Numbers grow in East German clinical trial scandal

Writing in Der Spiegel, journalists Nicola Kuhrt and Peter Wensierski expand on the clinical research scandal they first exposed late in 2012. According to records that they have discovered, at least 50,000 people in the German Democratic Republic (GDR, “East Germany”) were included in clinical trials for Western pharmaceutical companies in the 1970s and 1980s, often without their knowledge.

The reporters made their discovery using files from the private archives of individual physicians, the former East German Health Ministry and the Ministry for State Security (Stasi), and the country’s Institute for Drug Regulatory Affairs. They found evidence that companies (Bayer, Schering, Hoechst, Boehringer, Pfizer, Sandoz and Roche are named in the documents) conducted over 600 clinical trials in hospitals throughout the country.

The journalists allege that patients were not informed that they were taking part in clinical trials. They cite one document, which recorded that “the patient’s consent is documented by the signatures of the treating physician and one witness”, while others suggesting that “written informed consent was viewed as unnecessary”.

They claim that documents relating to these cases are being destroyed. As spokesman for the Charite hospital in the former East Berlin said that they were stopping this scheduled destruction of archived files, and would be conducting an investigation into the allegations.

Boehringer Ingelheim has said it was investigating the Spiegel report, but insisted that all trials would have conformed to international standards, while a spokesman for Bayer said that all of its clinical trials conformed to global standards “to the best of our knowledge.”

(It is worth noting that, although the Declaration of Helsinki was firmly established by the 1970s, the development of ICH GCP was still decades away!)