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Mitochondrial Replacement Therapy: How A Government For The People, Failed The People, Jeffery Mark Sauer

University of Miami Law Review

Despite having the potential to significantly reduce the passage of many lethal diseases and devastating birth defects, mitochondrial replacement therapy—a controversial medical procedure in which mitochondrial RNA from a healthy female replaces the mitochondrial RNA from the intended mother in vitro—will have no place in the United States anytime soon. Under the guise of purported safety concerns and ethical dilemmas, the Republican Congress used its “power of the purse” to halt any and all research furthering mitochondrial replacement therapy, notwithstanding the fact that many leaders in the medical community have advocated for further research. Several developed countries have already implemented …

Law & Health Care Newsletter, Fall 2018

Law & Health Care Newsletter

No abstract provided.

Introduction And Geographic Availability Of New Antibiotics Approved Between 1999 And 2014, Cecilia Kållberg, Christine Årdal, Hege Salvesen Blix, Eili Klein, Elena Martinez, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen, Ramanan Laxminarayan

Faculty Scholarship

Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood. In this study, we analyze geographic availability and market introduction of antibiotics approved between 1999 and 2014.

Law & Health Care Newsletter, Summer 2018

Law & Health Care Newsletter

No abstract provided.

The Global Person: Pig-Human Embryos, Personhood, And Precision Medicine, Yvonne Cripps

Indiana Journal of Global Legal Studies

Chimeras, in the form of pig-human embryos engineered by CRISPR-Cas9 and other biotechnologies, have been created as potential sources of organs for transplantation. Against that background, and in an era of "precision medicine," this Article examines the concept of the global genetically modified person and asks whether humanness and personhood are being eroded, or finding new boundaries in intellectual property and constitutional law.

Cold Genocide: Falun Gong In China, Maria Cheung, Torsten Trey, David Matas, Richard An

Genocide Studies and Prevention: An International Journal

The article explores patterns of a cold genocide in the eradication campaign against Falun Gong. Falun Gong is a spiritual practice that has been targeted for eradication by the Chinese regime since 1999. In comparison to the documented cases of genocide, the genocide of Falun Gong stands out as anomalous because it is virtually ignored. The article seeks to elucidate the multi-faceted nature of this concealed genocide from an interdisciplinary perspective encompassing social work, medicine and law, In particular, the article demonstrates that the eradication campaign against Falun Gong is distinguishable as a cold genocide as it is: (1) multi-dimensional …

Missing: Where Are The Migrants In Pandemic Influenza Preparedness Plans?, Kolitha Wickramage, Lawrence O. Gostin, Eric A. Friedman, Phusit Prakongsai, Rapeepong Suphanchaimat, Charles Hui, Patrick Duigan, Eliana Barragan, David R. Harper

Georgetown Law Faculty Publications and Other Works

Influenza pandemics are perennial global health security threats, with novel and seasonal influenza affecting a large proportion of the world’s population, causing enormous economic and social destruction. Novel viruses such as influenza A(H7N9) continue to emerge, posing zoonotic and potential pandemic threats. Many countries have developed pandemic influenza preparedness plans (PIPPs) aimed at guiding actions and investments to respond to such outbreak events.

Migrant and mobile population groups—such as migrant workers, cross-border frontier workers, refugees, asylum seekers, and other non-citizen categories residing within national boundaries—may be disproportionately affected in the event of health emergencies, with irregular/undocumented migrants experiencing even greater …

Essential Medicines Beyond Guilt Trips And Acta-Ing Up: A Global Pharmaforum For A New Era?, Veronica Pastor

DePaul Journal of Health Care Law

No abstract provided.

Telehealth: Exploring The Ethical Issues, Jeremy D. Young, Scott A. Borgetti, Philip J. Clapham

DePaul Journal of Health Care Law

No abstract provided.

Whose Sperm Is It Anyways In The Wild, Wild West Of The Fertility Industry?, Tatiana E. Posada

Georgia State University Law Review

Imagine a couple that is unable to conceive a child naturally. Luckily, they had the money and resources available to them to conceive a child through assisted reproductive technology (ART), so they decided to start their family through the use of intrauterine insemination. They selected a sperm bank and began the arduous process of selecting a sperm donor who fit the desired traits and characteristics for their child. The sperm bank matched them with an anonymous donor, Donor 9623, and assured the couple that the donor was “a healthy male with an IQ of 160, a bachelor’s of science in …

Reforming Regenerative Medicine Regulation, Sarah Duranske

Georgia State University Law Review

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …

Insights Into Early Stage Of Antibiotic Development In Small And Medium-Sized Enterprises: A Survey Of Targets, Costs, And Durations, Christine Årdal, Enrico Baraldi, Ursula Theuretzbacher, Kevin Outterson, Jens Plahte, Francesco Ciabuschi, John-Arne Røttingen

Faculty Scholarship

Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs’ targets, costs, and durations related to discovery and early phase development of antibacterial therapies.

