Through the Iron Curtain
(March 18th, 2016) Medical historians dug deep into hospital archives to examine the scope of drug testing in East Germany. Was everything ethically above board?
Those who think that there was mostly silence between East and West Germany during the times of the Cold War are wrong. There was some friendly contact, at least, between pharmaceutical companies on one side of the Iron Curtain and hospitals und university medical centres on the other. In 2013, German weekly newspaper Der Spiegel claimed to have exposed a major scandal. Thousands of East German patients were secretly recruited to participate in clinical trials without them knowing about it. According to Der Spiegel, “German-German experiments on human beings” affected 50,000 people and left several patients dead.
The accusations, obviously, demanded a thorough review of the actual events. Financed by, among others, the German government, medical historians from the Charité Berlin agreed to attempt the Sisyphean task. After combing through hospital as well as pharma firm’s archives, interviewing witnesses and physicians for two and a half years, the team has recently published its findings. In most cases, the Spiegel’s claims could not be confirmed.
Yes, West German (as well as French and British) pharmaceutical companies conducted clinical trials in the former GDR but the majority of these trials did not breach ethical standards. “The studies were performed in line with rules and laws in East and West Germany at that time. These, however, are very different from the high ethical standards we have today,” study leader, Volker Hess, told Süddeutsche Zeitung. “We have seen no indication of a systematic violation of existing rules on consent,” he added.
According to Hess and colleagues, most patients voluntarily participated as they hoped to be treated with new, more efficient drugs. “Some even asked to be included in a study, especially when drugs were tested, which weren’t available in the GDR. We found letters with those kinds of requests,” Hess said.
But why did West German pharma firms test their drugs in the GDR? Not only because this was much cheaper; it was also much quicker. Companies negotiated trial contracts with the East German secret police, the Stasi; then the totalitarian government took care of a fast and efficient study execution - without asking too many questions and pocketing “only” a million Deutsche Mark service charge. In this way, many studies could, for instance, be completed in two years instead of four in West Germany.
Despite looking like a win-win situation for everyone – faster trial completion, access to new drugs for patients, invitations to international congresses for physicians – the Charité team also uncovered some dark sides. “Some studies, however, left a bad aftertaste. For instance, the substance Ramipril to treat cardiac insufficiency in West Germany ought to have been compared to a competitor compound, which had already shown its efficacy. But there was no such drug with a similar active ingredient in the GDR. Hence, Ramipril was only compared to a placebo,” Hess elucidates.
With the publication of their findings, the matter still isn’t settled for Hess and colleagues. There remain many open questions, he says. For instance, he would like to find out why a few accompanying or ancillary studies were sourced out to the Czech Republic. “I would also like to know more about the volunteers. We have tried to contact former study participants. Unfortunately, we only reached very few. It would also be good to look through more patient records from that time. These records are also a part of our turbulent past.”