Every Publication has a Story

At GHPi, we are passionate about research and publishing. Every publication has its own story to tell, including how it was conceptualized and how it has had an impact. See below pieces co-authored by GHPi Director Tim Mackey by year of publication. Click the "learn more" button to hear their stories (still under construction.)

Number of Publications

188

(2008-2021)

Number of Unique Journals

108

*Denotes different journals published in

2022

Topics covered: COVID-19, tobacco, infodemiology,

  • Number of Publications: 4
Original Research
Original Research
Cuomo, R.E., et al. (2022). Spatial Disparities in School Proximity to Tobacco/Vape Outlets. Tobacco Regulatory Science (TRS), 84–95.

Abstract:
Objective: We sought to determine school and community characteristics associated with proximity to tobacco and ENDS storefronts within a 0.5-kilometer radius in California.


Methods: A list of licensed tobacco retailers was obtained from the California Department of Tax and Fee Administration; retailer names and addresses were used to scrape Yelp in order to determine sub-categorization of business as a vape or tobacco shop. US Census Bureau data was used to assess characteristics at the census tract level, and the California Department of Education provided school characteristics. Logistic regression with backward selection was used to assess for associations.


Results: The final regression model included six community variables which were all negatively associated with retailer proximity (percent male, percent age 5-10, percent age 15-20, percent age 25-30, percent age 55-60, and percent age 60-65) as well as four school characteristics which were all positively associated (percent female students, percent Hispanic students, percent White students, percent eligible for free and reduced priced meals [FRPM]).


Conclusions: Variation in demographics reflected most of the risk associated with school proximity to tobacco retailers. FRPM was associated with storefront proximity indicating that schools with lower socioeconomic status may be at higher exposure to tobacco retailing.


Original Research
Calac AJ, Haupt MR, Li Z, Mackey T. Spread of COVID-19 Vaccine Misinformation in the Ninth Inning: A Retrospective Observational Infodemic Study. JMIR Infodemiology. 18/01/2022:33587 (forthcoming/in press)

Abstract:
Background
Shortly after Pfizer and Moderna received emergency use authorizations from the FDA, there have been increased reports of COVID-19 vaccine-related deaths in the Vaccine Adverse Event Reporting System (VAERS). In January 2021, MLB legend and Hall of Famer Hank Aaron passed away at the age of 86 from natural causes, just two weeks after he received the COVID-19 vaccine. Anti-vaccination groups attempted to link his death to the Moderna vaccine, similar to other attempts to mispresent data from the VAERS to spread COVID-19 misinformation.

Objective
This study assessed the spread of misinformation linked to erroneous claims about Hank Aaron’s death on Twitter and then characterized different vaccine misinformation and hesitancy themes generated from users who interacted with this misinformation discourse.

Methods
An initial sample of tweets, from January 31 to February 6, 2021, was queried from the Twitter Search Application Programming Interface (API) using the keywords “Hank Aaron” and “vaccine”. The sample was manually annotated for misinformation, reporting or news media, and public reaction. Non-media user accounts were also classified if they were verified by Twitter. A second sample of tweets, representing direct comments or retweets to misinformation-labeled content was also collected. User sentiment toward misinformation, positive (agree) or negative (disagree), was recorded. The SAGE vaccine hesitancy matrix from the World Health Organization was used to code the second sample of tweets for factors influencing vaccine confidence.

Results
A total of 436 tweets were initially sampled from the Twitter Search API. Misinformation was the most prominent content type (56%, n = 244) detected, followed by public reaction (28%, n = 122) and media reporting (16%, n = 69). No misinformation-related content reviewed was labeled as misleading by Twitter at the time of the study. An additional 1,243 comments on misinformation-labeled Tweets from 973 unique users were also collected, with 779 comments deemed relevant to study aims. Most of these comments expressed positive sentiment (78.6%, n = 612) to misinformation and did not refute it. Based on the WHO SAGE framework, the most common vaccine hesitancy theme was individual or group influences (65%, n=508), followed by vaccine or vaccination-specific influences (14%, n=110) and contextual influences (12%, n=93). Common misinformation themes observed included linking the death of Hank Aaron to “suspicious” elderly deaths following vaccination, claims about vaccines being used for depopulation, death panels, federal officials targeting Black Americans, and misinterpretation of VAERS reports. Four users engaging with or posting misinformation were verified on Twitter at the time of data collection.

Conclusions
Our study found that the death of a high-profile ethnic minority celebrity led to the spread of misinformation on Twitter. This misinformation directly challenged the safety and effectiveness of COVID-19 vaccines at a time when ensuring vaccine coverage among minority populations was paramount. Misinformation targeted at minority groups and echoed by other verified Twitter users has the potential to generate unwarranted vaccine hesitancy at the expense of people like Hank Aaron who sought to promote public health and community immunity.


Original Research
Yang, J. S., & Mackey, T. (2022). Enforcement experiences on tobacco-free universities in California. SSM-Qualitative Research in Health, 100047.

Abstract: Smoke- and tobacco-free university polices have been expanding throughout the United States. In spite of the benefits of such policies, policy compliance remains a challenge. A better understanding of campus community enforcement approaches is needed to inform future policy implementation to bring about greater adherence to university smoke- and tobacco-free policies. To this end, thirteen focus groups with 76 participants from two universities in Southern California with tobacco-free policies were held from October 2019 through October 2020 to discuss attitudes toward and experiences with the campus smoking policy, campus tobacco use behavior, and policy enforcement. Focus groups discussions were recorded, transcribed, and analyzed using a general inductive analysis approach. A wide array of campus stakeholders were involved in enforcement actions, including formal entities such as police and parking enforcement, as well as the general campus community such as students and employees. However, the majority of participants in the study had never had an enforcement experience and those who did only did so on rare occasion. Enforcement experiences were often perceived as aggressive, which elicited a desire for a similarly aggressive response on the part of the person smoking or vaping. The enforcement of e-cigarettes is particularly challenging because of the speed and discretion with which they can be used compared to combustible tobacco and perceived favorable norms toward e-cigarettes. Universities should consider using proactive, consistent, and tailored actions to reinforce changing social norms for greater policy compliance.


Original Research
Nali, M. C., Purushothaman, V., Li, J., & Mackey, T. K. (2022). Characterizing California licensure status and tobacco user experience with adverse events using yelp data. Preventive Medicine Reports, 101720.

Abstract:
Various tobacco vendors, including alternative tobacco product sellers, are listed on the popular crowdsourced business listing platform Yelp. Yelp is used to rate and choose tobacco, electronic nicotine delivery systems (ENDS) goods/services and includes self-reporting of user experiences with shops and products. We cross-referenced California Department of Tax and Fee Administration (CDTFA) licensed tobacco, vape, and head shop retail stores with publicly available Yelp business listings to identify licensed and unlicensed stores in California. We extracted metadata associated with store accounts and analyzed user comments and ratings for discussion of tobacco-related complaints and adverse events. We detected a total of 3,717 shops that were categorized as tobacco/vape/head shops on Yelp and by cross-referencing with CDTFA data, licensed businesses accounted for 49.5% (n = 1,841), licensed individual retailers 31.6% (n = 1,174), and suspected unlicensed storefronts 18.9% (n = 702). Businesses and individuals with a state tobacco retail license received a higher average rating from Yelp users (3.86 out of 5) compared to unlicensed shops (3.57) (p < 0.001). Additionally, 4,682 unique comments about licensed businesses, 1,535 unique comments about individual retailers, and 560 unique comments about unlicensed vendors were reviewed, with themes including discussion about defective and counterfeit products and adverse events including coughing, difficulty breathing and reports of hospitalization detected. In contrast, comments about licensed stores predominantly discussed customer service issues. Close to one-fifth of tobacco, vape and/or head shops reviewed on Yelp were not in CDTFA’s licensure database. Overall self-reported tobacco user experiences appeared to differ in content and severity based on whether an establishment was licensed. These results have the potential to identify unauthorized stores and adverse events associated with their tobacco and vaping products or services.


Original Research
Haupt, M. R., Weiss, S. M., Chiu, M., Cuomo, R., Chein, J. M., & Mackey, T. (2022). Psychological and situational profiles of social distance compliance during COVID-19. Journal of Communication in Healthcare, 0(0), 1–10.

Abstract:
Background
Health advice in the wake of the COVID-19 pandemic has called upon the public to re-evaluate risk associated with recently routine behavior. However, di!erences in demographics, situational circumstances, and psychological dispositions create inequities in how people are able to respond to risks presented by the virus.

Method
Within a sample of 482 Americans, we examined the frequency of behavior reconceptualized as ‘risky’ by CDC public health guidelines released on 30 March 2020. We applied a cluster analysis using a data-driven persona framework from the "eld of user- design research, using only situational and dispositional (i.e. psychological) variables to identify pro"les of individuals.

Results
This pro"le approach unpacked important variability in the evaluation of risk for COVID-19 contagion, as well as adherence to public health guidance. Pro"les engaged in high-risk behaviors were more likely required to work on-site and report higher "nancial impact related to the pandemic.

Conclusion
Applying the pro"le approach facilitates personalized communications tailored to the psychological and situational circumstances of each pro"le that can promote compliance with public health guidelines and guide policy decisions. These results also suggest that risk- taking behaviors within the context of COVID-19 may also be driven by factors related to economic inequity since those who are more likely to be essential workers do not have the ability to remain as compliant to social distancing compared to those with higher economic status. Recommendations for policies promoting federally mandated paid leave policy in the US and employing qualitative methods for future research is discussed.



2021

Topics covered: COVID-19; data science; tobacco control; misinformation; blockchain; regenerative medicine; health policy; health equity

  • Number of Publications: 21
Original Research
Review
Short Report
Article
Commentary
Short Report
Yang JS, Cuomo RE, Purushothaman V, Nali M, Shah N, Bardier C, Obradovich N, Mackey TK. Campus Smoking Policies and Smoking-Related Twitter Posts Originating From California Public Universities: Retrospective Study. JMIR. doi: 10.2196/33331

Abstract:
Background
Increased public health and regulatory scrutiny concerning the youth vaping epidemic has led to greater attention to promotion and sales of vaping products on social media platforms.

Objectives
We used unsupervised machine learning to identify and characterise sale offers of electronic nicotine delivery systems (ENDS) and associated products on Instagram. We examined types of sellers, geographic ENDS location and use of age verification.

Methods
Our methodology was composed of three phases: data collection, topic modelling and content analysis. We used data mining approaches to query hashtags related to ENDS product use among young adults to collect Instagram posts. For topic modelling, we applied an unsupervised machine learning approach to thematically categorise and identify topic clusters associated with selling activity. Content analysis was then used to characterise offers for sale of ENDS products.

Results
From 70 725 posts, we identified 3331 engaged in sale of ENDS products. Posts originated from 20 different countries and were roughly split between individual (46.3%) and retail sellers (43.4%), with linked online sellers (8.8%) representing a smaller volume. ENDS products most frequently offered for sale were flavoured e-liquids (53.0%) and vaping devices (20.5%). Online sellers offering flavoured e-liquids were less likely to use age verification at point of purchase (29% vs 64%) compared with other products.

Conclusions
Instagram is a global venue for unregulated ENDS sales, including flavoured products, and access to websites lacking age verification. Such posts may violate Instagram’s policies and US federal and state law, necessitating more robust review and enforcement to prevent ENDS uptake and access.


Original Research
Shah N, Nali M, Bardier C, Li J, Maroulis J, Cuomo R, Mackey TK. Applying topic modelling and qualitative content analysis to identify and characterise ENDS product promotion and sales on Instagram. Tobacco Control. doi: 10.1136/tobaccocontrol-2021-056937

Abstract:
Objective
The objective of this study was to develop an inductive coding approach specifc to characterizing user-generated social media conversations about transition of use of different tobacco and alternative and emerging tobacco products (ATPs).

Results
A total of 40,206 tweets were collected from the Twitter public API stream that were geocoded from 2018 to 2019. Using data mining approaches, these tweets were then fltered for keywords associated with tobacco and ATP use behavior. This resulted in a subset of 5718 tweets, with 657 manually annotated and identifed as associated with user-generated conversations about tobacco and ATP use behavior. The 657 tweets were coded into 9 parent codes: inquiry, interaction, observation, opinion, promote, reply, share knowledge, use characteristics, and transition of use behavior. The highest number of observations occurred under transition of use (43.38%, n=285), followed by current use (39.27%, n=258), opinions about use (0.07%, n=46), and product promotion (0.06%, n=37). Other codes had less than ten tweets that discussed these themes. Results provide early insights into how social media users discuss topics related to transition of use and their experiences with different and emerging tobacco product use behavior.


Original Research
Xu Q, Yang J, Haupt MR, Cai M, Nali M, Mackey TK. Digital Surveillance to Identify California Alternative and Emerging Tobacco Industry Policy Influence and Mobilization on Facebook. Int. J. Environ. Res. Public Health. 2021; 18(21), 11150; https://doi.org/10.3390/ijerph182111150

Abstract:
Growing popularity of electronic nicotine-delivery systems (ENDS) has coincided with a need to strengthen tobacco-control policy. In response, the ENDS industry has taken actions to mobilize against public health measures, including coordination on social media platforms. To explore this phenomenon, data mining was used to collect public posts on two Facebook public group pages: the California Consumer Advocates for Smoke Free Alternatives Association (CCASAA) and the community page of the Northern California Chapter of SFATA (NC-SFATA). Posts were manually annotated to characterize themes associated with industry political interference and user interaction. We collected 288 posts from the NC-SFATA and 411 posts from CCASAA. A total of 522 (74.7%) posts were categorized as a form of political interference, with 339 posts (64.9%) from CCASAA and 183 posts (35.1%) from NC-SFATA. We identified three different categories of policy interference- related posts: (1) providing updates on ENDS-related policy at the federal, state, and local levels; (2) sharing opinions about ENDS-related policies; (3) posts related to scientific information related to vaping; and (4) calls to action to mobilize against tobacco/ENDS policies. Our findings indicate that pro-tobacco social media communities on Facebook, driven by strategic activities of trade associations and their members, may act as focal points for anti policy information dissemination, grass-roots mobilization, and industry coordination that needs further research.


Original Research
Haupt MR, Xu Q, Yang J, Cai M, Mackey TK. Characterizing Vaping Industry Political Influence and Mobilization on Facebook: Social Network Analysis. J Med Internet Res. 2021; in press

Abstract:
Growing popularity of electronic nicotine-delivery systems (ENDS) has coincided with a need to strengthen tobacco-control policy. In response, the ENDS industry has taken actions to mobilize against public health measures, including coordination on social media platforms. To explore this phenomenon, data mining was used to collect public posts on two Facebook public group pages: the California Consumer Advocates for Smoke Free Alternatives Association (CCASAA) and the community page of the Northern California Chapter of SFATA (NC-SFATA). Posts were manually annotated to characterize themes associated with industry political interference and user interaction. We collected 288 posts from the NC-SFATA and 411 posts from CCASAA. A total of 522 (74.7%) posts were categorized as a form of political interference, with 339 posts (64.9%) from CCASAA and 183 posts (35.1%) from NC-SFATA. We identified three different categories of policy interference-related posts: (1) providing updates on ENDS-related policy at the federal, state, and local levels; (2) sharing opinions about ENDS-related policies; (3) posts related to scientific information related to vaping; and (4) calls to action to mobilize against tobacco/ENDS policies. Our findings indicate that pro-tobacco social media communities on Facebook, driven by strategic activities of trade associations and their members, may act as focal points for anti-policy information dissemination, grass-roots mobilization, and industry coordination that needs further research. View Full-Text


Original Research
Bardier C, Yang J, Li J, Mackey TK. Characterizing Alternative and Emerging Tobacco Product Transition of Use Behavior on Twitter. BMC Res Notes. 2021;14:303

Abstract:
Objective
The objective of this study was to develop an inductive coding approach specific to characterizing user-generated social media conversations about transition of use of different tobacco and alternative and emerging tobacco products (ATPs).

Results
A total of 40,206 tweets were collected from the Twitter public API stream that were geocoded from 2018 to 2019. Using data mining approaches, these tweets were then filtered for keywords associated with tobacco and ATP use behavior. This resulted in a subset of 5718 tweets, with 657 manually annotated and identified as associated with user-generated conversations about tobacco and ATP use behavior. The 657 tweets were coded into 9 parent codes: inquiry, interaction, observation, opinion, promote, reply, share knowledge, use characteristics, and transition of use behavior. The highest number of observations occurred under transition of use (43.38%, n=285), followed by current use (39.27%, n=258), opinions about use (0.07%, n=46), and product promotion (0.06%, n=37). Other codes had less than ten tweets that discussed these themes. Results provide early insights into how social media users discuss topics related to transition of use and their experiences with different and emerging tobacco product use behavior.


Original Research
Yang J, Sou A, Faruqui A, Mackey TK. A Qualitative Examination of e-cigarette Use Among California Young Adults During the EVALI Outbreak. Prev Med Rep. 2021;24:101506

Abstract:
The 2019 outbreak of E-cigarette, or Vaping, Product Use-Associated Lung Injury (EVALI) increased awareness of potential health risks associated with vaping among the general public. Little is known, however, about how unfolding information regarding EVALI affected knowledge, attitudes, and behaviors among e-cigarette users, particularly among young adults. This study describes attitudinal and behavioral responses to EVALI among young adult e-cigarette users. In October and November 2019, seven focus groups were held with college-going young adult tobacco users from two four-year public universities in California. Focus groups included questions regarding knowledge of and reaction to EVALI news, and how the news affected product use. Text from current e-cigarette users was extracted to develop individual phenomenological textural-structural descriptions of e-cigarette use for 38 individuals which were used to create a composite experience of e-cigarette use in light of EVALI. Experiences indicated that e-cigarette users were aware of information regarding EVALI and received information from numerous sources. Information was filtered for legitimacy of EVALI claims and causes of EVALI. Risk rationalizations were developed to assess potential harm of continued e-cigarette use and provided reasoning for behavioral responses to EVALI. The emerging harm associated with EVALI prompted e-cigarette users to engage in a cognitive process resulting in employment of a range of rationalities to justify continued use. These results suggest how environmental, cognitive, and behavioral factors may interact as young adults negotiate e-cigarette-related harms.


Original Research
Cratsley K, Brooks MA, Mackey TK. Refugee Mental Health, Global Health Policy, and the Syrian Crisis. Front Public Health. 2021; 9:676000. doi: 10.3389/fpubh.2021.676000

Abstract:
The most recent global refugee figures are staggering, with over 82.4 million people forcibly displaced and 26.4 million registered refugees. The ongoing conflict in Syria is a major contributor. After a decade of violence and destabilization, over 13.4 million Syrians have been displaced, including 6.7 million internally displaced persons and 6.7 million refugees registered in other countries. Beyond the immediate political and economic challenges, an essential component of any response to this humanitarian crisis must be health-related, including policies and interventions specific to mental health. This policy and practice review addresses refugee mental health in the context of the Syrian crisis, providing an update and overview of the current situation while exploring new initiatives in mental health research and global health policy that can help strengthen and expand services. Relevant global health policy frameworks are first briefly introduced, followed by a short summary of recent research on refugee mental health. We then provide an update on the current status of research, service provision, and health policy in the leading destinations for Syrians who have been forcibly displaced. This starts within Syria and then turns to Turkey, Lebanon, Jordan, and Germany. Finally, several general recommendations are discussed, including the pressing need for more data at each phase of migration, the expansion of integrated mental health services, and the explicit inclusion and prioritization of refugee mental health in national and global health policy.


Original Research
Purushothaman V, Cuomo RE, Garland C, Mackey TK. Could age increase the strength of inverse association between ultraviolet B exposure and colorectal cancer?. BMC Public Health. 2021;21:1238

Abstract:
Background
Vitamin D has been identified as a potential protective factor in the development of colorectal cancer (CRC). We expect to see a stronger association of ultraviolet B (UVB) exposure and CRC crude rates with increasing age since chronic vitamin D deficiency leads to sustained molecular changes that increase cancer risk. The DINOMIT (disjunction, initiation, natural selection, overgrowth, metastasis, involution, and transition) model postulates various stages of cancer development due to vitamin D deficiency and the associated latency period. The purpose of this study is to examine this age-dependent inverse relationship globally.

Methods
In this ecological study, a series of linear and polynomial regression tests were performed between country-specific UVB estimates adjusted for cloud cover and crude incidence rates of CRC for different age groups. Multiple linear regression was used to investigate the association between crude incidence rates of colorectal cancer and UVB estimate adjusting for urbanization, skin pigmentation, smoking, animal consumption, per capita GDP, and life expectancy. Statistical analysis was followed by geospatial visualization by producing choropleth maps.

Results
The inverse relationship between UVB exposure and CRC crude rates was stronger in older age groups at the country level. Quadratic curve fitting was preferred, and these models were statistically significant for all age groups. The inverse association between crude incidence rates of CRC and UVB exposure was statistically significant for age groups above 45 years, after controlling for covariates.

Conclusion
The age-dependent inverse association between UVB exposure and incidence of colorectal cancer exhibits a greater effect size among older age groups in global analyses. Studying the effect of chronic vitamin D deficiency on colorectal cancer etiology will help in understanding the necessity for population-wide screening programs for vitamin D deficiency, especially in regions with inadequate UVB exposure. Further studies are required to assess the need for adequate public health programs such as selective supplementation and food fortification.


Original Research

Abstract:
Background
Suicide and substance use disorder (SUD) pose serious public health challenges among young adults in the United States. Increasing social media use among these populations can be leveraged as an alternative method to detect characteristics of suicide-related topics and behavior among substance users.Objective: To detect and characterize suicide and self-harm related conversations co-occurring with SUD posts and comments on the popular social media platform Instagram.

Methods
This study used big data and machine learning approaches to collect and classify Instagram posts containing 632 controlled substance-related hashtags. Posts were first classified for online drug diversion topics and then filtered to detect suicide and mental health discussions. Posts and comments were then manually annotated for SUD and mental health co-occurring themes. Associations between these characteristics were tested using the Chi-square test.

Results
We detected 719 Instagram posts/comments that included user-generated discussions about suicide, substance use and/or mental health. Posts self-reporting SUD and mental health topics were also more likely to discuss suicide compared to those that did not discuss SUD and mental health topics, respectively (p < 0.001). Major themes observed included concurrent discussions of suicide ideation and attempts and low self-esteem.

Conclusion
Our study results provide preliminary evidence of social media discussions about suicide and mental health among those with SUD. This co-occurrence represents a key health risk factor on a platform heavily utilized by young adults. Further studies are required to analyze specific patterns of suicide and self-harm ideations for the purposes of designing future suicide prevention campaigns through digital channels.


Original Research
Cuomo RE, Purushothaman V, Li J, Cai M, Mackey TK. A Longitudinal and Geospatial Analysis of COVID-19 Tweets During the Early Outbreak Period in the United States. BMC Public Health. 2021;21:793

Abstract:
Introduction
Early reports of COVID-19 cases and deaths may not accurately convey community-level concern about the pandemic during early stages, particularly in the United States where testing capacity was initially limited. Social media interaction may elucidate public reaction and communication dynamics about COVID-19 in this critical period, during which communities may have formulated initial conceptions about the perceived severity of the pandemic.

Methods
Tweets were collected from the Twitter public API stream filtered for keywords related to COVID-19. Using a pre-existing training set, a support vector machine (SVM) classifier was used to obtain a larger set of geocoded tweets with characteristics of user self-reporting COVID-19 symptoms, concerns, and experiences. We then assessed the longitudinal relationship between identified tweets and the number of officially reported COVID-19 cases using linear and exponential regression at the U.S. county level. Changes in tweets that included geospatial clustering were also assessed for the top five most populous U.S. cities.

Results
From an initial dataset of 60 million tweets, we analyzed 459,937 tweets that contained COVID-19-related keywords that were also geolocated to U.S. counties. We observed an increasing number of tweets throughout the study period, although there was variation between city centers and residential areas. Tweets identified as COVID-19 symptoms or concerns appeared to be more predictive of active COVID-19 cases as temporal distance increased.

Conclusion
Results from this study suggest that social media communication dynamics during the early stages of a global pandemic may exhibit a number of geospatial-specific variations among different communities and that targeted pandemic communication is warranted. User engagement on COVID-19 topics may also be predictive of future confirmed case counts, though further studies to validate these findings are needed.


Original Research

Abstract:
This study investigates the types of misinformation spread on Twitter that evokes scientific authority or evidence when making false claims about the antimalarial drug hydroxychloroquine as a treatment for COVID-19. Specifically, we examined tweets generated after former U.S. President Donald Trump retweeted misinformation about the drug using an unsupervised machine learning approach called the biterm topic model that is used to cluster tweets into misinformation topics based on textual similarity. The top 10 tweets from each topic cluster were content coded for three types of misinformation categories related to scientific authority: medical endorsements of hydroxychloroquine, scientific information used to support hydroxychloroquine’s use, and a comparison group that included scientific evidence opposing hydroxychloroquine’s use. Results show a much higher volume of tweets featuring medical endorsements and use of supportive scientific information compared to accurate and updated scientific evidence, that misinformation-related tweets propagated for a longer time frame, and the majority of hydroxychloroquine Twitter discourse expressed positive views about the drug. Metadata from Twitter accounts found that prominent users within misinformation discourse were more likely to have media or political affiliation and explicitly expressed support for President Trump. Conversely, prominent accounts within the scientific opposition discourse primarily consisted of medical doctors or scientists but had far less influence in the Twitter discourse. Implications of these findings and connections to related social media research are discussed, as well as cognitive mechanisms for understanding susceptibility to misinformation and strategies to combat misinformation spread via online platforms.


Original Research
Shah N, Li J, Mackey TK. An Unsupervised Machine Learning Approach for Detection and Characterization of Illicit Drug-dealing Comments and Interaction on Instagram. Substance Abuse. 2021; Jul 2;1-5. doi: 10.1080/08897077.2021.1941508

Abstract:
Background
Growing use of social media has led to the emergence of virtual controlled substance and illicit drug marketplaces, prompting calls for action by government and law enforcement. Previous studies have analyzed Instagram drug selling via posts. However, comments made by users involving potential drug selling have not been analyzed. In this study, we use unsupervised machine learning to detect and classify prescription and illicit drug-related buying and selling interactions on Instagram.

Methods
We used over 1,000 drug-related hashtags on Instagram to collect a total of 43,607 Instagram comments between February 1st, 2019 and May 31st, 2019 using data mining approaches in the Python programming language. We then used an unsupervised machine learning approach, the Biterm Topic Model (BTM), to thematically summarize Instagram comments into distinct topic groupings, which were then extracted and manually annotated to detect buying and selling comments.
Results
We detected 5,589 comments from sellers, prospective buyers, and online pharmacies from 531 unique posts. The vast majority (99.7%) of comments originated from drug sellers and online pharmacies. Key themes from comments included providing contact information through encrypted third-party messaging platforms, drug availability, and price inquiry. Commonly offered drugs for sale included scheduled controlled substances such as Adderall and Xanax, as well as illicit hallucinogens and stimulants. Comments from prospective buyers of drugs most commonly included inquiries about price and availability.

Conclusions
We detected prescription controlled substances and other illicit drug selling interactions via Instagram comments to posts. We observed that comments were primarily used by sellers offering drugs, and typically not by prospective buyers interacting with sellers. Further research is needed to characterize these “social” drug marketplace interactions on this and other popular social media platforms.


Review

Abstract:
Background
In 2016, the “Act on Support for Overseas Expansion of Healthcare System and Attraction of International Patients” was enacted by the South Korean government in an attempt to accelerate growth of its medical tourism industry. However, only a few years after its implementation, the benefits are not well understood, nor have the positive or negative impacts of expanding Korea’s medical tourism sector been properly evaluated.

Objective
We aimed to systematically review and summarize existing literature describing South Korea’s medical tourism policy and legislative history, while also assessing the impact of this domestic policy approach on the country’s public health systems.

Methods
A bilingual systematic literature review was conducted per PRISMA guidelines for all South Korean medical tourism legislative and policy literature using MeSH terms and other related keywords in two academic databases, PubMed and JSTOR. Published studies were included if they directly addressed South Korean medical tourism policy. To supplement results from the peer-review, the grey literature was also searched using Google search engine for relevant policy documents, information from government websites, and national statistics on medical tourism-related data.

Results
This review included 14 peer-reviewed journal articles and 9 websites. The majority of literature focused on the legislative history of South Korea’s pro-medical tourism policy, economic considerations associated with industry growth, and the specific experiences of medical tourists. There was a lack of studies, analytical or commentary-based, conducting in-depth analysis of the healthcare impact of these policies or comparing benefits and costs compared to other medical tourism destinations. Proponents of medical tourism continue to advocate the government for increased deregulation and investment in the sector.

Conclusion
This systematic review suggests that policy decisions may prioritize economic growth offered by medical tourism over negative effects on the healthcare workforce, access and equity, and its potential to undermine Universal Health Coverage. South Korea continues to examine ways to further amend the Act and grow this sector, but these actions should be taken with caution by critically examining how other countries have adapted their policymaking based on the real-world costs associated with medical tourism.


Original Research
Cuomo RE, Purushothaman VL, Li J, Bardier C, Nali M, Shah N, Obradovich N, Yang J, Mackey TK. Characterizing Self-reported Tobacco, Vaping, and Marijuana-related Tweets Geolocated for California College Campuses. Front in Pub Health. 2021; in press.

Abstract:
Introduction
College-aged youth are active on social media yet smoking-related social media engagement in these populations has not been thoroughly investigated. We sought to conduct an exploratory infoveillance study focused on geolocated data to characterize smoking-related tweets originating from California 4-year colleges on Twitter.

Methods
Tweets from 2015 to 2019 with geospatial coordinates in CA college campuses containing smoking-related keywords were collected from the Twitter API stream and manually annotated for discussions about smoking product type, sentiment, and behavior.

Results
Out of all tweets detected with smoking-related behavior, 46.7% related to tobacco use, 50.0% to marijuana, and 7.3% to vaping. Of these tweets, 46.1% reported first-person use or second-hand observation of smoking behavior. Out of 962 tweets with user sentiment, the majority (67.6%) were positive, ranging from 55.0% for California State University, Long Beach to 95.8% for California State University, Los Angeles.

