US Authorities Research Articles

Toxicology research for precautionary decision-making and the role of Human & Experimental Toxicology.

A key aim of toxicology is the prevention of adverse effects due to toxic hazards. Therefore, the dissemination of toxicology research findings must confront two important challenges: one being the lack of information on the vast majority of potentially toxic industrial chemicals and the other being the strict criteria for scientific proof usually required for decision-making in regard to prevention. The present study ascertains the coverage of environmental chemicals in four volumes of Human & Experimental Toxicology and the presentation and interpretation of research findings in published articles. Links in SciFinder showed that the 530 articles published in four selected volumes between 1984 and 2014 primarily dealt with metals (126 links) and other toxicants that have received substantial attention in the past. Thirteen compounds identified by US authorities in 2006 as high-priority substances, for which toxicology documentation is badly needed, were not covered in the journal issues at all. When reviewing published articles, reliance on p values was standard, and non-significant findings were often called 'negative.' This tradition may contribute to the perceived need to extend existing research on toxic hazards that have already been well characterized. Several sources of bias towards the null hypothesis can affect toxicology research, but are generally not considered, thus adding to the current inclination to avoid false positive findings. In this regard, toxicology is particularly prone to bias because of the known paucity of false positives and, in particular, the existence of a vast number of toxic hazards which by default are considered innocuous due to lack of documentation. The Precautionary Principle could inspire decision-making on the basis of incomplete documentation and should stimulate a change in toxicology traditions and in toxicology research publication.

Another nail in the coffin for non-literal software copyright infringement?

This article reviews a 2014 decision of the New Zealand Court of Appeal in Karum v Fisher & Paykel Finance, where in considering a claim for non-literal infringement of software copyright the court adopted the reasoning of UK and US authorities. As with decisions in the UK and USA, no protectable expression was found, despite homage being paid to the applicability of non-literal infringement in software copyright cases. Assuming the latter concept has validity, ‘it is necessary essentially to retrace and map each of the designer's steps—in opposite order in which they were taken in the program's creation’ (Computer Associates v Altai 982 F 2d 693, 707 (2d Cir 1992)). In this article, software engineering is employed to reveal the abstractions above program code by closely examining the design steps in software development models and in particular the Waterfall model. The objective is to ascertain if there are any areas left where protectable expression may reside within the hierarchy of abstractions which have not so far been excluded by courts. In this analysis software development work products (which may constitute ‘preparatory design material’) are comprehensively identified as a possible alternative basis for bringing claims of copyright infringement where similarities exist only at higher levels of abstraction. UK, EU and New Zealand cases reveal very clearly the influence of US law in this field of copyright whether or not it has received specific acknowledgment. Through the Software Directive and the Court of Justice of the European Union (CJEU) the continental copyright tradition (Football Dataco Ltd v Yahoo Ltd, C-604/10, EU:C:2012:115, Opinion of A-G Mengozzi, paras 36–37) has now infiltrated traditional UK copyright concepts. However, this article argues that not only are the majority of the US tests still ‘irrelevant and exotic’ (H Laddie et al, The Modern Law of Copyright and Designs (2nd edn, Butterworths, 1995) para 20.58), but the application of the doctrine of non-literal infringement to software copyright (thought to be a ‘syllogism’ by the 2nd Circuit in Computer Associates v Altai) is a logical fallacy.

Wirtschaftsdiplomatie im Totalen Krieg. Die Swiss Mission in den USA 1917

Abstract In the spring of 1917 the United States entered the First World War. Switzerland and the other neutral European countries came under increasing pressure as the US wanted to embargo their economies. Switzerland had to adapt quickly to the new political order and sent a diplomatic mission to the United States to secure its food and commodity supply. Even though an agreement with the US authorities could be concluded, the policy outcome was strongly influenced by the economic and political agenda of the belligerents. Thus the scope for Swiss foreign policy was limited. The Swiss case shows the increasing influence of the United States and sheds light on the politics of neutrality during the First World War.

The long arm of justice: U.S. structural power and international banking

How much authority can sovereign states exercise over international banking in times of financial globalization? While most literature on international finance is rather pessimistic, this article argues that in case of US law enforcement, this pessimistic view is increasingly erroneous. The reason is that US authorities can take advantage of international banks’ structural dependence on access to the dollar-based financial system to force banks into punitive agreements or to plead guilty in case of criminal offenses. Using the conflict between the USA and Swiss banks over tax evasion by US persons, this article demonstrates that banks in the liberal economic system can no longer survive without access to the US-controlled, dollar-based financial system, thus giving the USA structural power over banks. In addition, it is shown that US structural power can be used strategically during negotiation processes to apply pressure on banks. Finally, while the use of this structural power was originally restricted to smaller banks, whose collapse would not endanger the world economy, US authorities have recently learnt to manage market expectations in a way that allows them to also target banks that were previously considered “too big to jail.”

