Accuracy of drug advertisements in medical journals under new law regulating the marketing of pharmaceutical products in Switzerland

<p>Abstract</p> <p>Background</p> <p>New legal regulations for the marketing of pharmaceutical products were introduced in 2002 in Switzerland. We investigated whether claims in drug advertisements citing published scientific studies were justified by these studies after the introduction of these new regulations.</p> <p>Methods</p> <p>In this cross-sectional study, two independent reviewers screened all issues of six major Swiss medical journals published in the year 2005 to identify all drug advertisements for analgesic, gastrointestinal and psychopharmacologic drugs and evaluated all drug advertisements referring to at least one publication. The pharmaceutical claim was rated as being supported, being based on a potentially biased study or not to be supported by the cited study according to pre-specified criteria. We also explored factors likely to be associated with supported advertisement claims.</p> <p>Results</p> <p>Of 2068 advertisements 577 (28%) promoted analgesic, psychopharmacologic or gastrointestinal drugs. Among them were 323 (56%) advertisements citing at least one reference. After excluding multiple publications of the same drug advertisement and advertisements with non-informative references, there remained 29 unique advertisements with at least one reference to a scientific study. These 29 advertisements contained 78 distinct pairs of claims of analgesic, gastrointestinal and psychopharmacologic drugs and referenced studies. Thirty-seven (47%) claims were supported, 16 (21%) claims were not supported by the corresponding reference, and 25 (32%) claims were based on potentially biased evidence, with no relevant differences between drug groups. Studies with conflict of interest and studies stating industry funding were more likely to support the corresponding claim (RR 1.52, 95% CI 1.07–2.17 and RR 1.50, 95% CI 0.98–2.28) than studies without identified conflict of interest and studies without information on type of funding.</p> <p>Conclusion</p> <p>Following the introduction of new regulations for drug advertisement in Switzerland, 53% of all assessed pharmaceutical claims published in major medical journals are not supported by the cited referenced studies or based on potentially biased study information. In light of the discrepancy between the new legislation and the endorsement of these regulations, physicians should not trust drug advertisement claims even when they seem to refer to scientific studies.</p

Brain Branding: When Neuroscience and Commerce Collide

Products that align themselves with basic and clinical neurosciences do well in the market. There are reasons to be wary about such brain branding when commercial interests threaten to compromise scientific and clinical values. We describe three concerns. The first, exemplified in drug development and dissemination, is of the insidious effects of blurred boundaries between academia and industry. The second, exemplified by the sale of brain fitness products, if of commerce getting ahead of the motivating science. The first, exemplified by some functional imaging practices, if of the misuse of neuroscience in the marketing technology. We propose three reasons for why brain branding appears to work. First is the seductive allure of neuroscience as providing seemingly deeper explanations of complex phenomena. The second is the persuasive power of pictures, which converges with the allure of neuroscience in brain imaging. The third is the context in which many physicians and patients find themselves. The relative lack of control over the course of chronic diseases may dispose physicians and patients to believe claims made by companies that align themselves with neuroscience. We outline circumstances when clinicians, patients, and consumers should question the usefulness of diagnostic tools and therapeutic interventions

Análisis de los anuncios publicitarios en las revistas médicas

Las revistas médicas se publican periódicamente con la intención de transmitir el conocimiento científico. Sin embargo, es posible que incluyan anuncios publicitarios de medicamentos los cuales no siempre son ciertos ni están respaldados por estudios originales. Los comités editoriales deberán garantizar la independencia de la revista, pues algunas menciones podrían ubicarse en artículos financiados de manera total o parcial por laboratorios farmacéuticos

Drug Labeling in Developing Countries

This report discusses the pharmaceutical labeling requirements imposed on U.S.-based companies by the laws of the United States and the barriers to U.S. regulation of their labeling in other countries

In Sickness and in Health: Analyzing the Ethical Limits of the Marriage between Health Care and the Market in the United States

