Digital Commons Network^™

Food And Drug Regulation: Statutory And Regulatory Supplement (2024), Adam I. Muchmore

Faculty Scholarship

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than comprehensive.

War & Ip, Peter K. Yu

Faculty Scholarship

On February 24, 2022, war broke out between Russia and Ukraine, sparking concerns among government leaders, intergovernmental bodies and the public at large. A month later, the Russian government issued Decree 299, which reduced to zero the royalty rate for national security-based compulsory licenses to intellectual property rights held by individuals or entities originating from the United States or other "unfriendly" nations. Meanwhile, the United States and other members of the international community imposed sanctions on Russia, raising questions about whether those sanctions would prevent U.S. companies and individuals from engaging with Russian intellectual property agencies. Many multinational corporations also …

Sharing Pathogen Sequence Data For Global Scientific Research Under The Nagoya Protocol To The Convention On Biological Diversity, Jerome H. Reichman, Carolina Dos S. Ribeiro, George B. Haringhuizen, Paul F. Uhlir

Faculty Scholarship

The Nagoya Protocol to the Convention on Biological Diversity (CBD) has threatened to impede access to genetic resources and related data for cross-border scientific research. In principle, every use of genetic resources would require a set of contracts under the CBD, in a “bilateral” regime. The related transaction costs could overwhelm many transnational research undertakings, affecting even public health responses to outbreaks and epidemics. However, the Nagoya Protocol also offers a unique opportunity to resolve this dilemma, despite struggles to define the meaning and coverage of “digital sequence information.” The coverage of genetic sequence data under the CBD remains controversial …

Medical Expenditures And The Measurement Of Poverty In The United States, Luke Petach, David Wyant

Faculty Scholarship

Using data from the Medical Expenditure Panel Survey (MEPS) we estimate the fraction of the US population that is health poor. A person is health poor if their income prior to paying health insurance premiums and out-of-pocket healthcare costs is above the poverty line, but their income net-of-premiums and out-of-pocket healthcare costs is below the poverty line. Because resources used to finance health insurance premiums and out-of-pocket costs are (A) lexicographically preferred and (B) cannot be used to maintain an individual’s standard of living, they should be excluded from official poverty estimates. Approximately 1% to 2% of the US population …

Environmental Justice Beyond 2°C, Clifford Villa

Faculty Scholarship

In the last four decades, average temperatures have risen significantly across the United States, with Alaska and New Mexico among the fastest warming states. Since 1970, average temperatures in New Mexico have risen 3.5 degrees Fahrenheit (°F)—or nearly 2 degrees Celsius (°C). The international scientific community has urged world leaders to contain global warming above pre-industrial levels to 1.5°C ideally, and to 2°C at worst. Current trajectories, however, suggest we may shoot past 2°C of global warming this century and enter a world of 3-4°C or beyond... The “trade offs” and “letting go” as we confront the looming 4°C world …

Advancing Human Rights And The Rule Of Law In Haiti, Kate E. Bloch, Ariel Chéry, Marie Gerda Dorcy, Roxane Edmond Dimanche, Yvon Janvier, Maxo Mezilas, Benjamin Trouille

Faculty Scholarship

The rule of law in Haiti is precarious. The ESCDROJ law school clinic in the town of Jérémie champions indigent individuals whose human rights are under siege during their prolonged and unconstitutional pre-trial connement in prison. To our knowledge, it is the only operating in-house law school clinic in Ha1iti. Despite myriad obstacles, during its initial pre-pandemic period of op- eration in 2018-2019, the inaugural clinic team represented clients in 43 cases brought to trial and succeeded in garnering the release of 25 of those individuals. That is a trial release success rate of over 58%. Subsequently, however, the ad- …

Anti-Patents, Roy Baharad, Stuart Minor Benjamin, Ehud Gutte

Faculty Scholarship

Conventional wisdom has long perceived the patent and tort systems as separate legal entities, each tasked with a starkly different mission. Patent law rewards novel ideas; tort law deters harmful conduct. Against this backdrop, this Essay uncovers the opposing effects of patent and tort law on innovation, introducing the "injurer-innovator problem." Patent law incentivizes injurers --often uniquely positioned to make technological breakthroughs--by allowing them to profit from licensing their inventions to competitors. Yet tort law, by imposing liability for failures to invest in care, forces injurers to incur the cost of implementing their own innovations. When the cost of self-implementation …

Disability, Race, And Health Beyond The Carceral State, Benjamin Barsky, Craig Konnoth, Michael A. Stein

Faculty Scholarship

No abstract provided.

