Subject(s)
National Health Insurance, United States/history , Health Facilities/history , Health Facilities/legislation & jurisprudence , History, 20th Century , National Health Insurance, United States/legislation & jurisprudence , United States , United States Public Health Service/history , United States Public Health Service/legislation & jurisprudenceABSTRACT
The Report on Carcinogens (RoC), from the National Toxicology Program of the USA, is one of the world-leading programs for the identification and acknowledgment of substances that represent a hazard of cancer to humans. RoC covers several essential topics concerning environmental, occupational, and pharmaceutical agents that are known to be, or reasonably anticipated to be carcinogenic to humans. To promote the highest exploitation by its potential users, several RoC aspects and features were put together into one article. For doing so, a comprehensive description is provided regarding RoC history, scope, general features, listing criteria, contents, handbook, and website. Secondary and tertiary aims for this work were (a) to point out some improvement opportunities for the RoC, and (b) to discuss pending issues in regulatory science and cancer hazard assessments. In this regard, for agents classified as probably, likely, reasonably anticipated, possibly or suspected to be a human carcinogen, there is a lack of quantitative knowledge concerning the likelihood of those agents actually being carcinogenic to humans. Elucidating these probabilities is necessary, because the duration of current regulations and the arrival of new acts may depend on it. On the other hand, there is a dramatic imbalance in priorities toward carcinogens, compared with non-carcinogens, in current cancer hazard identification programs. That vision may ignore that the availability on the market of chemicals classified as probably not carcinogenic to humans can also be important for the employment, alimentation, economy, quality of life of consumers, and human health.
Subject(s)
Carcinogenicity Tests , Carcinogens/toxicity , Cell Transformation, Neoplastic/chemically induced , Environmental Exposure/adverse effects , Government Publications as Topic , Neoplasms/chemically induced , Public Health , United States Public Health Service , Animals , Carcinogens/classification , Environmental Exposure/legislation & jurisprudence , Government Regulation , Humans , Policy Making , Public Health/legislation & jurisprudence , Risk Assessment , Risk Factors , United States , United States Public Health Service/legislation & jurisprudenceSubject(s)
Anaphylaxis/epidemiology , Epinephrine/therapeutic use , Hypersensitivity/epidemiology , School Health Services/legislation & jurisprudence , United States Public Health Service/legislation & jurisprudence , Anaphylaxis/drug therapy , Emergency Medical Services , Humans , Hypersensitivity/drug therapy , Liability, Legal , United States/epidemiologySubject(s)
Community Participation , Human Experimentation/ethics , Human Experimentation/legislation & jurisprudence , Scientific Misconduct/ethics , Scientific Misconduct/legislation & jurisprudence , Community Participation/legislation & jurisprudence , Guatemala , History, 20th Century , Human Experimentation/history , Humans , Long Term Adverse Effects/ethnology , Scientific Misconduct/history , Syphilis/ethnology , Syphilis/history , United States , United States Public Health Service/ethics , United States Public Health Service/history , United States Public Health Service/legislation & jurisprudenceSubject(s)
Contraceptive Agents , Family Planning Services/legislation & jurisprudence , Health Services Accessibility/legislation & jurisprudence , Religion and Medicine , Women's Health/trends , Family Planning Services/standards , Female , Government Regulation , Humans , Patient Protection and Affordable Care Act , Pregnancy , United States , United States Public Health Service/legislation & jurisprudenceSubject(s)
Animals, Laboratory , Clinical Protocols/standards , United States Public Health Service/standards , Animal Care Committees/legislation & jurisprudence , Animal Welfare/legislation & jurisprudence , Animals , Policy , United States , United States Department of Agriculture , United States Public Health Service/legislation & jurisprudenceSubject(s)
Anniversaries and Special Events , Consumer Product Safety/legislation & jurisprudence , Government Regulation , Health Policy/legislation & jurisprudence , Public Health/legislation & jurisprudence , Smoking Cessation/legislation & jurisprudence , Smoking/legislation & jurisprudence , Tobacco Smoke Pollution/legislation & jurisprudence , United States Public Health Service/legislation & jurisprudence , Forecasting , Government Regulation/history , Health Policy/history , Health Policy/trends , Health Promotion/legislation & jurisprudence , History, 20th Century , History, 21st Century , Humans , Public Health/history , Public Health/trends , Risk Assessment , Risk Factors , Smoking/adverse effects , Smoking Cessation/history , Smoking Prevention , Time Factors , Tobacco Smoke Pollution/adverse effects , Tobacco Smoke Pollution/prevention & control , Tobacco Use Cessation Devices , United States , United States Public Health Service/history , United States Public Health Service/trendsABSTRACT
The study of wildlife, whether in the field or in the lab, may start with a hypothesis, a literature search, or a grant proposal, but in many cases, the work will never happen unless the researcher successfully navigates a maze of permit requirements. A single project can involve multiple permits at the national and state levels, and it can take months to obtain any one permit. Therefore, permits may not have been issued at the time of protocol review, but Public Health Service Policy makes accommodations for this situation. Once in hand, however, the permits convey critical information to the Institutional Animal Care and Use Committee (IACUC): one or more government agencies have determined that the activity will not be detrimental to the population or that any detriment is justified by the scientific knowledge that will be generated. This paper assumes that IACUCs are reviewing all wildlife protocols involving live vertebrates, regardless of the current, albeit temporary, distinction made by Animal and Plant Health Inspection Service Animal Care with regard to birds.
