GABA induces a hormonal counter-regulatory response in subjects with long-standing type 1 diabetes

IntroductionExperimentally, gamma-aminobutyric acid (GABA) has been found to exert immune-modulatory effects and induce beta-cell regeneration, which make it a highly interesting substance candidate for the treatment of type 1 diabetes (T1D). In many countries, including those in the European Union, GABA is considered a pharmaceutical drug. We have therefore conducted a safety and dose escalation trial with the first controlled-release formulation of GABA, Remygen (Diamyd Medical).Research design and methodsSix adult male subjects with long-standing T1D (age 24.8±1.5 years, disease duration 14.7±2.2 years) were enrolled in an 11-day dose escalation trial with a controlled-release formulation of GABA, Remygen. Pharmacokinetics, glucose control and hormonal counter-regulatory response during hypoglycemic clamps were evaluated at every dose increase (200 mg, 600 mg and 1200 mg).ResultsDuring the trial there were no serious and only a few, transient, adverse events reported. Without treatment, the counter-regulatory hormone response to hypoglycemia was severely blunted. Intake of 600 mg GABA more than doubled the glucagon, epinephrine, growth hormone and cortisol responses to hypoglycemia.ConclusionsWe find that the GABA treatment was well tolerated and established a counter-regulatory response to hypoglycemia in long-standing T1D. Further studies regarding not only the clinical potential of Remygen for beta-cell regeneration but also its potential use as hypoglycemic prophylaxis are warranted.Trail registration numberNCT03635437 and EudraCT2018-001115-73.

Rebalancing our regulatory response to Deepfakes with performers’ rights

Law experts have been actively looking for solutions within the law to control Deepfakes since their emergence in 2017. This article puts forward performers’ rights as a suitable regulatory tool for Deepfakes, defined as synthetic performances produced using artificial intelligence systems. In many respects, performers’ rights represent a more sophisticated response to the challenges posed by Deepfake technology compared to existing legal remedies and reform proposals introduced to regulate Deepfakes. In making its case for performers’ rights as suitable regulatory response to Deepfakes, this article uncovers a tension: performers’ rights are an attractive solution to regulate Deepfakes but this technology challenges their scope of application. This is because Deepfakes uses content protected by performers’ rights (performances) in a way unforeseen by intellectual property policy-makers at the time these rights were introduced into law. Despite this limitation, performers’ rights remain one of the most attractive legal remedies in regulating Deepfakes, if adequately reformed. This article proposes two routes for the reform of performers’ rights to address this gap. The first involves an ad hoc modification of performers’ rights to ensure that performances manipulated by Deepfakes are covered. The second and preferred recommendation replaces the regime of performers’ rights with a regime of performers’ copyright. This small, yet important, change in legal regimes can be the difference between piecemeal, uneven and, therefore, ineffective protection against unauthorized Deepfakes and a harmonized international approach to the technology.

Regulatory Response to the Rise of Fintech Credit in The Netherlands

The rise of financial technology (fintech) driven business models in banking poses a challenge for financial regulators. While the positive effects on the banking sector in terms of greater diversity and competition are generally recognized and encouraged by regulators, the nature of fintech business models may increase the risk of financial instability. Regulators are exploring ways to resolve this dilemma. The paper in hand makes a contribution to the literature by providing a framework for resolving the dilemma that is evaluated in the context of the regulatory response to the rise of fintech credit in the Netherlands. The semi-structured interviews which we conducted with four senior Dutch regulators resulted in three areas that–from their perspective–required urgent action: fintech credit companies need to lower the risk of overlending, increase pricing transparency, and improve lending standards. These findings were confirmed by the results of they survey among fintech credit clients. The current regulatory response to the rise of fintech in banking in the Netherlands provides an interesting case study that delineates the features of the future regulation of fintech in banking.

A Data Protection Regime

This chapter is focused on the need for and the likely problems to be encountered as we pursue a regulatory response, especially through the traditional framework for thinking about privacy and data protection. This regulatory framework is characterized through a consideration of an evolving tradition beginning with the contributions that were made by Samuel Warren and Louis Brandeis in 1890. Other perspectives, including those of Edward Bloustein, which suggested the importance of dignity and other intangible injuries are explored. Links between privacy interests and interests in intellectual property emerged within legislative and regulatory concerns being raised about rights to information. Of particular importance are struggles over information rights as they apply to individuals and rights claimed by corporate actors, including those rights being claimed by corporate pursuit of First Amendment, or speech, rights. Distinctions are also drawn in this chapter between rights sought as defenses against actions taken by corporate actors versus those of governmental actors, given the fact that the First Amendment as a constraint applies only to agencies of government. A variety of specific cases and continuing struggles within the legal and regulatory environment are described, and due note is taken of the increasing influence of a neoliberal framing of a “marketplace solution” as the appropriate solution for conflicts over informational rights. The chapter concludes with a discussion of “Fair Information Practices” as a strategy for assigning oversight responsibility for informational regulation to a government agency. While there was expression of hope and desire for a governmental agency focused solely on privacy-related concerns, the creation of such an agency in the United States was not forthcoming.