Discussion
We detected reporting of first- and second-hand smoking behavior on CA college campuses representing possible violation of campus smoking bans. The majority of tweets expressed positive sentiment about smoking behaviors, though there was appreciable variability between college campuses. This suggests that anti-smoking outreach should be tailored to the unique student populations of these college communities.

Conclusion
Among tweets about smoking from California colleges, high levels of positive sentiment suggest that the campus climate may be less receptive to anti-smoking messages or adherence to campus smoking bans. Further research should investigate the degree to which this varies by campuses over time and following implementation of bans including validating using other sources of data.


Original Research
Cuomo RE, Yang J, Purushothaman V, Nali M, Li J, Mackey TK. A Geospatial Analysis of Age Disparities in Resolute Localities of Tobacco and Vaping-Specific Storefronts in California. Tobacco Prev Cessation. 2021; in press.

Abstract:
Introduction
Concomitant with the popularization of vaping, vape shops have dramatically proliferated over the past years. This study assesses whether vape storefronts in California are significantly associated with density of different age groups, and whether this differs between tobacco storefronts or non-specific tobacco retailers.

Methods
Addresses for licensed tobacco retailers were obtained from the California Department of Tax and Fee Administration. Business names and addresses were used to obtain store categories cross-referenced from Yelp. Using a cross-sectional ecological design, stores categorized as ‘Vape Shop’ or ‘Tobacco Shop’ were geolocated and compared with age-related variables from the American Community Survey. Regression was conducted in R to determine relationships between age group concentration, in ventiles, and proportion of tracts with tobacco-specific or vape-specific stores. Geospatial visualization was conducted using ArcGIS.

Results
We found 848 vape shops, 820 tobacco shops, 419 categorized as both, and 20320 retailers with neither category. Overall, 1800 tobacco and/or vape shops were categorized in 1557 of California’s 23194 census tracts. A positive linear association was found between ventiles of two age categories, 20–24 and 25–34 years, and proportion of tracts with vape-specific or tobacco-specific shops separately.

Conclusions
Positive associations were found for ages 20–34 years but not for other ages, suggesting vape shops are strategically located in areas populated by young adults. Location-based targeting increases access, thereby increasing proportion of tobacco users, and could be a critical factor in e-cigarette uptake and use. Further study to identify additional age-related demographic characteristics among clientele of tobacco storefronts is warranted.


Original Research
Chavez J, Shah NA, Ruoss S, Cuomo RE, Ward SR, Mackey TK. Online Marketing Practices of Regenerative Medicine Clinics in U.S.-Mexico Border Region: A Web Surveillance Study. Stem Cell Research & Therapy. 2021;12:189.

Abstract:
Introduction
The potential of regenerative medicine to improve human health has led to the rapid expansion of stem cell clinics throughout the world with varying levels of regulation and oversight. This has led to a market ripe for stem cell tourism, with Tijuana, Mexico, as a major destination. In this study, we characterize the online marketing, intervention details, pricing of services, and assess potential safety risks through web surveillance of regenerative medicine clinics marketing services in Tijuana.

Methods
We conducted structured online search queries from March to April 2019 using 296 search terms in English and Spanish on two search engines (Google and Bing) to identify websites engaged in direct-to-consumer advertising of regenerative medicine services. We performed content analysis to characterize three categories of interest: online presence, tokens of scientific legitimacy, and intervention details.

Results
Our structured online searches resulted in 110 unique websites located in Tijuana corresponding to 76 confirmed locations. These clinics’ online presence consisted of direct-to-consumer advertising mainly through a dedicated website (94.5%) or Facebook page (65.5%). The vast majority of these websites (99.1%) did not mention any affiliation to an academic institutions or other overt tokens of scientific legitimacy. Most clinics claimed autologous tissue was the source of treatments (67.3%) and generally did not specify route of administration. Additionally, of the Tijuana clinics identified, 13 claimed licensing, though only 1 matched with available licensing information.

Conclusions
Regenerative medicine clinics in Tijuana have a significant online presence using direct-to-consumer advertising to attract stem-cell tourism clientele in a bustling border region between Mexico and the USA. This study adds to existing literature evidencing the unregulated nature of online stem cell offerings and provides further evidence of the need for regulatory harmonization, particularly to address stem cell services being offered online across borders.


Article

Abstract:
In the context of blockchain technology, “off-chain” refers to computation or data that is structurally external to the blockchain network. Off-Chain Blockchain Systems (OCBS) enable this information processing and management through distributed software architecture where the blockchain network interacts with off-chain resources. Hence, OCBS are a critical data governance component in the design of enterprise blockchain solutions, resulting in extensive research and development exploring the interplay between on-chain and off-chain storage and computation and efforts to evaluate their performance relative to other information management systems. Key features of OCBS’ are their ability to improve scalability, reduce data storage requirements, and enhance data privacy, all extremely critical issues to enable broader blockchain adoption. These OCBS features map well to the needs of the healthcare industry, particularly due to the need to manage various types of medical, consumer, and other health-related data. However, different types of health data are also subject to stringent regulatory, security and legal requirements, a key factor limiting blockchain adoption in the sector. In response, there is a critical need to better align OCBS design features to different types of healthcare data management and their respective governance and privacy regimes. This article first reviews the characteristics of different constructs of OCBS. It then proposes a modular hybrid privacy-preserving framework leveraging off-chain and on-chain blockchain system design applied to three different reference models that illustrate how blockchain can enhance healthcare information management. Through this privacy-preserving framework we hope to liberate healthcare data by enabling sharing, sovereignty and enhanced trust.


Commentary
Platt M, Hasselgren A, Román-Belmonte JM, Tuler de Oliveira M, De la Corte-Rodríguez H, Delgado Olabarriaga S, Rodríguez-Merchán EC, Mackey TK. Test, Trace, put on the Blockchain? A Viewpoint Evaluating the Use of Decentralized Systems for Algorithmic Contact Tracing to Combat a Global Pandemic. JMIR Public Health Surveil. 2021; in press

No abstract available.


Commentary
Mackey TK, Purushothaman V, Haupt M, Nali M, Li J. Application of Unsupervised Machine Learning to Identify and Characterize Hydroxychloroquine Misinformation on Twitter. Lancet Digital Health. 2021;3(2):e72-75.

No Abstract Available.


Original Research
Nali M, Purushothaman V, Xu Q, Cuomo RE, Mackey TK. Characterizing and Assessing Compliance of Online Vendors to the State of Massachusetts ENDS Product Sales Ban. Tob Induc Dis. 2021;19:5

Abstract:
Introduction
Recent reports of lung injury associated with Electronic Nicotine Delivery System (ENDS) products precipitated by increasing vaping prevalence and interest in flavors among adolescents has led to policies that restrict the sale, distribution, and accessibility of ENDS products. This study assessed compliance of online ENDS vendors to the Massachusetts temporary sales ban.

Methods
The study involved structured web surveillance for online ENDS vendors using keyword searches on Google search engine (October to November 2019.) Once vendors were identified, we conducted simulated online purchases, defined as placing an order for an ENDS product by putting it in the website shopping cart without finalizing payment. Simulated purchases and content analysis of websites was conducted to determine compliance characteristics. Fisher’s exact test was used to identify associations between compliance and website characteristics such as location and age verification requirements.

Results
Simulated online purchases from 50 identified ENDS vendors yielded 72% (n=36) stores that were non-compliant and allowed placement of ENDS product orders, without restrictions, to a Massachusetts address. The remaining 14 websites had processes in place to prevent orders from buyers located in Massachusetts. Other characteristics of interest, including use of age verification, location data, and web registrar/registrant data were collected and reported.

Conclusions
The September 2019 Massachusetts executive order was a comprehensive ban on selling ENDS products both online and offline. However, our study found that close to three-fourths of the vendors appeared to be non-compliant, indicating that implementation and enforcement are ongoing challenges for future tobacco control efforts on the internet. Policymaking needs to be specifically tailored to address the unique challenges of online environments, particularly in the context of identifying non-compliant sites, ensuring age verification, and addressing non-US sellers.


Original Research

Abstract:
The Open Payments database reports payments made to physicians by industry. Given the potential for financial conflicts of interest relating to patient outcomes, further scrutiny of these data is valuable. Therefore, the objective of this study was to analyze physician-industry relationships by specialty type, payment type, geospatial trend, and longitudinal trend between 2014–2018. We conducted an observational, retrospective data analysis of payments from the Open Payments database for licensed United States physicians listed in the National Plan & Provider Enumeration System (NPPES). Datasets from 2013–2018 were joined using the Python programming language. Aggregation and sub-setting by characteristics of interest was done in R to calculate means and frequencies of reported general physician payments from industry across different specialties, locations, timeframes, and payment types. Normalization was applied for numbers of physicians or payments. Geospatial statistical hot spot analysis was conducted in ArcGIS. 51.73 million payment records were analyzed. In total, 50,047,930 payments were issued to 771,113 allopathic or osteopathic physicians, representing $8,702,631,264 transferred from industry to physicians over the five-year period between 2014 and 2018. The mean payment amount was $179, with a standard deviation of $12,685. Variability in physicians’ financial relationships with industry were apparent across specialties, regions, time, and payment type. A limited match rate between records in the NPPES and Open Payments databases may have resulted in selection bias of trends related to physician characteristics. Further research is necessary, particularly in the context of changing industry payment trends and public perceptions of the appropriateness of these relationships.



2021

Topics covered: COVID-19; data science; tobacco control; misinformation; blockchain; regenerative medicine; health policy; health equity

  • Number of Publications: 21
Original Research
Review
Short Report
Article
Commentary
Short Report
Yang JS, Cuomo RE, Purushothaman V, Nali M, Shah N, Bardier C, Obradovich N, Mackey TK. Campus Smoking Policies and Smoking-Related Twitter Posts Originating From California Public Universities: Retrospective Study. JMIR. doi: 10.2196/33331

Abstract:
Background
Increased public health and regulatory scrutiny concerning the youth vaping epidemic has led to greater attention to promotion and sales of vaping products on social media platforms.

Objectives
We used unsupervised machine learning to identify and characterise sale offers of electronic nicotine delivery systems (ENDS) and associated products on Instagram. We examined types of sellers, geographic ENDS location and use of age verification.

Methods
Our methodology was composed of three phases: data collection, topic modelling and content analysis. We used data mining approaches to query hashtags related to ENDS product use among young adults to collect Instagram posts. For topic modelling, we applied an unsupervised machine learning approach to thematically categorise and identify topic clusters associated with selling activity. Content analysis was then used to characterise offers for sale of ENDS products.

Results
From 70 725 posts, we identified 3331 engaged in sale of ENDS products. Posts originated from 20 different countries and were roughly split between individual (46.3%) and retail sellers (43.4%), with linked online sellers (8.8%) representing a smaller volume. ENDS products most frequently offered for sale were flavoured e-liquids (53.0%) and vaping devices (20.5%). Online sellers offering flavoured e-liquids were less likely to use age verification at point of purchase (29% vs 64%) compared with other products.

Conclusions
Instagram is a global venue for unregulated ENDS sales, including flavoured products, and access to websites lacking age verification. Such posts may violate Instagram’s policies and US federal and state law, necessitating more robust review and enforcement to prevent ENDS uptake and access.


Original Research
Shah N, Nali M, Bardier C, Li J, Maroulis J, Cuomo R, Mackey TK. Applying topic modelling and qualitative content analysis to identify and characterise ENDS product promotion and sales on Instagram. Tobacco Control. doi: 10.1136/tobaccocontrol-2021-056937

Abstract:
Objective
The objective of this study was to develop an inductive coding approach specifc to characterizing user-generated social media conversations about transition of use of different tobacco and alternative and emerging tobacco products (ATPs).

Results
A total of 40,206 tweets were collected from the Twitter public API stream that were geocoded from 2018 to 2019. Using data mining approaches, these tweets were then fltered for keywords associated with tobacco and ATP use behavior. This resulted in a subset of 5718 tweets, with 657 manually annotated and identifed as associated with user-generated conversations about tobacco and ATP use behavior. The 657 tweets were coded into 9 parent codes: inquiry, interaction, observation, opinion, promote, reply, share knowledge, use characteristics, and transition of use behavior. The highest number of observations occurred under transition of use (43.38%, n=285), followed by current use (39.27%, n=258), opinions about use (0.07%, n=46), and product promotion (0.06%, n=37). Other codes had less than ten tweets that discussed these themes. Results provide early insights into how social media users discuss topics related to transition of use and their experiences with different and emerging tobacco product use behavior.


Original Research
Xu Q, Yang J, Haupt MR, Cai M, Nali M, Mackey TK. Digital Surveillance to Identify California Alternative and Emerging Tobacco Industry Policy Influence and Mobilization on Facebook. Int. J. Environ. Res. Public Health. 2021; 18(21), 11150; https://doi.org/10.3390/ijerph182111150

Abstract:
Growing popularity of electronic nicotine-delivery systems (ENDS) has coincided with a need to strengthen tobacco-control policy. In response, the ENDS industry has taken actions to mobilize against public health measures, including coordination on social media platforms. To explore this phenomenon, data mining was used to collect public posts on two Facebook public group pages: the California Consumer Advocates for Smoke Free Alternatives Association (CCASAA) and the community page of the Northern California Chapter of SFATA (NC-SFATA). Posts were manually annotated to characterize themes associated with industry political interference and user interaction. We collected 288 posts from the NC-SFATA and 411 posts from CCASAA. A total of 522 (74.7%) posts were categorized as a form of political interference, with 339 posts (64.9%) from CCASAA and 183 posts (35.1%) from NC-SFATA. We identified three different categories of policy interference- related posts: (1) providing updates on ENDS-related policy at the federal, state, and local levels; (2) sharing opinions about ENDS-related policies; (3) posts related to scientific information related to vaping; and (4) calls to action to mobilize against tobacco/ENDS policies. Our findings indicate that pro-tobacco social media communities on Facebook, driven by strategic activities of trade associations and their members, may act as focal points for anti policy information dissemination, grass-roots mobilization, and industry coordination that needs further research.


Original Research
Haupt MR, Xu Q, Yang J, Cai M, Mackey TK. Characterizing Vaping Industry Political Influence and Mobilization on Facebook: Social Network Analysis. J Med Internet Res. 2021; in press

Abstract:
Growing popularity of electronic nicotine-delivery systems (ENDS) has coincided with a need to strengthen tobacco-control policy. In response, the ENDS industry has taken actions to mobilize against public health measures, including coordination on social media platforms. To explore this phenomenon, data mining was used to collect public posts on two Facebook public group pages: the California Consumer Advocates for Smoke Free Alternatives Association (CCASAA) and the community page of the Northern California Chapter of SFATA (NC-SFATA). Posts were manually annotated to characterize themes associated with industry political interference and user interaction. We collected 288 posts from the NC-SFATA and 411 posts from CCASAA. A total of 522 (74.7%) posts were categorized as a form of political interference, with 339 posts (64.9%) from CCASAA and 183 posts (35.1%) from NC-SFATA. We identified three different categories of policy interference-related posts: (1) providing updates on ENDS-related policy at the federal, state, and local levels; (2) sharing opinions about ENDS-related policies; (3) posts related to scientific information related to vaping; and (4) calls to action to mobilize against tobacco/ENDS policies. Our findings indicate that pro-tobacco social media communities on Facebook, driven by strategic activities of trade associations and their members, may act as focal points for anti-policy information dissemination, grass-roots mobilization, and industry coordination that needs further research. View Full-Text


Original Research
Bardier C, Yang J, Li J, Mackey TK. Characterizing Alternative and Emerging Tobacco Product Transition of Use Behavior on Twitter. BMC Res Notes. 2021;14:303

Abstract:
Objective
The objective of this study was to develop an inductive coding approach specific to characterizing user-generated social media conversations about transition of use of different tobacco and alternative and emerging tobacco products (ATPs).

Results
A total of 40,206 tweets were collected from the Twitter public API stream that were geocoded from 2018 to 2019. Using data mining approaches, these tweets were then filtered for keywords associated with tobacco and ATP use behavior. This resulted in a subset of 5718 tweets, with 657 manually annotated and identified as associated with user-generated conversations about tobacco and ATP use behavior. The 657 tweets were coded into 9 parent codes: inquiry, interaction, observation, opinion, promote, reply, share knowledge, use characteristics, and transition of use behavior. The highest number of observations occurred under transition of use (43.38%, n=285), followed by current use (39.27%, n=258), opinions about use (0.07%, n=46), and product promotion (0.06%, n=37). Other codes had less than ten tweets that discussed these themes. Results provide early insights into how social media users discuss topics related to transition of use and their experiences with different and emerging tobacco product use behavior.


Original Research
Yang J, Sou A, Faruqui A, Mackey TK. A Qualitative Examination of e-cigarette Use Among California Young Adults During the EVALI Outbreak. Prev Med Rep. 2021;24:101506

Abstract:
The 2019 outbreak of E-cigarette, or Vaping, Product Use-Associated Lung Injury (EVALI) increased awareness of potential health risks associated with vaping among the general public. Little is known, however, about how unfolding information regarding EVALI affected knowledge, attitudes, and behaviors among e-cigarette users, particularly among young adults. This study describes attitudinal and behavioral responses to EVALI among young adult e-cigarette users. In October and November 2019, seven focus groups were held with college-going young adult tobacco users from two four-year public universities in California. Focus groups included questions regarding knowledge of and reaction to EVALI news, and how the news affected product use. Text from current e-cigarette users was extracted to develop individual phenomenological textural-structural descriptions of e-cigarette use for 38 individuals which were used to create a composite experience of e-cigarette use in light of EVALI. Experiences indicated that e-cigarette users were aware of information regarding EVALI and received information from numerous sources. Information was filtered for legitimacy of EVALI claims and causes of EVALI. Risk rationalizations were developed to assess potential harm of continued e-cigarette use and provided reasoning for behavioral responses to EVALI. The emerging harm associated with EVALI prompted e-cigarette users to engage in a cognitive process resulting in employment of a range of rationalities to justify continued use. These results suggest how environmental, cognitive, and behavioral factors may interact as young adults negotiate e-cigarette-related harms.


Original Research
Cratsley K, Brooks MA, Mackey TK. Refugee Mental Health, Global Health Policy, and the Syrian Crisis. Front Public Health. 2021; 9:676000. doi: 10.3389/fpubh.2021.676000

Abstract:
The most recent global refugee figures are staggering, with over 82.4 million people forcibly displaced and 26.4 million registered refugees. The ongoing conflict in Syria is a major contributor. After a decade of violence and destabilization, over 13.4 million Syrians have been displaced, including 6.7 million internally displaced persons and 6.7 million refugees registered in other countries. Beyond the immediate political and economic challenges, an essential component of any response to this humanitarian crisis must be health-related, including policies and interventions specific to mental health. This policy and practice review addresses refugee mental health in the context of the Syrian crisis, providing an update and overview of the current situation while exploring new initiatives in mental health research and global health policy that can help strengthen and expand services. Relevant global health policy frameworks are first briefly introduced, followed by a short summary of recent research on refugee mental health. We then provide an update on the current status of research, service provision, and health policy in the leading destinations for Syrians who have been forcibly displaced. This starts within Syria and then turns to Turkey, Lebanon, Jordan, and Germany. Finally, several general recommendations are discussed, including the pressing need for more data at each phase of migration, the expansion of integrated mental health services, and the explicit inclusion and prioritization of refugee mental health in national and global health policy.


Original Research
Purushothaman V, Cuomo RE, Garland C, Mackey TK. Could age increase the strength of inverse association between ultraviolet B exposure and colorectal cancer?. BMC Public Health. 2021;21:1238

Abstract:
Background
Vitamin D has been identified as a potential protective factor in the development of colorectal cancer (CRC). We expect to see a stronger association of ultraviolet B (UVB) exposure and CRC crude rates with increasing age since chronic vitamin D deficiency leads to sustained molecular changes that increase cancer risk. The DINOMIT (disjunction, initiation, natural selection, overgrowth, metastasis, involution, and transition) model postulates various stages of cancer development due to vitamin D deficiency and the associated latency period. The purpose of this study is to examine this age-dependent inverse relationship globally.

Methods
In this ecological study, a series of linear and polynomial regression tests were performed between country-specific UVB estimates adjusted for cloud cover and crude incidence rates of CRC for different age groups. Multiple linear regression was used to investigate the association between crude incidence rates of colorectal cancer and UVB estimate adjusting for urbanization, skin pigmentation, smoking, animal consumption, per capita GDP, and life expectancy. Statistical analysis was followed by geospatial visualization by producing choropleth maps.

Results
The inverse relationship between UVB exposure and CRC crude rates was stronger in older age groups at the country level. Quadratic curve fitting was preferred, and these models were statistically significant for all age groups. The inverse association between crude incidence rates of CRC and UVB exposure was statistically significant for age groups above 45 years, after controlling for covariates.

Conclusion
The age-dependent inverse association between UVB exposure and incidence of colorectal cancer exhibits a greater effect size among older age groups in global analyses. Studying the effect of chronic vitamin D deficiency on colorectal cancer etiology will help in understanding the necessity for population-wide screening programs for vitamin D deficiency, especially in regions with inadequate UVB exposure. Further studies are required to assess the need for adequate public health programs such as selective supplementation and food fortification.


Original Research

Abstract:
Background
Suicide and substance use disorder (SUD) pose serious public health challenges among young adults in the United States. Increasing social media use among these populations can be leveraged as an alternative method to detect characteristics of suicide-related topics and behavior among substance users.Objective: To detect and characterize suicide and self-harm related conversations co-occurring with SUD posts and comments on the popular social media platform Instagram.

Methods
This study used big data and machine learning approaches to collect and classify Instagram posts containing 632 controlled substance-related hashtags. Posts were first classified for online drug diversion topics and then filtered to detect suicide and mental health discussions. Posts and comments were then manually annotated for SUD and mental health co-occurring themes. Associations between these characteristics were tested using the Chi-square test.

Results
We detected 719 Instagram posts/comments that included user-generated discussions about suicide, substance use and/or mental health. Posts self-reporting SUD and mental health topics were also more likely to discuss suicide compared to those that did not discuss SUD and mental health topics, respectively (p < 0.001). Major themes observed included concurrent discussions of suicide ideation and attempts and low self-esteem.

Conclusion
Our study results provide preliminary evidence of social media discussions about suicide and mental health among those with SUD. This co-occurrence represents a key health risk factor on a platform heavily utilized by young adults. Further studies are required to analyze specific patterns of suicide and self-harm ideations for the purposes of designing future suicide prevention campaigns through digital channels.


Original Research
Cuomo RE, Purushothaman V, Li J, Cai M, Mackey TK. A Longitudinal and Geospatial Analysis of COVID-19 Tweets During the Early Outbreak Period in the United States. BMC Public Health. 2021;21:793

Abstract:
Introduction
Early reports of COVID-19 cases and deaths may not accurately convey community-level concern about the pandemic during early stages, particularly in the United States where testing capacity was initially limited. Social media interaction may elucidate public reaction and communication dynamics about COVID-19 in this critical period, during which communities may have formulated initial conceptions about the perceived severity of the pandemic.

Methods
Tweets were collected from the Twitter public API stream filtered for keywords related to COVID-19. Using a pre-existing training set, a support vector machine (SVM) classifier was used to obtain a larger set of geocoded tweets with characteristics of user self-reporting COVID-19 symptoms, concerns, and experiences. We then assessed the longitudinal relationship between identified tweets and the number of officially reported COVID-19 cases using linear and exponential regression at the U.S. county level. Changes in tweets that included geospatial clustering were also assessed for the top five most populous U.S. cities.

Results
From an initial dataset of 60 million tweets, we analyzed 459,937 tweets that contained COVID-19-related keywords that were also geolocated to U.S. counties. We observed an increasing number of tweets throughout the study period, although there was variation between city centers and residential areas. Tweets identified as COVID-19 symptoms or concerns appeared to be more predictive of active COVID-19 cases as temporal distance increased.

Conclusion
Results from this study suggest that social media communication dynamics during the early stages of a global pandemic may exhibit a number of geospatial-specific variations among different communities and that targeted pandemic communication is warranted. User engagement on COVID-19 topics may also be predictive of future confirmed case counts, though further studies to validate these findings are needed.


Original Research

Abstract:
This study investigates the types of misinformation spread on Twitter that evokes scientific authority or evidence when making false claims about the antimalarial drug hydroxychloroquine as a treatment for COVID-19. Specifically, we examined tweets generated after former U.S. President Donald Trump retweeted misinformation about the drug using an unsupervised machine learning approach called the biterm topic model that is used to cluster tweets into misinformation topics based on textual similarity. The top 10 tweets from each topic cluster were content coded for three types of misinformation categories related to scientific authority: medical endorsements of hydroxychloroquine, scientific information used to support hydroxychloroquine’s use, and a comparison group that included scientific evidence opposing hydroxychloroquine’s use. Results show a much higher volume of tweets featuring medical endorsements and use of supportive scientific information compared to accurate and updated scientific evidence, that misinformation-related tweets propagated for a longer time frame, and the majority of hydroxychloroquine Twitter discourse expressed positive views about the drug. Metadata from Twitter accounts found that prominent users within misinformation discourse were more likely to have media or political affiliation and explicitly expressed support for President Trump. Conversely, prominent accounts within the scientific opposition discourse primarily consisted of medical doctors or scientists but had far less influence in the Twitter discourse. Implications of these findings and connections to related social media research are discussed, as well as cognitive mechanisms for understanding susceptibility to misinformation and strategies to combat misinformation spread via online platforms.


Original Research
Shah N, Li J, Mackey TK. An Unsupervised Machine Learning Approach for Detection and Characterization of Illicit Drug-dealing Comments and Interaction on Instagram. Substance Abuse. 2021; Jul 2;1-5. doi: 10.1080/08897077.2021.1941508

Abstract:
Background
Growing use of social media has led to the emergence of virtual controlled substance and illicit drug marketplaces, prompting calls for action by government and law enforcement. Previous studies have analyzed Instagram drug selling via posts. However, comments made by users involving potential drug selling have not been analyzed. In this study, we use unsupervised machine learning to detect and classify prescription and illicit drug-related buying and selling interactions on Instagram.

Methods
We used over 1,000 drug-related hashtags on Instagram to collect a total of 43,607 Instagram comments between February 1st, 2019 and May 31st, 2019 using data mining approaches in the Python programming language. We then used an unsupervised machine learning approach, the Biterm Topic Model (BTM), to thematically summarize Instagram comments into distinct topic groupings, which were then extracted and manually annotated to detect buying and selling comments.
Results
We detected 5,589 comments from sellers, prospective buyers, and online pharmacies from 531 unique posts. The vast majority (99.7%) of comments originated from drug sellers and online pharmacies. Key themes from comments included providing contact information through encrypted third-party messaging platforms, drug availability, and price inquiry. Commonly offered drugs for sale included scheduled controlled substances such as Adderall and Xanax, as well as illicit hallucinogens and stimulants. Comments from prospective buyers of drugs most commonly included inquiries about price and availability.

Conclusions
We detected prescription controlled substances and other illicit drug selling interactions via Instagram comments to posts. We observed that comments were primarily used by sellers offering drugs, and typically not by prospective buyers interacting with sellers. Further research is needed to characterize these “social” drug marketplace interactions on this and other popular social media platforms.


Review

Abstract:
Background
In 2016, the “Act on Support for Overseas Expansion of Healthcare System and Attraction of International Patients” was enacted by the South Korean government in an attempt to accelerate growth of its medical tourism industry. However, only a few years after its implementation, the benefits are not well understood, nor have the positive or negative impacts of expanding Korea’s medical tourism sector been properly evaluated.

Objective
We aimed to systematically review and summarize existing literature describing South Korea’s medical tourism policy and legislative history, while also assessing the impact of this domestic policy approach on the country’s public health systems.

Methods
A bilingual systematic literature review was conducted per PRISMA guidelines for all South Korean medical tourism legislative and policy literature using MeSH terms and other related keywords in two academic databases, PubMed and JSTOR. Published studies were included if they directly addressed South Korean medical tourism policy. To supplement results from the peer-review, the grey literature was also searched using Google search engine for relevant policy documents, information from government websites, and national statistics on medical tourism-related data.

Results
This review included 14 peer-reviewed journal articles and 9 websites. The majority of literature focused on the legislative history of South Korea’s pro-medical tourism policy, economic considerations associated with industry growth, and the specific experiences of medical tourists. There was a lack of studies, analytical or commentary-based, conducting in-depth analysis of the healthcare impact of these policies or comparing benefits and costs compared to other medical tourism destinations. Proponents of medical tourism continue to advocate the government for increased deregulation and investment in the sector.

Conclusion
This systematic review suggests that policy decisions may prioritize economic growth offered by medical tourism over negative effects on the healthcare workforce, access and equity, and its potential to undermine Universal Health Coverage. South Korea continues to examine ways to further amend the Act and grow this sector, but these actions should be taken with caution by critically examining how other countries have adapted their policymaking based on the real-world costs associated with medical tourism.


Original Research
Cuomo RE, Purushothaman VL, Li J, Bardier C, Nali M, Shah N, Obradovich N, Yang J, Mackey TK. Characterizing Self-reported Tobacco, Vaping, and Marijuana-related Tweets Geolocated for California College Campuses. Front in Pub Health. 2021; in press.

Abstract:
Introduction
College-aged youth are active on social media yet smoking-related social media engagement in these populations has not been thoroughly investigated. We sought to conduct an exploratory infoveillance study focused on geolocated data to characterize smoking-related tweets originating from California 4-year colleges on Twitter.

Methods
Tweets from 2015 to 2019 with geospatial coordinates in CA college campuses containing smoking-related keywords were collected from the Twitter API stream and manually annotated for discussions about smoking product type, sentiment, and behavior.

Results
Out of all tweets detected with smoking-related behavior, 46.7% related to tobacco use, 50.0% to marijuana, and 7.3% to vaping. Of these tweets, 46.1% reported first-person use or second-hand observation of smoking behavior. Out of 962 tweets with user sentiment, the majority (67.6%) were positive, ranging from 55.0% for California State University, Long Beach to 95.8% for California State University, Los Angeles.

