Expanded FDA regulation of health and wellness apps

This paper argues that the Food and Drug Administration’s (FDA) policy for health and wellness apps is ethically problematic. Currently, the FDA does not regulate health and wellness apps that are not intended for medical use. As a result of this hands-off policy, preventing harm to consumers is left primarily to developers and app marketplaces. We argue that the FDA’s duties to prevent harm and maintain accountability to the American public require that they play a much stronger role. We also discuss concerns about efficiency and fostering innovation, and argue that while they should help shape FDA regulation of health and wellness apps, they do not justify complete absence of FDA involvement.     

A brave new beef: The US food and drug administration's review of the safety of cloned animal products

To meet its public mandate, the US Food and Drug Administration (FDA) collected studies on the potential health hazards of eating or drinking cloned food products. Based on an earlier National Academy of Sciences study that, on closer analysis, was not nearly as sanguine, the FDA's report found no evidence of a health risk from the public's ingestion of cloned food products. This article analyzes the risks the FDA considered, and concludes that there is a disconnect between the risks the FDA assessed in these studies and the risks that might arise from cloned food products. The FDA should consider instituting effective tracking mechanisms and other diagnostics that would permit scientists and the public to answer the question of health risks posed by cloned food products.     

Why do we need drugs to treat the patient with obesity?

Objective:

Obesity is a public health problem, which increases the risk of chronic diseases and mortality. Weight loss can reduce mortality and improve most of the detrimental health consequences of obesity.

Design and Methods:

This paper was developed from two presentations to the US Food and Drug Administration (FDA), which has responsibility for reviewing and approving drugs to treat obesity.

Results:

A weight loss of 5% or more is sufficient to significantly reduce health risks in individuals with impaired glucose tolerance, hypertension, or nonalcoholic fatty liver disease. Slightly more weight loss (16% on average, achieved by surgery) reduces mortality. The goal of medicating for obesity is to help more patients achieve more weight loss. A barrier to drug approval has been the concern that weight loss medications might be used by individuals with little or no health risks, thus mandating a low side effect profile for approval of any drug. This limits the options for patients who have obesity‐related health problems that could improve with weight loss. Recently the FDA signaled interest in identifying health benefits in higher risk patients that might justify medications with higher risk; however, the potential impact on a large segment of the population has led the FDA to consider requiring a cardiovascular outcome trial for all obesity medications, either prior to or after approval.

Conclusion:

This review argues that drugs are needed for obesity because they enhance behaviorally induced weight loss and that new medications for obesity are needed in the approval process.     

Current status of targets and assays for anti-HIV drug screening

HIV/AIDS is one of the most serious public health challenges globally. Despite the great efforts that are being devoted to prevent, treat and to better understand the disease, it is one of the main causes of morbidity and mortality worldwide. Currently, there are 30 drugs or combinations of drugs approved by FDA. Because of the side-effects, price and drug resistance, it is essential to discover new targets, to develop new technology and to find new anti-HIV drugs. This review summarizes the major targets and assays currently used in anti-HIV drug screening.      

Current Status of Targets and Assays for Anti-HIV Drug Screening

HIV/AIDS is one of the most serious public health challenges globally. Despite the great efforts that are being devoted to prevent,treat and to better understand the disease,it is one of the main causes of morbidity and mortality worldwide. Currently,there are 30 drugs or combinations of drugs approved by FDA. Because of the side-effects,price and drug resistance,it is essential to discover new targets,to develop new technology and to find new anti-HIV drugs. This review summarizes the major targets and assays currently used in anti-HIV drug screening.     

二级及以上公立医疗机构公共卫生相关科室设置分析

目的 摸底二级以上医疗机构公共卫生工作的组织方式,并对其设置公共卫生职能科室的必要性进行讨论。方法 检索北大法律信息数据库查找相关政府文件,梳理医疗机构设置公共卫生相关科室的要求。对发文要求设立公共卫生科室的省份和对比省份的163家医疗机构进行问卷调查。结果 原卫生部要求500张床位以上的医疗机构设立预防保健科,2003年以后部分省份发文要求二级以上医疗机构设立疾病预防控制或公共卫生科。72.5%的发文地区医疗机构和39.8%的未发文地区医疗机构设立了公共卫生相关科室,二级以上公立医疗机构设置公共卫生科室对公共卫生职责的承担有促进作用。结论 二级以上医疗机构应当设置公共卫生职能科室,以促进公共卫生职责的落实。     

Body composition of animals treated with partitioning agents: implications for human health.

Excess fat in meat products has been identified as a dietary problem by public health officials. The meat animal industry has responded during the last 25 years to concerns about excess fat intake from animal products by implementing strategies to depress fat deposition and increase lean (protein) tissue gain in meat animals. The most successful strategy to date is the use of large, late-maturing animals for meat production. At desired market weights, these animals are much leaner than smaller, early-maturing animals. In addition, exogenous agents such as anabolic steroids (FDA approved for cattle) have been used to increase lean gain and depress fat deposition in cattle. Growth hormone (GH) and beta-adrenergic agonists (beta AA) are not yet approved by the FDA, but if/when approved would also markedly increase lean gain and depress fat deposition. Both GH and beta AA are called partitioning agents because they partition nutrients and energy toward lean (protein) accretion and dramatically lower fat deposition. Contingent on approval by the FDA and subsequent adoption of partitioning agents by the animal industry would result in meat products containing less and 30% of total calories from fat.     

