Regulating Rare Disease: Safely Facilitating Access to Orphan Drugs

While approximately one in ten Americans suffers from a rare disease, only 5 percent of rare diseases have a U.S. Food and Drug Administration (FDA) approved treatment. Congressional and regulatory efforts to stimulate the development of rare-disease treatments, while laudable, have not resolved the fundamental issues surrounding rare-disease treatment development. Indeed, small patient populations, incomplete scientific understanding of rare diseases, and high development costs continually limit the availability of rare-disease treatments. To illustrate the struggle of developing and approving safe rare-disease treatments, this Note begins by discussing the approval of Eteplirsen, the first drug approved for treating a rare disease called Duchenne muscular dystrophy. After exploring the current drug regulation system and how this impacts the availability of rare-disease treatments, this Note examines the 21st Century Cures Act’s patient experience data provisions and the currently pending Trickett Wendler Right to Try Act. Ultimately, the unmet therapeutic needs of rare-disease patients can be met while protecting patient safety, this Note reasons that, if carefully implemented, the 21st Century Cures Act and the Trickett Wendler Right to Try Act could work in tandem to safely facilitate patient access to rare-disease treatments

Cut in Tiny Pieces: Ensuring That Fragmented Ownership Does Not Chill Creativity

The market for video entertainment is growing and becoming more diverse as technology reduces barriers to entry for small, independent moviemakers and distributors and increases consumers’ ability to access the media of their choice. The growing complexity of the market, however, increases transaction costs for new entrants who must obtain licenses to copyrighted music, characters, storylines, or scenes that they incorporate into their movies. The entertainment bonanza offered by new technologies may not be realized in practice because of market failure. The purposes of the Copyright and Patents Clause are frustrated because creators of new works wishing to use new technologies to build on prior creative effort confront a legal regime intertwined with older technologies and industry structures. This Article argues that the market needs new public and private law mechanisms to make it function more efficiently, by making it easier for creators of new works to (1) find the owners of preexisting content and (2) overcome other barriers to obtaining licenses, such as strategic behavior, irrational protection of entrenched bureaucracies, and obsolete, embedded capital. This Article begins with a hypothetical story of an independent moviemaker. It explains the problems that he confronts in making his movie, explores the relationship between the structure of the market for entertainment works and the circumstances that have traditionally justified legal intervention in a market economy, analyzes various models for such intervention, and proposes legislative, common law, and equitable solutions to mitigate the problems. The proposals afford a privilege for a new creator to use preexisting works when he cannot identify the holders of rights in the preexisting work, when he is unsuccessful in communicating with those rights holders, or when he proposes a reasonable royalty and is rebuffed. The purpose of copyright law is to encourage and reward creative effort. Current conditions frustrate achievement of that goal by making it easy for copyright owners to hide and then ambush creators of new works that build upon existing works. Amendment of the Copyright Act or application of the interpretive principles proposed in this article would further the law’s purpose

Straggler Root-Cause and Impact Analysis for Massive-scale Virtualized Cloud Datacenters

Increased complexity and scale of virtualized distributed systems has resulted in the manifestation of emergent phenomena substantially affecting overall system performance. This phenomena is known as “Long Tail”, whereby a small proportion of task stragglers significantly impede job completion time. While work focuses on straggler detection and mitigation, there is limited work that empirically studies straggler root-cause and quantifies its impact upon system operation. Such analysis is critical to ascertain in-depth knowledge of straggler occurrence for focusing developmental and research efforts towards solving the Long Tail challenge. This paper provides an empirical analysis of straggler root-cause within virtualized Cloud datacenters; we analyze two large-scale production systems to quantify the frequency and impact stragglers impose, and propose a method for conducting root-cause analysis. Results demonstrate approximately 5% of task stragglers impact 50% of total jobs for batch processes, and 53% of stragglers occur due to high server resource utilization. We leverage these findings to propose a method for extreme straggler detection through a combination of offline execution patterns modeling and online analytic agents to monitor tasks at runtime. Experiments show the approach is capable of detecting stragglers less than 11% into their execution lifecycle with 95% accuracy for short duration jobs

