Five years of pharmaceutical industry funding of patient organisations in Sweden: Cross-sectional study of companies, patient organisations and drugs.

BACKGROUND: Many patient organisations collaborate with drug companies, resulting in concerns about commercial agendas influencing patient advocacy. We contribute to an international body of knowledge on patient organisation-industry relations by considering payments reported in the industry's centralised 'collaboration database' in Sweden. We also investigate possible commercial motives behind the funding by assessing its association with drug commercialisation. METHODS: Our primary data source were 1,337 payment reports from 2014-2018. After extraction and coding, we analysed the data descriptively, calculating the number, value and distribution of payments for various units of analysis, e.g. individual companies, diseases and payment goals. The association between drug commercialisation and patient organisation funding was assessed by, first, the concordance between leading companies marketing drugs in specific diseases and their funding of corresponding patient organisations and, second, the correlation between new drugs in broader condition areas and payments to corresponding patient organisations. RESULTS: 46 companies reported paying €6,449.224 (median €2,411; IQR €1,024-4,569) to 77 patient organisations, but ten companies provided 67% of the funding. Small payments dominated, many of which covered costs of events organised by patient organisations. An association existed between drug commercialisation and industry funding. Companies supported patient organisations in diseases linked to their drug portfolios, with the top 3 condition areas in terms of funding-cancer; endocrine, nutritional and metabolic disorders; and infectious and parasitic disorders-accounting for 63% of new drugs and 56% of the funding. CONCLUSION: This study reveals close and widespread ties between patient organisations and drug companies. A relatively few number of companies dominated the funding landscape by supporting patient organisations in disease areas linked to their drug portfolios. This commercially motivated funding may contribute to inequalities in resource and influence between patient organisations. The association between drug commercialisation and industry funding is also worrying because of the therapeutic uncertainty of many new drugs. Our analysis benefited from the existence of a centralised database of payments-which should be adopted by other countries too-but databases should be downloadable in an analysable format to permit efficient and independent analysis.

Pushing partnerships: corporate influence on research and policy via the International Life Sciences Institute.

OBJECTIVE: There are concerns that some non-profit organisations, financed by the food industry, promote industry positions in research and policy materials. Using Freedom of Information (FOI) requests, we test the proposition that the International Life Sciences Institute (ILSI), one prominent non-for profit in international health and nutrition research, promotes industry positions. DESIGN: U.S. Right to Know filed five FOI from 2015 to 2018 covering communications with researchers at four US institutions: Texas A&M, University of Illinois, University of Colorado and North Carolina State University. It received 15 078 pages, which were uploaded to the University of California San Francisco's Industry Documents Library. We searched the Library exploring it thematically for instances of: (1) funding research activity that supports industry interests; (2) publishing and promoting industry-sponsored positions or literature; (3) disseminating favourable material to decision makers and the public and (4) suppressing views that do not support industry. RESULTS: Available emails confirmed that ILSI's funding by corporate entities leads to industry influence over some of ILSI activities. Emails reveal a pattern of activity in which ILSI sought to exploit the credibility of scientists and academics to bolster industry positions and promote industry-devised content in its meetings, journal and other activities. ILSI also actively seeks to marginalise unfavourable positions. CONCLUSIONS: We conclude that undue influence of industry through third-party entities like ILSI requires enhanced management of conflicts of interest by researchers. We call for ILSI to be recognised as a private sector entity rather than an independent scientific non-profit, to allow for more appropriate appraisal of its outputs and those it funds.

Ethical Advocacy Across the Autism Spectrum: Beyond Partial Representation.

Recent debates within the autism advocacy community have raised difficult questions about who can credibly act as a representative of a particular population and what responsibilities that role entails. We attempt to answer these questions by defending a set of evaluative criteria that can be used to assess the legitimacy of advocacy organizations and other nonelectoral representatives. With these criteria in hand, we identify a form of misrepresentation common but not unique to autism advocacy, which we refer to as partial representation. Partial representation occurs when an actor claims to represent a particular group of people but appropriately engages with only a subset of that group. After highlighting symbolic and substantive harms associated with partial representation, we propose several strategies for overcoming it.

What Should Health Care Organizations Do to Reduce Billing Fraud and Abuse?

