State risk discourse and the regulatory preservation of traditional medicine knowledge: The case of acupuncture in Ontario, Canada.

Several United Nations bodies have advised countries to actively preserve Traditional Medicine (TM) knowledge and prevent its misappropriation in regulatory structures. To help advance decision-making around this complex regulatory issue, we examine the relationship between risk discourse, epistemology and policy. This study presents a critical, postcolonial analysis of divergent risk discourses elaborated in two contrasting Ontario (Canada) government reports preceding that jurisdiction's regulation of acupuncture, the world's most widely practised TM therapy. The earlier (1996) report, produced when Ontario's regulatory lobby was largely comprised of Chinese medicine practitioners, presents a risk discourse inclusive of biomedical and TM knowledge claims, emphasizing the principle of regulatory 'equity' as well as historical and sociocultural considerations. Reflecting the interests of an increasingly biomedical practitioner lobby, the later (2001) report uses implicit discursive means to exclusively privilege Western scientific perspectives on risk. This report's policy recommendations, we argue, suggest misappropriation of TM knowledge. We advise regulators to consider equitable adaptations to existing policy structures, and to explicitly include TM evidentiary perspectives in their pre-regulatory assessments.

Enfoque de la Autoridad Reguladora Cubana sobre la reglamentación para la Medicina Natural y Tradicional / Approach of the Cuban regulatory authority to natural and traditional medicine regulations

Introducción: la medicina natural y tradicional (MNT) ocupa un espacio renovado en la salud y la sociedad cubana. Objetivos: caracterizar la reglamentación para la MNT y contribuir a su desarrollo mediante la recuperación de disposiciones nacionales que pautan los estándares para medicamentos y dispositivos médicos relacionados con la misma. Métodos: se realizó un estudio descriptivo, transversal y retrospectivo; la base reglamentaria se recuperó mediante revisión de las publicaciones de artículos científicos entre 1989 y 2012, así como de sesiones de trabajo con funcionarios clave y entrevistas a expertos. Resultados: el número de disposiciones compiladas ascendió a 22. El Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) se identificó entre los 6 principales reguladores en esta esfera y las instituciones reguladas fueron 5. Conclusiones: se mostró por primera vez un panorama general de la evolución de la reglamentación sobre la MNT, sus hitos, estructuras y necesidades de desarrollo. Se evidenció que el CECMED ha dado respuesta al mandato del Consejo de Ministros sobre el control en este campo, e investiga estrategias para cumplir las direcciones trazadas para la transformación del modelo económico y social del país con la perspectiva de la garantía sanitaria de medicamentos a utilizar en las modalidades de la MNT y dispositivos médicos con calidad, seguridad, eficacia y efectividad, en favor de preservar el derecho a la salud de los cubanos(AU)

Introduction: Natural and traditional medicine (NTM) has gained space in Cuban health and society. Objectives: characterize NTM regulations and contribute to their development by means of the retrieval of national regulations about standards for NTM drugs and medical devices. Methods: a descriptive cross-sectional retrospective study was conducted. The regulatory bases were retrieved from a review of scientific papers published between 1989 and 2012, as well as work sessions with key officials and interviews with experts. Results: a total 22 regulations were collected. The Center for State Control of the Quality of Drugs and Medical Equipment (CECMED) was identified as among the 6 main regulators in this field, with 5 institutions regulated. Conclusions: for the first time a general overview was provided of the evolution of NTM regulations, their milestones, structures and development needs. It was shown that CECMED has accomplished the mandate of the Council of Ministers about regulation in this field, and that it investigates strategies aimed at fulfilling the directives received in relation to the transformation of the Cuban economic and social development model ensuring the quality, safety, efficacy and efficiency of NTM drugs and medical devices to preserve the right of Cubans to health care(AU)

Enfoque de la Autoridad Reguladora Cubana sobre la reglamentación para la Medicina Natural y Tradicional / Approach of the Cuban regulatory authority to natural and traditional medicine regulations