Quarantine And The Federal Role In Epidemics, Michael R. Ulrich, Wendy K. Mariner

Faculty Scholarship

Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public’s health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response—demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining persons who may …

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Faculty Scholarship

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication

Don’T Let The Bed Bugs Bill: Landlord Liability For Bed Bug Infestations In Georgia, Megan M. Harrison

Georgia State University Law Review

Although the historical relationship between bed bugs and humans dates back to ancient Egypt, the common bed bug, or Cimex lectularius, vanished from the beds of Americans around World War II. In the late 1990s, however, our bloodsucking bedfellows returned. Bed bug infestations are a growing public health issue. Bed bugs are now found in all fifty states, with populations in five states reaching epidemic levels. Both the Environmental Protection Agency (EPA) and the Center for Disease Control and Prevention(CDC) consider bed bugs a “pest of significant public health importance."

Despite their name, bed bugs are not limited to …

Can They Do That?: The Limits Of Governmental Power Over Medical Treatment, Paul Jerome Mclaughlin Jr.

Library Faculty Publications

The government’s power over health care is strongest when health care treatments and precautions to protect the public welfare, such as quarantines and vaccinations, are at issue. Governmental power over health care decisions weakens when an individual’s health care decisions are in question. When health care decisions would only affect the individual making them, the government’s power is even less. This article argues that government agents must be cautious in making health care determinations for others and that they should aim to protect an individual’s right to self-determination so long as those choices do not pose a threat to the …

Can They Do That? : The Limits Of Governmental Power Over Medical Treatment, Paul Mclaughlin

Law Library Faculty Scholarship

Recommended citation: Paul Jerome McLaughlin Jr. (2017) Can They Do That?: The Limits of Governmental Power over Medical Treatment, Journal of Legal Medicine, 37:3-4, 371-388, DOI: 10.1080/01947648.2017.1385039

Zika, Pregnancy, And The Law, Sam F. Halabi

Arkansas Law Review

The public health emergency surrounding the spread of the Zika virus has resurrected and brought into sharp relief some of the most vexing questions surrounding the relationship between pregnancy and law: the appropriate circumstances, if any, in which fetal tissue research is permissible; when and how the government may sponsor statements intended to influence reproductive decisions; and how to balance the health and rights of both women and their unborn children when health threats target both.

Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman

All Faculty Scholarship

Vaccines developed by the public sector are key to preventing future outbreaks of infectious diseases. However, the licensure of these vaccines to private-sector companies under terms that do not ensure both their availability and affordability compromises their development. This Essay analyzes the recent attempted licensing deal for a Zika vaccine between the U.S. Army and Sanofi, a French pharmaceutical company. The proposed grant of an exclusive license to Sanofi triggered widespread concern because none of its substantive terms were disclosed. While § 209 of the Patent Act imposes limitations on exclusive licensure, the Army released no information supporting its finding …

Sovaldi: The High Price For A Cure, Theresa C. Mahfood

Annals of Health Law and Life Sciences

No abstract provided.

Make America Discriminate Again? Why Hobby Lobby's Expansion Of Rfra Is Bad Medicine For Transgender Health Care, Alexis M. Florczak

Health Matrix: The Journal of Law-Medicine

The article highlights the implications of the U.S. Supreme Court's decision in "Burwell v. Hobby Lobby Stores, Inc." which held for-profit corporations could be exempt from the Affordable Care Act's (ACA)contraceptive mandate because of their sincerely held religious beliefs. Topics discussed include ACA Nondiscrimination or Civil Rights provision provides valuable protections to transgender individuals; and Department of Health and Human Services' further guidance on the ACA's provision.

Paying Patients: Legal And Ethical Dimensions, Govind Persad

Sturm College of Law: Faculty Scholarship

This Article explores the implications for medical care of a debate that is more familiar in the law and ethics of human subjects research: whether people should be paid to receive or decline medical interventions, or to reach certain health objectives. It examines the legal and ethical issues such payments raise, and considers various actors who might make such payments, including governments, employers, insurers, care providers, and private parties. It argues for two interrelated conclusions: first, that these payments should not be subject to blanket normative condemnation, and, second, that payments made in different settings and contexts frequently share underlying …

The Moderating Relationship Of Comorbid Psychopathology And Treatment Outcome For Young Adult Offenders In Drug Court, Patrick Mcgonigal, Kathleen A. Moore, Matthew Scott Young

Mental Health Law & Policy Faculty Publications

Title: The moderating relationship of comorbid psychopathology and treatment outcome for young adult offenders in drug court.

