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Surveillance of U.S. Corporate Filings Provides a Proactive Approach to Inform Tobacco Regulatory Research Strategy

ABSTRACT: The popularity of electronic cigarettes in the United States and around the world has led to a startling rise in youth nicotine use. The Juul® e-cigarette was introduced in the U.S. market in 2015 and had captured approximately 13% of the U.S. market by 2017. Unlike many other contemporary electronic cigarette companies, the founders behind the Juul® e-cigarette approached their product launch like a traditional high-tech start-up company, not like a tobacco company. This article presents a case study of Juul’s corporate and product development history in the context of US regulatory actions. The objective of this article is to demonstrate the value of government-curated archives as leading indicators which can (a) provide insight into emergent technologies and (b) inform emergent regulatory science research questions. A variety of sources were used to gather data about the Juul® e-cigarette and the corporations that surround it. Sources included government agencies, published academic literature, non-profit organizations, corporate and retail websites, and the popular press. Data were disambiguated, authenticated, and categorized prior to being placed on a timeline of events. A timeline of four significant milestones, nineteen corporate filings and events, twelve US regulatory actions, sixty-four patent applications, eighty-seven trademark applications, twenty-three design patents and thirty-two utility patents related to Juul Labs and its associates is presented, spanning the years 2004 through 2020. This work demonstrates the probative value of findings from patent, trademark, and SEC filing literature in establishing a premise for emergent regulatory science research questions which may not yet be supported by traditional archival research literature. The methods presented here can be used to identify key aspects of emerging technologies before products actually enter the market; this shifting policy formulation and problem identification from a paradigm of being reactive in favor of becoming proactive. Such a proactive approach may permit anticipatory regulatory science research and ultimately shorten the elapsed time between market technology innovation and regulatory response.

SUBMITTER: Sarles S

PROVIDER: S-EPMC8002354 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Population-based strategies can expand the reach of tobacco cessation treatment beyond clinical encounters. OBJECTIVE:To determine the effect of two population-based tobacco cessation strategies, compared with usual care, on providing tobacco treatment outside of clinical encounters. DESIGN:3-arm pragmatic randomized controlled trial. PARTICIPANTS:Current smokers ??18 years old with a primary care provider at one of five community health centers in Massachusetts were identified via the electronic health record (n?=?5225) and recruited using automated phone calls. INTERVENTIONS:One intervention group involved engagement with a health system-based tobacco coach (internal care coordination), and the other connected patients to a national quitline (external community referral). MEASUREMENTS:Proportion of smokers with documentation of any evidence-based cessation treatment in the 6 months after enrollment. KEY RESULTS:Of 639 individuals who responded to the proactive treatment offer, 233 consented and were randomized 1:1:1 to study arm. At 6-month follow-up, the pooled intervention group, compared with usual care, had higher documentation of any smoking cessation treatment (63% vs. 34%, p?<?0.001), cessation medication prescription (52% vs. 30%, p?=?0.002), and counseling (47% vs. 9%, p?<?0.001). Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p?=?0.001) and at providing cessation medication (66% vs. 39%, p?<?0.001), but comparable at linking smokers to cessation counseling resources. CONCLUSIONS:Smokers responding to a population-based, proactive outreach strategy had better provision of tobacco cessation treatment when referred to either a health system-based or community-based program compared with usual care. The health system-based strategy outperformed the quitline-based one in several measures. Future work should aim to improve population reach and test the effect on smoking cessation rates. TRIAL REGISTRATION:ClinicalTrials.gov NCT03612895.

Project description:In this paper, we present the design and implementation of the integrated proactive surveillance system for prostate cancer (PASS-PC). The integrated PASS-PC is a multi-institutional web-based system aimed at collecting a variety of data on prostate cancer patients in a standardized and efficient way. The integrated PASS-PC was commissioned by the Prostate Cancer Foundation (PCF) and built through the joint of efforts by a group of experts in medical oncology, genetics, pathology, nutrition, and cancer research informatics. Their main goal is facilitating the efficient and uniform collection of critical demographic, lifestyle, nutritional, dietary and clinical information to be used in developing new strategies in diagnosing, preventing and treating prostate cancer.The integrated PASS-PC is designed based on common industry standards - a three tiered architecture and a Service- Oriented Architecture (SOA). It utilizes open source software and programming languages such as HTML, PHP, CSS, JQuery, Drupal and MySQL. We also use a commercial database management system - Oracle 11g. The integrated PASS-PC project uses a "confederation model" that encourages participation of any interested center, irrespective of its size or location. The integrated PASS-PC utilizes a standardized approach to data collection and reporting, and uses extensive validation procedures to prevent entering erroneous data. The integrated PASS-PC controlled vocabulary is harmonized with the National Cancer Institute (NCI) Thesaurus. Currently, two cancer centers in the USA are participating in the integrated PASS-PC project.THE FINAL SYSTEM HAS THREE MAIN COMPONENTS: 1. National Prostate Surveillance Network (NPSN) website; 2. NPSN myConnect portal; 3. Proactive Surveillance System for Prostate Cancer (PASS-PC). PASS-PC is a cancer Biomedical Informatics Grid (caBIG) compatible product. The integrated PASS-PC provides a foundation for collaborative prostate cancer research. It has been built to meet the short term goal of gathering prostate cancer related data, but also with the prerequisites in place for future evolution into a cancer research informatics platform. In the future this will be vital for successful prostate cancer studies, care and treatment.

