Co-author: Ulf Schmidt, Professor of Modern History, University of Kent, Canterbury, England
In 2013 the influential German magazine Der Spiegel published an expose about clinical trials conducted by Western drug companies in East Germany during the Cold War. The magazine reported that at least 50,000 people had been test subjects for around 900 studies done by manufacturers that included leading companies from Switzerland, the United States, and West Germany. Fifty hospitals were sites of the research, including the prestigious Charite in East Berlin. The principle motivation for the East Germans was money: they desperately needed hard currency for their failing medical system. For their part the companies appreciated the far greater efficiency of recruitment in the East, and paid the East Germans up to 800,000 West German marks per study.
The agency responsible for setting up these contracts? The notorious Stasi, the East German secret police force that included hundreds of thousands of paid agents and hundreds of thousands of more informants.
Der Spiegel's series about the drug trials contained language and themes familiar to many landmark bioethics cases. The revelations were described as a scandal that used the oppressed East Germans as human guinea pigs, including deaths and injuries that had not been properly reported, the indiscriminate use of low-birthweight infants and depressed patients, inadequate informed consent, powerful drug companies and physicians largely eager to cooperate in spite of the occasional protest. Complete with interviews with former test subjects and regretful doctors, the study had all the elements of a classical bioethics case study that could take its place along with the U.S. Public Health Service's Tuskegee syphilis study; the Guatemala sexually transmissible disease experiments; and some of the well-documented human radiation, biological, and chemical warfare experiments in the U.S. and the U.K. The magazine's series concluded on a hopeful note that justice would be served when the distinguished German medical historian, Volker Hess, reviews the study archives.
Hess and two co-authors recently concluded their exhaustive review, published in German as Testen im Osten or "Testing in the East." They concluded that, far from the scandal that the press anticipated, the East German trials were conducted largely within acceptable standards of medical ethics, especially by the conventions of the day. The authors do allow that consent procedures might not have been as thorough as in the West and in some cases there are serious questions about placebo controls and the adequacy of comparative treatment arms, but the practices were not dramatically different from those in West Germany at the time, they say.
Several other groups of historians and ethicists in Germany have also examined the material and published their results. Yet this dramatic episode has received virtually no attention in the bioethics literature, in spite of the fact that it raises compelling questions about the functioning of medical ethics standards and practices in an authoritarian system. With the glaring and extreme exceptions of the Nazi concentration camp experiments and the abuses of Soviet psychiatry, these are questions that are largely absent from the literature. Medical ethics in Central and Eastern Europe during the socialist period is a matter of near total ignorance among scholars.
In the years ahead other scholars will want to weigh in on the conclusions of Hess and others. But one lesson that can already be drawn is that expectations about medical ethics in authoritarian regimes should be critically received. More investigation needs to be conducted about these seemingly contrarian results. Usual explanations don't seem to be available. For example, although East Germany was not a member of the World Medical Association and therefore not philosophically committed to its Declaration of Helsinki, they do not appear to have violated that international agreement. And although Western firms had good reason to want to conduct trials that were in line with Helsinki requirements in order to ensure that their intellectual property would be protected, they often seem to have breached those requirements in other parts of the world. And yet in East Germany they seem to have complied with those requirements. Why was this the case?
Understanding the unique conditions of medical ethics in East Germany and the other socialist states in that period will require incorporating expertise from cultural history, law, and the social sciences, as well as dogged archival work. Challenging though it is, this often troubled region presents an exceptional opportunity to assess the development, interpretation, and application of ethical theories, standards, and practices under circumstances that were quite different from those anywhere else in the world, and to obtain an illuminating comparison with our own place and time.
Originally published on the Hastings Bioethics Forum, September 21, 2016.
The authors gratefully acknowledge the support of the Wellcome Trust.