Discussion
We detected reporting of first- and second-hand smoking behavior on CA college campuses representing possible violation of campus smoking bans. The majority of tweets expressed positive sentiment about smoking behaviors, though there was appreciable variability between college campuses. This suggests that anti-smoking outreach should be tailored to the unique student populations of these college communities.

Conclusion
Among tweets about smoking from California colleges, high levels of positive sentiment suggest that the campus climate may be less receptive to anti-smoking messages or adherence to campus smoking bans. Further research should investigate the degree to which this varies by campuses over time and following implementation of bans including validating using other sources of data.


Original Research
Cuomo RE, Yang J, Purushothaman V, Nali M, Li J, Mackey TK. A Geospatial Analysis of Age Disparities in Resolute Localities of Tobacco and Vaping-Specific Storefronts in California. Tobacco Prev Cessation. 2021; in press.

Abstract:
Introduction
Concomitant with the popularization of vaping, vape shops have dramatically proliferated over the past years. This study assesses whether vape storefronts in California are significantly associated with density of different age groups, and whether this differs between tobacco storefronts or non-specific tobacco retailers.

Methods
Addresses for licensed tobacco retailers were obtained from the California Department of Tax and Fee Administration. Business names and addresses were used to obtain store categories cross-referenced from Yelp. Using a cross-sectional ecological design, stores categorized as ‘Vape Shop’ or ‘Tobacco Shop’ were geolocated and compared with age-related variables from the American Community Survey. Regression was conducted in R to determine relationships between age group concentration, in ventiles, and proportion of tracts with tobacco-specific or vape-specific stores. Geospatial visualization was conducted using ArcGIS.

Results
We found 848 vape shops, 820 tobacco shops, 419 categorized as both, and 20320 retailers with neither category. Overall, 1800 tobacco and/or vape shops were categorized in 1557 of California’s 23194 census tracts. A positive linear association was found between ventiles of two age categories, 20–24 and 25–34 years, and proportion of tracts with vape-specific or tobacco-specific shops separately.

Conclusions
Positive associations were found for ages 20–34 years but not for other ages, suggesting vape shops are strategically located in areas populated by young adults. Location-based targeting increases access, thereby increasing proportion of tobacco users, and could be a critical factor in e-cigarette uptake and use. Further study to identify additional age-related demographic characteristics among clientele of tobacco storefronts is warranted.


Original Research
Chavez J, Shah NA, Ruoss S, Cuomo RE, Ward SR, Mackey TK. Online Marketing Practices of Regenerative Medicine Clinics in U.S.-Mexico Border Region: A Web Surveillance Study. Stem Cell Research & Therapy. 2021;12:189.

Abstract:
Introduction
The potential of regenerative medicine to improve human health has led to the rapid expansion of stem cell clinics throughout the world with varying levels of regulation and oversight. This has led to a market ripe for stem cell tourism, with Tijuana, Mexico, as a major destination. In this study, we characterize the online marketing, intervention details, pricing of services, and assess potential safety risks through web surveillance of regenerative medicine clinics marketing services in Tijuana.

Methods
We conducted structured online search queries from March to April 2019 using 296 search terms in English and Spanish on two search engines (Google and Bing) to identify websites engaged in direct-to-consumer advertising of regenerative medicine services. We performed content analysis to characterize three categories of interest: online presence, tokens of scientific legitimacy, and intervention details.

Results
Our structured online searches resulted in 110 unique websites located in Tijuana corresponding to 76 confirmed locations. These clinics’ online presence consisted of direct-to-consumer advertising mainly through a dedicated website (94.5%) or Facebook page (65.5%). The vast majority of these websites (99.1%) did not mention any affiliation to an academic institutions or other overt tokens of scientific legitimacy. Most clinics claimed autologous tissue was the source of treatments (67.3%) and generally did not specify route of administration. Additionally, of the Tijuana clinics identified, 13 claimed licensing, though only 1 matched with available licensing information.

Conclusions
Regenerative medicine clinics in Tijuana have a significant online presence using direct-to-consumer advertising to attract stem-cell tourism clientele in a bustling border region between Mexico and the USA. This study adds to existing literature evidencing the unregulated nature of online stem cell offerings and provides further evidence of the need for regulatory harmonization, particularly to address stem cell services being offered online across borders.


Article

Abstract:
In the context of blockchain technology, “off-chain” refers to computation or data that is structurally external to the blockchain network. Off-Chain Blockchain Systems (OCBS) enable this information processing and management through distributed software architecture where the blockchain network interacts with off-chain resources. Hence, OCBS are a critical data governance component in the design of enterprise blockchain solutions, resulting in extensive research and development exploring the interplay between on-chain and off-chain storage and computation and efforts to evaluate their performance relative to other information management systems. Key features of OCBS’ are their ability to improve scalability, reduce data storage requirements, and enhance data privacy, all extremely critical issues to enable broader blockchain adoption. These OCBS features map well to the needs of the healthcare industry, particularly due to the need to manage various types of medical, consumer, and other health-related data. However, different types of health data are also subject to stringent regulatory, security and legal requirements, a key factor limiting blockchain adoption in the sector. In response, there is a critical need to better align OCBS design features to different types of healthcare data management and their respective governance and privacy regimes. This article first reviews the characteristics of different constructs of OCBS. It then proposes a modular hybrid privacy-preserving framework leveraging off-chain and on-chain blockchain system design applied to three different reference models that illustrate how blockchain can enhance healthcare information management. Through this privacy-preserving framework we hope to liberate healthcare data by enabling sharing, sovereignty and enhanced trust.


Commentary
Platt M, Hasselgren A, Román-Belmonte JM, Tuler de Oliveira M, De la Corte-Rodríguez H, Delgado Olabarriaga S, Rodríguez-Merchán EC, Mackey TK. Test, Trace, put on the Blockchain? A Viewpoint Evaluating the Use of Decentralized Systems for Algorithmic Contact Tracing to Combat a Global Pandemic. JMIR Public Health Surveil. 2021; in press

No abstract available.


Commentary
Mackey TK, Purushothaman V, Haupt M, Nali M, Li J. Application of Unsupervised Machine Learning to Identify and Characterize Hydroxychloroquine Misinformation on Twitter. Lancet Digital Health. 2021;3(2):e72-75.

No Abstract Available.


Original Research
Nali M, Purushothaman V, Xu Q, Cuomo RE, Mackey TK. Characterizing and Assessing Compliance of Online Vendors to the State of Massachusetts ENDS Product Sales Ban. Tob Induc Dis. 2021;19:5

Abstract:
Introduction
Recent reports of lung injury associated with Electronic Nicotine Delivery System (ENDS) products precipitated by increasing vaping prevalence and interest in flavors among adolescents has led to policies that restrict the sale, distribution, and accessibility of ENDS products. This study assessed compliance of online ENDS vendors to the Massachusetts temporary sales ban.

Methods
The study involved structured web surveillance for online ENDS vendors using keyword searches on Google search engine (October to November 2019.) Once vendors were identified, we conducted simulated online purchases, defined as placing an order for an ENDS product by putting it in the website shopping cart without finalizing payment. Simulated purchases and content analysis of websites was conducted to determine compliance characteristics. Fisher’s exact test was used to identify associations between compliance and website characteristics such as location and age verification requirements.

Results
Simulated online purchases from 50 identified ENDS vendors yielded 72% (n=36) stores that were non-compliant and allowed placement of ENDS product orders, without restrictions, to a Massachusetts address. The remaining 14 websites had processes in place to prevent orders from buyers located in Massachusetts. Other characteristics of interest, including use of age verification, location data, and web registrar/registrant data were collected and reported.

Conclusions
The September 2019 Massachusetts executive order was a comprehensive ban on selling ENDS products both online and offline. However, our study found that close to three-fourths of the vendors appeared to be non-compliant, indicating that implementation and enforcement are ongoing challenges for future tobacco control efforts on the internet. Policymaking needs to be specifically tailored to address the unique challenges of online environments, particularly in the context of identifying non-compliant sites, ensuring age verification, and addressing non-US sellers.


Original Research

Abstract:
The Open Payments database reports payments made to physicians by industry. Given the potential for financial conflicts of interest relating to patient outcomes, further scrutiny of these data is valuable. Therefore, the objective of this study was to analyze physician-industry relationships by specialty type, payment type, geospatial trend, and longitudinal trend between 2014–2018. We conducted an observational, retrospective data analysis of payments from the Open Payments database for licensed United States physicians listed in the National Plan & Provider Enumeration System (NPPES). Datasets from 2013–2018 were joined using the Python programming language. Aggregation and sub-setting by characteristics of interest was done in R to calculate means and frequencies of reported general physician payments from industry across different specialties, locations, timeframes, and payment types. Normalization was applied for numbers of physicians or payments. Geospatial statistical hot spot analysis was conducted in ArcGIS. 51.73 million payment records were analyzed. In total, 50,047,930 payments were issued to 771,113 allopathic or osteopathic physicians, representing $8,702,631,264 transferred from industry to physicians over the five-year period between 2014 and 2018. The mean payment amount was $179, with a standard deviation of $12,685. Variability in physicians’ financial relationships with industry were apparent across specialties, regions, time, and payment type. A limited match rate between records in the NPPES and Open Payments databases may have resulted in selection bias of trends related to physician characteristics. Further research is necessary, particularly in the context of changing industry payment trends and public perceptions of the appropriateness of these relationships.



2020

Topics covered: COVID-19; data science; substance abuse; corruption; blockchain; conservation; global health governance; health policy; social media

  • Number of Publications: 15
Original Research
Review
Article
Commentary
Original Research

Abstract:
This paper analyzes online user conversation topics and discourse on Twitter related to the “Liberate” Protest movement in reaction to social distancing guidelines at the early stages of the COVID-19 pandemic. Interdisciplinary approaches in big data, machine learning, content analysis, and social network analysis (SNA) were used to characterize the communicative behavior, conversation themes, and network structures of Liberate protest supporters and non-supporters. Tweets were content coded and grouped within topic clusters produced from an unsupervised machine learning algorithm using natural language processing. An analysis of topic clusters found that tweets that support the protests are highly concentrated and have higher volumes of replicated tweets. Protest Supporters were also more likely to retweet other users while Non-Supporters were more likely to include a URL from an outside media source and produce a unique tweet. SNA was also used to assess the characteristics of retweet networks and found that the Protester Supporter network had a more centralized structure and was strongly influenced by a political organization, in contrast to the Non-Supporter network that had a larger number of smaller and more evenly-sized nodes and more driven by media personalities and commentators. Collectively, these characteristics indicate that protest supporters had more centralized, consistent and disseminated discourse protesting COVID-19 social distancing requirements compared to non-supporters who were more diverse in their criticism of the Liberate movement and generally more fragmented in their support of public health measures. Results from this study provide important insights into pandemic communication dynamics of opposing twitter communities, including in the context of those who oppose and support public health measures in a highly politicized social and online environment. Results are important in the context of assessing the messages, communication propagation and overall activities of social media communities in response to basic public health measures needed to contain this post-digital era global pandemic.


Commentary
Yang JS, Kotzias V, Crosbie E, Mackey TK. COVID-19 and a Window of Opportunity: Guiding Principles for a Health-Promoting Trade Agenda. Int J Health Policy Manag. 2020; in press.

No abstract available


Original Research
Xu Q, Shen Z, Shah N, Cuomo RE, Cai M, Li J, Mackey TK. Characterizing Weibo Social Media Posts from Wuhan, China During the Early Stages of the COVID-19 Pandemic: A Qualitative Content Analysis. JMIR Public Health Surveil. 2020;6(4):e24125.

Abstract:
Background:
The COVID-19 pandemic has reached 40 million confirmed cases worldwide. Given its rapid progression, it is important to examine its origins to better understand how people’s knowledge, attitudes, and reactions have evolved over time. One method is to use data mining of social media conversations related to information exposure and self-reported user experiences.

Objective:
This study aims to characterize the knowledge, attitudes, and behaviors of social media users located at the initial epicenter of the outbreak by analyzing data from the Sina Weibo platform in Chinese.

Methods:
We used web scraping to collect public Weibo posts from December 31, 2019, to January 20, 2020, from users located in Wuhan City that contained COVID-19–related keywords. We then manually annotated all posts using an inductive content coding approach to identify specific information sources and key themes including news and knowledge about the outbreak, public sentiment, and public reaction to control and response measures.

Results:
We identified 10,159 COVID-19 posts from 8703 unique Weibo users. Among our three parent classification areas, 67.22% (n=6829) included news and knowledge posts, 69.72% (n=7083) included public sentiment, and 47.87% (n=4863) included public reaction and self-reported behavior. Many of these themes were expressed concurrently in the same Weibo post. Subtopics for news and knowledge posts followed four distinct timelines and evidenced an escalation of the outbreak’s seriousness as more information became available. Public sentiment primarily focused on expressions of anxiety, though some expressions of anger and even positive sentiment were also detected. Public reaction included both protective and elevated health risk behavior.

Conclusions:
Between the announcement of pneumonia and respiratory illness of unknown origin in late December 2019 and the discovery of human-to-human transmission on January 20, 2020, we observed a high volume of public anxiety and confusion about COVID-19, including different reactions to the news by users, negative sentiment after being exposed to information, and public reaction that translated to self-reported behavior. These findings provide early insight into changing knowledge, attitudes, and behaviors about COVID-19, and have the potential to inform future outbreak communication, response, and policy making in China and beyond.


Original Research
Cuomo RE, Purushothaman V, Li J, Cai M, Mackey TK. Sub-national Longitudinal and Geospatial Analysis of COVID-19 Tweets. PLoS One. 2020;15(1): e0241330.

Abstract:
Objectives
According to current reporting, the number of active coronavirus disease 2019 (COVID-19) infections is not evenly distributed, both spatially and temporally. Reported COVID-19 infections may not have properly conveyed the full extent of attention to the pandemic. Furthermore, infection metrics are unlikely to illustrate the full scope of negative consequences of the pandemic and its associated risk to communities.

Methods
In an effort to better understand the impacts of COVID-19, we concurrently assessed the geospatial and longitudinal distributions of Twitter messages about COVID-19 which were posted between March 3rd and April 13th and compared these results with the number of confirmed cases reported for sub-national levels of the United States. Geospatial hot spot analysis was also conducted to detect geographic areas that might be at elevated risk of spread based on both volume of tweets and number of reported cases.

Results
Statistically significant aberrations of high numbers of tweets were detected in approximately one-third of US states, most of which had relatively high proportions of rural inhabitants. Geospatial trends toward becoming hotspots for tweets related to COVID-19 were observed for specific rural states in the United States.

Discussion
Population-adjusted results indicate that rural areas in the U.S. may not have engaged with the COVID-19 topic until later stages of an outbreak. Future studies should explore how this dynamic can inform future outbreak communication and health promotion.


Original Research
Li J, Chen W-H Xu Q, Shah N, Kohler JC, Mackey TK. Detection of Self-reported Experiences with Corruption on Twitter Using Unsupervised Machine Learning. Social Sciences & Humanities Open. 2020;2(1):100060.

Abstract:
Background
Corruption is a significant challenge to the future of human development, economic progress, and population health in the post millennium. Corruption, in its different forms of bribery, fraud, waste, collusion, and illicit financial flows, not only leads to waste but can also erode trust in government and public systems. Corruption is also complex and globalized with different forms of corruption occurring across different countries and multiple industries. One critical tool to leverage in the fight against corruption is the use of innovative technologies such as machine learning.

Methods
In this study, we deployed an unsupervised machine learning methodology using natural language processing to collect and analyze data from the popular social media platform Twitter with the aims of detecting self-reported experiences with corruption, including in the health sector. We collected data from the Twitter public API for keywords associated with corruption and used the biterm topic model to extract themes from the entire corpus of Tweets in order to detect user-generated messages reporting or discussing experiences with corruption.

Results
We analyzed 22, 180, 425 tweets filtered for corruption-related keywords from January–May 2019. Using a combination of NLP and manual annotation, we detected 2383 tweets from 1556 users that included self-reporting of corruption for two dominant themes: police bribery and healthcare corruption. Overall, we found a small number of users actively reporting experiences with corruption, identified users located in countries that are perceived as having higher levels of corruption by their citizens, and found that the majority of messages included reports of users’ own experiences and/or documentation of corruption.

Conclusion
Though technology is not a “silver bullet” that can entirely address the multifaceted nature of global corruption, this study demonstrates its potential utility as a force for good to enable better detection, characterize forms of corruption in different sectors, and hopefully inform future anti-corruption efforts. Additionally, the UN Sustainable Development Goals, with shared goals of fighting corruption, improving population health, encouraging technology adoption, and fostering multistakeholder partnerships, may serve as a critical governance space to catalyze technology-driven anti-corruption approaches.


Original Research
Mackey TK, Li J, Purushothaman V, Nali M, Shah N, Bardier C, Cai M, Liang BA. Big Data, Natural Language Processing, and Deep Learning to Detect and Characterize Illicit COVID-19 Product Sales: An Infoveillance Study on Twitter and Instagram. JMIR Public Health Surveill. 2020; 6(3):e20794.

Abstract:
Background:
The coronavirus disease (COVID-19) pandemic is perhaps the greatest global health challenge of the last century. Accompanying this pandemic is a parallel “infodemic,” including the online marketing and sale of unapproved, illegal, and counterfeit COVID-19 health products including testing kits, treatments, and other questionable “cures.” Enabling the proliferation of this content is the growing ubiquity of internet-based technologies, including popular social media platforms that now have billions of global users.

Objective:
This study aims to collect, analyze, identify, and enable reporting of suspected fake, counterfeit, and unapproved COVID-19–related health care products from Twitter and Instagram.

Methods:
This study is conducted in two phases beginning with the collection of COVID-19–related Twitter and Instagram posts using a combination of web scraping on Instagram and filtering the public streaming Twitter application programming interface for keywords associated with suspect marketing and sale of COVID-19 products. The second phase involved data analysis using natural language processing (NLP) and deep learning to identify potential sellers that were then manually annotated for characteristics of interest. We also visualized illegal selling posts on a customized data dashboard to enable public health intelligence.

Results:
We collected a total of 6,029,323 tweets and 204,597 Instagram posts filtered for terms associated with suspect marketing and sale of COVID-19 health products from March to April for Twitter and February to May for Instagram. After applying our NLP and deep learning approaches, we identified 1271 tweets and 596 Instagram posts associated with questionable sales of COVID-19–related products. Generally, product introduction came in two waves, with the first consisting of questionable immunity-boosting treatments and a second involving suspect testing kits. We also detected a low volume of pharmaceuticals that have not been approved for COVID-19 treatment. Other major themes detected included products offered in different languages, various claims of product credibility, completely unsubstantiated products, unapproved testing modalities, and different payment and seller contact methods.

Conclusions:
Results from this study provide initial insight into one front of the “infodemic” fight against COVID-19 by characterizing what types of health products, selling claims, and types of sellers were active on two popular social media platforms at earlier stages of the pandemic. This cybercrime challenge is likely to continue as the pandemic progresses and more people seek access to COVID-19 testing and treatment. This data intelligence can help public health agencies, regulatory authorities, legitimate manufacturers, and technology platforms better remove and prevent this content from harming the public.


Original Research
Mackey TK, Miyachi K, Fung D, Qian S, Short J. Combating Healthcare Fraud and Abuse: A Technology Framework and Prototype Leveraging Blockchain Technology. J Med Internet Res. 2020;22(9):e18623.

Abstract:
Background:
An estimated US $2.6 billion loss is attributed to health care fraud and abuse. With traditional health care claims verification and reimbursement, the health care provider submits a claim after rendering services to a patient, which is then verified and reimbursed by the payer. However, this process leaves out a critical stakeholder: the patient for whom the services are actually rendered. This lack of patient participation introduces a risk of fraud and abuse. Blockchain technology enables secure data management with transparency, which could mitigate this risk of health care fraud and abuse.

Objective:
The aim of this study is to develop a framework using blockchain to record claims data and transactions in an immutable format and to enable the patient to act as a validating node to help detect and prevent health care fraud and abuse.

Methods:
We developed a health care fraud and abuse blockchain technical framework and prototype using key blockchain tools and application layers including consensus algorithms, smart contracts, tokens, and governance based on digital identity on the Ethereum platform (Ethereum Foundation).

Results:
Our technical framework maps to the claims adjudication process and focuses on Medicare claims, with the US Centers for Medicare and Medicaid Services (CMS) as the central authority. A prototype of the framework system was developed using the blockchain platform Ethereum (Ethereum Foundation), with its design features, workflow, smart contract functions, system architecture, and software implementation outlined. The software stack used to build the system consisted of a front-end user interface framework, a back-end processing server, and a blockchain network. React was used for the user interface framework, and NodeJS and an Express server were used for the back-end processing server; Solidity was the smart contract language used to interact with a local Ethereum blockchain network.


Original Research

Abstract
At an estimated US$19 billion, the illicit wildlife trade is a serious threat to global conservation efforts. This criminal enterprise is now digital, expanding its footprint to consumers internationally by using the Internet and social media platforms. Recent studies have detected illegal wildlife selling posts on the popular social networking site Facebook in several different languages, including Chinese. In order to further explore this challenge to conservation, this study used big data approaches to identify and characterize wildlife trading activity in Chinese language on Facebook using an automated web scraper. We focused on keywords associated with elephants, rhinos and hawksbill turtles. We collected 10 303 unique Facebook posts over a 45-day period and were able to identify 639 posts from 268 unique users, which we suspect of directly marketing the sale of wildlife products. We also identified other species including Tibetan antelope, bears and African spurred tortoises. Facebook community pages appeared to have the highest percentage (48.2%) of wildlife selling posts. We also identified 14 different countries and regions with suspected wildlife-selling users, most located in Taiwan. Furthermore, we observed that the language used by some sellers changed from descriptive text to emojis and other code words. Collective action is needed from governments, law enforcement, civil society and technology companies leveraging big data approaches to better detect and interdict online Chinese-language wildlife trafficking.


Article
Yang J, Mamudu H, Mackey TK. Governing Noncommunicable Diseases Through Political Rationality and Technologies of Government: A Discourse Analysis. Int J Environ Res Public Health. 2020;17(12),4413

Abstract
In the last two decades, global action to address noncommunicable diseases (NCDs) has accelerated, but policy adoption and implementation at the national level has been inadequate. This analysis examines the role of rationalities of governing, or governmentality, in national-level adoption of global recommendations. Critical discourse analysis was conducted using 49 formal institutional and organizational documents obtained through snowball sampling methodology. Text were coded using a framework of five forms of governmentality and analyzed to describe the order of discourse which has emerged within the global NCD policy domain. The dominant political rationality used to frame NCDs is rooted in risk governmentality. Recommendations for tobacco control and prevention of harmful alcohol use rely on a governmentality of police mixed with discipline. The promotion of physical activity relies heavily on disciplinary governmentality, and the prevention of unhealthy diet mixed disciplinary measures, discipline, and neoliberal governmentalities. To translate global NCD prevention and control strategies to national action, acceptability for the political rationalities embodied in policy options must be nurtured as new norms, procedures, and institutions appropriate to the political rationalities of specific interventions are developed.


Commentary

Abstract
We discuss how corruption affects access to antiretroviral therapies (ARVs) globally. Recent cases of theft of ARVs, collusion, and manipulation in procurement found in countries such as Central African Republic, Bangladesh, Malawi, and Guinea, show there is still much work to be done to reduce the risk of corruption. This includes addressing the structural weaknesses in procurement mechanisms and supply chain management systems of health commodities and medicines.


Original Research
Mackey TK, Purushothaman V, Li J, Shah N, Nali M, Bardier C, Liang BA, Cai M, Cuomo RE. Machine Learning to Detect Self-Reporting of Symptoms, Testing Access and Recovery Associated with COVID-19 on Twitter: A Retrospective Big-Data Infoveillance Study. JMIR Public Health Surveill. 2020;6(2):e19509

Abstract:
Background:
The coronavirus disease (COVID-19) pandemic is a global health emergency with over 6 million cases worldwide as of the beginning of June 2020. The pandemic is historic in scope and precedent given its emergence in an increasingly digital era. Importantly, there have been concerns about the accuracy of COVID-19 case counts due to issues such as lack of access to testing and difficulty in measuring recoveries.

Objective:
The aims of this study were to detect and characterize user-generated conversations that could be associated with COVID-19-related symptoms, experiences with access to testing, and mentions of disease recovery using an unsupervised machine learning approach.

Methods:
Tweets were collected from the Twitter public streaming application programming interface from March 3-20, 2020, filtered for general COVID-19-related keywords and then further filtered for terms that could be related to COVID-19 symptoms as self-reported by users. Tweets were analyzed using an unsupervised machine learning approach called the biterm topic model (BTM), where groups of tweets containing the same word-related themes were separated into topic clusters that included conversations about symptoms, testing, and recovery. Tweets in these clusters were then extracted and manually annotated for content analysis and assessed for their statistical and geographic characteristics.

Results:
A total of 4,492,954 tweets were collected that contained terms that could be related to COVID-19 symptoms. After using BTM to identify relevant topic clusters and removing duplicate tweets, we identified a total of 3465 (<1%) tweets that included user-generated conversations about experiences that users associated with possible COVID-19 symptoms and other disease experiences. These tweets were grouped into five main categories including first- and secondhand reports of symptoms, symptom reporting concurrent with lack of testing, discussion of recovery, confirmation of negative COVID-19 diagnosis after receiving testing, and users recalling symptoms and questioning whether they might have been previously infected with COVID-19. The co-occurrence of tweets for these themes was statistically significant for users reporting symptoms with a lack of testing and with a discussion of recovery. A total of 63% (n=1112) of the geotagged tweets were located in the United States.

Conclusions:
This study used unsupervised machine learning for the purposes of characterizing self-reporting of symptoms, experiences with testing, and mentions of recovery related to COVID-19. Many users reported symptoms they thought were related to COVID-19, but they were not able to get tested to confirm their concerns. In the absence of testing availability and confirmation, accurate case estimations for this period of the outbreak may never be known. Future studies should continue to explore the utility of infoveillance approaches to estimate COVID-19 disease severity.


Original Research
Cuomo RE, Cai M, Shah N, Li J, Chen WH, Obradovich N, Mackey TK. Characterizing Communities Impacted by the 2015 Indiana HIV Outbreak: A Big Data Analysis of Social Media Messages Associated with HIV and Substance Abuse. Drug Alcohol Rev. 2020; in press.

Abstract:
Introduction and Aims
Infoveillance approaches (i.e. surveillance methods using online content) that leverage big data can provide new insights about infectious disease outbreaks and substance use disorder topics. We assessed social media messages about HIV, opioid use and injection drug use in order to understand how unstructured data can prepare public health practitioners for response to future outbreaks.

Design and Methods
We conducted an retrospective analysis of Twitter messages during the 2015 HIV Indiana outbreak using machine learning, statistical and geospatial analysis to examine the transition between opioid prescription drug abuse to heroin injection use and finally HIV transmission risk, and to test possible associations with disease burden and demographic variables in Indiana and Marion County. Tweets from October 2014 to June 2015 were compared to disease burden at the county level for Indiana, and classification of census blocks by presence of relevant messages was done at the census block level for Marion County. Marion County was used as it exhibited the highest total count of Tweets.

Results
257 messages about substance abuse and HIV were significantly related to HIV rates (P < 0.001) and opioid-related hospitalisations (P = 0.037). Using 157 characteristics from the American Community Survey, a linear classifier was computed with an appreciable correlation (r = 0.49) to risk-related social media messages from Marion County.

Discussion and Conclusions
Communities appear to communicate online in response to disease burden. Classification produced an accurate equation to model census block risk based on census data, allowing for high-dimensional estimation of risk for blocks with sparse populations.


Original Research

Abstract:
Background:
The coronavirus disease (COVID-19) pandemic, which began in Wuhan, China in December 2019, is rapidly spreading worldwide with over 1.9 million cases as of mid-April 2020. Infoveillance approaches using social media can help characterize disease distribution and public knowledge, attitudes, and behaviors critical to the early stages of an outbreak.

Objective:
The aim of this study is to conduct a quantitative and qualitative assessment of Chinese social media posts originating in Wuhan City on the Chinese microblogging platform Weibo during the early stages of the COVID-19 outbreak.

Methods:
Chinese-language messages from Wuhan were collected for 39 days between December 23, 2019, and January 30, 2020, on Weibo. For quantitative analysis, the total daily cases of COVID-19 in Wuhan were obtained from the Chinese National Health Commission, and a linear regression model was used to determine if Weibo COVID-19 posts were predictive of the number of cases reported. Qualitative content analysis and an inductive manual coding approach were used to identify parent classifications of news and user-generated COVID-19 topics.

Results:
A total of 115,299 Weibo posts were collected during the study time frame consisting of an average of 2956 posts per day (minimum 0, maximum 13,587). Quantitative analysis found a positive correlation between the number of Weibo posts and the number of reported cases from Wuhan, with approximately 10 more COVID-19 cases per 40 social media posts (P<.001). This effect size was also larger than what was observed for the rest of China excluding Hubei Province (where Wuhan is the capital city) and held when comparing the number of Weibo posts to the incidence proportion of cases in Hubei Province. Qualitative analysis of 11,893 posts during the first 21 days of the study period with COVID-19-related posts uncovered four parent classifications including Weibo discussions about the causative agent of the disease, changing epidemiological characteristics of the outbreak, public reaction to outbreak control and response measures, and other topics. Generally, these themes also exhibited public uncertainty and changing knowledge and attitudes about COVID-19, including posts exhibiting both protective and higher-risk behaviors.

Conclusions:
The results of this study provide initial insight into the origins of the COVID-19 outbreak based on quantitative and qualitative analysis of Chinese social media data at the initial epicenter in Wuhan City. Future studies should continue to explore the utility of social media data to predict COVID-19 disease severity, measure public reaction and behavior, and evaluate effectiveness of outbreak communication.