Self-Management Intervention For Reducing Epilepsy Burden Among Adult Ugandans With Epilepsy (Smart-U): Randomised Clinical Trial Protocol, Jennifer B. Levin, Carolyn Still, Christopher J. Burant, Martha Sajatovic

Faculty Scholarship

Background:Epilepsy is a common chronic brain disorder globally affecting people of all ages, with the majority living in developing countries. The introduction of epilepsy self-management approaches to help people with epilepsy is urgently needed to influence epilepsy-related outcomes. This 2-site randomised controlled trial building on promising preliminary data is intended to explore this further. Methods: A total of 188 adult people with epilepsy (PWE) attending the neurology clinics at Mulago and Mbarara hospitals and consent to participate in the study will be recruited. They will be randomised into intervention versus enhanced treatment control (eTAU) study groups. The intervention group will …

Changes In Energy Expenditure, Dietary Intake, And Energy Availability Across An Entire Collegiate Women’S Basketball Season: Erratum, Breyannah R. Zanders, Brad S. Currier, Patrick Harty, Hannah A. Zabriskie, Charles R. Smith, Richard A. Stecker, Scott R. Richmond, Andrew R. Jagim, Chad Kerksick

Faculty Scholarship

Erratum

The Effects Of Protein And Carbohydrate Supplementation, With And Without Creatine, On Occupational Performance In Firefighters, Kaia Elstad, Conley Malone, Joel Luedke, Salvadore J. Jaime, Ward C. Dobbs, Thomas Almonroeder, Chad M. Kerksick, Adam Markert, Andrew R. Jagim

Faculty Scholarship

Background: The purpose of this study was to assess the effects of protein and carbohydrate supplementation, with and without creatine, on occupational performance in firefighters. Methods: Using a randomized, double-blind approach, thirty male firefighters (age: 34.4 ± 8.4 yrs., height: 1.82 ± 0.07 m; weight: 88.6 ± 12.5 kg; BF%: 17.2 ± 5.8%) were randomized to receive either (A.) 25 g of whey protein isolate + 25 g of carbohydrate powder (ProCarb group); or (B.) ProCarb + 5 g of creatine (Creatine group) in a double-blind fashion over a period of 21–26 days (depending on shift rotations) to evaluate …

Naturally Bicarbonated Water Supplementation Does Not Improve Anaerobic Cycling Performance Or Blood Gas Parameters In Active Men And Women, Anthony M. Hagele, Johnathan L. Boring, Jessica M. Moon, Kyle L. Sunderland, Petey W. Mumford, Chad M. Kerksick

Faculty Scholarship

The completion of high-intensity exercise results in robust perturbations to physiologic homeostasis, challenging the body’s natural buffering systems to mitigate the accumulation of metabolic by-products. Supplementation with bicarbonate has previously been used to offset metabolic acidosis, leading to improvements in anaerobic exercise performance. Purpose: The purpose of this study was to investigate the presence of ergogenic properties in naturally occurring low-dose bicarbonated water and their effects on anaerobic cycling performance and blood gas kinetics in recreationally active men and women. Methods: Thirty-nine healthy, recreationally active men and women (28.1 ± 8.0 years, 169.8 ± 11.7 cm, 68.9 ± 10.8 kg, …

Swimming Together Upstream: How To Align Mlp Services With U.S. Healthcare Delivery, William M. Sage, Keegan D. Warren

Faculty Scholarship

Medical-legal partnership (MLP) embeds attorneys and paralegals into care delivery to help clinicians address root causes of health inequities. Notwithstanding decades of favorable outcomes, MLP is not as well-known as might be expected. In this essay, the authors explore ways in which strategic alignment of legal services with healthcare services in terms of professionalism, information collection and sharing, and financing might help the MLP movement become a more widespread, sustainable model for holistic care delivery.

