The First 10 Years: Reflecting on Opportunities and Challenges of the Tobacco Products Scientific Advisory Committee of the United States Food and Drug Administration.

Introduction: Tobacco control policies have helped to reduce the health, social, and economic burden of commercial tobacco use worldwide. Little is known about the long-term impact of regulatory policies and functioning bodies that make recommendations to inform policies. The Tobacco Products Scientific Advisory Committee (TPSAC) of the U.S. Food and Drug Administration (FDA) was formed in 2009 to evaluate the safety, health, and dependence of tobacco products and provide related advice and recommendations to the FDA and the Secretary of Health and Human Services. This article describes the first 10 years of the TPSAC activities and reflects on the impact of their service on regulatory actions.Methods: We reviewed public documents from the 2010-2019 TPSAC meetings to examine the purposes, TPSAC decisions, public health participation in meetings, and concordance of the TPSAC recommendations with regulatory actions. Meeting agendas, transcripts, public testimony, and presentations were reviewed to obtain this information.Results: Since 2010, the TPSAC held 25 public meetings with 178 speakers who provided oral public testimony. Sixty-four percent of meetings were held from 2010 to 2012, when three congressionally mandated reports were due on the topics of menthol cigarettes, harmful and potentially harmful constituents in tobacco products, and dissolvable tobacco products. Forty-four percent of meetings focused on menthol cigarettes, 32% on modified risk tobacco products, 16% on harmful and potentially harmful constituents, 12% on dissolvable tobacco, and 4% on tobacco addiction/dependence. FDA regulatory actions were largely nonconcordant with voting decisions by TPSAC.Conclusions: The TPSAC has evaluated an enormous amount of science during the first 10 years, but their influence on regulatory policies has been limited. The TPSAC roles and functioning should be reevaluated to determine how TPSAC can better fulfill its mandate to inform the FDA's regulatory decision making, which could ultimately reduce the burden of tobacco use in the United States.

A History of the International Commission on Non-Ionizing Radiation Protection.

Concern about health risks from exposure to non-ionizing radiation (NIR) commenced in the 1950s after tracking radars were first introduced during the Second World War. Soon after, research on possible biological effects of microwave radiation in the former Soviet Union and the U.S. led to public and worker exposure limits being much lower in Eastern European than in Western countries, mainly because of different protection philosophies. As public concern increased, national authorities began introducing legislation to limit NIR exposures from domestic microwave ovens and workplace devices such as visual display units. The International Radiation Protection Association (IRPA) was formed in 1966 to represent national radiation protection societies. To address NIR protection issues, IRPA established a Working Group in 1974, then a Study Group in 1975, and finally the International NIR Committee (INIRC) in 1977. INIRC's publications quickly became accepted worldwide, and it was logical that it should become an independent commission. IRPA finally established the International Commission on Non-Ionizing Radiation Protection (ICNIRP), chartering its remit in 1992, and defining NIR as electromagnetic radiation (ultraviolet, visible, infrared), electromagnetic waves and fields, and infra- and ultrasound. ICNIRP's guidelines have been incorporated into legislation or adopted as standards in many countries. While ICNIRP has been subjected to criticism and close scrutiny by the public, media, and activists, it has continued to issue well-received, independent, science-based protection advice. This paper summarizes events leading to the formation of ICNIRP, its key activities up to 2017, ICNIRP's 25th anniversary year, and its future challenges.

A History of the Council of State Neurosurgical Societies.

As neurological surgery evolved into its own subspecialty early in the 20th century, a need arose to create an environment for communication and education among those surgeons working in this burgeoning surgical discipline. As the socioeconomic climate in health care began to change in the United States, an unforeseen need arose that was outside the scope of the American Association of Neurological Surgeons, Congress of Neurological Surgeons, and Society of Neurological Surgeons. The capacity to understand and address the evolving socioeconomic landscape and to offer a platform for advocacy required a new entity. Grassroots efforts of neurosurgeons at the state level ultimately yielded a formal organization of state neurosurgical societies to fill this void by recognizing, understanding, and addressing socioeconomic factors affecting the practice of neurological surgery. This formal organization became the Council of State Neurosurgical Societies (CSNS). The CSNS provides a forum in which state societies can meet to identify, understand, and advocate for policies on behalf of organized neurosurgery. The purpose of this paper is to detail the history of the formation of the CSNS. By understanding this history and the need for the development of the CSNS, it is hoped that its evolving role as a voice for neurological surgeons in the modern era of health care will be made clear.

