Lessons from Theranos - Restructuring Biomedical Innovation.

After raising more than $700 million, Elizabeth Holmes, the founder and chief executive officer of a healthcare startup once valued at $10 billion, was found guilty on four charges of defrauding investors. Founded in 2003, Theranos Inc. was a privately held corporation that aimed to disrupt the diagnostics industry with rapid, direct-to-consumer laboratory testing using only "a drop of blood" and the company's patented Nanotainer technology. By exploiting gaps in regulatory policy, Theranos brought its panel of laboratory tests to patients without pre-market review or validation from peer-reviewed scientific research. Investigations into Theranos' dubious operations and inaccurate test results exposed the failed venture which had squandered millions of dollars. Theranos affected the lives and health of patients further disrupting an already tenuous relationship between healthcare and the public - the importance of which cannot be understated in the setting of the COVID-19 pandemic. As medical systems address a national public health crisis and pervasive structural inequities, we must align stakeholder incentives between industry and academic biomedical innovation to rebuild trust with our patients.

Incidence of fraud and adulterations in ASEAN food/feed exports: A 20-year analysis of RASFF's notifications.

This paper explored the occurrence of food fraud and adulterations (FFA) in exports from the Association of South- East Asia Nations (ASEAN), with implications on food chain and international trade. Data from European Union Rapid Alert System for Food and Feed (EU RASFF) about FFA notifications on ASEAN exports for a period of 20 years (2000-2020) were extracted and analyzed. Results from this study revealed that of all ten ASEAN member countries, seven had cases of FFA notified in the database with Thailand (n = 47, 32%) and the Philippines (n = 37, 26%) receiving the highest frequency of notifications in the region. There was a statistical significance difference in frequency of notifications received on products from these seven countries with herbs and spices ranking highest (n = 22, 15%). Highest notifications of FFA on ASEAN exports came from the United Kingdom (n = 31, 21%). All the seven countries experienced border rejections and consequent destruction of food products especially on exports from Indonesia where 95% of product with FFA were border rejected. Border rejections on products from these countries were significantly different. Therefore, a thorough implementation system, appropriate testing and constantly updating each country's FFA database could aid actions in curtailing future events.

A retrospective look at the predictions and recommendations from the 2009 AMIA policy meeting: did we see EHR-related clinician burnout coming?

Clinicians often attribute much of their burnout experience to use of the electronic health record, the adoption of which was greatly accelerated by the Health Information Technology for Economic and Clinical Health Act of 2009. That same year, AMIA's Policy Meeting focused on possible unintended consequences associated with rapid implementation of electronic health records, generating 17 potential consequences and 15 recommendations to address them. At the 2020 annual meeting of the American College of Medical Informatics (ACMI), ACMI fellows participated in a modified Delphi process to assess the accuracy of the 2009 predictions and the response to the recommendations. Among the findings, the fellows concluded that the degree of clinician burnout and its contributing factors, such as increased documentation requirements, were significantly underestimated. Conversely, problems related to identify theft and fraud were overestimated. Only 3 of the 15 recommendations were adjudged more than half-addressed.

Artificial Intelligence Crime: An Interdisciplinary Analysis of Foreseeable Threats and Solutions.

Artificial intelligence (AI) research and regulation seek to balance the benefits of innovation against any potential harms and disruption. However, one unintended consequence of the recent surge in AI research is the potential re-orientation of AI technologies to facilitate criminal acts, term in this article AI-Crime (AIC). AIC is theoretically feasible thanks to published experiments in automating fraud targeted at social media users, as well as demonstrations of AI-driven manipulation of simulated markets. However, because AIC is still a relatively young and inherently interdisciplinary area-spanning socio-legal studies to formal science-there is little certainty of what an AIC future might look like. This article offers the first systematic, interdisciplinary literature analysis of the foreseeable threats of AIC, providing ethicists, policy-makers, and law enforcement organisations with a synthesis of the current problems, and a possible solution space.

Insights From Organized Crime for Disorganized Health Care.

During college and medical school, the author's summer employment acquainted him with members of organized crime families. After a full career as a primary care clinician and geriatrician with research on improving health care delivery, the author opines that several insights from organized crime should be of interest to health care professionals: (1) don't damage the host; (2) protect the brand; and (3) lead necessary adaption. From these insights, the author presents symptoms of failure evidenced by the US health care system, followed by several adaptations that would reduce the system's costs, improve its image, and address future challenges.

Email fraud: The search for psychological predictors of susceptibility.