Subject(s)
Animals, Wild , Conservation of Natural Resources/legislation & jurisprudence , Ecology/legislation & jurisprudence , Licensure/legislation & jurisprudence , Research/legislation & jurisprudence , United States Public Health Service/legislation & jurisprudence , Zoology/legislation & jurisprudence , Animal Care Committees/trends , Animals , Ecology/methods , Species Specificity , United States , Zoology/methodsSubject(s)
Human Experimentation/legislation & jurisprudence , Informed Consent/legislation & jurisprudence , Judgment , Oxygen Inhalation Therapy/adverse effects , Oxygen Inhalation Therapy/methods , Parental Consent/legislation & jurisprudence , Randomized Controlled Trials as Topic/legislation & jurisprudence , Respiratory Distress Syndrome, Newborn/therapy , Retinopathy of Prematurity/etiology , Retinopathy of Prematurity/prevention & control , Uncertainty , United States Public Health Service/legislation & jurisprudence , Guideline Adherence , Humans , Infant, Newborn , Oxygen/blood , Respiratory Distress Syndrome, Newborn/blood , Respiratory Distress Syndrome, Newborn/mortality , Retinopathy of Prematurity/blood , Retinopathy of Prematurity/mortality , Risk , Survival Rate , United StatesSubject(s)
Human Experimentation/legislation & jurisprudence , Informed Consent/legislation & jurisprudence , Judgment , Oxygen Inhalation Therapy/adverse effects , Oxygen Inhalation Therapy/methods , Parental Consent/legislation & jurisprudence , Randomized Controlled Trials as Topic/legislation & jurisprudence , Respiratory Distress Syndrome, Newborn/therapy , Retinopathy of Prematurity/etiology , Retinopathy of Prematurity/prevention & control , Uncertainty , United States Public Health Service/legislation & jurisprudence , HumansABSTRACT
The high prevalence of chronic diseases in the United States with lifestyle-related risk factors, such as obesity and tobacco use, has sparked interest in legal strategies to influence health behavior. However, little is known about the public's willingness to accept these policies as legitimate, which in turn may affect compliance. We present results from a national survey of 1,817 US adults concerning the acceptability of different public health legal interventions that address noncommunicable, or chronic, diseases. We found that support for these new interventions is high overall; substantially greater among African Americans and Hispanics than among whites; and tied to perceptions of democratic representation in policy making. There was much support for strategies that enable people to exercise healthful choices--for example, menu labeling and improving access to nicotine patches--but considerably less for more coercive measures, such as insurance premium surcharges. These findings suggest that the least coercive path will be the smoothest and that support for interventions may be widespread among different social groups. In addition, the findings underscore the need for policy makers to involve the public in decision making, understand the public's values, and communicate how policy decisions reflect this understanding.
Subject(s)
Chronic Disease/prevention & control , Health Behavior , Health Policy/legislation & jurisprudence , Public Opinion , Adult , Chronic Disease/epidemiology , Cross-Sectional Studies , Female , Health Promotion/legislation & jurisprudence , Humans , Male , United States , United States Public Health Service/legislation & jurisprudenceABSTRACT
Human health experiments systematically expose people to conditions beyond the boundaries of medical evidence. Such experiments have included legal-medical collaboration, exemplified in the U.S. by the Public Health Service (PHS) Syphilis Study (Tuskegee). That medical experiment was legal, conforming to segregationist protocols and specific legislative authorization which excluded a selected group of African Americans from any medical protection from syphilis. Subsequent corrective action outlawed unethical medical experiments but did not address other forms of collaboration, including PHS submission to laws which may have placed African American women at increased risk from AIDS and breast cancer. Today, anti-lobbying law makes it a felony for PHS workers to openly challenge legally anointed suspension of medical evidence. African Americans and other vulnerable populations may thereby face excess risks-not only from cancer, but also from motor vehicle crashes, firearm assault, end stage renal disease, and other problems-with PHS workers as silent partners.