Reporte Final Del Estudio Del "Proyecto De Reintegración Mexicana", Guillermo J. Garcia Sanchez, Sonia Hernandez, Luz E. Herrera, Angela D. Morrison, Huyen Pham, Nancy Plankey-Videla

Faculty Scholarship

El fenómeno de los mexicanos que estan regresando a México después de una estadía prolongada en Estados Unidos es cada vez más importante. Aunque las estimaciones para el período de 2014 a 2019 muestran que más mexicanos han migrado a Estados Unidos de los que se fueron, la migración neta todavía está muy por debajo del pico de migración neta de 1995 a 2000. En el período de 2014-2019, la migración neta de mexicanos a Estados Unidos era de tan solo 160,000 versus 2.3 millones durante el periodo de 1995 a 2000. Entre 2005 y 2014, Estados Unidos experimentó una …

High Stakes, Bad Odds: Health Laws And The Revived Federalism Revolution, Nicole Huberfeld

Faculty Scholarship

The Supreme Court’s 2021 term produced a remarkable number of blockbuster decisions, nearly hiding an underlying federalism agenda that surfaced in health care, reproductive rights, administrative law, and public health related domains. Health law has been a vehicle for constitutional change before, but the stakes for older laws, most of which rely on states to accomplish national goals, have been raised. The Court has doubled down on interpretive methods that limit governmental power, using formalist tools like clear statement rules that demand specificity and offer little deference to lawmakers or regulators. These rules have constitutional dimensions, including separation of powers …

Preliminary Content And Construct Validity Of A New Model To Differentiate Research Skills From Evidence‐Based Practice Skills: Core, Evidence Application, Research (Cear) Model, Raeanne Jordan, Rosanna P. Watowicz, Catherine Phillips, Rita Obeid, Rosa K. Hand

Faculty Scholarship

Background: Research is the scientific basis for the profession of dietetics, as it must be located and applied in evidence‐based practice (EBP). EBP is often presented as a foundational skill for research. CEAR – Core, Evidence Application, Research – is a newly proposed model that separates Research and Evidence Application skills into distinct domains, jointly supported by a set of Core skills, thus acknowledging that education and advancement in one domain neither requires nor precipitates education and advancement in the other. The goal was to investigate the content and construct validity of the new CEAR Model. Methods: A cross‐sectional online …

International Society Of Sports Nutrition Position Stand: Effects Of Essential Amino Acid Supplementation On Exercise And Performance, Arny A. Ferrnado, Robert R. Wolfe, Katie R. Hirsch, David D. Church, Shiloah A. Kviatkovsky, Michael D. Roberts, Jeffrey R. Stout, Drew E. Gonzalez, Ryan J. Sowinski, Richard B. Kreider, Chad Kerksick, Nicholas A. Burd, Stefan M. Pasiakos, Michael J. Ormsbee, Shawn M. Arent, Paul J. Arciero, Bill I. Campbell, Trisha A. Van Dusseldorp, Ralf Jager, Darryn S. Willoughby, Douglas S. Kalman, Jose Antonio

Faculty Scholarship

Position Statement: The International Society of Sports Nutrition (ISSN) presents this position based on a critical examination of literature surrounding the effects of essential amino acid (EAA) supplementation on skeletal muscle maintenance and performance. This position stand is intended to provide a scientific foundation to athletes, dietitians, trainers, and other practitioners as to the benefits of supplemental EAA in both healthy and resistant (aging/clinical) populations. EAAs are crucial components of protein intake in humans, as the body cannot synthesize them. The daily recommended intake (DRI) for protein was established to prevent deficiencies due to inadequate EAA consumption. The following conclusions …

Managing Fires And Ecosystems Indigenous Fire Ecologies Session_Greenhouse Gas Emissions From Wildland Fires Workshop, Cynthia Twyford Fowler

Faculty Scholarship

No abstract provided.

Prevalence Of Adulteration In Dietary Supplements And Recommendations For Safe Supplement Practices In Sport, Andrew R. Jagim, Patrick Harty, Jacob L. Erickson, Grant M. Tinsley, Dan Garner, Andrew J. Galpin

Faculty Scholarship

The prevalence of dietary supplement use among athletes continues to rise with 60–80% of athletes often reporting current or previous use of dietary supplements. While select dietary ingredients have been shown to improve acute performance and enhance training adaptations over time, it is important to still consider the risk vs. reward for athletes before opting to consume a dietary supplement. Previous work has indicated that certain dietary supplements may pose risks for inadvertent doping, may be susceptible to mislabelling, could be banned by certain governing bodies of sport, or pose health risks for certain populations. The purpose of the current …

Federalism, Leadership, And Covid-19: Evolving Lessons For The Public’S Health, Nicole Huberfeld

