In the series "Die Toten von Marnow" a scandal about drug tests by Western pharmaceutical companies in the GDR is revealed. In fact there was. Her recovery started late. What really happened then?
by Thomas Naedler and Siv Stippekohl
Reports in the news magazine "Der Spiegel" and other newspapers in 2013 are explosive and fuel a suspicion:were there unexplained deaths as part of clinical studies that West German pharmaceutical giants had carried out in the GDR against West German money and which are now being clarified with the help of the Stasi files left?
Reports on pharmaceutical tests inspire the "Dead of Marnow"
According to the journalists' research, the state security and also the commercial coordination department, or KoKo for short, under East German foreign exchange procurer Alexander Schalck-Golodkowsi, was significantly involved in clinical studies commissioned by Western companies in the GDR. The reports also inspired screenwriter Holger Karsten Schmidt to write his crime novel and the screenplay for the crime series "Die Toten von Marnow".
The medical historian Rainer Erices, who specializes in the GDR health system and has been working at the Institute for History and Medical Ethics at the University of Nuremberg since 2010, was surprised at the time by the considerable influence of the Ministry for State Security (MfS) on the clinical studies of West German companies. In Mecklenburg-Western Pomerania, the Minister of Health and Social Affairs, Manuela Schwesig (SPD), now the state’s Prime Minister, then prohibited the destruction of documents in hospitals. In the university clinic in Rostock, too, files from the GDR era are being secured in a hurry on the instructions of the management, which are needed for the investigation.
Stasi files and study documents were evaluated
Starting in the summer of 2013, the documents will be evaluated by independent scientists for a research project led by the Berlin Charité, as will Stasi files and study documentation from the archives of the pharmaceutical companies involved. The scientists meticulously note every glass of water as well as biscuits and coffee that they received during their research at the company headquarters, conduct interviews with contemporary witnesses and place advertisements in search of those affected who may have been harmed as test subjects in the clinical studies.
GDR pharmaceutical laboratory? "In principle, all pharmaceutical companies are involved"
In 2016, the results of the "Testing in the East" study will be presented in Berlin. 320 clinical studies in the context of drug approval procedures commissioned by Western companies can be verified. Hoechst, Sandoz, Smith-Kline:"In principle, all pharmaceutical companies have conducted clinical studies in the GDR," says Volker Hess. The professor led the research project and is also head of the Institute for the History of Medicine and Ethics in Medicine at the Charité. More than 100 were tested in the GDR from the time the Wall was built until 1989, in large and small district and district hospitals throughout the Republic. The university clinics in Greifswald and Rostock, which were test centers for West German clinical studies, played a special role in the north.
Drug tests were organized centrally
The studies were organized centrally in the GDR - most were carried out in the East Berlin Charité.According to Hess, most of the studies were carried out by the Charité, Rostock was the leader in the north, although the hospitals did not do business with the pharmaceutical companies themselves. "Anyone who wanted to carry out a clinical study in the GDR after 1964 had to contact the counseling office in East Berlin, which means it was centrally regulated and then also organized centrally." Drugs for the circulatory system, against heart diseases and allergies were tested, and the effectiveness of psychotropic drugs was also put to the test in the GDR.
The scandal that wasn't
However, the result of the "Testing in the East" study is that there was no scandal at all, because, according to Volker Hess, the studies were also carried out in the GDR according to international standards that were valid at the time. Detailed test plans had to be submitted, and the consent of the subjects was mandatory for each test series. Often this is also archived. Irregularities or gross violations are not to be proven. Especially since most GDR citizens, according to Hess, were very interested in taking part in such studies - with the prospect of receiving a new West German drug for their ailments. Participation in a clinical trial for many:an opportunity.
There were deaths in the GDR as part of drug tests. However, they were meticulously evaluated, documented and sent to the client. Drugs were tested on patients, some of whom were seriously ill.
Attempts against currency?
So who benefited from the clinical trials and how? Both sides had a "win-win situation", according to the expert Voker Hess from the Charité. Although the notoriously sluggish East German economy made money from the clinical studies, the greatest benefit was of a non-material nature. The health system of the GDR, doctors and medical researchers, gained insights into valuable data by conducting the studies, the implementation of clinical studies and tried in this way to gain international professional connections.
Centralist GDR organization:an all-round carefree package
In addition, the delivery of medicines was often contractually agreed well beyond the completion of a series of tests. The price also played a rather subordinate role on the part of western pharmaceutical companies. Carrying out the tests in the GDR was not significantly cheaper than in other countries where the effectiveness and side effects of a preparation were tested parallel to the GDR. The advantage of the GDR studies:the centralized and time-saving organization. Elsewhere, carrying out test series is more like guarding fleas, says Volker Hess, but in the GDR there was an all-round carefree package. In addition, after the Contergan scandal, the willingness of West Germans to take part in a study decreased significantly. This is another reason for testing in the East.
Ethically, pharmaceutical tests "quite problematic"
From an ethical point of view, the drug tests should therefore also be viewed as problematic, says Volker Hess. The willingness of Western pharmaceutical companies to use the advantages of a tightly organised, centralized dictatorship for their own purposes without a critical counter-public casts a "certain light on the pharmaceutical industry".
The role of the Stasi in the series of tests
This is also confirmed by Anne Drescher, the state commissioner for the processing of the SED dictatorship for Mecklenburg-Western Pomerania, who accompanied the research project professionally. However, she points out that the State Security, which had regularly and unscrupulously violated applicable GDR laws on behalf of the party and state leadership, had no influence whatsoever on the selection or implementation of the clinical test phases in connection with the drug tests. She also considers a concealment of violations to be unlikely. The Stasi was more interested in clarifying and monitoring contacts between East and West German doctors, doctors and representatives of pharmaceutical companies from the West.
Pharma studies no "human experiments" under the rule of law
Another task of the State Security:skimming off information and data. In contrast to the systematic state doping program in GDR competitive sport, Drescher does not see the drug tests as "human experiments" contrary to the rule of law. There one could speak of it, also in relation to recently uncovered experiments on recreational athletes, but not in connection with drug studies by western pharmaceutical companies in the GDR.