Leo Alexander's Blueprint of the Nuremberg Code.

BACKGROUND: Nazi Germany surrendered to the Allies on May 8, 1945. Six months later, the Allies tried the surviving leaders of Nazi Germany at the first Nuremberg trial. Later, the United States conducted 12 additional trials. The first one, The Unites States of America versus Karl Brandt et al., has been dubbed the Doctors' Trial. During the trial, the prosecution relied on the testimony of Dr. Andrew Ivy and Dr. Leo Alexander. At the end of the trial, Judge Sebring enunciated 10 principles needed to conduct human subject research-the Nuremberg Code. Authorship of the Code has been the subject of dispute, with both Ivy and Alexander claiming sole authorship. METHODS: In the summer of 2017, I visited Duke University Medical Center's Archives and surveyed the contents of boxes labeled "Alexander's papers." I also explored online databases with information on the Doctors' Trial. Pertinent documents were compared across collections, and against scholarly works on the topic. RESULTS: Box 3 of Alexander's papers at Duke University Medical Center's Archives contains a three-page document with six principles that, nearly word for word, were included in what is known as the Nuremberg Code. Alexander's name and appointment are typed at the end of the document. CONCLUSIONS: Although the Nuremberg Code is likely to have been an unplanned collaboration among members of the prosecuting team and the judges, I present evidence suggesting that Alexander drafted the blueprint and was the main contributor to the final version of the Code.

FDA Regulation and Approval of Medical Devices: 1976-2020.

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

Dead or Alive? Stillbirth Registration, Premature Babies, and the Definition of Life in England and Wales, 1836-1960.

When stillbirth registration became mandatory in England and Wales in 1926, it was not to amass statistics in the service of public health. Instead, it was part of broader anxieties that victims of infanticide were being disposed of under the guise of having been stillborn. But because it necessitated distinguishing between the living and the dead, the legislation that introduced stillbirth registration generated debate about the definition of life itself. This focused both on what counted as a sign of life and on questions about the viability of preterm infants. These contentious disputes had serious repercussions for the treatment of premature births well into the twentieth century. Significantly, they also underscore that what classifies a person as dead or alive is never self-evident. Instead, the state's authorized definition of life is under permanent negotiation as it is always mobilized in the service of particular regimes of power.

La Medicina Legal y el delito de violación en Chile (1875-1922) / No disponible

En el presente artículo estudiamos el viraje interpretativo impulsado por los principales exponentes de la Medicina Legal en Chile, ante la resolución conservadora de las controversias teóricas suscitadas por el llamado «principio de ejecución», relativo al delito de violación, desde su aparición en la primera sistematización penal y hasta las primeras dos décadas del siglo XX. Mediante un análisis de documentos normativos, obras bibliográficas y colecciones de revistas médico-jurídicas especializadas, constatamos cómo el proceso de significación de este «principio», lejos de quedar establecido en 1875, fue elaborado y modificado paulatinamente, gracias sobre todo a la labor desempeñada desde los principales impulsores de la Medicina Legal en el país. Asimismo, con el objetivo de conocer cuál fue la actuación del peritaje médico legal en la comprobación de los delitos de violación y de observar la implementación que el contenido teórico tuvo en la práctica, analizamos cien procesos judiciales por violación, incoados en los tribunales criminales de Santiago y Valparaíso entre 1890 y 1920. Interpretando los discursos médicos y penales considerados como creadores de una realidad concreta, ahondamos en los procesos de alianza e institucionalización médico-jurídica dentro de esta rama del conocimiento y consideramos su implementación material en las labores periciales encargadas por los tribunales criminales, para mostrar, así, cómo estas acciones coadyuvaron a reformular, reconstruir y consolidar una longeva desigualdad penal

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Policing the social body: Medicine and the administration of legal gender recognition in France and Italy, an historical perspective.

This paper explores the role of medicine in the regulation of legal gender recognition for trans and gender diverse people in France and Italy. I focus on the processes that led the two countries to establish for the first time a procedure for legal gender change in the 1980s/1990s. Despite the differences, both in France and in Italy medical knowledge and technologies were embedded in the procedures for legal gender change and health professionals took a role as gatekeepers to gender recognition. The medicalization of legal gender recognition, I argue, was part of the deploying of a bio-political apparatus that aimed at regulating and controlling "gender transitions" through regulation and normalization rather then through repression.

[A new end-of-life law? An Italian detour]. / Une nouvelle loi pour la fin de vie ? - Détour par l'Italie.

On January 31, 2018, advance directives law has come into effect in Italy. It is a law that grants the right to any individual of full age to express his or her preferences regarding treatment in anticipation of the days when he or she might be unable to do so. In France, however, two years after its entry into effect, the Claeys-Leonetti law is increasingly under attack. Some are even calling for a new end-of-life legislation altogether. A discussion of the Italian case, focused on the debates that led to the approval of this new legislation, can help us re-contextualize the French case. While there are many similarities between the two laws, their differences in terms of practices and intellectual frameworks may suggest additional avenues of thinking and help improve end-of-life conditions.

The Right to Know? The Politics of Information about Contraception in France (1950s-80s).

In 1920 in France, a law was passed prohibiting abortion, the sale of contraceptives and 'anti-conception propaganda'. While contraception was legalised in 1967 and abortion in 1975, 'anti-natalist propaganda' remained forbidden. This article takes seriously the aim of the French state to prevent the circulation of information for demographic reasons. Drawing from government archives, social movement archives and media coverage, the article focuses on the way the propaganda ban contributed to shaping the public debate on contraception as well as lastingly impacting the ability of the state to communicate on the subject. It first shows how birth control activists challenged the legal interdiction against communicating about contraception (1956-67) without questioning the natalist obligation. It then shows how, after 1968, communication on contraception became a power struggle carried out by various actors (sexologists and feminist and leftist activists) and how the dissemination of information about contraception was thought of as a way to challenge moral and social values. Finally, the article describes the change of state communication policies in the mid-1970s, leading to the first national campaign on contraception launched in 1981, which defined information as a task that women should take on.

