Deadly Drug Trials Western Firms Bribed East German Doctors
It wasn't just the East German government that benefited from risky patient drug trials commissioned by Western pharmaceutical manufacturers decades ago. These companies also sent liaisons with lavish gifts to bribe and influence doctors to participate.
The presents always came in the springtime. When the representatives of Western pharmaceutical companies arrived at the Leipzig Trade Fair, they made sure that East German doctors were very well looked after.
One doctor enthusiastically described his experiences in a subsequent report to the Ministry of State Security, or Stasi. According to his account, things would get off to a cheerful start every morning at the booth run by Mack, now a Pfizer subsidiary: "There was champagne on the table, along with a carton of cigarettes, and the usual cosmetic products for my wife."
After that, he would head over to Swiss drug maker Ciba-Geigy, now part of Novartis. The doctor, an orthopedist identified by the code name "Jörg," says that he was taken "behind the scenes" and treated "very smoothly." At the booth for Frankfurt-based pharmaceutical industry supplier Degussa (now part of Evonik Industries), a representative made an effort to set things right with the physician when he learned that gifts sent for his children hadn't yet arrived. The rep promised they would be sent as a "direct package shipment."
The physician then proceeded to booths operated by Bayer, along with a British, an American and a Swiss company. After a few hours, "Jörg," then a department head in a hospital in Schwedt, in the state of Brandenburg, felt pleasantly tipsy. "By noon, I was almost drunk, and my head was filled with dirty stories about women that were not exactly professional."
Pharmaceutical companies from West Germany and other Western countries exercised little restraint when they wanted to test new drugs on the other side of the Berlin Wall. They paid the government of the German Democratic Republic (GDR) millions for extensive clinical trials, in which at least 50,000 East German citizens served as subjects, often unknowingly.
It has now emerged that these envoys from the West were running a corrupt system to recruit East German doctors for their controversial drug trials. Companies like Bayer and Sandoz also employed lobbyists to develop high-level contacts in the GDR.
Everyone Wins, Except for the Patient
It was a mutually beneficial arrangement. 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. According to a Stasi report, in 1981 alone, the companies sent East German researchers about 250 invitations for what were usually lavishly funded trips to the West. "To promote their commercial interests," the Stasi files read, the companies took advantage of "opportunities involving corruption and bribery."
The patients, however, were treated with far less consideration. They were neither compensated nor thoroughly informed about what would be done to their bodies, say victims today. Survivors report that they have yet to receive compensation for the harm they suffered.
Many of them have now contacted SPIEGEL, some with clear accusations and others with questions that have been on their minds for years. They all expect answers from the industry, as do lawmakers from all parties, who held a question-and-answer session last Wednesday to address the scandal over inter-German drug trials.
Leading drug manufacturers, however, have remained reticent. Bayer, based in Leverkusen near Cologne and one of the key players in the GDR drug trials affair, has rejected interview requests for weeks, without offering any reasons. Sanofi-Aventis, the legal successor of Hoechst, issued the following statement: "Please contact the German Association of Research-Based Pharmaceutical Companies (VFA)." The VFA, for its part, is directing journalists to its member companies.
Even after the recent revelations, several industry representatives insist that nothing untoward happened during their drug trials in East Germany. "To our knowledge, the clinical trials conducted in the GDR conformed to the standards of the day," says VFA Director-General Birgit Fischer.
But why then can many of the affected companies provide no evidence of their supposedly proper behavior? Are they unable to locate the consent forms from their former East German clinical trial subjects? Or did the forms never exist? And why are they not presenting the informational materials supposedly used to educate test subjects on risks and side effects at the time?
Guinea Pigs for the Bottom Line
Uwe Böhm is one of those affected by the trials. He began an alcohol treatment program at an East Berlin hospital in the summer of 1989, he says. On the very first day, says Böhm, he was told that in addition to the withdrawal therapy, he was to participate in a study.
