Overblog
Edit post Seguir este blog Administration + Create my blog
24 octubre 2014 5 24 /10 /octubre /2014 16:11

Graphic: Experimental Laboratories of East Germany

DER SPIEGEL: Experimental Laboratories of East Germany

 

 

Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain

http://jme.bmj.com/content/early/2014/09/17/medethics-2013-101925.full

En una RDA derrumbada económicamente, y sin fuentes de ingresos, el Estado vio en la salud una oportunidad para obtener financiación privada, y aceptó prácticas irregulares de las compañías farmacéuticas de Europa y América. En total, se obtuvieron, al menos, 16,5 millones de marcos alemanes.

 

http://jme.bmj.com/content/early/2014/09/17/medethics-2013-101925/F1.large.jpg

Gráfica con las principales empresas farmacéuticas que invirtieron, al menos, medio millón de marcos alemanes en ensayos clínicos en la Alemania del Este.

Hoechst; Sandoz; BoehringerMannheim; Casella; Schering; Bayer; Thlemann; CibaGeigy; BraunMelsungen; Gödecke; Behringwerke ... estuvieron en "la colada" ... entre los fármacos que se probaron, había quimioterapéuticos, insulina, heparina, antidepresivos, medicamentos contra la alergia e incluso pastas de dientes ...

Stasi files - Stasi police kept East Germans in fear for 40 years  

Huburt Bruchmüller believes he might "be the only survivor" of clinical trials of a medication performed in 1989 in one East German clinic.

.

Huburt Bruchmüller believes he might "be the only survivor" of clinical trials of a medication performed in 1989 in one East German clinic.

spiegel.de/international/germany/western-drugmakers-tested-medicines-on-unwitting-east-germans-a-899594.html

.

La Alemania del Este permitió a las farmacéuticas hacer ensayos clínicos sin informar a los pacientes

agenciasinc.es/Noticias/La-Alemania-del-Este-permitio-a-las-farmaceuticas-hacer-ensayos-clinicos-sin-informar-a-los-pacientes

 

 

Un grupo de investigadores de centros alemanes ha indagado en los ensayos clínicos realizados en la República Democrática Alemana (RDA) por parte de las compañías farmacéuticas occidentales durante la Guerra Fría, desde 1983 hasta 1990.

La investigación ha revelado que algunos de aquellos ensayos se hicieron sin que los pacientes estuvieran suficientemente informados sobre el proceso en el que participaban. En una RDA derrumbada económicamente, y sin fuentes de ingresos, el Estado vio en la salud una oportunidad para obtener financiación privada, y aceptó prácticas irregulares de las compañías farmacéuticas de Europa y América. En total, se obtuvieron, al menos, 16,5 millones de marcos alemanes.

 

Sus análisis, publicados en la revista Journal of Medican Ethics, han contabilizado 220 ensayos con 68 empresas y más de 14.000 pacientes de todas las edades, algunos de los cuales murieron durante los ensayos. Los documentos no aclaran si estas muertes estuvieron vinculadas a los ensayos clínicos.

Los archivos sugieren que la RDA intentó realizar los ensayos según los estándares éticos internacionales, y los investigadores reconocen que no encontraron ninguna evidencia de que los procedimientos dañaran sistemática e intencionadamente a los pacientes.

.

 

 

Entre los fármacos que se probaron, había quimioterapéuticos, insulina, heparina, antidepresivos, medicamentos contra la alergia e incluso pastas de dientes.

“Nuestra investigación muestra lo importante que es que el médico obtenga el consentimiento del paciente y que el derecho a la autodeterminación [a aceptar o rechazar tratamientos] esté garantizado”, explica a Sinc Rainer Erices, del Instituto de Historia y Ética de la Medicina de la Universidad Friedrich Alexander en Erlangen (Alemania).

 

Los investigadores señalan que el marxismo tuvo mucho que ver con la aceptación de tales prácticas en la sociedad de la Alemania comunista. Según los principios marxistas, los intereses del colectivo prevalecen sobre los del individuo. Los médicos y científicos, al igual que el resto de la población, estaban subordinados al bien común.

Según los autores del estudio, el Estado aprovechó la sumisión de los funcionarios y médicos de la RDA para consentir la intervención de la industria farmacéutica en la población sin tan siquiera un debate público.

Acceso al servicio secreto

Los investigadores analizaron los ensayos farmacéuticos desde 1983 hasta la reunificación de Alemania en 1990, que se almacenan en el Archivo Federal de Berlín. También contaron con la base de datos del servicio secreto de Alemania Oriental, la llamada Stasi, que recogía todos los ensayos de nuevos fármacos, junto con datos de los responsables de estas pruebas y los casos de pacientes terminales.