Article
Xu Q, Mackey TK, Cuomo RE, Liang BA. An Analysis of China Charity Credibility Before and After the 2016 Charity Law of the People’s Republic of China. Asian Journal of Criminology. 2020; in press.

Abstract:
Due to corruption and limited oversight, philanthropy in China has come under increasing scrutiny by both the Chinese government and public. In particular, corruption has impacted charities, resulting in operational funding declines that have also impacted legitimate charities serving the vulnerable. Hence, an increase in the number of Chinese charities without adequate transparency and needed good governance threatens the health of these organizations and their service groups. In response, the Chinese government enacted the 2016 Charity Law, implemented on September 1, 2016. Yet the impact of this law, if any, is unknown. We therefore conducted a literature review of the academic and gray literature to assess characteristics of the law, its strengths and limitations, and to explore anti-corruption case studies. In addition, we reviewed publicly available secondary data on the transparency status—complete financial information and responsible staff—of Chinese charity organizations and a group of health-related specific charities before and after the Law’s enactment. This included the transparency scores of the top 100 charities and top 30 health-related charities in China. The academic literature we reviewed focused on general governmental corruption and little on charity-related corruption. However, the gray literature reflected a poor view of charities in China due to publicized claims of fund and abuse. Based on our secondary data analysis, we found charity organizations’ transparency shows some variation but as a total continues to score low overall across the top net asset holding charities. Importantly, based on a regression analysis, the transparency scores of Chinese charities did not experience a significant change despite the Charity Law’s enactment. In response, strengthening the Charity Law by enhancing enforcement of financial regulations and implementing systemic good governance measures is needed. Further, efficiency initiatives such as philanthropy de-administration, e-government, and outsourcing monitoring of Chinese charities to external agencies would promote trustworthiness and credibility of Chinese charity organizations now and in the future.


Review
Mackey TK, Cuomo RE. An Interdisciplinary Review of Digital Technology to Facilitate Anti-Corruption, Transparency and Accountability in Medicines Procurement. Global Health Action. 2020; 13:sup1, 1695241, DOI: 10.1080/16549716.2019.1695241.

Abstract:
Background: Pharmaceutical corruption is a serious challenge in global health. Digital technologies that can detect and prevent fraud and corruption are particularly important to address barriers to access to medicines, such as medicines availability and affordability, stockouts, shortages, diversion, and infiltration of substandard and falsified medicines.

Objectives: To better understand how digital technologies are used to combat corruption, increase transparency, and detect fraud in pharmaceutical procurement systems to improve population health outcomes.

Methods: We conducted a multidisciplinary review of the health/medicine, engineering, and computer science literature. Our search queries included keywords associated with medicines procurement and digital technology in combination with terms associated with transparency and anti-corruption initiatives. Our definition of ‘digital technology’ focused on Internet-based communications, including online portals and management systems, supply chain tools, and electronic databases.

Results: We extracted 37 articles for in-depth review based on our inclusion criteria focused on the utilization of digital technology to improve medicines procurement. The vast majority of articles focused on electronic data transfer and/or e-procurement systems with fewer articles discussing emerging technologies such as machine learning and blockchain distributed ledger solutions. In the context of e-procurement, slow adoption, justifying cost-savings, and need for technical standards setting were identified as key challenges for current and future utilization.

Conclusions: Though there is a significant promise for digital technologies, particularly e-procurement, overall adoption of solutions that can enhance transparency, accountability and concomitantly combat corruption, is still underdeveloped. Future efforts should focus on tying cost-saving measurements with anti-corruption indicators, prioritizing centralization of e-procurement systems, establishing regulatory harmonization with standards setting, and incorporating additional anti-corruption technologies into procurement processes for improving access to medicines and to reach the overall goal of Universal Health Coverage.



2019

Topics covered: global governance; substance abuse; health policy; social media

  • Number of Publications: 15
Original Research
Review
Book Review
Article
Commentary
Author Reply
Correspondence
Article
Mackey TK, Shah N, Miyachi K, Short J, Clauson KA. A Framework Proposal for Blockchain-based Scientific Publishing Using Shared Governance. Front. Blockchain. 2019; https://doi.org/10.3389/fbloc.2019.00019.

Abstract
Corruption is diverse in its forms and embedded in health systems worldwide. Health-sector corruption directly impedes progress towards universal health coverage by inhibiting people’s access to quality health services and to safe and effective medicines, and undermining systems for financial risk protection. Corruption is also a cross-cutting theme in the United Nations’ sustainable development goals (SDGs) which aim to improve population health, promote justice and strong institutions and advance sustainable human development. To address health-sector corruption, we need to identify how it happens, collect evidence on its impact and develop frameworks to assess the potential risks and put in place protective measures. We propose that the SDGs can be leveraged to develop a new approach to anti-corruption governance in the health sector. The aim will be to address coordination across the jurisdictions of different countries and foster partnerships among stakeholders to adopt coherent policies and anti-corruption best practices at all levels. Combating corruption requires a focused and invigorated political will, better advocacy and stronger institutions. There is no single solution to the problem. Nevertheless, a commitment to controlling corruption via the SDGs will better ensure the integrity of global health and human development now and beyond 2030.


Review
Jue J, Shah N, Mackey TK. An Interdisciplinary Review of Surgical Data Recording Technology Features and Legal Considerations. Surgical Innovation. 2020;27(2):220-228.

Abstract
Surgical data recording technology has great promise to generate patient safety and quality data that can be utilized to potentially reduce medical errors. Variations of these systems aim to improve surgical technique, develop better training simulation, and promote adverse event investigation similar to the aims of black box technology utilized in other industries. However, many unknowns remain for surgical data recording utilization in operating rooms and clinical settings in the United States. This includes the need to appropriately design systems so they collect meaningful and useful data that can be discussed by surgical team members in an open and safe environment to optimize clinical care processes. In order to better understand the clinical and regulatory environment for surgical data recording systems, we conducted an interdisciplinary review to identify key technology approaches, and assess legal and regulatory implications associated with this potentially disruptive technology. We found technology ranging from audio and visual data, to systems utilizing mobile applications, and kinematic data capture. The data collected present legal questions over ownership of information and privacy, along with regulatory issues at the federal and state levels. The benefits of these data should be balanced with the need to develop appropriate policies and regulations that protect the interests of both clinicians and patients in order to encourage further innovation and better realize the potential of surgical data recording technology to improve clinical decision making and patient safety outcomes.


Original Research

Abstract
Objectives: Prior research has not adequately examined the relationship between international migration and colorectal cancer (CRC) by cultural regions in the US. The purpose of this exploratory study was to determine how annual CRC incidence varied with US annual international migrant inflow in ten different regions, corresponding to dominant ancestry group.

Design: County-level international migrant inflow and dominant ancestry type were obtained from the American Community Survey, and age-adjusted CRC incidence was obtained from the National Cancer Institute. A linear regression model was tested for each ancestry region to assess the relationship between migrant inflow and CRC incidence.

Results: Higher international migrant inflow was associated with lower CRC incidence among counties where the dominant ancestry group was African American (p = 0.0207), British (p = 0.0212), Hispanic (p = 0.0001), and Native American (p = 0.0056).

Conclusions: These findings suggest that US residents in certain ancestry groups are at higher risk for CRC.


Commentary
Mackey TK, Bekki H, Matsuzaki T, Mizushima H. Examining the Potential for Blockchain Technology to Meet the Needs of 21st Century Japanese Healthcare. J Med Internet Res. 2020;22(1):e13649

Abstract
Japan is undergoing a major population health transition as its society ages, and it continues to experience low birth rates. An aging Japan will bring new challenges to its public health system, highlighted as a model for universal health coverage (UHC) around the world. Specific challenges Japan’s health care system will face include an increase in national public health expenditures, higher demand for health care services, acute need for elder and long-term care, shortage of health care workers, and disparities between health care access in rural versus urban areas. Blockchain technology has the potential to address some of these challenges, but only if a health blockchain is conceptualized, designed, localized, and deployed in a way that is compatible with Japan’s centralized UHC-centric public health system. Blockchain solutions must also be adaptive to opportunities and barriers unique to Japan’s national health and innovation policy, including its regulatory sandbox system, while also seeking to learn from blockchain adoption in the private sector and in other countries. This viewpoint outlines the major opportunities and potential challenges to blockchain adoption for the future of Japan’s health care.


Review

Abstract:
In 2015, the World Health Organization (WHO) Expert Committee approved the addition of 16 cancer medicines to the WHO Model List of Essential Medicines (EML), bringing the total number of cancer medicines on the list to 46. This change represented the first major revision to the EML oncology section in recent history and reinforces international recognition of the need to ensure access and affordability for cancer treatments. Importantly, many low and middle-income countries rely on the EML, as well as the children’s EML, as a guide to establish national formularies, and moreover use these lists as tools to negotiate medicine pricing. However, EML inclusion is only one component that impacts cancer treatment access. More specifically, factors such as intellectual property rights and international trade agreements can interact with EML inclusion, drug pricing, and accessibility. To better understand this dynamic, we conducted an interdisciplinary review of the patent status of EML cancer medicines compared to other EML noncommunicable disease medicines using the 17th, 18th, 19th, 20th, and 21st editions of the list. We also explored the interaction of intellectual property rights with the international trade regime and how trade agreements can and do impact cancer treatment access and affordability. Based on this analysis, we conclude that patent status is simply one factor in the complex international environment of health systems, IPR policies, and trade regimes and that aligning these oftentimes disparate interests will require shared global governance across the cancer care continuum.


Original Research
Xu Q, Li J, Cai M, Mackey TK. Use of Machine Learning to Detect Wildlife Product Promotion and Sales on Twitter. Front. Big Data. 2019; https://doi.org/10.3389/fdata.2019.00028.

Abstract:
Social media is an important channel for communication, information dissemination, and social interaction, but also provides opportunities to illicitly sell goods online, including the trade of wildlife products. In this study, we use the Twitter public application programming interface (API) to access Twitter messages in order to detect and classify suspicious wildlife trafficking and sale using an unsupervised machine learning topic model combined with keyword filtering and manual annotation. We choose two prohibited wildlife animals and related products: elephant ivory and pangolin, and collected tweets containing keywords and known code words related to these species. In total, we collected 138,357 tweets filtered for these keywords over a 14-day period and were able to identify 53 tweets from 38 unique users that we suspect promoted the sale of Ivory products, though no pangolin related promoted post were detected in this study. Study results show that machine learning combined with supplement analysis approaches such as those utilized in this study have the potential to detect illegal content without the use of an existing training data set. If developed further, these approaches can help technology companies, conservation groups, and law enforcement officials to expedite the process of identifying illegal online sales and stem supply for the billion-dollar criminal industry of online wildlife trafficking.


Commentary

Abstract:

Corruption in the health sector has been a "dirty secret" in the health policy and international development community, but recent global activities point to a day when it will no longer be neglected as a key determinant of health. To further explore next steps forward, this commentary applies the Kingdon’s multiple-streams framework (MSF) to assess what opportunities are available to mobilize the global agenda to combat health corruption. Based on this analysis, it appears that Kingdon’s problem, policy, and political streams are coalescing to create a policy window opportunity that can be leveraged based on recent developments in the global health and international development community around corruption. This includes the recent formation of the Global Network on Anti-Corruption, Transparency and Accountability (GNACTA) led by the World Health Organization (WHO), the Global Fund, and the United Nations Development Programme in 2019. It also includes bridging shared goals of addressing corruption in order to make progress towards health-specific goals in the United Nations (UN) Sustainable Development Goals (SDGs) and for achieving universal health coverage.


Commentary
Shah N, Ju J, Mackey TK. Surgical Data Recording Technology: A Solution to Address Medical Errors? Ann Surgery. 2020;271(3):431-33

Abstract:
Reducing preventable medical errors remains a universal goal, yet implementing effective solutions remains a challenge. The development of surgical data recording technology shows promise to generate robust qualitative and quantitative data in the surgical theater. These data can allow physicians and their teams to capture specific sources of error and implement corrective interventions. Surgical data recording technology encompasses rudimentary data tabulation on notecards, to integrated audio-video systems containing cameras, microphones, and sensors, capturing and synthesizing intraoperative, environmental, and instrumentation information, along with devices tailored to robotic surgical systems. There is growing interest in the implementation of such technology in medical centers, particularly in the United States, Canada, and Europe, but existing medicolegal and regulatory challenges necessitate further research and clinical assessment in order for this technology to facilitate improved surgical patient safety.


Commentary

Abstract:

The U.S. health care system is in transition. Politicians, interest groups, and constituents disagree about how to change coverage, reduce costs, regulate health care markets, and navigate the future of health care reform after the Patient Protection and Affordable Care Act (ACA). Meanwhile, the number of uninsured adults has increased by 7 million since late 2016, and this number does not include the millions of Americans who remain underinsured. States have the power to regulate health insurance, medical benefits, providers, and other aspects of health care delivery, and they have started exploring reform measures to fill coverage gaps. However, these efforts face several federal barriers, some of which can be waived by the federal government and some of which cannot.


Article
Kato H, Mackey TK, Heng YK. Japan’s Health Diplomacy: Projecting Soft Power in the Era of Global Health. Global Health Governance. 2019;13(1&2):5-22.

Abstract:
Few scholars have studied the use of "Global Health Diplomacy" by the Japanese Government, a unique form of diplomacy that relies on the use of "soft power" and "smart power" but also one that is undergoing changes based on current geopolitical developments in Japan and the Asia-pacific region. This article will provide a review of the literature based on a multilingual document review on Japanese global health diplomacy by examining how health diplomacy has been used by the Japanese government in furtherance of broader foreign policy and diplomatic goals in the international fora. This article will also discuss the limitations of Japan's nascent health diplomacy strategy and possible challenges in the near-future; specifically, the possible revision of Article 9 of its Constitution.


Original Research

Abstract:
Background:
Social media use is now ubiquitous, but the growth in social media communications has also made it a convenient digital platform for drug dealers selling controlled substances, opioids, and other illicit drugs. Previous studies and news investigations have reported the use of popular social media platforms as conduits for opioid sales. This study uses deep learning to detect illicit drug dealing on the image and video sharing platform Instagram.

Objective:
The aim of this study was to develop and evaluate a machine learning approach to detect Instagram posts related to illegal internet drug dealing.

Methods:
In this paper, we describe an approach to detect drug dealers by using a deep learning model on Instagram. We collected Instagram posts using a Web scraper between July 2018 and October 2018 and then compared our deep learning model against 3 different machine learning models (eg, random forest, decision tree, and support vector machine) to assess the performance and accuracy of the model. For our deep learning model, we used the long short-term memory unit in the recurrent neural network to learn the pattern of the text of drug dealing posts. We also manually annotated all posts collected to evaluate our model performance and to characterize drug selling conversations.

Results:
From the 12,857 posts we collected, we detected 1228 drug dealer posts comprising 267 unique users. We used cross-validation to evaluate the 4 models, with our deep learning model reaching 95% on F1 score and performing better than the other 3 models. We also found that by removing the hashtags in the text, the model had better performance. Detected posts contained hashtags related to several drugs, including the controlled substance Xanax (1078/1228, 87.78%), oxycodone/OxyContin (321/1228, 26.14%), and illicit drugs lysergic acid diethylamide (213/1228, 17.34%) and 3,4-methylenedioxy-methamphetamine (94/1228, 7.65%). We also observed the use of communication applications for suspected drug trading through user comments.

Conclusions:
Our approach using a combination of Web scraping and deep learning was able to detect illegal online drug sellers on Instagram, with high accuracy. Despite increased scrutiny by regulators and policymakers, the Instagram platform continues to host posts from drug dealers, in violation of federal law. Further action needs to be taken to ensure the safety of social media communities and help put an end to this illicit digital channel of sourcing."


Article
Mackey TK, Kuo TT, Gummadi B, Clauson K, Church G, Grishin D, Obbad K, Barkovich R, Palombini M. ‘Fit-for-Purpose?’ – Challenges and Opportunities for Applications of Blockchain Technology in the Future of Healthcare. BMC Med. 2019;17:68.

Abstract:

Blockchain is a shared distributed digital ledger technology that can better facilitate data management, provenance and security, and has the potential to transform healthcare. Importantly, blockchain represents a data architecture, whose application goes far beyond Bitcoin – the cryptocurrency that relies on blockchain and has popularized the technology. In the health sector, blockchain is being aggressively explored by various stakeholders to optimize business processes, lower costs, improve patient outcomes, enhance compliance, and enable better use of healthcare-related data. However, critical in assessing whether blockchain can fulfill the hype of a technology characterized as ‘revolutionary’ and ‘disruptive’, is the need to ensure that blockchain design elements consider actual healthcare needs from the diverse perspectives of consumers, patients, providers, and regulators. In addition, answering the real needs of healthcare stakeholders, blockchain approaches must also be responsive to the unique challenges faced in healthcare compared to other sectors of the economy. In this sense, ensuring that a health blockchain is ‘fit-for-purpose’ is pivotal. This concept forms the basis for this article, where we share views from a multidisciplinary group of practitioners at the forefront of blockchain conceptualization, development, and deployment.


Article
Nayyar GM, Breman JG, Mackey TK, Clark JP, Hajjou M, Littrell M, Herrington JE. Falsified and Substandard Drugs: Stopping the Pandemic. Am J. Trop Med Hygiene. 2019;100(5):1058-1065.

Abstract

Falsified and substandard medicines are associated with tens of thousands of deaths, mainly in young children in poor countries. Poor-quality drugs exact an annual economic toll of up to US$200 billion and contribute to the increasing peril of antimicrobial resistance. The WHO has emerged recently as the global leader in the battle against poor-quality drugs, and pharmaceutical companies have increased their roles in assuring the integrity of drug supply chains. Despite advances in drug quality surveillance and detection technology, more efforts are urgently required in research, policy, and field monitoring to halt the pandemic of bad drugs. In addition to strengthening international and national pharmaceutical governance, in part by national implementation of the Model Law on Medicines and Crime, a quantifiable Sustainable Development Goal target and an international convention to insure drug quality and safety are urgent priorities.


Article

Abstract:

Background
Advances in science and technology coupled with globalization are changing access to and utilization of reproductive health services. This includes the transnational phenomenon of families who use surrogate mothers to reproduce, with forms of altruistic and commercial surrogacy becoming more commonplace. Simultaneously, changes in law, regulation, and policy are necessary to protect surrogates, intended parents, and resulting children. These developments have been slow to adapt to challenges inherent to surrogacy arrangements, most specifically in low-and middle-income countries, including in South American countries.

Methods
We conducted an interdisciplinary non-systematic literature review and legal analysis of existing and pending policy, laws, and regulations related to commercial surrogacy arrangements in Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Paraguay, Peru, Uruguay, and Venezuela. The review focused on articles that discussed topics of domestic and international law, policy, regulation, and governance related to commercial surrogacy. We queried PubMed, JSTOR, and Google Scholar for Spanish and English-language articles limited to those published between 2000 and 2016.

Results
Our literature and legal review found a wide variance in how different countries address the issue, including two (Brazil and Uruguay) that have issued guidance attempting to clarify the legality of commercial surrogacy, others who have introduced surrogacy-specific legislation, and a final group with no specific legal mechanisms in place. Our extracted legal case studies also indicate that courts have a hard time interpreting existing law and its applicability to surrogacy. The influence of Catholicism also played a role in the adoption of surrogacy and other advanced reproductive technology (ART)-related legislation.

Conclusions
Changes in global infertility rates, the emergence of new family structures, and advancement of ART are factors that will influence future development of legal frameworks addressing surrogacy in South America. Despite a growing transnational market for commercial surrogacy in many of the countries examined, the current patchwork of policy does little to clarify what forms of surrogacy are legally permissible, nor do they adequately protect surrogates, intended parents, or the children themselves. This points to an urgent need for regional legal and policy harmonization specifically designed to align with public health and human rights principles.


Article
Shakeel SI, Brown M, Shakeel S, Mackey TK. Achieving the End Game: Employing “Vaccine Diplomacy” to Eradicate Polio in Pakistan. BMC Public Health. 2019;19(1):79.

Abstract:
Background
On April 28, 2014, the World Health Organization (WHO) declared polio a “Public Health Emergency of International Concern” (PHIC) under the authority of the International Health Regulations. Although polio has been eradicated from nearly every nation on earth, Pakistan is one of three countries where wild polio and vaccine-derived polio strains remain, thwarting global eradication efforts.

Aims
Polio eradication progress is complicated by security and conflict issues at the border area between Pakistan and Afghanistan. In addition to security issues, other critical challenges, such as maintaining cold supply chain for vaccines, active and sentinel surveillance, false beliefs about vaccines, distrust of healthcare workers, and accessibility to conflict areas due to terrorist activities, all play a role in the continued persistence of Polio. In response to these challenges, we assess the local and international policy environment and its impact on polio eradication in Pakistan.

Findings
Based on our analysis of existing barriers and challenges associated with polio eradication in Pakistan, this study discusses why employing “vaccine diplomacy” represents a key policy and advocacy strategic approach to achieve the overall end game of polio eradication. Specifically, we identify a set of concrete public health, international development, and diplomatic and policy recommendations that can act synergistically under the umbrella of health and vaccine diplomacy to finally put an end to polio.



2018

Topics covered: global governance; substance abuse; health policy; social media

  • Number of Publications: 12
Original Research
Review
Book Review
Article
Commentary
Author Reply
Correspondence
Commentary
Mackey TK, Kohler JC, Vian T. The Sustainable Development Goals as a Framework to Combat Health-sector Corruption. Bull World Health Organ. 2018;96:634-643.

Abstract:
Corruption is diverse in its forms and embedded in health systems worldwide. Health-sector corruption directly impedes progress towards universal health coverage by inhibiting people’s access to quality health services and to safe and effective medicines, and undermining systems for financial risk protection. Corruption is also a cross-cutting theme in the United Nations’ sustainable development goals (SDGs) which aim to improve population health, promote justice and strong institutions and advance sustainable human development. To address health-sector corruption, we need to identify how it happens, collect evidence on its impact and develop frameworks to assess the potential risks and put in place protective measures. We propose that the SDGs can be leveraged to develop a new approach to anti-corruption governance in the health sector. The aim will be to address coordination across the jurisdictions of different countries and foster partnerships among stakeholders to adopt coherent policies and anti-corruption best practices at all levels. Combating corruption requires a focused and invigorated political will, better advocacy and stronger institutions. There is no single solution to the problem. Nevertheless, a commitment to controlling corruption via the SDGs will better ensure the integrity of global health and human development now and beyond 2030.


Research Article

Abstract:
The United States is in the midst of an opioid public health emergency, one that is also influenced by a convergence of Internet-based technology, health policy, and the need for stakeholder collaboration and action around the need to combat the illicit online sales of opioids by illegal online pharmacies and digital drug dealers. This risk is not new, however, with calls to actively reduce online opioid availability as online pharmacies use a growing array of digital channels, including search engines, social media platforms, and the dark Web. In response, the US Food and Drug Administration convened a special June 2018 summit bringing together technology companies, government agencies, researchers, and advocacy groups with the goal of collaboratively developing and implementing solutions to tackle the problem. Yet after this meeting, stakeholders remain fragmented in approaches despite the availability of technology that can detect, classify, and report illicit sellers who are in direct violation of Federal law. Despite ongoing challenges, advances in data science and the resources and expertise technology companies can contribute will be a key factor in ensuring that the Internet helps end and not fuel the public health emergency of opioid abuse.


Commentary
Mackey TK. Prevalence of Substandard and Falsified Essential Medicines Still an Incomplete Picture. JAMA Network Open. 2018;1(4):e181685. doi:10.1001/jamanetworkopen.2018.1685

Abstract:
In a press release reporting updates from the recent 71st World Health Assembly of the World Health Organization (WHO), member state delegates called special attention to development of a 5-year roadmap aimed at improving access to safe, effective, and affordable medicines and vaccines, a health target contained in the United Nations’ Sustainable Development Goals.1 The WHO also highlighted one of the key impediments of progress toward this target, the increasing numbers of substandard and falsified medicines (SF medicines) that undermine global health, social and economic progress, and human development.


Commentary
Kohler, J. C., Chang Pico, T. , Vian, T. and Mackey, T. K. (2018), The Global Wicked Problem of Corruption and Its Risks for Access to HIV/AIDS Medicines. Clin. Pharmacol. Ther.. . doi:10.1002/cpt.1172

Abstract:
We discuss how corruption affects access to antiretroviral therapies (ARVs) globally. Recent cases of theft of ARVs, collusion, and manipulation in procurement found in countries such as Central African Republic, Bangladesh, Malawi, and Guinea, show there is still much work to be done to reduce the risk of corruption. This includes addressing the structural weaknesses in procurement mechanisms and supply chain management systems of health commodities and medicines.


Commentary
Cuomo RE, Mackey TK. Policy and Governance Solutions for Ensuring Equitable Access to Cancer Medications in Low- and Middle-Income Countries. Annals Of Translational Medicine,2018; 0. doi:10.21037/19319

Abstract not available


Article

Abstract:
The United Nations has declared the Syrian conflict, with more than 50% of Syria’s population currently displaced, as the worst humanitarian crisis of the twenty-first century. The Syrian conflict has led to a collapse of infrastructure, including access to critical and lifesaving healthcare services. Women and children account for approximately 75% of internally displaced Syrians and refugees. This population is also particularly vulnerable to poor health outcomes, a condition worsened by lack of access to maternal and child health services. In response to this crisis, a partnership of Saudi and Syrian physicians established a non-profit healthcare facility named the Brotherhood Medical Center (BMC) to serve women and children within a safe area near the Syrian–Turkish border. The project began in September 2014 and was implemented in three phases of establishment, phased construction and formal launch and operation. Currently, the BMC is working at about 70% of its capacity and is run in partnership with the Syrian Expatriate Medical Association. Although there was strong initial support from donors, the BMC continues to face many financial and operational challenges, including difficulties in transferring money to Syria, shortage of medical supplies, and lack of qualified medical personnel. Despite these challenges, the BMC represents a critical model and an important case study of the challenges of delivering healthcare services to underserved populations during an ongoing conflict. However, more robust support from the international community is needed to ensure it continues its important health and humanitarian mission.


Original Research

Abstract:
Background
On December 6 and 7, 2017, the US Department of Health and Human Services (HHS) hosted its first Code-a-Thon event aimed at leveraging technology and data-driven solutions to help combat the opioid epidemic. The authors—an interdisciplinary team from academia, the private sector, and the US Centers for Disease Control and Prevention—participated in the Code-a-Thon as part of the prevention track.

Objective
The aim of this study was to develop and deploy a methodology using machine learning to accurately detect the marketing and sale of opioids by illicit online sellers via Twitter as part of participation at the HHS Opioid Code-a-Thon event.

Methods
Tweets were collected from the Twitter public application programming interface stream filtered for common prescription opioid keywords in conjunction with participation in the Code-a-Thon from November 15, 2017 to December 5, 2017. An unsupervised machine learning–based approach was developed and used during the Code-a-Thon competition (24 hours) to obtain a summary of the content of the tweets to isolate those clusters associated with illegal online marketing and sale using a biterm topic model (BTM). After isolating relevant tweets, hyperlinks associated with these tweets were reviewed to assess the characteristics of illegal online sellers.

Results
We collected and analyzed 213,041 tweets over the course of the Code-a-Thon containing keywords codeine, percocet, vicodin, oxycontin, oxycodone, fentanyl, and hydrocodone. Using BTM, 0.32% (692/213,041) tweets were identified as being associated with illegal online marketing and sale of prescription opioids. After removing duplicates and dead links, we identified 34 unique “live” tweets, with 44% (15/34) directing consumers to illicit online pharmacies, 32% (11/34) linked to individual drug sellers, and 21% (7/34) used by marketing affiliates. In addition to offering the “no prescription” sale of opioids, many of these vendors also sold other controlled substances and illicit drugs.

Conclusions
The results of this study are in line with prior studies that have identified social media platforms, including Twitter, as a potential conduit for supply and sale of illicit opioids. To translate these results into action, authors also developed a prototype wireframe for the purposes of detecting, classifying, and reporting illicit online pharmacy tweets selling controlled substances illegally to the US Food and Drug Administration and the US Drug Enforcement Agency. Further development of solutions based on these methods has the potential to proactively alert regulators and law enforcement agencies of illegal opioid sales, while also making the online environment safer for the public.


Commentary

Abstract:
Background
After 7 years of increasing conflict and violence, the Syrian civil war now constitutes the largest displacement crisis in the world, with more than 6 million people who have been internally displaced. Among this already-vulnerable population group, women and children face significant challenges associated with lack of adequate access to maternal and child health (MCH) services, threatening their lives along with their immediate and long-term health outcomes.

Discussion
While several health and humanitarian aid organizations are working to improve the health and welfare of internally displaced Syrian women and children, there is an immediate need for local medical humanitarian interventions. Responding to this need, we describe the case study of the Brotherhood Medical Center (the “Center”), a local clinic that was initially established by private donors and later partnered with the Syrian Expatriate Medical Association to provide free MCH services to internally displaced Syrian women and children in the small Syrian border town of Atimah.

Conclusions
The Center provides a unique contribution to the Syrian health and humanitarian crisis by focusing on providing MCH services to a targeted vulnerable population locally and through an established clinic. Hence, the Center complements efforts by larger international, regional, and local organizations that also are attempting to alleviate the suffering of Syrians victimized by this ongoing civil war. However, the long-term success of organizations like the Center relies on many factors including strategic partnership building, adjusting to logistical difficulties, and seeking sustainable sources of funding. Importantly, the lessons learned by the Center should serve as important principles in the design of future medical humanitarian interventions working directly in conflict zones, and should emphasize the need for better international cooperation and coordination to support local initiatives that serve victims where and when they need it the most.


Article
Clauson, K., Breeden, E., Davidson, C. and Mackey, T. 2018. Leveraging Blockchain Technology to Enhance Supply Chain Management in Healthcare: Blockchain in Healthcare Today. 1, (Mar. 2018). DOI:https://doi.org/https:/ doi.org/10.30953/bhty.v1.20.

