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.

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.

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.

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.

How does age affect the care dependency risk one year after stroke? A study based on claims data from a German health insurance fund.

BACKGROUND: The objective of this study is to investigate the effect of age on care dependency risk 1 year after stroke. Two research questions are addressed: (1) How strong is the association between age and care dependency risk 1 year after stroke and (2) can this association be explained by burden of disease? METHODS: The study is based on claims data from a German statutory health insurance fund. The study population was drawn from all continuously insured members with principal diagnoses of ischaemic stroke, hemorrhagic stroke, or transient ischaemic attack in 2007 who survived for 1 year after stroke and who were not dependent on care before their first stroke (n = 2864). Data were collected over a 1-year period. People are considered to be dependent on care if they, due to a physical, mental or psychological illness or disability, require substantial assistance in carrying out activities of daily living for a period of at least 6 months. Burden of disease was assessed by stroke subtype, history of stroke, comorbidities as well as geriatric multimorbidity. Regression models were used for data analysis. RESULTS: 21.6 % of patients became care dependent during the observation period. Post-stroke care dependency risk was significantly associated with age. Relative to the reference group (0-65 years), the odds ratio of care dependency was 11.30 (95 % CI: 7.82-16.34) in patients aged 86+ years and 5.10 (95 % CI: 3.88-6.71) in patients aged 76-85 years. These associations were not explained by burden of disease. On the contrary, age effects became stronger when burden of disease was included in the regression model (by between 1.1 and 28 %). CONCLUSIONS: Our results show that age has an effect on care dependency risk that cannot be explained by burden of disease. Thus, there must be other underlying age-dependent factors that account for the remaining age effects (e.g., social conditions). Further studies are needed to explore the causes of the strong age effects observed.

A hybrid approach of stepwise regression, logistic regression, support vector machine, and decision tree for forecasting fraudulent financial statements.

As the fraudulent financial statement of an enterprise is increasingly serious with each passing day, establishing a valid forecasting fraudulent financial statement model of an enterprise has become an important question for academic research and financial practice. After screening the important variables using the stepwise regression, the study also matches the logistic regression, support vector machine, and decision tree to construct the classification models to make a comparison. The study adopts financial and nonfinancial variables to assist in establishment of the forecasting fraudulent financial statement model. Research objects are the companies to which the fraudulent and nonfraudulent financial statement happened between years 1998 to 2012. The findings are that financial and nonfinancial information are effectively used to distinguish the fraudulent financial statement, and decision tree C5.0 has the best classification effect 85.71%.

Big pharma and the problem of disease inflation.

Over the course of the past decade, critics have increasingly called attention to the corrosive influence of the pharmaceutical industry on both biomedical research and the practice of medicine. Critics describe the industry's use of ghostwriting and other unethical techniques to expand their markets as evidence that medical science is all-too-frequently subordinated to the goals of corporate profit. While we do not dispute this perspective, we argue that it is imperative to also recognize that the goals of medical science and industry profit are now tightly wed to one another. As a result, medical science now operates to expand disease definitions, lower diagnostic thresholds, and otherwise advance the goals of corporate profit through the redefinition and expansion of what it means to be ill. We suggest that this process has led to a variety of ethical problems that are not fully captured by current critiques of ghostwriting and other troubling practices by the pharmaceutical industry. In our conclusion, we call for physicians, ethicists, and other concerned observers to embrace a more fundamental critique of the relationship between biomedical science and corporate profit.

Poor quality drugs: grand challenges in high throughput detection, countrywide sampling, and forensics in developing countries.

Throughout history, poor quality medicines have been a persistent problem, with periodical crises in the supply of antimicrobials, such as fake cinchona bark in the 1600s and fake quinine in the 1800s. Regrettably, this problem seems to have grown in the last decade, especially afflicting unsuspecting patients and those seeking medicines via on-line pharmacies. Here we discuss some of the challenges related to the fight against poor quality drugs, and counterfeits in particular, with an emphasis on the analytical tools available, their relative performance, and the necessary workflows needed for distinguishing between genuine, substandard, degraded and counterfeit medicines.

Counterfeit medicines: report of a cross-sectional retrospective study in Iran.

