Western pharmaceutical companies

In the late 1980s Western pharmaceutical companies ran clinical trials of new drugs on East Germans. Patients usually knew nothing about it — at best, only the side effects of the experimental drugs were hidden from them. The companies and former doctors now pass responsibility on to each other, while politicians score points ahead of elections by criticizing the world’s largest corporations and East Germany’s policies.

Documents about the human experiments ended up in the hands of Spiegel. The journalists analyzed archives from the East German Ministry of Health, the Stasi and the Pharmacology Institute. It turned out that before reunification more than 50 East German clinics allowed Western corporations to effectively experiment on their patients.

For how many years this practice continued is unknown. The documents indicate that in total about 600 medical products were tested on more than 50,000 East German citizens. Apparently everyone knew about it except the ordinary Germans used as test subjects. Hubert Bruchmüller, a former trial subject, said his attending physician transferred him to the clinic where the trials were performed. Conversations never mentioned it was a new-drug trial, and he was never given consent forms to sign.

Company representatives negotiated the trials with hospital management after first securing approval from the East German government and the Stasi. Attending physicians were of course informed. Patient consent was not required. The legal framework was such that the physician’s signature and one witness sufficed to confirm a patient’s participation.

For Western pharma such trials in West Germany would have caused loud scandals and accusations of breaching medical ethics. East German authorities and doctors, deciding for their citizens, made things much easier. Germany’s Ministry of Health assured that Bonn knew nothing of the practice — West German authorities had no right to interfere in private companies, which were not obliged to report where or under what conditions they tested their products outside the country.

Sanofi Deutschland — now successor to Hoechst AG — said testing of “Trental” in the 1980s was not limited to East Germany. The company studied the drug’s effect in stroke. Trials were conducted at 14 research centers in West and East Germany, Belgium, Finland, Italy, Sweden and Yugoslavia. The testing was halted earlier than planned because it produced no results. Twelve patients died during the experiments.

The trials were commissioned by the largest companies, and the risks to patients were not always limited to minor side effects. Some tests had to be stopped because subjects died. Hoechst AG — founded in 1836 (acquired by Sanofi in 2006) — ran studies of “Trental” and “Ramipril” in East Berlin. In 1988 two patients died. Based on physicians’ interrogation records, such risks were no surprise to them.

Two more people died at the Lostau pulmonary clinic during administration of “Spirapril” — a hypertension drug made by the Swiss company Sandoz. Testing was then halted. Sandoz, like Hoechst AG, has a long history and good reputation. Founded in Basel in 1886, since 1996 it has been part of the major Swiss concern Novartis AG after merger with Ciba-Geigy AG.

Other well-known companies also conducted trials. Berlin’s Charité clinic, Europe’s largest hospital, carried out work for German pharma Boehringer Mannheim (sold to Swiss F. Hoffmann-La Roche AG in 1997). In the 1980s Boehringer Mannheim was interested in the effect of erythropoietin (today used as a doping agent) on premature-newborn development. The clinic selected 30 of its patient children for the study.

Germany’s Bayer AG tested nimodipine — for improving cerebral circulation — on East Germans. Documents show the experiments used patients in alcohol-withdrawal delirium. Demanding conscious consent from such patients is impossible — which the company exploited.

On average companies were ready to pay about 800,000 West German marks per clinical study. Schering AG (part of Bayer AG since 2006) offered Charité a one-year contract worth six million marks.

Charité clinic in Berlin

Photo: Thomas Peter / Reuters

Current pharma management is clearly unwilling to take responsibility for the late-1980s practice. Many companies have apparently already conducted internal checks and calmed themselves once they found the documents. Sanofi (which now includes Hoechst AG) stated that all tests were performed in compliance with the ethical and legal norms in force at the time. Sanofi also claims documents exist showing that clinical tests in West Germany were agreed with the West German ethics commission, while in the East contracts were signed with the Ministry of Health.

The companies deny that patients were not warned. Sanofi states that under the agreements attending physicians had to inform patients of the tests and related risks. They are being somewhat disingenuous — according to Stasi records, Hoechst AG agreed that written explanations would not be given to patients.

The clinics also urge against dramatizing the past. Volker Hess, head of the Charité Institute for the History of Medicine, considers talk of “experiments on humans” incorrect, preferring “clinical testing of new drugs.” Everything was within the law, he says.

Although the clinic does not admit guilt, it cannot simply ignore the topic. The management plans to set up a historical commission and review patient cases soon because the 1980s documentation is starting to be disposed of. Charité does not want to bear this alone and hopes pharma companies will help fund the research.

Historians found that Matthias Wesser, current president of Thuringia’s medical chamber, directed Hoechst clinical trials in the 1980s. Documents show that in many cases patients did not give written consent. Wesser says he does not remember details but is sure he worked within the law — patients were informed and well cared for. “Patients received drugs not freely available in East Germany — that’s the positive side,” he argues.

The fact that clinical trials were conducted on humans in East Germany is not itself a sensation — it was known before. Right after reunification authorities analyzed the documents then available. But the scale of these trials and the number of potential victims was a real sensation for East German historians.

The situation is generally explainable. From the 1970s West Germany pursued rapprochement with the East. The easiest and most effective way was through the economy, since East Germany lagged behind. West Germany encouraged trade with the East and all economic ties — even subsidizing companies dealing with the GDR. Western pharma were in a sense implementing their government’s ideological agenda. On the other side the practice was seen as profitable cooperation: East German doctors lacked money even for basics like rubber gloves and cotton swabs, so hundreds of thousands of marks from Western companies were not unwelcome.

Today people expect repentance mainly from the pharma companies, which bear most of the responsibility. The companies say the practice is long past. For Germany it is — now trials are run in poor Asian and Latin American countries, where medical staff work for minimal pay and people agree to any medical help without probing details.

Perhaps the only ones who can profit from this story are politicians. Ahead of autumn parliamentary elections, representatives of every party rushed to defend the wronged citizens. The Interior Ministry plans to fund historical research at Charité. Ruling-coalition representatives threaten to punish the companies and seek compensation for the former victims. The victims themselves barely believe they will receive any money. Hubert Bruchmüller, who was unknowingly prescribed Spirapril in the 1980s, still cannot obtain his case file from the Lostau clinic and doubts giant corporations can be held accountable.