Direct-to-Consumer Drug Company Pharmacies.

The recent launch of direct-to-consumer pharmacy LillyDirect prompts the author of this Viewpoint to consider why it was created and also to raise concerns about allowing manufacturers to sell their drugs directly to patients.

US businesses engaged in direct-to-consumer marketing of perinatal stem cell interventions following the Food and Drug Administration's enforcement discretion era.

BACKGROUND AIMS: The goal of this study was to analyze online marketing representations made by 300 US businesses selling allogeneic perinatal stem cell products. The study was conducted after a period of enforcement discretion by the US Food and Drug Administration (FDA). METHODS: Data mining and content analysis were used to identify, analyze and categorize marketing claims made on the websites of 300 businesses selling perinatal stem cell interventions. RESULTS: The study identified types of perinatal interventions companies advertised, geographic locations of clinics selling such products, types of companies operating in this space, diseases and injuries such businesses claim to treat, prices companies charge for such interventions, brand names of advertised perinatal cell products and identities of suppliers. CONCLUSIONS: A substantial number of US businesses market unapproved perinatal stem cell products for various indications. This widespread commercial activity occurred following the conclusion of a period of enforcement discretion by the FDA and suggests the need for more robust and comprehensive regulatory responses to businesses selling unapproved perinatal stem cell products.

Direct-to-Consumer Advertising Survey of Psychiatrists in Massachusetts and Michigan.

PURPOSES/BACKGROUND: The goals of this preliminary study were to survey psychiatrists and to examine the impact of advertisements on their prescription of psychotropic medications. The study specifically looked at psychiatrists in Massachusetts and Michigan, as the authors were able to readily contact the members of their respective state psychiatric societies. METHODS/PROCEDURES: We used the survey software, Quatrics, to create an online survey that was sent via email link to the members of the Massachusetts Psychiatric Society (1400 estimated members), and the Michigan Psychiatric Society (700 estimated members). Details were obtained about how challenging it was for the psychiatrist to convince the patient that a medication was not indicated. Information regarding how the psychiatrist first heard about new medications and where they go to learn more about these medications was included in the survey. FINDINGS/RESULTS: We received 162 partial or full responses to our survey, representing a response rate of 8%. Those who were less than 10 years out of training were less likely to find it "easy" to change the minds of these patients, when compared with those more than 10 years out of training (Fisher exact test, P = 0.0396). The most frequent medication named as a response to "which medications do patients request" was Rexulti (brexpiprazole), followed by Vraylar (cariprazine), Caplyta (lumateperone), and aripiprazole. IMPLICATIONS/CONCLUSIONS: This survey points to the prevalence of psychiatrists getting requests for these advertised medications and illustrates that those with fewer years out of training may have a more difficult time redirecting patients from medications that are not indicated for their illness.

Compounded bioidentical menopausal hormone therapy ACOG clinical consensus nº 6

Many compounding pharmacies use the phrase "bioidentical hormone" as a marketing term to imply that these preparations are natural and, thus, safer and more effective than U.S. Food and Drug Administration (FDA)­approved menopausal medications that use bioidentical or synthetic hormones or both. However, evidence to support marketing claims of safety and effectiveness is lacking. Compounded bioidentical menopausal hormone therapy should not be prescribed routinely when FDA-approved formulations exist. Clinicians should counsel patients that FDA-approved menopausal hormone therapies are recommended for the management of menopausal symptoms over compounded bioidentical menopausal hormone therapy. If a patient requests the use of compounded bioidentical menopausal hormone therapy, clinicians should educate them on the lack of FDA approval of these preparations and their potential risks and benefits, including the risks specific to compounding. To truly understand the benefits and harms of compounded bioidentical menopausal hormone therapy, high quality placebo-controlled randomized controlled trials with long-term follow-up comparing custom-compounded products with FDA-approved menopausal hormone therapy are needed.

Regulatory claims made by US businesses engaged in direct-to-consumer marketing of purported stem cell treatments and exosome therapies.

