Direct-to-Consumer Advertising for Cancer Centers and Institutes: Ethical Dilemmas and Practical Implications.

In the United States, many cancer centers advertise their clinical services directly to the public. Although there are potential public benefits from such advertising, including increased patient awareness of treatment options and improved access to care and clinical trials, there is also potential for harm through misinformation, provision of false hope, inappropriate use of health care resources, and disruption in doctor-patient relationships. Although patient education through advertising is appropriate, misleading patients in the name of gaining market share, boosting profits, or even boosting trial accrual is not. It is critical that rigorous ethical guidelines are adopted and that oversight is introduced to ensure that cancer center marketing supports good patient care and public health interests. Patients with cancer have been identified as an especially vulnerable population because of fears and anxiety related to their diagnosis and the very real need to identify optimal sources of care. Cancer organizations have a fiduciary duty and a moral and legal obligation to provide truthful information to avoid deceptive, inaccurate claims associated with treatment success. In this article, actionable recommendations are provided for both the oncologist and the cancer center's marketing team to promote ethical marketing of services to patients with cancer. This tailored guidance for the oncology community includes explicit communication on (1) ensuring fair and balanced promotion of cancer services, (2) avoiding exaggeration of claims in the context of reputational marketing, (3) providing data and statistics to support direct and implied assertions of treatment success, and (4) defining eligible patient groups in the context of marketing for research. These recommendations for cancer centers are designed to promote ethical quality marketing information to patients with cancer.

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.

Online Direct-to-Consumer Advertising of Stem Cell Therapy for Musculoskeletal Injury and Disease: Misinformation and Violation of Ethical and Legal Advertising Parameters.

BACKGROUND: There has been a recent surge in health-care providers offering stem cell therapy (SCT) to patients with musculoskeletal disease. The purpose of this study was to identify and quantify the misinformation present in online direct-to-consumer (DTC) advertising of SCT targeting patients with musculoskeletal disease in the U.S. It was hypothesized that DTC advertising of SCT contains substantial misinformation. METHODS: A list of keywords was used to identify web sites of practices advertising SCT directly to patients with musculoskeletal disease. Web sites were evaluated to determine the specialties of providers offering SCT, types of SCT being advertised, and misinformation presented. Categories of misinformation included false general claims, inaccurate statements regarding mechanism of action, unfounded results, and scare tactics. RESULTS: Of the 896 practice web sites included in the analysis, 95.9% contained at least 1 statement of misinformation, with a mean of 4.65 ± 3.66 statements of misinformation among the sites. Practices associated with an orthopaedic surgeon provided 22% fewer statements of misinformation than practices without an orthopaedic surgeon when we controlled for the effects of other specialties. Practices associated with a podiatrist also provided 22% fewer statements of misinformation. CONCLUSIONS: Nearly all practices failed to accurately represent the clinical efficacy of SCT in DTC advertising. While practices associated with an orthopaedic surgeon were less likely to provide misinformation, the majority of all web sites contained some type of misinformation, ranging from errors in the basic science of stem cells to outright false and misleading claims of their clinical effectiveness.

The opioid crisis: Origins, trends, policies, and the roles of pharmacists.

PURPOSE: The purpose of this review is to (1) provide information concerning the opioid crisis including origins, trends, and some important related laws/policies; and (2) summarize the current involvement and impact of pharmacists in helping to address the crisis, as well as examine practices in other healthcare disciplines from which pharmacists might derive guidance and strategies. SUMMARY: Contributors to the opioid crisis included campaigns to treat pain as a fifth vital sign and to use opioids in treatment of non-cancer-related pain, as well as aggressive marketing of opioid analgesics by pharmaceutical companies. To address the crisis, numerous strategies have been implemented at the policy/legislative, health-system, and patient levels, such as prescription drug monitoring programs (PDMPs), increased regulation of pain clinics, and expanded use of naloxone. Pharmacists have a critical role to play in interventions to address opioid misuse and reduce harm resulting from misuse. Such interventions include patient screening and risk stratification, patient and community education and outreach concerning appropriate pain management, medication reviews/medication therapy management, education on safe storage and disposal, distribution of naloxone/opioid rescue kits and training on their proper use, and referral of patients to addiction treatment, among other strategies. CONCLUSION: Pharmacists have multiple, complex roles in addressing the opioid crisis. Outcomes of several studies provide substantial evidence that pharmacists can make an impact through appropriate pain management, use of PDMPs, opioid overdose prevention training, and medication reviews and counseling, among other interventions.

