Truth-in-Advertising Laws: Are They Working? A Cross-Sectional Analysis of a "Plastic Surgeon" Patient Search Simulation.

BACKGROUND: Non-board-certified plastic surgeons performing cosmetic procedures and advertising as plastic surgeons may have an adverse effect on a patient's understanding of their practitioner's medical training and patient safety. The authors aim to assess (1) the impact of city size and locations and (2) the impact of health care transparency acts on the ratio of board-certified and non-American Board of Plastic Surgeons physicians. METHODS: The authors performed a systematic Google search for the term "plastic surgeon [city name]" to simulate a patient search of online providers. Comparisons of board certification status between the top hits for each city were made. Data gathered included city population, regional location, practice setting, and states with the passage of truth-in-advertising laws. RESULTS: One thousand six hundred seventy-seven unique practitioners were extracted. Of these, 1289 practitioners (76.9 percent) were American Board of Plastic Surgery-certified plastic surgeons. When comparing states with truth-in-advertising laws and states without such laws, the authors found no significant differences in board-certification rates among "plastic surgery" practitioners (88.9 percent versus 92.0 percent; p = 0.170). There was a significant difference between board-certified "plastic surgeons" versus out-of-scope practitioners on Google search between large, medium, and small cities (100 percent versus 92.9 percent versus 86.5; p < 0.001). CONCLUSIONS: Non-board-certified providers tend to localize to smaller cities. Truth-in-advertising laws have not yet had an impact on the way a number of non-American Board of Plastic Surgery-certified practitioners market themselves. There may be room to expand the scope of truth-in-advertising laws to the online world and to smaller cities.

Australian regulation of autologous human cell and tissue products: implications for commercial stem cell clinics.

In 2018, Australia's Therapeutic Goods Administration introduced regulatory reforms that set stricter criteria around the regulation of products derived from a patient's own cells and tissues, posing significant implications for clinics offering stem cell treatments. We review the regulatory framework and discuss its potential commercial implications, including the ambiguities that may arise from it in practice, as well as the likely impact it will have on product development and advertising practices in the future.

Rogue stem cell clinics.

Cell therapies hold significant promise for the treatment of injured or diseased musculoskeletal tissues. However, despite advances in research, there is growing concern about the increasing number of clinical centres around the world that are making unwarranted claims or are performing risky biological procedures. Such providers have been known to recommend, prescribe, or deliver so called 'stem cell' preparations without sufficient data to support their true content and efficacy. In this annotation, we outline the current environment of stem cell-based treatments and the strategies of marketing directly to consumers. We also outline the difficulties in the regulation of these clinics and make recommendations for best practice and the identification and reporting of illegitimate providers. Cite this article: Bone Joint J 2020;102-B(2):148-154.

The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients.

The prevalence of businesses selling autologous stem cell-based interventions to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from 15 semistructured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments.

A Primer on Social Media Use by Young Plastic Surgeons.

Similar to the outcry over the ethics of website marketing by physicians in the 1990s, the resistance to plastic surgeons' use of social media has been loud and vehement. Many physicians, although receptive to website marketing, view social media as too radical or unprofessional. Despite the controversy, the value of social media as a communication tool for interacting with and educating patients is supported by studies showing that 65 percent of Americans and 90 percent of young adults use social media. Many plastic surgeons have been early adopters, as reflected by the articles written to help board-certified plastic surgeons use social media in academic medicine and for their practice. However, there is little guidance for young plastic surgeons who wish to use social media for professional purposes. In this study, the authors discuss the ethics and current literature on social media use by young plastic surgeons and make recommendations for how to use social media during training and after residency graduation.

Medical Marketing in the United States, 1997-2016.

