[Case: bioethical disputes of the donations of the pharmaceutical companies to the health centers]. / Caso: controversias bioéticas de las donaciones de las compañías farmacéuticas a los centros sanitarios.

The interaction between doctors and pharmaceutical companies has been and is common, occurs in multiple ways and has proven, in many cases, to be necessary for the development of medicine. However, some of the sales techniques of the pharmaceutical industry are not ethically acceptable and can compromise the independence of physicians. An ethical dilemma arises from a real case in which the search for vulnerability in prescription based on a donation by a pharmaceutical company was not easy to identify.

The Ban on US Government Funding Research Using Human Fetal Tissues: How Does This Fit with the NIH Mission to Advance Medical Science for the Benefit of the Citizenry?

Some have argued that human fetal tissue research is unnecessary and/or immoral. Recently, the Trump administration has taken the drastic--and we believe misguided--step to effectively ban government-funded research on fetal tissue altogether. In this article, we show that entire lines of research and their clinical outcomes would not have progressed had fetal tissue been unavailable. We argue that this research has been carried out in a manner that is ethical and legal, and that it has provided knowledge that has saved lives, particularly those of pregnant women, their unborn fetuses, and newborns. We believe that those who support a ban on the use of fetal tissue are halting medical progress and therefore endangering the health and lives of many, and for this they should accept responsibility. At the very least, we challenge them to be true to their beliefs: if they wish to short-circuit a scientific process that has led to medical advances, they should pledge to not accept for themselves the health benefits that such advances provide.

Understanding public reactions to commercialization of biobanks and use of biobank resources.

Biobanks will be essential to facilitate the translation of genomic research into real improvements to healthcare. Biobanking is a long-term commitment, requiring public support as well as appropriate regulatory, social and ethical guidelines to realize this promise. There is a growing body of research that explores the necessary conditions to ensure public trust in biomedical research, particularly in the context of biobanking. Trust is, however, a complex relationship. More analysis of public perceptions, attitudes and reactions is required to understand the primary triggers that influence gain and loss of trust. Further, the outcomes of these analyses require detailed consideration to determine how to promote trustworthy institutions and practices. This article uses national survey data, combined with the results of a community consultation that took place in Tasmania, Australia in 2013, to analyze the specific issue of public reactions to commercialization of biobanks and their outputs. This research will enhance the ability of biobanks to respond preemptively to public concerns about commercialization by establishing and maintaining governance frameworks that are responsive to those concerns. The results reveal that it is possible to counter the 'natural prejudice' that many people have against commercialization through independent governance of biobank resources and transparency with regard to commercial involvement. Indeed, most participants agreed that they would rather have a biobank with commercial involvement than none at all. This analysis provides nuanced conclusions about public reactions towards commercialization and equips researchers and biobank operators with data on which to base policies and make governance decisions in order to tackle participant concerns respectfully and responsively.

Bias in reporting of randomised clinical trials in oncology.

BACKGROUND: Bias in reporting efficacy and toxicity in clinical trials may impact treatment decisions. Here, we report quality of reporting of efficacy and of toxicity in articles describing randomised controlled trials (RCTs) of cancer therapy and the association between biased reporting and study results, funding and financial relationships of the authors with the sponsor. MATERIALS AND METHODS: We reviewed articles published from July 2010 to December 2012 in six high-impact journals reporting RCTs of systemic treatment for cancer. Bias in reporting of the primary end-point and toxicity were assessed. Associations between biased reporting and study results, funding source and financial ties of the author with the funding source were evaluated using logistic regression. RESULTS: Two hundred articles were identified. Among 107 RCTs where there was no statistically significant difference in the primary end-point between the two arms, 50 (47%) reports used biased reporting in the abstract of the paper to imply benefit of the experimental treatment. Toxicity was not reported in the abstract in 18.5% of the studies and this was associated with a positive primary end-point. Source of funding and financial ties were not associated with biased reporting. CONCLUSIONS: Bias in reporting of efficacy outcomes is common for studies with a negative primary end-point and can lead to off-label misuse of experimental therapies, if they are approved for other indications. Toxicity is under-reported, especially for studies with a positive primary end-point, leading to a biased view of the safety of new treatments.

Failure to discount for conflict of interest when evaluating medical literature: a randomised trial of physicians.

CONTEXT: Physicians are regularly confronted with research that is funded or presented by industry. OBJECTIVE: To assess whether physicians discount for conflicts of interest when weighing evidence for prescribing a new drug. DESIGN AND SETTING: Participants were presented with an abstract from a single clinical trial finding positive results for a fictitious new drug. Physicians were randomly assigned one version of a hypothetical scenario, which varied on conflict of interest: 'presenter conflict', 'researcher conflict' and 'no conflict'. PARTICIPANTS: 515 randomly selected Fellows in the American College of Obstetricians and Gynecologists' Collaborative Ambulatory Research Network; 253 surveys (49%) were returned. MAIN OBJECT MEASURES: The self-reported likelihood that physicians would prescribe the new drug as a first-line therapy. RESULTS: Physicians do not significantly discount for conflicts of interest in their self-reported likelihood of prescribing the new drug after reading the single abstract and scenario. However, when asked explicitly to compare conflict and no conflict, 69% report that they would discount for researcher conflict and 57% report that they would discount for presenter conflict. When asked to guess how favourable the results of this study were towards the new drug, compared with the other trials published so far, their perceptions were not significantly influenced by conflict of interest information. CONCLUSION: While physicians believe that they should discount the value of information from conflicted sources, they did not do so in the absence of a direct comparison between two studies. This brings into question the effectiveness of merely disclosing the funding sources of published studies.

Fairness opinions in health care transactions--cause and effect: the emergence of private equity funds as a driving force in big and small transactions and the resulting increased use of fairness opinions.

The use of fairness opinions has become increasingly common with respect to the sale or merger of any company or division in a private equity funded or sponsored deal. The fairness opinion is often used to demonstrate that the value at which the transaction took place was a fair value to the selling company and thus did not improperly or unfairly leave the common holders with little consideration. This article covers rules and guidelines that should be adhered to in the issuance and review of fairness opinions.

Is globalisation outpacing ethics and social responsibility in occupational health?

INTRODUCTION: The definition of globalisation is varied. However, one certainty is that in a globalised world the borders are porous in many aspects; people movement, goods exchange, knowledge sharing and redistribution of labour. The concept of globalisation, its impact on society, and its direction leads to a two-sided argument. Could this be the effect of globalisation on ethics and social responsibility, as it is perceived? This paper endeavours to further our understanding of the dynamic relationship of globalisation, ethics and social responsibility in occupational health. METHOD: The multidisciplinary activity approach to occupational health was used. The globalisation, ethical and social responsibility relationship of the activities in occupational health was analysed using a schematic map of the direct and indirect influences. RESULTS: The analysis revealed areas that can be clustered to address the interaction between driving forces in occupational health ethics and social responsibility for a healthy workforce. DISCUSSION: Each cluster is discussed highlighting areas of concern. In the discussion proposals are made on how we can modify the way we think in order to avoid repeating mistakes. Suggestion is made of using an innovative method borrowed from other disciplines and adopted for use in occupational health. A partnership approach is proposed and explored on how it will be applied in situations of unequal balance of power.