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.

Disease awareness campaigns in printed and online media in Latvia: cross-sectional study on consistency with WHO ethical criteria for medicinal drug promotion and European standards.

BACKGROUND: European legislation prohibits direct-to-consumer advertising of prescription medicines, but allows drug manufacturers to provide information to the public on health and diseases. Our aim was to measure the frequency of disease awareness campaigns in Latvian media and assess their compliance with international and European standards. METHODS: Materials on health/disease and treatments were collected between April and September 2015 from 12 newspapers and magazines and six online portals. Disease awareness campaigns were assessed using a previously developed instrument based on the WHO Ethical Criteria for Medicinal Drug promotion and European standards (EU law and pharmaceutical industry self-regulatory guidelines). Collected materials were used to examine the information provided on medical conditions and their diagnosis and treatment. The inter-rater reliability was calculated. RESULTS: We collected 263 materials from print (n = 149) and online media (n = 114); 94 were news items and 169 were disease-awareness advertisements. Cancer, cardiovascular problems, allergies and respiratory diseases were common topics. Of the 157 campaigns assessed, non-compliance was identified in 149 cases (inter-rater reliability 90%), mainly due to misleading or incomplete information, lack of balance and the absence of a listed author/sponsor. Six disease awareness campaigns directly mentioned a pharmaceutical product by brand name and other four included the logo or name of a manufacturer, referred to a condition and indirectly mentioned a treatment, all in contravention with European law. CONCLUSIONS: The compliance of disease awareness campaigns in Latvian media with international and European standards is low. This raises concerns about the nature of information being conveyed. Through lack of balance, missing sponsorship information, and misleading or incomplete information, these campaigns could contribute to inaccurate self-diagnosis and generate demand among those who might not need medical treatment.

Marketing of food and beverage in Brazil: scientific literature review on regulation and self-regulation of advertisements / Publicidade de alimentos e bebidas no Brasil: revisão de literatura científica sobre regulação e autorregulação de propagandas / Publicidad de alimentos y bebidas en Brasil: revisión de la literatura científica sobre regulación y auto-regulación de propagandas

The effects of marketing strategies for promotion of foods and beverages have been investigated due to its potential impacts on populations' food choices, particularly among children and adolescents. The paper presents an academic literature review on regulation and self-regulation of food and beverage advertisements in Brazil, based on search performed in electronic databases. Majority of studies were based on law analysis or qualitative study of advertisements. There are sufficient evidences on the need for government regulation of advertisements addressed to children and adolescents complementarily to institutional self-regulation in order to tackle ethical transgressions on food and beverage advertisements identified in Brazil. Additionally, there should be imposition of rigorous penalties for noncompliance to ethical rules and proposition of incentives towards actions encouraging healthy food consumption patterns, in order to comprise an actual system for promotion of public health.

Os efeitos de estratégias de marketing para promoção de alimentos e bebidas têm sido investigados devido aos potenciais impactos sobre escolhas alimentares populacionais, particularmente entre crianças e adolescentes. O artigo apresenta revisão de literatura acadêmica sobre regulação e autorregulação de propagandas de alimentos e bebidas no Brasil, baseada em busca realizada em bases de dados eletrônicas. A maioria dos estudos identificados referia-se a análise de legislação ou estudo qualitativo das propagandas. Há evidências de necessidade de regulação das propagandas direcionadas a crianças e adolescentes em complementação ao sistema de autorregulação institucional para combate às transgressões éticas identificadas em propagandas de alimentos e bebidas no Brasil. Adicionalmente, há necessidade de aplicação de penalidades severas para transgressões éticas, assim como incentivos às ações de apoio à alimentação saudável para compor um sistema efetivo de promoção da saúde pública.