IMPORTANCE: Manufacturers, companies, and health care professionals and organizations use an array of promotional activities to sell and increase market share of their products and services. These activities seek to shape public and clinician beliefs about laboratory testing, the benefits and harms of prescription drugs, and some disease definitions. OBJECTIVE: To review the marketing of prescription drugs, disease awareness campaigns, health services, and laboratory tests and the related consequences and regulation in the United States over a 20-year period (1997-2016). EVIDENCE: Analysis (1997-2016) of consumer advertising (Kantar Media data for spending and number of ads); professional marketing (IQVIA Institute for Human Data Science, Open Payments Data [Centers for Medicare & Medicaid Services]); regulations and legal actions of the US Food and Drug Administration (FDA), Federal Trade Commission (FTC), state attorneys general, and US Department of Justice; and searches (1975-2018) of peer-reviewed medical literature (PubMed), business journals (Business Source Ultimate), and news media (Lexis Nexis) for articles about expenditures, content, and consequences and regulation of consumer and professional medical marketing. Spending is reported in 2016 dollars. FINDINGS: From 1997 through 2016, spending on medical marketing of drugs, disease awareness campaigns, health services, and laboratory testing increased from $17.7 to $29.9 billion. The most rapid increase was in direct-to-consumer (DTC) advertising, which increased from $2.1 billion (11.9%) of total spending in 1997 to $9.6 billion (32.0%) of total spending in 2016. DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies. Pharmaceutical companies increased DTC marketing about diseases treated by their drugs with increases in disease awareness campaigns from 44 to 401 and in spending from $177 million to $430 million. DTC advertising for health services increased from $542 million to $2.9 billion, with the largest spending increases by hospitals, dental centers, cancer centers, mental health and addiction clinics, and medical services (eg, home health). DTC spending on advertising for laboratory tests (such as genetic testing) increased from $75.4 million to $82.6 million, although the number of ads increased more substantially (from 14 100 to 255 300), reflecting an increase in less expensive electronic media advertising. Marketing to health care professionals by pharmaceutical companies accounted for most promotional spending and increased from $15.6 billion to $20.3 billion, including $5.6 billion for prescriber detailing, $13.5 billion for free samples, $979 million for direct physician payments (eg, speaking fees, meals) related to specific drugs, and $59 million for disease education. Manufacturers of FDA-approved laboratory tests paid $12.9 million to professionals in 2016. From 1997 through 2016, the number of consumer and professional drug promotional materials that companies submitted for FDA review increased from 34 182 to 97 252, while FDA violation letters for misleading drug marketing decreased from 156 to 11. Since 1997, 103 financial settlements between drug companies and federal and state governments resulted in more than $11 billion in fines for off-label or deceptive marketing practices. The FTC has acted against misleading marketing by a single for-profit cancer center. CONCLUSIONS AND RELEVANCE: Medical marketing increased substantially from 1997 through 2016, especially DTC advertising for prescription drugs and health services. Pharmaceutical marketing to health professionals accounted for most spending and remains high even with new policies to limit industry influence. Despite the increase in marketing over 20 years, regulatory oversight remains limited.

Insta-grated Plastic Surgery Residencies: The Rise of Social Media Use by Trainees and Responsible Guidelines for Use.

BACKGROUND: Ethical guidelines for appropriate use of social media are beginning to be delineated. As social media becomes ingrained in plastic surgery culture, education of residents on appropriate use of social media is increasingly important. Recently, plastic surgery residency programs have begun to utilize social media. OBJECTIVES: This study characterized the trends and content of plastic surgery residency-associated Instagram accounts. METHODS: Active individual residency program Instagram accounts were identified for integrated plastic surgery programs. Metrics for each account were retrieved on September 16, 2017, including date of first post, number of posts, and followers. Individual posts were analyzed for content of post. RESULTS: Fourteen of 67 (21%) integrated plastic surgery programs were found to have active Instagram accounts. There has been an exponential growth of programs adopting Instagram since August 2015. A total of 806 posts were created. Thirty-two (3.97%) posts had intraoperative photos and only one (0.12%) showed a patient image. There were 4466 followers of plastic surgery residency programs. A linear correlation was found between number of posts and number of followers, while there was no correlation of number of followers and time since account start. CONCLUSIONS: Instagram use by plastic surgery integrated programs continues to grow exponentially, and programs are appropriately using the platform. Active use of the resident social media results in increased influence. Resident use of social media has many benefits. We propose social media guidelines for plastic surgery trainees and advocate for continued appropriate use and autoregulation by plastic surgery trainees.

Regulating the advertising and promotion of stem cell therapies.

There are widespread concerns with the ways in which 'unproven' stem cell therapies are advertised to patients. This article explores the potential and limits of using laws that regulate advertising and promotion as a tool to address these concerns. It examines general consumer protection laws and laws and policies on advertising medical products and services, focusing on the USA, Canada and Australia. The content of existing laws and policies covers most of the marketing practices that cause concern, but several systemic factors are likely to limit enforcement efforts. Potential reforms in Australia that would prevent direct-to-consumer advertising of autologous cell therapies are justified in principle and should be considered by other jurisdictions, but again face important practical limits to their effectiveness.

Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine.

