LeRoy Walters's Legacy of Bioethics in Genetics and Biotechnology Policy.

LeRoy Walters was at the center of public debate about emerging biological technologies, even as "biotechnology" began to take root. He chaired advisory panels on human gene therapy, the human genome project, and patenting DNA for the congressional Office of Technology Assessment. He chaired the subcommittee on Human Gene Therapy for NIH's Recombinant DNA Advisory Committee. He was also a regular advisor to Congress, the executive branch, and academics concerned about policy governing emerging biotechnologies. In large part due to Prof. Walters, the Kennedy Institute of Ethics was one of the primary sources of talent in bioethics, including staff who populated policy and science agencies dealing with reproductive and genetic technologies, such as NIH and OTA. His legacy lies not only in his writings, but in those people, documents, and discussions that guided biotechnology policy in the United States for three decades.

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.

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.

Getting to grips with the cannabis problem: the evolving contributions and impact of Griffith Edwards.

Griffith Edwards played an important role in cannabis policy debates within government advisory committees in the United Kingdom from the early 1970s until the early 1980s. This has largely been hidden from public knowledge by the confidentiality of these committee discussions. The purpose of this paper is to use Griffith's writings and the results of recent historical scholarship to outline the views he expressed, the reasons he gave for them, and to provide a brief assessment of his contribution to the development of British cannabis policy.

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.

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.

Modernization and rural health in Mexico: the case of the Tepalcatepec Commission.

Mexican policymakers instituted community-based health programs in the 1940s and 1950s to encourage rural participation in state-sponsored health and economic development initiatives. The Tepalcatepec Commission (1947-1961) united previously independent government programs into a multi-tiered collaboration that addressed regional development through national, state, and local networks. While national policymakers and state officials designed plans to improve agricultural production, promote industrialization, utilize the area's natural resources, and expand communication channels, health workers established unprecedented relationships with indigenous community members by introducing the Commission's projects in culturally relevant ways. They used their on-the-ground experiences to learn local languages, customs, and beliefs, and incorporated these factors into their health education and disease treatment campaigns. The result serves as an example of short-term cooperative relationships between healthcare workers and indigenous groups that not only reduced the major health risks in the area, but also paved the way for collective economic development.

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.

[Principles and criteria used by the National Evaluation Committee of Research Activity (CNEAI-Spain) for the assessment of scientific publications: 1989-2009]. / Principos y criterios utilizados en España por la Comisión Nacional Evaluadora de la Actividad Investigadora (CNEAI) para la valoración de las publicaciones científicas: 1989-2009.

Study of the origins, philosophy and history of the criteria used to assess research activities in Spain by the CNEAI. The assessment criteria and quality evidence of publications is discussed. Results are presented on the temporal development of the criteria used, grouped by publication type (articles and books) and fields of knowledge. Between 1989-1996, assessment was based on the definition and goals set by the Spanish scientific framework and on general criteria. Between 1996-2004, the formulation of indicators began to be almost exclusively based on Journal Citation Reports (JCR). Success rates up to 2004 indicate that the evaluation criteria and publishing behaviour matched the "hard sciences", but not the Social Sciences and Economics. In 2005, the criteria used were further developed and reoriented with an eye to softening the preceding JCR-centrism by taking into consideration other databases and defining the quality criteria to be met by journals, books and conferences not included in JCR. Correspondingly, the success rates for 2007 indicate a dramatic recovery in Economics. In the last 4 years, Humanities and Social Sciences have consolidated the further opening of the criteria used with the addition of new benchmarks and the full integration of books.

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.

[Proposals for inspecting pharmacies in Transylvania before the General Health Regulation of 1770]. / Az 1770-es Egészségügyi Foszabályzatot megelozo erdélyi javaslatok a gyógyszertárak ellenorzésére.

After sketching the history of the regulation of pharmacies in Hungary and in Transylvania during the Middle Ages and the 16-17. centuries, author analyses the attempts of the regulation of Translyvanian pharmacies during the second part of the 18th century including official and civil proposals for inspection of pharmacies written in the 1750ies by eminent Transylvanian physicians and pharmacists. These proposals were based on very informative reports written by Mihály Felfalusi and József Zoltán--whose biographies are also attached and analysed here. Although these proposals--regarding their contents--mostly followed the scheme of the former Hungarian (and western) regulations, they contained lots of special local issues. The article--rich in details published first time--is illustrated by a supplement containing the original Latin texts of the reports and proposals and their Hungarian translations as well.