Were Clinical Trial Practices in East Germany Questionable?

[Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain Online First doi:10.1136/medethics-2013-101925]

Clinical trials carried out in the former East Germany in the second half of the 20th century were not always with the full knowledge or understanding of participants with some questionable practices taking place, according to a paper published online in the Journal of Medical Ethics.

Moreover, the country agreed to the trials due to impending bankruptcy there and Western pharmaceutical companies took advantage of the situation, said researchers who have studied documents from the time.

The German Democratic Republic (GDR), known as East Germany, was a state within the Eastern Bloc during the Cold War period and between 1949 and 1990, it administered the part of Germany that was occupied by Soviet forces at the end of World War II.

Since the 1990s, the media has reported unofficial clinical trials were conducted by Western pharmaceutical companies in Eastern Germany from the 1960s onwards, and a similarly themed article published in 2013 in the German news magazine Der Spiegel brought international attention to the claims.

Claims were made that the German Democratic Republic (GDR) had ‘sold’ its patients as ‘guinea pigs’ for experiments in exchange for hard currency, for example, for tests on doping effects in premature babies and on treating seriously ill patients with placebo instead of actual medicine.

However, there is still a lack of reliable data about the extent of studies taking place then, the contracts, the amount of money paid, and more moral issues such as patient education and informed consent.

German researchers, therefore, set out to bring a more scientific and objective account of these trials by describing and evaluating the clinical trials performed in the GDR based on archival material from the health system and the secret service.

They found documents relating to 220 trials carried out between 1983 and 1990 involving more than 14,000 patients and 68 Western companies.

There was, however, no record of patient information forms or systematic documentation regarding the provision of patient consent.

A range of drugs was tested in these studies, including chemotherapeutic agents, insulin, heparin, anti-depressants, anti-allergy drugs, as well as contrast agents and toothpastes.

Hundreds of patients were involved in clinical trials of cardiovascular drugs, which were among the most expensive studies and resulted in a number of deaths, probably due to the fact that an inclusion criterion for participants in some of these double-blind studies was the presence of a severe New York Heart Association class III–IV heart condition.

Between 1983 and 1990, the country’s health system received approximately DM 16.5 million for the clinical trials, which were cost effective for the drug firms and which they capitalised on, said the researchers.

Despite some strict legal regulations, the state was obliging due to its desperate need for hard currency so companies were able to legally test new drugs, while at the same time opening up new markets in the Eastern Bloc and getting test results faster and more cheaply than they could elsewhere.

The researchers found that overall, the files they studied suggested that the GDR attempted to conduct trials according to international ethical standards and there was no evidence to suggest the trials systematically and intentionally damaged patients.

These trials were, however, conducted without the knowledge of the public, and state legislation stipulated that patients had to consent to the trials, but no evidence was found to suggest that patients were systematically informed.

Some documents suggested that at least some of the trials were carried out without patients having a comprehensive understanding of what the trial involved and it was unclear whether the patients themselves knew that they were participating in trials and were aware of all risks.

Further investigation of any ethical violation during these trials was needed, concluded the authors, who said: “In this case, media sensationalisation of the trials seems unjustified: the reports were tendentious, distorted and, in many cases incorrect.

“We need reliable results and objective investigation in order to deepen our historical and ethical understanding. Currently, there is very little independent research on the GDR healthcare system of the 1980s. Specific trials now need to be studied separately.”

Contact:
Dr Rainer Erices, Institute for the History and Ethics of Medicine, Erlangen, Germany
Tel: +49 9131 85 26430
Email: [email protected]

Link: http://jme.bmj.com/lookup/doi/10.1136/medethics-2014-101925.pdf