Memória da Comissão Intersetorial de Saúde Indígena: Cisi/CNS 2000-2006 / Memory of the Intersectoral Commission on Indigenous Health: Cisi /CNS 2000-2006

Com grande satisfação apresentamos este documento que registra o planejamento, os resultados e as articulações intersetoriais da Comissão Intersetorial de Saúde Indígena (Cisi), do Conselho Nacional de Saúde (CNS) do MS, realizados entre janeiro de 2000 e junho de 2006. Temos a compreensão de que este registro representa apenas uma parte de todas as ações desenvolvidas pela Cisi ao longo destes anos. A preservação da história, que integra a cultura indígena, o seu sofrimento e a relação causal multissetorial dos agravos à sua saúde poderão orientar os passos futuros e garantir a continuidade de iniciativas que atendam à expectativa da população indígena. Esta memória destaca os planos de trabalho da Cisi, aprovados a cada ano no CNS, procurando acompanhar a resposta dada à demanda das 3a e 4a Conferências de Saúde Indígena. As principais realizações de cada ano, a partir de 2000, quando começa a organização dos 34 Distritos Sanitários Especiais Indígenas, com os respectivos Conselhos de Saúde Indígena, foram apreciadas e debatidas em cada reunião da Cisi, com a apresentação pela Fundação Nacional de Saúde (Funasa) da execução das políticas de saúde, suas difi culdades e suas expectativas. A Cisi constatou que entre os principais entraves que obstruíram maior avanço na execução das políticas de saúde indígena se destacaram as difi culdades de gerenciamento, as ingerências políticas na indicação de chefi as, bem como à insufi ciente preparação e o acompanhamento de algumas organizações conveniadas para as quais foi delegada a execução das políticas de saúde. O defi ciente sistema de informação e monitoramento, a sua falta de retorno às bases, como estímulo ao trabalho no alcance das metas, a falta de autonomia, a descontinuidade na capacitação e no acompanhamento dos Distritos Sanitários Especiais Indígenas, os confl itos pelas terras, que infl uíram nas decisões de muitas prefeituras, possibilitaram que os convênios com as prefeituras não se realizassem de acordo com o proposto e assinado.

A ten-year history: the Cancer Quality Council of Ontario.

One of the longest-established quality oversight organizations in Canadian healthcare, the Cancer Quality Council of Ontario (CQCO) is an advisory group formed in 2002 by the Ministry of Health and Long-Term Care. Although quasi-independent from Cancer Care Ontario (CCO), the council was established to provide advice to CCO and the ministry in their efforts to improve the quality of cancer care in the province. The council is composed of a multidisciplinary group of healthcare providers, cancer survivors and experts in the areas of oncology, health system policy and administration, governance, performance measurement and health services research. Its mandate is to monitor and report publicly on the performance of the Ontario cancer system and to motivate improvement through national and international benchmarking. Since its formation, the council has played an evolving role in improving the quality of care received by Ontario cancer patients. This article will briefly describe the origins and founding principles of the CQCO, its changing role in monitoring quality and its relationship with CCO.

Breast cancer screening: a 35-year perspective.

Screening for breast cancer has been evaluated by 9 randomized trials over 5 decades and recommended by major guideline groups for more than 3 decades. Successes and lessons for cancer screening from this history include development of scientific methods to evaluate screening, by the Canadian Task Force on the Periodic Health Examination and the U.S. Preventive Services Task Force; the importance of randomized trials in the past, and the increasing need to develop new methods to evaluate cancer screening in the future; the challenge of assessing new technologies that are replacing originally evaluated screening tests; the need to measure false-positive screening test results and the difficulty in reducing their frequency; the unexpected emergence of overdiagnosis due to cancer screening; the difficulty in stratifying individuals according to breast cancer risk; women's fear of breast cancer and the public outrage over changing guidelines for breast cancer screening; the need for population scientists to better communicate with the public if evidence-based recommendations are to be heeded by clinicians, patients, and insurers; new developments in the primary prevention of cancers; and the interaction between improved treatment and screening, which, over time, and together with primary prevention, may decrease the need for cancer screening.