Aim: This study investigated whether US businesses engaged in direct-to-consumer online marketing of purported stem cell therapies and stem cell-derived exosome products made claims concerning the regulatory status of these interventions. Methods: We used data mining and content analysis of company websites to examine regulatory-related representations made by US businesses marketing stem cell treatments and exosome therapies. Results: More than two thirds of such businesses did not make explicit representations about the regulatory status of their marketed products. Businesses that made claims about the regulatory status of the stem cell and exosome products they sold used range of representations concerning the legal standing of these interventions. Conclusion: The absence of information addressing the regulatory status of stem cell interventions and exosome products and the use of what appeared to be inaccurate information concerning the regulatory status of numerous products likely complicates efforts by customers to make informed health-related decisions.

Websites Selling Direct-to-Consumer Anti-Mullerian Hormone Tests.

Importance: The recent provision of direct-to-consumer (DTC) Anti-Mullerian Hormone (AMH) testing in several countries has been contentious, particularly due to concerns about judicious testing and informed consent. Objective: To describe and analyze information on websites that sell DTC AMH tests. Design, Setting, and Participants: Qualitative study including content analysis of text information from websites in multiple countries that sell AMH tests DTC. The top 50 search results from 4 different internet search strings were captured and reviewed for eligibility. Data were extracted in March 2022 and analyzed from April 2022 to July 2023. Main outcomes and measures: Themes and categories were derived from the website content using a conventional inductive approach, with a particular focus on information content, quality and accuracy, as well as the tone and language used. Results: Twenty-seven websites across 7 different countries formed the sample for analysis. Information varied considerably across websites and was organized into 6 overarching categories: (1) whether a test description was included (25 websites [93%]); (2) statements about what the test can do, which included indicating ovarian reserve (26 websites [96%]) and indicating likelihood of conceiving (20 websites [74%]); (3) statements about the usefulness of the test result, which included enabling women to adjust their reproductive timeline (11 websites [41%]) and determining whether egg freezing was a viable option (8 websites [30%]); (4) blood collection method (ie, through a laboratory or an at-home sample); (5) promotion tactics, such as stating the convenience of testing (24 websites [89%]) and using language promoting empowerment and control (7 websites [26%]); and (6) statements about limitations of the test, which included polycystic ovary syndrome falsely inflating AMH levels (13 websites [48%]) and that it cannot accurately predict chances of conceiving (9 websites [33%]). Conclusion and relevance: In this qualitative study including content analysis, most websites selling DTC AMH tests included false and misleading claims which might lead consumers to purchase an AMH test in the belief that it can reliably predict fertility potential and age of menopause. Depending on the test result, this may in turn lead to misplaced anxiety or reassurance about one's fertility and modifications to subsequent conception or contraceptive plans and behavior.

Critical Test of the Beneficial Consequences of Lifting the Ban on Direct-to-Consumer Advertising for Prescription Drugs in Italy: Experimental Exposure and Questionnaire Study.

