Were Clinical Trial Practices in East Germany Questionable?

Pharmaceutical companies took advantage of East Germany’s financial problems during the second half of the 20th century to carry out clinical trials with ethically uncertain processes, according to new research published today online by the Journal of Medical Ethics.

Trials carried out in the former East Germany – officially known as the German Democratic Republic, GDR - were not always with the full knowledge or understanding of participants with some questionable practices taking place, wrote Dr. Rainer Erices and colleagues from the Institute for the History and Ethics of Medicine in Erlangen, Germany. The country agreed to the trials due to impending bankruptcy there, and Western pharmaceutical companies took advantage of the situation, they noted.

There is still a lack of reliable data about the extent of studies taking place during this period, including the contracts, the amount of money paid, and more moral issues such as patient education and informed consent, but 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.

Among the drugs tested were chemotherapeutic agents, insulin, heparin, anti-depressants, anti-allergy and cardiovascular drugs, as well as contrast agents and toothpastes. Between 1983 and 1990, the country’s health system received approximately 16.5 million German Marks for the clinical trials, which were cost effective for the drug firms and which they capitalized on, said the researchers.

Further investigation of any ethical violation during these trials is needed, concluded the authors. “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.”

Read the full release here.