Subject(s)
Human Experimentation/legislation & jurisprudence , United States Public Health Service/legislation & jurisprudence , Adolescent , Adult , Black or African American/statistics & numerical data , Aged , Aged, 80 and over , Alabama , Contact Tracing , Female , HIV Infections/ethnology , HIV Infections/mortality , Human Experimentation/ethics , Humans , Mammography/statistics & numerical data , Medicare , Middle Aged , Syphilis/ethnology , United States , White People/statistics & numerical data , Young AdultABSTRACT
The United States Public Health Service Administration is alerting medical professionals that a substantial percentage of cocaine imported into the United States is adulterated with levamisole, a veterinary pharmaceutical that can cause blood cell disorders such as severe neutropenia and agranulocytosis. Levamisole was previously approved in combination with fluorouracil for the treatment of colon cancer; however, the drug was withdrawn from the U.S. market in 2000 because of the frequent occurrence of agranulocytosis. The detection of autoantibodies such as antithrombin (lupus anticoagulant) and an increased risk of agranulocytosis in patients carrying the human leukocyte antigen B27 genotype suggest that toxicity is immune-mediated. In this perspective, we provide an historical account of the levamisole/cocaine story as it first surfaced in 2008, including a succinct review of levamisole pharmacology, pharmacokinetics, and preclinical/clinical evidence for levamisole-induced agranulocytosis. Based on the available information on levamisole metabolism in humans, we propose that reactive metabolite formation is the rate-limiting step in the etiology of agranulocytosis associated with levamisole, in a manner similar to other drugs (e.g., propylthiouracil, methimazole, captopril, etc.) associated with blood dyscrasias. Finally, considering the toxicity associated with levamisole, we propose that the 2,3,5,6-tetrahydroimidazo[2,1-b]thiazole scaffold found in levamisole be categorized as a new structural alert, which is to be avoided in drug design.
Subject(s)
Agranulocytosis/chemically induced , Agranulocytosis/immunology , Agranulocytosis/metabolism , Cocaine/metabolism , Drug Contamination , Levamisole/metabolism , Animals , Cocaine/chemistry , Cocaine/poisoning , Humans , Levamisole/chemistry , Levamisole/poisoning , United States , United States Public Health Service/legislation & jurisprudence , Veterinary Drugs/chemistry , Veterinary Drugs/metabolism , Veterinary Drugs/poisoningSubject(s)
Animal Care Committees/legislation & jurisprudence , Animal Experimentation/standards , Animal Welfare/standards , Animal Experimentation/legislation & jurisprudence , Animal Welfare/legislation & jurisprudence , Animals , Animals, Laboratory , United States , United States Public Health Service/legislation & jurisprudenceABSTRACT
This final rule with comment period revises the regulations implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act in order to address the treatment of "mini-med" and expatriate policies under these regulations for years after 2011; modify the way the regulations treat ICD-10 conversion costs; change the rules on deducting community benefit expenditures; and revise the rules governing the distribution of rebates by issuers in group markets.
Subject(s)
Insurance, Health/economics , Patient Protection and Affordable Care Act , Fraud/prevention & control , Humans , Insurance, Health/legislation & jurisprudence , International Classification of Diseases/economics , International Classification of Diseases/legislation & jurisprudence , Private Sector , Quality Improvement/economics , Quality Improvement/legislation & jurisprudence , United States , United States Public Health Service/economics , United States Public Health Service/legislation & jurisprudenceABSTRACT
This interim final rule with comment period revises the regulations implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act in order to establish rules governing the distribution of rebates by issuers in group markets for non-Federal governmental plans.
Subject(s)
Insurance, Health/economics , Humans , Insurance, Health/legislation & jurisprudence , Patient Protection and Affordable Care Act , United States , United States Public Health Service/economics , United States Public Health Service/legislation & jurisprudenceABSTRACT
This final rule implements changes to the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors. Since the promulgation of the regulations in 1995, biomedical and behavioral research and the resulting interactions among government, research Institutions, and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, led to changes that expand and add transparency to Investigators' disclosure of Significant Financial Interests (SFIs), enhance regulatory compliance and effective institutional oversight and management of Investigators' financial conflicts of interests, as well as increase the Department of Health and Human Services' (HHS) compliance oversight.