Reliability of East German Pharmaceutical Investigations Questioned

MedicalResearch.com Interview with: Dr. med. Rainer Erices Institut für Geschichte und Ethik der MedizinMedicalResearch.com Interview with:
Dr. med. Rainer Erices
Institut für Geschichte und Ethik der Medizin

Medical Research: What are the main findings of the study?

Dr. Erices: The study presents the results of a first systematic investigation of clinical drug trials carried out by Western pharmaceutical firms in Eastern Germany in the 1980s. The scientific investigation of the East German Health system has only just started. The study shows that in that period of time, around 220 clinical trials were carried out. We now know how many patients took part and what remuneration the GDR received. It continues to be difficult to evaluate these tests. Despite intensive research efforts in different archives, we have been unable to find documentation on how detailed (and systematically) patients were informed about the trial they were taking part in. The responsible institutions repeatedly advised testers to stick to the law during the clinical trials. The law required that these trials should only be carried out on patients which had given their informed consent and had decided to participate voluntarily. However, so far there is no convincing proof that these legal requests were met.

Medical Research: What was most surprising about the results?

Dr. Erices: The sheer number of institutions all over Eastern Germany that participated in the studies is surprising, faculties of medicine, hospitals, smaller clinics, etc. The tests were practically carried out nationwide. Still in the early 80s, officials would say that the country should not be seen as a testing field for Western pharmaceutical companies. There were also doubts about whether there were enough experts available to carry out the clinical trials. The public was not informed. The GDR did not want not want to admit that the national health system was in bad need of hard currency.

Medical Research: What should clinicians and patients take away from your report?

Dr. Erices: Our investigation shows how important it is that the consultant in charge obtains the patient´s informed consent and that the patient´s right of self-determination is guaranteed. We are showing the risks that exist when the medical service of a country is subordinated to political or economic interests.

The GDR health system was obliged to generate income in hard currency. Thus, in this special case, 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.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Erices: Single studies are necessary to investigate the question under what circumstances the trial series were carried out, preferably in peripheral hospitals (psychiatry, geriatrics). A final assessment can only be done if we are able to find protocols of the informed consent talks prior to the trials. For this we will need the voluntary cooperation of the Western pharmaceutical firms in question

Citation:

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

J Med Ethics medethics-2013-101925Published Online First: 23 October 2014 doi:10.1136/medethics-2013-101925