Destabilizing Effects of Fair Value Accounting During US Banking Crisis

The aim of this paper is to analyze the pros and cons of the financial accounting standards rule, known also as Mark-to-Market Rule. Enacted November 15, 2007, required that all companies to be evaluated on the basis of prices reflecting actual market situation. We have shown this pro-cyclical rule significantly worsened the U.S. Financial Crisis of 2007. The article includes a discussion of reasons why US authorities adopted this rule for already third time in history, whereas the two preceding cases are also discussed. The US government did implement the discussed rule just on the eve of the recession or the financial crisis to relatively ease the rule during the period when the US economy was due for a rebound. Based on our analysis of the definition and strong pro-cyclical effects of MTM rule we have shown that just in the aftermath of factual easing of this rule the economy and equity markets sharply rebounded (other reasons for the last rebound of March 2009 have been discussed too). Timeline of important dates and developments during the US banking crisis of 2007 has been presented and so we hope such a rule will never be adopted again, especially not ahead or just after the start of a financial crisis in any country as it happened in 2007.

The marine biology of law and human health

This review uses a multidisciplinary approach to investigate legal issues concerning the oceans and human health. It firstly seeks to define the boundaries of oceans and human health research. We use three case studies as examples: biomedical research, marine litter and human well-being. Biomedical research raises complex issues relating to coastal states’ sovereign rights to exploit their marine resources and the patenting processes. Coastal states have differing degrees of control over research at sea. There are differences in EU and US law over the status of genetic discoveries, with the US having stricter criteria to qualify for patent protection. International law sets the standard for bioprospecting in developing countries under the Nagoya Protocol. The cost and complexity of marine biomedical research mean that it cannot be left to commercial exploration and needs some public funding. The second case study highlights the rise in marine plastics pollution using Marine Conservation Society beachwatch data. It details the need to alter product design to avoid marine pollution and records an unsuccessful attempt by academics and an NGO to make contact with the manufacturers of one polluting product. It also introduces the concept that faulty design could amount to a public nuisance. The third case study highlights the potential health benefits from access to the coast and the statutory responsibility which sits with the US and UK authorities in the provision of well-being. It posits that there needs to be greater inter-agency coordination to promote access to the coast for human well-being.

FATCA violation underlies latest US tax and securities fraud charges

Purpose – To explain the details and implications of a September 9, 2014 federal indictment, US v. Robert Bandfield, the first time a Foreign Account Tax Compliance Act (FATCA) violation has been charged as an “overt act” in furtherance of a tax conspiracy and securities fraud. Design/methodology/approach – Provides background, including the enactment of FATCA and the details of the indictment; describes an undercover investigation conducted by President Obama’s Financial Fraud Enforcement Task Force; and discusses the warnings this indictment sends to the global financial community. Findings – The indictment confirms the coordinated and aggressive tactics US law enforcement is now employing to investigate and prosecute offshore financial fraud. Practical implications – Banks and financial service providers need to be aware of the impact of enhanced US regulatory obligations and implement appropriate compliance measures. These institutions must also remain sensitive to risks presented by unscrupulous customers. Finally, they must be ready to manage appropriately information-gathering and investigatory inquiries originating with US authorities. Originality/value – Practical guidance from experienced tax controversy lawyers.

Market perceptions of US and European policy actions around the subprime crisis

This paper explores the impacts of key policy actions by US and European authorities on stock returns of systemically important banks in Europe and US around the subprime crisis. We find that the US policy announcements had a stronger impact on the European and US banking industry than the European policy announcements. In particular, the announcements of monetary policies by the US authorities were accompanied by higher abnormal returns compared to related announcements of European authorities. We also find that the policy announcements, regardless of which side of the Atlantic the news arrived from, has increased the return volatility during the crisis. We further analyze the reactions of implied volatility. The findings suggest that the currency swaps had a non-negligible effect in reducing future uncertainty.