INTRODUCCIÓN: la medicina natural y tradicional (MNT) ocupa un espacio renovado en la salud y la sociedad cubana. OBJETIVOS: caracterizar la reglamentación para la MNT y contribuir a su desarrollo mediante la recuperación de disposiciones nacionales que pautan los estándares para medicamentos y dispositivos médicos relacionados con la misma. MÉTODOS: se realizó un estudio descriptivo, transversal y retrospectivo; la base reglamentaria se recuperó mediante revisión de las publicaciones de artículos científicos entre 1989 y 2012, así como de sesiones de trabajo con funcionarios clave y entrevistas a expertos. RESULTADOS: el número de disposiciones compiladas ascendió a 22. El Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) se identificó entre los 6 principales reguladores en esta esfera y las instituciones reguladas fueron 5. CONCLUSIONES: se mostró por primera vez un panorama general de la evolución de la reglamentación sobre la MNT, sus hitos, estructuras y necesidades de desarrollo. Se evidenció que el CECMED ha dado respuesta al mandato del Consejo de Ministros sobre el control en este campo, e investiga estrategias para cumplir las direcciones trazadas para la transformación del modelo económico y social del país con la perspectiva de la garantía sanitaria de medicamentos a utilizar en las modalidades de la MNT y dispositivos médicos con calidad, seguridad, eficacia y efectividad, en favor de preservar el derecho a la salud de los cubanos.

INTRODUCTION: Natural and traditional medicine (NTM) has gained space in Cuban health and society. OBJECTIVES: characterize NTM regulations and contribute to their development by means of the retrieval of national regulations about standards for NTM drugs and medical devices. METHODS: a descriptive cross-sectional retrospective study was conducted. The regulatory bases were retrieved from a review of scientific papers published between 1989 and 2012, as well as work sessions with key officials and interviews with experts. RESULTS: a total 22 regulations were collected. The Center for State Control of the Quality of Drugs and Medical Equipment (CECMED) was identified as among the 6 main regulators in this field, with 5 institutions regulated. CONCLUSIONS: for the first time a general overview was provided of the evolution of NTM regulations, their milestones, structures and development needs. It was shown that CECMED has accomplished the mandate of the Council of Ministers about regulation in this field, and that it investigates strategies aimed at fulfilling the directives received in relation to the transformation of the Cuban economic and social development model ensuring the quality, safety, efficacy and efficiency of NTM drugs and medical devices to preserve the right of Cubans to health care.

[Domestic violence: any progress?]. / Violences conjugales : a-t-on progressé ?

Since the publication of the French national survey of violence against women in 2000, the fight against domestic violence has made steady progress. Knowledge of the phenomenon has significantly improved. A nationwide study of murders and manslaughters perpetrated by one partner of a couple against the other has been published annually since 2006. In 2012, domestic violence resulted in the deaths of 314 persons: 166 women, 31 men, 25 children, 9 collateral victims, 14 rivals, and two former spouses killed by their ex-fathers in law. In addition, 67 perpetrators committed suicide (51 men and3 women). The number of victims fluctuates from year to year but has remained fairly stable since 2006 (n=168). Legislation has improved significantly: eight new laws have been passed since 2004, all designed to protect women and to ensure that violent men are restrained and treated. New measures to inform and protect women have been implemented and others have been improved, such as the anonymous helpline (phone no 3919, "domestic violence information"). An inter-ministerial committee on the protection of women from violence and the prevention of human trafficking (MIPROF) was created on 3 January 2013. A website entitled "Stop violence against women " (Stop violences faites aux femmes) is now available. The "Imminent Danger" mobile phone system, designed to alert police if a suspected or known perpetrator breaches restraint conditions, will be extended to the entire country from January 2014. Referees charged with coordinating comprehensive long-tern care of women victims have been deployed at the county level. Information centers on the rights of women and families (CIDFF) now form a local nationwide network. Routine interviews with a midwife during the fourth month of pregnancy, focusing on the woman's emotional, economic and social conditions, have been implemented in 21 % of maternity units and should gradually be generalized. The authorities who have enforced the law have modified their behavior, as have the victims, although for a lesser extent. Perpetrators are increasingly subject to restraining orders, with an obligation to undergo treatment and to attend awareness sessions. Victims are also more likely to go to the police. Social workers, self-help groups and, since 2006, psychologists are now available for victim support in police stations. Management of perpetrators has improved. Finally, despite the continuing reluctance of many physicians, an encouraging trend is emerging among younger members of the profession. A recent survey of 1472 French medical students showed that, while 90 % of them said they had received no training in this area, 93 % considered that doctors should play a role and 95 % said they felt highly concerned. Specific university diplomas have been created and domestic violence is now included in the midwifery curriculum. The delicate question of prevention remains to be resolved; a program is currently being tested.