Faculty Scholarship

The COVID-19 pandemic has had an enduring effect across the entire spectrum of law and policy, in areas ranging from health equity and racial justice, to constitutional law, the law of prisons, federal benefit programs, election law and much more. This collection provides a critical reflection on what changes the pandemic has already introduced, and what its legacy may be. Chapters evaluate how healthcare and government institutions have succeeded and failed during this global 'stress test,' and explore how the US and the world will move forward to ensure we are better prepared for future pandemics. This timely volume identifies …

Sex Differences In Resting Metabolic Rate Among Athletes And Association With Body Composition Parameters: A Follow-Up Investigation, Andrew R. Jagim, Margaret T. Jones, Andrew T. Askow, Joel Luedke, Jacob L. Erickson, Jennifer B. Fields, Chad Kerksick

Faculty Scholarship

The purpose of this study was to examine sex differences in resting metabolic rate (RMR) and associations between measured RMR and body composition parameters in athletes. One-hundred and ninety collegiate men (n = 98; age: 20.1 ± 1.6 yr.; body mass: 92.7 ± 17.5 kg; height: 181.6 ± 6.2 cm, body mass index: 28.0 ± 4.7 kg/m2) and women (n = 92; age: 19.4 ± 1.1 yr.; body mass: 65.2 ± 11.0 kg; height: 168.0 ± 6.6 cm, body mass index: 23.0 ± 3.6 kg/m2) athletes volunteered to participate in this study. Athletes completed a body composition assessment using air …

A Randomized Controlled Trial To Examine The Impact Of A Multi-Strain Probiotic On Self-Reported Indicators Of Depression, Anxiety, Mood, And Associated Biomarkers, Kylie E. Walden, Jessica M. Moon, Anthony M. Hagele, Leah E. Allen, Connor J. Gaige, Joesi M. Krieger, Ralf Jäger, Petey W. Mumford, Marco Pane, Chad M. Kerksick

Faculty Scholarship

Objective: To examine the efficacy of supplementing with a multi-strain probiotic (MSP) on changes associated with mood, anxiety, and neurotransmitter levels.

Method: In a randomized, double-blind, placebo-controlled fashion, 70 healthy men and women (31.0  ±  9.5  years, 173.0  ±  10.4  cm, 73.9  ±  13.8  kg, 24.6  ±  3.5  kg/m2 ) supplemented with a single capsule of MSP (a total daily dose of 4 × 109 colony forming units [CFU] comprised of a 1 × 109   CFU dose from each of the following strains: Limosilactobacillus fermentum LF16, Lacticaseibacillus rhamnosus LR06, Lactiplantibacillus plantarum LP01, and Bifidobacterium longum 04, Probiotical S.p.A., Novara, …

Editorial: Pre-Workout Nutrition, Chad Kerksick, Jamie N. Pugh

Faculty Scholarship

Unavailable.

International Society Of Sports Nutrition Position Stand: Coffee And Sports Performance, Lonnie M. Lowery, Dawn E. Anderson, Kelsey F. Scanlon, Abigail Stack, Guillermo Escalante, Sara C. Campbell, Chad M. Kerksick, Michael T. Nelson, Tim N. Vandusseldorp, Douglas S. Kalman, Bill I. Campbell, Richard B. Kreider, Jose Antonio

Faculty Scholarship

Based on review and critical analysis of the literature regarding the contents and physiological effects of coffee related to physical and cognitive performance conducted by experts in the field and selected members of the International Society of Sports Nutrition (ISSN), the following conclusions represent the official Position of the Society:

(1) Coffee is a complex matrix of hundreds of compounds. These are consumed with broad variability based upon serving size, bean type (e.g. common Arabica vs. Robusta), and brew method (water temperature, roasting method, grind size, time, and equipment).