Scientific knowledge and our understanding of the human body and diseases have limited any possible treatment tailoring to each patient. The technological advances enabling the integration of various data sets (e.g. '-omics', microbiome, epigenetics and environmental exposure) have facilitated a greater understanding of the human body, the molecular basis of disease and all the factors influencing disease onset, progression and response to treatment, thereby ushering in the era of personalized medicine. We evaluate the regulatory approaches available to facilitate early patient access to efficacious and safe compounds in the EU and the USA in order to make more informed recommendations in the future as to the gaps in regulations for early patient access. An in-depth analysis of conditional approvals (EU) and accelerated approvals (USA) is performed based on the publicly available information (European public assessment reports and a summary review of products approved under both programmes). The types of product, indications, time to approval and type of evidence submitted were analysed. Between 2007 and early 2015, 17 products were conditionally approved in the EU and 25 in the USA, most of them in the area of oncology and based on evidence from phase II clinical trial data. Early approval of promising products based on data from early phases of development is already possible in the EU and the USA. Some of the improvements could entail implementing a rolling assessment of evidence in Europe and extending the scope of early dialogues.

Biosimilars: from technical to pharmacoeconomic considerations. 30th Rencontres Nationales de Pharmacologie et Recherche clinique pour l'Innovation et l'Evaluation des Technologies de Santé. Tables rondes.

A biosimilar is a biological medicinal product claimed to be similar to a reference biological medicinal product. Its development plan includes studies comparing it with the reference product in order to confirm its similarity in terms of quality, preclinical safety, clinical efficacy, and clinical safety, including immunogenicity. Biosimilars differ from generics both in their molecular complexity and in the specific requirements that apply to them. Since patents on many biological medicinal products will expire within the next 5 years in major therapeutic areas such as oncology, rheumatology and gastroenterology and as those products are so costly to the French national health insurance system, the availability of biosimilars would have a considerable economic impact. The round table has issued a number of recommendations intended to ensure that the upcoming arrival of biosimilars on the market is a success, in which prescribing physicians would have a central role in informing and reassuring patients, an efficient monitoring of the patients treated with biologicals would be set up and time to market for biosimilars would be speeded up.

Cosmetic websites Scotland: legal or lurid.

BACKGROUND: The provision of cosmetic interventions and their advertising have recently come under intense scrutiny in the wake of the PIP scandal and Keogh report. AIM: A study of Scottish websites offering esthetic procedures was conducted to determine adherence to the advertising standards and regulations currently in place. METHODS: Regulations are provided by the Advertising Standards Authority, Committee on Advertising Practice, Independent Healthcare Advisory Services and General Medical Council. An Internet search was then conducted to search for providers of non-surgical and surgical cosmetic procedures. RESULTS: Overall 125 websites were reviewed. 109 local and 16 national with 17 websites associated with cosmetic surgeons. 26 websites failed to adhere to regulations. Failure was related to advertising of POM on the homepage or dropdown menu (20), offering enticements inappropriately (6). 26.6% of websites did not display qualifications of the practitioners. Only 16.6% of websites described the specific and the non-specific side effects of "anti-wrinkle injections" and only 12.5% mentioned alternative treatments. CONCLUSIONS: The majority of websites reviewed adhered to current advertising standards. Plastic surgeons provide a small percentage of cosmetic procedures. Greater regulation at the point of product entry and of all esthetic practitioners is required.

Aesthetic surgery and Google: ubiquitous, unregulated and enticing websites for patients considering cosmetic surgery.

BACKGROUND: Patient safety is a fundamental issue in aesthetic surgery. In an attempt to improve safety, the Department of Health (DoH) and Professor Sir Bruce Keogh published a review in 2013 of the regulation of cosmetic interventions. Proposals included: (1) Banning free consultations; (2) Restricting time-limited promotional deals; (3) Two-stage written pre-operative consent; (4) Consultations with a medical professional rather than a sales 'consultant'. The Cosmetic Surgical Practice Working Party (CSWP) recommended a two week "cooling off" period before surgery. This study quantified compliance with the above national initiatives by aesthetic surgery providers in the UK. METHODS: To replicate a patient searching for aesthetic surgery providers, "cosmetic surgery UK" was searched via Google. The top fifty websites of aesthetic surgery providers were included in the study. Websites were analysed for compliance with the DoH Keogh and CSWP recommendations. When clarification was required, aesthetic surgery providers were contacted via telephone. Pearson's Chi-squared test compared actual compliance with national recommendations of full compliance. RESULTS: Fifty cosmetic surgery providers in the UK entered the study. Consultations with the operating surgeon occurred in 90% of cases. Mean compliance with all parameters from the national guidelines was 41%, significantly less than the desired level of full compliance (P < 0.001). The majority offered free consultations (54%) and promotional deals (52%), of which 27% were time limited. No provider stipulated compliance with two stages of signed consent. CONCLUSION: This study demonstrated low compliance with national guidelines for aesthetic surgery. Aggressive sales techniques and enticing offers by aesthetic surgery providers were widespread. Statutory government guidelines on aesthetic surgery and increased public awareness into potential risks from inappropriate cosmetic surgery may improve patient decision making and safety.