 

 

El acceso a tal cantidad de datos ha retrasado el análisis. “Los archivos de la Stasi no estaban centralizados y contenían una gran cantidad de información acerca de los participantes, los grados de confidencialidad y los problemas especiales durante los ensayos –explica Erices–. Tuvimos que dedicarle mucho tiempo”.

“Cuando empezamos a publicar los resultados de nuestro estudio, muchas personas se dieron cuenta de la importancia que tenían. En algunos casos nos contactaron varios pacientes antiguos y en otros, sus hijos” cuenta Erices. “Estaban más molestos por no haber dado su consentimiento expreso que por haber participado en el ensayo clínico en cuestión”.

El reparto del pastel

Los investigadores también descubrieron información sobre los ingresos. Entre 1983 y 1990, el sistema de salud de la RDA recibió aproximadamente 16,5 millones de marcos alemanes de los ensayos.

Según los informes, parte del pago se realizó a la Berliner Import Export GmbH (BIEG), que era el organismo encargado de los aspectos financieros de las ofertas de explotación. La BIEG percibió aproximadamente la mitad del total, cuyo destino final se desconoce. La cantidad restante se distribuyó entre el Ministerio de Salud, el Ministerio de Educación Superior e Investigación, y la Academia de Ciencias.

 

 

Aunque no había ninguna obligación de compartir los beneficios con las instituciones participantes, los médicos y los equipos hospitalarios recibieron un extra para aumentar su motivación. Por el contrario, los participantes no recibieron ninguna bonificación.

Los estudios clínicos se hicieron en nueve facultades de medicina de la RDA, la mayoría en la Universidad Humboldt de Berlín, la Charité, y las Academias Médicas de Dresde, Magdeburgo y Rostock. Los investigadores descartan que otras instituciones, como orfanatos y centros militares, participaran en los ensayos.

El sensacionalismo de los medios

Desde que el periódico alemán Der Spiegel desatara en 2012 la polémica con la publicación de información sobre los ensayos clínicos de este periodo, en la que tachaba a la RDA de “utilizar a la población alemana como conejillos de indias”, se ha hecho evidente la necesidad de aclarar los hechos con una investigación exhaustiva. 

Erices considera que “la profesión médica tiene la obligación ética de participar en este tipo de investigaciones, que no deben dejarse en manos de los medios de comunicación”.

En la actualidad, aún no se sabe qué paso realmente con los ensayos clínicos realizados durante la década de los ochenta en la República Democrática Alemana. Según Erices,  “la investigación histórica del sistema de salud de Alemania del Este, sobre todo en la década de 1980, no ha hecho más que empezar”.

.

 

Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain

Western pharmaceutical companies conducted clinical trials in the Eastern Bloc during the Cold War. Recently, media reports about alleged human experimentation provoked a wave of indignation. However, a scientific and objective account of these trials is lacking. The aim of this study was to describe and evaluate the clinical trials performed in the German Democratic Republic (GDR) based on archival material from the health system and the secret service. We found documents relating to 220 trials involving more than 14 000 patients and 68 Western companies. However, no record of patient information forms or systematic documentation regarding the provision of patient consent was discovered. There was no evidence to suggest that the trials systematically and intentionally damaged patients. The trials were conducted without the knowledge of the public. GDR legislation stipulated that patients must consent to the trials, but no evidence was found to suggest that patients were systematically informed. Documents suggest that at least some of the trials were carried out without patients having a comprehensive understanding of what the trial involved. The GDR agreed to the trials due to impending bankruptcy and Western pharmaceutical companies capitalised on this situation.

 

Ethical evaluation

The general moral problem is that the pharmaceutical trials were carried out without the public being informed. Specifically, the commercial transactions were conducted without the knowledge of East German citizens, in order to serve the economic interests of a country that was fast approaching financial bankruptcy.7 Of course, testing without patient consent would be far more serious. However, we could not conclusively determine whether or to what extent patients were informed. On the one hand, the study conducted by the University Jena showed that some patients knew that they had taken part in a trial. On the other hand, we could not find any information sheets for patients. In addition, the fact that officials demanded a clearer patient information process suggests that at least some of the trials were conducted illegally. This assumption, however, remains speculative.

