furthermore, long duration of shift work may also be associated with greater weight gain. Although these findings need to be confirmed in men and other ethnic groups, because a large proportion of the working population is involved in some kind of permanent night and rotating night shift work, these findings are of potential public health significance. Additional preventative strategies in rotating night shift workers should therefore be considered.
The Toxic Effects of Cigarette Additives. Philip Morris’ Project Mix Reconsidered: An Analysis of Documents Released through Litigation
Background
In 2009, the promulgation of US Food and Drug Administration (FDA) tobacco regulation focused attention on cigarette flavor additives. The tobacco industry had prepared for this eventuality by initiating a research program focusing on additive toxicity. The objective of this study was to analyze Philip Morris’ Project MIX as a case study of tobacco industry scientific research being positioned strategically to prevent anticipated tobacco control regulations.
Methods and Findings
We analyzed previously secret tobacco industry documents to identify internal strategies for research on cigarette additives and reanalyzed tobacco industry peer-reviewed published results of this research. We focused on the key group of studies conducted by Phillip Morris in a coordinated effort known as “Project MIX.” Documents showed that Project MIX subsumed the study of various combinations of 333 cigarette additives. In addition to multiple internal reports, this work also led to four peer-reviewed publications (published in 2001). These papers concluded that there was no evidence of substantial toxicity attributable to the cigarette additives studied. Internal documents revealed post hoc changes in analytical protocols after initial statistical findings indicated an additive-associated increase in cigarette toxicity as well as increased total particulate matter (TPM) concentrations in additive-modified cigarette smoke. By expressing the data adjusted by TPM concentration, the published papers obscured this underlying toxicity and particulate increase. The animal toxicology results were based on a small number of rats in each experiment, raising the possibility that the failure to detect statistically significant changes in the end points was due to underpowering the experiments rather than lack of a real effect.
Conclusion
The case study of Project MIX shows tobacco industry scientific research on the use of cigarette additives cannot be taken at face value. The results demonstrate that toxins in cigarette smoke increase substantially when additives are put in cigarettes, including the level of TPM. In particular, regulatory authorities, including the FDA and similar agencies elsewhere, could use the Project MIX data to eliminate the use of these 333 additives (including menthol) from cigarettes.
See: New analysis casts doubt on results of tobacco industry studies into safety of cigarette additives (EurekAlert!)
The Role of Group Dynamics in Scientific Inconsistencies: A Case Study of a Research Consortium
The Role of Group Dynamics in Scientific Inconsistencies: A Case Study of a Research Consortium
Source: PLoS Medicine
Summary Points
- Findings reported in published articles often provide an unrealistic picture of the data that are actually generated in scientific research.
- This is partly due to ineffective group dynamics within research groups and collaborations.
- These practices may be improved by having clearly defined overall goals, explicitly described roles and responsibilities for all coauthors, and a rational choice of methodological strategies.
