Remember, do no harm?

When the advocacy group America's Frontline Doctors appeared on the steps of the United States Supreme Court in 2020, falsely stating that hydroxychloroquine was a cure for COVID-19, their pronouncement was virally shared by right-wing media and soundly debunked by medical academicians. A year later, one of these frontliners, Joseph Ladapo, became the surgeon general of Florida and a faculty member at the University of Florida College of Medicine. He has continued to spread dangerous misinformation about COVID-19 while his academic colleagues are shamefully silent.

Examining Physician Interactions with Disease Advocacy Organizations.

Disease advocacy organizations (DAOs) have traditionally focused on raising awareness of rare diseases, providing educational resources to patients, and supporting patients and families. Previous research has described how scientists collaborate with DAOs, but few empirical data are available regarding the extent to which physicians interact with DAOs and how those interactions impact patient care. We conducted a national survey of 230 board-certified pediatric neurologists to assess their engagement with DAOs and their beliefs about the impact of DAOs on patient care. In that context, we evaluated a set of 24 items describing interactions between physicians and DAOs. Exploratory factor analysis produced a 19-item model capturing four types of physician-DAO engagement: (1) accessing or distributing DAO-produced materials (6 items, alpha = 0.80); (2) consulting on DAO activities (5 items, alpha = 0.81); (3) collaborating with DAOs on research activities (6 items, alpha = 0.80); and (4) co-producing scholarly materials with DAOs (2 items, alpha = 0.80). Our data indicate that physicians engage with DAOs in more frequent and diverse ways than has been previously reported. Almost all physicians in our sample had interacted directly with a DAO in some way, from low-effort activities such as visiting a DAO's website to deeper forms of engagement including coauthoring journal articles. These findings may provide a framework for bioethicists to characterize the nature and extent of physician interactions with advocacy organizations, which is critical for evaluating the ethical implications of physician-DAO relationships.

Genética a gusto del consumidor: una práctica que no encaja en nuestro Derecho / No disponible

Los test genéticos directos al consumidor tienen por objeto conocer la predisposición a padecer enfermedades comunes de origen multifactorial. Tal y como se ofrecen constituyen un reclamo cuya calidad y utilidad no ha sido probada, ya que, en muchos casos, no predicen el desarrollo de la enfermedad ni su gravedad. Objeciones tales como la falta de información y de consejo genético, el impacto en el individuo y en su familia, la agresiva publicidad y el riesgo de estigmatización justifican la adopción de cautelas y el sometimiento a unos estrictos estándares éticos y jurídicos

Direct-to-consumer genetic testing aim to meet the predisposition to common diseases of multifactorial origin. These tests are offered as a form of claim whose quality and usefulness has not been tested, since in many cases do not predict the development of the disease or its severity. Objections such as lack of information and genetic counselling, the impact on the individual and his family, aggressive advertising and the risk of stigmatization justify the need to take precautionary measures and to be subject to strict ethical and legal standards

Free access to genetic testing - guaranteeing or threatening the right to privacy?

The development of market for commercial genetic testing allows free access to them for an unlimited number of people. Everyone can carry out genetic tests in every chosen medical service provider and receive interesting results. Moreover, the transfer of genetic material for testing and the results of these tests may be sent by post without a personal visit in the service provider. Theoretically, free access to genetic tests can be assessed as a guarantee of the right to protect private life. Everyone can receive detailed information about his person, in particular in the field of health and existing or potential diseases. Therefore, the genetic tests give the opportunity to broaden the scope of information about the state of health. What is more important, this information can allow, for instance, to choose appropriate treatment or to make some preventive decisions. In this context, even the ECHR treats the access to genetic testing as a possible way to guarantee the right to protect private life (for example prenatal genetic testing). However, free access to genetic tests is also connected with the threat to the right to protect private life. The possibility of sending the biological material for testing by post and the easy access to this material opens wide possibilities for receiving the genetic data of any person. This method of conducting genetic tests does not allow to prevent from obtaining the sensitive data of another person without his/her knowledge and consent. Furthermore, the advisory services for people conducting genetic tests privately does not exist. Patients cannot receive the proper interpretation of the results of genetic tests obtained commercially. Misinterpreted results of genetic tests may have the very negative impact on the life, on life decisions, and consequently on the realization of the right to protect private life. Therefore, he admissibility of conducting commercial genetic testing, in particular conducting by post, requires an appropriate balance between guarantees and threats to the right to protect private life. The proper protection of this right probably requires that direct-to-consumer genetic tests probably should be done only on the order of a physician

