Drug Promotions Between Ethics, Regulations, and Financial Interests.

BACKGROUND: The promotion of the latest medicines produced by the pharmaceutical industry is an important issue both from an ethical point of view (the level of accessibility, the way research is carried out) and from the point of view of marketing and especially from the lobbying issues raised. AREAS OF UNCERTAINTY: The ethical dilemmas raised by the promotion of new drugs revolve between the need to discover new molecules important for treating a wide range of diseases and the need to establish a battery of ethical rules, absolutely necessary for regulations in the field to be compliant with all ethical principles. DATA SOURCES: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2023) using combinations of keywords, including drugs, medical publicity, and pharma marketing plus ethical dilemma. ETHICS AND THERAPEUTIC ADVANCES: The promotion of medicines is governed by advertising laws and regulations in many countries, including at EU level, based on the need for countries to ensure that the promotion and advertising of medicines is truthful, based on information understood by consumers. The ethical analysis of the issues raised is more necessary and complex as the channels used for promotion are more accessible to the population, and the information, easier to obtain, can be the cause of increased self-medication and overeating. Large amounts of money invested in the development of new molecules, but also the risk of scientific fraud through manipulation of data during clinical trials, selective or biased publication of information can have repercussions on the health of the population. CONCLUSIONS: The development of new pharmaceutical molecules is necessary to intervene and treat as many conditions as possible, but marketing must not neglect the observance of ethical principles. The promotion of medicines should be the attribute especially of the medical staff, which should also be a mandatory part of the mechanism for approving the marketing methods and means used by the pharmaceutical companies.

Assessment of Turkey IVF (In Vitro Fertilization) websites according to the American Society for Reproductive Medicine (ASRM)/Society for Assisted Reproductive Technology (SART) guidelines.

OBJECTIVE: To evaluate websites of in-vitro fertilisation centres in terms of standardised ethical guidelines for advertising. METHODS: The cross-sectional study was conducted in Turkey from February to April 2017. A total of 148 IVF centre websites were evaluated in terms of objective criteria in accordance with American Medical Association, American College of Obstetricians and Gynaecologists, American Society for Reproductive Medicine / Society for Assisted Reproductive. Technology guidelines for advertising. Websites were surveyed with attention paid to success rates, testimonials, sales promotions, price, psychological support offered as part of the service, regulating / certifying bodies, misleading language, and the ethical principles of autonomy, beneficence, non-maleficence and justice. Data was analysed using SPSS 23. RESULTS: Out of 193 centres, 148(76.7%) had active websites; 104(70.3%) private, 38(25.7%) in university hospitals and 6(4%) in state hospitals. Of them, 103(69.6%) centres used at least one example of misleading language when compared to the relevant guidelines. Among these centres, 82(79.6%) were private, 18(17.5%) university hospitals and 3(2.9%) were state hospitals. CONCLUSIONS: A massive majority of websites related to in-vitro fertilisation centres did not follow standardised guidelines for advertising.

Legal and Ethical Analysis of Advertising for Elective Egg Freezing.

This paper reviews common advertising claims by egg freezing companies and evaluates the medical evidence behind those claims. It then surveys legal standards for truth in advertising, including FTC and FDA regulations and the First Amendment right to free speech. Professional standards for medical advertising, such as guidelines published by the American Society for Reproductive Medicine (ASRM), the American College of Obstetricians and Gynecologists (ACOG), and the American Medical Association (AMA), are also summarized. A number of claims, many of which relate to the targeting of younger women for eOC, are found to breach legal and ethical standards for truth in advertising. The ethical implications of misleading advertising claims are also discussed, and the central narrative woven by OC ads - that egg freezing is empowering to women - is examined. The paper concludes that a more balanced approach to the risks and benefits of OC is necessary to truly respect women's autonomy. Moreover, justice requires us to look beyond a medical procedure accessible only to a minority of women in order to address inequities in the workplace.

