Western drug test to GDR citizens

Secret Western drug test on GDR citizens: University Hospital Jena reports on drug trials

22/10/2013

Were secret tests on medicines carried out on former GDR citizens? This question was asked by researchers at the University Hospital Jena (UKJ) as part of a pilot project and came to the conclusion that at the clinic site Jena quite „Patients were involved in studies of Western pharmaceutical companies“, so the message from the UKJ.

GDR citizens as „Guinea pigs“?
Were former GDR citizens experimental objects of Western pharmaceutical companies? A working group at the University Hospital Jena (UKJ) has dealt with the scientific review of drug trials of Western pharmaceutical companies in the former GDR and has now submitted its final report. The researchers were primarily concerned with three drug studies that were performed in Jena during the 1980s: A study with the drug „mifepristone“ Abortion, a study with the antidepressant „levoprotiline“ and a growth hormone study „somatotropin“ for use in children and adolescents with growth disorders, according to the announcement of the University Hospital Jena.

With the investigation „important goal achieved“
The working group of the UKJ had come a long way in the investigation of the cases, because „This analysis is a first step for a necessary all-German and multi-site evaluation of the former studies of Western companies in hospitals in the GDR. For the clinic location Jena we could confirm that patients were involved in studies of Western pharmaceutical companies. In addition, we have developed a scientific method of working that now allows cross-site comparisons. With this we have reached an important goal“, as the Medical Board of the UKJ, Prof. dr. Klaus Höffken - nevertheless, it must also be taken into account that it is not yet possible to say whether the studies of that time „appropriate and legally compliant“ had expired.

Missing patient records on test with drug for abortion
The test with the active ingredient of the so-called „abortion pill“ Mifepriston, for example, had confronted the researchers with a series of open questions: research by medical historian Dr. Ing. Rainer Erices in the Federal Archives in Berlin show that in 1988 in Jena a „drug testing“ with a total of 50 women - patient files could not be found. These had apparently been destroyed instead, because it was found that the women had been given the drug on an outpatient basis at that time, but outpatient medical records are destroyed after only ten years.

Testing with antidepressant leaves many questions unanswered
In a second step was a study with the anxiety-inhibiting substance „levoprotiline“ checked. According to the hospital, 20 patients took part in this - but only seven patient records contained proof of study participation. For Dr. med. Erices of the Friedrich-Alexander-University Erlangen-Nuremberg a clear result: „These records suggest that the study was part of everyday clinical practice. Thus, the files contain information about the start of the study, about the end, about laboratory tests in the context of the study, referral reports to other physicians, which sometimes explicitly refer to study participation.“ According to Dr. Accordingly, Erices would find no indication that those affected without their knowledge as „Guinea pigs“ had been used - however, the files found had also no patient information sheets contain.

An estimated at least 34 corresponding studies only in Jena
According to Erices, the cases investigated are not an isolated case. Instead, it could be assumed that at the Jena hospital in the 1980s at least 34 corresponding studies were performed, bringing Jena „in the midfield “The university clinics former medical academies of the GDR, Erices continues. The Jena University Hospital now wants to continue to ensure transparency and to enlighten the topic together with the university hospitals in Halle and Leipzig. (No)