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| UDK 615.2.065(73+430)"195"; 614.35(73+430)"195" |
ISSN 0350-2899, 34(2009) br 2 p.126-134 |
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History of medicine and health culture Thalidomide tragedy - Lesson learned in the past Irena Mandić, Dušanka Krajnović Farmaceutski fakultet, Beograd |
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| Summary: Thalidomide disaster, with more than 10.000 newborns with stunted arms and legs, was one of the biggest disasters in the history of the pharmaceutical industry. Although it has been almost fifty years since the story began, there are still questions to be answered – could the tragedy have been prevented and how? The aim of the comparative analysis of the circumstances in the United States of America (USA) and West Germany made in this paper was to find out if the ethical principles of the introduction of this medicine in the therapy were followed and to what extent legal regulations in this field caused the situation of 17 thalidomide children in United States vs. 4.000 thalidomide children in West Germany. According to the legal regulations in West Germany, the processes of licensing, registration and presenting a drug on the market were under the authority of the Federal Health Office. However, no one had the authority to order possible withdrawal of a drug from the market. Paediatrician Dr. Widukind Lenz was the first to indicate the connection of the application of Contergan® (brand name for thalidomide) in pregnant women and related birth defects. Due to some lacks in related legal regulations, Dr. Lenz was degraded booth as an expert and as a man. The result of the trial against the pharmaceutical company was the establishment of a fund for children injured by Contergan®. In the United States, legal regulations and the Food and Drug Agency (FDA) stood by Dr. Frances Kelsey who refused to approve the application of thalidomide without prior clinical testing. Comparative analysis of the two “thalidomide” stories in these countries leads us to the conclusion that the introduction of a new drug in a therapy, in addition to strict legal regulations, entails conscience and responsibility of individuals within institutions participating in the process, but also of pharmaceutical companies that register new drugs. Key words: thalidomide, ethics, Dr. Widukind Lenz, Dr. Frances Kelsey Napomena: kompletan
tekst rada na srpskom jeziku |
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Corresponding Address: Irena Mandić Džona Kenedija 37, 11070 Novi Beograd tel: 011 2607 450, mob: 062 255 575 e-mail: irenam78@hotmail.com |
Paper received: 10.12.2008. Paper accepted: 08.03.2009. Published online: 06.08.2009. |
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