Gestão de marketing e o sexismo na comunicação: o papel da liderança / Gestión de marketing y el sexismo en la comunicación: el papel del liderazgo / Marketing management and sexism in promotion: the role of leadership

RESUMO Estudos indicam que as mulheres enfrentam mais dificuldades nas áreas empresariais (gestão, contabilidade, finanças, ciências do comportamento e gestão de pessoas) do que os seus colegas homens, devido a considerações estereotipadas sobre o seu papel, que têm consequências negativas nas oportunidades no local de trabalho. Neste sentido, a liderança surge, nesta investigação, com um papel reforçado e como uma ferramenta crucial no apoio à gestão do marketing (em específico, o caso da comunicação e da publicidade) e na sua relação com o sexismo e a igualdade do género. Em específico, torna-se necessário compreender até que ponto a comunicação social e a indústria publicitária influenciam os estereótipos que vão ditar a ascensão ou não da liderança feminina. O presente trabalho visa contribuir, em nível teórico, para a compreensão deste fenómeno, reunindo alguns dos principais contributos da literatura. Estudos futuros deverão conduzir os investigadores no sentido de testar empiricamente qual o papel da liderança na definição das políticas e planos de comunicação das organizações (em específico, a promoção da igualdade de género). Numa perspetiva interdisciplinar, o presente estudo pretende contribuir para o marketing e para o comportamento organizacional. Futuros trabalhos deverão conduzir à elaboração de focus group e entrevistas em profundidade reunindo alguns agentes da tomada de decisão (na ótica da empresa) e consumidores (na ótica da procura).

RESUMEN Los estudios indican que las mujeres se enfrentan a más dificultades en las áreas empresariales (gestión, contabilidad, finanzas, ciencias de comportamiento y gestión de personas) que sus colegas varones, debido a consideraciones estereotipadas sobre su papel, que tienen consecuencias negativas en las oportunidades en el lugar de trabajo. En este sentido, el liderazgo surge en esta investigación con un papel reforzado y como una herramienta crucial en el apoyo a la gestión del marketing (en particular, el caso de la comunicación y la publicidad) y en su relación con el sexismo y la igualdad de género. En concreto, es necesario comprender hasta qué punto la comunicación social y la industria publicitaria influencian los estereotipos que van a dictar la ascensión o no del liderazgo femenino. El presente trabajo pretende contribuir, en nivel teórico, a la comprensión de este fenómeno, reuniendo algunas de las principales contribuciones de la literatura. Los estudios futuros deben conducir a los investigadores a probar empíricamente cuál es el papel del liderazgo en la definición de las políticas y planes de comunicación de las organizaciones (en particular, la promoción de la igualdad de género). En una perspectiva interdisciplinaria, el presente estudio pretende contribuir al marketing y al comportamiento organizacional. Los futuros trabajos conducen a la elaboración de focus group y entrevistas en profundidad reuniendo algunos agentes de la toma de decisión (en la óptica de la empresa) y consumidores (en la óptica de la demanda).

ABSTRACT Studies show us that women face more difficulties in business (management, accounting, finance, behavioral sciences and people management) than their male counterparts because of stereotypical considerations about their role, which have negative consequences on opportunities on the workplace. So, leadership emerges in this research with a reinforced role and as a crucial way in supporting marketing management (specifically the case of communication and advertising) and in its relation to sexism and gender equality. It is necessary to understand to what extent the media and the advertising industry influences the stereotypes that will dictate the rise or not of female leadership. The present work aims to contribute, theoretically, to the understanding of this phenomenon, gathering some of the main contributions of the existent literature. Future studies should lead researchers to empirically test the role of leadership in shaping organizations' communication policies and plans (specifically, promoting gender equality). In an interdisciplinary perspective, this study intends to contribute to marketing and to organizational behavior. Future work will help to the elaboration of a focus group and in-depth interviews bringing together some decision-making agents (in the company's perspective) and consumers (from a demand perspective).

Adherence of Drug Promotional Literatures Distributed by Pharmaceutical Companies to World Health Organization Ethical Criteria for Medicinal Drug Promotion.

BACKGROUND: Drug Promotional Literatures are usually relied upon for drug promotion, however studies have shown them to contain several pitfalls. World Health Organization has time and often revised the guideline to address the issue and World Health Organization Ethical Criteria for Medicinal Drug Promotion was established. Based on this guideline, several regional as well as national guidelines have been formulated. Though laws to regulate drug promotion is existent, studies have shown problems with drug promotional literatures in Nepal also. This study was carried out to analyse the drug promotional literatures distributed by pharmaceutical companies in Nepal as per World Health Organization Ethical Criteria for Medicinal Drug Promotion. METHODS: A cross-sectional study over a period of one year was conducted at our department. Pharmaceutical companies registered in Department of Drug Administration, Kathmandu and consenting for the study were requested to provide ten unique drug promotional literatures of their products. Collected drug promotional literatures were analysed for inclusion of essential information as per World Health Organization Ethical Criteria for Medicinal Drug Promotion, level of biasness. Different drug promotional literatures were also classified and compared for these aspects. RESULTS: A total of 48 pharmaceutical companies were included in the study. Drug promotional literatures (n = 372) were analysed during the study. Adherence to criteria concerned with positive attributes of the promoted medicine was found to be higher, most of the drug promotional literatures adhered to 5-8 criteria of World Health Organization Ethical Criteria for Medicinal Drug Promotion and were categorised into grade B. Difference in adherence as well as number of biased drug promotional literatures was also seen when drug promotional literatures were compared on different basis. CONCLUSIONS: Adherence to World Health Organization Ethical Criteria for Medicinal Drug Promotion was found to vary when drug promotional literatures were classified as per pharmaceutical company, type of formulation being promoted, type of drug promotional literatures.