Decisions of British Courts during 2014 Involving Questions of Public or Private International Law

The claimant’s father was killed in a missile strike launched from a drone that was believed to have been operated by the US Central Intelligence Agency (CIA). He sought permission to appeal the decision of the Divisional Court (Moses LJ and Simon J) refusing permission to apply for judicial review.1 In the event that permission were granted, the claimant sought a declaration that a UK national who kills a person in a drone strike in Pakistan is not entitled to rely on the defence of combatant immunity. Accordingly, when an officer of the UK Government Communications Headquarters (GCHQ) passes intelligence on the location of an individual to US authorities for use in drone strikes in Pakistan, he/she may commit the offence of ‘encouraging or assisting in [murder]’ under section 44-46 of the Serious Crime Act 2007 (SCA), as read with the jurisdictional provisions in section 52(2) and Schedule 4 of that Act. These provisions are ‘by no means straightforward’, but a plain reading suggests that an individual may be liable for encouraging or assisting an offence committed wholly or partly outside England and Wales: The claimant submitted (1) that on this construction of the SCA, which is supported by the authors of Simester & Sullivan’s Criminal Law,3 the question for the court is not whether the principal has actually committed an offence triable in England and Wales, but only whether ‘any conduct which the UK national is assisting would be within the jurisdiction of the English court if the notional principal were a UK national’;4and (2) neither the CIA nor GCHQ officers are entitled to combatant immunity, either because they are not combatants or because there is no international armed conflict in Pakistan between the US and those targeted by the drone strikes.5 The claimant accepted that in any individual case an official would not be guilty of an offence unless he had the requisite mens rea and the defence of reasonableness under section 50 SCA was not available, but contended that these issues ‘are not material for present purposes’ because the claim concerned the lawfulness of the Foreign Secretary’s policy and not the guilt of individual officials or the lawfulness of drone strikes under US law.6

A 25-Year Experience of Gastroenteropancreatic Neuroendocrine Tumors and Somatostatin (Congeners) Analogs: From Symptom Control to Antineoplastic Therapy.

Radioimmunoassay technology was utilized in the discovery of somatostatin and was quickly brought into therapeutics; however, it took the development of somatostatin congeners to solve its limitations of a short half-life. Therapeutic medical control of hyperhormonal states such as acromegaly, carcinoid syndrome and VIPoma significantly advanced from a nonspecific approach to one that specifically and effectively targeted the underlying pathophysiology. Clinical care was transformed from nonspecific symptom control to one of a significant improvement in not only quality of life, but also quantity of life. These data submitted to US and European regulatory authorities for approval included many investigative sites with no uniform protocol and multiple investigational new drugs, and have not been previously published. This review includes the original data demonstrating the transformational impact this class of agents had on specific disease subsets resulting in regulatory approval 25 years ago. Autoradiography techniques using somatostatin resulted in identifying, localizing and characterizing its receptor subtypes. Translating in vitro data to in vivo resulted in scintigraphic whole body and SPECT scans with (111)In-pentetreotide and was incorporated into standard clinical care 20 years ago. (68)Ga-octreotide congeners using PET scanning offers a major imaging advance. Peptide receptor radiotherapy has evolved over the last 2 decades and utilizes several therapeutic isotopes, including (90)Y and (177)Lu.

The Balance between Competition Policy and Patent Rights in Terms of Reverse Paymentt - a Comparative Research between European Union and the United States

In the pharmaceutical industry, it is not unusual that brand-name drug manufacturers have been compensating with large amounts of money potential generic entrants to induce them to delay bringing low-cost generic drugs into the market and to abandon its patent challenge and agree not to sell its generic drug product for a number of years. In the United States, for many years Federal Courts have refused to declare these “reverse payment” settlements, also called pay-to-delay payments, anti-competitive and/or subject them to the antitrust laws. In June 2013, however, the Supreme Court ruled in its “reverse payment decision” in FTC v. Actavis that reverse payment settlement agreements between branded and generic pharmaceutical companies are subject to antitrust scrutiny and should be analyzed under the traditional antitrust law’s “Rule of Reason”. Since 2008, following a broad competition inquiry into the pharmaceutical sector, the European Commission has been focusing increasingly on reverse settlement agreements in the European market. In 2013, the European Commission has handed an international pharma company the largest fine for not complying with EU competition law and restricting potential competition with generic producers. The core scope of this paper is to compare the legal approaches taken by the US and EU competition authorities in terms of reverse payment settlements and considers its recent development in the context of the US and EU case law. Furthermore, this paper analyzes how competition authorities in the US and EU are tackling these anti-competitive settlements.

