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Animal Research: One of FDA’s Core Values

Earlier this year, ABC’s Nightline did a story about alleged abuses at the nation’s largest primate research center. Fueled by this, the Great Ape Protection Act (HR 1326) now has 95 co-sponsors, compared to 29 sponsors on a similar bill in the last Congress.

The bill would virtually eliminate research using chimpanzees, even where there is no other animal model that could serve to predict safety in humans. This is a threat to animal research and, ultimately, to ourselves. The loss of chimpanzees would be a serious blow to research and would encourage animal rights activists to push for even more restrictions.

The value of animal research in the life sciences is considered an NIH issue. The research advocacy groups opposing the legislation are all part of the network that supports NIH

FDA Matters believes that the FDA and its stakeholders should be equally concerned.

Animal research is the vital first step in the development of new medical products. Before any safety or efficacy testing is permitted in humans, FDA must be satisfied with animal testing data submitted by the product sponsor. Pick any medical breakthrough and you will find animals were tested prior to humans.

For understandable reasons, we tend to focus on the human part of new products. What patients will be helped and by how much? By the time a company files a New Drug Application (NDA) or the equivalent in biologics and devices, the headline is the human data. While the animal data is always relevant, it has largely served its purpose as the gateway for human trials.

We talk about the people part without recognizing that the pipeline of innovative drugs and devices would narrow without chimpanzee research. It would collapse completely if a broader range of research on animals (e.g. monkeys, pigs, sheep, dogs, rats) was heavily restricted.

Everybody should be for protecting the welfare of animals. Any means to lessen our dependence on research animals should be welcome. Animals should always be treated ethically and pain reduced or eliminated. The fewest number of animals should be used to reach a conclusion that can be relied upon. Laboratories should be accredited and subject to inspection. Problems should be addressed within a facility under the watchful eye of government, accrediting and licensing agencies.

While purportedly about the welfare of animals, the House bill is really designed to grant rights to animals, starting with chimpanzees. There are elaborate arguments about whether animals should have rights or just have their welfare protected. For me, the choice is easy. I want a product or procedure tested in animals before it is given to me or my loved ones. I believe in protecting animals, but human rights come first.

Chimpanzees are crucial to animal research. If the House bill were to become law, important animal research might be halted in vaccines, hepatitis A, B and C, HIV/AIDS, malaria and some types of cancer. I am told that in these diseases areas, research on chimpanzees often provides essential information that cannot be obtained in any other way.

The importance of animal research needs to be a core value for FDA. The stakeholder community needs to “seize the day” and make clear where its stands. Those who benefit from animal research (including patients) need to provide the manpower and financial resources to counter the animal rights movement in America and its threat to medical progress for humans.


The ABC Nightline story is at: http://i.abcnews.com/Nightline/story?id=6997869&page=1.

A good review of appropriate animal research activities and processes is at: http://www.arvo.org/EWEB/dynamicpage.aspx?site=arvo2&webcode=AnimalsResearch

There are many good organizations that work to counter the People for the Ethical Treatment of Animals (PETA) and other animal rights organizations. One of the most effective is Americans for Medical Progress (AMP), an organization that educates media and the public about the importance of animal testing in advancing human health. Among other projects, they are organizing scientists to be more pro-active and articulate about the importance of testing on animals. AMP can always use more support for their work, www.amprogress.org.

2 Responses to “Animal Research: One of FDA’s Core Values”

  1. dketai says:

    I appreciate your distinction between protecting animals’ welfare and granting them rights. Nonetheless, I’m troubled by your stance in this posting.

    A few items in particular: Where would it leave us with regard to deliberately breeding animals for susceptibility to various diseases and disabilities? What does it say about societies that consider various groups of humans — blacks, untouchables, convicts — less than human? Would those societies be justified in testing on those groups? How do you “protect the welfare” of a test animal? Relieve symptoms? Euthanize it after causing incurable disease or pain?


  2. NABRorg says:

    Excellent blog entry; It is good to see that the research community at FDA is discussing the negative ramifications of passing GAPA. NABR (http://www.nabr.org) and FBR (http://www.fbresearch.org) are always happy to help communicate the importance of biomedical research, and have compiled several helpful documents on the important contribution made to human and animal health through biomedical and observational research with chimpanzees.

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