Negotiating exclusion: MSM, identity, and blood policy in the age of AIDS.

In the US, blood donors face a variety of restrictions that leave many people excluded entirely from the donor pool. This paper explores the specific circumstances and meanings surrounding the donor ban on Men-who-have-Sex-with-Men (MSM). The ban on MSM is one of the few existing donor guidelines to receive considerable criticism on grounds that it effectively prohibits any sexually active gay man from donating blood and thus discriminates against gays. Due in part to these questions of fairness, the Blood Products Advisory Committee (BPAC) of the Food and Drug Administration (FDA) met to reconsider the decades-old policy, first in 1997 and again in 2000. The FDA asked its advisory committee to address the efficacy and utility of the MSM ban in light of technological developments in blood-banking, epidemiological data on the spread of HIV, and mounting pressures from gay rights and blood-banking organizations to update the policy. Through a detailed reading of meeting and conference transcripts that took place between 1997 and 2000, I argue that 'MSM' became a contested definitional category during the FDA's reappraisal of the policy. During and between the Committee's discussions, presenters and experts debated the differences between sexual behavior and sexual identity in relation to HIV and, eventually, HHV-8, a virus known to cause Kaposi's sarcoma in immunosuppressed individuals. I argue that the underlying flexibility in the meanings behind the term 'MSM' allowed Committee members, in the end, to retract their more nuanced discussions of human behavior and HIV and to uphold the contested policy. Finally, I suggest how the debates surrounding the MSM donor ban can help us to better understand the place of sexuality in discussions and claims of biopolitical citizenship in early 21st-century America.

The Hoadley Commission (1932-34) and health insurance in Alberta.

The role of Albertans in the evolution of health insurance in Canada, and particularly the Hoadley Commission, has been overlooked and assumed to be non-contributory. The Commission proposed for the first time that all citizens be insured, and the provincial government would pay for those who could not afford the premiums. The proposed plan was to be centrally administrated by a government-appointed commission. The Commission's principles were supported by the AMA/CPSA in 1932 and incorporated into the CMA's health insurance plan between 1934 and 1935. The proposal stimulated the first Blue Cross plan in Canada in Edmonton in 1934. It was supported by the Social Credit government, who in 1942 re-passed the UFA Health Insurance Act of 1935. The Act meshed perfectly with the federal Heagerty Advisory Committee proposal of 1943.

One minute after the detonation of the atomic bomb: the erased effects of residual radiation.

The U.S. Government's official narrative denies the effects of residual radiation which appeared one minute after the atomic bomb detonations in Hiroshima and Nagasaki. This paper explores declassified documents from the U.S. Atomic Energy Commission, the Atomic Bomb Casualties Commission, and others and shows that these documents actually suggested the existence of serious effects from residual radiation.

Meanings & motives. Experts debating tobacco addiction.

Over the last 50 years, tobacco has been excluded from and then included in the category of addictive substances. We investigated influences on these opposing definitions and their application in expert witness testimony in litigation in the 1990s and 2000s. A scientist with ties to the tobacco industry influenced the selection of a definition of addiction that led to the classification of tobacco as a "habituation" in the 1964 Surgeon General's Advisory Committee report. Tobacco was later defined as addictive in the 1988 surgeon general's report. Expert witnesses for tobacco companies used the 1964 report's definition until Philip Morris Tobacco Company publicly changed its position in 1997 to agree that nicotine was addictive. Expert witnesses for plaintiffs suing the tobacco industry used the 1988 report's definition, arguing that new definitions were superior because of scientific advance. Both sides viewed addiction as an objective entity that could be defined more or less accurately.

The genesis of advanced nursing practice in New Zealand: policy, politics and education.

When New Zealand's first Nurse Practitioner was approved by the Nursing Council of New Zealand in December 2001, it was the centenary year of New Zealand nursing registration, but less than a decade after the commencement of New Zealand's first pre-registration nursing degrees. What were the conditions and forces in play that saw nursing achieve a new emphasis on advanced clinical education and practice, culminating in the development of an advanced, expanded scope of nursing practice? This contemporary historical study examines the professional and sectoral milieu of the 1990s and the turn of the 21st century, together with the policy initiatives undertaken to advance nursing in New Zealand during that period.