Jumat, 24 Mei 2013

New Evidence of Big Pharma's Shady Soviet-Era Drug Trials

Germany’s Der Spiegel recently published a string of articles indicating that, until the fall of the Berlin Wall, major pharmaceutical companies conducted hundreds of drug trials in East Germany. In all, the reports suggest, more than 50,000 East German patients served as guinea pigs—many without their knowledge or consent. That’s according to documents acquired from the private archives of physicians and from files of the former East German Health Ministry, the Ministry for State Security (Stasi), and Germany’s Institute for Drug Regulatory Affairs.

Apparently drugmakers, mostly from West Germany, Switzerland, and the U.S., tested more than 600 drugs on East German patients, including prematurely born infants, alcoholics, and depressives. “The trials resulted in several fatalities, which the participating hospitals were slow to investigate,” writes Spiegel International. “Some studies had to be discontinued because of serious side effects that had suddenly occurred.” Companies involved include some that are now subsidiaries of drug giants Pfizer (PFE), Bayer (BAY), and Roche (ROG).

Collaborating East German institutions included roughly 50 cash-starved hospitals in such cities as Berlin and Dresden that accepted up to 800,000 deutsche marks per study. “It was a mutually beneficial arrangement,” writes Spiegel International in an article detailing how western firms bribed East German doctors. “The companies gained access to clinical trial results at a low cost, while their partners in the East received cash, gifts and medical technology for their hospitals.”

The fact that such trials took place is not news in itself. Similar claims were brought up and dismissed by investigators in 1991, points out Germany’s Der Tagespiegel. But the range and repercussions of the trials may be bigger than previously thought, according to a measured article in Germany’s Die Zeit.

Contacted for comment on Thursday, Roche and Bayer did not reply, but Pfizer sent the following statement: “Pfizer is not aware of any information indicating the activities of any companies operating in the former GDR that were subsequently acquired by Pfizer failed to comply with the legal requirements or applicable internationals standards at that time.” (Bayer—and perhaps others—also told the German media that all its global tests were conducted according to uniform standards.)

Germany’s Interior Ministry, meanwhile, plans to help fund an investigation of the patient trials but expects pharma companies to pitch in, writes Spiegel International. The Bundestag is also debating whether drugs with a shady GDR past should lose their approval.

points out Germany’s

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