Mapping of Health Communication and Education Strategies Addressing the Public Health Dangers of Illicit Online Pharmacies.

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 on 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.

Emerging and reemerging neglected tropical diseases: a review of key characteristics, risk factors, and the policy and innovation environment.

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.

It's time to shine the light on direct-to-consumer advertising.

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.

The rise of digital direct-to-consumer advertising?: Comparison of direct-to-consumer advertising expenditure trends from publicly available data sources and global policy implications.

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.

A call for a moratorium on the .health generic top-level domain: preventing the commercialization and exclusive control of online health information.

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.

Health domains for sale: the need for global health Internet governance.

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.

Improving global health governance to combat counterfeit medicines: a proposal for a UNODC-WHO-Interpol trilateral mechanism.

BACKGROUND: 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.

Evolution of tobacco labeling and packaging: international legal considerations and health governance.

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.

Pharmaceutical digital marketing and governance: illicit actors and challenges to global patient safety and public health.

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.

Global reach of direct-to-consumer advertising using social media for illicit online drug sales.

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.

Digital social media, youth, and nonmedical use of prescription drugs: the need for reform.

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.

Assessing Characteristics and Compliance of Online Delta-8 Tetrahydrocannabinol Product Sellers.

Introduction: The debate over the legal status of many cannabis- and hemp-derived products, including delta-8 tetrahydrocannabinol (THC), is in question. Although low concentrations of delta-8 THC are legal at the Federal level, many states have implemented their own regulations to both allow and restrict its use and sale. Of concern, sellers with unknown legal credentials have appeared online and are actively selling this product. Materials and Methods: We characterized the marketing, sale, and compliance of online delta-8 THC sellers using (1) data collected from the Twitter Application Programming Interface with delta-8 THC-related keywords; (2) unsupervised topic modeling using the Biterm Topic Model to identify clusters of tweets involved in marketing and selling; (3) inductive coding to identify marketing and selling characteristics; and (4) web forensics and simulated shopping to determine compliance with state restrictions for delta-8 THC sales. Results: In total, 110 unique hyperlinks associated with 7085 tweets that included marketing and selling activity for delta-8 THC were collected. From these links, we conducted simulated purchasing in January 2021 to identify compliant and noncompliant websites. Among the vendors, age verification was not found in over half of websites (59, 53.63%); 60 (54.55%) did not report a physical address; and 74 (65.45%) sold delta-8 products direct-to-consumer. Sixty-seven (90.54%) of detected vendors shipped delta-8 products to addresses in states that prohibit sales. Forty-three (64.18%) of Internet Protocol addresses were located within the United States; all others were international. Conclusion: Our analysis suggests that online storefronts are illegally selling and shipping cannabinoid derivatives to U.S. consumers. Further research is needed to understand downstream health and regulatory impacts from this unregulated access.

Integrating biodiversity management and indigenous biopiracy protection to promote environmental justice and global health.

Many potentially useful medicines arise from developing countries' biodiverse environments and indigenous knowledge. However, global intellectual property rules have resulted in biopiracy, raising serious ethical concerns of environmental justice, exploitation, and health disparities in these populations. Furthermore, state-based approaches have not led to adequate biodiversity protection, management, or resource sharing, which affect access to lifesaving drugs. In response, country delegates adopted the Nagoya Protocol, which aims at promoting biodiversity management, combating biopiracy, and encouraging equitable benefits sharing with indigenous communities. However, the effectiveness of this framework in meeting these objectives remains in question. To address these challenges, we propose a policy building on the Nagoya Protocol that employs a World Health Organization-World Trade Organization Joint Committee on Bioprospecting and Biopiracy.

Combating healthcare corruption and fraud with improved global health governance.

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.

Online availability and safety of drugs in shortage: a descriptive study of internet vendor characteristics.

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.

Deficiencies of the FDA in evaluating generic formulations: addressing narrow therapeutic index drugs.

Generic drugs represent a significant portion of the medical arsenal in treating disease. As copies of originator drugs, these drugs have been permitted abbreviated approval under the Hatch-Waxman Act. Yet with the current cost focus upon generic formulations, potential safety issues with generics have arisen. Although there is an established criterion of "bioequivalence" that generic formulations must demonstrate, narrow-therapeutic index drugs for sensitive clinical circumstances such as epilepsy, antiplatelet therapies, and mental health treatments may require different regulatory treatment than other generic drugs. Further, in these circumstances, differences in generic formulations may lead to adverse clinical outcomes due to less stringent bioequivalence tolerances. Yet there is no mandate for comparison between different generic formulations. Countries outside the United States advocate for narrowing tolerance ranges for these high risk health situations and the drugs for their treatment. We argue in this paper that additional patient safety matters must be taken into account for narrow therapeutic disease drugs, and regulatory bodies should emphasize greater tightness in bioequivalence before these narrow-therapeutic drug generic formulations are approved.

Prevalence and Global Health implications of social media in direct-to-consumer drug advertising.

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.

Confronting conflict: addressing institutional conflicts of interest in academic medical centers.

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.