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.

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.

Illicit Internet availability of drugs subject to recall and patient safety consequences.

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.

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.

Counterfeit drug penetration into global legitimate medicine supply chains: a global assessment.

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.

After counterfeit Avastin®--what have we learned and what can be done?

Three years have passed since the FDA announced that it had detected counterfeit versions of the injectable anticancer drug bevacizumab (Avastin(®), Genentech, USA) in the US drug-supply chain. Following this discovery, almost 1,000 FDA warning letters were sent to physicians and medical practices in 48 different states and two US territories, as more batches of counterfeit Avastin were uncovered. In response, criminal prosecutions have been pursued against certain distributors and clinicians, and other individuals who trafficked, sold, purchased, and/or administered an unsafe and ineffective treatment while also defrauding the government. Although limited and targeted legal action has been taken, patients potentially affected by this seminal patient safety event have not been appropriately identified. Hence, despite the clear and documented patient-safety and public-health risks posed by the transnational criminal trade in counterfeit medicines, the case study of counterfeit bevacizumab detection in the USA demonstrates the continued lack of information, knowledge, and solutions that would be necessary to protect those who are most affected--the patients. In response, we call for greater investment in multisector, multistakeholder strategies to enhance surveillance for counterfeit medicines and enable improvements in communication of risk information, to better protect patients with cancer.

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.

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.

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.

Pathology and medical malpractice. Academic and trainee empirical review of cases by State of Texas physicians.

OBJECTIVES: This study examines whether the assumptions that pathologists understand the medical malpractice negligence rule and have a clear single standard of care are reasonable. METHODS: Two hundred eighty-one Texas academic pathologists and trainees were presented 10 actual pathology malpractice cases from publicly available sources, representing the tort system's signal. RESULTS: Of the respondents, 55.52% were trainees, and 44.48% were pathology faculty. Only in two cases did more than 50% of respondents correctly identify the behavior of pathologists as defined by legal outcomes. In only half of the cases did more than 50% of pathologists concur with the jury verdict. CONCLUSIONS: This study provides further evidence that physicians do not understand the legal rule of negligence. Pathologists have a poor understanding of negligence and cannot accurately predict a jury verdict. There is significant divergence from the single standard of care assumption. Alternative methods to provide appropriate compensation and to establish physician accountability should be explored. Additional education about medical negligence is needed.

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.

Prescription drug coupons: evolution and need for regulation in direct-to-consumer advertising.

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.

The Minamata Convention on Mercury: attempting to address the global controversy of dental amalgam use and mercury waste disposal.

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.

Policy review: Japan-Philippines Economic Partnership Agreement (JPEPA)--analysis of a failed nurse migration policy.

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.