Regulatory and policy tools to address unproven stem cell interventions in Canada: the need for action.

BACKGROUND: The marketing of unproven direct-to-consumer stem cell interventions is becoming widespread in Canada. There is little evidence supporting their use and they have been associated with a range of harms. Canada has been slower to act against clinics offering these interventions than other jurisdictions, including the United States. Here, we outline the regulatory and policy tools available in Canada to address this growing problem. MAIN BODY: Health Canada's regulations governing cell therapies are complex, but recent statements make it clear that Health Canada believes it has jurisdiction over many of the currently marketed stem cell interventions. Still, further regulatory clarity is needed from Health Canada, as are increased directed enforcement efforts on interventions that fall within their scope. The Competition Bureau, via the Competition Act, prohibits advertisers from making materially false or misleading promotional representations. The Competition Bureau could collaborate with the scientific community to analyze the claims of existing clinics in Canada, and impose sanctions upon those who breach the established standard. Professional regulators, including provincial colleges of physicians and surgeons, have considerable power over what products and services their members can offer. Every college of physicians in Canada requires, via policy and codes of ethics, that doctors maintain evidence-based practices. This requirement is incompatible with offering many unproven stem cell interventions. Litigation may be another tool, including the use of fraud, misrepresentation and/or negligence claims for failing to meet the required standard of care. Finally, political pressure on federal and provincial lawmakers could encourage changes to marketing, cell therapy and professional regulations that would allow a more comprehensive response. CONCLUSIONS: In sum, there are many existing tools that can be used to protect the public from unproven stem cell interventions. Increased bureaucratic will and grassroots efforts are needed in order to effect a positive policy response.

Facebook advertising for recruitment of midlife women with bothersome vaginal symptoms: A pilot study.

BACKGROUND: The MsFLASH (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) Network recruited into five randomized clinical trials (n = 100-350) through mass mailings. The fifth trial tested two interventions for postmenopausal vulvovaginal symptoms (itching, pain, irritation, dryness, or pain with sex) and thus required a high level of sensitivity to privacy concerns. For this trial, in addition to mass mailings we pilot tested a social media recruitment approach. We aimed to evaluate the feasibility of recruiting healthy midlife women with bothersome vulvovaginal symptoms to participate in the Vaginal Health Trial through Facebook advertising. METHODS: As part of a larger advertising campaign that enrolled 302 postmenopausal women for the 12-week randomized, double-blind, placebo-controlled Vaginal Health Trial from April 2016 to February 2017, Facebook advertising was used to recruit 25 participants. The target population for recruitment by mailings and by Facebook ads included women aged 50-70 years and living within 20 miles of study sites in Minneapolis, MN and Seattle, WA. Design of recruitment letters and Facebook advertisements was informed by focus group feedback. Facebook ads were displayed in the "newsfeed" of targeted users and included a link to the study website. Response rates and costs are described for both online ads and mailing. RESULTS: Facebook ads ran in Minneapolis for 28 days and in Seattle for 15 days, with ads posted and removed from the site as needed based on clinic flow and a set budget limit. Our estimated Facebook advertising reach was over 200,000 women; 461 women responded and 25 were enrolled at a cost of US$14,813. The response rate per estimated reach was 0.22%; costs were US$32 per response and US$593 per randomized participant. The social media recruitment results varied by site, showing greater effectiveness in Seattle than in Minneapolis. We mailed 277,000 recruitment letters; 2166 women responded and 277 were randomized at a cost of US$98,682. The response rate per letter sent was 0.78%; costs were US$46 per response and US$356 per randomized participant. Results varied little across sites. CONCLUSION: Recruitment to a clinical trial testing interventions for postmenopausal vaginal symptoms is feasible through social media advertising. Variability in observed effectiveness and costs may reflect the small sample sizes and limited budget of the pilot recruitment study.

