The Delay in the Licensing of Protozoal Vaccines: A Comparative History.

Although viruses and bacteria have been known as agents of diseases since 1546, 250 years went by until the first vaccines against these pathogens were developed (1796 and 1800s). In contrast, Malaria, which is a protozoan-neglected disease, has been known since the 5th century BCE and, despite 2,500 years having passed since then, no human vaccine has yet been licensed for Malaria. Additionally, no modern human vaccine is currently licensed against Visceral or Cutaneous leishmaniasis. Vaccination against Malaria evolved from the inoculation of irradiated sporozoites through the bite of Anopheles mosquitoes in 1930's, which failed to give protection, to the use of controlled human Malaria infection (CHMI) provoked by live sporozoites of Plasmodium falciparum and curtailed with specific chemotherapy since 1940's. Although the use of CHMI for vaccination was relatively efficacious, it has some ethical limitations and was substituted by the use of injected recombinant vaccines expressing the main antigens of the parasite cycle, starting in 1980. Pre-erythrocytic (PEV), Blood stage (BSV), transmission-blocking (TBV), antitoxic (AT), and pregnancy-associated Malaria vaccines are under development. Currently, the RTS,S-PEV vaccine, based on the circumsporozoite protein, is the only one that has arrived at the Phase III trial stage. The "R" stands for the central repeat region of Plasmodium (P.) falciparum circumsporozoite protein (CSP); the "T" for the T-cell epitopes of the CSP; and the "S" for hepatitis B surface antigen (HBsAg). In Africa, this latter vaccine achieved only 36.7% vaccine efficacy (VE) in 5-7 years old children and was associated with an increase in clinical cases in one assay. Therefore, in spite of 35 years of research, there is no currently licensed vaccine against Malaria. In contrast, more progress has been achieved regarding prevention of leishmaniasis by vaccine, which also started with the use of live vaccines. For ethical reasons, these were substituted by second-generation subunit or recombinant DNA and protein vaccines. Currently, there is one live vaccine for humans licensed in Uzbekistan, and four licensed veterinary vaccines against visceral leishmaniasis: Leishmune® (76-80% VE) and CaniLeish® (68.4% VE), which give protection against strong endpoints (severe disease and deaths under natural conditions), and, under less severe endpoints (parasitologically and PCR-positive cases), Leishtec® developed 71.4% VE in a low infective pressure area but only 35.7% VE and transient protection in a high infective pressure area, while Letifend® promoted 72% VE. A human recombinant vaccine based on the Nucleoside hydrolase NH36 of Leishmania (L.) donovani, the main antigen of the Leishmune® vaccine, and the sterol 24-c-methyltransferase (SMT) from L. (L.) infantum has reached the Phase I clinical trial phase but has not yet been licensed against the disease. This review describes the history of vaccine development and is focused on licensed formulations that have been used in preventive medicine. Special attention has been given to the delay in the development and licensing of human vaccines against Protozoan infections, which show high incidence worldwide and still remain severe threats to Public Health.

How PAs became licensed to practice in the United States.

The history of how PAs in the United States were first granted practice authority under the medical practice acts of the various states and territories begins in the 1960s with an imaginative way to circumvent the moratorium on licensure of new healthcare occupations in place at the time, while allowing the requisite flexibility for the new profession to take hold and thrive. In the subsequent decades, separate licensure for PAs was required and adopted. Despite the enormous success of the PA profession over its first 50 years, challenges remain.

El papel de la prensa en la lucha contra la consolidación de la profesión médica en Buenos Aires, 1890-1900 / No disponible

El objetivo de este artículo es poner de relieve el papel desempeñado por la prensa en las resistencias contra la consolidación de la profesión médica en Buenos Aires en la década de 1890. Se parte de la hipótesis según la cual las tribunas periodísticas fueron instanciasesenciales tanto para la instauración del proyecto sanitario del gremio médico como para la prosecución de las luchas de quienes lo objetaron. Las columnas no sólo reflejaron los conflictos y negociaciones producidas, sino que formaron parte de las armas utilizadas porambas partes. En otros términos, el periodismo fue, en gran medida, la arena y el material primordial de esas contiendas. En esta ocasión en particular intentamos mostrar, en base al estudio de unos pocos casos, los distintos modos a través de los cuales los enemigos de lamedicalización recurrieron a la prensa a los fines de hacer oír sus reclamos. Sanadores, médicos extranjeros, magnetizadores e ilusionistas difundieron sus exigencias mediante distintas tácticas que giraban en torno a las publicaciones periódicas (a través de cartas abiertas, entrevistas y artículos desde los cuales se impugnaron las iniciativas de los profesionales). Incluso llegaron a editar publicaciones periódicas propias, que hasta el momento no habían recibido suficiente atención de los historiadores (AU)

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John Buchanan's Philadelphia Diploma Mill and the Rise of State Medical Boards.

The absence of medical licensing laws in most states during the years following the American Civil War made it possible for unscrupulous individuals to capitalize upon the weak governmental role in medical practice and educational charters. The practices of John Buchanan during much of his tenure at the Eclectic Medical College of Pennsylvania, in issuing thousands of dubiously earned diplomas, caused a national and international scandal. The traffic in diplomas became so flagrant that regulatory oversight of physicians and their practice, such as that conducted by the Illinois Board of Health led by Dr. John Rauch, developed rapidly across the United States. Though multiple factors prompted the rebirth of medical licensing laws, professional, educational, journalistic, and public concerns for bogus diplomas played an important role.

GRANTING A LICENCE FOR OPENING A PHARMACY IN BOLOGNA DURING ACTIVITY OF THE BOLOGNESE ARTE DE' SPEZIALI (13TH - 18TH CENTURY).