Whether physicians are being trained or encouraged to commit fraud within corporatized organizational cultures through contractual incentives (or mandates) to optimize billing and process more patients is unknown. What is known is that upcoding and misrepresentation of clinical information (fraud) costs more than $100 billion annually and can result in unnecessary procedures and prescriptions. This article proposes fraud mitigation strategies that combine organizational cultural enhancements and deployment of transparent compliance and risk management systems that rely on front-end data analytics.

Evaluating the transparency of pharmaceutical company disclosure of payments to patient organisations in the UK.

Patient organisations contribute to many areas of pharmaceutical policy. In developing their organisational capacity, many turn to financial support from pharmaceutical companies, which may create conflicts of interests. However, the transparency of the industry's self-regulatory approach to the disclosure of payments to patient organisations has evaded scrutiny. Using company reports disclosing payments to UK patient organisations in 2012-2016, we evaluate the transparency of reporting using indicators derived from industry's European patient organisation Code. We found a large proportion of companies did not have any disclosure reports available despite many having made payments, confirmed by comparing with annual financial accounts of patient organisations registered as charities. Where disclosure reports were available, many payments were not adequately described, resulting in large portions of money being disclosed without clarity as to the payment type and purpose. We found companies were clearer regarding whether payments were financial or benefits-in-kind, but transparency was particularly inadequate as to whether it could be determined if payments were indirect or direct and restricted or unrestricted, and almost no companies mentioned the VAT status of payments. Our findings suggest that the industry's self-regulatory approach to transparency has not been working efficiently. We suggest ways for standardising and increasing the precision of information by pharmaceutical companies and advocate for the introduction of a centralised, and easily accessible national-level payment database.

Institutional Conflicts of Interest in Academic Research.

Financial relationships in academic research can create institutional conflicts of interest (COIs) because the financial interests of the institution or institutional officials may inappropriately influence decision-making. Strategies for dealing with institutional COIs include establishing institutional COI committees that involve the board of trustees in conflict review and management, developing policies that shield institutional decisions from inappropriate influences, and establishing private foundations that are independent of the institution to own stock and intellectual property and to provide capital to start-up companies.

The interactions of Canadian ethics consultants with health care managers and governing boards during times of crisis.

BACKGROUND: Health care organizations can be very complex, and are often the setting for crisis situations. In recent years, Canadian health care organizations have faced large-scale systemic medical errors, a nation-wide generic injectable drug shortage, iatrogenic infectious disease outbreaks, and myriad other crises. These situations often have an ethical component that ethics consultants may be able to address. Organizational leaders such as health care managers and governing boards have responsibilities to oversee and direct the response to crisis situations. This study investigates the nature and degree of involvement of Canadian ethics consultants in such situations. METHODS: This qualitative study used semi-structured interviews with Canadian ethics consultants to investigate the nature of their interactions with upper-level managers and governing board members in health care organizations, particularly in times of organizational crisis. We used a purposive sampling technique to identify and recruit ethics consultants throughout Canada. RESULTS: We found variability in the interactions between ethics consultants and upper-level managers and governing boards. Some ethics consultants we interviewed did not participate in managing organizational crisis situations. Most ethics consultants reported that they had assisted in the management of some crises and that their participation was usually initiated by managers. Some ethics consultants reported the ability to bring issues to the attention of upper-level managers and indirectly to their governing boards. The interactions between managers and ethics consultants were characterized by varying degrees of collegiality. Ethics consultants reported participating in or chairing working groups, participating in incident management teams, and developing decision-making frameworks. CONCLUSIONS: Canadian ethics consultants tend to believe that they have valuable skills to offer in the management of organizational crisis situations. Most of the ethics consultants we interviewed believed that they play an important role in this regard.

As violências institucional e estrutural vivenciadas por moradoras de rua / The institutional violence and structural violence experienced by homeless women / La violencia institucional y estructural experimentado por mujeres sin vivenda