Decisions that we make about email legitimacy can result in a pernicious threat to security of both individuals and organisations. Yet user response to phishing emails is far from uniform; some respond while others do not. What is the source of this diversity in decision-making? From a psychological perspective, we consider cognitive and situational influences that might explain why certain users are more susceptible than others. Alongside an email judgment task employed as a proxy for fraud susceptibility, 224 participants completed a range of cognitive tasks. In addition, we manipulated time pressure for email legitimacy judgments. We identify cognitive reflection and sensation seeking as significant, albeit modest, predictors of susceptibility. Further to this, participants asked to make quicker responses made more judgment errors. We conclude there are cognitive signatures that partially contribute to email fraud susceptibility, with implications for efforts to limit online security breaches and train secure behaviors.

ATM Card Cloning and Ethical Considerations.

With the advent of modern technology, the way society handles and performs monetary transactions has changed tremendously. The world is moving swiftly towards the digital arena. The use of Automated Teller Machine (ATM) cards (credit and debit) has led to a "cash-less society" and has fostered digital payments and purchases. In addition to this, the trust and reliance of the society upon these small pieces of plastic, having numbers engraved upon them, has increased immensely over the last two decades. In the past few years, the number of ATM fraud cases has increased exponentially. With the money of the people shifting towards the digital platform, ATM skimming has become a problem that has eventually led to a global outcry. The present review discusses the serious repercussions of ATM card cloning and the associated privacy, ethical and legal concerns. The preventive measures which need to be taken and adopted by the government authorities to mitigate the problem have also been discussed.

A dupla epidemia: febre amarela e desinformação / Two epidemics: the yellow fever and a lack of information / La dupla epidemia: la fiebre amarilla y la falta de información

Esta nota apresenta um breve histórico da origem da febre amarela no Brasil, das medidas de controle e das dificuldades para que orientações de saúde pública cheguem à população. Nela analisam-se alguns episódios de geração de boatos, assim como informações mentirosas e suas consequências muitas vezes danosas.Aponta-se a necessidade de oferecer e divulgar fontes confiáveis para os profissionais e a comunidade, em especial por meio do fortalecimento das instituições e de suas áreas de comunicação social. Assinala-se também a importância do trabalho de campo das equipes de atenção básica, para localizar pessoas expostas a risco, levando-lhes informações e vacinas.(AU)

This paper presents a brief history of yellow fever origin in Brazil, of the control measures and of the difficulties to the public health guidance to reach the population. It analyzes some cases of rumour propagation, as wellas fake information and its often damaging consequences. It points out the need to offer and disseminatereliable sources to professionals and the community, especially through the strengthening of institutions and their areas of social communication. It also highlights the importance of the fieldwork of the primary health care teams, so that they can find people at risk and bring information and vaccines to them.

Esta nota presenta una breve historia del origen de la fiebre amarilla en Brasil, de las medidas de control yde las dificultades de las orientaciones de salud pública para llegar a la población. Analiza algunos casos degeneración de rumores, así como informaciones falsas y sus consecuencias a menudo perjudiciales. Señalala necesidad de ofrecer y difundir fuentes confiables a los profesionales y a la comunidad, en especial a través del fortalecimiento de las instituciones y sus áreas de comunicación social. También destaca la importancia del trabajo de campo de los equipos de atención primaria de salud, para localizar personas expuestas alriesgo y así llevar a ellas informaciones y vacunas.

Medical prescriptions falsified by the patients: a 12-year national monitoring to assess prescription drug diversion.

Diversion of prescription drugs is difficult to assess in quality and quantity. This study aimed to characterize diversion of prescription drugs in France through a comparative analysis of falsified prescriptions collected during three periods from 2001 to 2012. The data recorded in a national program which records all falsified prescriptions presented to community pharmacies were studied. Included data regarded: subjects, prescription forms, and drugs. Description of the dataset in three periods (2001-2004, 2005-2008, and 2009-2012) was completed with clustering analyses to characterize profiles of prescriptions and subjects associated with the most reported drugs. The 4469 falsified prescriptions concerned most often females (51.6%). Average age was 46.5 years. Zolpidem, bromazepam, and buprenorphine were the most frequent drugs. Alone, 13 drugs (1.7%, 13/772) represented more than 40% of the total reports (3055/7272). They were associated with three diversion profiles: (i) buprenorphine, flunitrazepam, and morphine were mentioned on overlapping secure prescription forms presented by young men; (ii) alprazolam, bromazepam, zolpidem, codeine/acetaminophen were mentioned on simple prescription forms presented by experienced women; and (iii) acetaminophen and lorazepam were mentioned on modified prescription forms presented by elderly subjects. Clonazepam, clorazepate, dextropropoxyphene, zopiclone moved between those profiles. The patterns of falsified prescriptions provided in this study contribute to enhance the scientific knowledge on the most diverted prescription drugs. The latter follow distinct trajectories across time depending on their pharmacology (including their abuse/addiction potential) and on their regulation's history. The close and continuous analysis of falsified prescriptions is an excellent way to monitor prescription drug diversion.

