580 research outputs found
Representing Veterans
Federal law has long deprived American veterans of certain fundamental legal rights enjoyed by non-veterans and attributable to veteran sacrifice. Federal case law, for example, denies veterans the right to bring an action in tort against the federal government to vindicate in-service injuries. And the United States Code deprives veterans of their right to robust judicial oversight of Department of Veterans Affairs (VA) service-connected benefit decisions. This pair of due process deprivations is compounded by the federal statute that prohibits veterans from exercising the fundamental right to counsel during the initial stage of the VA claims process. This Article examines the federal statutory scheme and pertinent case law that has long denied veterans the right to counsel throughout the VA veteran claims adjudication process, debunks the rationales underlying that law, and concludes by recommending that the federal government extend to veterans the right to counsel throughout the VA’s benefits adjudication proceedings
Symposium: Gender, Health, and the Constitution: Reforming Clinical Trial Pregnancy Exclusions
This essay argues the exclusion of pregnant people from drug and biologic clinical trials is paternalistic, unjust, and counterproductive because the failure to include pregnant people in experimental trials can enhance risks to maternal and fetal health. Bioethicists, legal scholars, and other researchers have pleaded for reform in this context for decades. This article describes pregnancy medical drug use and the genesis and evolution of federal regulations and policies that operate to exclude pregnant people from clinical trials. It argues that the implementation of legal reforms that ensure the inclusion of pregnant people in clinical trials is imperative given Covid, the likelihood of enhanced pregnancy drug use surveillance and policing post-Dobbs, and the potential implications of the challenge to the FDA’s approval of mifepristone. It proposes three categories of reforms: regulatory reforms to the current clinical trials participation rules that pertain to pregnant people, statutory mandates and incentives aimed at enhancing the inclusion of pregnant people in clinical trials, and legal reforms to mitigate research liability concerns
Prescription-Drug Policing: The Right To Health Information Privacy Pre- and Post-Carpenter
This Article operates at the intersection of privacy law, Fourth Amendment doctrine, and prescription-drug surveillance instigated by the U.S. drug-overdose crisis. Reputable reporting sources frequently frame that ongoing crisis as a prescription-drug-overdose “epidemic.” Current epidemiological data, however, indicate that the majority of American overdose deaths are now a result of illicit and polysubstance drug use and not prescription-opioid misuse. The prescription-opioid-centric frame has nonetheless sparked the rapid rise of surveillance of prescribers and patients in the form of state prescription-drug monitoring program (“PDMP”) databases. State PDMPs, which maintain and analyze significant data concerning every dispensed controlled substance, surreptitiously collect a stunning amount of sensitive health information.
PDMPs are predominantly law enforcement investigative tools dressed up in public-health-promoting rhetoric. Under the guise of rogue prescriber, pill mill, and doctor–shopper crackdowns, the Drug Enforcement Administration (“DEA”) routinely self-issues subpoenas that permit the agency to conduct warrantless sweeps of the voluminous data stored in state PDMP databases. These rampant law enforcement sweeps procure highly sensitive health information and raise serious constitutional privacy concerns. The Supreme Court’s recent Fourth Amendment decision in Carpenter v. United States , however, may limit the DEA’s otherwise unfettered access to state PDMP databases.
Carpenter and the Fourth Amendment doctrines central to its holding motivate this Article and animate its two core contentions. First, pertinent pre-Carpenter precedent requires the DEA to obtain a warrant in order to conduct sweeps of state PDMP databases. Second, courts are even more likely to rule that warrantless DEA searches of highly sensitive health-care data run afoul of the Fourth Amendment in the post-Carpenter world. Simply stated, patient prescribing records stored in state PDMP databases are entitled to Fourth Amendment protection
Policing Pregnancy Crimes
The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization held that there is no right to abortion healthcare under the United States Constitution. This Essay details how states prosecuted pregnant people for pregnancy behaviors and speculative fetal harms prior to the Dobbs decision. In this connection, it also identifies two, related post-Dobbs concerns: (1) that states will ramp up their policing of pregnancy behaviors and (2) that prosecutors will attempt to substantiate these charges by relying on invalid scientific evidence. This Essay examines the faulty forensic science that states have used to support fetal harm allegations and reminds defense attorneys of their obligation to challenge junk science in the courtroom
Periodontitis and rheumatoid arthritis—Global efforts to untangle two complex diseases
Understanding the impact of oral health on rheumatoid arthritis (RA) will inform how best to manage patients with both periodontitis and RA. This review seeks to provide an update on interventional and mechanistic investigations, including a brief summary of European Research programs investigating the link between periodontitis and RA. Recent clinical studies are described that evaluate how the treatment of one disease impacts on the other, as are studies in both humans and animal models that have sought to identify the potential mechanisms linking the two diseases
Dynamics of bacterial blight disease in resistant and susceptible rice varieties
Bacterial blight (X. oryzae pv. oryzae) is a serious disease in rice across the world. To better control the disease, it is important to understand its epidemiology and how key aspects of this (e.g. infection efficiency, and spatial spread) change according to environment (e.g. local site conditions and season), management, and in particular, variety resistance. To explore this, we analysed data on the disease progress on resistant and susceptible varieties of rice grown at four sites in the Philippines across five seasons using a combination of mechanistic modelling and statistical analysis. Disease incidence was generally lower in the resistant variety. However, we found no evidence that the primary infection efficiency was lower in resistant varieties, suggesting that differences were largely due to reduced secondary spread. Despite secondary spread being attributed to splash dispersal which is exacerbated by wind and rain, the wetter sites of Pila and Victoria in south Luzon tended to have lower infection rates than the drier sites in central Luzon. Likewise, we found spread in the dry season can be substantial and should therefore not be ignored. In fact, we found site to be a greater determinant of the number of infection attempts suggesting that other environmental and management factors had greater effect on the disease than climate. Primary infection was characterised by spatially-random observations of disease incidence. As the season progressed, we observed an emerging short-range (1.6 m-4 m) spatial structure suggesting secondary spread was predominantly short-range, particularly where the resistant variety was grown
Enhancing access to alcohol use disorder pharmacotherapy and treatment in primary care settings: ADaPT-PC.