The Roman state and genetic pacification.

Over the last 10,000 years, the human genome has changed at an accelerating rate. The change seems to reflect adaptations to new social environments, including the rise of the State and its monopoly on violence. State societies punish young men who act violently on their own initiative. In contrast, non-State societies usually reward such behavior with success, including reproductive success. Thus, given the moderate to high heritability of male aggressiveness, the State tends to remove violent predispositions from the gene pool while favoring tendencies toward peacefulness and submission. This perspective is applied here to the Roman state, specifically its long-term effort to pacify the general population. By imperial times, this effort had succeeded so well that the Romans saw themselves as being inherently less violent than the "barbarians" beyond their borders. By creating a pacified and submissive population, the empire also became conducive to the spread of Christianity--a religion of peace and submission. In sum, the Roman state imposed a behavioral change that would over time alter the mix of genotypes, thus facilitating a subsequent ideological change.

Why the United States still needs improved dietary supplement regulation and oversight.

It has been 3 years since the American Society for Clinical Pharmacology and Therapeutics (ASCPT) issued a position statement regarding dietary supplement safety and regulation. I was the Chair of the ASCPT task force charged with issuing the statement. At the time, after careful review of available data, the other members and I concluded that dietary supplement legislation in the United States was lacking and that enhanced oversight was essential to increase the safety of these products for the American consumer.

Of germs, public hygiene, and the healthy body: the making of the medicalizing state in Thailand.

The historical study of Western medicine in nineteenth-century Siam has emphasized the dichotomy between Western medicine and traditional Thai medical practice. The former is often represented as a monolith, and the epistemological transformation of Western medicine during the nineteenth century is glossed over without sufficient attention. Pasteurian medicine, especially the idea of germs, was introduced to Siam by the American missionary Dan Beach Bradley. Its introduction spurred a process of negotiation with both pre-Pasteurian Western and traditional Thai medicine. In its pre-Pasteurian and Pasteurian variants, Western medicine was constituted as a new medical practice and disciplinary regime in Siam. As a discursive instrument of state hegemony, the ideas, structures, policies, and institutions of Western medicine furthered the understanding and management of virulent epidemics, the institution of the sanitary system, the shaping of new concepts of population and a healthy workforce, and not least, the framing of a medicalizing project to police people's bodies pursued by the Thai state in the 1930s.

Paradigm lost, paradigm found: the re-emergence of hormesis as a fundamental dose response model in the toxicological sciences.

This paper provides an assessment of the toxicological basis of the hormetic dose-response relationship including issues relating to its reproducibility, frequency, and generalizability across biological models, endpoints measured and chemical class/physical stressors and implications for risk assessment. The quantitative features of the hormetic dose response are described and placed within toxicological context that considers study design, temporal assessment, mechanism, and experimental model/population heterogeneity. Particular emphasis is placed on an historical evaluation of why the field of toxicology rejected hormesis in favor of dose response models such as the threshold model for assessing non-carcinogens and linear no threshold (LNT) models for assessing carcinogens. The paper argues that such decisions were principally based on complex historical factors that emerged from the intense and protracted conflict between what is now called traditional medicine and homeopathy and the overly dominating influence of regulatory agencies on the toxicological intellectual agenda. Such regulatory agency influence emphasized hazard/risk assessment goals such as the derivation of no observed adverse effect levels (NOAELs) and the lowest observed adverse effect levels (LOAELs) which were derived principally from high dose studies using few doses, a feature which restricted perceptions and distorted judgments of several generations of toxicologists concerning the nature of the dose-response continuum. Such historical and technical blind spots lead the field of toxicology to not only reject an established dose-response model (hormesis), but also the model that was more common and fundamental than those that the field accepted.

