Animal Testing: How To Save Those Rats And Mice
4 CommentsBy Ed Silverman // January 9th, 2008 // 11:06 am
Revamping drug development may not only save money, but lives. Lives of rats and mice, that is. That’s the finding of an extensive review of research practices, which found that eliminating acute toxicity tests can be redundant, Reuters reports. These are designed to measure lethal doses in animals.
This is a big deal, because animal tests are an especially contentious issue. Animal-rights activists have long staged protests - some violent - against the use of various creatures in pharmaceutical testing. And recently, a coalition of groups petitioned the FDA to end such tests.
In Europe alone, just under half a million rats and mice are used each year to test the toxicity of new meds, accounting for 4 percent of overall animal use. Dropping the acute toxicity test would save around 15,000 a year, or about 3.5 percent of the rats and mice used. “While we recognise that this reduction represents a small proportion of the total, it is an important step in the right direction,” says Sally Robinson of AstraZeneca, who led the review, in a statement.
Robinson and her colleagues concluded the single-dose acute toxicity test, which is traditionally required to identify the dose of a drug that causes a major toxic effect, was outmoded because of changes in the process of drug development, according to Reuters. Screening for harmful side effects using animals remains important, but simple acute toxicity tests are no longer needed before a new drug is tested in humans.
A total of 18 drugmakers and the UK’s National Centre for the Replacement, Refinement and Reduction of Animals (NC3Rs) in Research pooled evidence from 2003 to 2007 for their research, which was published in the journal Regulatory Toxicology and Pharmacology. The next step will be to change the regulations that require acute toxicity testing, according to Kathryn Chapman of the NC3Rs.
But, in practice, drugmakers are already cutting back on the test without running into problems with the regulators. Overall, firms involved in the review have reduced animal use in acute toxicity tests by more than 70 percent, suggesting there is even greater potential for reductions worldwide. Other major drugmakers involved in the review included Glaxo, Novartis, Roche Sanofi-Aventis and Pfizer.
Nathan
Testing drugs in animals is expensive and time consuming — so there is a natural “free-market” drive that will cause companies to minimize animal testing.
My question is this: If toxicity testing only accounts for 4% of all animal use in Europe, what is the other 96% being used for? I had always assumed that toxicity testing represented the biggest chunk of lab animal use, particularly in the pharma industry. Those figures suggest that I’m clearly wrong in my thinking.
Tom
Nathan, I think the article refers to acute testing - single dose or short-term studies. From what I recall, most testing is for chronic effects (e.g. carcinogenicity)and happens over periods of 6 months to 2 years. To find more unusual adverse effects also takes larger groups of animals given different doses.
ol cranky
Nathan:
I doubt use of animal models to evaluate mechanism of action account for a lot of the animal use but BOTOX and similar biologics use A LOT of mice for potency and immunogenicity testing. in vitro models have submitted as an alternative but as far as I know, no changes to methodologies have been made. That could explain a substantial amount of the animal use in testing of biologics.
As Tom states, repro-tox and long-term tox/carcinogenity testing for compounds to be used on a chronic basis are also required. I’ve been told that some of the most insane and unnecessary testing is actually to meet DOT requirements.
Northerntracey
The so-called ‘replacement’ of animal tests is just as fraudulent as vivisection itself.
Testing drugs on animals has been consistently shown to be totally unreliable when correlated to humans. As it is so unreliable and obviously defunct why replace it with something which has to be tested to render similar results.
The only way we will ever get truly safe drugs and new treatments is by abolishing this outdated and dangerous practice.