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14 May, 2013 14:37

Germany to investigate Western pharm companies over ‘human guinea pig’ drug trials

Germany to investigate Western pharm companies over ‘human guinea pig’ drug trials

German authorities are planning to launch an investigation into tens of thousands of patients in former East Germany who were allegedly used for drug trials without their consent “as guinea pigs,” after a media report sparked a wave of outrage.

Previously unpublished documents indicate that at least 50,000 patients, including premature babies, were involved in more than 600 trials at dozens of DDR hospitals until the 1989 fall of the Berlin Wall, a report published in the German weekly Der Spiegel says.

Many patients reportedly involuntarily took part in the research to assess the effects of various pharmaceutical products, including chemotherapeutic substances and heart medication, with at least four people having died during the clinical trials.

In 1983, a special office was allegedly set up by the authorities to deal with Western companies who wanted to carry out medical trials in East Germany.

The money from each trial, which was up to 800,000 German marks (around 400,000 euro at the current exchange rate), was divided between the government of East Germany and about 50 medical facilities which participated.

The material for the publication came from archives of the former East German Health Ministry, the Stasi secret police, the country's pharmaceutical authority and private collections, according to Der Spiegel.

There were no copies of the documents posted online. However, excerpts were included in the printed edition of the magazine.

The corporations which took part in the trials reportedly included Boehringer Ingelheim and Bayer AG, as well as firms later acquired by Roche Group and Novartis AG in Switzerland, and by Sanofi of France.

Those of the companies which were available for comment, however, indicated that they always follow strict protocols in drug trials.

Germany's federation of pharmaceutical manufacturers said it saw "currently no reason to suspect that anything irregular happened."

‘Massive scandal’: Outrage over allegations

Major German politicians have already vented their fury following the allegations.

"If [the testing] resulted in bodily harm all the way to the loss of life, then it becomes a question of compensation for damages. And then the question of liability has to be answered," the deputy chairperson of Chancellor Merkel's CDU group in the Bundestag parliament Arnold Vaatz told the daily Berliner Zeitung.

It would be a "massive scandal if thousands of DDR citizens - [whose rights under DDR law had presumably been violated] were made into cheap guinea pigs," the federal government's current commissioner for eastern German Affairs Christoph Bergner said adding, "It's time for independent investigations to get underway."

The Charite hospital was the biggest medical facility in former East Germany, and it is now waiting for the financing to begin their investigation, along with several agencies. The German government indicated that it has already begun funding various research groups to look into the issue.

As for the Germany's Health Ministry, it pointed out that it couldn't confirm or deny Der Spiegel's figures for the numbers of patients involved in such trials.