Abstract:
Background
Effective supply chain management is a challenge in every sector, but in healthcare there is added complexity and risk as a compromised supply chain in healthcare can directly impact patient safety and health outcomes. One potential solution for improving security, integrity, data provenance, and functionality of the health supply chain is blockchain technology.

Objectives
Provide an overview of the opportunities and challenges associated with blockchain adoption and deployment for the health supply chain, with a focus on the pharmaceutical supply, medical device and supplies, Internet of Healthy Things (IoHT), and public health sectors.

Methods
A narrative review was conducted of the academic literature, grey literature, and industry publications, in addition to identifying and characterizing select stakeholders engaged in exploring blockchain solutions for the health supply chain.

Results
Critical challenges in protecting the integrity of the health supply chain appear well suited for adoption of blockchain technology. Use cases are emerging, including using blockchain to combat counterfeit medicines, securing medical devices, optimizing functionality of IoHT, and improving the public health supply chain. Despite these clear opportunities, most blockchain initiatives remain in proof-of-concept or pilot phase.

Conclusion
Blockchain technology has the unrealized promise to help improve the health supply chain, but further study, evaluation and alignment with policy mechanisms is needed.


Perspective

Abstract:
The withdrawal of the UK from the European Union (EU) is a complicated event. Although implications vary by industry, the biotechnology sector is especially vulnerable to the consequences of Brexit. Accordingly, here we evaluate potential repercussions under four post-Brexit political pathways: European Economic Area (EEA) affiliation (Norwegian Model); negotiated bilateral access (Swiss Model); limited participation in EU Customs Union (Turkish Model); or independence under the World Trade Organization (WTO) designation. We conclude that all four pathways fail to protect the mutually beneficial UK–EU biotechnology relationship and that alternative pathways need to be explored. Accordingly, we outline a suite of policy mechanisms aimed at ensuring continued EU–UK regulatory synergy, with the central aim of ensuring access to biomedical innovations and ensuring patient safety.


Commentary
Cratsley K, Mackey TK. Global Mental Health and the United Nations’ Sustainable Development Goals. Families, Systems, and Health. 2018;in press.

Abstract:
Introduction
Increased awareness of the importance of mental health for global health has led to a number of new initiatives, including influential policy instruments issued by the World Health Organization (WHO) and the United Nations (UN).

Method
This policy brief describes two WHO instruments, the Mental Health Action Plan for 2013–2020 (World Health Organization, 2013) and the Mental Health Atlas (World Health Organization, 2015), and presents a comparative analysis with the Sustainable Development Goals (SDGs) of the UN’s 2030 Agenda for Sustainable Development (United Nations, 2015).

Results
The WHO’s Action Plan calls for several specific objectives and targets, with a focus on improving global mental health governance and service coverage. In contrast, the UN’s Sustainable Development Goals include only one goal specific to mental health, with a single indicator tracking suicide mortality rates.

Discussion
The discrepancy between the WHO and UN frameworks suggests a need for increased policy coherence. Improved global health governance can provide the basis for ensuring and accelerating progress in global mental health.


Article

Abstract:
Background
Global health diplomacy (GHD) is a burgeoning field bridging the priorities of global health and foreign affairs. Given the increasing need to mobilize disparate global health stakeholders coupled with the need to design complex public health partnerships to tackle issues of international concern, effective and timely cooperation among state actors is critical. Health Attachés represent this coordination focal point and are key diplomatic professionals at the forefront of GHD. Despite their unique mandate, little is published about this profession and the perspectives of those who work in the field.

Methods
Through purposive sampling, we performed in-depth qualitative interviews with seven Health Attachés: three foreign Health Attachés accredited to the United States and four U.S. Health Attachés accredited to foreign governments. Our interviews explored four key topics: the role and mission of Health Attachés, skills needed to perform GHD, examples of successes and challenges in accomplishing their respective missions, and suggestions for the future development of the diplomatic profession.

Results
We identified several lessons to apply to the growing field of GHD. First, GHD actors need to receive appropriate training to successfully negotiate the intersection of global health and foreign affairs. Participants suggested several areas of training that would benefit GHD actors: diplomacy and negotiation, applied science, and cross-cultural competency. Second, participants articulated the need for a career path for GHD practitioners, increased opportunities for on-the-job training and mentored experiences, and GHD competencies with defined levels of mastery that can be used in occupational evaluation and career development.

Conclusions
Our findings indicate that skills in diplomacy and negotiation, applied science, and cross cultural competency are essential for the statecraft of Health Attachés. Additionally, establishing a clear career pathway for Health Attachés is critical for future maturation of the profession and for fostering effective global health action that aligns public health and foreign diplomacy outcomes. Achieving these goals would ensure that this special cadre of diplomats could effectively practice GHD and would also better position Health Attachés to take the lead in advancing shared global health goals among nation states in a new era of twenty-first century diplomacy.



2017

Topics covered: heath and human rights; global governance; substance abuse; health policy; social media

  • Number of Publications: 16
Original Research
Review
Book Review
Article
Commentary
Author Reply
Correspondence
Original Research
Kalyanam J, Mackey T. Detection and Characterization of Illegal Marketing and Promotion of Prescription Drug Abuse on Twitter. NIPS 2017 Workshop on Machine Learning for Health (ML4H). 2017; https://arxiv.org/abs/1712.00507.

Illicit online pharmacies allow the purchase of prescription drugs online without a prescription. Such pharmacies leverage social media platforms such as Twitter as a promotion and marketing tool with the intent of reaching out to a larger, potentially younger demographics of the population. Given the serious negative health effects that arise from abusing such drugs, it is important to identify the relevant content on social media and exterminate their presence as quickly as possible. In response, we collected all the tweets that contained the names of certain preselected controlled substances over a period of 5 months. We found that an unsupervised topic modeling based methodology is able to identify tweets that promote and market controlled substances with high precision. We also study the meta-data characteristics of such tweets and the users who post them and find that they have several distinguishing characteristics that sets them apart. We were able to train supervised methods and achieve high performance in detecting such content and the users who post them.


Review
Guerra C, Mackey TK. Am J. Public Health. Criminal and Civil Prosecutions Associated with Illicit Online Pharmacies: Legal Analysis and Global Implications. Medicines Access @ Point of Care. 2017;1(1):e104-e118.

Abstract:
The rise of digital technologies has created a complex online environment that now includes illicit Internet pharmacies, online facilitators, advertising sites, and foreign entities. Collectively, these networks create significant patient safety risks, including acting as unregulated access points encouraging prescription drug abuse. Although law enforcement is active in combating this form of cybercrime, there are several difficulties in prosecuting individuals involved in online prescription drug distribution. We characterize these challenges by conducting a comprehensive legal review and analysis of USA civil and criminal cases associated with online pharmacies. This is accomplished by reviewing legal documents/filings available via the Public Access to Court Electronic Records (PACER) database, the Drug Enforcement Agency's website, and structured search queries using the Google search engine. We found more than 100 cases, including criminal indictments, sentencing documents, judgments, forfeiture orders, motions, civil complaints, and restitution documents. Our review indicates that current legal tools and regulatory policies do not effectively deter this highly profitable criminal activity. Hence, we issue a “Call to Action,” advocating the need for more robust legal remedies and criminal penalties, and greater legal and policy coherence at the domestic, regional, and global level aimed at improving patient safety and ensuring the integrity of the drug supply chain.


Original Research
Mackey TK, Kalyanam J, Katsuki T, Lanckriet G. Twitter-Based Detection of Illegal Online Sale of Prescription Opioid. Am J. Public Health. 2017; 107:1910-1915.

Abstract:
Objectives
To deploy a methodology accurately identifying tweets marketing the illegal online sale of controlled substances.

Methods
We first collected tweets from the Twitter public application program interface stream filtered for prescription opioid keywords. We then used unsupervised machine learning (specifically, topic modeling) to identify topics associated with illegal online marketing and sales. Finally, we conducted Web forensic analyses to characterize different types of online vendors. We analyzed 619 937 tweets containing the keywords codeine, Percocet, fentanyl, Vicodin, Oxycontin, oxycodone, and hydrocodone over a 5-month period from June to November 2015.

Results
A total of 1778 tweets (< 1%) were identified as marketing the sale of controlled substances online; 90% had imbedded hyperlinks, but only 46 were “live” at the time of the evaluation. Seven distinct URLs linked to Web sites marketing or illegally selling controlled substances online.

Conclusions
Our methodology can identify illegal online sale of prescription opioids from large volumes of tweets. Our results indicate that controlled substances are trafficked online via different strategies and vendors.


Book Review
Mackey TK. Who Governs Global Health? International Politics Reviews. 2017; 5: 72. https://doi.org/10.1057/s41312-017-0030-8.

No abstract available.


Review
Kalyanam J, Mackey TK. A Review of Digital Surveillance Methods and Approaches to Combat Prescription Drug Abuse. Current Addiction Rep. 2017; i 4: 397. https://doi.org/10.1007/s40429-017-0169-4.

Abstract:
Purpose of Review
The use of social media to conduct digital surveillance to address different health challenges is growing. This multidisciplinary review assesses the current state of methods and applied research used to conduct digital surveillance for prescription drug abuse.

Recent Findings
Fifteen studies met our inclusion criteria from the databases reviewed (PubMed, IEEE Xplore, and ACM Digital Library). The articles were characterized based on their overarching goals and aims, data collection and dataset attributes, and analysis approaches. Overall, reviewed studies grouped into two overarching categories as either being method-focused (advancing novel methodologies using social media data), applied-focused (generating new information on prescription drug abuse behavior), or having both elements. The social media platform most predominantly used was Twitter, with wide variation in sample size and duration of data collection. Several data analysis strategies were employed, including machine learning, temporal analysis, rule-based approaches, and statistical analysis.

Summary
Our review indicates that the field of prescription drug abuse digital surveillance is still maturing. Though many studies captured large volumes of data, the majority did not analyze data to characterize user behavior, a critical step needed in order to better explain the underlying risk environment for prescription drug abuse. Future studies need to better translate method-based approaches into applied research, use data generated from social media platforms other than Twitter, and take advantage of emerging data analysis strategies, including deep learning and multimodal approaches.


Original Research
Cuomo RE, Seidman RL, Mackey TK. Country and Regional Variation in Purchase Prices for Essential Cancer Medications. BMC Cancer. 2017;17:566.

Abstract:
Background
Accessibility to essential cancer medications in low- and middle-income countries is threatened by insufficient availability and affordability. The objective of this study is to characterize variation in transactional prices for essential cancer medications across geographies, medication type, and time.

Methods
Drug purchase prices for 19 national and international buyers (representing 29 total countries) between 2010 and 2014 were obtained from Management Sciences for Health. Median values for drug pricing were computed, to address outliers in the data. For comparing purchase prices across geographic units, medications, and over time; Mann-Whitney U tests were used to compare two groups, Kruskal Wallis H tests were used to compare more than two groups, and linear regression was used to compare across continuous independent variables.

Results
During the five-year data period examined, the median price paid for a package of essential cancer medication was $12.63. No significant differences in prices were found based on country-level wealth, country-level disease burden, drug formulation, or year when medication was purchased. Statistical tests found significant differences in prices paid across countries, regions, individual medications, and medication categories. Specifically, countries in the Africa region appeared to pay more for a package of essential cancer medication than countries in the Latin America region, and cancer medications tended to be more expensive than anti-infective medications and cardiovascular medications.

Conclusions
Though preliminary, our study found evidence of variation in prices paid by health systems to acquire essential cancer medications. Primarily, variations in pricing based on geographic location and cancer medication type (including when comparing to essential medicines that treat cardiovascular and infectious diseases) indicate that these factors may impact availability, affordability and access to essential cancer drugs. These factors should be taken into consideration when countries assess formulary decisions, negotiate drug procurement terms, and when formulating health and cancer policy.


Commentary
Mackey TK, Kohler JC, Lewis M, Vian T. Combating Corruption in Global Health. Science Transl Med. 2017;9(402):eaaf9547.

Abstract not available.


Correspondence
Annaloro J, Mackey TK. Policy Implications for post-Brexit Biotech. Nature Biotechnol. 2017;35:710-711.

Abstract not available.


Original Research
Tringale K, Marshall D, Mackey TK, Connor M, Murphy J, Hattangadi-Gluth J. Types and Distribution of Payments from Industry to Physicians in 2015. JAMA. 2017;317(17):1774-1784.

Abstract:
Importance
Given scrutiny over financial conflicts of interest in health care, it is important to understand the types and distribution of industry-related payments to physicians.

Objective
To determine the types and distribution of industry-related payments to physicians in 2015 and the association of physician specialty and sex with receipt of payments from industry.

Design, Setting, and Participants
Observational, retrospective, population-based study of licensed US physicians (per National Plan & Provider Enumeration System) linked to 2015 Open Payments reports of industry payments. A total of 933 295 allopathic and osteopathic physicians. Outcomes were compared across specialties (surgery, primary care, specialists, interventionalists) and between 620 166 male (66.4%) and 313 129 female (33.6%) physicians using regression models adjusting for geographic Medicare-spending region and sole proprietorship.

Exposures
Physician specialty and sex.

Main Outcomes and Measures
Reported physician payment from industry (including nature, number, and value), categorized as general payments (including consulting fees and food and beverage), ownership interests (including stock options, partnership shares), royalty or license payments, and research payments. Associations between physician characteristics and reported receipt of payment.

Results
In 2015, 449 864 of 933 295 physicians (133 842 [29.8%] women), representing approximately 48% of all US physicians were reported to have received $2.4 billion in industry payments, including approximately $1.8 billion for general payments, $544 million for ownership interests, and $75 million for research payments. Compared with 47.7% of primary care physicians (205 830 of 431 819), 61.0% of surgeons (110 604 of 181 372) were reported as receiving general payments (absolute difference, 13.3%; 95% CI, 13.1-13.6; odds ratio [OR], 1.72; P < .001). Surgeons had a mean per-physician reported payment value of $6879 (95% CI, $5895-$7862) vs $2227 (95% CI, $2141-$2314) among primary care physicians (absolute difference, $4651; 95% CI, $4014-$5288). After adjusting for geographic spending region and sole proprietorship, men within each specialty had a higher odds of receiving general payments than did women: surgery, 62.5% vs 56.5% (OR, 1.28; 95% CI, 1.26-1.31); primary care, 50.9% vs 43.0% (OR, 1.38; 95% CI, 1.36-1.39); specialists, 36.3% vs 33.4% (OR, 1.15; 95% CI, 1.13-1.17); and interventionalists, 58.1% vs 40.7% (OR, 2.03; 95% CI, 1.97-2.10; P < .001 for all tests). Similarly, men reportedly received more royalty or license payments than did women: surgery, 1.2% vs 0.03% (OR, 43.20; 95% CI, 25.02-74.57); primary care, 0.02% vs 0.002% (OR, 9.34; 95% CI, 4.11-21.23); specialists, 0.08% vs 0.01% (OR, 3.67; 95% CI, 1.71-7.89); and for interventionalists, 0.13% vs 0.04% (OR, 7.98; 95% CI, 2.87-22.19; P < .001 for all tests).

Conclusions and Relevance
According to data from 2015 Open Payments reports, 48% of physicians were reported to have received a total of $2.4 billion in industry-related payments, primarily general payments, with a higher likelihood and higher value of payments to physicians in surgical vs primary care specialties and to male vs female physicians


Review
Mackey TK, Nayyar G. A Review of Existing and Emerging Digital Technology to Combat the Global Fake Medicines Trade. Expert Opinion Drug Safety. 2017; advanced online publication

Abstract:
Introduction
The globalization of the pharmaceutical supply chain has introduced new challenges, chief among them, fighting the international criminal trade in fake medicines. As the manufacture, supply, and distribution of drugs becomes more complex, so does the need for innovative technology-based solutions to protect patients globally.

Areas covered
We conducted a multidisciplinary review of the science/health, information technology, computer science, and general academic literature with the aim of identifying cutting-edge existing and emerging ‘digital’ solutions to combat fake medicines. Our review identified five distinct categories of technology including mobile, radio frequency identification, advanced computational methods, online verification, and blockchain technology.

Expert opinion
Digital fake medicine solutions are unifying platforms that integrate different types of anti-counterfeiting technologies as complementary solutions, improve information sharing and data collection, and are designed to overcome existing barriers of adoption and implementation. Investment in this next generation technology is essential to ensure the future security and integrity of the global drug supply chain.


Original Research

Abstract:
Objective
Compared to most other diseases, the total burden of common cancers is rapidly increasing in low- and middle-income countries (LMICs). The World Health Organization (WHO) publishes the Essential Medicines List, which provides guidance to countries in selecting which cancer medications should be prioritized for general public access. Countries commonly have formularies which are representative of the specific medications that the national government has prioritized for its populations.

Methods
National formularies were collected from 116 countries, and the quantification of essential cancer medication was computed using text-matching software. The proportion of essential cancer medications listed on national formularies (i.e. “concordance”) was compared to per capita gross domestic product, per capita healthcare expenditures, the human development index, smoking prevalence, and the combined prevalence of overweight and obesity.

Results
Median concordance with cancer drugs among low- and middle-income countries (LMICs) was 42.71%. In bivariate comparisons, concordance was significantly associated with per capita GDP at PPP (p = 0.005), per capita health expenditures (p = 0.050), the human development index (p < 0.001), and the combined prevalence of overweight and obesity (p = 0.006). However, concordance was not associated with smoking prevalence (p = 0.292).

Conclusion
With national formularies analyzed for over 80% of all LMICs, this study found that most LMICs listed under half of cancer medications considered by the WHO to be essential. LMIC decision-making for policies related to cancer drug access may be heavily influenced by economic development, as well as by the high prevalence of certain cancer risk factors. The results from this study suggest that LMICs are generally ill-prepared to adequately provide essential treatment for their rapidly rising numbers of cancer patients.


Author Reply
Mackey TK, Liang BA. In Reply - EHR and Drugs Prescribed for Off-label Indications. Mayo Clin Proc. 2017; 92(4):684-685.

Abstract not available


Article
Akbarzada S, Mackey TK. The Syrian Public Health and Humanitarian Crisis: A “Displacement” in Global Governance? Glob Public Health. 2017; advanced online publication

Abstract:
Ongoing failure by the international community to resolve the Syrian conflict has led to destruction of critical infrastructure. This includes the collapse of the Syrian health system, leaving millions of internally displaced persons (IDPs) in urgent need of healthcare services. As the conflict intensifies, IDP populations are suffering from infectious and non-communicable disease risks, poor maternal and child health outcomes, trauma, and mental health issues, while healthcare workers continually exit the country. Healthcare workers who remain face significant challenges, including systematic attacks on healthcare facilities and conditions that severely inhibit healthcare delivery and assistance. Within this conflict-driven public health crisis, the most susceptible population is arguably the IDP. Though the fundamental ‘right to health’ is a recognised international legal principle, its application is inadequate due to limited recognition by the UN Security Council and stymied global governance by the broader international community. These factors have also negatively impacted other vulnerable groups other than IDPs, such as refugees and ethnic minorities, who may or may not be displaced. Hence, this article reviews the current Syrian conflict, assesses challenges with local and global governance for IDPs, and explores potential governance solutions needed to address this health and humanitarian crisis.


Original Research

Abstract:
Since the end of the Cold War, health has gone from a peripheral concern in foreign policy negotiations to a prominent place on the global political agenda. While the rise of health onto the foreign policy agenda is by now old news, the driving forces behind its expansion into new political spheres remain understudied and undertheorized. This article builds on empirical findings from a four-country study of the integration of health into foreign policy, and proposes a conceptual approach to GHD to improve understanding of the conditions under which health is successfully positioned on the foreign policy agenda. Our approach consists of three dimensions: features of institutions and the interest various actors represent in GHD; the ideational environment in which GHD operates; and issue characteristics of the specific health concern entering foreign policy. Within each dimension, we identify specific variables that, in combination, make up the explanatory power of the proposed approach. The proposed approach does not relate to, or build upon, a single social sciences, public health, or international relations (IR) theory, but can be seen as a heuristic device to identify dimensions and variables that may shape why certain health issues rise onto the foreign policy agenda.



2016

Topics covered: tobacco control; health migration; international trade; biotechnology; digital health; social media; health policy; health communication; online pharmacies; drug access; pharmaceutical policy; global health governance; infectious diseases; health emergencies; patient safety; health diplomacy; pharmaceutical marketing; substance abuse; corruption; environmental health; health diplomacy; genetics;

  • Number of Publications: 19
Original Research
Review
Article
Short Report
Commentary
Perspective
Debate
Policy Forum
Editorial
Professional Review
Forum
Perspective
Aleeban M, Mackey TK. Global Health Policy and Visa Reform to Address Dangers of Hajj During Summer Seasons. Front. Public Health. 2016; 4:280

Abstract:
Every year on the 12th month of the Islamic calendar, 2–3 million Muslims from over 160 countries migrate to Holy sites in Saudi Arabia to perform the Hajj, representing one of the largest mass gathering events worldwide. Yet, the Hajj poses several challenges to global health and public safety, including the unique health risks posed by seasonal variability when Hajj occurs during summer months. Specifically, pilgrims taking the journey to Mecca are at higher risk for heat illnesses, heat-related injuries and exhaustion, and stampedes, when summer temperatures can reach up to 48.7°C. In response, we propose that the Saudi government, in coordination with the Organization of Islamic Cooperation and the World Health Organization, explore the establishment of an expert committee, create and use a predictive risk modeling tool, and establish a dynamic quota on Hajj visas to limit potential heat exposure for high-risk populations when the Hajj falls on seasons associated with extreme weather exposure. As climate change is projected to lead to future increases in temperatures in the region, this form of dynamic and evidence-based policymaking is needed to ensure human health and safety for generations of Hajj pilgrims to come.


Debate

Abstract:
Background
As the 2014 Ebola virus disease outbreak (EVD) transitions to its post-endemic phase, its impact on the future of global public health, particularly the World Health Organization (WHO), is the subject of continued debate. Criticism of WHO’s performance grew louder in the outbreak’s wake, placing this international health UN-specialized agency in the difficult position of navigating a complex series of reform recommendations put forth by different stakeholders. Decisions on WHO governance reform and the broader role of the United Nations could very well shape the future landscape of 21st century global health and how the international community responds to health emergencies.

Discussion
In order to better understand the implications of the EVD outbreak on global health and infectious disease governance, this debate article critically examines a series of reports issued by four high-level commissions/panels convened to specifically assess WHO’s performance post-Ebola. Collectively, these recommendations add increasing complexity to the urgent need for WHO reform, a process that the agency must carry out in order to maintain its legitimacy. Proposals that garnered strong support included the formation of an independent WHO Centre for Emergency Preparedness and Response, the urgent need to increase WHO infectious disease funding and capacity, and establishing better operational and policy coordination between WHO, UN agencies, and other global health partners. The recommendations also raise more fundamental questions about restructuring the global health architecture, and whether the UN should play a more active role in global health governance.

Summary
Despite the need for a fully modernized WHO, reform proposals recently announced by WHO fail to achieve the “evolution” in global health governance needed in order to ensure that global society is adequately protected against the multifaceted and increasingly complex nature of modern public health emergencies. Instead, the lasting legacy of the EVD outbreak may be its foreshadowing of a governance “shift” in formal sharing of the complex responsibilities of global health, health security, outbreak response, and managing health emergencies to other international structures, most notably the United Nations. Only time will tell if the legacy of EVD will include a WHO that has the full support of the international community and is capable of leading human society in this brave new era of the globalization of infectious diseases


Forum
Mackey TK, Kohler JC, Savedoff WD, Vogl F, Lewis M, Sale J, Michaud J, Vian T. The disease of corruption: views on how to fight corruption to advance 21st century global health goals. BMC Med. 2016;14(1):149.

Abstract:
Corruption has been described as a disease. When corruption infiltrates global health, it can be particularly devastating, threatening hard gained improvements in human and economic development, international security, and population health. Yet, the multifaceted and complex nature of global health corruption makes it extremely difficult to tackle, despite its enormous costs, which have been estimated in the billions of dollars. In this forum article, we asked anti-corruption experts to identify key priority areas that urgently need global attention in order to advance the fight against global health corruption. The views shared by this multidisciplinary group of contributors reveal several fundamental challenges and allow us to explore potential solutions to address the unique risks posed by health-related corruption. Collectively, these perspectives also provide a roadmap that can be used in support of global health anti-corruption efforts in the post-2015 development agenda.


Original Research
Marshall DC, Moy B, Jackson ME, Mackey TK, Hattangadi-Gluth JA. Distribution and Patterns of Industry-Related Payments to Oncologists in 2014. J. Natl Cancer Inst. 2016; advanced online publication

Abstract:
Background
Industry-physician collaboration is critical for anticancer therapeutic development, but financial relationships introduce conflicts of interest. We examined the specialty variation and context of physician payments and ownership interest among oncologists.

Methods
We performed a population-based multivariable analysis of 2014 Open Payments reports of industry payments to US physicians matched to physician and practice data, including sex, specialty, practice location, and sole proprietor status. Payment data were aggregated per physician and compared by specialty (medical, radiation, surgical, and nononcology), and practice location linked with spending level (low, average, and high). Primary outcomes included likelihood, mean annual amount, and number of general payments. Secondary outcomes included likelihood of holding ownership interests and receipt of royalty/license payments. Estimates for each outcome were determined using multivariable models, including logistic regression for likelihood and linear regression with gamma distribution and log-link for value, adjusted for physician specialty, sex, sole proprietor status, and practice spending. All statistical tests were two-sided.

Results
In 2014, there were 883 438 physicians, including 22 712 oncologists, licensed to practice in the United States. Among oncology specialties, 52.4% to 63.0% of physicians received a general payment in 2014, totaling $76 million, $4 million, and $5 million to medical, radiation, and surgical oncology, respectively. The median annual per-physician payment to medical oncologists was $632 (IQR = 136–2500), compared with $124 (IQR = 39–323) in radiation oncology and $250 (IQR = 84–1369) in surgical oncology. After controlling for physician and practice characteristics, oncologists were 1.09 to 1.75 times as likely to receive a general payment compared with nononcologists (overall P < .001). There was a 67.6% difference (95% confidence interval [CI] = 63.6 to 71.5, P < .001) in the mean annual value of payments between medical oncology and nononcology specialties (vs −92.7%, 95%CI = −100.2 to −85.0, P < .001] for radiation oncology). Medical and radiation oncologists were more likely to hold ownership interest (adjusted OR = 3.72, 95% CI = 3.22 to 4.27, and 2.27, 95% CI = 1.65 to 3.03, respectively, P < .001 both comparisons).

Conclusions
In 2014, industry-oncologist financial relationships were common, and their impact on oncology practice should be further explored.


Article
Brown M, Bergmann J, Mackey T, Eichbaum Q, McDougal L, Novotny T. Mapping Foreign Affairs and Global Public Health Competencies: Towards a Competency Model for Global Health Diplomacy. Global Health Governance. 2016;X(2):3-49

Abstract:
The largest Ebola Virus Disease outbreak in recorded history required not only the greatest global health response in history, but also placed new demands on both the diplomatic corps and public health officials. Coordinated action to address public health issues that cross national boundaries is referred to as global health diplomacy (GHD), broadly defined as political activity that meets dual goals of improving public health and strengthening relations among nations. However, there is no GHD core competency model to inform training of professionals, or to help direct efforts requiring cross-disciplinary coordinated global health action. No institution has yet developed a GHD core competency model which would help bridge the fields of global public health and foreign affairs, providing additional guidance to diplomats and public health officials to prepare for global health emergencies. Without defined competencies in field of GHD, professionals changed with public health action may lack knowledge, skills, and abilities to effectively manage or lead during a global health emergency. This research identifies and maps core competencies that can be used to address this gap in the training of professionals in the fields of foreign affairs and global public health. We conducted focused internet searches to identify two core competency models in foreign affairs and six competency models in global public health. Employing domain word counts, we compared models to determine degree of association, divergence, and emphasis. Based on this analysis, we propose a GHD core competency model to inform training within global public health and foreign affairs organizations and institutions. This initial model could assure that both foreign affairs and global health professionals have the necessary knowledge, skills, and abilities to support effective global health action.


Debate

Abstract:
The U.S Congress initiated sanctions against Iran after the 1979 U.S. Embassy hostage crisis in Tehran, and since then the scope of multilateral sanctions imposed by the United States, the European Union, and the United Nations Security Council have progressively expanded throughout the intervening years. Though primarily targeted at Iran’s nuclear proliferation activities, sanctions have nevertheless resulted in negative public health outcomes for ordinary Iranian citizens. This includes creating vital domestic shortages to life-saving medicines, leaving an estimated 6 million Iranian patients with limited treatment access for a host of diseases. Sanctions have also crippled Iran’s domestic pharmaceutical industry, leading to the disruption of generic medicines production and forcing the country to import medicines and raw materials that are of lower or questionable quality.


Commentary
Schandera J, Mackey TK. Mitochondrial Replacement Therapy: Divergence in Global Policy. Trends Genet. 2016; 32(7):385-90

Abstract:
In 2015, the UK became the first country permitting the clinical application of mitochondrial replacement techniques (MRT). Here, we explore how MRT have led to diverging international policy. In response, we recommend focused regulatory efforts coupled with United Nations (UN) leadership to build international consensus on the future of MRT.


Review

Abstract:
Background
Amidst the rise of e-commerce, there has been a proliferation of illicit online pharmacies that threaten global patient safety by selling drugs without a prescription directly to the consumer. Despite this clear threat, little is known about the key risk characteristics, central challenges and current legal, regulatory and law enforcement responses.

Sources of data
A review was conducted of the English literature with search terms ‘online pharmacies’, ‘Internet pharmacies’, ‘cyber pharmacies’, ‘rogue pharmacies’, and ‘e-pharmacies’ using PubMed, JSTOR, and Google Scholar from 1999–2005.

Areas of agreement
Illicit online pharmacies are a rapidly growing public health threat and are characterized by a number of complex and interrelated risk factors.

Areas of controversy
Solutions are varied and are of questionable utility in the face of evolving technology that enables this form of transnational cybercrime.