Structural Violence and Migrant Deaths in Southern Arizona: Data from the Pima County Office of the Medical Examiner, 1990–2013

This article analyzes numeric trends and demographic characteristics of undocumented border crossers (UBCs) who have perished in southern Arizona between 1990 and 2013 in the area covered by the Pima County Office of the Medical Examiner (PCOME) in Tucson, Arizona. Of 2,413 UBC decedents investigated during this period, 95 percent died after 1999 and 65 percent after 2005. The rate of UBC deaths in the Tucson Border Patrol Sector has been consistently high, with an average of nearly 163 deaths investigated per year between 1999 and 2013. The increase in border enforcement during the mid-to-late 1990s, which led to a shifting of unauthorized migration flows into more desolate areas, coincided with an increase in migrant remains investigated by the PCOME. Despite a decrease in the number of unauthorized crossers traversing the area as measured by the number of Border Patrol apprehensions in the Tucson Sector, the number of remains examined for every 100,000 apprehensions nearly doubled between 2009 and 2011. These findings suggest that migrants are being forced to travel for longer periods of time through remote areas in an attempt to avoid detection by US authorities, thus increasing the probability of death. The typical UBC decedent can be described as a male near the age of 30 from central or southern Mexico who perished in a remote area of southern Arizona after attempting to cross into the United States. Nevertheless, the share of non-Mexican UBCs in the region has increased notably over time. The findings show other important differences in UBC decedent characteristics across time periods, which speak to the dynamic nature of unauthorized migration as a social process. The authors contend that these deaths and demographic changes are the result of structural and political transformations over the past two decades. They argue that the tragic, yet mostly preventable, migrant deaths in southern Arizona constitute a form of structural violence.

Evaluation of comparative performance of orally inhaled drug products in view of the classical bioequivalence paradigms: an analysis of the current scientific and regulatory dilemmas of inhaler evaluation.

Since the early 1960s, there has been a continuous evolution in scientific understanding regarding bioequivalence (BE) of oral dosage forms, intermittently punctuated by some breakthrough research findings and conceptual advances. The accumulated knowledge from this body of research has been translated into a sophisticated risk management framework of regulations and guidelines supported by an extensive set of tools and decision rules. This has permitted us to arrive at a state that now allows, in the majority of cases, not only the unrestricted substitution of a generic product for the innovator version, but also unquestioned substitution between different generic manufacturers. This framework has been successfully extended or adapted to go beyond oral dosage forms to include, for example, topical semisolid applications and nasal sprays. In the case of orally inhaled locally acting drug products (OIP), a similar level of success has yet to be realized. For OIP's, the risk management toolbox is incompletely outfitted due to missing science, knowledge, and experience in some key areas. This article presents a gap analysis of the situation highlighting unresolved residual risks. Assessment of the residual risks by US and EU medicines authorities has interestingly led to different regulatory positions with respect to BE for this class of drug products in these two regions. A parallel comparison with the history for BE of oral dosage forms shows that resolution for inhaled products will come eventually with the final outcome and timeframe, depending as much on science as it does on economics and the degree to which legislators intervene.

Youth depression alleviation: the Fish Oil Youth Depression Study (YoDA‐F): A randomized, double‐blind, placebo‐controlled treatment trial

US authorities have recommended 'black-box' warnings for antidepressants because of the increased risk of suicidality for individuals up to age 25. There is thus a clinical and ethical imperative to provide effective treatment for youth depression with an acceptable risk-benefit balance. Long-chain omega-3 polyunsaturated fatty acids (PUFAs) play an important role in a range of physiological processes in living organisms. Supplementation with omega-3 PUFAs has been shown to have a range of beneficial effects on both physical and mental health, and results of previous trials suggest that omega-3 PUFAs may be a safe and effective treatment for depression. However, conclusions from these trials have been limited by their relatively small sample sizes. This trial will test the effectiveness of a 12-week parallel group, double-blind, randomized, placebo-controlled trial of 1.4 g day(-1) omega-3 PUFAs in help seeking 15- to 25-year-olds (N = 400) presenting with major depressive disorder. The primary hypothesis is that young people will show greater improvement of depressive symptoms after 12 weeks of treatment with omega-3 PUFAs plus cognitive behavioural case management compared with treatment with placebo plus cognitive behavioural case management. Because of using a large sample, results from this study will provide the strongest evidence to date to inform the use of omega-3 PUFAs as first-line therapy in young people presenting with major depressive disorder. The study also heralds an important step towards indicated prevention of persistent depression, which may reduce the burden, stigmatization, disability and economic consequences of this disorder.