Are Big Food's corporate social responsibility strategies valuable to communities? A qualitative study with parents and children.

OBJECTIVE: Recent studies have identified parents and children as two target groups whom Big Food hopes to positively influence through its corporate social responsibility (CSR) strategies. The current preliminary study aimed to gain an in-depth understanding of parents and children's awareness and interpretation of Big Food's CSR strategies to understand how CSR shapes their beliefs about companies. DESIGN: Community-based qualitative semi-structured interviews. SETTING: New South Wales, Australia. SUBJECTS: Parents (n 15) and children aged 8-12 years (n 15). RESULTS: Parents and children showed unprompted recognition of CSR activities when shown McDonald's and Coca-Cola brand logos, indicating a strong level of association between the brands and activities that target the settings of children. When discussing CSR strategies some parents and most children saw value in the activities, viewing them as acts of merit or worth. For some parents and children, the companies' CSR activities were seen as a reflection of the company's moral attributes, which resonated with their own values of charity and health. For others, CSR strategies were in conflict with companies' core business. Finally, some also viewed the activities as harmful, representing a deceit of the public and a smokescreen for the companies' ultimately unethical behaviour. CONCLUSIONS: A large proportion of participants valued the CSR activities, signalling that denormalising CSR to sever the strong ties between the community and Big Food will be a difficult process for the public health community. Efforts to gain public acceptance for action on CSR may need greater levels of persuasion to gain public support of a comprehensive and restrictive approach.

Analysis of the truth in advertising on the efficacy provided by assisted reproduction clinics / Análisis sobre la autenticidad de la publicidad sobre la eficacia de clínicas de reproducción asistida / Análise da verdade na publicidade sobre a eficácia fornecida pelas clínicas de reprodução assistida

Abstract: This paper analyses the efficacy data from assisted reproduction clinics, obtained from both scientific society reports and from studies published in specialised journals, in order to compare them with information published by Spanish assisted reproduction clinics on their websites. It aims to verify whether this information matches the reality of the findings in the media analysed or, in contrast, differs from the aforementioned scientific evidence. Our study shows marked discrepancies between the evidence of existing statistical data, and figures published by most of the clinics on their websites, which could constitute false advertising.

Resumen: Este estudio analiza los datos de eficacia de clínicas de reproducción asistida, obtenidos tanto de informes de sociedades científicas como de estudios publicados en revistas especializadas, para compararlos con la información publicada por las clínicas de reproducción asistida de España en sus sitios web. El objetivo es verificar si esta información es conforme a los hallados en informes y revistas o, por el contrario, difiere de la evidencia científica mencionada. Nuestro estudio demuestra marcadas discrepancias entre la evidencia de datos estadísticos existentes y las cifras publicadas por la mayoría de los sitios web de las clínicas, lo cual constituye falsa publicidad.

Resumo: Este artigo analisa os dados de eficácia de clínicas de reprodução assistida, obtidas de relatórios da sociedade científica e de estudos publicados em revistas especializadas, a fim de compará-los com informações publicadas por clínicas de reprodução assistida espanholas em seus websites. O artigo visa verificar se esta informação coincide com a realidade dos resultados encontrados nos meios de comunicação analisados ou, por outro lado, difere da evidência científica acima mencionada. Nosso estudo mostra discrepâncias entre a evidência dos dados estatísticos existentes e indicadores publicados pela maioria das clínicas em seus sites, que podem constituir falsa publicidade.

An empirical analysis of ethical and professional issues in physicians' advertising: A comparative cross-sectional study.

The purpose of this study is to investigate current attitudes and opinions of physicians' advertising and to compare them to the attitudes expressed 10 years previously. This study was designed to determine (a) consumers' attitudes toward advertising by physicians, and (b) whether age, occupation, income, education, or sex of consumer accounted for any significant difference in attitudes toward physicians who advertise. The study seems to confirm the belief of many marketing professionals that advertising and marketing do not have a place in the management and operation of professional services.

Advertising as a cue to consume: a systematic review and meta-analysis of the effects of acute exposure to unhealthy food and nonalcoholic beverage advertising on intake in children and adults.