 

An aggravating factor was that the GDR ideology required the subordination of the individual to the interests of the collective, a basic precept of Marxism.28 Therefore, the rights of the individual were not always fully taken into account. This goes against traditional medical ethics where patient autonomy is the primary concern. In the GDR, decisions were often made for purely ideological reasons.29 State politics followed a socialist collective code of ethics and ethical freedom was non-existent, a fact that even formerly loyal GDR ethicists openly admit today.30 Medical employees, doctors and scientists were expected to subordinate their interests to prioritise tasks of importance to society.31 A truly independent medical opinion was not wanted. Given these external conditions, the potential risks of using unapproved drugs or of conducting double-blind randomised placebo-controlled trials were secondary considerations.32 One could argue that medical ethics principles change when we do not regard autonomy as being paramount and that the approach of the GDR Ministry of Health might be justified on these grounds. However, following this line of argument requires recognition of the norms and values of the socialist society of the GDR. In this sense, bioethical discussion cannot be separated from socio-critical debate.

 

With no information given to the public and no public dialogue, patients in the GDR were hardly aware of their own rights and responsibilities. The origin of the bioethical problem lies in the special relationship between doctor and patient. Specifically, patients expect the doctor to cure them or at least to have their best interests at heart. Patients are highly dependent on doctors’ medical decisions, which patients are aware they often do not understand. Witnesses report that East German doctors usually welcomed the opportunity to use modern drugs, especially if they were supplied by the supposedly ‘better’ Western world. Doctors were, therefore, ‘emotionally’ very much in favour of their patients participating in these trials. This had consequences. In a society requiring subordination of the individual to the interests of the collective, renunciation of autonomy meant increased dependence on authorities, in this case, the medical authorities.33

 

.

With respect to the clinical trials, the patients had to choose whether or not to participate although given little time to decide, providing they were given the chance to carefully consider this decision at all.

 

Another critical point was that the GDR health system was obliged to generate income in hard currency. The state saw the health sector not as promoting patient well-being as a central concern but rather as providing an opportunity to earn much-needed hard currency. The contracts between the East and West were not primarily drawn up by medical or pharmaceutical professionals but by the GDR foreign trade department under the direct control of the Stasi.

 

Importantly, most medical facilities were experiencing a general supply shortage.34 Those in charge, therefore, normally went out of their way to accede to any requests made by the state. Moreover, they would be paid for their participation in the trials, albeit in local currency.

 

Of course, the problem can only be evaluated within the general context of the morality of a dictatorial state. In the GDR, health care was organised by the state. The goal was an almost free, centrally planned healthcare system, equally available to every citizen. The healthcare system was seen as one of the major achievements of the country. Even today many are convinced that the East German health system was one of the more important benefits of the GDR.35 However, despite the propaganda, the state healthcare system as well as the entire East German economy was barely able to survive in the late 1980s.34 ,36 However, the public were unaware of this as the picture of the country presented to its citizens was one of unfailing confidence.37

 

.

An example illustrates this highly problematic lack of consideration of human and patients’ rights. Before the West German Chancellor, Helmut Schmidt visited the GDR in 1980, the Stasi ordered that ‘a list of all mentally disturbed citizens in the district’ be created and that the affected people should not be informed. The fact that such a demand completely disregarded medical confidentiality was of no concern to the state.3

 

This system often falsified the past, the present and the future,37 so it was impossible for citizens to determine the truth. In such a situation, it was difficult for anyone to make an independent decision, especially since public opinion was extensively manipulated and controlled. Consequently, the state had no interest in a public debate on clinical trials and their reasons. This fact suited the Western pharmaceutical companies very well. They took advantage of the submissiveness of GDR officials and doctors, which facilitated a smooth process without public debate. This may have played a key role in company decisions to test their drugs in Eastern Germany. For instance, Roussel Uclaf conducted two trials of mifepristone, a drug used for medical abortion, in the GDR: in 1988, the company stopped distribution of this drug in France after anti-abortion protests but simultaneously began a trial in the GDR.9

 

The media and conclusions

Health is important to all of us and medical research in particular often causes controversy. The media are always ready to accuse researchers of exploiting vulnerable ‘human guinea pigs’.38 In addition, we are discussing a contentious period of recent history.

Of course, public interest sparked by the media is welcome—we need public interest so that research is supported. However, the fierce controversy ignited by the Der Spiegel article shows that the issue is unresolved and further investigation is urgently needed. Certainly, we need critical reports to shed light on ethical violations. However, in this case the media sensationalisation of the trials seems unjustified: the reports were tendentious, distorted and in many cases incorrect. This can be clearly illustrated by two examples.

