BUAV congratulates UK veterinary agency for removing obsolete batch animal tests

Wednesday, 13 July 2011 1:40 PM

The BUAV has welcomed the outcome of a review by the UK Veterinary Medicines Directorate (VMD) into unnecessary animal testing of some veterinary drugs. This development comes as the Home Office announces a shocking 3% increase in the number of animal experiments in 2010 (3.7 million experiments were started on 3,642,517 animals).

The review by the VMD found that 26 veterinary drugs were being tested on animals when there was no longer any scientific need. This has prompted a change in the licences for all 26 drugs, sparing an estimated 38,000 animals over the next 5 years.

The review by the Government agency came about as a consequence of the BUAV investigation into Wickham Laboratories in Hampshire in 2009. Our investigation found that the laboratory was conducting horrendous rabbit and mouse tests for some veterinary drugs that international regulations no longer required.

The BUAV raised its concerns with the VMD and was delighted to see the VMD instantly launch a review into the drugs it licences. The agency found 26 veterinary products still had a redundant animal test listed in their licence – i.e. it was no longer required by International regulations. The VMD wrote to the companies and has confirmed to the BUAV this week that all 26 products will no longer be tested on animals. The companies have either submitted a successful application to remove the need for the animal test from their licence or have promised to not animal test until they have done so.

The animal tests were:

Pyrogenicity test- this test assesses the likelihood that any contaminant of injectable drug products will cause a fever reaction. It involves restraining rabbits in ‘stocks’ by their necks, injecting the substance in their ear vein and taking their temperature over several hours via a probe inserted deep into their rectums. Rabbits are starved of food and water before and during the test and are typically held in the stocks for 8 hours at a time. Rabbits are repeatedly re-used in these experiments, unless they show a reaction in which case they are killed. International regulators have agreed that for most drugs an alternative, in vitro test is a better test.

Abnormal toxicity test- this even cruder test is a ‘catch- all’ to determine if a drug is likely to cause any other, unforeseen reaction when injected into a human patient. It involves injecting samples of the drug into the abdominal cavity of mice. If the mice die then the batch of drug is withdrawn. It was largely deleted from international requirements years ago as it was considered unreliable and unnecessary, and yet, for unknown reasons, still persists for a few drugs.

Dr Katy Taylor, the BUAV’s scientific adviser says; “We are delighted with the prompt action by the VMD. We estimate their action alone will spare over seven thousand animals every year. Nonetheless, it is an absolute disgrace that animals have continued to be used for years in tests that were no longer required by international regulations. Once again it calls into question the oft-repeated claim that animals are only used when absolutely necessary. The Home Office should be enforcing this legal requirement and regulators given the power to force companies to keep up to date with scientific and regulatory requirements in order to reduce animal experiments.”

Notes

The VMD has confirmed that rabbit pyrogen tests for 16 products, safety/acute toxicity tests for 8 products and both types of test for a further 2 products have now been halted. For all the 26 products the VMD has now either obtained a commitment from the company that no further testing involving animals will be performed, which means no further batches will be released to the UK (as an interim step before they submit the necessary variation and gain approval to remove the test, at which point release of batches of product to the UK will resume) or they have already approved variations to stop the test.

During its investigation at the contract testing laboratory, Wickham Laboratories Ltd, the BUAV found that 12 out of 14 drugs known to have been tested during the investigation did not appear to require the test, based on International regulations, which are the EU and US pharmacopoeias. Wickham were testing veterinary drugs such as injectable mineral supplements, pain killers and antibiotics and human drugs for cancer, fungal infections and diagnostics. Out of the seven companies contacted by the BUAV that were commissioning the tests, only one, GE Healthcare replied. They confirmed that, as a result, they had updated their licence and ceased to commission the animal test.
It is difficult to estimate how many animals have been saved as the number of tests depends on the extent of production of each drug, which is not known. Drugs produced in small quantities or less frequently will have fewer ‘batch’ tests. The number of animals who have been spared is based on our knowledge of testing demands at Wickham. Pyrogen tests for a single veterinary product were conducted up to 122 occasions each year using 3 rabbits each time. 18 products have now ceased being tested. Each year this would constitute 6,588 rabbits. Abnormal/safety toxicity tests for a single veterinary product were conducted up to 23 occasions each year using 5 mice each time. 10 products have now ceased being tested. Each year this would constitute 1,150 mice. The estimated total number of animals spared is 7,738 each year. It is likely that without this review the testing would have gone on for several more years.

These tests are called ‘batch tests’ as they are conducted on batches of the drug after it is manufactured. They were designed as early as the 1940s as a crude safety measure to check that drugs that are injected are not contaminated. However, the need for these ‘batch tests’ has frequently been questioned in recent years and, for most drugs, the international regulators have ceased to require them. This is because studies have shown that the test is redundant as laboratories improve their quality control in production or alternatives can be used instead.

The unnecessary animal testing seems to have continued because as these international regulations are updated, the requirements for specific drugs are not automatically updated. It is up to the companies to submit ’variations’ to their licence but they are not forced to under UK current practice if the only reason is animal welfare. The Home Office, as the regulator of animal experiments, has a statutory responsibility, however, to ensure that animal tests do not take place unnecessarily.

The BUAV has written to the EMA and the MHRA to ask them to perform similar reviews to the VMD of their products. We will also be asking regional regulators in other EU countries to do the same.

Further information and images from our investigation can be found here:
http://www.buav.org/undercover-investigations/theuglytruth/
 

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