OBJECTIVES: To gain insight into the pharmaceutical grey market in Iran by reviewing inspection files of the Special Inspectorate Unit, Deputy Ministry for Food and Drugs, Ministry of Health and Medical Education, and to define the counterfeit pharmaceutical pattern in Iran. STUDY DESIGN: Cross-sectional retrospective study. METHODS: In total, 382 inspection files of pharmaceutical counterfeit cases between 2007 and 2008 were reviewed. A database was constructed in Microsoft Access, and all cases of counterfeit medicines together with the details recorded in the files were entered. A primary list of all items in all files was produced (n = 7910), and this contained 716 different counterfeit medicines. This article reports the analysis of these 716 items and the outcome. Subsequently, the list of items was further filtered, and a final working list of 100 items was selected for further analysis. Drug samples of the working list were collected and checked against a modified version of the 'Checklist for the visual inspection of medicines to identify suspicious drug products' of the US Pharmacopeia Convention, Inc. and recommended by IMPACT (International Medical Products Anti-Counterfeiting Taskforce). Details of items in the working list recorded in the checklist were then entered into the database. Data were analysed using Statistical Package for the Social Sciences Version 12.0 and Microsoft Excel. RESULTS: Of the 716 items, 64.5% were supplements, 10.2% were analgesics, 7.8% were hormones and 3.2% were antihistamines. Unnamed items and/or items of unknown origin accounted for 2.4% of the total. Herbal medicines, drugs used in the central nervous system, gastrointestinal system and genito-urinary systems, and drugs used for cardiovascular disease and diabetes represented 1-2% of items, and other drug groups accounted for <1% of the 716 counterfeit medicines. Drugs used in professional settings accounted for 20% and drugs used in non-professional settings accounted for 15% of the 716 items. Selected items were checked against the World Health Organization's visual checking tool, and the following observations were made: 15.8% showed mismatch between the label and the container, 7.9% showed the incorrect manufacturer's name and address, 82.9% showed existence or a different view of the logo and hologram of the product, and 18.4% used poor-quality paper for the insert. In 73.7% of products checked, the ink of the packaging or inserts was not smudge-proof. CONCLUSION: Results from this study have been utilized by the Deputy Ministry for Food and Drugs in Iran and the outcome was a faster registration and market authorization of supplements compared with other pharmaceutical products. Inter- and intra-section collaboration, active vigilance and conducting educational programs at different levels would reduce the risk of counterfeit medicines and protect public health.

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.

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.

Counterfeit drugs: analytical techniques for their identification.

In recent years, the number of counterfeit drugs has increased dramatically, including not only "lifestyle" products but also vital medicines. Besides the threat to public health, the financial and reputational damage to pharmaceutical companies is substantial. The lack of robust information on the prevalence of fake drugs is an obstacle in the fight against drug counterfeiting. It is generally accepted that approximately 10% of drugs worldwide could be counterfeit, but it is also well known that this number covers very different situations depending on the country, the places where the drugs are purchased, and the definition of what constitutes a counterfeit drug. The chemical analysis of drugs suspected to be fake is a crucial step as counterfeiters are becoming increasingly sophisticated, rendering visual inspection insufficient to distinguish the genuine products from the counterfeit ones. This article critically reviews the recent analytical methods employed to control the quality of drug formulations, using as an example artemisinin derivatives, medicines particularly targeted by counterfeiters. Indeed, a broad panel of techniques have been reported for their analysis, ranging from simple and cheap in-field ones (colorimetry and thin-layer chromatography) to more advanced laboratory methods (mass spectrometry, nuclear magnetic resonance, and vibrational spectroscopies) through chromatographic methods, which remain the most widely used. The conclusion section of the article highlights the questions to be posed before selecting the most appropriate analytical approach.

Spurious and counterfeit drugs: a growing industry in the developing world.

Spread of spurious/counterfeit/substandard drugs is a modern day menace which has been recognised internationally, especially so in developing countries. The problem assumes added significance in view of rapid globalisation. The market of spurious and counterfeit drugs is a well-organised, white collar crime. Poverty, high cost of medicines, lack of an official supply chain, legislative lacunae, easy accessibility to computerised printing technology, ineffective law enforcement machinery, and light penalties provide the counterfeiters with an enormous economic incentive without much risk. The consequences of the use of such medicines may vary from therapeutic failure to the occurrence of serious adverse events and even death. Proper drug quality monitoring, enforcement of laws and legislation, an effective and efficient regulatory environment, and awareness and vigilance on part of all stakeholders can help tackle this problem.