Prenatal Diagnosis in France: Between Regulation of Practices and Professional Autonomy.

Prenatal diagnosis (PND) was introduced in France in the 1970s on the initiative of medical researchers and clinicians. For many years the regulation of practices was self-imposed, decentralised and idiosyncratic. The advent of 'therapeutic modernity' in the 1990s gave rise to an ethical, legal and scientific framework designed to homogenise PND at a national level, with the creation of multidisciplinary centres (CPDPN) and the Agence de la biomédecine. This article first recovers the history of PND in France. It then compares the activities of two CPDPNs, using ethnographic fieldwork and by analysing national quantitative data compiled by the Agence. It argues that the official policy of nationally homogeneous practices is not born out in practice, at the local level. This lack of homogeneity is most apparent in the number of authorisations for pregnancy termination due to foetal malformation, which varies considerably from one centre to another. Rooted in local culture, this variation relates to organisational methods, decision-making processes and variable levels of tolerance towards the risk of disability. Foetal medicine practitioners, thus, maintain a certain amount of autonomy that is collective rather than individual and that is reflected in the particular 'identity' of a given centre.

[CRIMINAL RESPONSIBILITY OF MEDICAL AND ITS CASE LAW EVOLUTION. LEGAL AND ECONOMIC PROFILES].

The article deals with the regulatory and jurisprudential evolution of medical criminal responsibility from the 70s to the Gelli-Bianco law of 2017. Subsequently it winds through the contribution of the last important judgments of the subject up to the decisions of the Supreme Court with United Sections of 2018, finally to conclude with an economic analysis on the increasement of the legal disputes registered in recent years.

Santayana's Axiom: The South Dakota State Medical Association and Medical Practice Legislation in 1929 and 2017.

In 1928 members of the South Dakota State Medical Association (SDSMA or the Association) held a special meeting in Huron to consider a basic science bill that conformed "…in its entirety to the conditions existing in our state." Their draft bill proposed a standardized examination for all practitioners of the healing arts. A legislative committee, with its attorney, "…was in Pierre during the early part of the 1929 legislative session to make sure the bill was properly launched and in effective channels." Shortly after its introduction, the bill was withdrawn due to opposition from one SDSMA district whose legislative representatives were among the most influential in the legislature. A similar bill promoted by the SDSMA in 1933 also failed. It would be another six years before a basic science bill was enacted by the legislature. Eighty-nine years later, a bill governing the practice of certified nurse practitioners (NP) and certified nurse midwives (NM), including a board independent of the South Dakota Board of Medical and Osteopathic Examiners, was considered (Senate Bill 61). Introduced by a senator who characterized herself as representing the "House of Nursing," the bill challenged "…the overarching role that medicine thinks and perceives that they may have regarding advanced practice nursing practice." SB 61 passed in the senate and house and was signed by the governor. For this legislation in the 1930s and in 2017, the SDSMA's interest was defining and maintaining control of medical practice under the twin rubrics of quality and patient welfare. In both circumstances, legislators and other health care professional organizations contested not only the SDSMA's motivations, but also the evidence supporting their efforts. Our research explored (1) whether the collective viewpoints and conduct of the legislature, the SDSMA, and non-physician medical professionals are comparable in the two circumstances; and (2) if the circumstances are comparable, can we derive a useful concept or theme that could help guide the SDSMA in the future?

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management.

The History and Challenges of Blood Donor Screening in China.

Since the establishment of People's Republic of China in 1949, the Chinese government has encountered several catastrophes related to transfusion transmitted diseases. The government's increasing attention to blood safety has prompted the initiation of a series of policies and measures that have enhanced the level of safety for the blood supply and met the basic clinical demands of blood for 1.3 billion people in the country. Blood donation screening strategies in China predominantly comprise donor screening and donor testing. Donor screening includes selection of low-risk blood donors by the use of a donor history questionnaire, predonation physical examination, and initial rapid donor testing. Donor testing includes direct pathogen detection and serology tests. The year 1998 marked the most transformative change in blood donor selection and screening policies in China. Before 1998, paid donation was the predominant mode of blood donation. Donor screening and donor testing were conducted before donation, and only those who were eligible were allowed to donate. To ensure the safety of blood, donor testing was performed again after donation. After the implementation of the Blood Donation Law in 1998, to promote voluntary and unpaid donation, predonation donor testing was eliminated to reduce the amount of waiting time and to provide a more convenient donation experience for blood donors. However, it is the national requirement that donated blood should undergo 2 rounds of testing using different equipment or reagents, conducted by different personnel. Donor selection has transitioned from paid donation and obligatory donation to voluntary donation with fixed volunteer groups, as the latter mode of donation provides the lowest risks. Donations are currently screened for syphilis, hepatitis C virus, HIV, and hepatitis B virus (HBV). Units, previously typed only for ABO, are now routinely tested for both ABO and Rh(D). Innovations in testing technologies and methods have also brought changes to screening parameters. For instance, screening for HBV pathogens evolved from the early use of hemagglutination method to the later use of radioimmunoassay, independent enzyme-linked immunosorbent assay, and now the widespread application of nucleic acid test (NAT). Since 2010, the Chinese government has established NAT capacity in several blood centers; and in 2015, the government invested 900 million RMB on the nationwide expansion of NAT. Although the Chinese government has worked to enhance blood safety, many challenges remain. Concern exists for rising rates of HIV infection. The existence of occult HBV infection and the transmission of emerging blood-borne diseases continue to challenge the safety of the blood supply.