Have you been in a clinical trial

Testing in the east

Frankfurter Allgemeine Zeitung | Meeting of 08/23/2016Another less scandal. . .
Western drugs tested by East German test subjects from 1964 to 1990

Shortly after the fall of the Berlin Wall, news about clinical studies that Western pharmaceutical manufacturers had carried out in the GDR since the 1960s made scandalous headlines. In the summer of 1991, the first independent studies on the "practice of drug proving" in the SED dictatorship were initiated. Today the public is comprehensively informed about the problem, as illustrated by a volume in which the drug studies carried out in the "second German state" are now systematically analyzed and classified. At the same time, the study represents the sober final report of an interdisciplinary commission of inquiry, which, under the leadership of the Institute for the History of Medicine and Ethics in Medicine at the Charité Berlin, began its work in state and company archives and backed up the results through expert interviews and interviews with contemporary witnesses.

The list of a total of around 150 western companies includes almost all industry giants: Boehringer Mannheim, Hoechst, Schering, Bayer, Sandoz, Ciba Geigy and numerous other European, American and Japanese manufacturers commissioned clinical studies in East Berlin. It is well known that the GDR was not squeamish in the medical field: deals with clinical studies, organ trafficking, psychiatry and sport doping are just a few catchwords that indicate the whole scope of the use of medicine to maintain power and to expand the power of the nomenclature under Ulbricht and Honecker .

And yet there is comparatively little left of the press reports that excitedly reported in 2013 about "guinea pigs" and "human experiments". "The scandal that wasn't": That is the title of the final chapter. For the period between 1982 and the fall of the GDR alone, the authors scrutinized 447 recognized commissioned studies. In their study, which was supplemented with numerous tables and happily managed without technical jargon, they name five weighty reasons: First of all, the corresponding tests as a central element of clinical research were not the exception, but the rule when trying to develop new active ingredients or treatment options in the case of proven medicinal products. They were mostly part of large-scale research projects that were also carried out in Western European countries at the same time.

Second, although the tests did not meet the standards currently in force with regard to the education of test subjects and patients, this was in line with common practice worldwide - it is a standard today to make correspondingly higher demands on pharmaceutical companies. The commission found "no reliable indications" with regard to the clinical documentation, test protocols and accompanying examinations that other standards were applied in the GDR than in the West. On the whole, the study found, there were "no significant differences in the design and implementation of clinical studies in Austria, West Germany or the GDR".

Also with regard to the remuneration of the drug tests, there is now largely clarity: the western pharmaceutical companies in the GDR paid lower case-based lump sums than in western countries, but this difference corresponded to the discounts customary in domestic German trade - and the Stasi carefully noted that the GDR was in the The pharmaceutical industry was even considered excessively expensive compared to Czechoslovakia and Hungary. Some clinics in the GDR received equipment or material that they would otherwise not have been able to get because of the lack of Western foreign exchange. And throughout the "second German state", as one of the doctors involved recalled in a conversation with a contemporary witness, there was the "nimbus of Western preparations", which were considered to be true miracle cures. Some patients were also willing to take part in the studies as test subjects because they knew that they would receive a special level of care.

A side effect of the investigation, so to speak, is that it becomes clear once again how present the Western European pharmaceutical companies have always been in the GDR. Even after the Wall was built, the existing connections remained, and the policy of détente since the 1960s, as well as the international recognition of the GDR in the following decade, led to the fact that "half the world is in a hand in hand with the responsible East Berlin drug control agency." gave".

There was another reason why the East German clinics were used for drug studies: the GDR authorities strictly monitored the execution of the case studies, adherence to the schedule and the correct completion and fulfillment of the agreements. The pharmaceutical companies did not have to negotiate complex contracts with chief and senior physicians, as is usual in the West. This was particularly attractive to western drug manufacturers.

The strict government of the GDR regime was therefore very welcome to the pharmaceutical companies. The authors smugly emphasize that this strategy also seems remarkable when one considers how pronounced the resistance of pharmaceutical companies to the demands for state control and supervision of clinical drug trials is today.

JOACHIM SCHOLTYSECK

Volker Hess / Laura Hottenrott / Peter Steinkamp: Testing in the East. GDR drug studies on behalf of the western pharmaceutical industry, 1964-1990. be.bra Verlag, Berlin 2016. 272 ​​pp., 26, - [Euro].

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