El desarrollo del mercado de pruebas genéticas comerciales permite el acceso gratuito a ellas para un número ilimitado de personas. Todo el mundo puede realizar pruebas genéticas con cada proveedor de servicios médicos elegido y recibir resultados interesantes. Además, la transferencia de material genético para las pruebas y los resultados de éstas, pueden enviarse por correo sin una visita personal al proveedor del servicio. Teóricamente, el acceso libre a pruebas genéticas puede evaluarse como una garantía del derecho a proteger la vida privada. Todo el mundo puede recibir información detallada sobre su persona, en particular en el campo de la salud y las enfermedades existentes o potenciales. Por lo tanto, las pruebas genéticas brindan la oportunidad de ampliar el alcance de la información sobre el estado de salud. Lo que es más importante, esta información puede permitir, por ejemplo, elegir el tratamiento adecuado o tomar algunas decisiones preventivas. En este contexto, incluso el Tribunal Europeo de Derechos Humanos trata el acceso a las pruebas genéticas como una forma posible de garantizar el derecho a proteger la vida privada (por ejemplo, pruebas genéticas prenatales). Sin embargo, el libre acceso a las pruebas genéticas también está relacionado con la amenaza al derecho de proteger la vida privada. La posibilidad de enviar el material biológico para la prueba por correo y el fácil acceso a este material abre amplias posibilidades para recibir los datos genéticos de cualquier persona. Este método de realizar pruebas genéticas no permite evitar la obtención de datos confidenciales de otra persona sin su conocimiento y consentimiento. Además, los servicios de asesoramiento para personas que realizan pruebas genéticas de forma privada no existen. Los pacientes no pueden recibir la interpretación adecuada de los resultados de las pruebas genéticas obtenidas comercialmente. Los resultados malinterpretados de las pruebas genéticas pueden tener un impacto muy negativo en la vida, en decisiones vitales y, en consecuencia, en la realización del derecho a proteger la vida privada. Por lo tanto, la admisibilidad de realizar pruebas genéticas comerciales, en particular la realización por correo, requiere un equilibrio adecuado entre las garantías y las amenazas al derecho a proteger la vida privada. La protección adecuada de este derecho probablemente requiera que las pruebas genéticas directas al consumidor solo se realicen por orden de un médico

El TJUE reafirma que las bebidas vegetales no pueden llamarse «leche» en base a las normas de protección del mercado lácteo, pero ¿qué hay del interés del consumidor? / The CJEU confirms firms that plant based products cannot use the term «milk» because of the rules of protection of the dairy market. But what about consumer interest? / El TJUE reafirma que les begudes vegetals no poden anomenar-se «llet» en base a les normes de protecció del mercat làctic, però què hi ha de l’interès del consumidor?

El pasado 14 de junio, el Tribunal de Justicia de la Unión Europea resolvió en cuestión prejudicial que la denominación «leche» y otras denominaciones de "productos lácteos" deben reservarse a productos de origen animal. El fallo responde a la cuestión prejudicial planteada por un Tribunal alemán durante el litigio entre VSW, asociación empresarial alemana y TofuTown, productora y distribuidora de alimentos vegetarianos/veganos. El fallo del Tribunal señala que designar un producto puramente vegetal como «leche de…» vulnera el derecho de la Unión por ser contrario a la normativa de protección del sector lácteo. Pero la sentencia no analiza si estas denominaciones ponen en jaque la protección del derecho del consumidor a una información alimentaria clara, objetiva y contrastada científicamente

On June 14, the Court of Justice of the European Union resolved in a preliminary ruling that the name "milk" and other denominations of "dairy products" must be reserved for products of animal origin. The verdict responds to the preliminary ruling proposed by a German Court during the lawsuit between VS W, German business association and TofuTown, a company that produces and distributes vegetarian/vegan foodstuffs. The Court's ruling indicates that designating a purely plant based product like "milk" breaks the Union Law to be contrary to the legislation protecting the dairy sector. However, the ruling does not analyze whether these descriptions check the protection of the consumer right to clear, objective and scientifically corroborated food information

El passat 14 de juny, el Tribunal de Justícia de la Unió Europea va resoldre en qüestió prejudicial que la denominació «llet» i altres denominacions de «productes làctics» han de reservar-se a productes d'origen animal. La decisió respon a la qüestió prejudicial plantejada per un Tribunal alemany durant el litigi entre VSW, associació empresarial alemanya i TofuTown, productora i distribuïdora d'aliments vegetarians/vegans. La decisió del Tribunal estableix que designar un producte purament vegetal com a «llet de…» vulnera el dret de la Unió Europea perquè és contrari a la normativa de protecció del sector làctic. Però la sentència no analitza si aquestes denominacions posen en entredit la protecció del dret del consumidor a una informació alimentària clara, objectiva i contrastada científicament

Academic advocacy in public health: Disciplinary 'duty' or political 'propaganda'?

