Clinical trials and the origins of pharmaceutical fraud: Parke, Davis & Company, virtue epistemology, and the history of the fundamental antagonism.

This paper describes one possible origin point for fraudulent behavior within the American pharmaceutical industry. We argue that during the late nineteenth century therapeutic reformers sought to promote both laboratory science and increasingly systematized forms of clinical experiment as a new basis for therapeutic knowledge. This process was intertwined with a transformation in the ethical framework in which medical science took place, one in which monopoly status was replaced by clinical utility as the primary arbiter of pharmaceutical legitimacy. This new framework fundamentally altered the set of epistemic virtues-a phrase we draw from the philosophical field of virtue epistemology-considered necessary to conduct reliable scientific inquiry regarding drugs. In doing so, it also made possible new forms of fraud in which newly emergent epistemic virtues were violated. To make this argument, we focus on the efforts of Francis E. Stewart and George S. Davis of Parke, Davis & Company. Therapeutic reformers within the pharmaceutical industry, such as Stewart and Davis, were an important part of the broader normative and epistemic transformation we describe in that they sought to promote laboratory science and systematized clinical trials toward the twin goals of improving pharmaceutical science and promoting their own commercial interests. Yet, as we suggest, Parke, Davis & Company also serves as an example of a company that violated the very norms that Stewart and Davis helped introduce. We thus seek to describe one possible origin point for the widespread fraudulent practices that now characterize the pharmaceutical industry. We also seek to describe an origin point for why we conceptualize such practices as fraudulent in the first place.

[Scientific misconduct: A major threat for medical research]. / Fraude scientifique : une menace majeure pour la recherche médicale.

Scientific misconduct (fabrication, falsification, and plagiarism) and detrimental research practices (selective reporting of data, inappropriate citation practice, ghostwriting) are admitted respectively by 2 % and 33 % of researchers. The consequences of scientific misconduct and detrimental research practices are disastrous, both for the doctors, who are the most affected researchers in view of the number of retracted articles, and for the patients, victims of false information that may have health consequences. In order to fight against the causes (promotion of doctors and allocation of resources to clinical wards and laboratories on purely quantitative research criteria, lack of training in scientific integrity in medical studies, heterogenous quality of reviewing, legal impunity), there are legislative, academic, technological and editorial solutions, but radical and urgent cultural change is needed first.

[A historical view of breast implants: Controversy on silicones and breast implant associated -anaplastic large cell lymphoma]. / Seins à dessein. Une histoire d' implants mammaires : controverses autour de la silicone et du lymphome anaplasique a grandes cellules-associe implants mammaires.

Since the dawn of breast implantation back in the sixties, five generations of breast implants have tried to provide the most natural-looking results while striving to eliminate the risk of unpleasant ruptures or capsular contractures. National Health regulators (i.e. the FDA in USA and ANSM in France) have had an "after the facts" reaction, which led to a so-called "dirty war" among producers in the form of a 1992 Silicone's Moratorium (after suspicions of associated cancer or immune-related disorders) all this under the rigid oversight of a FDA director, who seemed more sensible to media scandal than scientific data. After more than a decade of consistent scientific evidence, the interdiction was finally ended in France in 2001 and in the USA in 2006, however the scandals resurfaced again in 2011 after a proven fraud on the "PIP - affair" and most recently with "breast implant associated - anaplastic large cell lymphoma", an extremely serious and rare pathology, treated only by surgical means, until further research. We describe also a chronology on the way the FDA finally recognized this dramatic complication.

[Unmasking impostors: Professional physicians and their struggle against fake doctors in Peru]. / Desenmascarando a los impostores: Los médicos profesionales y su lucha contra los falsos médicos en Perú.

The characterization of non-professional healers as "quacks" or "impostors" has influenced much of how such actors have been perceived by public opinion and in academic research. As a result of this, a divide has emerged between professional physicians, on the one hand, and those who acquired their knowledge in a traditional and non-academic way, on the other. This work questions the alleged divide between these two groups in the health field in order to offer a more complex and richer picture of local practices in Peru. Based mainly on correspondence from the Faculty of Medicine in Lima and newspaper ads, we reconstructed the attempts made by medical authorities to contain and exclude healers of Asian, European, or local backgrounds, many of which failed. For this reason, we studied two specific devices designed to legitimate and monitor physicians trained professionally: degrees or diplomas and lists of graduates, both of which are predecessors to our current identification cards and databases.

