Informed consent was not completely ignored in the 1980s, researchers find.
Respect for informed consent is not regarded as one of the greatest virtues of East German medicine in the 1980s. Elite athletes in East Germany (GDR) were routinely given drugs to enhance their performance, even to the point of endangering their health. With such scandals in mind, no one was surprised when reports surfaced in the German media last year that the GDR had leased out patients as guinea pigs to Western pharmaceutical firms to support its failing health care system.
However, researchers at the Institute for the History and Ethics of Medicine, in Erlangen, Germany, have concluded that these sensational claims were “tendentious” and “distorted”. In an article in the Journal of Medical Ethics they say the GDR attempted to conduct trials according to international ethical standards and that there was no evidence to suggest the trials systematically and intentionally damaged patients.
Nonetheless, the surviving records do not exonerate the GDR authorities. The trials were conducted without the knowledge of the public and although GDR legislation stipulated that patients had to consent to the trials, there is no evidence that patients were systematically informed. Many different drugs were tested, including, chemotherapeutic agents, insulin, heparin, anti-depressants, anti-allergy drugs, toothpastes and cardiovascular drugs.
Some documents suggest that some of the trials were carried out without patients having a comprehensive understanding of what the trial involved. It is also unclear whether the patients knew that they were participating in trials and were aware of all the risks.
But even if the patients did not benefit, the companies and the government did. The companies were able to test new drugs legally, while at the same time opening up new markets in the Eastern Bloc and getting test results faster and more cheaply than they could elsewhere. The government appears to have earned DM16.5 million from 220 trials between 1983 and 1990 involving more than 14,000 patients and 68 Western companies, mainly from West Germany, Austria and Switzerland.
What accounts for the ethical shortcomings of the GDR health system? The researchers say:
“… the GDR ideology required the subordination of the individual to the interests of the collective, a basic precept of Marxism. Therefore, the rights of the individual were not always fully taken into account. This goes against traditional medical ethics where patient autonomy is the primary concern. In the GDR, decisions were often made for purely ideological reasons. State politics followed a socialist collective code of ethics and ethical freedom was non-existent, a fact that even formerly loyal GDR ethicists openly admit today. Medical employees, doctors and scientists were expected to subordinate their interests to prioritise tasks of importance to society. A truly independent medical opinion was not wanted.”
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