Growing points
Legal, regulatory and technology solutions must address the entire illicit online pharmacy ecosystem in order to be effective.

Areas timely for developing research
There is a critical need to build international consensus, conduct additional research and develop technology to combat illicit online pharmacies.


Professional Review
Foster-Bollman C, Mackey TK. Gadolinium-based Contrast Agents: Patient Safety Concerns. Radiol Technol. 2016;87(5):552-556

No abstract available.


Commentary
Mackey TK. Lessons from Liberia: Global Health Governance in the Post-Ebola Paradigm. Global Health Governance. 2016;X(1):60-70. 

Abstract:
Liberia is a country that has arguably borne the largest brunt of the 2014 Ebola Virus disease (EVD) outbreak, with the highest number of fatalities of all countries since the outbreak began in late March 2014. Though significant progress has been made in halting the spread of the disease, declarations by the World Health Organization that the country was "Ebola free" have been cut-short by detection of new cases, raising concerns that the country and greater region are still in ongoing danger during the post-pandemic phase of the outbreak. More importantly, the unprecedented nature of the Liberian EVD outbreak provides a compelling case study exposing the fragilities of international responses to global public health emergencies. Hence, this commentary will explore lessons learned from Ebola in Liberia and how they could affect the WHO, the International Health Regulations, and the future landscape of global health governance.


Commentary
Mackey TK, Liang BA. After Amarin: What Will the Future Hold for Off-Label Promotion Regulation? Mayo Clin Proc. 2016; 91(6):701-706

Abstract:
On August 7, 2015, the US District Court in Amarin v FDA handed down a ruling that the US Food and Drug Administration (FDA) lacked the authority to prohibit nonmisleading forms of off-label speech.1 When a drug is approved by the FDA for a specific indication, licensed clinicians are nevertheless free to prescribe it for any clinical use they see fit. In fact, off-label drug use (ie, prescribing medications for a different disease or medical condition, different route of administration, and/or different dosage than that approved by the FDA) is relatively common, with a 2006 study estimating that 21% of commonly used drugs are prescribed off-label.2 Despite regular off-label use of prescription drugs (including high rates in certain patient populations and conditions such as pediatrics, cancer, and psychotic disorders), manufacturers are only allowed to engage in product promotion for the indication approved on the label.3 When manufacturers engage in promotion for any indication, dosage, or administration outside the FDA approval, they engage in illegal off-label promotion.4 However, the lines between illegal and permitted off-label promotion are now being blurred in the wake of the Amarin decision, which is likely to have a lasting impact on future drug promotion practices, regulatory and enforcement activities, and the role of the physician in patient care.


Policy Forum
Alsaraf M, Mackey TK. Child-Resistant Packaging for Liquid Nicotine: Are Current State and Federal Policy Responses Adequate? Food and Drug Law Institute Policy Forum. 2016;6(2):1-13

Abstract not available.


Editorial
Attaran A, Mackey TK, Reed, B. Lowering the High Cost of Cancer Drugs - III. Mayo Clin Proc. 2016;91(3):399-400

Abstract not available.


Article
Anderson A, Mackey TK, Attaran A, Liang BA. Mapping of Health Communication and Education Strategies Addressing the Public Health Dangers of Illicit Online Pharmacies. J. Health Commun. 2016;21(4):397-407

Abstract:
Illicit online pharmacies are a growing global public health concern. Stakeholders have started to engage in health promotion activities to educate the public, yet their scope and impact has not been examined. We wished to identify health promotion activities focused on consumer awareness regarding the risks of illicit online pharmacies. Organizations engaged on the issue were first identified using a set of engagement criteria. We then reviewed these organizations for health promotion programs, educational components, public service announcements, and social media engagement. Our review identified 13 organizations across a wide spectrum of stakeholders. Of these organizations, 69.2% (n = 9) had at least one type of health promotion activity targeting consumers. Although the vast majority of these organizations were active on Facebook or Twitter, many did not have dedicated content regarding online pharmacies (Facebook: 45.5%, Twitter: 58.3%). An online survey administered to 6 respondents employed by organizations identified in this study found that all organizations had dedicated programs on the issue, but only half had media planning strategies in place to measure the effectiveness of their programs. Overall, our results indicate that though some organizations are actively engaged on the issue, communication and education initiatives have had questionable effectiveness in reaching the public. We note that only a few organizations offered comprehensive and dedicated content to raise awareness n the issue and were effective in social media communications. In response, more robust collaborative efforts between stakeholders are needed to educate and protect the consumer about this public health and patient safety danger.


Article

Abstract:
Social media is fundamentally altering how we access health information and make decisions about medical treatment, including for terminally ill patients. This specifically includes the growing phenomenon of patients who use online petitions and social media campaigns in an attempt to gain access to experimental drugs through expanded access pathways. Importantly, controversy surrounding expanded access and “compassionate use” involves several disparate stakeholders, including patients, manufacturers, policymakers, and regulatory agencies—all with competing interests and priorities, leading to confusion, frustration, and ultimately advocacy. In order to explore this issue in detail, this correspondence article first conducts a literature review to describe how the expanded access policy and regulatory environment in the United States has evolved over time and how it currently impacts access to experimental drugs. We then conducted structured web searches to identify patient use of online petitions and social media campaigns aimed at compelling access to experimental drugs. This was carried out in order to characterize the types of communication strategies utilized, the diseases and drugs subject to expanded access petitions, and the prevalent themes associated with this form of “digital” patient advocacy. We find that patients and their families experience mixed results, but still gravitate towards the use of online campaigns out of desperation, lack of reliable information about treatment access options, and in direct response to limitations of the current fragmented structure of expanded access regulation and policy currently in place. In response, we discuss potential policy reforms to improve expanded access processes, including advocating greater transparency for expanded access programs, exploring use of targeted economic incentives for manufacturers, and developing systems to facilitate patient information about existing treatment options. This includes leveraging recent legislative attention to reform expanded access through the CURE Act Provisions contained in the proposed U.S. 21st Century Cures Act. While expanded access may not be the best option for the majority of individuals, terminally ill patients and their families nevertheless deserve better processes, policies, and availability to potentially life-changing information, before they decide to pursue an online campaign in the desperate hope of gaining access to experimental drugs.


Commentary

Abstract:
Background
For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers.

Methods
The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed.

Results
Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling.

Conclusion
Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of prescription drugs.


Article
Azar S, Mackey TK. Crowdfunding: A New Untapped Opportunity for Biotechnology Start-ups? Journal of Commercial Biotechnology: 2016; 21(4):15-28

Abstract:
Crowdfunding is an evolving popular Internet-based process used to raise funding that has been employed by a few start-ups in the biotechnology industry. To solicit crowdfunding, companies profile their case on a specialized web platform (generally called a “crowdfunding portalâ€) to site members (i.e., the “crowdâ€) who choose which projects they would like to fund, in exchange for financial and nonfinancial inducements. We examine the evolving commercial and regulatory crowdfunding landscape and also identifies case studies of biotechnology industry use. We have found that a variety of crowdfunding mechanisms have been used and this alternative financing strategy may represent a viable option for biotechnology start-ups during early stage research or early stage clinical trials. A successful crowdfunding campaign may pave the way for the enterprise’s future capital formation phases by attracting angel investors or venture capital because it shows that the business or project is viable. Crowdfunding, like all other forms of capital formation, requires careful planning and execution before, during, and after a campaign. Strategies that appropriately tap into this innovative and disruptive use of technology and social networks may prove to be a unique capital formation niche for biotechnology start-ups; one that has yet to be fully leveraged.


Article
Efendi F, Mackey TK, Huang MC, Chen CM. IJEPA – A Gray Area in Health Policy and Trade for Indonesian Nurse Migration. Nurs Ethics: 2016; advanced online publication

Abstract:
Indonesia is recognized as a nurse exporting country, with policies that encourage nursing professionals to emigrate abroad. This includes the country’s adoption of international principles attempting to protect Indonesian nurses that emigrate as well as the country’s own participation in a bilateral trade and investment agreement, known as the Indonesia–Japan Economic Partnership Agreement that facilitates Indonesian nurse migration to Japan. Despite the potential trade and employment benefits from sending nurses abroad under the Indonesia–Japan Economic Partnership Agreement, Indonesia itself is suffering from a crisis in nursing capacity and ensuring adequate healthcare access for its own populations. This represents a distinct challenge for Indonesia in appropriately balancing domestic health workforce needs, employment, and training opportunities for Indonesian nurses, and the need to acknowledge the rights of nurses to freely migrate abroad. Hence, this article reviews the complex operational and ethical issues associated with Indonesian health worker migration under the Indonesia–Japan Economic Partnership Agreement. It also introduces a policy proposal to improve performance of the Indonesia–Japan Economic Partnership Agreement and better align it with international principles focused on equitable health worker migration.


Short Report
Cuomo RE, Miner A, Mackey TK. Pricing and Sales Tax Collection Policies for E-Cigarette Starter Kits and Disposable Products Sold Online. Drug Alcohol Rev: 2016; advanced online publication

Abstract:
Background
Previous studies have examined marketing characteristics of e-cigarettes sold online and others have examined e-cigarettes pricing in retail (non-Internet) settings. This study expands on these findings by examining pricing and marketing characteristics of interest among e-cigarette online vendors.

Methods
Structured web searches were conducted from August–September 2014 to identify popular e-cigarette Internet vendors. We then collected pricing data (e-cigarette starter kits and disposables), sales tax collection policies and other vendor marketing characteristics. Average price for each product category was then compared with marketing characteristics using linear regression for continuous variables and independent t-tests for binary variables.

Results
Our searches yielded 44 e-cigarette Internet vendors of which 77% (n = 34) sold a total of 238 starter kit offerings (Mprice = $55.89). Half (n = 22) sold disposable types of e-cigarettes (Mprice = $7.17 p/e-cigarette) at a price lower than reported elsewhere in retail settings. Average disposable e-cigarette prices were also significantly higher for vendors displaying more health warning notices (P = 0.001). Only 46% disclosed sales tax collection policies and only 39% collected sales tax in their state of business.

Conclusions
This study expands on current understanding of e-cigarette pricing and availability online and finds variation in e-cigarette pricing may be influenced by type of product, use of online health warnings and vendor sales tax collection policies. It also finds that e-cigarette online access and availability may be impacted by a combination of pricing and marketing strategies uniquely different from e-cigarette retail settings that requires further study and targeted policy-making."


2015

Topics covered: drug safety, social media, tobacco control, pharmaceutical policy; pharmaceutical marketing; digital health; fake medicines; substance abuse; indigenous health; health policy; health diplomacy; healthcare ethics

  • Number of Publications: 13
Original Research
Article
Commentary
Review
Perspective
Article
Lincoln E, Liang BA, Mackey TK. Interculturalidad and Chilean Health: Stakeholders Perceptions and the Intercultural Hospital Delivery Model. International Journal of Indigenous Health: 2015; 10(2): 66-87

Abstract:
This study examined interculturality of Indigenous Mapuche healthcare in Chile’s Makewe Hospital. We conducted a descriptive, qualitative, semi-structured, cross-sectional pilot study interviewing key stakeholders, resulting in 11 interviews of patients, Mapuche and occidental providers, public health professionals, administration, and community leaders. We focused on six topics: services and preferences, community participation, interculturality, access to culturally appropriate care, government integration of Indigenous culture and interculturality promotion, and the future of Indigenous care. All groups believed in the need for both kinds of care. However, for community participation, Mapuche indicated no knowledge of interculturality in healthcare, nor any participation, compared with some professionals who believed there was a focus on it. Interculturality expressed by respect for Mapuche ethnomedicine was uniform; however, integration did not appear to Mapuche as effective, whereas professionals and administration interpreted interculturality as a philosophical goal. Regarding culturally appropriate access, Mapuche responses were focused on practical issues, whereas administration and professionals responded by explaining exclusion of Mapuche machi providers as being sensitive to community desires. Government promotion of interculturality was uniformly agreed to be poor. Finally, the future of Indigenous care was seen by Mapuche both optimistically and pessimistically, due to concerns regarding general cultural preservation, whereas professionals emphasized the need to promote preservation. These results indicate a fractionated understanding of definitions and goals among stakeholders. Future policy should focus upon a broader group to implement interculturality, including nongovernmental organizations, academics, and cultural advisors, combined with community-based participatory research, to promote evidence-based, efficient policy efforts and implementation for interculturality in health for the Mapuche.


Original Research
Katsuki T, Mackey TK., Cuomo RE. Establishing a Link Between Prescription Drug Abuse and Illicit Online Pharmacies: Analysis of Twitter Data. Journal of Medical Internet Research: 2015; 17(12): e280.

Abstract:
Background
Youth and adolescent non-medical use of prescription medications (NUPM) has become a national epidemic. However, little is known about the association between promotion of NUPM behavior and access via the popular social media microblogging site, Twitter, which is currently used by a third of all teens.

Objective
In order to better assess NUPM behavior online, this study conducts surveillance and analysis of Twitter data to characterize the frequency of NUPM-related tweets and also identifies illegal access to drugs of abuse via online pharmacies.

Methods
Tweets were collected over a 2-week period from April 1-14, 2015, by applying NUPM keyword filters for both generic/chemical and street names associated with drugs of abuse using the Twitter public streaming application programming interface. Tweets were then analyzed for relevance to NUPM and whether they promoted illegal online access to prescription drugs using a protocol of content coding and supervised machine learning.

Results
A total of 2,417,662 tweets were collected and analyzed for this study. Tweets filtered for generic drugs names comprised 232,108 tweets, including 22,174 unique associated uniform resource locators (URLs), and 2,185,554 tweets (376,304 unique URLs) filtered for street names. Applying an iterative process of manual content coding and supervised machine learning, 81.72% of the generic and 12.28% of the street NUPM datasets were predicted as having content relevant to NUPM respectively. By examining hyperlinks associated with NUPM relevant content for the generic Twitter dataset, we discovered that 75.72% of the tweets with URLs included a hyperlink to an online marketing affiliate that directly linked to an illicit online pharmacy advertising the sale of Valium without a prescription.

Conclusions
This study examined the association between Twitter content, NUPM behavior promotion, and online access to drugs using a broad set of prescription drug keywords. Initial results are concerning, as our study found over 45,000 tweets that directly promoted NUPM by providing a URL that actively marketed the illegal online sale of prescription drugs of abuse. Additional research is needed to further establish the link between Twitter content and NUPM, as well as to help inform future technology-based tools, online health promotion activities, and public policy to combat NUPM online.


Review

Abstract:
Throughout the world, indigenous peoples have advocated for the right to retain their cultural beliefs and traditional medicine practices. In 2007, the more than 370 million people representing 5000 distinct groups throughout the world received global recognition with the adoption of the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP). UNDRIP Article 24 affirms the rights of indigenous peoples to their traditional medicines and health practices, and to all social and health services. Although not a legally binding agreement, UNDRIP encourages nation states to comply and implement measures to support and uphold its provisions. Within the context of indigenous health and human rights, Nicaragua serves as a unique case study for examining implementation of UNDRIP Article 24 provisions due to the changes in the Nicaraguan Constitution that strive for the overarching goal of affirming an equal right to health for all Nicaraguans and supporting the integration of traditional medicine and biomedicine at a national and regional level. To explore this subject further, we conducted a review of the policy impact of UNDRIP on health services accessible to the Miskitu indigenous peoples of the North Atlantic Autonomous Region (RAAN). We found that although measures to create therapeutic cooperation are woven into Nicaraguan health plans at the national and regional level, in practice, the delivery of integrated health services has been implemented with varying results. Our review suggests that the method of policy implementation and efforts to foster intercultural collaborative approaches involving respectful community engagement are important factors when attempting to assess the effectiveness of UNDRIP implementation into national health policy and promoting traditional medicine access. In response, more study and close monitoring of legislation that acts to implement or align with UNDRIP Article 24 is necessary to ensure adequate promotion and access to traditional medicines and health services for indigenous populations in Nicaragua and beyond.


Original Research

Abstract:
Background
The electronic cigarette (e-cigarette) market is maturing into a billion-dollar industry. Expansion includes new channels of access not sufficiently assessed, including Internet sales of e-cigarettes. This study identifies unique e-cigarette Internet vendor characteristics, including geographic location, promotional strategies, use of social networking, presence/absence of age verification, and consumer warning representation.

Methods
We performed structured Internet search engine queries and used inclusion/exclusion criteria to identify e-cigarette vendors. We then conducted content analysis of characteristics of interest.

Results
Our examination yielded 57 e-cigarette Internet vendors including 54.4% (n = 31) that sold exclusively online. The vast majority of websites (96.5%, n = 55) were located in the U.S. Vendors used a variety of sales promotion strategies to market e-cigarettes including 70.2% (n = 40) that used more than one social network service (SNS) and 42.1% (n = 24) that used more than one promotional sales strategies. Most vendors (68.4%, n = 39) displayed one or more health warnings on their website, but often displayed them in smaller font or in their terms and conditions. Additionally, 35.1% (n = 20) of vendors did not have any detectable age verification process.

Conclusions
E-cigarette Internet vendors are actively engaged in various promotional activities to increase the appeal and presence of their products online. In the absence of FDA regulations specific to the Internet, the e-cigarette e-commerce marketplace is likely to grow. This digital environment poses unique challenges requiring targeted policy-making including robust online age verification, monitoring of SNS marketing, and greater scrutiny of certain forms of marketing promotional practices.


Original Research
Mackey TK, Aung P, Liang BA. Illicit Internet availability of drugs subject to recall and patient safety consequences. Int’l J. Clinc Pharm: 2015; 37(6):1076-1085

Abstract:
Background Permanently recalled drugs are a public health concern if they remain accessible in violation of applicable regulation. Illicit online pharmacies act as an alternative form of access and have been associated with the sale to patients of counterfeit/falsified/fraudulent/substandard drugs. We wished to determine if permanently recalled and significantly restricted drugs were illegally marketed for sale online. Objective The study was conducted in two phases with two objectives. The first phase attempted to identify drugs subject to permanent recall in certain major pharmaceutical markets as well as those listed as recalled or significantly restricted by the United Nations. We also examined the market authorization status of identified drugs in China and India. The second phase used structured searches on the Internet to determine if identified drugs were marketed for sale online. Setting The World Wide Web. Method After identification of permanently recalled and restricted drugs we conducted Internet searches for illegal “no prescription” marketing events. We assessed the form of marketing, whether a site offered direct-to-patient sale, use of social media marketing, and the site’s compliance status with external monitoring bodies. Main Outcome Number of recalled drugs marketed as available for purchase on the Internet. Results We identified 16 class I equivalent permanently recalled or restricted drugs, 56.3 % (n = 9) of which maintained market authorization in either China or India. Half (n = 8) were marketed for sale online without a prescription direct-to-patient. Use of social media marketing was mixed, with only 18.8 % (n = 3) of recalled drugs having a presence on Facebook, though 50.0 % (n = 8) had content on Twitter. We also found the majority (68.8 %, n = 11) were available and marketed for sale by vendors on the wholesale/business-to-business website alibaba.com primarily as active pharmaceutical ingredient. Conclusion Despite efforts in several countries to restrict access to these drugs or permanently remove them from the market, our study indicates that various sources actively market recalled drugs for sale online. Drug regulators, public health agencies, and law enforcement officials should act with urgency to appropriately restrict and regulate these sales to protect global patients and consumers.


Original Research

Abstract:
Background
Pharmaceutical marketing is undergoing a major shift in the United States, in part due to new transparency regulations under the healthcare reform act. Changes in pharmaceutical marketing practices include a possible shift from more traditional forms of direct-to-consumer advertising towards emerging use of Internet-based DTCA (“eDTCA”) given the growing importance of digital health or “eHealth.” Though legally allowed only in the U.S. and New Zealand, eDTCA poses novel regulatory challenges, as it can cross geopolitical boundaries and impact health systems and populations outside of these countries.

Methods
We wished to assess whether changes in DTCA and eDTCA expenditure trends was occurring using publicly available pharmaceutical marketing data. DTCA data was analyzed to compare trends in aggregate marketing expenditures and to assess if there were statistically significant differences in trends and magnitudes for data sources and DTCA sub-categories (including eDTCA). This was accomplished using regression lines of DTCA trend data and conducting pairwise comparisons of regression coefficients using t-tests. Means testing was utilized for comparing magnitude of DTCA expenditure.

Results
Data from multiple data sources indicate that aggregate DTCA expenditures have slightly declined during the period from 2005–2009 and are consistent with results from other studies. For DTCA sub-categories, television remained the most utilized form of DTCA, though experienced trends of declining expenditures (−13.2 %) similar to other traditional media platforms such as radio (−30.7 %) and outdoor ads (−12.1 %). The only DTCA sub-category that experienced substantial increased expenditures was eDTCA (+109.0 %) and it was the only medium that had statistically significant differences in its marketing expenditure trends compared to other DTCA sub-categories.

Conclusions
Our study indicates that traditional DTCA marketing may be on the decline. Conversely, the only DTCA sub-category that experienced significant increases was eDTCA. However, to fully understand this possible shift to “digital” DTCA, improvements in publicly available DTCA data sources are necessary to confirm changing trends and validate existing data. Hence, utilizing the newly implemented U.S. physician-payment expenditure transparency requirements, we advocate for the mandatory disclosure of DTCA/eDTCA in order to inform future domestic and international health policy efforts regarding appropriate regulation of pharmaceutical promotion.


Article

Abstract:
The problems of poor or biased information and of misleading health and well-being advice on the Internet have been extensively documented. The recent decision by the Internet Corporation for Assigned Names and Numbers to authorize a large number of new generic, top-level domains, including some with a clear connection to health or healthcare, presents an opportunity to bring some order to this chaotic situation. In the case of the most general of these domains, “.health,” experts advance a compelling argument in favor of some degree of content oversight and control. On the opposing side, advocates for an unrestricted and open Internet counter that this taken-for-granted principle is too valuable to be compromised, and that, once lost, it may never be recovered. We advance and provide evidence for a proposal to bridge the credibility gap in online health information by providing provenance information for websites in the .health domain.


Original Research

Abstract:
The problems of poor or biased information and of misleading health and well-being advice on the Internet have been extensively documented. The recent decision by the Internet Corporation for Assigned Names and Numbers to authorize a large number of new generic, top-level domains, including some with a clear connection to health or healthcare, presents an opportunity to bring some order to this chaotic situation. In the case of the most general of these domains, “.health,” experts advance a compelling argument in favor of some degree of content oversight and control. On the opposing side, advocates for an unrestricted and open Internet counter that this taken-for-granted principle is too valuable to be compromised, and that, once lost, it may never be recovered. We advance and provide evidence for a proposal to bridge the credibility gap in online health information by providing provenance information for websites in the .health domain.


Original Research
Mackey TK, Liang BA, York P, Kubic T. Counterfeit Drug Penetration into Global Legitimate Supply Chains: A Global Assessment. Am J. Trop. Med. Hygiene: 2015; 92(6):59-67

Abstract:
Purpose
In 2012, the Food and Drug Administration (FDA) sent warning notices to clinics and medical practitioners that may have purchased or administered counterfeited versions of the angiogenesis cancer drug Avastin Genentech, South San Francisco, California, USA. The purpose of this study was to explore potential differences in demographic, economic, and healthcare coverage characteristics between areas that received these counterfeit warning notices and those that did not receive notices. The aims of this study are to improve future counterfeit drug surveillance and better assess potential risk factors associated with counterfeit cancer drugs.

Methods
Addresses for warning notices sent to healthcare practitioners were obtained from the FDA and then geocoded using arcgis. Variables chosen for statistical and geospatial analyses were then identified and assessed based on their potential association with Avastin access and affordability. These variables included demographic and economic factors (percent below the poverty line, percent uninsured, and median household income) and healthcare coverage data (percent Medicare enrollees) available from the US Center for Medicare and Medicaid Services. All variables were analyzed at the US county level.

Results
Our analysis uncovered 401 distinct US counties where the FDA sent at least one counterfeit Avastin warning notice. A hot spot analysis of notices and variables was carried out using arcgis software to identify and visualize risk features with high and low values of clustering. In a multiple logistic regression model reassessing visually observed geospatial associations, the receipt of a notice was not significantly associated with percent uninsured (p = 0.3121), but was significantly associated with percent Medicare enrollees (OR = 0.874 per 10% increase; p = 0.0121), individuals below federal poverty line (OR = 2.990 per 10% increase; p < 0.0001), and median household income (OR = 2.698 per $10 000 increase; p < 0.0001).

Conclusions
Our study found that county-level economic and demographic factors are potentially associated with counterfeit Avastin warning receipt after controlling for the total number of people residing in each county. These geographic associations indicate that individuals in counties where patients have greater ability to afford more expensive treatment, and consequently where providers can seek higher reimbursement, may have been at higher risk to counterfeit Avastin exposure. These findings can help inform future efforts to improve drug safety surveillance and more proactively identify patients at the highest risk for counterfeit cancer drugs.


Commentary

Abstract:
Introduction
Peace and stability in Eastern Europe is now at a crossroads with the rapidly deteriorating foreign policy crisis continuing to unfold in the Ukraine. However, largely overlooked in the context of other foreign policy and diplomatic priorities are the serious public health consequences for the region following the annexation of Crimea and the subsequent decision to ban opioid substitution therapy in the disputed territory.

Discussion
On 1 May 2014, the Republic of Crimea officially announced it would end access to opioid substitution therapy, an essential harm reduction tool recognized by international organizations and virtually all other European countries. The policy development marks a critical reversal in the region’s fight against its growing HIV epidemic and also threatens years of public health gains aimed at providing evidence-based and integrated treatment approaches to combat drug dependence and HIV. Beyond these risks, the Ukrainian conflict could also negatively impact control of other infectious diseases that are converging with HIV and injection drug use, such as multidrug-resistant tuberculosis and hepatitis C virus. The continuing conflict is also likely to have a significant negative impact on Ukraine’s fragile public health system leading to even worse population health outcomes than currently experienced by the country.

Conclusions
In response to this crisis, the application of global health diplomacy principles represents a possible route of advocacy to ensure that HIV prevention, humane treatment of substance using populations, and improving public health outcomes in the region are pursued among concerned international stakeholders. In order to be effective, global health diplomacy efforts must be coordinated and advocated in all forms of diplomatic engagement, including at the core, multistakeholder and informal levels and through existing channels such as the different human rights bodies of the United Nations as well as amongst other actors. Hence, the Ukraine crisis represents a critical moment for the practice and advancement of global health diplomacy in order to ensure global public health priorities are given their rightful place in foreign policy making to hopefully help in bringing resolution to the current conflict.


Perspective
Mackey TK, Cuomo RE, Guerra C, Liang BA. After Counterfeit Avastin – What Have We Learned and What can be Done? Nat Rev Clin Oncol: 2015; 12:302-308

Abstract:
Counterfeit medicines are a global public health risk. We assess counterfeit reports involving the legitimate supply chain using 2009–2011 data from the Pharmaceutical Security Institute Counterfeit Incident System (PSI CIS) database that uses both open and nonpublic data sources. Of the 1,510 identified CIS reports involving counterfeits, 27.6% reported China as the source country of the incident/detection. Further, 51.3% were reported as counterfeit but the specific counterfeit subcategory was not known or verifiable. The most prevalent therapeutic category was anti-infectives (21.1%) with most reports originating from health-related government agencies. Geographically, Asian and Latin American regions and, economically, middle-income markets were most represented. A total of 127 (64.8%) of a total of 196 countries had no legitimate supply chain CIS counterfeit reports. Improvements in surveillance, including detection of security breaches, data collection, analysis, and dissemination are urgently needed to address public health needs to combat the global counterfeit medicines trade.


Commentary
Mackey TK, Strathdee SA. Big Events and Risks to Global Substance Using Populations: Unique Threats and Common Challenges. Substance Use & Misuse: 2015; 50(7): 885-890

Abstract:
In this commentary, we review a set of “Big Events” from around the world that have adversely impacted substance using populations by first identifying common thematic areas between them, and then describing the unique challenges faced by the diverse and vulnerable populations impacted. The Big Events reviewed are multifaceted and complex in nature, and include the recent global financial crisis, economic and trade sanctions, political transition and its impact on ethnic minorities, colonialism and indigenous communities, and ecological disasters. All have led to immense trauma, displacement, and disruption to critical healthcare services/treatment for people who use drugs, populations who are left underserved in the midst of these crises. It is our hope that through this comparative assessment, global policymakers will proactively identify Big Events and prioritize the development of interventions and policy that meet the unique and immediate needs of substance using population in order to mitigate the significant negative short- and long-term impacts on global public health.


Commentary
Mackey TK, Liang BA. It’s Time to Shine the Light on Direct-to-Consumer Advertising. Ann Fam Med.: 2015; 13(1):82-85

Abstract:
Pharmaceutical marketing is undergoing a transition as the business, delivery, and consumption of health care have increasingly become part of a growing digital landscape. Changes in pharmaceutical promotion also coincide with federal “sunshine” regulations newly implemented under the Affordable Care Act that require disclosure of certain marketing and industry payments to physicians. Collectively, these trends could lead to fundamental shifts in physician-directed and direct-to-consumer advertising (DTCA) that have yet to be adequately identified or explored. In response, we advocate for greater DTCA transparency, especially in the emerging digital forms of DTCA, to complement forthcoming sunshine transparency data. This will allow more robust study and understanding of changes in overall pharmaceutical marketing trends and their impact on health care consumption and behavior. This can also lead to more targeted state and federal policy interventions leveraging existing federal transparency regulations to ensure appropriate marketing, sales, and consumption of pharmaceutical products.


2014

Topics covered: fake medicines; drug safety; patient safety; substance abuse; global health governance; infectious diseases; innovation; public health and IP; digital health; tobacco control; biologics; drug access; pharmaceutical marketing; health migration; international trade; dental policy; environmental health; health policy; health diplomacy

  • Number of Publications: 14
Original Research
Review
Article
Commentary
Debate
Policy Forum
Editorial
Law Review
Original Research

Abstract:
Objective
To explore healthcare policy and system improvements that would more proactively respond to future penetration of counterfeit cancer medications in the USA drug supply chain using geospatial analysis.