La caracterización de sanadores no-titulados como "charlatanes" o "impostores" ha influido notablemente en cómo han sido percibidos por la opinión pública y en las investigaciones académicas. Se creó, entonces, una división entre los médicos profesionales y aquellos que adquirieron su conocimiento de modo tradicional y no-académico. Este artículo cuestiona la supuesta división entre dichos especialistas en el campo de la salud para ofrecer un cuadro más complejo y rico de prácticas locales a partir del caso peruano. A partir, sobre todo, de correspondencia de la Facultad de Medicina de Lima y de avisos en periódicos, reconstruimos la dinámica de las autoridades médicas en sus intentos, muchas veces infructuosos, de contener y excluir a sanadores de origen asiático, europeo o local. Para ello, estudiamos dos artefactos diseñados para legitimar y monitorear a los médicos formados profesionalmente: los títulos o diplomas y las listas de graduados, predecesores de nuestros modernos documentos de identidad y bases de datos.

Desenmascarando a los impostores: Los médicos profesionales y su lucha contra los falsos médicos en Perú / Unmasking impostors: Professional physicians and their struggle against fake doctors in Peru

RESUMEN La caracterización de sanadores no-titulados como "charlatanes" o "impostores" ha influido notablemente en cómo han sido percibidos por la opinión pública y en las investigaciones académicas. Se creó, entonces, una división entre los médicos profesionales y aquellos que adquirieron su conocimiento de modo tradicional y no-académico. Este artículo cuestiona la supuesta división entre dichos especialistas en el campo de la salud para ofrecer un cuadro más complejo y rico de prácticas locales a partir del caso peruano. A partir, sobre todo, de correspondencia de la Facultad de Medicina de Lima y de avisos en periódicos, reconstruimos la dinámica de las autoridades médicas en sus intentos, muchas veces infructuosos, de contener y excluir a sanadores de origen asiático, europeo o local. Para ello, estudiamos dos artefactos diseñados para legitimar y monitorear a los médicos formados profesionalmente: los títulos o diplomas y las listas de graduados, predecesores de nuestros modernos documentos de identidad y bases de datos.

ABSTRACT The characterization of non-professional healers as "quacks" or "impostors" has influenced much of how such actors have been perceived by public opinion and in academic research. As a result of this, a divide has emerged between professional physicians, on the one hand, and those who acquired their knowledge in a traditional and non-academic way, on the other. This work questions the alleged divide between these two groups in the health field in order to offer a more complex and richer picture of local practices in Peru. Based mainly on correspondence from the Faculty of Medicine in Lima and newspaper ads, we reconstructed the attempts made by medical authorities to contain and exclude healers of Asian, European, or local backgrounds, many of which failed. For this reason, we studied two specific devices designed to legitimate and monitor physicians trained professionally: degrees or diplomas and lists of graduates, both of which are predecessors to our current identification cards and databases.

Skide godt! - Phenomenon Olsen gang from a forensic point of view.

INTRODUCTION: The Olsen gang is a 14-episode film series about a gang of three thieves, who are very imaginative, but often unsuccessful in their burglary attempts "to score a real hit". In Denmark, the German Democratic Republic and Poland the films about Egon Olsen were blockbusters and still enjoy cult status there. Apart from a small amount of popular literature, the phenomenon of the Olsen gang has never been scientifically investigated from a forensic point of view so far. METHODS: The films, produced between 1968 and 1998 (more than 22 hours of footage), were evaluated and compared with each other under forensic, legal and forensic-psychiatric aspects. The cooperation between the three scientific disciplines was intended to add a new perspective to the crime comedies. RESULTS: A wide variety of medically relevant facts are presented in the movies. Even with all their criminal enthusiasm the Olsen gang commits almost no crimes against anyone's physical integrity. The films show legally comparable crimes, especially cases of severe band theft. Based on the criminal offenses committed, no gang member suffers from a psychiatric disorder fulfilling the criteria defined in Sections 20, 21 German Criminal Code. CONCLUSIONS: The great international success of the Olsen gang is certainly attributable to the imaginative theft plans for "fund-raising" and their almost pitiful failure. Many forensically relevant aspects are not shown in a realistic way. The accumulation of offenses and periods of imprisonment could result in preventive detention. The offenders are driven by normal psychological motives.