Prevalence of Financial Fraud and Scams Among Older Adults in the United States: A Systematic Review and Meta-Analysis.

BACKGROUND: The financial exploitation of older adults was recently recognized by the Centers for Disease Control and Prevention as a serious public health problem. Knowledge of the prevalence of elder financial exploitation is mostly limited to the category of financial abuse, which occurs in relationships involving an expectation of trust. Little is known about the other major category of elder financial exploitation-elder financial fraud and scams, which is perpetrated by strangers. A valid estimate of elder financial fraud-scam prevalence is necessary as a foundation for research and prevention efforts. OBJECTIVES: To estimate the prevalence of elder financial fraud-scam victimization in the United States based on a systematic review and meta-analysis. SEARCH METHODS: Multiple investigators independently screened titles and abstracts and reviewed relevant full-text records from PubMed, Medline, PsycINFO, Criminal Justice Abstracts, Social Work Abstracts, and AgeLine databases. SELECTION CRITERIA: To maximize the validity and generalizability of prevalence estimation, we restricted eligibility to general population-based studies (English speaking, 1990 onward) using state- or national-level probability sampling and collecting data directly from older adults. DATA COLLECTION AND ANALYSIS: Information on elder financial fraud-scam prevalence and study-level characteristics was extracted independently by 2 investigators. Meta-analysis of elder financial fraud-scam prevalence used generalized mixed models with individual studies as levels of a random classification factor. MAIN RESULTS: We included 12 studies involving a total of 41 711 individuals in the meta-analysis. Overall pooled elder financial fraud-scam prevalence (up to 5-year period) across studies was 5.6% (95% confidence interval [CI] = 4.0%, 7.8%), with a 1-year period prevalence of 5.4% (95% CI = 3.2%, 7.6%). Studies using a series of questions describing specific fraud-scam events to measure victimization found a significantly higher prevalence (7.1%; 95% CI = 4.8%, 9.4%) than studies using a single, general-question self-report assessment approach (3.6%; 95% CI = 1.8%, 5.4%). AUTHOR'S CONCLUSIONS: Elder financial fraud and scams is a common problem, affecting approximately 1 of every 18 cognitively intact, community-dwelling older adults each year; it requires further attention from researchers, clinicians, and policymakers. Elder financial fraud-scam prevalence findings in this study likely underestimate the true population prevalence. We provide methodological recommendations to limit older adult participation and reporting bias in future population-based research. Public Health Implications. Elder financial exploitation victimization is associated with mortality, hospitalization, and poor physical and mental health. Health care professionals working with older adults likely routinely encounter patients who are fraud-scam victims. Validation of instruments to screen for elder financial fraud and scams in clinical settings is an important area of future research. Without effective primary prevention strategies, the absolute scope of this problem will escalate with the growing population of older adults.

Counterfeit medicines in Peru: a retrospective review (1997-2014).

OBJECTIVE: To consolidate and assess information on counterfeit medicines subject to pharmaceutical alerts issued by the Peruvian Medicines Regulatory Authority over 18 years (1997-2014) of health monitoring and enforcement. DESIGN: A retrospective review of drug alerts. SETTING: A search of the website of the General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Ministry of Health of Peru for drug alerts issued between 1997 and 2014. ELIGIBILITY CRITERIA: Drug alerts related to counterfeit medicines. RESULTS: A total of 669 DIGEMID alerts were issued during the study period, 354 (52.91%) of which cover 1738 cases of counterfeit medicines (many alerts deal with several cases at a time). 1010 cases (58.11%) involved pharmaceutical establishments and 349 (20.08%) involved non-pharmaceutical commercial outlets. In 126 cases (7.25%), counterfeit medicines were seized in an unauthorised trade (without any marketing authorisation); in 253 cases (14.56%) the type of establishment or business associated with the seized product was not identified. CONCLUSIONS: Counterfeit medicines are a serious public health problem in Peru. A review of the data cannot determine whether counterfeit medicines in Peru increased during the study period, or if monitoring by different government health agencies highlighted the magnitude of the problem by providing more evidence. The problem is clearly structural, since the majority of cases (58.11% of the total) were detected in legitimate supply chains. Most counterfeit medicines involve staple pharmaceutical products and common dosage forms. Considerable work remains to be done to control the serious problem of counterfeit medicines in Peru.