Single Visit Evaluation and Tympanostomy Tube Placement for the Treatment of Acute Otitis Media in Children.

OBJECTIVE: To review our experiences with development of a single visit surgery (SVS) program for children with recurrent acute otitis media (AOM) undergoing tympanostomy tube (TT) placement the same day as their otolaryngology surgical consultation. STUDY DESIGN: Retrospective cohort analysis. METHODS: Retrospective series of patients participating in SVS from inception March 1, 2014 to April 30, 2020 were analyzed, with attention to factors associated with increasing interest and participation in SVS and parent experiences/satisfaction. RESULTS: A total of 224 children had TT placed through SVS for AOM management. The average age of patients was 18.1 months (standard deviation 7.8 months), and 130 (58.0%) were male. The median interval between initial contact to schedule SVS, and the SVS date was 15 days (interquartile range 9-23 days). When analyzing year-over-year volumes from inception of SVS, notable increases were seen in 2016 and 2017 after a radio advertisement was played locally. A marked increase in volume was noted after implementation of a Decision Tree Scheduling (DTS) algorithm for children with recurrent AOM. Sixty-six (28.8%) procedures were performed after institution of DTS. A parent survey demonstrated high levels of satisfaction with the SVS experience. Estimations of savings to families in terms of time away from work demonstrated potential for indirect healthcare benefits. CONCLUSIONS: SVS for TT placement was a successful, alternative model of care for management of children with AOM. Marketing strategies regarding SVS, and the inclusion of SVS pathway in DTS platforms increased rates of interest and choice of this option. Parents of children undergoing TT through SVS were satisfied with the overall experience. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2823-2829, 2021.

Moving somatic gene editing to the clinic: routes to market access and reimbursement in Europe.

Somatic gene editing (SGE) holds great promise for making genetic therapy possible for many monogenic conditions very soon. Is our current system of European market authorization and reimbursement ready for the expected tsunami of gene therapies? At a recent workshop of the Netherlands ZonMw consortium on ethical, legal, and social implications of personalized medicine, we discussed the current possibilities for bringing new gene therapies to the clinic. In Europe, it is not yet clear whether the route via the European medicines agency as an advanced therapy medicinal product is the most appropriate for evaluation of highly personalized SGE applications, although this may optimally guarantee safety and effectiveness. Compassionate use may ensure faster access than the centralized procedure but does not stimulate the commercial development of products. Prescription to named patients may only provide adequate access for single patients. Temporary authorization of use may allow access to medication half a year before formal market authorization has been granted, but may also have large budget impacts. Magistral compounding under a hospital exemption may be an attractive solution for rare, tailor-made applications at an acceptable price. To approve local experimental use of a therapy on a case-by-case basis may be fast, but does not guarantee optimal safety, effectiveness, and broad implementation. We argue that alternative routes should be considered for products developed for a market of large groups of patients versus unique personalized treatments. A balance between scientific evidence for safety and effectiveness, affordability, and fast access may demand a range of alternative solutions.

Instacash: The Ethics of Leveraging Medical Student Status on Social Media.

Some medical students leverage their medical student status for profit as social media influencers on platforms such as Instagram. Depending on the size of their following and the brand they are promoting, students can make thousands of dollars per year by advertising products ranging from scrubs to protein powder to mattresses. Yet, they receive few tools as part of their education to help them understand how to reconcile their professional obligations with a desire to generate an income. After examining the potential benefits and harms of social media use, this article considers the possibility of medical student financial gain from being an influencer in light of seasoned physicians' own efforts to profit from industry alliances. Through both historical and contemporary lenses, the authors consider the tension between doctors as healers and moneymakers, before concluding with practical and philosophical approaches for guiding medical student influencers.

Innovative Recruitment Strategies to Increase Diversity of Participation in Parkinson's Disease Research: The Fox Insight Cohort Experience.