BACKGROUND: There are only two countries in the world (the United States and New Zealand) that allow the pharmaceutical branch to advertise prescription medication directly to consumers. There is pressure on governments to allow direct-to-consumer advertising (DTCA) for prescription drugs elsewhere too. One argument the industry uses frequently is the claim that exposure to DCTA, through various methods and occasions, is supposed to improve customers' knowledge of a disease and treatment. This argument has been part of the health care community's wider discussion of whether DTCA of prescription drugs benefits the population's general interest or is only an attempt to increase the sales of the pharmaceutical branch. Belief in true learning by DTCA is rooted in concepts of empowered consumers and their autonomous and empowered decision-making. OBJECTIVE: In this study, we tested the hypotheses that contact with DTCA increases recipients' literacy/knowledge, especially regarding the side effects of treatment (hypothesis 1), and empowerment (hypothesis 2). We further hypothesized that DTCA exposure would not increase depression knowledge (ie, about treatments, symptoms, and prevalence) (hypothesis 3). METHODS: A snowball sample of 180 participants was randomly split into three experimental groups receiving (1) a traditional information sheet, (2) a DTCA video clip for an antidepressant prescription drug, or (3) both. The video was original material from the United States translated into Italian for the experiment. Dependent variables were measures of depression knowledge (regarding treatments, symptoms and prevalence, and antidepressant side effects), depression literacy, and empowerment. RESULTS: None of the experimental groups differed significantly from the others in the empowerment measure (hypothesis 2 not confirmed). Partial confirmation of hypothesis 1 was obtained. Lower values on the depression literacy scale were obtained when participants had been given the video compared to the sheet condition. However, the general depression knowledge and its subscale on side effects reached higher scores when participants were exposed to the DTCA, alone or in combination with the information sheet. Finally, participants showed lower scores on knowledge about treatment and symptoms or prevalence after watching the video compared to the sheet condition (hypothesis 3 confirmed). Symptoms and prevalence knowledge increased only when the video was presented in combination with the sheet. CONCLUSIONS: There is no evidence for an increase in empowerment following DTCA exposure. An increase in knowledge of the side effects of the medication was observed in the group exposed to the DTCA video. This was the only result that confirmed the hypothesis of the beneficial effect of DTCA videos on knowledge. Written information proved to be the most suitable way to convey knowledge on treatments and symptoms prevalence. Our findings support the necessity of studying health literacy and patient empowerment together and the consequences of such an increase in knowledge in terms of help-seeking behavior.

Is exposure to pharmaceutical direct-to-consumer advertising for heart disease and diabetes associated with physical activity and dietary behavior?

CONTEXT: Scholars have suggested that direct-to-consumer advertising (DTCA) of prescription drugs may discourage or encourage changes in lifestyle to improve health. The current paper informs this debate by examining associations between estimated exposure to DTCA for drugs focused on heart disease/cholesterol and diabetes and self-reported exercise and consumption of a variety of unhealthy foods (candy, sugary drinks, alcohol, and fast food). METHODS: We estimated exposure to DTCA by combining data from Kantar Media Intelligence (Kantar) on televised pharmaceutical DTCA airings in the U.S. from January 2003 to August 2016 (n = 7,696,851 airings) with thirteen years of data from the Simmons National Consumer Survey (Simmons), a mailed survey on television viewing patterns. We estimated associations between exposure to advertising (both overall and for advertisements with specific content) and self-reported physical activity and dietary behavior using Simmons data from January 2004 to December 2016 (n = 288,483 respondents from n = 157,621 unique households in the U.S.). Our analysis controls for many potential confounders including respondent demographics, temporal trends, and program placement to account for purposeful ad targeting to higher-risk adults. FINDINGS: Higher estimated exposure to DTCA for heart disease and diabetes drugs were not consistently associated with meaningful differences in the frequency of engaging in regular physical activity. Greater estimated exposure to DTCA for both diseases were, linked to small but consistently higher volume of consumption of candy, sugar-sweetened beverages, alcohol, and fast food. Specific DTCA message content about diet and exercise explained very little of the observed association between overall DTCA exposure volume and study outcomes. CONCLUSIONS: Many Americans were regularly exposed to pharmaceutical DTCA for heart disease and diabetes from 2003 to 2016. Widespread exposure to such DTCA is associated with higher levels (though small in magnitude) of consuming alcohol, fast food, candy, and sugar-sweetened beverages.

