Western pharmaceutical firms allegedly conducted drug tests on unwitting patients in communist East Germany. The lucrative clinical trials enabled the GDR government to bring much needed Deutschmarks into the country.
It sounds like a scene from a science-fiction movie: Until the fall of the Berlin Wall, communist officials from East Germany allegedly allowed Western pharmaceutical companies to conduct drug trials on sick patients - often without their knowledge.
According to German news weekly Der Spiegel, firms such as Bayer and Novartis were involved in more than 600 clinical studies at dozens of hospitals in the former German Democratic Republic (GDR). The companies allegedly offered up to 800,000 Deutschmarks (about 410,000 euros) per trial.
Among other things, the companies tested chemotherapy drugs and heart medication. Other substances fresh from the laboratory were reportedly given to premature babies. Many people are believed to have died as a consequence of the trials. One of the institutions involved was Berlin's renowned Charité hospital.
Trials without consent
The allegations are not completely new. Back in 2012 the Berlin-based daily Der Tagesspiegel claimed to have gained information proving that West German drug manufacturers had tested medication on GDR citizens. The paper said it knew of at least seven patients who were tested without their prior consent.
But according to the paper, medical standards of the time in both West and East Germany stipulated that hospitals were not only obliged to inform participants of the impending tests. They also needed the patients' written consent.
No signature required?
However, Susan Knoll, director of communications for the German Association of Research-based Pharmaceutical Companies (VFA) has a different viewpoint. "The so-called Helsinki declaration from 1964 laid the ethical foundations for conducting clinical trials on people," Knoll told DW.
It states that patients must be informed on whether they are to take part in a medical study. "Since 1996 patients must confirm in writing that they have been made aware of everything. Until this point, however, only the physician was required to sign a letter of consent stating that the patient had been informed."
According to Knoll, this leads to the conclusion that drug companies are not to blame for the missing patient signatures. But the VFA spokeswoman also believes that it is not the doctors' fault neither. "I don't want to accuse anyone but there might have been communication problems between patients and physicians", Knoll says.
The communications expert also disagrees with the claim made by Der Spiegel that the clinical trials led to the death of some of the participants. "There is no proof of any direct correlation."
Ronald Lässig, head of an association responsible for helping GDR victims, doesn't agree with Knoll's argument. He is convinced that the experiments in East Germany were conducted deliberately and has therefore called for the creation of an independent inquiry committee.
Lässig also demands compensation for the victims and their families arguing that not only the drug companies involved but also the East German hospitals skimmed huge profits from the clinical trials. "This shows how desperate the economic situation of East Germany was at the time," Lässig said.
A tedious investigation
This view is shared by Dagmar Hovestädt, who works for Germany's Federal Commissioner for the Stasi records: "The job of the Stasi (Ministry for State Security) was to make this new income source thrive." Hovestädt said that her office would make available all documents at its disposal that could help with the inquiry. She is convinced that patient records would be needed in order to launch an official investigation.