Project description:BackgroundSuccessful reduction of malaria transmission to very low levels has made Isabel Province, Solomon Islands, a target for early elimination by 2014. High malaria transmission in neighbouring provinces and the potential for local asymptomatic infections to cause malaria resurgence highlights the need for sub-national tailoring of surveillance interventions. This study contributes to a situational analysis of malaria in Isabel Province to inform an appropriate surveillance intervention.MethodsA mixed method study was carried out in Isabel Province in late 2009 and early 2010. The quantitative component was a population-based prevalence survey of 8,554 people from 129 villages, which were selected using a spatially stratified sampling approach to achieve uniform geographical coverage of populated areas. Diagnosis was initially based on Giemsa-stained blood slides followed by molecular analysis using polymerase chain reaction (PCR). Local perceptions and practices related to management of fever and treatment-seeking that would impact a surveillance intervention were also explored using qualitative research methods.ResultsApproximately 33% (8,554/26,221) of the population of Isabel Province participated in the survey. Only one subject was found to be infected with Plasmodium falciparum (Pf) (96 parasites/?L) using Giemsa-stained blood films, giving a prevalence of 0.01%. PCR analysis detected a further 13 cases, giving an estimated malaria prevalence of 0.51%. There was a wide geographical distribution of infected subjects. None reported having travelled outside Isabel Province in the previous three months suggesting low-level indigenous malaria transmission. The qualitative findings provide warning signs that the current community vigilance approach to surveillance will not be sufficient to achieve elimination. In addition, fever severity is being used by individuals as an indicator for malaria and a trigger for timely treatment-seeking and case reporting. In light of the finding of a low prevalence of parasitaemia, the current surveillance system may not be able to detect and prevent malaria resurgence.ConclusionAn adaption to the malERA surveillance framework is proposed and recommendations made for a tailored provincial-level surveillance intervention, which will be essential to achieve elimination, and to maintain this status while the rest of the country catches up.

Project description:BackgroundUtilization of spatial statistics and Geographic Information Systems (GIS) technologies remain underrepresented in the community-engagement literature, despite its potential role in informing community outreach efforts and in identifying populations enthusiastic to participate in biomedical and health research. Such techniques are capable not only of examining the epidemiological relationship between the environment and a disease, but can also focus limited resources and strategically inform where on the landscape outreach efforts may be optimized.MethodsThese analyses present several spatial statistical techniques among the HealthStreet population, a community-engaged organization with aims to link underrepresented populations to medical and social care as well as opportunities to participate in University-sponsored research. Local Indicators of Spatial Association (LISA) and Getis-Ord Gi*(d) statistics are utilized to examine where cancer-related "hot spots" exist among minority and non-minority HealthStreet respondents within Alachua County, Florida, United States (US). Interest in research is also reported, by minority status and lifetime history of cancer.ResultsOverall, spatial clustering of cancer was observed to vary by minority status, suggesting disparities may exist among minorities and non-minorities in regards to where cancer is occurring. Specifically, significant hot spots of cancer were observed among non-minorities in more urban areas throughout Alachua County, Florida, US while more rural clusters were observed among minority members, specifically west and southwest of urban city limits.ConclusionsThese results may help focus future outreach efforts to include underrepresented populations in health research, as well as focus preventative and palliative oncological care. Further, global community engaged studies and community outreach efforts outside of the United States may use similar methods to focus limited resources and recruit underrepresented populations into health research.

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Surveillance of U.S. Corporate Filings Provides a Proactive Approach to Inform Tobacco Regulatory Research Strategy

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