BACKGROUND: Only 7.8 % of individuals meeting diagnostic criteria for alcohol use disorder (AUD) receive treatment in a given year. Most individuals with AUDs are identified in primary care (PC) settings and referred to substance use disorders (SUD) clinics; however, only a minority of those referred attend treatment services. Safe and effective pharmacological treatments for AUD exist, but they are rarely prescribed by PC providers. The objective of this study is to refine, implement, and evaluate an intervention to integrate pharmacological AUD treatment options into PC settings. This paper provides a detailed description of the intervention design and the evaluation components.
METHODS/DESIGN: Three large Veterans Health Administration (VHA) facilities are participating in the intervention. The intervention targets stakeholder groups with tailored strategies based on implementation theory and prior research identifying barriers to implementation of AUD pharmacotherapy. Local SUD providers and primary care mental health integration (PCMHI) providers are trained to serve as local implementation/clinical champions and receive external facilitation. PC providers receive access to consultation from local and national clinical champions, educational materials, and a dashboard of patients with AUD on their caseloads for case identification. Veterans with AUD diagnoses receive educational information in the mail just prior to a scheduled PC visit. Effectiveness of the intervention will be evaluated through an interrupted time series with matched controls to monitor change in facility level AUD pharmacotherapy prescribing rates. Following Stetler\u27s four-phase formative evaluation (FE) strategy, FE methods include (1) developmental FE (pre-implementation interviews with champions, PC providers, and Veterans), (2) implementation-focused FE (tracking attendance at facilitation meetings, academic detailing efforts by local champions, and patient dashboard utilization), (3) progress-focused FE (tracking rates of AUD pharmacotherapy prescribing and rates of referral to PCMHI and SUD specialty care), and (4) interpretive FE (post-implementation interviews with champions and PC providers). Analysis of FE data will be guided by the Consolidated Framework for Implementation Research (CFIR).
DISCUSSION: If demonstrated to be successful, this implementation strategy will provide a replicable, feasible, and relative low-cost method for integrating AUD treatment services into PC settings, thereby increasing access to AUD treatment
Enhancing access to alcohol use disorder pharmacotherapy and treatment in primary care settings: ADaPT-PC
Background: Only 7.8% of individuals meeting diagnostic criteria for alcohol use disorder (AUD) receive treatment in a given year. Most individuals with AUDs are identified in primary care (PC) settings and referred to substance use disorders (SUD) clinics; however, only a minority of those referred attend treatment services. Safe and effective pharmacological treatments for AUD exist, but they are rarely prescribed by PC providers. The objective of this study is to refine, implement, and evaluate an intervention to integrate pharmacological AUD treatment options into PC settings. This paper provides a detailed description of the intervention design and the evaluation components.
Methods/design: Three large Veterans Health Administration (VHA) facilities are participating in the intervention. The intervention targets stakeholder groups with tailored strategies based on implementation theory and prior research identifying barriers to implementation of AUD pharmacotherapy. Local SUD providers and primary care mental health integration (PCMHI) providers are trained to serve as local implementation/clinical champions and receive external facilitation. PC providers receive access to consultation from local and national clinical champions, educational materials, and a dashboard of patients with AUD on their caseloads for case identification. Veterans with AUD diagnoses receive educational information in the mail just prior to a scheduled PC visit. Effectiveness of the intervention will be evaluated through an interrupted time series with matched controls to monitor change in facility level AUD pharmacotherapy prescribing rates. Following Stetler\u27s four-phase formative evaluation (FE) strategy, FE methods include (1) developmental FE (pre-implementation interviews with champions, PC providers, and Veterans), (2) implementation-focused FE (tracking attendance at facilitation meetings, academic detailing efforts by local champions, and patient dashboard utilization), (3) progress-focused FE (tracking rates of AUD pharmacotherapy prescribing and rates of referral to PCMHI and SUD specialty care), and (4) interpretive FE (post- implementation interviews with champions and PC providers). Analysis of FE data will be guided by the Consolidated Framework for Implementation Research (CFIR).
Discussion: If demonstrated to be successful, this implementation strategy will provide a replicable, feasible, and relative low-cost method for integrating AUD treatment services into PC settings, thereby increasing access to AUD treatment
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