Drugs used in clinical trials involving erythropoietin in preterm infants were described as doping substances.1 The use of the term ‘doping’ is misleading as the fact that erythropoietin is essential for red blood cell production was omitted. The report implied that the conduction of these trials was criminal, thus prejudicing the impartiality of any reappraisal. A second example concerns the deaths of patients. Newspapers reported various numbers of fatalities, usually without reference to the fact that many of the patients were already seriously ill.39 This material concealment is, of course, unacceptable from a scientific perspective and leads to wrong conclusions.

.

The term ‘human experiment’ is also inappropriate in this context.40 Reference to Nazi crimes where doctors coerced prisoners to participate in trials without consent usually with the acceptance or even the aim of killing the participants, has nothing to do with the clinical studies in the GDR. Such a comparison is highly negligent and can trivialise crimes and serious human rights violations even if the basic problem is one of consent in both cases.

People from different backgrounds are trying to come to terms with the history of the GDR. Therefore, accounts of East Germany history should meet scientific and not ideological standards. We need reliable results and objective investigation in order to deepen our historical and ethical understanding. Currently, there is very little independent research on the GDR healthcare system of the 1980s. Specific trials now need to be studied separately. Particular incidents, for example deaths, must be considered as part of a meticulous examination of individual case studies. The medical profession has an ethical obligation to participate in future investigations, which should not be left to the media.

 

http://jme.bmj.com/content/early/2014/09/17/medethics-2013-101925.full

 

Full text - Journal of Medical Ethics - BMJ

jme.bmj.com/content/.../medethics-2013-101925.full -  

hace 15 horas - Western pharmaceutical companies conducted clinical trials in the Eastern ... Another information source was the archives of the East German Secret ... in stroke patients.14 The documents do not indicate whether these deaths ... of Health decided that Western inspectors should be allowed into the country .

 

 

Syringe kit

 

 

 

READ MORE

 

 

Were clinical trial practices in East Germany questionable?
medicalxpress.com › Other
Clinical trials carried out in the former East Germany in the second half of the 20th ... to a paper published online in the Journal of Medical Ethics. ... unofficial clinical trials were conducted by Western pharmaceutical ... and more moral issues such as patient education and informed consent. ... not rated yet ...

Were Clinical Trial Practices in East Germany Questionable ...
www.appliedclinicaltrialsonline.com/appliedclinicaltr...
hace 2 horas - Pharmaceutical companies took advantage of East Germany's financial problems, report found. ... to new research published today online by the Journal of Medical Ethics. ... known as the German Democratic Republic, GDR - were not always ... There was, however, no record of patient information forms or ...

 

New Details Emerge in East German Drug Test Scandal
www.spiegel.de › English SiteGermanyDrugs
14/5/2013 - The data from the clinical trials are stored in their archives, and if a .... Western Pharmaceutical Trials: Patients Misused as Guinea Pigs in East ...

 

Human Guinea Pigs In East Germany? Hospital ...

www.medicaldaily.com/human-guinea-pigs-east-ger...

14/5/2013 - Hospital Investigating Drug Trials That Used 50,000 Unknowing Patients ... being investigated for human guinea pig clinical trials that involved testing new ... According to health ministry records called Stasi secret police files, .

 

 

East Germany's Stasi secret police sold citizens to western ...
www.dailymail.co.uk/.../East-Germanys-Stasi-secret-...
4/12/2012 - Recently opened Stasi files show how firms payed millions in hard currency to test sick people ... companies to use as human guinea pigs in drug trials .... I have worked in clinical research in big pharma since 1980 and never ...

 

* Malcolm Allison H  2014

Compartir este post

Repost0

Comentarios

Présenta

  • : cinabrio blog
  • : Ecología y sostenibilidad socioambiental, énfasis en conservación de ríos y ecosistemas, denuncia de impacto de megaproyectos. Todo esto es indesligable de la política y por ello esta también se observa. Ecology, social and environmental sustainability, emphasis on conservation of rivers and ecosystems, denounces impact of megaprojects. All this is inseparable from politics, for it, the politics is also evaluated.
  • Contacto

Perfil

  • Malcolm Allison H malcolm.mallison@gmail.com
  • Biólogo desde hace más de treinta años, desde la época en que aún los biólogos no eran empleados de los abogados ambientalistas. Actualmente preocupado …alarmado en realidad, por el LESIVO TRATADO DE(DES)INTEGRACIÓN ENERGÉTICA CON BRASIL
  • Biólogo desde hace más de treinta años, desde la época en que aún los biólogos no eran empleados de los abogados ambientalistas. Actualmente preocupado …alarmado en realidad, por el LESIVO TRATADO DE(DES)INTEGRACIÓN ENERGÉTICA CON BRASIL

Recherche

Liens