Los efectos de estrategias de marketing para promoción de alimentos y bebidas se han investigado debido a los potenciales impactos sobre elecciones alimenticias poblacionales, particularmente entre niños y adolescentes. El artículo presenta una revisión de la literatura académica sobre regulación y auto-regulación de propagandas de alimentos y bebidas en Brasil, con base en una búsqueda realizada en bases de datos electrónicas. La mayoría de los estudios identificados se refería al análisis de la legislación o estudio cualitativo de las propagandas. Hay evidencias de la necesidad de regulación de las propagandas dirigidas a niños y adolescentes en complementación al sistema de auto-regulación institucional para el combate a las transgresiones éticas identificadas en propaganda de alimentos y bebidas en Brasil. Adicionalmente, hay la necesidad de aplicación de penalidades severas para transgresiones éticas, así como incentivos a las acciones de apoyo a la alimentación saludable para componer un sistema efectivo de promoción de la salud pública.

The possibility of obtaining marketing authorization of orphan pharmaceutical compounding preparations: 3,4-DAP for Lambert-Eaton Myasthenic Syndrome.

BACKGROUND: Pharmaceutical compounding preparations, produced by (hospital) pharmacies, usually do not have marketing authorization. As a consequence, some of these pharmaceutical compounding preparations can be picked-up by a pharmaceutical company to obtain marketing authorization, often leading to price increases. An example is the 3,4-diaminopyridine slow release (3,4-DAP SR) tablets for Lambert-Eaton Myasthenic Syndrome (LEMS). In 2009 marketing authorization was given for the commercial immediate release phosphate salt of the drug, including a fifty-fold price increase compared to the pharmaceutical compounding preparation. Obtaining marketing authorization for 3,4-DAP SR by academia might have been a solution to prevent this price increase. To determine whether the available data of a pharmaceutical compounding preparation with long-term experience in regular care are adequate to obtain marketing authorization, 3,4-DAP SR is used as a case study. METHODS: A retrospective qualitative case-study was performed. Initially, document analysis was executed by collecting the required data for marketing authorization in general and whether data of Firdapse® and 3,4-DAP SR met these requirements. Secondly, the (non-) available data of the two formulations were compared with each other to determine the differences in availability. RESULTS: At the time of approval, almost all data were available for both Firdapse® and 3,4-DAP SR. Conversely, much of the data used for the approval of Firdapse® originated from the 3,4-DAP immediate release (3,4-DAP IR) formulation. Only two bioequivalence studies and one pharmacology safety study was performed with Firdapse® before marketing authorization application. CONCLUSIONS: In conclusion, at time Firdapse® obtained approval, the data available did not differ substantially from 3,4-DAP SR, indicating that approval with 3,4-DAP SR would have been possible. We make a plea for approval of orphan medicinal products developed and manufactured by academic institutions as to keep utilization of these products affordable.

How can we restrict the sale of sports and energy drinks to children? A proposal for a World Health Organization-sponsored framework convention to restrict the sale of sports and energy drinks.

High-sugar drinks, including fruit drinks, soft drinks, sports drinks and energy drinks, are of no nutritional value and contribute to the burden of dental disease in all age groups. The manufacturers of sports and energy drinks have elected to target children in their marketing campaigns and promote a misleading association between their products, healthy lifestyles and sporting prowess. The World Health Organization (WHO) has acknowledged that strategies aimed at prevention of dental disease are the only economically viable options for managing the oral health of children in low- and middle-income countries. Developed nations will also be advantaged by preventive programmes given that the cost of providing dental care to those who cannot pay draws valuable resources away from more pressing health issues. The Convention on the Rights of the Child (CRC) obligates governments to develop legislation to protect the health of children. A framework convention modelled on the existing Framework Convention for Tobacco Control, supported by the WHO, would assist governments to proactively legislate to restrict the sale of sports and energy drinks to children. This article will consider how a framework convention would be an advantage with reference to the strategies used by sports and energy drink manufacturers in Australia.

FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process.