Science vs Legislation – a clash of logic

I’ve long been a fan of the work of Dr Ray Greek.  His writings opposing animals as models in medical research directly address the scientific arguments. He does not delve into the ethical debate. I have found his books - Specious Science, Sacred Cows and Golden Geese, and What will we do if we don’t experiment on animals? – to be incredibly informative but not overly technical for the average person to comprehend. I highly recommend them!

It was therefore with great interest that I read his recent paper, co-authored with Lisa A. Kramer: “Human Stakeholders and the Use of Animals in Drug Development”[1]. Most significantly for me, it answered a crucial question that is often asked – if animals are not good models on which to base human medicine, then why do they continue to be used?

“We cite hundreds of biomedical studies from journals including Nature, Science, and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs. Legislation still requires animal testing prior to human testing even though the pharmaceutical sector has better options that were unavailable when animal modeling was first mandated.”

In other words, science acknowledges that animals are not good models on which to base human medicine, but outdated legislation insists they continue to be used. This absurd conflict must be resolved.

The paper “document[s]the fact that animal-based research for drug development is grounded on a scientific paradigm that is flawed” and “present[s] voluminous evidence that this blind spot regarding animal modeling is depriving humans of promising treatments”.

It quotes from an article in Nature which says “The issue is crucial, as public opinion is behind animal research only if it helps develop better drugs.”

The paper also states “While the public (mis)perception of the use of animals in biomedical research might be succinctly characterized as an unfortunate but still necessary evil, we show that many experts in biomedical research across academia, industry, and government have come to recognize that use of the animal model in drug development is unreliable and ill-advised.”

Its conclusion is that the pharmaceutical industry continues to rely on data from outmoded animal-based research and animal-based tests – despite “decades of research that demonstrates the lack of predictive value of animal testing for determining the safety and efficacy of drugs”. The onus should therefore be on them, with their powerful influence, to lobby for legislative change.

The situation is somewhat different in Australia. After checking with some legal experts, and with the Principal Medical Advisor of the TGA, HRA’s understanding is that unlike other countries, Australian legislation does not specifically require animal testing. The problem is however, that any drug development would be capitalised for an international market, and would therefore need to satisfy the US FDA requirements. And FDA requires that potential drug candidates be tested on two different species – ironically because they expect different outcomes.

Drug development is only one area of animal experimentation, but it is the one which most people cite as a “necessary evil” to develop treatments and cures for human disease. We now know differently. It is not only unnecessary, it can be dangerously misleading, but also, it is diverting substantial precious resources away from methods that are far more likely to result in genuine outcomes for people with illness. (“the industry spends more than a hundred billion dollars each year building upon misleading results from animal tests to develop drugs that have little chance of being safe and effective for humans and, in fact, have a high chance of being harmful.”)

I’m sure you will be familiar with regular media reports on medical “breakthroughs” – giving hope to those suffering  from Alzheimers, Parkinsons disease or cancer, only to hear that the research has been based on animal data and will soon move to human clinical trials. Unfortunately that’s often the last you hear of them as they rarely pass the human trials and reach clinical translation. 

The paper is probably one of the most succinct arguments I have read against animal testing in some time. It did however, make me angry – angry that so much time and resources have been wasted over the years, so many potential cures have been discarded and so many people have died waiting for a miracle cure that never eventuated because the drugs were tested and only worked on mice, not in humans (or didn’t work on mice, hence were discarded when they could have worked on humans).

“Despite the widely held faith among members of the public that animal modeling must take place in order to identify drugs that are safe and effective for humans, neither theory nor the empirical evidence supports the position. Moreover, many experts in the drug development process cite the failure of animal modeling as the main reason for high attrition rates and costly medications. Additionally, directing resources to animal models stands in the way of viable research that might have identified more promising treatments.”

This then, raises another concerning question. What do we tell our children and future generations that continue to lose loved ones through cancer and other diseases for which there is no cure? Yes, we knew we were doing it wrong, but we followed the law, and we didn’t challenge the law? It is imperative that the legislation catches up with the science – otherwise we will continue losing loved ones to insidious diseases that we constantly fail to cure.

For further information about animal experiments: Please visit www.HumaneResearch.org.au
Like us on Facebook: www.facebook.com/HumaneResearchAustralia/

Follow us on Twitter: https://twitter.com/HRAust

---

[1] Human Stakeholders and the Use of Animals in Drug Development, Lisa A. Kramer and Ray Greek, Business and Society Review 123:1 3–58