This dissertation aims to determine what should be the appropriate base ethical limits of health care markets in the United States. I argue that because we do not value health care goods and services as commodities, treating them as commodities available for market sale can only be ethical when health care markets accord with at least the principles of honesty, respect for autonomy, and increased access to essential health care goods and services. I begin by establishing the theoretical foundation of my argument by expositing three theories of commodification and ethical markets that critically examine the relationship of goods to the market. Each theory shows how commodification often fails to account for the non-market value(s) we attribute to many goods. I then apply these theories to health care goods and services to show how they are not properly valued merely as commodities, and to lay the foundation of my argument regarding the ethical limits of health care markets. I then argue why honesty, respect for autonomy, and increased access to essential health care goods and services should be considered the base ethical limits of health care markets by examining how each ideally applies to both health care and the market. Lastly, I apply my argument to two health care markets: the pharmaceutical industry and a possible legal organ market. For the former, I show how many of the practices of the pharmaceutical industry violate what I argue should be the base ethical limits of health care markets. For the latter, I show the extent to which a legal organ market in the United States could or would violate these limits

Institutional Oversight of Clinical Trials and the Drug Approval Process

The institutional and federal bodies responsible for regulatory review and oversight of clinical trials in Canada serve distinct yet complementary functions in ensuring that clinical trials provide scientifically rigorous and ethically sound evaluation of new therapeutic products. To date, academics and reformers alike have discussed reform priorities for federal and institutional review in isolation, as if their guiding purposes are distinct. This article identifies the overlapping objectives of federal and institutional review, argues for the importance of coordination of institutional and federal oversight structures, and identifies potential points of coordination

Corporate social responsibility practices of pharmaceutical companies in China: a scale development & empirical study

JEL Classification: M14 - Corporate Culture; Social Responsibility; I11 - Analysis of Health Care MarketsCorporate Social Responsibility (CSR) has been a hot topic in literature ever since a couple of decades ago, and it roughly refers to the positive influence that a company’s operations have on its stakeholders. Amongst various industries, the pharmaceutical sector is one of the most debated in that these companies produce disease-curing and even life-saving products in a for-profit manner, thereby involving many CSR-related issues. Now China’s pharmaceutical industry has the second largest output in the world, but various problems have also emerged and led to negative consequences, many of which were caused by failure to abide by CSR norms. In order to assess the CSR practices of pharmaceutical companies in China, a reliable and credible measurement instrument has to be available. However, currently there is still no universally accepted definition of CSR, and existing theoretical models fail to fit either characteristics of the pharmaceutical industry or China’s cultural context. As a result, a new model has to be built that takes both factors into account. The study has two main purposes: one is to design an original and valid scale for measuring the CSR practices of pharmaceutical companies in China, and the other is to use this tool to evaluate their actual CSR performance. Based on a standard scale development process (in-depth interviews, open-ended questionnaire, discussions with experts, reliability and validity evaluation with exploratory and confirmatory factor analyses), finally an eight-dimensional and 36-item measurement tool was validated. The eight initial dimensions (Shareholders, Managers, and Employees; Creditors & Suppliers, Patients & Doctors; Government, Environment, and Local Community) were then transformed into three second-order dimensions: CSR for Internal Parties, CSR for External Partners, and CSR for Public Entities. This conceptual model was later applied to reveal the circumstances within China’s pharmaceutical industry. Results show that CSR practices in the pharmaceutical industry in China coexist at very different levels: foreign-owned companies and joint ventures generally outperformed their state-owned and privately owned counterparts, and larger companies also had better CSR citizenship than smaller ones.A Responsabilidade Social das Empresas (RSE) tem sido um tópico recorrente na literatura nas duas últimas décadas e, de forma muito resumida, refere-se à influência positiva que a atividade empresarial pode ter nos seus diversos stakeholders. De entre os múltiplos setores de atividade, a indústria farmacêutica é uma das mais discutidas por produzir medicamentos que curam doenças e salvam vidas mas de forma lucrativa, e por isso, envolvendo muitos problemas relacionados com a RSE. Atualmente, a indústria farmacêutica na China é segunda em termos de produção mundial, mas apresenta problemas variados com consequências negativas, muitas delas resultantes do não cumprimento das normas de resonsabilidade social. Para que se possam avaliar as práticas de RSE na China, é necessário um instrumento de medida fiável e válido. No entanto, até ao momento não existe uma escala de medida da RSE universalmente aceite e os atuais modelos teóricos não incorporam as características da indústria farmacêutica e o contexto cultural específico da China. Daí a necessidade de desenvolvimento de um modelo teórico que possa incluir estas duas dimensões. Este estudo tem como principais objectivos desenhar e validar um instrumento de medida das práticas de RSE na indústria farmacêutica chinesa e, utilizando essa escala de medida, avaliar o atual desempenho das empresas chinesas deste setor em termos de práticas de responsabilidade social. Foi utilizada uma metodologia estandardizada para o desenvolvimento de uma escala de medida (entrevistas em profundidade, perguntas abertas, pré-teste ao questionário, validade e fiabilidade do questionário com análises fatoriais exploratória e confirmatória). Foi validada uma escala com 36 itens e oito dimensões (Acionistas, Gestores e Colaboradores; Credores & Fornecedores, Doentes & Médicos; Governo, Ambiente e Comunidade Local) que, de seguida, foram transformadas em três dimensões de segunda ordem: RSE para as partes internas, RSE para os parceiros externos e RSE para as entidades públicas. Este modelo conceptual foi depois aplicado para identificar as particularidades da indústria farmacêutica na China. Os resultados mostram que as práticas de RSE coexistem a níveis muito diferentes: em geral as empresas de capital estrangeiro ou joint ventures apresentam melhor performance que as empresas públicas ou privadas; as empresas maiores revelam mais práticas de RS que as mais pequena

