The Nuremberg Code Subverts Human Health and Safety by Requiring Animal Modeling

The Nuremberg Code Subverts Human Health and Safety by Requiring Animal Modeling

UC San Diego UC San Diego Previously Published Works Title The Nuremberg Code subverts human health and safety by requiring animal modeling Permalink https://escholarship.org/uc/item/2947x3sq Journal BMC Medical Ethics, 13(1) ISSN 1472-6939 Authors Greek, Ray Pippus, Annalea Hansen, Lawrence A Publication Date 2012-07-08 DOI http://dx.doi.org/10.1186/1472-6939-13-16 Peer reviewed eScholarship.org Powered by the California Digital Library University of California Greek et al. BMC Medical Ethics 2012, 13:16 http://www.biomedcentral.com/1472-6939/13/16 DEBATE Open Access The Nuremberg Code subverts human health and safety by requiring animal modeling Ray Greek1*, Annalea Pippus1 and Lawrence A Hansen2 Abstract Background: The requirement that animals be used in research and testing in order to protect humans was formalized in the Nuremberg Code and subsequent national and international laws, codes, and declarations. Discussion: We review the history of these requirements and contrast what was known via science about animal models then with what is known now. We further analyze the predictive value of animal models when used as test subjects for human response to drugs and disease. We explore the use of animals for models in toxicity testing as an example of the problem with using animal models. Summary: We conclude that the requirements for animal testing found in the Nuremberg Code were based on scientifically outdated principles, compromised by people with a vested interest in animal experimentation, serve no useful function, increase the cost of drug development, and prevent otherwise safe and efficacious drugs and therapies from being implemented. Keywords: Animal, Biological complexity, Ethics, Evolution, Law, Nuremberg code, Species variation Background which is well-known today as an ingredient in anti- Using animals to learn more about life in general and freeze, killed one hundred and seven people. This inci- humans in particular dates back to ancient times. In the dent led directly to the enactment of the US Federal first century BCE, researchers dissected the optic nerve Food, Drug and Cosmetic Act of 1938 to mandate some in living animals, vivisected a pig while it was swallowing animal testing [3]. colored water in order to evaluate the action, and The Nuremberg Code came out of a trial in post-war observed intact beating hearts [1]. Animal experimenta- Germany in December of 1946, the second of the tion continued with Galen in the first century CE but Nuremberg trials. The first tried 24 Nazis, including modern animal use in research and testing dates to Hermann Göring and Rudolf Hess, at the International Claude Bernard in 19th century France [2]. Military Tribunal for crimes against humanity. This first The notion that testing chemicals on animals could be trial lasted eight months with ultimately seven of the 24 predictive of human responses and therefore should be defendants being executed. Some were sentenced in legally mandated dates back to the 1930s, when the sulfa absentia, some were acquitted, some committed suicide drugs were being introduced for infections. Sulfa drugs or could not be tried for medical reasons, and others were some of the first drugs that were shown to be ef- were incarcerated [4]. fective against certain bacterial infections, but they were As the first trial progressed it became obvious that more difficult to dissolve in solution. This was a problem, as people were responsible than merely the 24 under scru- children usually require a liquid version of a medication tiny, so a total of 12 more trials were held [5]. These trials because they will not swallow pills. In 1937, one sulfa were held before US military tribunals, with the sole trier drug was dissolved in ethylene glycol and subsequently of fact being the United States. Thus the second trial was administered to children and adults. The ethylene glycol, formally designated United States of America v. Karl Brandt et al.,colloquiallyreferredtoasthe“Doctors’ * Correspondence: [email protected] Trial” or the “Medical Case.” Four judges presided over 1 Americans For Medical Advancement, 2251 Refugio Rd, Goleta, CA 93117, the eight-month case, hearing 85 witnesses, and viewing USA Full list of author information is available at the end of the article 1,471 documents and 11,538 pages of transcript [6]. © 2012 Greek et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Greek et al. BMC Medical Ethics 2012, 13:16 Page 2 of 17 http://www.biomedcentral.com/1472-6939/13/16 Twenty out of 23 defendants were physicians. All had Association, was a medical adaption of the Nuremberg been singled out as being responsible for the execution of Code and came out in 1964. It has been revised six times humans they deemed “unworthy of life” and