Assessment of Reasons for Ownership and Attitudes About Policies Among Firearm Owners With and Without Children.

Importance: Given the dangers that firearms in the home pose to children, it is critical to engage parents in effective firearm safety counseling. This requires a broader understanding of how the presence of children in the home is associated with motivations surrounding gun ownership. Objective: To examine the association of having children in the home and gun owners' attitudes and beliefs. Design, Setting, and Participants: This cross-sectional survey study analyzed data from the National Lawful Use of Guns Survey conducted in 2019. A representative sample of 3698 adult gun owners nationwide were randomly invited to participate, with a 56.5% survey response rate. Survey responses were weighted to account for survey nonresponse and selection bias, and comparison groups were matched by age. Statistical analysis was performed in 2020. Main Outcomes and Measures: Reasons for gun ownership, symbolic meaning of guns, and attitudes toward gun policies. Results: Of the 2086 respondents, 383 (18.4%) had children in the home, 68.7% (95% CI, 66.4%-71.0%) were male, 8.2% (95% CI, 6.8%-9.7%) were Black, 76.3% (95% CI, 73.8%-78.6%) were White, 79.4% (95% CI, 77.5%-81.2%) were living in metropolitan areas, 51.3% (95% CI, 48.9%-53.8%) identified as Republican; 34.7% (95% CI, 32.6%-36.9%) were aged 60 years or older. Despite the majority of respondents feeling safe in their local communities (respondents with children: 93.4% [95% CI,: 89.3%-96.0%]; without children: 88.9% [95% CI, 87.0%- 90.6%]), 92.3% (95% CI, 87.0%-95.6%) of respondents with children stated the primary reason for gun ownership was to protect their family, compared with 68.6% (95% CI, 65.2%-71.8%) of respondents without children. On logistic regression analysis, having children in the home remained an independent factor associated with reasons for gun ownership. Gun owners with children were more likely than those without children to feel that guns make them feel more valuable to their family (23.5% [95% CI, 18.9%-28.8%] vs 17.0% [95% CI, 15.0%-19.2%]). Among those with children, 35.2% (95% CI, 30.0%-40.8%) believed gun laws should be more strict compared with 40.7% (95% CI, 38.1%- 43.3%) of those without children. Conclusions and Relevance: These findings suggest that acknowledging parental motivations for gun ownership is a pivotal component of educational efforts toward firearm injury prevention. These findings can guide clinicians to engage in effective individual counseling and community level efforts to reduce pediatric gun injuries.

Pet primates for sale in the United States.

Our research goal was to investigate the primate pet trade in the United States. While dogs and cats are the most common type of pet, there are an estimated 15,000 pet primates in the United States and the demand for exotic pets in general has been rising. Most research on pet primates occurs in habitat countries and little is known about these pets in the United States. We collected data from six exotic pet-trade websites twice a month for 12 months. We recorded the type of primate for sale, sex, age, location, and price. We used Chi-Square Goodness-of-Fit tests to compare whether the number of male and female pet primates for sale and the number of different age categories of pet primates for sale differed from equality and Spearman Correlation to examine associations between price and size and price and supply. We recorded 551 pet primates for sale between June 2019-June 2020, with 69.1% platyrrhines, 21.6% strepsirrhines, and 8.9% catarrhines. Marmosets were sold most often (36.7%, N = 202) followed by lemurs (21.6%, N = 119), capuchins (11.3%, N = 62), and squirrel monkeys (10.5%, N = 58). Almost two-thirds of the pet primates for sale were male (Chi-Square = 16.056, df = 1, P = 0. 00006) and 78.7% were under one year old (Chi-Square = 440.264, df = 2, P<0.00001). The median price was $3,800 though price was highly variable, even for the same taxa. There are several potential drivers for the primate pet trade, including media influence, fashion/status, and profitable breeding though these are not mutually exclusive. Primates do not make good pets and even when captive-bred, pet primates impact the conservation of their wild counterparts. Advertisement campaigns focusing on disease transmission and legal consequences and a federal ban on pet primate ownership are two avenues to pursue to end the ownership of pet primates in the United States.

Assessment of losses to the local population due to restrictions on their ownership rights to land and property assets: The case of the Tunkinsky National Park, Russia.