The article discusses the main changes in legislation concerning granting the licenses for opening a new pharmacy in Bologna in the Middle Ages and Early Modern period. The organization of all traders, including apothecaries, was subordinated, as almost everywhere in Italy, to the Guilds. In the 2nd half of 16th century the Arte de' Speziali of Bologna came under the jurisdiction of the Collegio di Medicina, leading to disagreements between the two corporations. Giovanni Baldi, in his Notizie storiche su la farmacia bolognese (Bologna, 1955) mentioned one of these controversies, dating on the second half of 18th century. The Authors present this controversy basing on original documents from Archivio di Stato di Bologna.

Kleoniki Klonari (c 1872 - 1951): the turbulent life of the first licensed nurse in Greece.

Miss Kleoniki Klonari, a Greek woman from Mantamado of Lesbos, then occupied by the Turks, decided to go to America, in the 1890s, to study Pediatric Nursing and specialize in Hospitals Administration. Now a qualified nurse she was hired by Princess Sophia, in around 1902, as Medical Director of the Children's Hospital "Aghia Sofia". She had a turbulent life, as her professional route was full of dismissals and returns to the hospital she loved. She died after a long adventure in Africa's jungle, leaving all her money to the hospital.

Alcohol licensing in Scotland: a historical overview.

AIM: This paper provides a historical overview of licensing law in Scotland. It seeks to put important contemporary policy developments into their historical context and to draw attention to key themes in licensing policy debates across the United Kingdom. DESIGN: Based on a survey of statutes, commissions of enquiry and consumption and retail data, this paper draws together historical evidence to present a synopsis of Scottish licensing history. SETTINGS: The article focuses on Scotland, but also discusses UK-wide licensing policy over a 250-year period. FINDINGS: Scottish licensing has diverged from licensing in England and Wales and has addressed some historical licensing weaknesses, including problems of accountability, overprovision and systemic oversight regarding off-sales. Distinctive features of current Scottish legislation include public health protection as a statutory licensing objective; local Licensing Forums and Licensing Standards Officers; a requirement for explicit policies on the 'overprovision' of licensed premises; mandatory restrictions on price promotions in the on- and off-trades; and limitations on opening hours for off-licences. CONCLUSION: Scotland has developed alcohol policies several times addressing long-standing licensing weaknesses throughout the United Kingdom. Some Scottish alcohol policies have later become the norm in England and Wales.

A difficult time with the permit process.

In the 1970s, new forms of public scrutiny were applied to the research methods of field biologists in the United States, particularly those studying endangered species and marine mammals. This paper shows how such scrutiny affected researchers' choice of research methods through an analysis of a key moment in a decade-long controversy over the conservation of bowhead whales. In 1978, researchers at the Naval Arctic Research Laboratory received funding from the Bureau of Land Management to radio-tag bowhead whales. Although this promising but still largely untested technique might have answered one of the central scientific questions in the controversy, it ultimately went unused. Technical considerations played a role in the decision not to use the technique, but the most important factor was scientists' concerns about potential backlash from Iñupiat whalers and animal protectionists. The same forces that had made marine mammalogists more influential than ever and that had put into their hands the resources necessary to develop more effective research techniques also placed serious constraints on where, when, and how they could do their research.

The Triple Qualification examination of the Scottish medical and surgical colleges, 1884-1993.

The Triple Qualification (TQ) examination of the three Scottish medical colleges was founded in 1884 in the aftermath of the Medical Act of 1858, to offer a medical qualification that would have equal status with that of the universities and other medical schools. Continued efforts to amend the Act had threatened that the universities might dominate basic medical education to the exclusion of the colleges, which opposed this perceived threat to their viability. The TQ proved surprisingly durable and catered for a changing constituency of candidates over the century of its existence, offering a route to medical qualification for individuals from Great Britain and Ireland, the dominions and such diverse groups as exiled Jews from Europe and Rhodesians following independence. This article examines the origins and structure of the examination and assesses the changing candidate profile over the century of its existence.

[State control of medicine through legislation and revision of the Medical Law: licensed and unlicensed medical practices in the 1950s - 60s].

In the 1950s and 1960s, Korea overcame the aftermath of the war and laid the foundations for modernization of economy and professionalization of medicine. The National Medical Services Law, enacted in 1951 was the first medical law to be legislated since the establishment of the Republic of Korea. The law provided a medical system for the traditional Korean medical practitioners, activated opening of hospitals through report-only system and prohibition of interference in medical practice, and facilitated mobilization of the doctors by the government. The Medical Law, legislated in 1962 by the Park Jong-Hee administration contained practice license system, regular practice reporting system and practice designation, thereby strengthening the government control on the medical practitioners, inducing professionalism and high-quality of medical practitioners and abolished unlicensed medical practitioners such as acupuncturists, moxa cauterists and bone setters. The Medical Assistant Law of 1963 was introduced so that medical examination and assistance could be carried out under supervision of professional doctors. To reduce areas without healthcare system, region-specified medical practitioners got licensure and a community doctor system was organized. However, due to expensive medical fees in comparison to economic status and medical needs of patients, shortage of doctors, low accessibility to hospitals led to the prevalence of illegal medical practice by unlicensed practitioners. Absence of national budget or policy on the health care system and the American-style noninterference medical system were other factors causing the situation. Government, Korean Medical Associations and Korean Dental Association tried, without success, to exercise control over the unlicensed medical practice. President Park Jong-Hee had to introduce a special law concerning the health-care related crimes with life sentence as the highest penalty. While the government put modernization before social welfare, operated on a policy of state-controlled medical care system, and doctors achieved specialization system similar to that of the United States, the public had to suffer, being treated by unlicensed medical practitioners. Inevitably, the need for a national medical practitioner supply plan and a policy to support health service was raised.