[Internet presence of neurologists, psychiatrists and medical psychotherapists in private practice]. / Internetauftritte niedergelassener Neurologen, Psychiater und ärztlicher Psychotherapeuten.

OBJECTIVE: The world wide web provides new options to physicians in terms practice marketing, information brokerage, and process optimization. This study explores prevalence and content of homepages of neurologists, psychiatrists and medical psychotherapists in private practice. METHODS: Through the legal bodies of physicians in private practice in six northern German states neurologists, psychiatrists and medical psychotherapists were identified. According to a standardized and operationalized criteria catalogue, homepages were rated. RESULTS: 1804 physicians were identified, 352 (19.5 %) had operated a homepage. Higher frequencies of homepages found for male physicians (vs. female physicians), practice centres (vs. single practices) and urban practices (vs. rural practices). In average, practices reached 18.8 (±â€Š5.3) of 42 points; contact data and accessibility information were generally available; information as to qualification and specialization was provided more infrequently. Legal specifications were not considered in more than every second homepage, interactive elements like online appointment of follow-up prescription were only rarely offered. CONCLUSIONS: Only every fifth neurological or psychiatric practice operates an own homepage, higher competition (urban area) and higher professionalization (practice centres) seem to act as promotors. The legal framework has to be focused, and patient needs should be taken into account.

Conflicto de valores en el sistema de salud de Colombia: entre la economía de mercado y la normativa constitucional, 2007-2009 / Conflicting values in Colombia's health system: balancing the market economy and constitutional legislation, 2007-2009

OBJETIVO: Presentar los aspectos morales en conflicto en los procesos de toma de decisiones clínico-administrativas dentro del Sistema General de Seguridad Social en Salud (SGSSS) de Colombia. MÉTODOS: La investigación se llevó a cabo entre 2007 y 2009 en seis ciudades colombianas (Barranquilla, Bogotá, Bucaramanga, Leticia, Medellín y Pasto), según una metodología cualitativa basada en la teoría fundamentada. Se realizaron 179 entrevistas en profundidad a médicos, personal de enfermería y administradores con amplia experiencia en el sector de la salud, y 10 grupos focales con usuarios y líderes de organizaciones comunitarias vinculadas a la salud. Las entrevistas, con preguntas semiestructuradas y según una guía elaborada previamente, recababan información personal y profesional. RESULTADOS: En el proceso de toma de decisiones en la atención en salud en Colombia se identificaron elementos de dos morales enfrentadas: la rentista, caracterizada por la axiología neoliberal de la economía de mercado (práctica) y otra fundamentada en la axiología constitucional (normativa) del Estado social de derecho. Predomina el enfoque utilitarista e individualista y se promueve el lucro individual y empresarial por encima del interés colectivo; esto favorece prácticas que contravienen los derechos de las personas y la comunidad. CONCLUSIONES: El predominio de la moral que responde al modelo de mercado en el SGSSS colombiano genera condiciones adversas a los principios y valores que deben orientar el sistema de salud como garante del derecho a la salud y la dignidad humana. Para la toma de decisiones en salud es necesario tener en cuenta, además de los elementos técnicos y científicos, los principios y valores que están enfrentados y reflexionar sobre ellos para su legitimación.

OBJECTIVE: To present the conflicting moral issues that arise in clinical and administrative decision-making processes in Colombia's General Health Social Security System (SGSSS). METHODS: A study was conducted between 2007 and 2009 in six Colombian cities (Barranquilla, Bogotá, Bucaramanga, Leticia, Medellín, and Pasto) using a theory-based qualitative methodology. A total of 179 in-depth interviews were held with physicians, nursing personnel, and administrators with broad experience in the health sector, as well as 10 focus groups representing users and leaders of community organizations involved in health. The interviews, which followed a predetermined script and used semistructured questions, gathered personal and professional information from the respondents. RESULTS: The health care decision-making process in Colombia is seen from two different moral perspectives: the rentier, or profit-making, motive, characterized by a neoliberal view of the market economy (the practical perspective), and the constitutional axiology of social democracy (the regulatory perspective). It was found that the utilitarian and individualistic motive predominates, in which individual and business profits are promoted over the collective interest, and this trend favors practices that undermine the rights of people and the community. CONCLUSIONS: Predominance of a morality that views the Colombian SGSSS in terms of the market model generates conditions that go against the principles and values that are supposed to guide the health system as guarantor of the right to health and human dignity. Health decisions should take into account not only technical and scientific criteria but also the principles and values involved, and consideration should be given to safeguarding them.