BACKGROUND: Several studies have assessed the effects of food and nonalcoholic beverage (hereafter collectively referred to as food) advertising on food consumption, but the results of these studies have been mixed. This lack of clarity may be impeding policy action. OBJECTIVE: We examined the evidence for a relation between acute exposure to experimental unhealthy food advertising and food consumption. DESIGN: The study was a systematic review and meta-analysis of published studies in which advertising exposure (television or Internet) was experimentally manipulated, and food intake was measured. Five electronic databases were searched for relevant publications (SCOPUS, PsycINFO, MEDLINE, Emerald Insight, and JSTOR). An inverse variance meta-analysis was used whereby the standardized mean difference (SMD) in food intake was calculated between unhealthy food advertising and control conditions. RESULTS: Twenty-two articles were eligible for inclusion. Data were available for 18 articles to be included in the meta-analysis (which provided 20 comparisons). With all available data included, the analysis indicated a small-to-moderate effect size for advertising on food consumption with participants eating more after exposure to food advertising than after control conditions (SMD: 0.37; 95% CI: 0.09; 0.65; I(2) = 98%). Subgroup analyses showed that the experiments with adult participants provided no evidence of an effect of advertising on intake (SMD: 0.00; P = 1.00; 95% CI: -0.08, 0.08; I(2) = 8%), but a significant effect of moderate size was shown for children, whereby food advertising exposure was associated with greater food intake (SMD: 0.56; P = 0.003; 95% CI: 0.18, 0.94; I(2) = 98%). CONCLUSIONS: Evidence to date shows that acute exposure to food advertising increases food intake in children but not in adults. These data support public health policy action that seeks to reduce children's exposure to unhealthy food advertising.

Ethical issues in advertising and promotion of medical units.

Bioethics tries to define the medical activity and any other related activity needed to maintain the function of a health institution, through the development of principles and moral values. Bioethics is quite broad and has a background that combines various disciplines such as medicine, philosophy, law, sociology, and theology. Advertising and promotion are part of the strategy aimed at developing and maintaining relationships with the targeted audience (patients). To regulate this activity, it was necessary to develop ethical rules of healthcare marketing. The content of promotional messages must be truthful and should not create unjustified expectations. The doctor or the healthcare unit must be able to provide the services claimed in the advertisement. From an ethical point of view, marketing communication should be more consistent with reality, even if its purpose is to shed light on more attractive issues. In this context, the categories and groups vulnerable to certain content of the advertising message should be mentioned. A patient with a serious suffering will be easily influenced and will tend to trust any promise easily, with the desire to heal. Ethically, the information presented must not alter the reality and should not give false hopes to patients. Those responsible for marketing in the healthcare field must keep in mind the ethics code of the medical profession, must maintain an honest marketing communication, which does not create inaccurate expectations, must not denigrate other colleagues, and must use a message whose content should respect the dignity of the profession.

Emerging Dental Specialties and Ethics.

This paper discusses ethical dimensions related to the formal recognition of emerging dental specialties. It explores several issues related to the potential emergence of several new dental specialty areas. There are good reasons that dentistry should open the door to these new specialties, and patients would benefit. The ethical considerations for and against formal acceptance are examined.

When Does FDAMA Section 114 Apply? Ten Case Studies.

BACKGROUND: Section 114 of the Food and Drug Administration Modernization Act of 1997 regulates the promotion of health economic information by pharmaceutical companies to US health plans. Greater clarity is important given demands by payers and other stakeholders for evidence of value. OBJECTIVES: To develop hypothetical case studies of health economic promotions to examine legal and policy implications. METHODS: We constructed for pedagogical purposes 10 categories of potential health economic promotions. We generated hypothetical case studies for each category, including questions about whether each might be allowable under Section 114. The case studies were developed around the following categories: 1) costing out on-label clinical end points; 2) promotion of a costing exercise to physicians working in an accountable care organization setting; 3) burden-of-illness claims; 4) economic analysis of a formulary restriction policy; 5) extrapolations to doses, populations, or settings not covered in trials; 6) adherence claims; 7) "utilization of care" as a secondary end point in randomized clinical trials; 8) costing out a competitor drug's adverse event; 9) economic analysis of comparative effectiveness claims using an indirect treatment comparison; and 10) extrapolating from surrogate to long-term outcomes in an economic model. DISCUSSION: Most cases seem to fall into a gray zone given haziness around what constitutes "competent and reliable evidence" and "directly relate[d]" to an approved indication. In practice, it is difficult to know what the section allows given the imprecision of the statute and lack of guidance about its scope. CONCLUSION: Ideally, future guidance will provide clarity and flexibility.