[Fraud and pharmacist: an old companionship from Antiquity to nowadays]. / La fraude et le pharmacien: un vieux compagnonnage de l'Antiquité à nos jours.

Fraudulent trading often deals with pharmacist, from several viewpoints. Pharmacist had often suffered from it, but he was also sometimes the source of falsification which initiated the need for inspection of pharmacy shops. The scientific knowledge of pharmacists, and particularly his analytical skills, explains their role to detect falsifications for products outside drugs, especially for food and also for drug use in competitive sport. Drug falsification goes back to time immemorial and goes on today very actively with Internet expansion. States and WHO try to fight against this plague with more and more complex tools such as Datamatrix progressively implemented worldwide. Pharmacy and falsifications, two words that will be unfortunately associated during the whole human history.

Good enough for America.

Adulterated and counterfeit drugs were pouring into the U.S. Providing poor medicines was a growing business, and the market was growing with the rapid expansion of the country itself. There seemed to be little that could be done to slow or stop it. The sophistication of the adulterations was superior to available tests, standards were lacking, and there were few trained pharmacists or physicians who could apply them. There were no laws that would prohibit the importation of these products nor limit their sale once ashore. This was the situation when a small group of New York pharmacists took it upon themselves to convince other health professionals and legislators that there was a problem and devised a solution that would establish patient safety as the core value of the emerging profession of pharmacy.

[Health-care services in the GDR during the 1980s: A status report based on the files of the state security agency]. / Das DDR-Gesundheitswesen in den 1980er Jahren: Ein Zustandsbild anhand von Akten der Staatssicherheit.

BACKGROUND: The situation of the health-care services in the GDR during the 1980s has been reconstructed on the basis of the in part not previously released files of the Ministry for State Security (Stasi files). METHOD: A research application was submitted to the responsible German Agency to examine the Stasi files on district physicians in the GDR. 78 extensive files were made available and evaluated according to the topics drugs and other medicinal aids, medical techniques, building status, procurement of foreign currencies, hygiene, Chernobyl, appeals and shortage of physicians. RESULTS: The Stasi files reveal a dismal picture for the status of health-care services in the GDR during the 1980s. The authorities responsible for public health and the Ministry for State Security were well informed about the existing problems. Towards the end of the GDR the Ministry of Sate Security admitted internally that research and technology were lagging about 10 years behind that in Western countries. CONCLUSION: The discrepancy between the official reports and inofficial opinions was considerable. The Ministry of State Security worked mainly passively in an ideological fantasy world in which all such discrepencies had to be denied.

'Just a quack who can cure cancer': John Braund, and regulating cancer treatment in New South Wales, Australia.

In 1948 the New South Wales government instituted an inquiry into the claims of John Braund ­ a 78-year-old self-described 'quack' ­ that his secret treatment had cured 317 cancer sufferers. The 'Braund controversy', as it became known, was one of Australia's most prominent cases of medical fraud. This paper examines that controversy and its effects on cancer philanthropy, medical research, and especially on legislation regulating treatment providers up to the present. With the Braund controversy in mind, the New South Wales (NSW) parliament struggled to develop legislation that would protect patients and punish quacks but also allow for serendipitous, unorthodox discoveries. Recent decades saw new elements added to this calculus ­ allowing a wide-ranging health marketplace, and allowing patients to choose their therapies. This paper argues that the particular body of law legislatures used in regulating cancer treatment and how regulations were framed reflected the changing context of healthcare and illustrates the calculus legislatures have undertaken in regulating the health marketplace, variously factoring in public safety, serendipitous discovery, the authority of orthodox medicine, patient choice, and economic opportunity.

[Young man with gunshot wound (GSW)--what killed Ernst vom Rath?].

On the morning of November 7, 1938 vom Rath, a diplomat at the German embassy in Paris, was shot by Herschel Grynzspan, a Jewish teenager. Of the 5 shots fired, 2 hit vom Rath, one in the right shoulder and one in the abdomen. He was rushed to Alma Women's Hospital near the embassy, where emergency surgery was undertaken. Two days later his condition deteriorated rapidly and succumbed 55 hours after the shooting. It is believed that the assassination triggered the "Kristallnacht"--the organized Nazi pogrom against Jews across Germany. Based on the Alma hospital registry, autopsy findings and articles from recent years, the course of his condition and possible cause of his death are discussed. The possibility of malpractice, and even medical fraud, which led to his death are also mentioned.