The evolution of law in biopreparedness

The decade following the terrorist attacks on September 11, 2001, and ensuing anthrax exposures that same fall has seen significant legal reforms designed to improve biopreparedness nationally. Over the past 10 years, a transformative series of legal changes have effectively (1) rebuilt components of federal, state, and local governments to improve response efforts; (2) created an entire new legal classification known as "public health emergencies"; and (3) overhauled existing legal norms defining the roles and responsibilities of public and private actors in emergency response efforts. The back story as to how law plays an essential role in facilitating biopreparedness, however, is pocked with controversies and conflicts between law- and policymakers, public health officials, emergency managers, civil libertarians, scholars, and others. Significant legal challenges for the next decade remain. Issues related to interjurisdictional coordination; duplicative legal declarations of emergency, disaster, and public health emergency; real-time legal decision making; and liability protections for emergency responders and entities remain unresolved. This article explores the evolving tale underlying the rise and prominence of law as a pivotal tool in national biopreparedness and response efforts in the interests of preventing excess morbidity and mortality during public health emergencies.     

Bioterrorism with zoonotic disease: public health preparedness lessons from a multiagency exercise

Responding to agricultural bioterrorism with pathogenic agents that are communicable from animals to humans (zoonotic diseases) requires effective coordination of many organizations, both inside and outside of government. Action must be simultaneously taken to address public health concerns, respond to the agricultural dimensions of the event, and carry out the necessary law enforcement investigation. As part of a project focused on examining public health preparedness in Georgia, an exercise was carried out in July 2005 examining the intentional introduction of avian influenza (H5N1) in commercial poultry operations. The attack scenario, which was written to occur during an already severe human influenza season, enabled exploration of a range of issues associated with public health preparedness for major disease outbreaks including pandemic influenza, coordination of a multiagency response operation at multiple levels of government, and effective management of interdisciplinary response activities. The exercise is described and broader policy lessons regarding preparedness planning are discussed.     

The US national antimicrobial resistance monitoring system.

The use of antimicrobial agents in food animals can select for resistant bacterial pathogens that may be transmitted to humans via the commercial meat supply. In the USA, the FDA's Center for Veterinary Medicine regulatory duties require a determination that antimicrobial drugs are safe and effective for use in food animals. In addition, a qualitative assessment of risks to human health from antimicrobial resistance requires development. This risk assessment process is supported by data generated by the FDA's National Antimicrobial Resistance Monitoring System (NARMS) for enteric bacteria. NARMS data on antimicrobial susceptibility among Salmonella, Campylobacter, Escherichia coli and Enterococcus is collected. Research activities defining the genetic bases of resistance helps to understand the potential public health risks posed by the spread of antimicrobial resistance from food animal antimicrobial use. These activities help insure that antimicrobials are used judiciously to promote human and animal health.     

Access to essential medicines: a Hobbesian social contract approach

Medicines that are vital for the saving and preserving of life in conditions of public health emergency or endemic serious disease are known as essential medicines. In many developing world settings such medicines may be unavailable, or unaffordably expensive for the majority of those in need of them. Furthermore, for many serious diseases (such as HIV/AIDS and tuberculosis) these essential medicines are protected by patents that permit the patent-holder to operate a monopoly on their manufacture and supply, and to price these medicines well above marginal cost. Recent international legal doctrine has placed great stress on the need to globalise intellectual property rights protections, and on the rights of intellectual property rights holders to have their property rights enforced. Although international intellectual property rights law does permit compulsory licensing of protected inventions in the interests of public health, the use of this right by sovereign states has proved highly controversial. In this paper I give an argument in support of states' sovereign right to expropriate private intellectual property in conditions of public health emergency. This argument turns on a social contract argument for the legitimacy of states. The argument shows, further, that under some circumstances states are not merely permitted compulsory to license inventions, but are actually obliged to do so, on pain of failure of their legitimacy as sovereign states. The argument draws freely on a loose interpretation of Thomas Hobbes's arguments in his Leviathan, and on an analogy between his state of War and the situation of public health disasters.     

Effective communication between hospital staff and patients in compliance with personal data protection regulations

Secure communication between patients and health care facilities is especially important In 2016, the European Union (EU) introduced a new regulation — the General Data Protection Regulation (GDPR), applicable in all EU member states — aimed at improving protection of personal data. The GDPR provides broad guidelines on data protection, but generally lacks specific details. Consequently, although member states must comply with the GDPR, there is some flexibility to develop new regulations to suit national characteristics and practices, especially in key economic sectors, such as health care. The aim of the present article is to discuss the benefits and limitations of legal provisions governing the patient identification (both in-person and remotely). This analysis is based on Polish laws that were recently passed to comply with the GDPR. In some cases, these data protection regulations may be unnecessarily strict, making routine care more difficult than intended by the GDPR. National legislation in Poland imposes strict data protection measures, such as prohibiting the public display of patient names or calling out the patient’s name in public. However, after health care personnel around the country criticised many of these measures, the law will be modified to address those concerns. For example, the patient’s name can be displayed on a wrist band and on containers with the patient’s medicines. Nonetheless, numerous questions still need to be resolved to adapt the general data protection rules to ensure the effective operation of the hospital to avoid problems related to accurate patient identification.     