for experi- since then. The Declaration of Helsinki [13] came to ments conducted on concentration camp prisoners. supersede the Nuremberg Code as the normative ethical Experiments contained in the indictments included those guidance for medical researchers [6]. The Declaration of pertaining to treatments for persons who had been se- Helsinki represents an improvement over the Nuremberg verely chilled, the effects of various poisons and vaccines, Code in the sense that it balances the concerns of indivi- and testing for pharmaceutical treatments for phosphorus duals against the benefits to the society [14]. burns from incendiary bombs. All of the experiments were Both the Nuremberg Code and the Declaration of performed on unconsenting humans who were inmates of Helsinki indicate that animal-based research should be concentration camps [7]. The defendants were charged conducted before human experimentation, the former with and tried for conspiracy to commit war crimes more unequivocally than the latter. Principle 3 of the against humanity, war crimes, and crimes against human- Nuremberg Code states: ity. The tribunal did not convict on the first charge; 15 of the defendants were convicted on counts two and three. The experiment should be so designed and based on Ten of the 23 defendants were further charged with, and the results of animal experimentation and a found guilty of, membership in a criminal organization knowledge of the natural history of the disease or (the SS) [7]. The Nuremberg Code also came out of these other problem under study that the anticipated results proceedings, comprising ten ethical ideals that strive to lay will justify the performance of the experiment [15]. the groundwork for ensuring that human rights are (Emphasis added.) respected in human experimentation. The American Medical Association appointed an ad- This principle is predicated on the assumption that the visor to the prosecutor for US v. Brandt, Dr Andrew animal experimentation will have predictive value for the C Ivy [8]. Ivy was a scientist himself and had con- efficacy of the ultimate experimentation on humans. Iron- ducted research similar to what was being discussed at ically, experiments were also conducted on animals in the trial, such as the effects of altitude on pilots [9]. Nazi Germany despite the commonly held position that Ivy was also a staunch opponent of those seeking to they were not [16-20]. The following is from a document remove animals from laboratories during the 1930s presented at the Doctor’s Trial (USA v. Karl Brandt, et al.) and 1940s. He was a co-founder of the National Soci- at Nuremberg and is titled “The Blood Picture of the ety for Medical Research, an organization that cam- White Mouse in Experimental Infections and Chemother- paigned in favor of animal experiments, and served as apy” (spelling per the original document). its secretary-treasurer for years. It was Ivy who wrote the manuscript the prosecutors used to evaluate the In former works 1) we have reported on the scientific aspects of the charges [10,11]. This manu- application of hematolytic technique to prove the script included: functional condition of the mesenchyma in artificially infected animals and chemotherapeut treatment. The The experiment to be performed must be so designed differential blood picture in normal mice as we as in and based on the results of animal experimentation mice infected with recurring spirochetes and nagana and a knowledge of the natural history of the disease trypanosomes treated with salvarsan and solganol was under study that the anticipated results will justify the only briefly discussed and publication at a later date performance of the experiment. The experiment was promised. To cause hyperemia the tails of the must be conducted . on the basis of the results of mice was dipped for a short while into water of 40oC, previous adequate animal experimentation, there is no were severed and a drop . a priori reason to believe that death or disabling injury will occur, except in such experiments as those Principle 12 of the Declaration of Helsinki advises that on Yellow Fever where the experimenters serve as medical research on humans must be based on animal ex- subjects along with non-scientific personnel. perimentation as appropriate. Again, the assumption is that animal experimentation will have predictive value for The American Medical Association quickly adopted Ivy’s human research or experimentation, thus protecting rules and this was presented at Nuremberg in such a way human rights. As we will see, the opposite is the case: reli- as to make it appear that the rules were well established in ance on animal-based research in conducting human ex- the US ([10,11] also see [12]). Ivy’s wording would appear perimentation is antithetical to a respect for human rights. almost verbatim in the ultimate Nuremberg Code.

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