BACKGROUND: Clinical research in Parkinson's disease (PD) faces practical and ethical challenges due to two interrelated problems: participant under-recruitment and lack of diversity. Fox Insight (FI) is a web-based longitudinal study collecting patient-reported outcomes and genetic data worldwide to inform therapeutic studies. FI's online platform provides an opportunity to evaluate online strategies for recruiting large, diverse research cohorts. OBJECTIVE: This project aimed to determine 1) whether FI's digital marketing was associated with increased enrollment overall and from under-represented patient groups, compared to traditional recruitment methods; 2) the clinical and demographic characteristics of samples recruited online, and 3) the cost of this online recruitment. METHOD: FI recruitment during a 6-week baseline period without digital promotion was compared to recruitment during several periods of digital outreach. Separate online recruiting intervals included general online study promotion and unique Facebook and Google ad campaigns targeting under-represented subgroups: early PD, late/advanced PD, and residents of underrepresented/rural geographic areas. RESULTS: Early PD, late PD, and geotargeting campaigns enrolled more individuals in their respective cohorts compared to baseline. All online campaigns also yielded greater total FI enrollment, attracting more participants who were non-White, Hispanic, older, female, and had lower educational attainment and income, and more medical comorbidities. Cost per new participant ranged from $21 (Facebook) to $108 (Google). CONCLUSION: Digital marketing may allow researchers to increase, accelerate, and diversify recruitment for PD clinical studies, by tailoring digital ads to target PD cohort characteristics.

The case for philanthropic investment to increase colorectal cancer screening rates: A novel paradigm to address a public health challenge.

BACKGROUND: Colorectal cancer (CRC) remains a leading cause of cancer-related death despite being highly preventable. Efforts to increase participation in CRC screening have not met national goals. We developed a novel approach: building a business case for philanthropic investment in CRC screening. METHODS: A taskforce representing the public health community, professional societies, charitable foundations, academia, and industry was assembled to: (a) quantify the impact of improving CRC screening rates; (b) identify barriers to screening; (c) estimate the "activation cost" to overcome barriers and screen one additional person; (d) develop a holistic business case that is attractive to philanthropists; and (e) launch a demonstration project. RESULTS: We estimated that of 50 600 CRC deaths annually in the US, 55% occur in 50- to 85-year-olds and are potentially addressable by improvements in CRC screening. Barriers to screening were identified in all patient journey phases, including lack of awareness or insurance and logistical challenges in the pre-physician phase. The cost to activate one person to undergo screening was $25-175. This translated into a cost of $6000-36 000 per CRC death averted by philanthropic investment. Based on this work, the Colorectal Cancer Alliance launched the effort "March Forth" to prevent 100 000 CRC deaths in the US over 10 years, with the first pilot in Philadelphia. CONCLUSIONS: A holistic business plan can attract philanthropy to promote CRC screening. A simple message of "You can save a life from CRC with a $25 000 donation" can motivate demonstration projects in regions with high CRC rates and low screening participation.

Competition and price among brand-name drugs in the same class: A systematic review of the evidence.

BACKGROUND: Some experts have proposed combating rising drug prices by promoting brand-brand competition, a situation that is supposed to arise when multiple US Food and Drug Administration (FDA)-approved brand-name products in the same class are indicated for the same condition. However, numerous reports exist of price increases following the introduction of brand-name competition, suggesting that it may not be effective. We performed a systematic literature review of the peer-reviewed health policy and economics literature to better understand the interplay between new drug entry and intraclass drug prices. METHODS AND FINDINGS: We searched PubMed and EconLit for original studies on brand-brand competition in the US market published in English between January 1990 and April 2019. We performed a qualitative synthesis of each study's data, recording its primary objective, methodology, and results. We found 10 empirical investigations, with 1 study each on antihypertensives, anti-infectives, central nervous system stimulants for attention deficit/hyperactivity disorder, disease-modifying therapies for multiple sclerosis, histamine-2 (H2) blockers, and tumor necrosis factor (TNF) inhibitors; 2 studies on cancer medications; and 2 studies on all marketed or new drugs. None of the studies reported that brand-brand competition lowers list prices of existing drugs within a class. The findings of 2 studies suggest that such competition may help restrain how new drug prices are set. Other studies found evidence that brand-brand competition was mediated by the relative quality of competing drugs and the extent to which they are marketed, with safer or more effective new drugs and greater marketing associated with higher intraclass list prices. Our investigation was limited by the studies' use of list rather than net prices and the age of some of the data. CONCLUSIONS: Our findings suggest that policies to promote brand-brand competition in the US pharmaceutical market, such as accelerating approval of non-first-in-class drugs, will likely not result in lower drug list prices absent additional structural reforms.

India's family planning market and opportunities for the private sector: An analysis using the total market approach.