(2) Coffee’s constituents, including but not limited to caffeine, have neuromuscular, …

Behavioral Paradigm For The Evaluation Of Stimulation-Evoked Somatosensory Perception Thresholds In Rats, Jeffrey R. Capadona

Faculty Scholarship

Intracortical microstimulation (ICMS) of the somatosensory cortex via penetrating microelectrode arrays (MEAs) can evoke cutaneous and proprioceptive sensations for restoration of perception in individuals with spinal cord injuries. However, ICMS current amplitudes needed to evoke these sensory percepts tend to change over time following implantation. Animal models have been used to investigate the mechanisms by which these changes occur and aid in the development of new engineering strategies to mitigate such changes. Non-human primates are commonly the animal of choice for investigating ICMS, but ethical concerns exist regarding their use. Rodents are a preferred animal model due to their availability, …

Effects Of Fucoidan Supplementation On Inflammatory And Immune Response After High-Intensity Exercise, Bridget A. Mcfadden, Caroline S. Vincenty, Alexa J. Chandler, Harry P. Cintineo, Blaine S. Lints, Gianna F. Mastrofini, Shawn M. Arent

Faculty Scholarship

Introduction: High-intensity exercise (HIE) can damage the musculotendon complex and impact the immune response, resulting in post-exercise inflammation. Sufficient rest and recovery will improve muscular resilience against future damaging bouts; however, HIE with minimal durations of rest is common in athletic competitions that facilitate persistent inflammation and immune dysregulation. Fucoidans are fucose-rich sulfated polysaccharides with demonstrated anti-inflammatory and pro-immune responses. Fucoidans may improve inflammation and immune responses, which may prove beneficial for individuals who regularly engage in repeated HIE. The research purpose was to investigate the safety and efficacy of fucoidans on inflammatory and immune markers following HIE.

Methods …

Femtechnodystopia, Leah R. Fowler, Michael Ulrich

Faculty Scholarship

Reproductive rights, as we have long understood them, are dead. But at the same time history seems to be moving backward, technology moves relentlessly forward. Femtech products, a category of consumer technology addressing an array of “female” health needs, seem poised to fill gaps created by states and stakeholders eager to limit birth control and abortion access and increase pregnancy surveillance and fetal rights. Period and fertility tracking applications could supplement or replace other contraception. Early digital alerts to missed periods can improve the chances of obtaining a legal abortion in states with ever-shrinking windows of availability or prompt behavioral …

Inhibition Of Wnt/Β‐Catenin Pathway Overcomes Therapeutic Resistance To Abiraterone In Castration‐Resistant Prostate Cancer, Ibrahim M. Atawia, Prem P. Kushwaha, Shiv Verma, Spencer Lin, Eswar Shankar, Sanjay Gupta

Faculty Scholarship

Abiraterone acetate has been clinically approved for the treatment of patients with advanced‐stage prostate cancer. It reduces testosterone production by blocking the enzyme cytochrome P450 17 alpha‐hydroxylase. Despite improved survival outcomes with abiraterone, almost all patients develop therapeutic resistance and disease recurrence, progressing to a more aggressive and lethal phenotype. Bioinformatics analyses predicted activation of canonical Wnt/β‐catenin and involvement of stem cell plasticity in abiraterone‐resistant prostate cancer. Increased expression of androgen receptor (AR) and β‐catenin and their crosstalk causes activation of AR target genes and regulatory networks for which overcoming acquired resistance remains a major challenge. Here we show that …

Glucose-Dependent Insulinotropic Polypeptide Monoclonal Antibodies Prevent And Treat Obesity In Wild-Type And Hyperphagic Mice, M Michael Wolfe, Michael O. Boylan

Faculty Scholarship

Objective: This study aimed to investigate whether a glucose-dependent insulinotropic polypeptide (GIP) monoclonal antibody (mAb) will promote weight loss in wild-type mice and to determine effects of this mAb in preventing weight gain in ob/ob mice. Methods: Phosphate-buffered saline (PBS) or GIP mAb was injected intraperitoneally to wild-type mice fed a 60% high-fat diet (HFD). After 12 weeks, mice that received PBS were divided into two groups and were fed a 37% HFD for 5 weeks; one group received PBS, and one group received GIP mAb. In a separate study, PBS or GIP mAb was injected intraperitoneally to ob/ob mice …

The Public Stakes Of Consumer Law: The Environment, The Economy, Health, Disinformation, And Beyond, Rory Van Loo

Faculty Scholarship

This Article shows how consumer law, a field “derided as the law of small problems,”⁴ is more accurately viewed as important for addressing large-scale societal threats. It also offers a more integrated conceptual and institutional approach to consumer law so that the field can have a better chance of fulfilling its societal potential.

Part I of this Article outlines the importance of consumer law. It maps consumer law’s connections to some of the most pressing societal threats: climate change, public health, inequality, and disinformation. Part II focuses on consumer law’s place in the legal academy and government. Currently, important …