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.

The political economy of bovine tuberculosis in Great Britain.

A brief history of bovine tuberculosis (bTB) and its control in Great Britain (GB) is presented. Numerous diverse policies to control the disease in humans, cattle and wildlife have been pursued over the last 100 years and many millions of pounds have been spent. After notable success in reducing the incidence and prevalence of bTB in cattle in GB from the 1950s to the mid-1980s, the geographical spread of the disease and the number of cattle slaughtered have increased continually since that time, with a high point of bTB incidence in 2008. This increase appeared to coincide with changing policy regarding the control of the disease in badgers, with a more humane approach adopted and with strengthened protection for badgers through legislation. Indeed, there has been much controversy in the debate on the role of badgers in disease transmission to cattle and the need for their control as vectors of the disease. The issue has attracted the attention of the media and there have been various commissioned research projects, trials and public consultations. The findings of two social science investigations presented as examples showed that citizens generally believed that bTB in cattle is an important issue that needs to be tackled, but objected to badgers being killed, whilst cattle farmers were willing to pay around £17/animal/year for a bTB cattle vaccine. It is noted that successes regarding the control of bTB in other countries have combined both cattle and wildlife controls and involved industry working in close partnership with government.

L'auteur retrace brièvement l'histoire de la tuberculose bovine et de la lutte contre cette maladie en Grande-Bretagne. Diverses mesures sanitaires ont été appliquées au cours des cent dernières années afin de maîtriser la maladie chez l'homme, chez les bovins et dans la faune sauvage, pour une dépense totale de plusieurs millions de livres. Après la chute remarquable de l'incidence et de la prévalence de la tuberculose bovine en Grande-Bretagne enregistrée depuis les années 50, la situation s'est inversée au milieu des années 80 et tant la distribution géographique de la maladie que le nombre de bovins abattus n'ont cessé de croître depuis cette date, l'année 2008 marquant le pic de l'incidence de la tuberculose bovine. Il est désormais établi que cette hausse a coïncidé avec l'évolution des politiques de lutte contre la tuberculose chez les blaireaux, à la faveur d'une approche plus respectueuse du bien-être animal qui s'est traduite par une protection renforcée des blaireaux dans la législation. En effet, le rôle des blaireaux dans la transmission de la tuberculose aux bovins et l'impératif de lutter contre les blaireaux en tant que vecteurs ont fait l'objet de très fortes controverses. Cette question a attiré l'attention des médias et il y a eu de nombreux projets de recherche commandités sur le sujet, d'expériences et de consultations publiques. D'après deux enquêtes sociologiques citées par l'auteur, les citoyens étaient généralement convaincus de l'importance de la tuberculose chez les bovins et de la nécessité de s'y attaquer mais ils s'opposaient aux mesures d'abattage des blaireaux, tandis que les éleveurs de bovins étaient disposés à payer environ 17 livres par bovin et par année pour pouvoir vacciner leurs bovins contre la tuberculose bovine. L'auteur fait observer que les succès enregistrés dans d'autres pays dans la lutte contre la tuberculose bovine sont liés à l'application combinée de mesures de contrôle chez les bovins et dans la faune sauvage et à une étroite collaboration entre les éleveurs et le gouvernement.

El autor repasa sucintamente la historia de la tuberculosis bovina y de su control en Gran Bretaña. En los últimos 100 años se han aplicado numerosas y variadas políticas y se han invertido muchos millones de libras para combatir la enfermedad en el ser humano, el ganado vacuno y la fauna silvestre. Entre mediados del decenio de 1950 y mediados del de 1980 se trabajó con notable éxito para reducir la incidencia y prevalencia de la enfermedad en el ganado vacuno británico. Pero a partir de ahí hubo una progresión constante en la propagación geográfica de la enfermedad y en el número de cabezas de ganado sacrificadas, con un máximo de incidencia registrado en 2008. Tal incremento parece coincidir con una inflexión de la política aplicada para luchar contra la enfermedad en los tejones, con la adopción de métodos más clementes y de medidas legislativas que instauraban un mayor nivel de protección de los tejones. Ha habido en efecto una gran controversia acerca del papel de los tejones en los procesos de transmisión de la enfermedad al ganado vacuno y la necesidad de controlar a esos animales como vectores de la infección. El tema ha suscitado gran atención mediática y ha sido objeto de una serie de proyectos de investigación, experimentos y consultas públicas. Según demuestran las conclusiones de dos investigaciones de ciencias sociales presentadas como ejemplo, en general los ciudadanos pensaban que la tuberculosis bovina en el ganado era un problema importante al que había que dar respuesta, pero se oponían al sacrificio de los tejones, a la vez que los ganaderos estaban dispuestos a pagar alrededor de 17 libras/animal/año por la vacunación antituberculosa de sus rebaños vacunos. El autor señala que los éxitos obtenidos en otros países a la hora de combatir la tuberculosis bovina pasan por instaurar controles a la vez en el ganado y en la fauna silvestre y por lograr que la industria trabaje en estrecha asociación con las instancias públicas.