The impact of protected areas on local communities is the subject of intense discussions as part of the implementation of the global ecosystem protection agenda. Conflicts between the interests of environmental protection and the needs of socio-economic development become particularly acute when large areas of land are taken out of economic circulation as a result of organizing protected areas. In this case, there is an urgent need for detailed and reliable information about the social impacts of such land withdrawal on the well-being of the local population. An analysis of the methodological approaches widely presented in the literature, used to assess the social impact of protected areas, testifies to the insufficiency of completed and practically applicable methodological guidelines for the areas with significant restrictions for people who form part of the protected landscape. In this study, we understand the cost estimate of the social impact of national parks on the local population as a quantitative calculation of the losses due to restrictions on their ownership rights to land and property assets. The methodological approach consists in considering the category of losses as a sum total of the actual damage and lost profits. The assessment algorithm includes three stages: systematization of social impacts on citizens, development of indicators and data collection, and calculation of actual damage to the population and lost profits. The assessment is performed using the example of the Tunkinsky National Park located in the Tunkinsky municipal district of the Republic of Buryatia, a region of the Russian Federation, where there are 14 rural settlements with a population of more than 20,000 people. The results of the calculations show that the losses of the rural population due to legal restrictions on the registration of land dealings amount to 170.4 million USD. Taking into account the potential amount of administrative fines and the value of property subject to demolition, the losses amount to 239.2 million USD. It is more than an order of magnitude greater than the amount of own revenues of the Tunkinsky municipal district in 2011-2019. The results obtained demonstrate the real picture of the impact of restrictions on the rights of local people to land within the boundaries of national parks and are useful for developing measures to account for their interests and include protected areas in the socio-economic development of regions. The methodological approach developed by the authors can be used in other national parks, where it is necessary to optimize the policy of improving land use for local residents.

Intimate partner violence and female property rights.

Intimate partner violence (IPV) affects 30% of ever-partnered women worldwide. This study demonstrates how stronger female marital property rights can lead to lower levels of IPV. If women are financially protected outside of marriage, they in turn experience lower levels of violence inside marriage. Using a natural experiment from the colonization of Sub-Saharan Africa, this study aims to isolate the direct effect of large-scale changes to women's property rights from other IPV risk factors. The findings show that more equitable marital property rights could both reduce the incidence of IPV and also increase women's own condemnation of the violence. The empirical estimates suggest that legal property reform could render at least 12 million women less vulnerable to IPV across Sub-Saharan Africa.

Simulating the Suicide Prevention Effects of Firearms Restrictions Based on Psychiatric Hospitalization and Treatment Records: Social Benefits and Unintended Adverse Consequences.

Objectives. To estimate the number of lives saved from firearms suicide with expansions of gun restrictions based on mental health compared with the number who would be unnecessarily restricted. Methods. Agent-based models simulated effects on suicide mortality resulting from 5-year ownership disqualifications in New York City for individuals with any psychiatric hospitalization and, more broadly, anyone receiving psychiatric treatment. Results. Restrictions based on New York State Office of Mental Health-identified psychiatric hospitalizations reduced suicide among those hospitalized by 85.1% (95% credible interval = 36.5%, 100.0%). Disqualifications for anyone receiving psychiatric treatment reduced firearm suicide rates among those affected and in the population; however, 244 820 people were prohibited from firearm ownership who would not have died from firearm suicide even without the policy. Conclusions. In this simulation, denying firearm access to individuals in psychiatric treatment reduces firearm suicide among those groups but largely will not affect population rates. Broad and unfeasible disqualification criteria would needlessly restrict millions at low risk, with potential consequences for civil rights, increased stigma, and discouraged help seeking.

Alienation from the Objectives of the Patent System: How to Remedy the Situation of Biotechnology Patent.

Some fundamental biotechnologies hold unprecedented potential to eradicate many incurable diseases. However, in absence of regulations, the power of patent makes the future use of some important biotechnology in few institution's hands. The excessive patents restrict researcher access to the fundamental technologies. It generates concerns and complaints of deteriorating the public health and social welfare. Furthermore, intellectual curiosities, funding, respect among colleagues etc., rather than patents, are the real motivations driving a major ground-breaking discoveries in biotechnology. These phenomena reveal that some biotechnology patents are alienated from the purpose of patent system. Therefore, it is necessary to take some approaches to stop over-patenting these fundamental biotechnology inventions. This article proposes a model regulatory framework for controlling biotechnology patent alienating from the purpose of patent system.

Similar or the Same? Why Biosimilars are not the Solution.

Advancements in the field of biotechnology have accelerated the development of drugs that are manufactured from cultures of living cells, commonly referred to as "biologics." Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference product, and accordingly are referred to as "biosimilars." Encouraging the development of biosimilars has been presented as the key solution to decrease prices and increase access to biologics, but the development and use of biosimilars continues to raise problems, none of which can easily be addressed. Developing a biosimilar requires considerable time and financial resources, and legitimate safety concerns necessitate elaborate clinical testing of biosimilars. As a consequence, the introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist. This article will explain how the biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as a key condition for benefiting from the corresponding monopoly position. Hence, we propose establishing a mechanism of mandatory deposit of the original biologic's cell line at the stage of the regulatory approval as the most effective remedy.