A presença de mulheres moradoras de rua é uma realidade crescente no Brasil e há escassos estudos sobre esse fenômeno, principalmente os que evidenciam os fatores de risco enfrentados pelas mesmas. Este estudo investigou a percepção de moradoras de rua da cidade Porto Alegre, Brasil, sobre a violência que vivenciaram em seus sistemas ecológicos, por meio da Teoria Bioecológica do Desenvolvimento Humano. Trata-se de um estudo qualitativo de cunho exploratório, no qual seis participantes foram entrevistadas. Os dados foram submetidos à análise de conteúdo, e emergiram duas categorias: violência institucional e a violência estrutural. Essas violências estão presentes em todos os contextos ecológicos (micro-, meso-, exo-e macrossistema). Na institucional, evidenciou-se principalmente aquela perpetrada por profissionais vinculados a instituições públicas; e na estrutural, relacionada às diferentes formas de manutenção das desigualdades sociais, culturais, de gênero, etárias e étnicas que produzem a miséria, a fome e as várias formas de submissão e exploração de umas pessoas pelas outras. Conclui-se que a existência de múltiplas formas de violência leva a situações de vulnerabilidade que agravam ainda mais o quadro de miserabilidade a que estão expostas e a qualidade de vida dessas moradoras. Além disso essas violências oprimem sua individualidade, seus desejos e necessidades.

Homeless women population is a growing reality in Brazil and there are few studies on this phenomenon, especially those that show the risk factors faced by them. This study aimed to investigate the homeless women perception in the city of Porto Alegre, Brazil, regarding the violence they experienced in their ecological systems through the Ecological Systems Theory of Human Development. This is a qualitative and exploratory study, in which six women were interviewed. After content analysis, two categories regarding violence emerged: the Institutional Violence and the Structural Violence, that are present in all ecological contexts (micro, meso, exo and macrosystem). In Institutional, the violence mainly evidenced is that perpetrated by professionals linked to public institutions; and structural, related to different forms of maintenance of social, cultural, gender, age and ethnic inequalities, producing misery, hunger, and various forms of submission and exploitation of some people by others. In conclusion, the existence of multiple forms of violence leads to vulnerabilities that further aggravate the misery situation/scenario which they are exposed to and also the quality of life of these residents. Moreover, such violence oppresses their individuality, their wishes and needs.

La presencia de las mujeres sin vivienda es una realidad que crece en Brasil y hay pocos estudios sobre este fenómeno, especialmente aquellos que muestran los factores de riesgo que enfrentan las mujeres. Este estudio investigó la percepción de los residentes de la calle de la ciudad de Porto Alegre, Brasil, en la violencia que se vive en sus sistemas ecológicos a través de la Teoría Bioecológica de Desarrollo Humano. Se trata de un estudio cualitativo de carácter exploratorio, en el que se entrevistó a seis participantes. Los datos fueron sometidos a análisis de contenido, y emergieron dos categorías: violencia institucional y estructural. Este tipo de violencia está presente en todos los contextos ecológicos (micro, meso, exo y macrosistema). En institucional, principalmente evidenciado perpetrado por profesionales vinculados a las instituciones públicas; y estructural, relacionada con diferentes formas de mantenimiento de las desigualdades sociales, culturales, de género, la edad y la miseria que produce étnica, el hambre, y diversas formas de presentación y explotación de algunas personas por otros. De ello se desprende que la existencia de múltiples formas de violencia conduce a vulnerabilidades que agravan aún más el marco dentro del cual la miseria están expuestas y la calidad de vida. Por otra parte, este tipo de violencia oprime a su individualidad, sus deseos y necesidades.

Standardised tobacco packaging: a health policy case study of corporate conflict expansion and adaptation.

OBJECTIVES: To investigate opposition to standardised tobacco packaging in the UK. To increase understanding of how transnational corporations are adapting to changes in their access to policymakers precipitated by Article 5.3 of the Framework Convention on Tobacco Control (FCTC). DESIGN: Case study web-based documentary analysis, using NVivo V.10. Examination of relationships between opponents of standardised packaging and transnational tobacco companies (TTCs) and of the volume, nature, transparency and timing of their activities. SETTING: UK standardised packaging policy debate 2011-2013. PARTICIPANTS: Organisations selected on basis of opposition to, or facilitation thereof, standardised tobacco packaging in the UK; 422 associated documents. RESULTS: Excluding tobacco manufacturing and packaging companies (n=12), 109 organisations were involved in opposing standardised packaging, 82 (75%) of which had a financial relationship with 1 or more TTC. These 82 organisations (43 actively opposing the measure, 39 facilitating opposition) were responsible for 60% of the 404 activities identified, including the majority of public communications and research production. TTCs were directly responsible for 28% of total activities, predominantly direct lobbying, but also financially underwrote third party research, communication, mass recruitment and lobbying. Active organisations rarely reported any financial relationship with TTCs when undertaking opposition activities. CONCLUSIONS: The multifaceted opposition to standardised packaging was primarily undertaken by third parties with financial relationships with major tobacco manufacturers. Low levels of transparency regarding these links created a misleading impression of diverse and widespread opposition. Countries should strengthen implementation of Article 5.3 of the FCTC by systematically requiring conflict of interest declarations from all organisations participating in political or media debates on tobacco control.