Analysis of the promotion of consumer psychological analysis and marketing to sports propaganda / Análisis de la promoción del análisis psicológico del consumidor y marketing a la propaganda deportiva

In recent years, the number of sports enthusiasts in China has increased. Other domestic and international sporting goods manufacturers have also cited running gear as a primary development focus. The geographical environment and its environment heavily influence the marketing approach for the running brand Decay in a particular region. This study used the PEST analysis tool to investigate the region's political, economic, social, cultural, technological development, and other environmental factors. The SWOT analysis tool evaluated Decathlon's strengths, weaknesses, opportunities, and threats. This study studied Decathlon's marketing strategies from the 4P and 4C perspectives, described and assessed the emerging marketing strategies, including the tactics to encourage and inhibit its development, and offered some improvement approaches. In 2021, the Decathlon sports brand will see a growth rate of 65.69%, while in 2022, the growth rate will drastically drop to 15.69%. Even though the company's revenue growth rate has slowed, the overall profit margin has not altered substantially and has maintained at roughly 29%, demonstrating that the marketing strategy is highly significant. A sports brand's marketing plan offers more advantages than its price and channel strategies.(AU)

Patient Understanding of Oncology Clinical Trial Endpoints in Direct-to-Consumer Television Advertising.

BACKGROUND: This study examined how people interpret overall survival (OS), overall response rate (ORR), and progression-free survival (PFS) endpoints in the context of direct-to-consumer television ads. Although there is little research on this topic, initial evidence suggests that people can misinterpret these endpoints. We hypothesized that understanding of ORR and PFS would be improved by adding a disclosure ("We currently do not know if [Drug] helps patients live longer") to ORR and PFS claims. METHODS: We conducted 2 online studies with US adults examining television ads for fictional prescription drugs indicated to treat lung cancer (N = 385) or multiple myeloma (N = 406). The ads included claims about OS, ORR with and without a disclosure, or PFS with and without a disclosure. In each experiment, we randomized participants to view 1 of 5 versions of a television ad. After viewing the ad twice, participants completed a questionnaire that measured understanding, perceptions, and other outcomes. RESULTS: In both studies, participants correctly differentiated between OS, ORR, and PFS via open-ended responses; however, participants in the PFS conditions (versus ORR conditions) were more likely to make incorrect inferences about OS. Supporting the hypothesis, adding a disclosure made expectations around living longer and quality-of-life improvements more accurate. CONCLUSION: Disclosures could help reduce the extent to which people misinterpret endpoints like ORR and PFS. More research is needed to establish best-practice recommendations for using disclosures to improve patient understanding of drug efficacy without changing their perception of the drug in unintended ways.

A scoping review of empirical research on prescription drug promotion.

BACKGROUND: Pharmaceutical spending on prescription drug promotion is considerable, and exposure to advertising can influence demand and behavior. The U.S. Food and Drug Administration (FDA) provides industry guidance to help ensure that communications to consumers and health care providers about prescription drug promotion are truthful, balanced, and accurately communicated. As empirical research has accelerated on this topic in the past decade, an understanding of the current landscape of the science will help inform future research. OBJECTIVES: Using systematic methods, this rigorous scoping review of the literature over the past decade (2012-2021) (1) examined the extent to which prescription drug promotion has been empirically investigated with consumers, patients, and health care providers; (2) examined the extent to which content and features of prescription drug promotion have been empirically investigated; and (3) identified themes across the literature to better understand the current landscape of prescription drug promotion. METHODS: Databases searched include PubMed, Web of Science, CINAHL, APA PsycInfo, Business Source Corporate, Communication Source, Cochrane Library, and ClinicalTrials.gov for original research published in English from January 1, 2012, through November 10, 2021, using terms related to direct-to-consumer advertising, prescription drugs, and outcomes of interest (e.g., attitudes, perceptions, intentions, behaviors). RESULTS: Of 804 screened references, 151 studies addressed the first research question, and 40 studies addressed the second. The most common theme across the body of evidence focused on testing of features and content in prescription drug promotional materials (84), followed by studies examining attitudes, perceptions, and behaviors toward prescription drug promotion more generally (43). Some (27) studies focused on targeted populations, such as patients, the elderly, non-English speaking people or individuals of a non-white race/ethnicity. Twenty-four studies assessed influence of exposure to prescription drug promotion on actual clinical outcomes, while 11 studies examined emerging technologies around prescription drug promotion. Seven studies evaluated the extent to which prescription drug promotion complied with existing guidelines and requirements. CONCLUSIONS: Findings from this scoping review suggest there has been an increase in the number of empirical studies conducted on prescription drug promotion over the past decade. Potential areas that warrant further study include examination of emerging technologies, an expanded focus on targeted populations, and construct measurement.

Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising.

Importance: Some drugs are heavily marketed through direct-to-consumer advertising. Objective: To identify drug characteristics associated with a greater share of promotional spending on advertising directly to consumers. Design, Setting, and Participants: Exploratory cross-sectional analysis of drug characteristics and promotional spending for the 150 top-selling branded prescription drugs in the US in 2020 as identified from IQVIA National Sales Perspectives data. Promotional spending data were provided by IQVIA ChannelDynamics. Exposures: Drug characteristics (total 2020 sales; total 2020 promotional spending; clinical benefit ratings; number of indications, off-label use; molecule type; nature of condition treated; administration type; generic availability; US Food and Drug Administration [FDA] approval year, World Health Organization anatomical therapeutic chemical classification; Medicare annual mean spending per beneficiary; percent sales attributable to the drug; market size; market competitiveness) assessed from health technology assessment agencies (France's Haute Autorité de Santé and Canada's Patented Medicine Prices Review Board) and drug data sources (Drugs@FDA, the FDA Purple Book, Lexicomp, Merative Marketscan Research Databases, and Medicare Spending by Drug data). Main Outcomes and Measures: Proportion of total promotional spending allocated to direct-to-consumer-advertising for each drug. Results: The 2020 median proportion of promotional spending allocated to direct-to-consumer advertising was 13.5% (IQR, 1.96%-36.6%); median promotional spending, $20.9 million (IQR, $2.72-$131 million); and median total sales, $1.51 billion (IQR, $0.97-$2.26 billion). Of the 150 best-selling drugs, 16 were missing data and key covariates; therefore, the primary study sample comprised 134 drugs. After adjustment for multiple drug characteristics, the mean proportion of total promotional spending allocated to direct-to-consumer advertising for the remaining 134 drugs was an absolute 14.3% (95% CI, 1.43%-27.2%; P = .03) higher for those with low added clinical benefit than for those with high added clinical benefit and an absolute 1.5% (95% CI, 0.44%-2.56%; P = .005) higher for each 10% increase in total sales. Conclusions and Relevance: Among top-selling US drugs in 2020, a rating of lower added benefit and higher total drug sales were associated with a higher proportion of manufacturer total promotional spending allocated to direct-to-consumer advertising. Further research is needed to understand the implications of these findings.

Direct-to-consumer orthodontics: Exploring laypeople's perception of orthodontic treatment complexity.

BACKGROUND: The authors aimed to explore the treatment preferences of laypeople regarding direct-to-consumer (DTC) orthodontics and to identify whether case complexity, as perceived by laypeople, is one of the factors influencing interest in DTC orthodontics. METHODS: An online cross-sectional survey was conducted. Data analysis was performed using logistic regression models. RESULTS: A total of 1,362 surveys were completed. A significant inverse association was identified between the complexity of an orthodontic case, as measured using the American Board of Orthodontics' discrepancy index (DI) score, and the likelihood of choosing DTC treatment over an orthodontist. Participants were 3.53 times more likely to choose DTC treatment for a mild case (DI score, 0-10) compared with a complex case (DI score, > 20), although the likelihood of choosing DTC treatment for a moderate case (DI score, 11-20) was only 1.79 times higher than for a complex case. CONCLUSIONS: When laypeople were asked to consider each case as if it were their own dentition, there was a significant inverse association between the complexity of an orthodontic case, as measured using the DI score, and the likelihood of choosing DTC treatment over an orthodontist. Laypeople were seemingly more likely to choose DTC orthodontics for dentitions that did not appear crowded and were well aligned within the arches. Laypeople seemed to have an understanding that there are some limitations to DTC orthodontics. PRACTICAL IMPLICATIONS: Orthodontists should better understand the factors influencing consumers' decisions to select DTC orthodontics and dental organizations should focus their educational campaigns on these factors.

