Weapons, people, art. When it came to earning hard currency, the bankrupt German Democratic Republic (East Germany) made use of every source of money before it came crashing down with the Berlin Wall in 1989.
Clinical trials conducted on behalf of Western pharmaceutical companies were just one of many. But only half the revenues flowed back to the GDR’s healthcare system. “Like a pimp, the government sold its sick citizens and prostituted the country as a laboratory for the West’s clinical trials,” wrote the German news magazine Der Spiegel in 2013.
The outrage over the human experiments was huge. Medical historians were commissioned to investigate the accusations. Two and a half years later, and after forensically studying thousands of files belonging to the East German Ministry for State Security (the Stasi) and other authorities companies and hospitals, their report on the scandal is ready.
In their report, “Clinical Drug Research in the GDR,” the historians found a total of 900 clinical trials commissioned by Western producers; the details of 321 of them are well documented, and the drugs tested typical of the time.
The Stasi kept a critical eye on these Western contacts, meaning that clinical tests couldn’t be organized without the state’s involvement, or used as a potential escape route for staff.
Cooperation between the two sides began in the 1960s, with even the building of the Berlin Wall in 1961 failing to obstruct the historical ties of the medical and pharmaceutical professions in the divided German states. The testing usually involved so-called phase three clinical trials. This means that the testing of basic tolerability in humans was not the aim, rather it was more about testing the effectiveness on as many patients as possible in different countries.
The project manager of the report, Volker Hess, a professor at the large Charité University Hospital in Berlin, has no use for the term “human experiments.” That formulation, he says, is applicable to Nazi injustices, not to the drug testing in the GDR. The fact that such tests were carried out is no scandal, he adds, and the standards enforced in the GDR were years ahead of those in West Germany. There were violations, he says, but the centralized system of the GDR is likely to have contributed to them having been rare. Participants mostly benefited from them.
Still, there were some problematic aspects.
“A critical public was lacking. The doctor-patient relationship was very paternalistic,” says Carola Sachse from the Department of Contemporary History of the University of Vienna and chair of the project’s scientific advisory board. In individual cases, the companies must be asked the question whether they were abiding by all the regulations – but still consciously exploiting the shortages of medication in the East.
One drug tested in the East was Ramipril, a so-called ACE inhibitor that today is a widely used medicine for high blood pressure and heart disease. The first version of it was approved for use in 1981, after which other firms followed suit and did additional testing on patients with severe heart failure.
One of these trials, conducted in Scandinavia, was even cut short because the death rate among the trial volunteers was lowered so convincingly, and doctors wanted to make the drug available as soon as possible. Referring to a key part of the trial, the researchers concluded that “no comparative testing of ACE inhibitors against a placebo is warranted.”
The pharmaceuticals company Hoechst, now part of French giant Aventis, found the same result in a trial it was conducting. But it continued with it regardless, perhaps knowing that the poor availability of drugs in the GDR would mean that those volunteers benefiting from the ACE inhibitor would cease to get it if the trial stopped.
This imbalance in medical supplies made it possible to warrant the testing, wrote the project researchers.
At Hoechst, there was also awareness of a potential problem. The testing centers in the GDR didn’t communicate serious side effects to the pharmaceutical companies within 24 hours, as was the standard. Rather they used an indirect route through the East German advisory office in Berlin, which led to considerable delays.
But there were undoubtedly advantages for the western firms. In 1985, West German pharmaceutical firms had sales of around 20 billion Deutsche marks (€10.2 billion/$11.5 billion today), according to their own information. Of this, they invested about 15 percent in research and development. Given such amounts, it is irrelevant whether 1.8 or 2.5 million Deutsche marks flowed into the GDR, write the historians.
All told, the West German firms were saving about a third of testing costs by carrying out trials in the GDR. But it would have been even cheaper in Czechoslovakia or Hungary. The GDR offered extremely committed, precise doctors as well as patient collectives that were pooled together in special centers. That ensured the quality of the test data and saved – in comparison to the West – time and organizational costs, says Mr. Hess.
The GDR also benefitted from the deal. In 1985, the hard currency it received from trials was only a tiny fraction of the national debt of 27 billion Deutsche marks – all the same, the state didn’t want to pass up this source of income. At the same time, it was a matter of developing know-how and infrastructure for their own clinical tests, keeping pace through scientific exchange, and softening equipment and drug shortages.
Nevertheless, the Stasi kept a critical eye on these Western contacts, meaning that clinical tests couldn’t be organized without the state’s involvement, or used as a potential escape route for staff.
Such were the shortages of drugs in the GDR, that volunteers lined up to take part in trials. They signed up “because Western medicine had such a Santa Claus bonus,” says a treating physician. But to what extent the patients were told that they were participating in a clinical trial, a key ethical requirement, remains unclear, the report says.
The project researchers found it impossible to examine this issue in detail because of limited time and financing. Laws in the GDR provided clear rules, including the provision of supervisory bodies, but records about how much patients were told vary. The test reports available today contain only anonymized lists of participants.
But the uncertainty over how much information patients were given is not unique to the GDR. In West Germany as well, governance standards in force in the 1980s were well below those of today. What was lacking in the East was a critical public media. It can be assumed that skepticism about drugs was lower in the GDR and that its citizens had heightened expectations of the “miracles” that West German drugs could perform.
The report is only a first systematic overview, further detailed studies should follow, stressed Mr. Sachse, noting that researchers needed to be given access to the companies’ archives to achieve this. He also wants to save the patient files in the former testing centers from being shredded after 30 years so that it may become possible to identify volunteers and to research in depth. The team has not yet found any records from before 1985.
Mr. Hess also thinks there should also be a counseling center for patients who were victims of injustices in the GDR’s healthcare system.
This article originally appeared in the newspaper Der Tagesspiegel. To contact the author: firstname.lastname@example.org