Portrayal of sustainability principles in the mission statements and on home pages of the world's largest organizations.

Conservation can be achieved only if sustainability is embraced as core to organizational cultures. To test the extent to which the related concepts of sustainability, conservation, response to climate change, poverty alleviation, and gender equity have been incorporated into organizational culture, we compared mission statements published from 1990 to 2000 with those published in 2014 for 150 organizations, including conservation nongovernmental organizations (NGOs), aid NGOs, government development agencies, resource extraction companies, and retailers (30 in each category). We also analyzed the 2014 home web pages of each organization. Relative to the earlier period, the frequency with which mission statements mentioned poverty alleviation, biodiversity conservation, and a range of sustainable practices increased only slightly by 2014, particularly among resource extractors and retail companies. Few organizations in any sector had embedded either climate change or gender equity into their mission statements. In addition, the proportional intensity with which any of the aspirations were expressed did not change between periods. For current home pages, conservation NGOs, resource extractors, and government agencies were significantly more likely to acknowledge the importance of matters that were not part of their core business, but few aid agencies or retail companies promoted goals beyond alleviation of crises and profit maximization, respectively. Overall, there has been some progress in recognizing poverty alleviation, biodiversity conservation, and sustainable practices, but gender equity and a determination to reduce impacts on climate change are still rarely promoted as central institutional concerns. Sustainability in general, and biodiversity conservation in particular, will not be achieved unless their importance is more widely apparent in core communication products of organizations.

The dynamics of corruptogenic organizations.

Corruptogenic organizational dynamics have been largely ignored in reporting about recent corporate scandals. Using a large group framework, the author identifies factors within an organization that create a breeding ground for unethical or illegal behavior and attract individuals unconsciously looking for ways to damage themselves or others. An organizational culture that promotes questionable attitudes and behaviors along with subgroups that produce powerful corruptive forces can destroy a firm and damage the economy. Enron and the Madoff investment group are identified as corruptogenic organizations put together by founders and a leadership core bent on self-destruction and traumatizing the community-outcomes beyond that which are usually linked to greed. Suggestions are provided to organizational consultants and policy makers as to how to determine the potential for corruption hidden in their midst and to implement countervailing structures and processes.

Common and conflicting interests in the engagements between conservation organizations and corporations.

The conservation community increasingly views the corporate sector as a positive force for conservation. Collaborations between corporations and nongovernmental conservation organizations (NGOs) seek to mitigate the negative effects of corporate activities and augment positive conservation outcomes. I reviewed the establishment of corporate social responsibility (CSR) policies by corporations; the emerging focus on environmental practices and sustainability; and the history of engagement between corporations and nongovernmental organizations. I considered the ethical and reputation vulnerabilities of these collaborations, which depend especially on the financial nature of the relationship and reviewed how CSR approaches have influenced corporate practices. I concluded that whereas CSR practices can act to mitigate negative environmental impact, to date they have had limited positive effect on biodiversity conservation.

Non-financial conflicts of interest in academic grant evaluation: a qualitative study of multiple stakeholders in France.