Direct-to-consumer prescription medication advertisements on social media: The role of social factors.

This study examines the association of social factors with the intention to seek and behavior of obtaining additional prescription medication information after direct-to-consumer prescription medication advertisement (DTCA) exposure. Data were analyzed from 667 college students who were exposed to online social media advertisements. Subjective norms and trust were both positively associated with intentions and behavior. Bridging social capital was positively associated with intentions but not with behavior. Bonding social capital was negatively associated with intentions while it was positively associated with behavior. Pharmaceutical companies should consider subjective norms and trust when advertising prescription medications on online social media.

Association of Direct-to-Consumer Advertising of Prescription Drugs With Consumer Health-Related Intentions and Beliefs Among Individuals at Risk of Cardiovascular Disease.

Importance: Consumers in the US are exposed to unprecedented high levels of direct-to-consumer advertising (DTCA) for prescription drugs, yet there is limited evidence regarding their effect on health-related intentions and beliefs. Objective: To provide evidence on the association of DTCA for prescription drugs with consumer health-related intentions and beliefs. Design, Setting, and Participants: This cross-sectional study recruited participants from a nationally representative sample of individuals at high risk of cardiovascular disease. Participants were randomly assigned into 1 of 3 study arms: (1) exposure to DTCA for heart disease medications (treatment 1 [n = 926]), (2) exposure to DTCA for heart disease medications with price disclosure (treatment 2 [n = 921]), (3) and exposure to nonpharmaceutical advertising (control group [n = 902]). Each study arm viewed five 1-minute video advertisements, totaling 5 minutes of advertising exposure. The 2 treatment arms viewed pharmaceutical advertising videos for 4 heart disease medications, and the control arm viewed nonpharmaceutical advertising videos. Participants then completed a survey questionnaire to measure medication- and lifestyle-related intentions and health-related beliefs and perceptions. Exposures: Direct-to-consumer advertising for heart disease medications (treatment 1), DTCA for heart disease medications with price disclosure (treatment 2), and nonpharmaceutical advertising (control group). Main Outcomes and Measures: The primary outcomes included ordinal measures of medication- and lifestyle-related intentions, health-related beliefs, and brand perceptions. Results: Among the 2874 included participants (mean [SD] age, 53.8 [7.1] years; 1549 [54%] male) χ2 tests confirmed that there were no statistically significant differences in baseline demographic characteristics across study arms. There was a positive association between DTCA and medication-related behavioral intentions, including intention to switch medication (marginal effect [ME] = 0.004; P = .002) and engage in information-seeking behaviors (ME = 0.02; P = .01). There was no evidence that pharmaceutical DTCA discouraged use of nonpharmacological lifestyle interventions that can help manage heart disease (eg, diet and exercise), and DTCA exposure also had a positive association with consumers' favorable perceptions of pharmaceutical manufacturers (competence: ME = 0.03; P = .01; innovative: ME = 0.03; P = .008). There was no evidence for differential associations of price disclosures in DTCA. Conclusions and Relevance: In this cross-sectional study, results showed that brief exposure to pharmaceutical DTCA had a large and positive association with medication-related demand intentions with no offsetting negative spillovers on lifestyle-related intentions. Lack of associations with price disclosure in DTCA suggests that policy makers should consider alternative strategies to promote value-based decision-making for prescription drugs.

Responses to direct-to-consumer advertising in Australia: Comparing experience.

AbsractThis paper examines the potential effect of Direct-to-Consumer (DTC) advertising on consumers' behavioral intentions in relation to a medical issue. Using an online experiment, 1295 people were randomized to two information conditions. One group watched an advertisement for a hypothetical cold sore medicine, while a second (control) group did not view the advertisement, before both groups answered questions on symptoms. The responses were analyzed based on group allocation and the respondents' experience with cold sores. Results indicate that those who viewed the advertisement were more likely to choose the product, and the advertisement had larger effects based on consumer experience.