Digital Commons Network^™

All That Is Gold Does Not Glitter In Human Clinical Research: A Law– Policy Proposal To Brighten The Global “Gold Standard” For Drug Research And Development, Michael J. Malinowski, Grant G. Gautreaux

Journal Articles

This Article challenges the global science standard for putting new drugs on pharmacy shelves. The primary premise is that the “gold standard” of group experimental design is an antiquated extension of drug development’s crude-science past, and is inconsistent with the precision of contemporary genetics— the science that increasingly dominates the drug development pipeline. The Article identifies law– policy options that would raise the standard for human clinical research under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Government Rx--Back To The Future In Science Funding? The Next Era In Drug Development, Michael J. Malinowski

Journal Articles

The roles of government, industry, and academia in science research have been recast repeatedly since the U.S. began infusing tremendous funding during WWII. Recently, the National Institutes of Health (NIH) proposed a billion-dollar center to intervene in commercial drug development with the objective of lifting it out of a frightening fifteen-year slump in productivity. This article questions the role of the U.S. government in pharmaceutical development after completion of a map of the human genome (the touchstone of the Human Genome Project, HGP), a research undertaking spearheaded by the U.S. Government that spanned more than a decade. Specifically, the article …

Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Journal Articles

This article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century, and regulatory necessity due to the limits of science and innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based upon genetic expression). Although both factors have changed immensely, the standard for drug approval has …

Drug Development--Stuck In A State Of Puberty?: Regulatory Reform Of Human Clinical Research To Raise Responsiveness To The Reality Of Human Variability, Michael J. Malinowski

Journal Articles

Scathing critiques of the Food and Drug Administration's (“FDA”) performance by the Government Accountability Office and Institutes of Medicine, a plummet in innovative new drug approvals in spite of significant annual investment increases in biopharmaceutical research and development (“R&D”), and market controversies such as the painkiller Vioxx and the diabetes drug Avandia (both associated with significantly escalated risks of heart attacks and strokes) have raised doubts about the sufficiency of FDA *364 regulation. This Article questions how prescription medicines reach the market and proposes law-policy reforms to enhance the FDA's science standard for human clinical trials and new drug approvals. …

Louisiana Oil & Gas Update, Keith B. Hall

Journal Articles

No abstract provided.

From Agnatic Succession To Absolute Primogeniture: The Shift To Equal Rights Of Succession To Thrones And Titles In The Modern European Constitutional Monarchy, Christine Corcos

Journal Articles

No abstract provided.

Regulators As Market-Makers: Accountable Care Organizations And Competition Policy, Thomas L. Greaney

All Faculty Scholarship

Of the many elements animating structural change under health reform, Accountable Care Organizations (ACOs) have drawn the greatest attention. The ACO strategy entails regulatory interventions that at once aim to reshape the health care delivery system, improve outcomes, promote adoption of evidence based medicine and supportive technology, and create a platform for controlling costs under payment system reform. Ambitious aims to be sure. Implementation, however, has proved a wrenching process. This article looks at the intersection of markets and regulation under the Affordable Care Act. Specifically, it analyzes regulatory interventions under the MSSP designed to foster commercial market competition. Assessing …

Whose Britain Is This Anyway: Questioning Race, Class, Immigration And Nationality In Great Britain Between 1948 And 2011, Christina Jayne Cruce

Senior Independent Study Theses

This work discusses how questions of race, class, immigration and nationality have changed since 1948. To answer it I looked at the 1981 Brixton race riot and the 2011 UK urban youth riots. I argue that, despite improvements in black and white race relations, British society has continued to discriminate against black-Brits on multiple levels. I have also found that since the 1980s there has been a governmental and, more generally, a societal neglect of the working-class population as a whole. In regards to the findings of other scholars and historians, my work looks at both urban, poor blacks and …

Current Accounting Issues And Risks For Financial Management And Reporting–2012 /13; Financial Reporting Alert, American Institute Of Certified Public Accountants (Aicpa)

Industry Guides (AAGs), Risk Alerts, and Checklists

No abstract provided.

General Accounting And Auditing Developments, 2012/13; Audit Risk Alerts, American Institute Of Certified Public Accountants (Aicpa)

Industry Guides (AAGs), Risk Alerts, and Checklists

No abstract provided.

Nieman V. Versuslaw, United States District Court For The Central District Of Illinois

Historical and Topical Legal Documents

No abstract provided.