Service Now: CMDB Research

The MAPFRE Capstone team has been tasked with reviewing and recommending roadmap on the existing CMDB configuration. Paper discusses the team’s overall research on ServiceNow CMDB, Client’s deliverables and introduction to the latest technological innovations. Based on given objectives and team’s analysis we have recommended key solutions for the client to better understand the IT environment areas of business service impact, asset management, compliance, and configuration management. In addition, our research has covered all the majority of the technical and functional areas to provide greater visibility and insight into existing CMDB and IT environment

A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, and First Amendment Overprotection

Is more information always better? First Amendment commercial speech jurisprudence takes this as a given. However, when information is only available from a self-interested and marketing-savvy pharmaceutical company, more information may simply lead to more misinformation. Notably, doctors are also misled. This can result in public health harms when companies are promoting unapproved uses of prescription drugs that the Food and Drug Administration (FDA) has approved for other purposes—commonly referred to as “off-label” uses. Contrary to judicial presumptions, as well as the presumptions of some doctors and scholars, doctors are not sophisticated enough to always discern what is true versus misleading information. Doctors are susceptible to the same largely unconscious cognitive biases as all individuals; this means that they operate on “schemas” (mental presumptions) that impact how they interpret marketing information. Courts also rely on schemas about how doctors interact with marketing. These schemas have contributed to a First Amendment jurisprudence that has serious consequences for public health because it fails to account for how doctors actually interact with marketing of off-label uses, and such uses are associated with adverse health consequences. This Article argues that pharmaceutical marketing, especially regarding “offlabel” uses, should be more critically evaluated and entitled to less First Amendment protection—contrary to recent court trends, beginning with the 2011 Supreme Court case Sorrell v. IMS Health Inc. In other words, this Article is taking a new approach to address court cases that a number of scholars have criticized as unduly expanding the scope of First Amendment protection for pharmaceutical marketing with negative policy repercussions for public health. Not only are many off-label uses medically unsupported, but permitting broader promotion of such uses undermines incentives for companies to scientifically study those uses. Whereas prior articles have tended to focus on how to adapt to the new law or advocate rejecting the existing law based primarily on policy grounds, this Article uses cognitive bias literature to explain why recent cases actually fail to achieve key First Amendment goals. This Article further provides an empirically supported argument against expansion of First Amendment law for off-label promotion

Free Culture and the Digital Library Symposium Proceedings 2005: Proceedings of a Symposium held on October 14, 2005 at Emory University, Atlanta, Georgia.

Outlines the themes and contributions of the Free Culture and the Digital Library Symposium.The article provides a summary of the conflict of interests between those who seek to preserve ashared commons of information for society and those who seek to commodify information. Iintroduce a theoretical framework called Transmediation to help explain the changes in mediathat society is currently experiencing

Halted Innovation: The Expansion of Federal Jurisdiction over Medicine and the Human Body

Modern medical innovations are blurring the line between medical practice and medical devices and drugs. Historically, many techniques have been developed in medicine, without any interference from the federal government, as medical practice is (and has historically been) an area of state jurisdiction. Over the past two decades, however, the U.S. Food and Drug Administration (FDA) has been exerting jurisdiction over the human body and the practice of medicine by targeting new medical techniques for oversight and subjecting the continued use of those treatments to onerous and legally questionable regulatory requirements that hinder the use of those treatments in practice. This Article examines developing innovations in medicine and the life sciences, including gene editing (and CRISPR-Cas9, a system of gene editing that has been the subject of significant media coverage due to its wide-ranging potential uses), forms of assisted reproductive technology that could prevent the transmission of genetic diseases, stem cell therapies, and fecal microbiota transplants. The Article makes several claims. First, the Article argues that innovations in the life sciences largely fall outside of the jurisdiction of the FDA. Second, the FDA is applying a regime intended to regulate medical devices and pharmaceuticals to new innovations in the life sciences, which has a chilling effect on innovation and patient health. The Article also reveals that States—due to their historic police powers over the practice of medicine—retain a critical piece of jurisdiction over the life sciences such that the only method of accurately and adequately regulating the life sciences must include the States. Ultimately, it is critical that the regulatory apparatus surrounding the life sciences be improved, as the pace of innovation indicates that the regulation of the life sciences will continue to be salient in the near and distant future