Screening Out Controversy: Human Genetics, Emerging Techniques of Diagnosis, and the Origins of the Social Issues Committee of the American Society of Human Genetics, 1964-1973.

In the years following World War II, and increasingly during the 1960s and 1970s, professional scientific societies developed internal sub-committees to address the social implications of their scientific expertise (Moore, Disrupting Science: Social Movements, American Scientists, and the Politics of the Military, 1945-1975. Princeton: Princeton University Press, 2008). This article explores the early years of one such committee, the American Society of Human Genetics' "Social Issues Committee," founded in 1967. Although the committee's name might suggest it was founded to increase the ASHG's public and policy engagement, exploration of the committee's early years reveals a more complicated reality. Affronted by legislators' recent unwillingness to seek the expert advice of human geneticists before adopting widespread neonatal screening programs for phenylketonuria (PKU), and feeling pressed to establish their relevance in an increasingly resource-scarce funding environment, committee members sought to increase the discipline's expert authority. Painfully aware of controversy over abortion rights and haunted by the taint of the discipline's eugenic past, however, the committee proceeded with great caution. Seeking to harness interest in and assert professional control over emerging techniques of genetic diagnosis, the committee strove to protect the society's image by relegating ethical and policy questions about their use to the individual consciences of member scientists. It was not until 1973, after the committee's modest success in organizing support for a retrospective public health study of PKU screening and following the legalization of abortion on demand, that the committee decided to take a more publicly engaged stance.

History and evolution of the advisory committee on immunization practices--United States, 1964-2014.

The Advisory Committee on Immunization Practices (ACIP) is chartered as a federal advisory committee to provide expert external advice to CDC and the Secretary of the U.S. Department of Health and Human Services (DHHS) on the use of vaccines in the civilian population of the United States. This report summarizes the evolution of ACIP over the 50 years since its establishment in 1964 by the Surgeon General of the U.S. Public Health Service (USPHS).

Edmund Pellegrino and the art of civilized dialectics.

I had the good fortune to work with Edmund Pellegrino from 2005 until 2009, while he was chairman and I was a member of the President's Council on Bioethics. We came from different disciplines--medicine and law--and from different generations. Until that point, our paths had rarely crossed. I am so glad that I finally did have an opportunity to get to know him. Pellegrino contributed a great deal to the council during his time as chairman. I cannot begin to cover all that he brought to the council during his four years of leadership. In this essay, I describe how his views of both public bioethics and clinical ethics shaped his council participation.

A short historical review of SCNP with special reference to the UKU.

OBJECTIVE: To give a review of the history of SCNP since the first meeting in 1960 with specific focus on UKU. METHODS: Consulting the appropriate minutes from the meetings. RESULTS: One of the major goals of the SCNP was the standardization of clinical trials with psychotropic drugs. In 1969, the SCNP established a Committee for Clinical Investigations (UKU) with the representation of clinical investigators and the drug industry; moreover, during the 1970s and '80s, the UKU initiated clinical trials and contributed to the methodology of clinical investigations with psychotropic drugs. With the decrease in governmental funding and increasing influence of the US Food and Drug Administration on the methodology of clinical investigations around the world in the 1990s, the UKU was dissolved. The changes had a detrimental effect on the developments on the methodology of clinical investigations, and the lack of clinical feedback led to an impasse in psychotropic drug development with some pharmaceutical companies abandoning research in the central nervous system area. CONCLUSION: It is suggested that a revival of UKU to provide a platform for dialogue among government, industry, and academia could help break the impasse.

