Outline of a Suggested Campaign Against Animal Experiments as Part of AIA’s FIVE YEAR STRATEGY 2022 – 2026
By Dr Andre Menache
This campaign is intended to raise public, parliamentary and stakeholder awareness of the urgent need to replace animal tests in the context of regulatory requirements, which are outdated and no longer fit for purpose.
The need is urgent because these outdated regulatory requirements are responsible for untold animal suffering in laboratories. In the case of the pharmaceutical industry, in addition to animal suffering, there is also untold human suffering in the form of severe adverse drug reactions not predicted by animal testing. In the case of the chemical industry, the regulatory requirement for animal testing is equally unable to predict damage to human health as well as damage to the environment by synthetic chemicals, pesticides, etc.
It is hoped that this campaign, as part of an overall collective strategy, will end animal testing as a regulatory requirement in the pharmaceutical, the chemical and the cosmetics industry by 2026. In terms of the technology available, this is certainly realistic. The major obstacles are, resistance by industry to abandoning 75 year old animal tests and political inertia on the part of government agencies. These obstacles can be overcome through the mobilisation of public opinion, together with an informed parliamentary debate and shareholder informed consent to corporate policy.
Groups in the Netherlands have already suggested 2025 as a realistic date by which to replace regulatory animal tests. The EU and the US suggest 2035 instead. The final date depends on how soon and how effectively we can mobilise public opinion as described above. It is important to stress that the necessary technology is already available to replace the animal tests. The pharmaceutical and chemical industries could, if they wanted to, replace these animal tests right now. They have all the necessary resources as well as the means to steer these new test methods through the regulatory maze. All that is missing is the political will to do so.
The testing of new pharmaceutical drugs involves several stages, including in vitro tests using human cells and in vivo tests using animals.
The use of animals is justified in various ways, the most common being that human cell tests in vitro do not mimic the complexity of a whole living organism and hence the need to test new pharmaceutical drugs in two or three different species of mammal, most commonly the rat, the dog and the monkey.
A 10 year old child can probably see the flaw in this logic, namely that a whole living rat, dog or monkey is not the same as a whole living human being.
According to the US Food and Drug Administration (FDA), nine out of ten new drugs that pass animal tests fail during clinical trials in humans, either due to lack of efficacy or else due to significant human toxicity not revealed in the animal studies. Thus animal testing represents a 90% failure rate.
How does the pharmaceutical industry justify the continued use of such a failed model? Answer: it doesn’t need to because the animal tests are a legal requirement, albeit 75 years old.
The following two quotes support this thesis.
“Most of the animal tests we accept have never been validated. They evolved over the past 20 years and the FDA is comfortable with them.” – Anita O’Connor, Office of Science, FDA (1988).
“Animal studies are done for legal reasons and not for scientific reasons. The predictive value for such studies for man is meaningless – which means our research may be meaningless“.
James D Gallagher, Lederle Laboratories, Journal of the American Medical Association (1964).
There are, however, some signs that this legal requirement is now being challenged on scientific grounds. In 2018 in the US, a pharmaceutical company challenged the need to conduct a 9 month toxicity test using beagle dogs for a drug candidate already undergoing early clinical trials in human patients. For more detailed information, please refer to the Open letter below, written to the FDA by the drug company (Vanda pharmaceuticals).
Although the drug company challenged the FDA in court, it eventually lost the case on grounds that the animal tests were consistent with the regulatory requirements.
As a result, an NGO called « White Coat Waste Project » has called on Congress to pass legislation that would allow drug companies in the US to bypass animal testing.
The « Alternatives to Animals for Regulatory Fairness Act », or the AARF Act, is intended to amend the 75 year old law to allow the use of « alternatives » to animal testing to meet regulatory requirements. For more detailed information, please refer to the links below:
A battery of currently available human based test methods would far out perform the 90% failure rate seen in animal tests. The pharmaceutical industry is well aware of this fact and probably does rely to some extent on human based test methods, but there is no way of knowing which human tests are being used and which are being ignored and we can expect the industry to keep this information under wraps on grounds of intellectual property or commercial confidentiality.
If the 90% failure rate for routine animal testing of pharmaceutical drugs sounds shocking, it actually gets worse with respect to animal testing used to detect drugs that cause birth defects in humans.
The animal species used to detect possible birth defects are usually the rat (3 weeks gestation) and the rabbit (4 weeks gestation).
Out of 1,500 chemicals that resulted in drug-induced birth deformities in laboratory animals, only 40 had human correlates, yielding a positive predictive value (PPV) of just 3%.
Reference. Shepard TH, Lemire, RJ. Catalogue of Teratogenic Agents. 11th ed. Baltimore, MD: The Johns Hopkins University Press; 2004
MATERIALS AND METHODS:
AIA does not have the resources to challenge industry or the regulatory framework head-on. However, AIA can raise awareness of the problem in the form of a pilot project with a view to informing public and stakeholder opinion, initially on a small scale. If the pilot project succeeds, it could lead to bigger projects and also encourage some of the major established organisations to launch their own campaigns, based on the AIA model.
A steering committee comprising interested AIA directors and/or patrons will formulate the awareness campaign, which, when ready, will be submitted to the AIA board of Directors.
This pilot project will be funded by outside sources and not from AIA’s own general funds. An additional possibility is to earmark a special AIA fund for this project, subject to the approval of the AIA board of Directors.