Establishing The Quality Management Baseline In The Use Of Computed Tomography Machines In Kenya, Geoffrey K. Korir, Jeska S. Wambani, Ian K. Korir, Bernard O. Ochieng

Imaging & Diagnostic Radiology, East Africa

The objective of this study was to assess the level of compliance to quality assurance and image quality standards in computed tomography facilities in Kenyan hospitals. A quality assurance inspection and physical image quality assessment in eighteen representative computed tomography facilities were completed. A quantitative method was developed and used to score the results obtained from the physical image quality measurements using the American Association of Physicists in Medicine (AAPM) water phantom. Inspection was done in order to establish the level of compliance with internationally recognized standards such as those stipulated in the European Guidelines Quality Criteria for Computed Tomography …

Indigenous Secondary Education: What Implications For Counsellors Lie In The Stories Of Indigenous Adults, Who As Children, Left Their Home Communities To Attend School?, Suzanne Jenkins

Theses

Education is the great engine of personal development. It is through education that the daughter of the peasant can become a doctor, that the son of a mineworker can become the head of the mine, that the child of a farm worker can become the president of a great nation. Nelson Mandela

Access to a ‘good’ education is often argued as deserving of the highest priority. The available research pertaining to the educational experience of Australian Indigenous students, however, too often reflects a picture of profound disadvantage, particularly in relation to their non-Indigenous counterparts. In 2008, Prime Minister Rudd announced …

Forestry Kaimin, 2011-2012, University Of Montana--Missoula. College Of Forestry And Conservation. Forestry Club

Forestry Kaimin, 1915-2015

Annual yearbook of the University of Montana’s Forestry Student Association (Forestry Club).

Brown Abroad: An Empirical Analysis Of Foreign Judicial Citation And The Metaphor Of Cosmopolitan Conversation, Sheldon B. Lyke

Vanderbilt Journal of Transnational Law

This Article generates a data set (twelve courts and thirty-two decisions) of foreign judicial citations to the landmark U.S. Supreme Court decision in Brown v. Board of Education. The purpose of this Article is to learn what happens when a case is deterritorialized and reconstituted in a different national scenario, and to conceptualize how courts around the world use foreign authority. My analysis reveals that few foreign courts used Brown in decisions involving education or race and ethnicity. Foreign courts used the case as a form of factual evidence, as a guide in understanding the proper role of a court …

The Psychic Costs Of Violating Corruption Laws, Philip M. Nichols

Vanderbilt Journal of Transnational Law

Understanding corruption is imperative for legal scholarship, both as an intellectual subject and because corruption impedes the operation of law in much of the world and inflicts damage on well-being, governance, and quality of life. Legal scholars have contributed substantial quantitative research on corruption; this paper adopts a qualitative methodology. The similarities and differences between Singapore and Malaysia present opportunities for research. Interviews with discussants in those two countries indicate a real difference in the degree to which corruption laws have been internalized. Differences in the degree of internalization suggest differences in the psychic costs imposed by violation of corruption …

Promises Of Leniency: Whether Companies Should Self-Disclose Violations Of The Foreign Corrupt Practices Act, Sarah Marberg

Vanderbilt Journal of Transnational Law

Over the last ten years, the Department of Justice (DOJ) has prosecuted an increasing number of Foreign Corrupt Practices Act (FCPA) violations, imposing larger and larger penalties. In fiscal year 2010, the Criminal Division of the DOJ imposed $1 billion in penalties as a result of violations of the FCPA, the largest in FCPA enforcement history.

Most FCPA enforcement actions are brought against corporations for conduct that American law enforcement agencies have difficulty detecting because it occurs outside of the United States. As a result, the DOJ encourages companies to voluntarily disclose FCPA violations, claiming that it will take a …

Market-Oriented Subnational Debt Regimes: Empowering The Developing World To Construct Infrastructure, S. Samuel Young

Vanderbilt Journal of Transnational Law

Globally, as national governments continue to decentralize fiscal and governmental responsibility, the sound facilitation of subnational debt markets will play a critical role in the construction of infrastructure. However, sparse scholarship exploring the optimal legal and financial frameworks for encouraging the construction of infrastructure at the subnational level has left a number of open questions. This Note primarily provides a basic overview of subnational debt trends and policies. It first reviews subnational debt regimes, comparing market-oriented regimes with regimes with varying levels of involvement by central governments. Though not always possible, the Note concludes that market-driven incentives generally produce the …

Reconsidering The U.S. Patent System: Lessons From Generics, Molly F.M. Chen

Vanderbilt Journal of Transnational Law

Scholars and pharmaceutical industry representatives consider the United States a worldwide leader in pharmaceutical innovation. However, the recent expansion of the international generics market has threatened the strength of the U.S. pharmaceutical industry. The pressure has led to the U.S. market's overreliance on a patentability standard that blocks generics competition without contributing substantially to the state of the art. This Note contrasts the U.S. nonobviousness standard and patent linkage regime with those of generics giants India and Israel and considers the effects of these policies on the relevant national and international generics industries. This Note proposes that the United States …

Dynamics Of Healthcare Reform: Bitter Pills Old And New, Christopher N.J. Roberts

Vanderbilt Journal of Transnational Law

The United States is at a crossroads--albeit one it has visited several times before. Although the Supreme Court has ruled upon the constitutionality of the Patient Protection and Affordable Care Act, the polarizing controversy surrounding national healthcare that began several generations ago is likely to continue into the foreseeable future. In this latest round of national debates, the issue of healthcare has been framed exclusively as a domestic issue. But history shows that the question of national healthcare in the United States has also been an extremely important issue for international law and international politics. To shed light on the …

2012 Series A & 2012 Refunding Series B & 2012 Refunding Series C (Federally Taxable) : Official Statement, Second Program Bonds, Tennessee State School Bond Authority.