Early warning indicators of changes in soil ecosystem functioning

In the last decades, soil is facing numerous environmental threats and climatic changes that are causing a rapid decline of soil fertility and biodiversity. Soil organic matter (SOM), has the most widely recognized influence on soil quality, but it hardly puts in evidence processes associated to the new soil threats, because of its insensitivity in assessing soil quality changes in the short-term. A series of chemical and biochemical analyses were carried out in agricultural and forestry soil ecosystems subjected to different threats, to identify the parameters that better evidence changes in soil characteristics in a short term, but the identification of basic universal indicators and the choice of the number of estimated measures are still under investigation and discussion. The main aim of this paper was to identify biochemical markers to be used routinely and applicable to different soil ecosystems, as early warning indicators of alteration in soil ecosystem functioning. The results obtained allowed to identify three indicators, microbial biomass (MBC), water soluble phenols (WSP), and fluorescein diacetate hydrolase (FDA), as effective tools in the evaluation of soil quality changes in the short term, showing also a threat-indicator specificity. MBC reflected changes mainly induced by abiotic stress, FDA displayed modification caused by climate, and WSP pointed out alteration due to the organic amendment.     

Maternal and child health in China.

China has made great progress in improving the health of women and children over the past two generations. The success has been attributed to improved living standards, public health measures, and good access to health services. Although overall infant and maternal mortality rates are relatively low there are large differences in patterns of mortality between urban and rural areas. The Chinese have developed a hierarchical network of maternal and child health services, with each level taking a supervisory and teaching role for the level below it. Maternal and child health in China came to international attention in 1995 with the promulgation of the maternal and child health law. In China this was seen as a means of prioritising resources and improving the quality of services, but in the West it was widely described as a law on eugenics.     

Genomics, public health and developing countries: the case of the Mexican National Institute of Genomic Medicine (INMEGEN)

In 2004, the government of Mexico established the National Institute of Genomic Medicine (INMEGEN), to carry out disease-related genomic studies that will address national health problems and stimulate scientific and technological development by generating new commercial products and services in genomic medicine. Towards this end, INMEGEN is carrying out a large-scale genotyping project to map genomic variation within its own population. The initiative is expected to generate a key resource for local researchers to understand disease susceptibility and variation in drug responses, which will contribute to Mexico's goal of developing public health genomics - a field in which Mexico is proving to be a leader amongst emerging economies.     

The use of government to protect and promote the health of the public through nutrition.

There are broad requirements for translation of scientific knowledge in nutrition to public policy through the legislative process. First, it requires an ability to take highly objective, highly specific, scientifically derived facts--the stuff of scientific knowledge--and translate them into legislation based on highly subjective, quite general, broadly perceived values. Another requirement is to keep the level of uncertainty to tolerable levels during consideration of a legislative proposal. Finally, the governmental action proposed must conform to the perception held at that particular time of the role of government in carrying out the law. Three examples of the use of government to protect and promote the health of the public through nutrition are given. They illustrate very well the trials and tribulations of the untidy process of translating scientific knowledge in nutrition to public policy. Governmental action to improve the health of the general public through dietary means has been much a part of this country's policies. The augmentation of purchasing power of the poor, the distribution of surplus commodities to the indigent, the provision of meals to school children and the elderly, etc., are examples of govermental action. There will be further use of government to protect and promote the health of the public through nutrition. A basic requirement is further understanding of the relationship between nutrients and health through good scientific work.     

Legal challenges posed by the use of antimicrobials in food animal production

This review article provides a general analysis of the legal challenges presented by antimicrobial use in food animal production and the emerging public health responses to such use. The article stresses the importance of national and international law to the public health strategies and the interdependence between national and international law. The article argues that antimicrobial use in food animal production poses a challenge to the development of global health jurisprudence.     

Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing

Background

Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.

Methods and Findings

Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1–14). Six “teaser” advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.

Conclusions

Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.     

突发性公共卫生事件中法医工作者的角色探究

突发性公共卫生事件已经成为当前人类社会面临的一项重大难题和挑战。在应对和处置各类突发性公共卫生事件法医工作者被社会和国家赋予了重要的义务和责任。本文对法医工作者在解决各类突发性公共卫生事件中的角色定位进行了探讨,阐明法医工作者在应对和处置突发性公共卫生事件中发挥的重要作用。同时,针对现在和未来突发性公共卫生事件的发生发展趋势,对法医工作者在应对和处置这些事件中的角色作用提出了展望,并对法医工作者如何来提高自身的综合业务能力和素质,以便更好地来扮演好在突发性公共卫生事件中的角色。