Review, historical context, and clarifications of the NINDS rt-PA stroke trials exclusion criteria: Part 1: rapidly improving stroke symptoms.

BACKGROUND AND PURPOSE: Since Food and Drug Administration approval of intravenous tissue-type plasminogen activator (tPA) for treatment of acute ischemic stroke in 1996, it has become clear that several criteria used for exclusion from therapy were not based on actual data or operationally defined for use in clinical practice. All eligibility criteria from the National Institute of Neurological Disorders and Stroke (NINDS) recombinant tPA Stroke Study were adopted within the alteplase package insert as contraindications/warnings. Many clinicians have expressed the need for clarification and better definition of these treatment criteria. METHODS: A group of investigators who also practice as stroke physicians convened a collaborative endeavor to work toward developing more clinically meaningful and consensus-driven exclusion criteria for intravenous tPA. The first of these exclusion criteria chosen was rapidly improving stroke symptoms (RISS). We reviewed and clarified the historical context and intention with the original investigators, held e-mail discussions, convened an in-person RISS Summit, and obtained the understanding of experienced stroke physicians broadly. RESULTS: Historically, the intent of this exclusion criterion within the NINDS recombinant tPA Stroke Trial was to avoid treatment of transient ischemic attacks-who would have recovered completely without treatment. There was unanimous consensus that, in the absence of other contraindications, patients who experience improvement of any degree, but have a persisting neurological deficit that is potentially disabling, should be treated with intravenous tPA. This statement is supported from the methods established for the original NINDS trial, on the basis of detailed discussions and interviews with the former NINDS trialists. It was agreed that improvement should only be monitored for the extent of time needed to prepare and administer the intravenous tPA bolus/infusion. An explicit operational definition of RISS was developed by consensus to guide future decision making in acute stroke. There was unanimous agreement that all neurological deficits present at the time of the treatment decision should be considered in the context of individual risk and benefit, as well as the patient's baseline functional status. CONCLUSIONS: A structured framework and quantitative approach toward defining RISS emerged through expert opinion and consensus. The term, RISS, should be reserved for those who improve to a mild deficit, specifically one which is perceived to be nondisabling. This is recommended to guide decision making on intravenous tPA eligibility going forward, including the design of future studies. An additional study of patients with rapid improvement to nonmild deficits is not justified because these patients should be treated.

A history of the DSM-5 Scientific Review Committee.

This article describes the history of the Scientific Review Committee (SRC) for DSM-5 and reviews its background, procedures and deliberative processes, and conceptual/philosophical framework. The results of its work and the most important and contentious issues that arose in its efforts are reviewed. The central role of the SRC was to provide external review for all proposals for diagnostic change in DSM-5, evaluate them on their level of empirical support using objectively structured rules of evidence agreed upon in advance and make appropriate recommendations to the leadership of the American Psychiatric Association. While the creation of the SRC necessitated a great deal of additional work on the part of the SRC, the workgroups and the DSM-5 Task Force, the SRC succeeded in increasing the focus on empirical standards for nosologic change and providing a greater degree of consistency and objectivity in the DSM review process. The article concludes with recommendations, based on lessons learned, for similar efforts that might be included in future iterations of our psychiatric nosology.

An historical summary of advisory boards for aerospace medicine at NASA.

Over the past 50 years, the National Aeronautics and Space Administration (NASA) has interacted with numerous advisory committees. These committees include those established by NASA, the National Academy of Sciences, the Institute of Medicine, or through Congressional oversight. Such groups have had a relatively passive role while providing sage advice on a variety of important issues. While these groups cover a wide range of disciplines, the focus of this paper is on those that impacted aerospace medicine and human spaceflight from NASA's beginning to the present time. The intent is to provide an historical narrative of the committees, their purpose, their outcome, and how they influenced the development of aerospace medicine within NASA. Aerospace medicine and life sciences have been closely aligned and intertwined from NASA's beginning. While several committees overlap life sciences within NASA, life sciences will not be presented unless it is in direct reference to aerospace medicine. This paper provides an historical summary chronicling those individuals and the groups they led when aerospace medicine was emerging as a discipline for human spaceflight beginning in 1957.