Colonialization: a health determinant for pregnant Dogrib women.

Childbirth for many Aboriginal women living in remote communities of the Northwest Territories, Canada, includes separation from their family and community for weeks at a time. This colonialization of childbirth, enforced for decades, is true for Dogrib Dene. Colonialization produces serious social consequences on the everyday lives of pregnant Aboriginal women, which results in lower health outcomes. This article provides a literature review of colonialization in Canada's far north establishing the position that colonialization is a determinant of health. The purpose of this article is to generate knowledge that will inform health professionals and ultimately reduce health disparities as experienced and evident among Dogrib women. By highlighting the concept of colonialization and establishing this concept as a determinant of health, nurses and midwives will identify disparities created through stressors of power and control. From there, culturally meaningful health promotion strategies will be developed and implemented within their nursing practice.

Assessing elemental mercury vapor exposure from cultural and religious practices.

Use of elemental mercury in certain cultural and religious practices can cause high exposures to mercury vapor. Uses include sprinkling mercury on the floor of a home or car, burning it in a candle, and mixing it with perfume. Some uses can produce indoor air mercury concentrations one or two orders of magnitude above occupational exposure limits. Exposures resulting from other uses, such as infrequent use of a small bead of mercury, could be well below currently recognized risk levels. Metallic mercury is available at almost all of the 15 botanicas visited in New York, New Jersey, and Pennsylvania, but botanica personnel often deny having mercury for sale when approached by outsiders to these religious and cultural traditions. Actions by public health authorities have driven the mercury trade underground in some locations. Interviews indicate that mercury users are aware that mercury is hazardous, but are not aware of the inhalation exposure risk. We argue against a crackdown by health authorities because it could drive the practices further underground, because high-risk practices may be rare, and because uninformed government intervention could have unfortunate political and civic side effects for some Caribbean and Latin American immigrant groups. We recommend an outreach and education program involving religious and community leaders, botanica personnel, and other mercury users.

"Have a piss, drink ogogoro, smoke igbo, but don't take gbana"--hard and soft drugs in Nigeria: a critical comparison of official policies and the view on the street.

One of the consequences of increased exposure to Western influences has been the spread of drug use among Nigerian young people over the last two decades. There is now a buoyant consumer market for home-grown cannabis, and a smaller market for heroin and cocaine within the country. Under successive military regimes, drug use was either downplayed, or regarded as a law enforcement issue. Little work was carried out to gauge the extent of use, or obtain an understanding of the user constituencies. Government policies are entirely informed by Western models and sadly inadequate in understanding Nigerian drug trends and in devising schemes to meet local needs. This article, by giving voice to Nigerian drug users, is an attempt to dispel some misconceptions about drug use and abuse, and to widen the debate surrounding African drug control. There is a grave danger of the war on drugs being exported to African countries where civil societies are weakest in withstanding the onslaught of government and international agencies. This article is therefore an ethnographic drugs study engaging with crucial development issues.

A comparison of the use of complementary therapies in Australia and Iceland.

The use of complementary therapies in Iceland and Australia is compared in this paper, along with information regarding research into native plants in both countries. Attitudes towards complementary therapists from the medical profession are discussed, and the use of complementary medicine by pregnant women and midwives is given special emphasis.

Complementary medicine: legal status of the non-licensed provider in the USA.

European providers of complementary medicine may be surprised by the formal structures which their US counterparts face. A major hurdle to holistic practice in the USA is the statutory prohibition against the unlicensed practice of medicine. State statutes define 'medicine' broadly, creating a legal risk for unlicensed providers of holistic healthcare, as well as for licensed providers whose services are deemed to exceed their legislatively authorized scope of practice and cross into 'diagnosis' and 'treatment' of disease. This paper does not address scope of practice; rather, it focuses on the legal status of non-licensed (or 'unenfranchised') providers. For these providers, seeking occupational licensure will provide some protection against medical practice acts, as well as opportunity to elevate professional competence and prestige. However, many holistic providers prefer to remain outside the regulatory scheme. Mandatory licensure, title licensure and registration offer means of upgrading professional status and achieving state sanction for professional practice.