Background: The drug court system is an alternative to incarceration that provides offenders with non-violent, substance motivated crimes with an opportunity to dismiss their charges and undergo a rigorous substance abuse treatment program. It is unknown whether drug court is effective for young adult clients and the role of co-occurring psychopathology within this context.

Methods: This study evaluated the overall effectiveness of a drug court system applied to young adult offenders ages 18-26, and additionally explored the moderating relationship of psychiatric symptoms on …

Three Lost Ebola Facts And Public Health Legal Preparedness, Robert Gatter

Saint Louis University Journal of Health Law & Policy

Three key facts about Ebola Transmission should drive policy designed to control the risk of transmission during a crisis.

• Ebola—like HIV—is not easily transmissible human-to-human.
• Ebola has “dry” and “wet” symptoms, and only the wet symptoms threaten public health.
• A fever is Ebola’s canary in a coal mine; it provides timely warning of a coming threat.

Yet, during the U.S. Ebola scare in 2014, these three facts were lost. Unnecessary quarantine, stigma, and burden on those exposed to Ebola resulted, including especially for those who volunteered to fight the disease at its source abroad. Tragically, the law permitted these injustices …

The International Right To Health Care: A Legal And Moral Defense, Michael Da Silva

Michigan Journal of International Law

In the following, I outline the case against the international right to health care and explain why recognition of such a right is still necessary. The argument is explicitly limited to international human rights law and is primarily descriptive in nature, but I go on to explain the moral reasons to accept this account. Both the positive law and moral reasoning could be used in other health rights debates, but I do not attempt to make such claims here.

The structure of my work is as follows. I first outline three problems with recognizing an international right to health care. …

“Heal Thyself.”—An Argument For Granting Asylum To Healthcare Workers Persecuted During The 2014 West African Ebola Crisis, Bethany Echols

SMU Law Review

This article argues for a change in United States asylum policy at a time when change is needed most. Those seeking asylum must prove that they fear persecution in their home country based on one of five protected categories and that their government is the persecutor or is unable to control the actions of the persecutors. Multiple articles have recognized that the “particular social group” is the most difficult category of asylum seeker to analyze. Not only do the standards for particular social groups (PSGs) vary among circuit courts, but judicial consistency is lacking.

This article focuses on a particular …

Witch Doctors, Zombies, And Oracles: Rethinking Health In America, Ali S. Khan

Health Matrix: The Journal of Law-Medicine

To the extent we can even refer to an American healthcare "system," it functions brilliantly ... to make money. The system is designed to reward executives or major shareholders of pharmaceutical & health insurance companies, healthcare facilities, and related entities. With a rapidly aging population, healthcare will soon surpass a fifth of our economy. Of course, the American healthcare system does not function brilliantly when one considers the perspective of patients and over-extended primary care providers. Prices are growing faster than inflation or wages, healthcare is twice as costly as other comparable nations, and one third is a result of …

Public Health Preparedness & Response: An Exercise In Administrative Law, John D. Blum, Jordan Paradise

Faculty Publications & Other Works

Responses to epidemics, pandemics, and other biological disasters require multiple coordinated initiatives that combine sophisticated planning, sound emergency management, effective stockpiles, solid geographic information systems, well-developed laboratory surveillance and response, and effective management capabilities. Critical to the noted elements of planning and response is the existence of a legal structure, which underpins the operations of necessary programs. While the law may not be the first public health tool considered in a disaster, it is fundamental to the effective functioning of multiple actors and must be harmonized across jurisdictional lines. This article explores the role of law in pandemics and other …

Researching Colorado Health Law, Kerri Rowe

Publications

No abstract provided.

Data Collection, Ehrs, And Poverty Determinations, Craig Konnoth

Publications

Collecting and deploying poverty-related data is an important starting point for leveraging data regarding social determinants of health in precision medicine. However, we must rethink how we collect and deploy such data. Current modes of collection yield imprecise data that is unsuited for research. Better data can be collected by cross-referencing other sources such as employers and public benefit programs, and by incentivizing and encouraging patients and providers to provide more accurate information. Data thus collected can be used to provide appropriate individual-level clinical and non-clinical care, and to systematically determine what share of social resources healthcare should consume.