Design
A statistical and geospatial analysis of areas that received notices from the Food and Drug Administration (FDA) about the possibility of counterfeit Avastin penetrating the US drug supply chain. Data from FDA warning notices were compared to data from 44 demographic variables available from the US Census Bureau via correlation, means testing and geospatial visualisation. Results were interpreted in light of existing literature in order to recommend improvements to surveillance of counterfeit medicines.

Setting and Participants
This study analysed 791 distinct healthcare provider addresses that received FDA warning notices across 30 431 zip codes in the USA.

Outcomes
Statistical outputs were Pearson's correlation coefficients and t values. Geospatial outputs were cartographic visualisations. These data were used to generate the overarching study outcome, which was a recommendation for a strategy for drug safety surveillance congruent with existing literature on counterfeit medication.

Results
Zip codes with greater numbers of individuals age 65+ and greater numbers of ethnic white individuals were most correlated with receipt of a counterfeit Avastin notice. Geospatial visualisations designed in conjunction with statistical analysis of demographic variables appeared more capable of suggesting areas and populations that may be at risk for undetected counterfeit Avastin penetration.

Conclusions
This study suggests that dual incorporation of statistical and geospatial analysis in surveillance of counterfeit medicine may be helpful in guiding efforts to prevent, detect and visualise counterfeit medicines penetrations in the US drug supply chain and other settings. Importantly, the information generated by these analyses could be utilised to identify at-risk populations associated with demographic characteristics. Stakeholders should explore these results as another tool to improve on counterfeit medicine surveillance.


Commentary
Mackey TK, Liang BA. Digital Iatrogenesis: Policy Advocacy to Prevent Patient Harm from Access to Dangerous Drugs Online. Harvard Health Policy Review: 2014; 14(1): 11-13

Abstract:
Iatrogenesis is an old concept that has broadened in scope and depth since Ivan Illich’s book Medical Nemesis sparked new debate about the need to recognize differences between clinical, social and cultural iatrogenesis types in the 1970s. Yet, in today’s increasingly digitized world, there may be need for further modernization of iatrogenesis to reflect growing potential for patient harm from the Internet and related technologies. This specifically includes the patient safety and public health risks emanating from illicit online pharmacies, many of which sell questionable and counterfeit drugs directly to the patient. This piece outlines these risks, including summarized findings from studies showing that clearly dangerous drugs are available online. It also suggests a modernizing of iatrogenesis to include the new concept of “digital iatrogenesis” in order to raise awareness and address a constantly changing online health environment


Commentary
Mackey TK, Werb D, Beletsky L, Rangel G, Arredondo J, Strathdee SA. Mexico’s “ley de narcomenudeo” Drug Policy Reform and the International Drug Control Regime. Harm Reduction Journal: 2014; 11:31

Abstract:
It has been over half a century since the landmark Single Convention on Narcotic Drugs was adopted, for the first time unifying international drug policy under a single treaty aimed at limiting use, manufacture, trade, possession, and trafficking of opiates, cannabis, and other narcotics. Since then, other international drug policy measures have been adopted, largely emphasizing enforcement-based approaches to reducing drug supply and use. Recently, in response to concerns that the historic focus on criminalization and enforcement has had limited effectiveness, international drug policies have begun to undergo a paradigm shift as countries seek to enact their own reforms to partially depenalize or deregulate personal drug use and possession. This includes Mexico, which in 2009 enacted national drug policy reform partially decriminalizing possession of small quantities of narcotics for personal consumption while also requiring drug treatment for repeat offenders. As countries move forward with their own reform models, critical assessment of their legal compatibility and effectiveness is necessary. In this commentary we conduct a critical assessment of the compatibility of Mexico’s reform policy to the international drug policy regime and describe its role in the current evolving drug policy environment. We argue that Mexico’s reform is consistent with flexibilities allowed under international drug treaty instruments and related commentaries. We also advocate that drug policy reforms and future governance efforts should be based on empirical evidence, emphasize harm reduction practices, and integrate evidence-based evaluation and implementation of drug reform measures.


Review
Mackey TK, Liang BA, Cuomo R, Hafen R, Brouwer KC, Lee DE. Emerging and Reemerging Neglected Tropical Diseases: A Review of Key Characteristics, Risk Factors, and the Policy and Innovation Environment. Clin. Microbiol. Rev. 2014; 27(4):949

Abstract:
In global health, critical challenges have arisen from infectious diseases, including the emergence and reemergence of old and new infectious diseases. Emergence and reemergence are accelerated by rapid human development, including numerous changes in demographics, populations, and the environment. This has also led to zoonoses in the changing human-animal ecosystem, which are impacted by a growing globalized society where pathogens do not recognize geopolitical borders. Within this context, neglected tropical infectious diseases have historically lacked adequate attention in international public health efforts, leading to insufficient prevention and treatment options. This subset of 17 infectious tropical diseases disproportionately impacts the world's poorest, represents a significant and underappreciated global disease burden, and is a major barrier to development efforts to alleviate poverty and improve human health. Neglected tropical diseases that are also categorized as emerging or reemerging infectious diseases are an even more serious threat and have not been adequately examined or discussed in terms of their unique risk characteristics. This review sets out to identify emerging and reemerging neglected tropical diseases and explore the policy and innovation environment that could hamper or enable control efforts. Through this examination, we hope to raise awareness and guide potential approaches to addressing this global health concern.


Article
Brown M, Mackey TK, Shapiro CN, Kolker J, Novotny TE. Bridging Public Health and Foreign Affairs: The Tradecraft of Global Health Diplomacy and the Role of Health Attachés. Science & Diplomacy: 2014; 3(3)

Abstract not available.


Commentary
Mackey TK, Eysenbach G, Liang BA, Kohler JC, Geissbuhler A, Attaran A. A Call for a Moratorium on the .health Generic Top-Level Domain: Preventing the Commercialization and Exclusive Control of Online Health Information. Global Health: 2014; 10:62 

Abstract:
In just a few weeks, the Internet could be expanded to include a new .health generic top-level domain name run by a for-profit company with virtually no public health credentials - unless the international community intervenes immediately. This matters to the future of global public health as the “Health Internet” has begun to emerge as the predominant source of health information for consumers and patients. Despite this increasing use and reliance on online health information that may have inadequate quality or reliability, the Internet Corporation for Assigned Names and Numbers (ICANN) recently announced it intends to move forward with an auction to award the exclusive, 10 year rights to the .health generic top-level domain name. This decision is being made over the protests of the World Medical Association, World Health Organization, and other stakeholders, who have called for a suspension or delay until key questions can be resolved. However, rather than engage in constructive dialogue with the public health community over its concerns, ICANN chose the International Chamber of Commerce—a business lobbying group for industries to adjudicate the .health concerns. This has resulted in a rejection of challenges filed by ICANN's own independent watchdog and others, such that ICANN's Board decided in June 2014 that there are “no noted objections to move forward” in auctioning the .health generic top-level domain name to the highest bidder before the end of the year. This follows ICANN's award of several other health-related generic top-level domain names that have been unsuccessfully contested. In response, we call for an immediate moratorium/suspension of the ICANN award/auction process in order to provide the international public health community time to ensure the proper management and governance of health information online.


Editorial
Werb D, Medina Mora ME, Beletsky L, Rafful C, Mackey T, Arrendondo J, Strathdee S. Mexico’s Drug Policy Reform: Cutting Edge Success or Crisis in the Making? Int’l J. Drug Policy: 2014; 25:823-825

Abstract:
In August 2009, Mexico's federal government took the bold step of passing a law partially decriminalizing possession of small quantities of drugs such as cannabis, cocaine, amphetamines, and heroin (Consejo Nacional contras las Adicciones, 2010). Concurrently, the law (known as the ‘ley de narcomenudeo’) also mandates that individuals found to be in possession of these drugs be diverted to addiction treatment, including methadone maintenance therapy (MMT) (Consejo Nacional contras las Adicciones, 2010). Specifically, individuals carrying illegal drugs under a threshold amount subject to the law who are stopped by police are released with a warning up to two times. However, upon a third drug- related infraction, individuals are either mandated to addiction treatment or jail (Consejo Nacional contras las Adicciones, 2010).


Policy Forum

Abstract:
- The United States is one of the few signatories that has not ratified the landmark World Health Organization Framework Convention on Tobacco Control (FCTC) public health treaty despite the passage of the Family Smoking Prevention and Control Act (FSPCA) that complies with the treaty.
- Tobacco control measures to regulate tobacco marketing and packaging have been vigorously challenged by the industry worldwide. In the US, constitutional challenges have led to a delay in legally mandated graphic warnings on packaging.
- In order to promote global tobacco control and protect future tobacco marketing regulation and interventions, the US should immediately ratify the FCTC using the FSPCA as implementing legislation. Ratification would establish FCTC provisions as domestic law under FSPCA and ensure that international norms and principles combating tobacco are achieved.
- By ratifying FCTC, the US would reinforce its own domestic tobacco control efforts and provide international support and leadership in the fight against the global tobacco epidemic. This is crucial as the industry continues to challenge tobacco regulation globally, and failure in US health policy could have a detrimental effect on FCTC implementation in other countries.


Commentary
Mackey TK, Liang BA, Kohler JC, Attaran A. Health Domains for Sale: The Need for Global Health Internet Governance. J Med Internet Res. 2014;16(3):e62

Abstract:
A debate on Internet governance for health, or “eHealth governance”, is emerging with the impending award of a new dot-health (.health) generic top-level domain name (gTLD) along with a host of other health-related domains. This development is critical as it will shape the future of the health Internet, allowing largely unrestricted use of .health second-level domain names by future registrants, raising concerns about the potential for privacy, use and marketing of health-related information, credibility of online health content, and potential for Internet fraud and abuse. Yet, prospective .health gTLD applicants do not provide adequate safeguards for use of .health or related domains and have few or no ties to the global health community. If approved, one of these for-profit corporate applicants would effectively control the future of the .health address on the Internet with arguably no active oversight from important international public health stakeholders. This would represent a lost opportunity for the public health, medical, and broader health community in establishing a trusted, transparent and reliable source for health on the Internet. Countries, medical associations, civil society, and consumer advocates have objected to these applications on grounds that they do not meet the public interest. We argue that there is an immediate need for action to postpone awarding of the .health gTLD and other health-related gTLDs to address these concerns and ensure the appropriate development of sound eHealth governance rules, principles, and use. This would support the crucial need of ensuring access to quality and evidence-based sources of health information online, as well as establishing a safe and reliable space on the Internet for health. We believe, if properly governed, .health and other domains could represent such a promise in the future.


Debate
Kohler JC, Mackey TK, Ovtcharenko N. Why the MDGs need Good Governance in Pharmaceutical Systems to Promote Global Health. BMC Public Health. 2014;14(63) 

Abstract:
Background
Corruption in the health sector can hurt health outcomes. Improving good governance can in turn help prevent health-related corruption. We understand good governance as having the following characteristics: it is consensus-oriented, accountable, transparent, responsive, equitable and inclusive, effective and efficient, follows the rule of law, is participatory and should in theory be less vulnerable to corruption. By focusing on the pharmaceutical system, we explore some of the key lessons learned from existing initiatives in good governance. As the development community begins to identify post-2015 Millennium Development Goals targets, it is essential to evaluate programs in good governance in order to build on these results and establish sustainable strategies. This discussion on the pharmaceutical system illuminates why.

Discussion
Considering pharmaceutical governance initiatives such as those launched by the World Bank, World Health Organization, and the Global Fund, we argue that country ownership of good governance initiatives is essential but also any initiative must include the participation of impartial stakeholders. Understanding the political context of any initiative is also vital so that potential obstacles are identified and the design of any initiative is flexible enough to make adjustments in programming as needed. Finally, the inherent challenge which all initiatives face is adequately measuring outcomes from any effort. However in fairness, determining the precise relationship between good governance and health outcomes is rarely straightforward.

Summary
Challenges identified in pharmaceutical governance initiatives manifest in different forms depending on the nature and structure of the initiative, but their regular occurrence and impact on population-based health demonstrates growing importance of addressing pharmaceutical governance as a key component of the post-2015 Millennium Development Goals. Specifically, these challenges need to be acknowledged and responded to with global cooperation and innovation to establish localized and evidence-based metrics for good governance to promote global pharmaceutical safety.


Law Review

Abstract:
Biosimilars have tremendous potential to reduce the costs of biologic therapies. Emerging markets may represent a significant fraction of future biosimilar production, development, and consumption. Yet safety concerns, price sensitivity, and lower quality standards represent challenges to public health in emerging markets. Well-crafted public-private partnerships between public health agencies, local biosimilar manufacturers, and global pharmaceutical firms that leverage advantages of each can result in biosimilar production targeted to local public health needs using a safety-focused infrastructure. The key clinical risk for biosimilars— immunogenicity—can be addressed by leveraging patient safety tools and incentivizing local producers to work with global drug firms and local public health departments, while technical expertise in large scale current Good Manufacturing Practices (“cGMP”) can be provided by global drug firms. Once this infrastructure is in place, public health departments in partnership with their local and global producers can provide incentives, such as limited market exclusivity, to produce drugs in these emerging markets at higher than required levels (i.e., at or above cGMP). They can also target specific immunotherapies relevant for that particular community’s needs. By doing so, global firms, local producers, and local public health departments can provide direction and improved quality and safety so benefits can inure directly to these populations. Moreover, as global populations begin to rely on these emerging market-produced drugs, greater access, sustainability and affordability may also be promoted


Commentary
Mackey TK, Yagi N, Liang BA. Prescription Drug Coupons: Evolution and Need for Regulation in Direct-to-Consumer Advertising. Res Social Admin Pharm.; 2014; 10(3):588-594

Abstract:
Pharmaceutical marketing in the United States had undergone a shift from largely exclusively targeting physicians to considerable efforts in targeting patients through various forms of direct-to-consumer advertising (“DTCA”). This includes the use of DTCA in prescription drug coupons (“PDCs”), a new form of DTCA that offers discounts and rebates directly to consumers to lower costs of drug purchasing. Our examination of PDCs reveals that the use and types of PDC programs is expanding and includes promotion of the vast majority of top grossing pharmaceuticals. However, controversy regarding this emerging form of DTCA has given rise to health policy concerns about their overall impact on prescription drug expenditures for consumers, payers, and the health care system, and whether they lead to optimal long-term utilization of pharmaceuticals. In response to these concerns and the growing popularity of PDCs, what we propose here are clearer regulation and regulatory guidance for PDC DTCA use. This would include review for appropriate disclosure of marketing claims, increased transparency in PDC use for pharmaceutical pricing, and leveraging potential positive benefits of PDC use for vulnerable or underserved patient populations.


Review

Abstract:
In 2008, the bilateral Japan–Philippines Economic Partnership Agreement took effect. Contained within this regional free trade agreement are unique provisions allowing exchange of Filipino nurses and healthcare workers to work abroad in Japan. Japan's increasing need for healthcare workers due to its aging demographic and the Philippines need for economic development could have led to shared benefits under the Japan–Philippines Economic Partnership Agreement. However, 4 years following program implementation, results have been disappointing, e.g., only 7% of candidates passing the programs requirements since 2009. These disappointing results represent a policy failure within the current Japan–Philippines Economic Partnership Agreement framework, and point to the need for reform. Hence, amending the current Japan–Philippines Economic Partnership Agreement structure by potentially adopting a USA based approach to licensure examinations and implementing necessary institutional and governance reform measures may be necessary to ensure beneficial healthcare worker migration for both countries.


Commentary

Abstract:
In October 2013, a new international binding treaty instrument called the Minamata Convention on Mercury opened for signature in Minamata City, Japan, the site of arguably the worst public health and environmental disaster involving mercury contamination. The treaty aims to curb the significant health and environmental impacts of mercury pollution and includes provisions addressing the mining, export and import, storage, and waste management of products containing mercury. Importantly, a provision heavily negotiated in the treaty addresses the use of dental fillings using mercury amalgam, an issue that has been subject to decades of global controversy. Though use of dental amalgam is widespread and has benefits, concerns have been raised regarding the potential for human health risk and environmental damage from emissions and improper waste management. While the Minamata Convention attempts to address these issues by calling for a voluntary phase-down of dental amalgam use and commitment to other measures, it falls short by failing to require binding and measurable targets to achieve these goals. In response, the international community should begin exploring ways to strengthen the implementation of the dental amalgam treaty provisions by establishing binding phase-down targets and milestones as well as exploring financing mechanisms to support treaty measures. Through strengthening of the Convention, stakeholders can ensure equitable access to global oral health treatment while also promoting responsible environmental stewardship.


2013

Topics covered: fake medicines; pharmaceutical marketing; digital health; conflicts of interest; stem cells; substance abuse; social media; reproductive health; online pharmacies; pharmaceutical policy; elder abuse; global health governance; tobacco control; health policy; health migration

  • Number of Publications: 17
Original Research
Article
Review
Commentary
Debate
Law Review
Correspondence
Author Reply
Debate

Abstract:
Introduction
Perhaps no greater challenge exists for public health, patient safety, and shared global health security, than fake/falsified/fraudulent, poor quality unregulated drugs, also commonly known as “counterfeit medicines”, now endemic in the global drug supply chain. Counterfeit medicines are prevalent everywhere, from traditional healthcare settings to unregulated sectors, including the Internet. These dangerous medicines are expanding in both therapeutic and geographic scope, threatening patient lives, leading to antimicrobial resistance, and profiting criminal actors.

Discussion
Despite clear global public health threats, surveillance for counterfeit medicines remains extremely limited, with available data pointing to an increasing global criminal trade that has yet to be addressed appropriately. Efforts by a variety of public and private sector entities, national governments, and international organizations have made inroads in combating this illicit trade, but are stymied by ineffectual governance and divergent interests. Specifically, recent efforts by the World Health Organization, the primary international public health agency, have failed to adequately incorporate the broad array of stakeholders necessary to combat the problem. This has left the task of combating counterfeit medicines to other organizations such as UN Office of Drugs and Crime and Interpol in order to fill this policy gap.

Summary
To address the current failure of the international community to mobilize against the worldwide counterfeit medicines threat, we recommend the establishment of an enhanced global health governance trilateral mechanism between WHO, UNODC, and Interpol to leverage the respective strengths and resources of these organizations. This would allow these critical organizations, already engaged in the fight against counterfeit medicines, to focus on and coordinate their respective domains of transnational crime prevention, public health, and law enforcement field operations. Specifically, by forming a global partnership that focuses on combating the transnational criminal and patient safety elements of this pre-eminent global health problem, there can be progress against counterfeit drugs and their purveyors."


Debate

Abstract:
Background
Digital forms of direct-to-consumer pharmaceutical marketing (eDTCA) have globalized in an era of free and open information exchange. Yet, the unregulated expansion of eDTCA has resulted in unaddressed global public health threats. Specifically, illicit online pharmacies are engaged in the sale of purportedly safe, legitimate product that may in fact be counterfeit or substandard. These cybercriminal actors exploit available eDTCA mediums over the Internet to market their suspect products globally. Despite these risks, a detailed assessment of the public health, patient safety, and cybersecurity threats and governance mechanisms to address them has not been conducted.

Discussion
Illicit online pharmacies represent a significant global public health and patient safety risk. Existing governance mechanisms are insufficient and include lack of adequate adoption in national regulation, ineffective voluntary governance mechanisms, and uneven global law enforcement efforts that have allowed proliferation of these cybercriminals on the web. In order to effectively address this multistakeholder threat, inclusive global governance strategies that engage the information technology, law enforcement and public health sectors should be established.

Summary
Effective global “eHealth Governance” focused on cybercrime is needed in order to effectively combat illicit online pharmacies. This includes building upon existing Internet governance structures and coordinating partnership between the UN Office of Drugs and Crime that leads the global fight against transnational organized crime and the Internet Governance Forum that is shaping the future of Internet governance. Through a UNODC-IGF governance mechanism, investigation, detection and coordination of activities against illicit online pharmacies and their misuse of eDTCA can commence.


Correspondence
Mackey TK, Liang BA, Kohler J, Attaran A. The Fight over dot-health: Ensuring the Future of Health Information Online. The Lancet. 2013; 382:1404

Abstract not available.


Article
Liang BA, Mackey TK, Lovett KM. Technology and Medicine: Academic Dishonesty and Risks to Global Health. J Comm Biotech. 2013;19(4):42-48

Abstract:
Technology has promoted global health. Yet advancing technology has also allowed physicians and trainees to cheat, and inappropriate experimentation with medical technology has resulted in study patient deaths. Further, journal editors have not made significant inroads in employing technology to identify dishonesty. Unfortunately, this continues to be strongly within the culture of the profession. Due to corruption of medicine, global health promotion will be severely retarded by falsified and suspect data that lower-and-middle income countries cannot afford to reproduce themselves and must rely upon for clinical decisionmaking. Further, clinical environments that facilitate dishonesty will result in poorer patient care. In addition, emerging markets rely on research to produce advanced therapeutics such as biosimilars that will be used by developed and developing economies, compounding the potential risks of dishonesty globally. By employing relevant antiplagiarism technology and accessing funding sources for all parties including authors, reviewers, and journal editors; "honesty" accreditation that includes mandated participation by journals; and external audits and whistleblowing of dishonesty, medical culture globally can move toward honesty and take advantage of technological evolution to promote global health. [ABSTRACT FROM AUTHOR]


Review

Abstract:
Objective
Counterfeit medicines are a global, multi-faceted, and complex public health problem. Global health diplomacy and cooperative efforts relying on governance systems have been limited in effectively addressing proliferation of this dangerous trade.

Methods
This review conducts a comprehensive mapping exercise of governance efforts by international organizations to address counterfeit medicines, including analysis of related international treaties and conventions that may be applicable to anticounterfeit efforts. This work also reviews governance and global health diplomacy proposals from the literature that addresses counterfeit medicines.

Summary of Findings
A number of international organizations have become active in addressing the global trade of counterfeit medicines. However, governance approaches by international organizations, including the World Health Organization (WHO),
the United Nations Office on Drugs and Crime (UNODC), Interpol and the World Customs Organization (WCO), have varied in scope and effectiveness. Treaty instruments with applicability to counterfeit medicines have also not been fully leveraged to combat this issue. Results indicate that a formalized and multi-stakeholder governance mechanism is needed to address the issue. The UNODC is uniquely situated to act as a
forum for such a proposal in partnership with other international organizations.

Implications of Findings
Global health diplomacy efforts to combat counterfeit medicines require multi-stakeholder and formalized governance structures that can leverage stakeholder participation and resources. Through cooperative arrangements leveraging the strengths of partners such as UNODC (combating transnational crime), Interpol (law enforcement purposes), the WCO (customs and border control), and the WHO (for public health science and analysis), the international community can mobilize a coordinated, inclusionary, health diplomacy response to the crisis of global counterfeit medicines.


Article

Abstract:
Stem cell-based therapies represent a potential pathway for a new era of 21st century regenerative medicine. In support of this new form of treatment, a global multibillion-dollar research endeavor is currently underway in an effort to establish a scientific evidence base for safe and effective clinical use of stem cells. At present, due to its early stages, only a few stem cell therapies are approved for use. Yet despite very limited evidence-based data, a proliferation of questionable and often illegal stem cell providers around the world are now offering unfettered access to largely experimental stem cell treatment claiming cures for virtually any disease or condition. These stem cell clinics promote their services globally to patients using unregulated Internet and forms of direct-to-consumer advertising. In this paper we examine marketing characteristics of these questionable stem cell clinics and discuss pathways of access through the globalization of medical tourism. We conclude with an examination of the similarities between unproven stem cell therapy access and illicit online pharmacies and explore possible lessons that can be learned to inform future global regulation and policymaking in this arena.


Commentary
Mackey TK, Liang BA, Strathdee SA. Digital Social Media, Youth and Non-Medical Use of Prescription Drugs: The Need for Reform. J Med Internet Res. 2013; 15(7):e143

Abstract:
The tragic death of 18-year-old Ryan Haight highlighted the ethical, public health, and youth patient safety concerns posed by illicit online nonmedical use of prescription drugs (NUPM) sourcing, leading to a federal law in an effort to address this concern. Yet despite the tragedy and resulting law, the NUPM epidemic in the United States has continued to escalate and represents a dangerous and growing trend among youth and adolescents. A critical point of access associated with youth NUPM is the Internet. Internet use among this vulnerable patient group is ubiquitous and includes new, emerging, and rapidly developing technologies—particularly social media networking (eg, Facebook and Twitter). These unregulated technologies may pose a potential risk for enabling youth NUPM behavior. In order to address limitations of current regulations and promote online safety, we advocate for legislative reform to specifically address NUPM promotion via social media and other new online platforms. Using more comprehensive and modernized federal legislation that anticipates future online developments is critical in substantively addressing youth NUPM behavior occurring through the Internet.


Author Reply
Liang BA, Mackey TK, Lovett KM. Reply to Stanback et al. “Suspect Online Sellers and Contraceptive Access”? Contraception. 2013;88(4):583

Abstract not available.


Commentary
Liang BA, Mackey TK, Archer-Hayes A, Shinn L. Illicit Online Marketing of Lorcaserin Before DEA Scheduling. Obesity. 2013;21(5):861-864

Abstract:
Objective
Antiobesity drugs have been marketed illicitly by “no prescription” online pharmacies after approval and scheduling by the drug enforcement agency. We assess whether antiobesity drug Belviq® (lorcaserin HCl) was available from illicit online vendors before DEA-scheduling when sales are unauthorized.

Design and Methods
Online searches of “buy Belviq no prescription” examining first five result pages marketing the drug. Searches were performed from 11/5/2012-12/8/2012, prior to DEA scheduing.

Results
Belviq® is actively marketed by “no prescription” online vendors despite official unavailability and prescription requirements. Approaches included direct-to-consumer advertising using descriptive website URLs; linking to illicit marketers; and directing customers to other weight-loss websites for additional marketing. Finally, large quantities were marketed by business-to-business vendors.

Conclusion
Illicit online “no prescription” pharmacies are marketing unauthorized, suspect antiobesity drugs before DEA scheduling and permitted marketing. Regulators must legally intercede to ensure patient safety, and providers must educate patients about online-sourcing risks.


Original Research
Mackey TK, Liang BA. Global Reach of Direct-to-Consumer Advertising Using Social Media for Illicit Online Drug Sales. J Med Internet Res. 2013;15(5):e105 

Abstract:
Background
Illicit or rogue Internet pharmacies are a recognized global public health threat that have been identified as utilizing various forms of online marketing and promotion, including social media.

Objective
To assess the accessibility of creating illicit no prescription direct-to-consumer advertising (DTCA) online pharmacy social media marketing (eDTCA2.0) and evaluate its potential global reach.

Methods
We identified the top 4 social media platforms allowing eDTCA2.0. After determining applicable platforms (ie, Facebook, Twitter, Google+, and MySpace), we created a fictitious advertisement advertising no prescription drugs online and posted it to the identified social media platforms. Each advertisement linked to a unique website URL that consisted of a site error page. Employing Web search analytics, we tracked the number of users visiting these sites and their location. We used commercially available Internet tools and services, including website hosting, domain registration, and website analytic services.

Results
Illicit online pharmacy social media content for Facebook, Twitter, and MySpace remained accessible despite highly questionable and potentially illegal content. Fictitious advertisements promoting illicit sale of drugs generated aggregate unique user traffic of 2795 visits over a 10-month period. Further, traffic to our websites originated from a number of countries, including high-income and middle-income countries, and emerging markets.

Conclusions
Our results indicate there are few barriers to entry for social media–based illicit online drug marketing. Further, illicit eDTCA2.0 has globalized outside US borders to other countries through unregulated Internet marketing.


Original Research
Liang BA, Mackey TK, Lovett KM. Illegal “No Prescription” Internet Access to Narrow Therapeutic Index Drugs. Clin Ther. 2013;35(5):694-700

Abstract:
Background
Narrow therapeutic index (NTI) drugs, because of proximity of therapeutic amounts to toxic amounts, require close professional oversight, particularly when switching formulations. However, safe use may be compromised by unsupervised switching through access to online “no prescription” Web sites.

Objective
We assessed no prescription online availability of NTI drugs, using an academically published list (core NTI drugs).

Methods
Using the Google search term “buy DRUG no prescription,” we reviewed the first 5 search result pages for marketing of no prescription NTI drugs. We further assessed if National Association of Boards of Pharmacy (NABP) Not Recommended vendors were marketing NTI drugs. Searches were conducted from November 3, 2012 to January 3, 2013.

Results
For core NTI drugs, we found 13 of 14 NTI drugs (92%) marketed as available without prescription, all from NABP Not Recommended vendors. On the basis of these initial findings, we expanded our core list to 12 additional NTI drugs; 11 of 12 of these drugs (92%) were available from no prescription Web sites. Overall, 24 of 26 NTI drugs (92%) were illegally marketed as available online without the need for a prescription.

Conclusion
Suspect online NTI drug access from no prescription vendors represents a significant patient safety risk because of potential patient drug switching and risk of counterfeit versions. Further, state health care exchanges with coverage limitations may drive patients to seek formulations online. Food and Drug Administration harmonization with tighter international NTI drug standards should be considered, and aggressive action against suspect online marketers should be a regulatory and public health priority.


Law Review
Lovett KM, Mackey TK. Online Threats to Senior Safety: The Direct-to-Consumer Medical Marketplace and eElder Abuse. Nat Acad Elder Law Attorneys J. 2013;9(1):91-113

Abstract not available.


Commentary

Abstract:
Numerous national governments have recently adopted packaging and labeling legislation to curb global tobacco uptake. This coincides with the World Health Organization’s 2011 World No Tobacco Day, which recognized the extraordinary progress of the Framework Convention on Tobacco Control (FCTC).The tobacco industry has presented legal challenges to countries, including Australia, Uruguay, and the United States, for enacting legislation meeting or exceeding FCTC obligations.We argue that national governments attempting to meet the obligations set forth in public health treaties such as the FCTC should be afforded flexibilities and protection in developing tobacco control laws and regulations, because these measures are necessary to protect public health and should be explicitly recognized in international trade and legal agreements.