The role of 'advocacy' within public health attracts considerable debate but is rarely the subject of empirical research. This paper reviews the available literature and presents data from qualitative research (interviews and focus groups conducted in the UK in 2011-2013) involving 147 professionals (working in academia, the public sector, the third sector and policy settings) concerned with public health in the UK. It seeks to address the following questions: (i) What is public health advocacy and how does it relate to research?; (ii) What role (if any) do professionals concerned with public health feel researchers ought to play in advocacy?; and (iii) For those researchers who do engage in advocacy, what are the risks and challenges and to what extent can these be managed/mitigated? In answering these questions, we argue that two deeply contrasting conceptualisations of 'advocacy' exist within public health, the most dominant of which ('representational') centres on strategies for 'selling' public health goals to decision-makers and the wider public. This contrasts with an alternative (less widely employed) conceptualisation of advocacy as 'facilitational'. This approach focuses on working with communities whose voices are often unheard/ignored in policy to enable their views to contribute to debates. We argue that these divergent ways of thinking about advocacy speak to a more fundamental challenge regarding the role of the public in research, policy and practice and the activities that connect these various strands of public health research.

Commercial speech in the realm of direct-to- consumer genetic testing. Are the current bans in the Spanish legal framework necessary and proportionate?

This paper explores the right to commercial speech of the companies that offer Direct To Consumer (DTC) genetic tests in the market. The paper discusses whether the bans to commercial speech currently in force in Spain are necessary and proportional or not, attending to the rights and public interests they try to protect, and balancing them with the communicative rights of the companies and the customers

El presente artículo analiza el derecho a la comunicación publicitaria de las empresas que ofrecen test directos al consumidor. Tras un análisis de la normativa vigente en España, se plantea la necesidad y proporcionalidad de las restricciones que el ordenamiento español impone a este tipo de publicidad, ponderando los intereses en conflicto: de un lado, el derecho a la comunicación de las empresas y los potenciales clientes de otro, la protección de la salud pública y de los consumidores y usuarios

Perspective: Hope for Health Equity.

Times like these test the soul. We are now working for health equity in a time of overt, aggressive opposition. Yet, hope in the face of overwhelming obstacles is the force that has driven most of the world's progress toward equity and justice. Operationalizing real-world hope requires an affirmative vision, an expectation of success, broad coalitions taking action cohesively, and frequent measures of collective impact to drive rapid-cycle improvement.

Anything to Stay Alive: The Challenges of a Campaign for an Experimental Drug.

Drug-resistant tuberculosis (TB) has a high mortality rate. Most medicines used to treat it are poorly tested and have terrible side effects. Activists have campaigned for patients with drug-resistant TB to have access to experimental drugs, particularly one called bedaquiline, before these have been approved by regulatory authorities such as the Food and Drug Administration (FDA) in the United States (US) and the Medicines Control Council (MCC) in South Africa. Some activists have also campaigned for bedaquiline to be approved by regulatory authorities before testing of the drug is completed. These campaigns raise ethical concerns about whether patients should be offered experimental, unapproved, medicines for the treatment of life-threatening illnesses, and if authorities should approve drugs for life-threatening illnesses when vital questions about safety and efficacy remain outstanding.

Family tree and ancestry inference: is there a need for a 'generational' consent?

BACKGROUND: Genealogical research and ancestry testing are popular recreational activities but little is known about the impact of the use of these services on clients' biological and social families. Ancestry databases are being enriched with self-reported data and data from deoxyribonucleic acid (DNA) analyses, but also are being linked to other direct-to-consumer genetic testing and research databases. As both family history data and DNA can provide information on more than just the individual, we asked whether companies, as a part of the consent process, were informing clients, and through them clients' relatives, of the potential implications of the use and linkage of their personal data. METHODS: We used content analysis to analyse publically-available consent and informational materials provided to potential clients of ancestry and direct-to-consumer genetic testing companies to determine what consent is required, what risks associated with participation were highlighted, and whether the consent or notification of third parties was suggested or required. RESULTS: We identified four categories of companies providing: 1) services based only on self-reported data, such as personal or family history; 2) services based only on DNA provided by the client; 3) services using both; and 4) services using both that also have a research component. The amount of information provided on the potential issues varied significantly across the categories of companies. 'Traditional' ancestry companies showed the greatest awareness of the implications for family members, while companies only asking for DNA focused solely on the client. While in some cases companies included text recommending clients inform their relatives, showing they recognised the issues, often it was located within lengthy terms and conditions or privacy statements that may not be read by potential clients. CONCLUSIONS: We recommend that companies should make it clearer that clients should inform third parties about their plans to participate, that third parties' data will be provided to companies, and that that data will be linked to other databases, thus raising privacy and issues on use of data. We also suggest investigating whether a 'generational consent' should be created that would include more than just the individual in decisions about participating in genetic investigations.

Defending the jurisdiction of the clinical ethicist.

In this essay I suggest that the bioethics profession's jurisdiction over healthcare ethics consultation is in need of reinforcement. I argue that as the profession becomes more successful, competitors will challenge the profession to justify its ethical claims and ask whose ethics the profession represents. This challenge will come more quickly as the profession tries to influence the ethics of healthcare organizations. I propose a method of bolstering jurisdiction that will make the profession less vulnerable to challenge in the future.