(NaturalNews) An often lethal test required for drugs to gain regulatory approval is scientifically worthless, an extensive procedural review has concluded.
Millions of animals are used for research each year, with two million in Europe alone. Of these two million, half a million are used to test the toxicity of new drugs, including 15,000 subjected to the acute toxicity test.
The review, led by Sally Robinson of AstraZeneca Plc and using data compiled from 18 pharmaceutical companies and Britain's National Center for the Replacement, Refinement and Reduction of Animals in Research (NC3R), concluded that the single-dose acute
toxicity test provides no useful
information about a drug's health risks to humans.
The test involves giving
animals, usually mice and rats, large doses of a new
drug and recording at what dose major
toxic effects first emerge. Animals are given doses up to 2,000 milligrams per kilogram of body weight - technically the maximum possible dose - and scientists observe for toxic reactions within 24 hours. In many cases, these doses are lethal.
Currently, European Union
regulations require acute toxicity
tests before a drug can move to human clinical trials. But according to the
review, the test provides no useful scientific information. Routine studies were much more effective at determining the nature of toxic drug effects, the researchers concluded, while acute toxicity tests do not provide this specific information.
In light of the new study, the regulations that require these tests should be changed, said Kathy Chapman of NC3R.
Robinson agreed that the tests should be eliminated.
"While we recognize that this reduction represents a small proportion of the total [animal testing conducted], it is an important step in the right direction," Robinson said.
Acting within existing drug regulations,
pharmaceutical companies have already reduced their use of acute toxicity tests by more than 70 percent in recent years, in recognition of the test's limited usefulness.
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