Advancing the Right to Health: The Vital Role of Law

Effective laws and an enabling legal environment are essential to a healthy society. Most public health challenges – from infectious and non-communicable diseases to injuries, from mental illness to universal health coverage – have a legal component. At global, national and local levels, law is a powerful tool for advancing the right to health. This tool is, however, often underutilized. This report aims to raise awareness about the role that public health laws can play in advancing the right to health and in creating the conditions for all people to live healthy lives. The report provides guidance about issues and requirements to be addressed during the process of developing or reforming public health laws, with case studies drawn from countries around the world to illustrate effective practices and critical features of effective public health legislation. Advancing the right to health: the vital role of law is the result of a collaboration between the World Health Organisation, the International Development Law Organisation (IDLO), the O’Neill Institute for National and Global Health Law, Washington D.C., USA, and Sydney Law School, University of Sydney. The Project Directors were: Professor Lawrence O. Gostin, Linda D. and Timothy J. O’Neill Professor of Global Health Law and University Professor, Georgetown University; Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University; Mr David Patterson, Senior Legal Expert – Health; Department of Research & Learning, International Development Law Organization; Professor Roger Magnusson, Professor of Health Law & Governance, Sydney Law School, University of Sydney; Mr Oscar Cabrera, Executive Director, O’Neill Institute for National and Global Health Law, Georgetown University Law Center; Ms Helena Nygren-Krug (2011–2013), Senior Advisor, Human Rights & Law, UNAIDS. The content and structure of the report reflect the consensus reached at the second of two international consultations in public health law that preceded the preparation of the report, hosted by WHO and IDLO in Cairo, Egypt, 26-28 April 2010. Part 1 introduces the human right to health and its role in guiding and evaluating law reform efforts, including efforts to achieve the goal of universal health coverage. Part 2 discusses the process of public health law reform. The law reform process refers to the practical steps involved in advancing the political goal of law reform, and the kinds of issues and obstacles that may be encountered along the way. Part 2 identifies some of the actors who may initiate or lead the public health law reform process, discusses principles of good governance during that process, and ways of building a consensus around the need for public health law reform. Part 3 turns from the process of reforming public health laws to the substance or content of those laws. It identifies a number of core areas of public health practice where regulation is essential in order to ensure that governments (at different levels) discharge their basic public health functions. Traditionally, these core areas of public health practice have included: the provision of clean water and sanitation, monitoring and surveillance of public health threats, the management of communicable diseases, and emergency powers. Building on these core public health functions, Part 3 goes on to consider a range of other public health priorities where law has a critical role to play. These priorities include tobacco control, access to essential medicines, the migration of health care workers, nutrition, maternal, reproductive and child health, and the role of law in advancing universal access to quality health services for all members of the population. The report includes many examples that illustrate the ways in which different countries have used law to protect the health of their populations in ways that are consistent with their human rights obligations. Countries vary widely in terms of their constitutional structure, size, history and political culture. For these reasons, the examples given are not intended to be prescriptive, but to provide useful comparisons for countries involved in the process of legislative review