Provenance and risk in transfer of biological materials.

Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers how risk aversion dominates MTA negotiations and the impact it may have on scientific progress. Risk aversion is often based on unwarranted fears of incurring liability through the use of a material or loss of control or missing out on commercialisation opportunities. Evidence to date has suggested that complexity tends to permeate even straightforward transactions despite extensive efforts to implement simple, standard MTAs. We argue that in most cases, MTAs need do little more than establish provenance, and any attempt to extend MTAs beyond this simple function constitutes stifling behaviour. Drawing on available examples of favourable practice, we point to a number of strategies that may usefully be employed to reduce risk-averse tendencies, including the promotion of simplicity, education of those engaged in the MTA process, and achieving a cultural shift in the way in which technology transfer office (TTO) success is measured in institutions employing MTAs.

Malpractice Environment vs Direct Litigation: What Drives Nursing Home Exit?

An ongoing concern about medical malpractice litigation is that it may induce provider exit, potentially affecting consumer welfare. The nursing home sector is subject to substantial litigation activity but remains generally understudied in terms of the effects of litigation, due perhaps to a paucity of readily available data. In this article, we estimate the association between litigation and nursing home exit (closure or change in ownership), separating the impact of malpractice environment from direct litigation. We use 2 main data sources for this study: Westlaw's Adverse Filings database (1997-2005) and Online Survey, Certification and Reporting data sets (1997-2005). We use probit models with state and year fixed effects to examine the relationship between litigation and the probability of nursing home closure or change in ownership with and without adjustment for malpractice environment. We examine the relationship on average and also stratify by profit status, chain membership, and market competition. We find that direct litigation against a nursing home has a nonsignificant effect on the probability of closure or change in ownership within the subsequent 2 years. In contrast, the broader malpractice environment has a significant effect on change in ownership, even for nursing homes that have not been sued, but not on closure. Effects are stronger among for-profit and chain facilities and those in more competitive markets. A high-risk malpractice environment is associated with change of ownership of nursing homes regardless of whether they have been directly sued, indicating that it is too blunt an instrument for weeding out low-quality nursing homes.

The inherent risks associated with newly traded biopharmaceutical firms.

Here, we provide a comprehensive study related to the risks of all biopharmaceutical firms going public in the USA between 1996 and 2015. We found 355 firms that met our requirements for being in the sector that focuses on creating drugs for humans. Collectively, these firms spent approximately US$86.9 billion on research and development (R&D) during this time. They also lost approximately US$69.3 billion in combined net income. We also examine the delisting of these firms from a public market, their number of collaborators at the initial public offering (IPO), and estimate the percentage ownership by other biopharmaceutical firms at the IPO.

Reconsidering the Affordable Care Act's Restrictions on Physician-Owned Hospitals: Analysis of CMS Data on Total Hip and Knee Arthroplasty.

BACKGROUND: Concerns about financial incentives and increased costs prompted legislation limiting the expansion of physician-owned hospitals in 2010. Supporters of physician-owned hospitals argue that they improve the value of care by improving quality and reducing costs. The purpose of the present study was to determine whether physician-owned and non-physician-owned hospitals differ in terms of costs, outcomes, and patient satisfaction in the setting of total hip arthroplasty (THA) and total knee arthroplasty (TKA). METHODS: With use of the U.S. Centers for Medicare & Medicaid Services (CMS) Inpatient Charge Data, we identified 45 physician-owned and 2,657 non-physician-owned hospitals that performed ≥11 primary TKA and THA procedures in 2014. Cost data, patient-satisfaction scores, and risk-adjusted complication and 30-day readmission scores for knee and hip arthroplasty patients were obtained from the multiyear CMS Hospital Compare database. RESULTS: Physician-owned hospitals received lower mean Medicare payments than did non-physician-owned hospitals for THA and TKA procedures ($11,106 compared with $12,699; p = 0.002). While the 30-day readmission score did not differ significantly between the 2 types of hospitals (4.48 compared with 4.62 for physician-owned and non-physician-owned, respectively; p = 0.104), physician-owned hospitals had a lower risk-adjusted complication score (2.83 compared with 3.04; p = 0.015). Physician-owned hospitals outperformed non-physician-owned hospitals in all patient-satisfaction categories, including mean linear scores for recommending the hospital (93.9 compared with 87.9; p < 0.001) and overall hospital rating (93.4 compared with 88.4; p < 0.001). When controlling for hospital demographic variables, status as a non-physician-owned hospital was an independent risk factor for being in the upper quartile of all inpatient payments for Medicare Severity-Diagnosis Related Group (MS-DRG) 470 (odds ratio, 3.317; 95% confidence interval, 1.174 to 9.371; p = 0.024), which may be because of a difference in CMS payment methodology. CONCLUSIONS: Our findings suggest that physician-owned hospitals are associated with lower mean Medicare costs, fewer complications, and higher patient satisfaction following THA and TKA than non-physician-owned hospitals. Policymakers should consider these data when debating the current moratorium on physician-owned hospital expansion. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