BACKGROUND: Peer review is the most widely used method for evaluating grant applications in clinical research. Criticisms of peer review include lack of equity, suspicion of biases, and conflicts of interest (CoI). CoIs raise questions of fairness, transparency, and trust in grant allocation. Few observational studies have assessed these issues. We report the results of a qualitative study on reviewers' and applicants' perceptions and experiences of CoIs in reviews of French academic grant applications. METHODOLOGY AND PRINCIPAL FINDINGS: We designed a qualitative study using semi-structured interviews and direct observation. We asked members of assessment panels, external reviewers, and applicants to participate in semi-structured interviews. Two independent researchers conducted in-depth reviews and line-by-line coding of all transcribed interviews, which were also subjected to Tropes® software text analysis, to detect and qualify themes associated with CoIs. Most participants (73/98) spontaneously reported that non-financial CoIs predominated over financial CoIs. Non-financial CoIs mainly involved rivalry among disciplines, cronyism, and geographic and academic biases. However, none of the participants challenged the validity of peer review. Reviewers who felt they might be affected by CoIs said they reacted in a variety of ways: routine refusal to review, routine attempt to conduct an impartial review, or decision on a case-by-case basis. Multiple means of managing non-financial CoIs were suggested, including increased transparency throughout the review process, with public disclosure of non-financial CoIs, and careful selection of independent reviewers, including foreign experts and methodologists. CONCLUSIONS: Our study underscores the importance of considering non-financial CoIs when reviewing research grant applications, in addition to financial CoIs. Specific measures are needed to prevent a negative impact of non-financial CoIs on the fairness of resource allocation. Whether and how public disclosure of non-financial CoIs should be accomplished remains debatable.

AIDS NGOS and corruption in Nigeria.

Using two ethnographic case studies, the intersecting dynamics of inequality, morality, and corruption are examined as they play out in Nigerian AIDS NGOs. To the Nigerian public, local AIDS organizations are widely seen as conduits for corruption. But local opinions of particular NGOs and their leaders turn less on whether donor resources were misused and more on the ways that people who accumulate the benefits of corruption use them socially. Nevertheless, discontent swirls about corruption in general, a fact that suggests a gradual change in people's understandings of the processes that produce inequality in Nigeria.

[Ethics and esthetics in international cooperation]. / Ética y estética en la Cooperación Internacional.

Although more optimistic, the new report by the World Health Organization (WHO) continues to cast horrifying statistics on inequalities, not only in life expectancy but in many areas. Many Non-Governmental Organisations (NGOs) related to medicine seek to address this imbalance. To cooperate does not in any way appeal to the call of sentimentality. Cooperation moves money and is accountable. It requires a strong background in both professional and human values. It requires research on vaccines and diseases foreign to our society. To cooperate means "operate with" local counterparts, according to their needs and global health project. And finally, cooperation implies the demand for change in certain aspects of the global economic order. We reflect on these questions and describe the different ethical frameworks for the population and NGOs.

Health advocacy organizations and the pharmaceutical industry: an analysis of disclosure practices.

Health advocacy organizations (HAOs) are influential stakeholders in health policy. Although their advocacy tends to closely correspond with the pharmaceutical industry's marketing aims, the financial relationships between HAOs and the pharmaceutical industry have rarely been analyzed. We used Eli Lilly and Company's grant registry to examine its grant-giving policies. We also examined HAO Web sites to determine their grant-disclosure patterns. Only 25% of HAOs that received Lilly grants acknowledged Lilly's contributions on their Web sites, and only 10% acknowledged Lilly as a grant event sponsor. No HAO disclosed the exact amount of a Lilly grant. As highly trusted organizations, HAOs should disclose all corporate grants, including the purpose and the amount. Absent this disclosure, legislators, regulators, and the public cannot evaluate possible conflicts of interest or biases in HAO advocacy.

Are drug companies living up to their human rights responsibilities? The Merck perspective.

BACKGROUND TO THE DEBATE: The human rights responsibilities of drug companies have been considered for years by nongovernmental organizations, but were most sharply defined in a report by the UN Special Rapporteur on the right to health, submitted to the United Nations General Assembly in August 2008. The "Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines" include responsibilities for transparency, management, monitoring and accountability, pricing, and ethical marketing, and against lobbying for more protection in intellectual property laws, applying for patents for trivial modifications of existing medicines, inappropriate drug promotion, and excessive pricing. Two years after the release of the Guidelines, the PLoS Medicine Debate asks whether drug companies are living up to their human rights responsibilities. Sofia Gruskin and Zyde Raad from the Harvard School of Public Health say more assessment is needed of such responsibilities; Geralyn Ritter, Vice President of Global Public Policy and Corporate Responsibility at Merck & Co. argues that multiple stakeholders could do more to help States deliver the right to health; and Paul Hunt and Rajat Khosla introduce Mr. Hunt's work as the UN Special Rapporteur on the right to the highest attainable standard of health, regarding the human rights responsibilities of pharmaceutical companies and access to medicines.