He was then instructed to take nimodipine, a drug used to improve cerebral blood flow that Bayer was having tested in the GDR at the time, three times a day. Although Böhm was told the name of the drug, he was kept in the dark about its effects. "I participated," he says. "I had no other choice." He recalls that he struggled with unpleasant side effects for days. "I really went off the deep end psychologically," says Böhm. He is still trying to find out more about his case today, albeit unsuccessfully. The proposal to conduct the trial came from the East German doctors themselves, Bayer explained.
Sylvia Bungers also wants answers. She has long suspected that drugs were tested on her father, a bricklayer. After feeling faint, he was admitted to the Köthen-Süd Hospital near Dessau in March 1988. He soon felt better, says Bungers, but the doctor who was treating her father didn't want to release him. According to Bungers, her father was injected with drugs at the hospital for another six weeks.
He wasn't the same person anymore after his release, says Bungers, and he often felt very ill. "He used to say: 'I don't know what they did to me at the hospital, but I know that they made me sick." Bungers' father, who died in 1993 at the age of 59, never found out which drugs were tested on him.
'An Intimate Relationship'
While patients' questions were left unanswered, the pharmaceutical representatives paid a great deal of attention to their contacts in the hospitals. Boehringer Mannheim, which was later acquired by the Swiss Roche Group, even assigned an employee with a PhD in chemistry to a liaison office in West Berlin. The lobbyist was given something that was very unusual: an official permanent visa, which allowed him to enter the GDR at any time.
The Stasi noted that when he was there, the Boehringer employee maintained "extensive and, in some cases, personal contact with many scientists in the GDR," and even presented them with wedding gifts when the occasion arose. East German intelligence also learned that he was engaged in an "intimate relationship with a female employee at the Advisory Office for Drugs and Medical Devices of the GDR." The Boehringer representative also showered this woman with gifts, presumably in the hope that he could use the relationship to his company's advantage.
The Boehringer chemist went to "great lengths to promote the interests of his company," the Stasi noted. In addition to the woman at the Advisory Office, the recipients of various "favors" included a doctor at a Dresden polyclinic, the director of the main laboratory at the district hospital in Görlitz, in the state of Saxony, and a senior employee at the Leipzig Research Institute for Sports Medicine.
Sandoz also sent its own lobbyist to East Germany. On June 3, 1987, the employee visited a regional clinic for psychiatry and neurology in Bernburg, near Leipzig. A doctor watched him unload his drug samples, and then the two men had coffee and talked business.
According to the Stasi report, the Sandoz envoy said that he had a problem. His company wanted him to arrange for "drug trials to be cheap and as extensive and scientifically precise as possible," but that this was becoming "more and more difficult" in West Germany. The East German doctor, whom the Stasi identified by the code name "Schubert," had no illusions about his visitor's expectations. "He wants the trial to be processed as quickly and with as few complications as possible," the doctor noted. "Of course, for him every day and every week the trial is prolonged costs money."
Who Takes Responsibility?
The executives at the drug companies knew what was going on -- at least that was the impression of the East Germans. In the case of one Bayer lobbyist, the Stasi even gained access to his reports to management. "One such report contains information on which individuals were given certain drugs or received other gifts from representatives," reads one Stasi document.
According to the reports, the Bayer employee advised his managers to continue with the "old approach." To be able to do so, he requested "the transfer of a sum of money to the relevant GDR scientists."
Now, decades later, money is at issue once again, but this time it is a matter of who will pay for the investigation of the scandal. Although the German Interior Ministry plans to fund the lion's share of a comprehensive study on the patient tests, it also expects the pharmaceutical industry to participate in the cost. But the drug companies don't appear to be willing to do so, at least not yet.
And while Health Minister Daniel Bahr, a member of the pro-business Free Democratic Party (FDP), aims to prevent further documents from being destroyed at places where the trials were carried out, such as Berlin's Charité University Hospital, the pharmaceutical companies are only hesitantly beginning to comb through their archives. But at least a few of them, like Roche and Boehringer Ingelheim, have started the process.
For some pharmaceutical executives, a different issue is currently more important than coming to terms with the past. They must now investigate whether it's currently legal to market medicine tested under conditions allowed by the East German government. Last Wednesday, the Bundestag held a debate over whether drugs with a questionable GDR past could in fact lose their approval.
Translated from the German by Christopher Sultan