An imaginary legal conundrum: A reply to the response by Mahomed, Nöthling-Slabbert and Pepper.

In their original article on the subject of research using human biological material, Mahomed, Nöthling-Slabbert and Pepper advanced the notion that the law regarding ownership of human biological material is uncertain, and proposed that our country's healthcare policy of altruism be changed to mandatory profit-sharing by research participants. In my critique article, I took issue with the notion that the relevant law is uncertain, and suggested that Mahomed et al. failed to present a convincing argument in support of the proposed policy change from altruism to profit-sharing. In their response to my critique article, Mahomed et al. persist with the notion that the relevant law is uncertain; I suggest that this notion is erroneous, as our common law in this regard is well established, and as the authors base their argument exclusively on foreign case law. The authors further fail to make use of the opportunity to augment their argument in support of their proposed policy change from altruism to profit-sharing - in fact, they contradict themselves by disavowing their proposed policy change.

Affordable orphan drugs: a role for not-for-profit organizations.

AIMS: The success of the Regulation on Orphan Medicinal Products in the European Union is evidenced by the 127 orphan drugs that have had market authorization since 2000. However, the incentives aimed at stimulating research and development have had the unintended consequence of increasing drug cost, resulting in many orphan drugs not being cost-effective. Orphan drugs command an increasing share of the pharmaceutical market and account for a disproportionate amount of healthcare expenditure. Orphan drug ownership by socially motivated, not-for-profit organizations may facilitate access to more affordable orphan drugs, for the benefit of patients and healthcare systems alike. This study aims to describe opportunities for such organizations to become orphan drug Market Authorization Holders. METHODS: We reviewed data on the ownership of EMA designated and approved orphan drugs, identified funding opportunities and business models for not-for-profit organizations, and summarised relevant legal and policy documents concerning intellectual property rights and drug regulation. RESULTS: Using repurposed drugs as a paradigm, this narrative review navigates the regulatory hurdles, describes the legal context and identifies funding opportunities, in a bid to facilitate and encourage not-for-profit organizations to lead on the development of affordable orphan drugs. CONCLUSIONS: Although the regulatory steps required to obtain an MA for an orphan drug are numerous and challenging, they are not insurmountable and can be achieved by not-for-profit organizations that are socially motivated to reduce the costs of orphan drugs to the payers of healthcare. Opportunities for orphan drug development resulting in affordable products lie mainly with repurposed drugs.

Legal Implications of Physician Investment and Ownership in Health Care Enterprises.

This article presents a case in which a neurology group practice is considering investing in an imaging center that is owned by nonphysician investors with the aim of referring patients to this imaging center. The article reviews some important legal pitfalls in federal law that physicians must be aware of when considering such an investment and focuses on the general outlines of and exceptions to the Stark Law and the Federal Anti-Kickback Statute.

The Affordable Care Act's Effects On The Formation, Expansion, And Operation Of Physician-Owned Hospitals.

The Affordable Care Act (ACA) imposed new restrictions on the formation and expansion of physician-owned hospitals. These restrictions provided incentives for the hospitals and their owners to take preemptive actions before the effective dates of ACA provisions and modify their operations thereafter. We studied 106 physician-owned hospitals in Texas to determine how they responded to ACA restrictions. We found that there were significant pre-ACA increases in the formation, physician ownership, and physical capacity of physician-owned hospitals, which suggests that they reacted quickly to the policy changes. After the ACA's provisions took effect, the hospitals improved the use of their assets to generate increased amounts of services, revenue, and profits. We found no evidence that existing physician-owned hospitals stopped accepting Medicare to avoid the ACA restrictions, although some investors adopted a seemingly unsuccessful strategy of not accepting Medicare at physician-owned hospitals formed after implementation of the ACA. We conclude that the ACA restrictions effectively eliminated the formation of new physician-owned hospitals, thus accomplishing what previous legislative efforts had failed to do.