Higher Education Facilities Program Bonds

No abstract provided.

The Foreign Trade Antitrust Improvements Act: Do We Really Want To Return To American Banana?, Joseph P. Bauer

Journal Articles

The extra-territorial reach of the antitrust laws is subject to multiple constraints, including the Commerce Clause of the constitution, the text of the antitrust statutes, and a variety of policy considerations. At the beginning of the twentieth century, in the American Banana case, the Supreme Court severely limited the application of the antitrust laws to anti-competitive behavior beyond our shores. The next eighty years saw an expansion of their extra-territorial reach, by including within their coverage a range of foreign conduct which had domestic effects. However, confusion among the lower courts as to the extent of this coverage, as well …

Overcoming Overcriminalization, Stephen F. Smith

Journal Articles

The literature treats overcriminalization (and, at the federal level, the federalization of crime) as a quantitative problem. Legislatures, on this view, have simply enacted too many crimes, and those crimes are far too broad in scope. This Article uses federal criminal law as a basis for challenging this way of conceptualizing the overcriminalization problem. The real problem with overcriminalization is qualitative, not quantitative: federal crimes are poorly defined, and courts all too often expansively construe poorly defined crimes. Courts thus are not passive victims in the vicious cycle of overcriminalization. Rather, by repeatedly interpreting criminal statutes broadly, courts have taken …

A Consumer Decision-Making Theory Of Trademark Law, Mark P. Mckenna

Journal Articles

The consumer search costs theory has dominated discussion of trademark law for the last several decades. According to this theory, trademark law aims to increase consumer welfare by reducing the cost of shopping for goods or services, and it accomplishes this goal by preventing uses of a trademark that might confuse consumers about the source of the goods with which the mark is used. This conceptual frame is wrong, and it is complicit in most of trademark law’s extraordinary expansion. “Search costs” is not sufficiently precise; many types of search costs are irrelevant to consumer behavior, and even when search …

Change V. Wozo, United States District Court For The District Of Massachusetts

Historical and Topical Legal Documents

No abstract provided.

Comparative Climate Change Torts, Robert F. Blomquist

Valparaiso University Law Review

No abstract provided.

Tracking Articulator Movements Using Orientation Measurements, An Ji, Michael T. Johnson, Jeffrey J. Berry

Speech Pathology and Audiology Faculty Research and Publications

This paper introduces a new method to track articulator movements, specifically jaw position and angle, using 5 degree of freedom (5 DOF) orientation data. The approach uses a quaternion rotation method to accomplish this jaw tracking during speech using a single senor on the mandibular incisor. Data were collected using the NDI Wave Speech Research System for one pilot subject with various speech tasks. The degree of jaw rotation from the proposed approach is compared with traditional geometric calculation. Results show that the quaternion based method is able to describe jaw angle trajectory and gives more accurate and smooth estimation …

The Experience Of Homelessness And The Human-Companion Animal Bond : A Quantitative Study : A Project Based Upon An Investigation At San Francisco Community Clinic Consortium/Veterinary Street Outreach Services, San Francisco, California, Erin J. Brewbaker

Theses, Dissertations, and Projects

This qualitative study explores homeless pet owners' perceptions regarding their experience of homelessness and the impact of companion pet accompaniment on this experience. In-person, semi-structured interviews were held with a diverse sample of 12 homeless pet owners receiving services from Veterinary Street Outreach Services (VET SOS), a volunteer-based project providing free veterinary care for the companion animals of homeless individuals in San Francisco. Participant narratives were used to explore the complexities of the experience of homelessness while being accompanied by a companion animal, personal experiences of homelessness, insights concerning the bond shared between companion animals and owner, and the experience …

Responding To Stern V. Marshall, Stephanie J. Bentley

Emory Bankruptcy Developments Journal

Stern v. Marshall is the most recent decision in a series of cases decided by the Supreme Court that involves the doctrine of public rights. The Court found that although 28 U.S.C. § 157(b)(2)(C) permits a bankruptcy court to enter final judgments on all counterclaims, Article III of the Constitution does not. The Court reiterated that Article III, Section 1 of the Constitution mandates the judicial power of the United States "be vested in one Supreme Court, and in such inferior Courts as the Congress may from time to time ordain and establish." The judges for these courts must have …

The Paradox Of Political Power: Post-Racialism, Equal Protection, And Democracy, William M. Carter Jr.

Emory Law Journal

Racial minorities have enjoyed increasing electoral success in recent years, while continuing to rank at or near the bottom in terms of health, wealth, income, education, and the effects of the criminal justice system. Some observers, including some members of the Supreme Court, have pointed to evidence of isolated electoral success as proof of "post-racialism," while ignoring the evidence of substantial continued disparities for the vast majority of people of color.