Commentary
Mackey TK, Liang BA. Physician Payment Disclosure Under Healthcare Reform: Will the Sun Shine? J Am Board Fam Med. 2013;26: 327-331.

Abstract:
Pharmaceutical marketing has become a mainstay in U.S. health care delivery and traditionally has been directed toward physicians. In an attempt to address potential undue influence of industry and conflicts of interest that arise, states and the recently upheld health care reform act have passed transparency, or “sunshine,” laws requiring disclosure of industry payments to physicians. The Centers for Medicare & Medicaid Services recently announced the final rule for the Sunshine Provisions as part of the reform act. However, the future effectiveness of these provisions are questionable and may be limited given the changing landscape of pharmaceutical marketing away from physician detailing to other forms of promotion. To address this changing paradigm, more proactive policy solutions will be necessary to ensure adequate and ethical regulation of pharmaceutical promotion.


Article

Abstract:
Background
Health worker migration from resource-poor countries to developed countries, also known as ‘‘brain drain’’, represents a serious global health crisis and a significant barrier to achieving global health equity. Resource-poor countries are unable to recruit and retain health workers for domestic health systems, resulting in inadequate health infrastructure and millions of dollars in healthcare investment losses.

Methods
Using acceptable methods of policy analysis, we first assess current strategies aimed at alleviating brain drain and then propose our own global health policy based solution to address current policy limitations.

Resulta
Although governments and private organizations have tried to address this policy challenge, brain drain continues to destabilise public health systems and their populations globally. Most importantly, lack of adequate financing and binding governance solutions continue to fail to prevent health worker brain drain.

Conclusions
In response to these challenges, the establishment of a Global Health Resource Fund in conjunction with an international framework for health worker migration could create global governance for stable funding mechanisms encourage equitable migration pathways, and provide data collection that is desperately needed.


Author Reply

No abstract available.


Commentary
Mackey TK, Liang BA. A United Nations Global Health Panel for Global Health Governance. Soc Sci Med. 2013;76(1):12-15

Abstract:
The World Health Organization now relies upon voluntary contributions tied to specific projects, underwriting 75% of operations. A resulting cacophony of non-governmental, foundation, and private sector actors have emerged overlapping and fractionating WHO programs. In this expanding world of “global health organizations,” WHO's role must be redefined. We propose coordination of global health initiatives through a United Nations Global Health Panel with active participation of WHO. Given recent events, the UN is poised to take a greater leadership role in global health.


2012

Topics covered: global health governance; pharmaceutical policy; online pharmacies; corruption; pharmaceutical promotion; drug access; infectious diseases; reproductive health; health migration; health security; biologics; medical screening; fake medicines; stem cells; sleep health; elder abuse; health economics; health diplomacy

  • Number of Publications: 29
Original Research
Review
Article
Commentary
Perspective
Debate
Short Report
Editorial
Correspondence
Article

Abstract:
Global health governance is widely considered fragmented after more than a decade of inconsistent support for multi-lateral organizations and faced with the emergence of many new global health donors and non-state enterprises. This paper addresses a series of events marked by enactment of the Helms-Biden agreement in 1999. This legislation ensured that
United States funding for the United Nations was to be conditional upon reforms and reductions of U.S. assessments. Although passage of the legislation allowed its largest contributor/debtor to pay back arrears and continue payments going forward, it also represented a growing trend in U.S. unilateralism and disengagement from support for multi-national organizations. In particular, continued arrears and budgetary restrictions have affected specialized U.N. agencies such as the World Health Organization. This agency has experienced a zero nominal growth budget that may have impacted its governance capacity. We review the potential impact of the Helms-Biden legislation on WHO governance, and suggest that the governance of this important global health agency may benefit from its timely repeal.


Commentary
Mackey TK, Liang BA. Oncology and the Internet: Regulatory Failure and Reform. J Onc Prac. 2012;8(6);341-343

Abstract:
The oncology drug shortage is exacerbated by current policy and governance failures of Internet regulation, now being exploited by illicit online drug sellers targeting vulnerable patients and providers.


Debate
Mackey TK, Liang BA. Combating Healthcare Corruption and Fraud with Improved Global Health Governance. BMC Intl Health Hum Rights. 2012;12:23

Abstract:
Corruption is a serious threat to global health outcomes, leading to financial waste and adverse health consequences. Yet, forms of corruption impacting global health are endemic worldwide in public and private sectors, and in developed and resource-poor settings alike. Allegations of misuse of funds and fraud in global health initiatives also threaten future investment. Current domestic and sectorial-level responses are fragmented and have been criticized as ineffective. In order to address this issue, we propose a global health governance framework calling for international recognition of “global health corruption” and development of a treaty protocol to combat this crucial issue.


Commentary
Lovett KM, Liang BA, Mackey TK. Online Direct-to-Consumer Access to Insulin: Patient Safety Considerations and Reform. J Diab Sci Tech. 2012;6(6):1503-1506

Abstract:
The online, direct-to-consumer (DTC) medical marketplace is proliferating more rapidly than regulation is evolving to ensure proper patient safety and public health controls. Along with this growing body of unrestrained medical testing and pharmaceuticals offered DTC online, most types of insulin and insulin administration products may now be purchased without prescriptions or physician guidance. Given the relatively significant risks of insulin use, the abuse potential, the high prevalence of diabetes mellitus, and the rising population of uninsured and underinsured, it is imperative to reform the online DTC medical marketplace to ensure that patient safety and public health are protected.


Original Research

Abstract:
Objective
The threat of non-communicable diseases (“NCDs”) is increasingly becoming a global health crisis and are pervasive in high, middle, and low-income populations resulting in an estimated 36 million deaths per year. There is a need to assess intellectual property rights (“IPRs”) that may impede generic production and availability and affordability to essential NCD medicines.

Methods
Using the data sources listed below, the study design systematically eliminated NCD drugs that had no patent/exclusivity provisions on API, dosage, or administration route. The first step identified essential medicines that treat certain high disease burden NCDs. A second step examined the patent and exclusivity status of active ingredient, dosage and listed route of administration using exclusion criteria outlined in this study.

Materials
We examined the patent and exclusivity status of medicines listed in the World Health Organization’s (“WHO”) Model List of Essential Drugs (Medicines) (“MLEM”) and other WHO sources for drugs treating certain NCDs. i.e., cardiovascular and respiratory disease, cancers, and diabetes. We utilized the USA Food and Drug Administration Orange Book and the USA Patent and Trademark Office databases as references given the predominant number of medicines registered in the USA.

Results
Of the 359 MLEM medicines identified, 22% (79/359) address targeted NCDs. Of these 79, only eight required in-depth patent or exclusivity assessment. Upon further review, no NCD MLEM medicines had study patent or exclusivity protection for reviewed criteria.

Conclusions
We find that ensuring availability and affordability of potential generic formulations of NCD MLEM medicines appears to be more complex than the presence of IPRs with API, dosage, or administration patent or exclusivity protection. Hence, more sophisticated analysis of NCD barriers to generic availability and affordability should be conducted in order to ensure equitable access to global populations for these essential medicines.


Review
Mackey TK, Liang BA. Threats from Emerging and Re-emerging Neglected Tropical Diseases. Infec Ecol Epi. 2012;2(1):18667 

Abstract:
Background
Neglected tropical diseases impact over 1 billion of the world's poorest populations and require special attention. However, within the NTDs recognized by the World Health Organization, some are also dually categorized as emerging and re-emerging infectious diseases requiring more detailed examination on potential global health risks.

Methods
We reviewed the 17 NTDs classified by the WHO to determine if those NTDs were also categorized by the US Centers for Disease Control and Prevention as emerging and re-emerging infectious diseases (‘‘EReNTDs’’). We then identified common characteristics and risks associated with EReNTDs.

Results
Identified EReNTDs of dengue, rabies, Chagas Disease, and cysticercosis disproportionately impact resource-poor settings with poor social determinants of health, spread through globalization, are impacted by vector control, lack available treatments, and threaten global health security. This traditionally neglected subset of diseases requires urgent attention and unique incentive structures to encourage investment in innovation and coordination.

Discussion
Multi-sectorial efforts and targeted public–private partnerships would spur needed R&D for effective and accessible EReNTD treatments, improvement of social determinants of health, crucial low-income country development, and health system strengthening efforts. Utilization of One Health principles is essential for enhancing knowledge to efficaciously address public health aspects of these EReNTDs globally.


Commentary

Abstract:
The appropriate role of innovation and intellectual property (IP) in global public health is a controversial issue. Discussion is one-sided, with potential benefits advocated by industry in stark contrast to condemnation by certain civil society players. WHO's Public Health, Innovation and Intellectual Property Department (PHI) was established to address healthcare resource need for developing countries, assess impact of innovation and IP on access to medicines, explore innovative funding mechanisms for R&D and provide evidence-based policy-making recommendations in response to the changing global health landscape. Importantly, PHI could represent a potential forum to bridge shared, yet often diverse, interests and opportunities between various public and private stakeholders, a crucial issue for ensuring the future viability of WHO.


Original Research
Liang BA, Mackey TK, Lovett KM. Suspect Online Sellers and Contraceptive Access. Contraception. 2012;86(5):551-556

Abstract:
Study Design
We assessed online availability of reversible, prescription contraceptive methods resulting in < 10 undesired pregnancies/year, i.e., Depo-Provera shot; oral contraceptives; NuvaRing; Ortho Evra patch; Paragard and Mirena IUDs; and Implanon/Nexplanon implants. Using Google search “buy ITEM no prescription,” we reviewed the first five result pages for “no prescription” vendors. Searches were conducted 1/3/2012–2/20/2012.

Results
All contraceptives were available as “no prescription” products. Furthermore, IUDs were advertised as “over-the-counter” and YouTube videos provided “how to” videos, including a cartoon version. We also found that illicit online pharmacy marketing is shifting from direct search engine access to social media (Facebook, Twitter, Slidehare, flickr).

Conclusion
Online contraceptive sales represent patient safety risks and a parallel system of high-risk product access absent professional guidance. Providers should educate patients, while policy makers employ legal strategies to address these systemic risks.


Article
Liang BA, Mackey TK, Lovett KM. Emerging Dangers from Direct Botulinum Access and Use. J Homeland Sec Emerg Manag. 2012;9(1):art.9

Abstract:
Botulinum toxin (BTX-A) is the most deadly substance known. Yet it has clinical applications, particularly cosmetic uses. With the latter’s exploding popularity, unauthorized BTX-A is emerging from suspect sources. In combination with the Internet as a virtually unregulated marketplace, BTX-A is available for direct purchase and use. This represents a safety threat against individuals and civil society. Since extant technology and Internet marketing can easily target individual consumers by changing BTX-A concentration and pose risks for society by scaling up production for terrorist purposes, BTX-A availability is a homeland security threat. To address this, BTX-A should be deemed a controlled substance subjecting it to track-and-trace and other requirements. Simultaneously, this categorization would subject it to federal law requiring Drug Enforcement Agency registration and state licensure for sales. This relatively simple step can be a strategy adopted for other high risk materials and an international approach to limit the availability of potentially harmful materials.


Article

Abstract:
Global public health is threatened by an imbalance in health worker migration from resource-poor countries to developed countries. This "brain drain" results in health workforce shortages, health system weakening, and economic loss and waste, threatening the well-being of vulnerable populations and effectiveness of global health interventions. Current structural imbalances in resource allocation and global incentive structures have resulted in 57 countries identified by WHO as having a "critical shortage" of health workers. Yet current efforts to strengthen domestic health systems have fallen short in addressing this issue. Instead, global solutions should focus on sustainable forms of equitable resource sharing. This can be accomplished by adoption of mandatory global resource and staff-sharing programs in conjunction with implementation of state-based health services corps.


Original Research
Lovett KM, Mackey TK, Liang BA. Evaluating the evidence: direct-to-consumer screening tests advertised online. J Med Screen. 2012;19:141–153

Abstract:
Objectives
Unsupervised online direct-to-consumer (DTC) access to medical services has rapidly expanded to medical screening tests, which have not been critically evaluated for their evidence basis. The objective of this study is to identify the scope of online-advertised DTC screening tests, outline the evidence for use of available DTC testing and suggest regulatory reform to address the relevant issues.

Methods
An observational study of website advertisements, testing services and counselling/follow-up services for DTC testing was conducted. Data were collected from websites between 4 April and 1 June 2011. Each website was assessed for tests offered, advertised indications and availability of counselling/follow-up services. Advertised testing indications were compared with US Preventive Services Task Force recommendations and/or specialty guidelines and categorized as Supported, Against, Insufficient Evidence or No Guidance.

Results
Of 20 companies identified as offering DTC screening tests, 95% (19/20) do not clearly offer pretest counselling, post-test counselling and/or test follow-up. One hundred and twenty-seven different tests were identified. Only 19/127 (15%) could be Supported for screening in a target group selected for testing; 38/127 (30%) were given recommendations to avoid use in specific target group(s) selected for testing (‘Against recommendations’); 29/127 (23%) had Insufficient Evidence of value, and for 64/127 (50%) No Guidance could be given. Only 4/127 (3%) tests were Supported for general screening use.

Conclusions
Virtually all identified medical tests advertised and offered DTC are not recommended for use in screening by evidence-based guidelines. Limited oversight may lead to inaccurate self-diagnosis, treatment and wasted health resources.


Article

Abstract:
Biosimilars, also known as follow on biologics, are complex biotechnology drugs that are similar, but not identical, to original biologic drug forms, and represent potential lower cost versions that may improve access. Yet biologics and their biosimilar forms have a key safety concern: unwanted immunogenicity. Emerging markets have tremendous interest in biosimilars, but are at a tipping point: they are moving from developing country concerns (e.g., communicable disease) to developed country needs (e.g., cancer therapies) that require biologic drugs. Production, however, is at lower than current Good Manufacturing Practice levels standard in highlyregulated markets. Emerging market public-private partnerships between public agencies, local producers, and global pharmaceutical !rms, can incentivize biosimilar production at higher quality levels than required for local markets as well as position themselves for entry into developed markets.


Article

Abstract:
Pharmaceutical marketing has rapidly evolved over the past century and has now entered the digital revolution. This is exempli!ed by the rise of direct-to-consumer-advertising (“DTCA”), which has traditionally been only allowed in the United States and New Zealand in developed countries, but is now expanding in reach to other jurisdictions. Enabling the “globalization” of pharmaceutical DTCA is Internet-related technologies that are not limited to geographical borders and are highly unregulated. This DTCA digital “spillover” into markets that prohibit it can have adverse impact on health outcomes and health-related spending. Emerging markets may represent the next logical step for digital DTCA proliferation, given their untapped market potential and explosive growth. Further research and global health policy reform is necessary to address this “emerging” global health issue.


Article

Abstract:
China is the largest emerging market in the world. It is also on the front lines of health diplomacy, where the tools of diplomatic statecraft are being employed by public health professions of both the US and China to help improve the practice of public health. This article examines the US Department of Health and Human Services’ (HHS) and the US Centers for Control and Prevention (US CDC) in China, describes critical features of the Chinese health system, presents two examples of US-China collaborations, and describes common management mechanisms and strategies supporting both. This examination will help inform other global health collaborations between the US and China as well as lessons for supporting global health collaborations in other middle income countries.


Editorial
Liang BA, Mackey TK. Sexual Medicine: Online Risks to Health-The Problem of Counterfeit Drugs. Nature Rev Urol. 2012;9:480-482 

Abstract not available.


Commentary
Liang BA, Mackey TK. Stem Cells, Dot-Com. Sci Trans Med. 2012;4(151):151cm9

Abstract not available.


Editorial

Abstract not available.


Editorial
Mackey TK, Liang BA. Global Health Policy Coordination to Address Neglected Tropical Diseases. Trop Med Inter Health 2012;17(9):1053-1056

Abstract not available.


Review
Mackey TK, Liang BA. Transparency in Physician-Industry Relationships: State and Federal Efforts. Path Case Rev. 2012;17(4):144-147

Abstract:
The rise of pharmaceutical marketing has had a lasting impact on the provisioning of health care in the United States. Industry promotional expenditures have largely been targeted at influencing physicians through various forms of payment, resulting in physician-industry conflicts of interests with potential negative consequences. These conflicts have led to state efforts to increase transparency and require disclosure of payments made to physicians as well as other efforts. However, limitations of these state-based initiatives have led to the passage of national physician payment disclosure provisions in the recently enacted and upheld health care reform act. Yet, the future viability and potential impact of these laws remain in question. A fundamental shift away from industry marketing to physicians toward health care consumerism and an emphasis on direct-to-consumer advertising may significantly limit their impact. State and Federal policymaking efforts should be combined to address these challenges and more dynamically promote patient care.


Commentary

Abstract not available.


Commentary

Abstract not available.


Commentary
Lovett KM, Liang BA, Mackey TK. Risks of Online Direct-to-Consumer Tumor Markers for Cancer Screening. J Clin. Onc. 2012;30(13):1411-1414

Abstract not available.


Editorial

Abstract not available.


Correspondence

Abstract not available.


Commentary
Mackey TK, Liang BA, Lovett KM. Waking Up to the Risks of Online Direct-to-Consumer Advertising of Sleep Apnea Screening Tests. J Clin Sleep Med. 2012;8(1):5-6

Abstract not available.


Original Research

Abstract:
Background
Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online.

Objective
To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks.

Methods
We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs.

Results
Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list.

Conclusions
FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing.


Editorial
Liang BA, Lovett KM, Mackey, TK. Elder Abuse. J Am Geriatr Soc. 2012;60:398–400. doi: 10.1111/j.1532-5415.2011.03798.x

Abstract not available.


Article
Mackey TK, Liang BA. Lessons from SARS and 2009 H1N1 influenza: Employing a WHO-WTO Forum to Promote Optimal Economic-Public Health Pandemic Response. J Pub Health Policy 2012;33(1):119-131 doi:10.1057/jphp.2011.51 [accompanied by editorial commentary]

Abstract:
No formal system exists to review trade restrictions imposed during international public health emergencies rapidly. Failure to put one in place creates disincentives for surveillance and reporting, thereby undermining protection efforts. The 2003 SARS outbreak exposed weaknesses in global governance that caused uncoordinated public health and economic responses. New International Health Regulations (IHR), applied first during the 2009 H1N1 influenza outbreak, demonstrated improvement. Yet they failed to allow for management of public health emergencies in a way that balanced threats to health and those to economies and trade. Establishment of a joint WHO–WTO committee to adjudicate these conflicts might better achieve that balance.


Short Report
Liang BA, Mackey TK. Vaccine Shortages and Suspect Online Pharmacy Sellers. Vaccine. 2012;30(2):103-105

Abstract:
Vaccines represent half the products on the FDA Biologics Product Shortages list. As a result, providers and patients may purchase them online, a process rife with patient safety risks. We examined vaccine online availability by assessing up to 5 identified online sellers. We determined if sites were accredited by the National Association of Boards of Pharmacy (NABP) VIPPS program, listed as US or international, employed social media linking to suspect online pharmacies, and if they were on the NABP Not Recommended list. All vaccines were advertised by online pharmacies and through data aggregation and social media sites, none were VIPPS-accredited, and most were on the NABP Not Recommended list. We found some online sellers advertising vaccines as over-the-counter. We extended our analysis to WHO Essential Medicines List vaccines and found all are also available online from suspect, non-VIPPS accredited sellers. Stakeholders should be aware of these online patient safety dangers.


2011

Topics covered: health ethics; health policy; biologics; pharmaceutical promotion; pharmaceutical policy; healthcare reform; fake medicines; social media; online pharmacies; medical malpractice

  • Number of Publications: 10
Original Research
Law Review
Commentary
Article
Article
Liang BA, Mackey TK, Lovett, KM. eHealth Ethics: The Online Medical Marketplace and Emerging Ethical Issues. Ethics Biol Eng Med. 2011;2(3):253-265

Abstract:
The history of medical ethics has been marked by responses to novel challenges faced by the medical, clinical, and legal communities. These challenges have arisen from innovative treatment methods, scientific progress, and new technologies that continually pose new questions about how we frame and apply medical and clinical ethics. These questions have recently given rise to the burgeoning field of "eHealth Ethics," which attempts to evaluate the impact of digital technologies on health services and outcomes. Yet this area of study has failed to address many current challenges in the eHealth Marketplace, including direct-to-consumer advertising and the sale of medical products online. These digital interactions give rise to a number of issues that impact healthcare providers and patients, as well as businesses that require ethical scrutiny. In this article, we identify some of these emerging relationships and the problems they pose for patient safety and public health, and we suggest potential solutions to mitigate these developments. This dynamic area of medical ethics needs greater attention and coordination among various stakeholders and should continually evolve with changes in the digital environment.


Commentary
Liang BA, Mackey TK. Emerging Patient Safety Issues Under Healthcare Reform: Follow On Biologics and Immunogenicity. Ther Clin Risk Manag. 2011;7:483-489

Abstract not available.


Law Review
Mackey TK, Liang BA. Off Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access and Limiting Inappropriate Pharmaceutical Marketing. Univ Mich J Law Reform. 2011; 45(1):1-54

Abstract:
Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire consequences for patient safety and the prevention of healthcare fraud and abuse. Worse still, because of these policies, vulnerable disease patients and their physicians are often unaware of appropriate off-label treatments, and the lack of information places these patients at risk. To address these concerns, we propose the creation of a targeted and regulated off-label promotion system that enables vulnerable patient populations to access life-saving treatments and simultaneously creates clear incentives to avoid inappropriate off-label promotion. This federal legislation would create FDA-targeted exemptions of off-label prohibitions for vulnerable patient populations, if certain requirements of enrollment, risk management, and pharmacovigilance are met. Any proposed off-label promotion would also be pre-reviewed by the FDA to ensure that the program was safe and properly monitored. To create incentives for appropriate off-label marketing and avoid the problem of repeat corporate offenders, additional penalties would be available without preempting other causes of action. This system of carrots and sticks would increase drug access for vulnerable patient populations while discouraging illegal marketing that could threaten patient safety and public health.


Article
Liang BA, Mackey TK. Quality and Safety in Health Care: What Does What the Future Hold? Arch Path Lab Med. 2011;135:1425-1431

Abstract:
Context
The rapid changes in health care policy, embracing quality and safety mandates, have culminated in programs and initiatives under the Patient Protection and Affordable Care Act.

Objective
To review the context of, and anticipated quality and patient safety mandates for, delivery systems, incentives under health care reform, and models for future accountability for outcomes of care.

Design
Assessment of the provisions of Patient Protection and Affordable Care Act, other reform efforts, and reform initiatives focusing on future quality and safety provisions for health care providers.

Results
Health care reform and other efforts focus on consumerism in the context of price. Quality and safety efforts will be structured using financial incentives, best-practices research, and new delivery models that focus on reaching benchmarks while reducing costs. In addition, patient experience will be a key component of reimbursement, and a move toward “retail” approaches directed at the individual patient may supplant traditional “wholesale” efforts at attracting employers.

Conclusions
Quality and safety have always been of prime importance in medicine. However, in the future, under health care reform and associated initiatives, a shift in the paradigm of medicine will integrate quality and safety measurement with financial incentives and a new emphasis on consumerism.


Commentary
Mackey TK, Liang BA. The Global Counterfeit Drug Trade: Patient Safety and Public Health Risks. J Pharm Sci. 2011;100(11):4571-4579

Abstract not available.


Original Research

Abstract:
Background
Direct-to-consumer advertising (DTCA), linked to inappropriate medication use and higher health care expenditures, is the fastest growing form of pharmaceutical marketing. DTCA is legal only in the United States and New Zealand. However, the advent of online interactive social media “Web 2.0” technologies—that is, eDTCA 2.0—may circumvent DTCA legal proscriptions.

Objective
The purpose of this study was to assess the prevalence of DTCA of leading pharmaceutical company presence and drug product marketing in online interactive social media technologies (eDTCA 2.0).

Methods
We conducted a descriptive study of the prevalence of eDTCA 2.0 marketing in the top 10 global pharmaceutical corporations and 10 highest grossing drugs of 2009.

Results
All pharmaceutical companies reviewed (10/10, 100%) have a presence in eDTCA 2.0 on Facebook, Twitter/Friendster, sponsored blogs, and really simple syndication (RSS) feeds. In addition, 80% (8/10) have dedicated YouTube channels, and 80% (8/10) developed health care communication-related mobile applications. For reviewed drugs, 90% (9/10) have dedicated websites, 70% (7/10) have dedicated Facebook pages, 90% (9/10) have health communications-related Twitter and Friendster traffic, and 80% (8/10) have DTCA television advertisements on YouTube. We also found 90% (9/10) of these drugs had a non-corporate eDTCA 2.0 marketing presence by illegal online drug sellers.

Conclusion
Pharmaceutical companies use eDTCA 2.0 to market themselves and their top-selling drugs. eDTCA 2.0 is also used by illicit online drug sellers. Regulators worldwide must take into account the current eDTCA 2.0 presence when attempting to reach policy and safety goals.


Article

Abstract:
Illicit online pharmacies selling counterfeit drugs in a global virtual marketplace remain a critical problem in global health. Yet they continue to operate with little regulation while growing numbers of consumers access the Internet for health information that may lead them to purchase dangerous drugs online. This global social problem requires immediate action to protect patient safety and public health. Public – private partnerships models represent a potentially effective way to address this issue through promoting mechanisms of collaboration and coordination of multiple stakeholders.


Commentary
Liang BA, Mackey TK. Reforming Direct-to-Consumer Advertising. Nature Biotech. 2011; 29(5):397-400

Abstract not available.


Commentary

Abstract not available.


Commentary
Mackey TK, Liang BA. The Role of Practice Guidelines in Medical Malpractice Litigation. AMA Journal of Ethics (formerly Virtual Mentor). 2011;13(1):36-41

Abstract not available.


2010

Topics covered: conflicts of interest; pharmaceutical policy; rare diseases; health policy

  • Number of Publications: 4
Law Review
Policy Forum
Commentary
Author Reply
Commentary
Liang BA, Mackey TK. Addressing Institutional Conflict of Interest to Promote Patient Safety. Pat Safety Qual Healthcare. 2010;7(6):36-39

Abstract not available.


Law Review

Abstract:
Individual conflicts of interest are rife in healthcare, and substantial attention has been given to address them. Yet a more substantive concern-institutional conflicts of interest (“ICOIs”) in academic medical centers (“AMCs”) engaged in research and clinical care—have yet to garner sufficient attention, despite their higher stakes for patient safety and welfare. ICOIs are standard in AMCs, are virtually unregulated, and have led to patient deaths. Upon review of ICOIs, we find a clear absence of substantive efforts to confront these conflicts. We also assess the Jesse Gelsinger case, which resulted in the death of a study participant exemplifying a deep-seated culture of institutional indifference and complicity in unmanaged conflicts. Federal policy, particularly the Bayh-Dole Act, also creates and promotes ICOIs. Efforts to address ICOIs are narrow or abstract, and do not provide for a systemic infrastructure with effective enforcement mechanisms. Hence, in this paper, we provide a comprehensive proposal to address ICOIs utilizing a “Centralized System” model that would proactively review, manage, approve, and conduct assessments of conflicts, and would have independent power to evaluate and enforce any violations via sanctions. It would also manage any industry funds and pharmaceutical samples and be a condition of participation in public healthcare reimbursement and federal grant funding.

The ICOI policy itself would provide for disclosure requirements, separate management of commercial enterprise units from academic units, voluntary remediation of conflicts, and education on ICOIs. Finally, we propose a new model of medical education—academic detailing—in place of current marketing-focused “education.” Using such a system, AMCs can wean themselves from industry reliance and promote a culture of accountability and independence from industry influence. By doing so, clinical research and treatment can return to a focus on patient care, not profits.


Author Reply
Liang BA, Mackey TK. Consent Contraindicated? In Reply. Science.2010;328(5974):45

Abstract not available.


Policy Forum
Liang BA, Mackey TK. Reforming Off-Label Promotion to Enhance Orphan Disease Treatment. Science. 2010; 327(5963):273-274

Abstract not available.


2009

Topics covered: online pharmacies; digital health; health policy; environmental policy

  • Number of Publications: 3
Law Review
Commentary
Author Reply
Commentary
Mackey TK, Liang BA. Incentivizing “Green” Technology Transfer to Developing Countries. J Biolaw Bus. 2009;12(4): 11-14

Abstract not available.


Author Reply
Liang BA, Mackey TK. Searching for Safety: A Reply to Cooperman and Levitt. Am J Law Med. 2009;35(4):687-694

Abstract not available.


Law Review

Abstract:
Online sales of pharmaceuticals are a rapidly growing phenomenon. Yet despite the dangers of purchasing drugs over the Internet, sales continue to escalate. These dangers include patient harm from fake or tainted drugs, lack of clinical oversight, and financial loss. Patients, and in particular vulnerable groups such as seniors and minorities, purchase drugs online either naïvely or because they lack the ability to access medications from other sources due to price considerations. Unfortunately, high risk online drug sources dominate the Internet, and virtually no accountability exists to ensure safety of purchased products. Importantly, search engines such as Google, Yahoo, and MSN, although purportedly requiring “verification” of Internet drug sellers using PharmacyChecker.com requirements, actually allow and profit from illicit drug sales from unverified websites. These search engines are not held accountable for facilitating clearly illegal activities. Both website drug seller anonymity and unethical physicians approving or writing prescriptions without seeing the patient contribute to rampant illegal online drug sales. Efforts in this country and around the world to stem the tide of these sales have had extremely limited effectiveness. Unfortunately, current congressional proposals are fractionated and do not address the key issues of demand by vulnerable patient populations, search engine accountability, and the ease with which financial transactions can be consummated to promote illegal online sales. To deal with the social scourge of illicit online drug sales, this article proposes a comprehensive statutory solution that creates a nocost/low-cost national Drug Access Program to break the chain of demand from vulnerable patient populations and illicit online sellers, makes all Internet drug sales illegal unless the Internet pharmacy is licensed through national Internet pharmacy licensing program, prohibits financial transactions for illegal online drug sales, and establishes criminal penalties for all parties—including websites, search engines, and health care providers— who engage in and facilitate this harmful activity.

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