Western Pharmaceutical Trials Patients Misused as Guinea Pigs in East Germany
Prior to the fall of the Berlin Wall, East Germany sold patients as unwitting guinea pigs in drug trials conducted on behalf of Western pharmaceutical companies, according to a TV documentary. Journalists have spoken to former patients and their relatives and unearthed official documents proving secret collusion between the East and West.
It was as though Gerhard Lehrer suspected that something was amiss. He was being treated in an East German hospital in Dresden after suffering a heart attack in May 1989, and he decided not to hand back the box of drugs he had been given.
Three weeks after he was discharged, he was feeling increasingly ill. The clinic told him to stop taking the mystery drug immediately and to return all the pills he had left. But Lehrer disobeyed. "Keep hold of them, you may need them one day," he told his wife. He died a year later.
His widow Anneliese Lehrer kept the red packet. It was strange, she recalls, how the doctor praised the red-and-white capsules when her husband was taken to the hospital. "You can only get them with me," he said. When she later saw a television documentary about risky drug tests in East German clinics, she rang up broadcaster MDR.
The pharmaceutical laboratory of Leipzig University analyzed the capsules and found that the pills contained no active ingredient. The result showed that Gerhard Lehrer had been used as a guinea pig in a drug test as part of a group of patients given a placebo. A man with serious heart disease was denied proper treatment.
Dangerous Alliance with Western Firms
Research by journalists Stefan Hoge and Carsten Opitz for a documentary film called "Test und Tote," or "Tests and the Dead," which aired on Monday, shows that communist East Germany became an important location for testing new drugs in the late 1980s. They interviewed affected patients and their relatives as well as pharmaceutical experts and a former manager of the Hoechst drugs company. They also found documents proving the cooperation between state agencies, doctors and Western drugs firms.
They used a number printed on Gerhard Lehrer's packet of pills to trace documents in the archives of the former East German Health Ministry that showed Lehrer had unknowingly taken part in a study of the ingredient Ramipril. Hoechts had been looking for new applications for the successful antihypertensive drug.
The secret tests resulted in part from a chronic shortage of drugs in East Germany during the 1980s. "There were pharmacies that couldn't supply 20 percent of drugs at certain times," said Christoh Friedrich, a historian at Marburg University. "And that situation was, of course, reflected in the clinics."
At that time, drugs firms were feeling the effects of the biggest drugs scandal to date. In the early 1960s, several thousand babies were born with serious physical defects after their mothers had taken the sleeping pill Thalidomide (Contergan in German) developed by German company Grünenthal. The West German government responded by tightening its approval procedures for new drugs. A new drug law came into force in 1978 requiring patients to be informed of their rights and the risks in drug trials.
Western Money for Tests on Humans
The new legal requirements for market approval forced producers to do more extensive studies of their drugs on large groups of patients, which subsequently intensified the search for more doctors and patients willing to participate. Western German companies found these new areas for testing in the German Democratic Republic (GDR).
In the late 1970s, complaints by doctors about the failings of the health system in the country were impossible to ignore, says Opitz, citing files created by East Germany's feared secret police, the Stasi. As a result, the country's health minister, Ludwig Mecklinger, sent a number of urgent letters directly to East German leader Erich Honecker, warning that a growing number of doctors might consider leaving the country. Honecker reacted with a secretive move, ordering the access of state emergency reserves.
In a secret meeting in the spring of 1983 with members of the Central Committee who were responsible for healthcare, the course was set for a deal that would have serious consequences, historian Friedrich says. Select hospitals were to conduct tests on medications from western pharmaceutical companies that had not yet been approved. The money received in exchange was then to be invested in these facilities. Before this, the only western medications to be tested were those set to be approved for import. "They called this 'immaterial exports'," says Opitz, who examined countless documents for the film and spoke to experts and witnesses over the course of two years.
Trial Stopped After Deaths
Documentation reveals how the West German companies took up contracts with a corporation set up to handle East German exports. Months of tough negotiations yielded an agreement for lump-sum compensations for every successfully conducted test, and files from the Health Ministry show that this cross-border cooperation worked well. The number of tests ordered rose from 20 in 1983 to 165 in 1988.
"We weren't just stupid East Germans," says Hubert Bruchmüller, an electrician who lives on a disability pension today. "But when it was presented, one just did it." He had planned on pursuing a career as an athlete, but an undiscovered heart ailment put that to a stop. He was 30 years old when he was sent to the Lostau district hospital in the city of Magdeburg, one of the country's few specialized medical facilities. Without his knowledge, doctors tested the medication Spirapril by the company Sandoz on him. While he was in the hospital, his roommate had a heart attack. "I never saw him again," he says. They were both among the 17 patients who were in the trial in Lostau, of whom six died. At that point, the doctors were stopped, the federal archive files show.
The tests stopped when the Berlin Wall came down, having earned the state millions of deutsche marks. But just how much each study earned can no longer be determined because many of the files were lost after the GDR's Health Ministry was dissolved. But some medication trials are shown to have brought in up to 860,000 deutsche marks.
Research as to whether patients were informed about their unknowing participation in the trials likewise failed to provide much clarity. Despite repeated inquiries at the archives of both hospitals and pharmaceutical companies, the legally valid written consent of patients remains missing. Naturally, they tried contacting the successor companies to Hoechst and Sandoz, Opitz says, but to no avail. Sanofi-Aventis, however, was cooperative and sent a number of test files for patient Gerhard Lehrer out of the archive they took over from Hoechst.
But supposedly neither pharmaceutical industry associations nor the responsible ministries could produce a responsible party who knew about the cross-border tests. Still, the journalists were able to find some workers who had organized tests by Hoechst in the GDR, though on-camera interviews were refused on both sides of the former border.
Just one former GDR doctor was willing to discuss his testing assignments on the patients who were interviewed. But most former East German doctors would prefer to remember their health care services during that time as free of political and economic pressure, Opitz says. His documentary proves that this was not the case.