Why Crude Oil Vapor Pressure Should Be Tested Prior to Rail Transport

Recent crude oil rail car accidents have forced US and Canadian authorities to issue Emergency Testing Orders to ensure safe transportation of crude oils. One crucial parameter in meeting these safety requirements is the testing of the vapor pressure (VP) of crude oil. This paper explains the impact of highly volatile components inside the crude oil on the vapor pressure measurement. It describes typical VP measurement errors and discusses guidelines and technology for proper crude oil classification. It offers measurement data to show the effect of sample outgassing and to describe the impact of temperature changes and the vapor-liquid ratio (V/L) on vapor pressure test results. The second part of the paper discusses methods to measure the True Vapor Pressure (TVP) and Bubble Point Pressure (BPP) of Crude Oils for safety purposes. Key words : Crude oil; Volatility testing; Safety data sheet; Hazardous material regulations (HMR); Emergency testing order; Vapor pressure (VP); ASTM D6377; Reid vapor pressure (RVP); ASTM D323; True vapor pressure (TVP); Vapor-liquid ratio (V/L); Bubble point pressure (BPP); Floating piston cylinder (FPC)

THU0337 Lower-Dose Solumatrix® Indomethacin: Combined Safety Data from Two Phase 3 Studies in Patients with Acute Pain following Elective Surgery

BackgroundIndomethacin, a potent non-steroidal anti-inflammatory drug (NSAID) used to treat acute pain, is, like other NSAIDs, associated with dose-dependent gastrointestinal (GI), cardiovascular (CV), and renal adverse events (AEs). US and...

US authorities capture long-time fugitive with facial recognition

Law enforcement authority use of facial recognition technology has had a high profile success with the capture of long-time fugitive James Robert Jones.

The Intra-Day Impact of Communication on Euro-Dollar Volatility and Jumps

In this paper, we examine the intra-day effects of verbal statements and comments on the FX market uncertainty using two measures: continuous volatility and discontinuous jumps . Focusing on the euro-dollar exchange rate, we provide empirical evidence of how these two sources of uncertainty matter in measuring the short-term reaction of exchange rates to communication events. Talks significantly trigger large jumps or extreme events for approximately an hour after the news release. Continuous volatility starts reacting prior to the news, intensifies around the release time and stays at high levels for several hours. Our results suggest that monetary authorities generally tend to communicate with markets on days when uncertainty is relatively severe, and higher than normal. Disentangling the US and Euro area statements, we also find that abnormal levels of volatility are mostly driven by the communication of the Euro area officials rather than US authorities.

The intra-day impact of communication on euro-dollar volatility and jumps

In this paper, we examine the intra-day effects of verbal statements and comments on the FX market uncertainty using two measures: continuous volatility and discontinuous jumps. Focusing on the euro-dollar exchange rate, we provide empirical evidence of how these two sources of uncertainty matter in measuring the short-term reaction of exchange rates to communication events. Talks significantly trigger large jumps or extreme events for approximately an hour after the news release. Continuous volatility starts reacting prior to the news, intensifies around the release time and stays at high levels for several hours. Our results suggest that monetary authorities generally tend to communicate with markets on days when uncertainty is relatively severe, and higher than normal. Disentangling the US and Euro area statements, we also find that abnormal levels of volatility are mostly driven by the communication of the Euro area officials rather than US authorities.

Structural Violence and Migrant Deaths in Southern Arizona: Data from the Pima County Office of the Medical Examiner, 1990-2013

This article analyzes numeric trends and demographic characteristics of undocumented border crossers (UBCs) who have perished in southern Arizona between 1990 and 2013 in the area covered by the Pima County Office of the Medical Examiner (PCOME) in Tucson, Arizona. Of 2,413 UBC decedents investigated during this period, 95 percent died after 1999 and 65 percent after 2005. The rate of UBC deaths in the Tucson Border Patrol Sector has been consistently high, with an average of nearly 163 deaths investigated per year between 1999 and 2013. The increase in border enforcement during the mid-to-late 1990s, which led to a shifting of unauthorized migration flows into more desolate areas, coincided with an increase in migrant remains investigated by the PCOME. Despite a decrease in the number of unauthorized crossers traversing the area as measured by the number of Border Patrol apprehensions in the Tucson Sector, the number of remains examined for every 100,000 apprehensions nearly doubled between 2009 and 2011. These findings suggest that migrants are being forced to travel for longer periods of time through remote areas in an attempt to avoid detection by US authorities, thus increasing the probability of death.The typical UBC decedent can be described as a male near the age of 30 from central or southern Mexico who perished in a remote area of southern Arizona after attempting to cross into the United States. Nevertheless, the share of non-Mexican UBCs in the region has increased notably over time. The findings show other important differences in UBC decedent characteristics across time periods, which speak to the dynamic nature of unauthorized migration as a social process. The authors contend that these deaths and demographic changes are the result of structural and political transformations over the past two decades. They argue that the tragic, yet mostly preventable, migrant deaths in southern Arizona constitute a form of structural violence.