The private (commercial) sector in India can complement public sector for family planning services, but the roadmap to engage these two sectors remains a challenge. The total market approach (TMA) offers a strategy by understanding the comparative advantage of public, commercial, and nonprofit sectors. We estimated TMA indicators using data of four rounds of the National Family Health Surveys: 1992-93, 1998-99, 2005-06, and 2015-16. The contraceptive prevalence of modern methods in India did not increase in recent years, but the number of users increased, and so did the market size for the commercial sector. In rural areas, the current market size in 2015-16 (75 million) failed to reach its potential size in 1992-93 (84 million). In urban areas, the market of modern contraceptives is mostly composed of the users from higher wealth, and a high percentage of users obtain contraceptives from subsidized sources. The family planning market of northern part of Bihar and Uttar Pradesh and of Northeast India are in the "early" stage and need more demand generation; "matured" markets are mostly concentrated in and around big metros. Subsidization in urban areas should be offered to the targeted population who need family planning products and services at low cost.

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.

Regional Market Competition and the Use of Immediate Breast Reconstruction After Mastectomy.

BACKGROUND: Prior work has shown that the competitiveness of the market in which hospitals operate is associated with use of surgical procedures. This study examined the association between regional market competition and use of breast reconstruction for women with breast cancer and ductal carcinoma in situ undergoing mastectomy. METHODS: Women who underwent mastectomy from 2010 to 2011 recorded in the National Inpatient Sample were selected. The competitive market environment for each hospital in which patients were treated was estimated using the Herfindahl-Hirschman Index. Multivariable models were developed to examine the association between regional market competition and breast reconstruction, with adjustment for other clinical, demographic, and structural variables. RESULTS: Immediate breast reconstruction was performed for 9902 (45%) of 22,011 women. The rate of immediate breast reconstruction was 34.5% at hospitals in non-competitive markets, 49% at hospitals in moderately competitive markets, and 56.4% at hospitals in highly competitive markets (P < 0.0001). In a multivariable model, women in moderately competitive markets were 24% (risk ratio [RR] 1.24; 95% confidence interval [CI] 1.10-1.41) more likely to undergo immediate breast reconstruction than women in noncompetitive markets, whereas those in competitive markets were 25% (RR 1.25; 95% CI 1.11-1.41) more likely to have reconstruction. Later year of treatment, higher census tract income level, and residence in an urban area were associated with an increased likelihood of reconstruction (P < 0.05 for all). In contrast, older age, non-white race, and non-commercial insurance were associated with a lower likelihood of reconstruction (P < 0.05 for all). CONCLUSION: Patients who undergo mastectomy at hospitals in competitive markets are more likely to undergo immediate breast reconstruction.

Direct-to-Member Household or Targeted Mailings: Incentivizing Medicaid Calls for Quitline Services.

INTRODUCTION: Innovative methods are needed to promote tobacco cessation services. The Medi-Cal Incentives to Quit Smoking project (2012-2015) promoted modest financial and medication incentives to encourage Medi-Cal smokers to utilize the California Smokers' Helpline (Helpline). This article describes the implementation and impact of two different direct-to-member mailing approaches. METHODS: Medi-Cal Incentives to Quit Smoking promotional materials were mailed directly to members using two approaches: (1) household mailings: households identified through centralized membership divisions and (2) individually targeted mailings: smokers identified by medical codes from Medi-Cal managed care plans. Mailings included messaging on incentives, such as gift cards or nicotine patches. Number of calls per month, calls per unit mailed, and associated printing costs per call were compared during and 1 month after mailings. Activated caller response was based on reporting a household mailing promotional code or based on requesting financial incentives for individually targeted mailings. Analyses were conducted in 2018. RESULTS: Direct-to-member mailings, particularly with incentive messaging, demonstrated an increase in call volumes during and 1 month after mailing, and increased Medi-Cal calls to the Helpline per unit mailed. Mailings with only counseling messages had the lowest percentage of activated calls per unit mailed, whereas the incentive messaging mailings were consistently higher. Although household mailings demonstrated lower printing costs per call, individually targeted mailings had a higher percentage of activated calls per unit mailed. CONCLUSIONS: Household and individually targeted mailings are feasible approaches to increase Medi-Cal calls to the Helpline, particularly with incentive messaging. Choosing an approach and messaging depends on available resources, timing, and purpose. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Advancing Smoking Cessation in California's Medicaid Population, which is sponsored by the California Department of Public Health.