Monday, March 2, 2009

When Human Trials Come Before Animal Trials

A genetically modified rice trial financially supported by the U.S. National Institutes of Health had recently created uproar among scientists and ethicisits. The genetically altered rice, called Golden Rice, carrying higher than normal amounts of vitamin A and beta carotene was intended to treat vitamin A deficiency. While these elevated levels of vitamin A and beta carotene are potentially beneficial for restoring eyesight, it was also noted that overconsumption could lead to toxic effects. Despite such knowledge, scientists and ethicists were appalled that this rice had been fed to children ranging from 6 to 10 years old despite insufficient evidence of the rice’s safety in animal trials and had seriously violated the Nuremburg Code (Poulter)
The necessity of animal trials for safety evaluation before proceeding to human trials may seem obvious. As pointed out in a letter by the scientists protesting this trial: “Our greatest concern is that the rice…has never been tested in animals.” But Dr. Dubock, project manager of Golden Rice, defended the ethicality of the study by reasoning that “as humans are the designed beneficiaries of Golden Rice, the animal testing could not answer the questions posed” (Poulter).
Although humans and other animals are physiologically different, we cannot simply ignore potential warnings if they were presented in animal studies. Additionally, how far would we go in jeopardizing the safety of one population of humans to save another? In this case, it is risking the health of young children in order to vitamin A deficient patients. Even if children were replaced with vitamin A deficient adults, would the study be justified without previous animal trials?


Poulter, Sean. “British Scientists Condemn Using Children in GM Food Trials as Unacceptable.” http://www.commondreams.org/headline/2009/02/17-12

1 comment:

YingYu Gao said...

Even though I doubt such experiments would cause any actual harm, I agree with the critics’ opinion that experimental foods should not be tested on humans first, especially on children. Proper scientific procedure should not be ignored, regardless of how innocuous the trials may appear; nor should commercial interest should an excuse for regulatory oversights.

However, I am rather skeptical about one of the complaints posed by the scientists. According to the article, “critics of the GM experiments says the Nuremburg code states that children under 10 are not considered legally capable of giving consent to participation…” (Poulter) However, the age limit specified seems extremely arbitrary to me. The statement does not even illustrate the ethical questionability, but rather the legal concern of testing children. As such, couldn’t the same complaint pertain to all minors, rather than only under 10 years of age?

To test their claim, I searched through the various points of the Nuremberg Code. Their view that animals should be tested first was indeed justified, but nowhere did it mention any specific age. Rather, it simply states that all individuals should have the “legal capacity to give consent.” As the result of such evidence, I can’t help but feel that the critics’ viewpoint – or perhaps the article itself – is biased. I suppose that news articles should not be taken as an authoritative source, but rather one of opinion.

http://www.hhs.gov/ohrp/references/nurcode.htm