# BUAV In The News



## testmg80 (Jul 28, 2008)

*Animal tests probed after cruelty claim*

THE Government is investigating claims that animals at a Hampshire laboratory are suffering cruel deaths.

The British Union for the Abolition of Vivisection (BUAV) said its footage showed staff at Wickham Laboratories, in Wickham, accidentally breaking the back of mice when trying to kill them with ballpoint pens.

Official guidelines allow mice to have their necks broken to ensure a quick death, but the secret film allegedly shows some were left writhing after their backs were mistakenly broken.

The BUAV placed an undercover worker at the laboratories for eight months up to the end of October where she filmed thousands of animals being used to test the anti-wrinkle product Dysport.

Technical director Chris Bishop said he was unable to comment on specific allegations due to the ongoing Home Office investigation.

We are fully committed to animal welfare and will work with the Home Office to ensure that high standards are maintained. We are fully committed to seeking continuous improvement in our operations, Mr Bishop said.

Dysport is one of the toxins we test and we work closely with regulatory authorities on the testing methods required. Currently all regulatory authorities worldwide require the LD50 test; at this time there is no satisfactory alternatives to ensure patient safety and efficacy.

Our laboratory is continuing to work on alternatives to various toxin tests and our staff are actively involved in the European working group reviewing test procedures.

The BUAV also accused the Home Office of not enforcing the use of non-animal alternatives and of failing to minimise the suffering inflicted on animals.

Sarah Kite, from BUAV, said: Time and time again the Government and animal research community claim that animals are only used as a last resort for vital medical research and that animal suffering is kept to a minimum.

This BUAV investigation has blown those claims wide open.

Confirming the inquiry, a Home Office spokesman said: We take these allegations seriously and are taking urgent steps to look into them further. We authorise animal research only when it can be justified.

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*Government probe into animal lab cruelty video*

The government has launched an investigation after claims that animals are facing cruel and agonising deaths at a testing laboratory.
Official guidelines allow mice to have their necks broken to ensure a quick death, and ballpoint pens are often used. But film shot at Wickham Laboratories shows some being left writhing after their backs were mistakenly broken.

The footage, shot
ADVERTISEMENTby an investigator from the British Union for the Abolition of Vivisection over eight months, also includes botched injections given to struggling rabbits, which are immobilised in 'stocks' for up to eight hours in experiments that test whether drugs cause fevers. Staff are also reportedly seen swearing at the rabbits.

Many of the rabbit tests, although licensed by the government, are not required under international pharmaceutical testing standards. The Home Office has launched a probe into the claims. A spokesman said: 'We authorise animal research only when it can be justified. We require the highest standards, and will examine any evidence that suggests these standards are not being met.'

Chris Bishop, the technical director of Wickham Laboratories, said he could not comment on the footage but would seek opportunities to improve lab practice. The company added: 'The welfare and care of our research animals is paramount.'

The full article contains 221 words and appears in The News newspaper.
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*Staff maim lab mice with ballpoints*

Thousands of animals being used to test a wrinkle-erasing rival to Botox are facing cruel and agonising experiments at a Home Office-approved laboratory, an undercover investigation has found.

Secret footage of the tests on Dysport, a drug used to erase frown lines in cosmetic surgery clinics, shows laboratory staff accidentally breaking the backs of mice when trying to kill them with ballpoint pens. The pens were then used to fill out their death records.

The film, obtained using a hidden camera inside Wickham Laboratories, a long-established facility in Hampshire that tests drugs for pharmaceutical companies, also shows rabbits being incompetently injected with other drugs.

Staff are filmed botching injections and swearing at struggling rabbits, which are immobilised in stocks for up to eight hours in experiments that test whether drugs cause fevers.

Many of the rabbit tests, although licensed by the government, are not required under international pharmaceutical testing standards. The Home Office itself boasts about how these tests can be replaced by a new technique using human blood cells instead of rabbits.

The footage, shot by an investigator from the British Union for the Abolition of Vivisection, has led the government to launch an inquiry. A Home Office spokesman said: We take these allegations seriously and are taking urgent steps to look into them further. We authorise animal research only when it can be justified.

We expect and require the highest standards, and will thoroughly examine any evidence that suggests these standards are not being met.

The filming, compiled over a period of eight months, included a sequence in which a member of staff made a number of attempts to inject a rabbit.

She is recorded calling the animal a little shit and a disgrace. She warned the rabbit that it could end up with ear-rings  a reference to punctures in its ear from failed attempts at injections. Another member of staff is recorded remarking that blood is coming out of the rabbits ear.

William Cartmell, the official vet charged with overseeing the welfare of the animals used for testing at Wickham, is also a founder and a big shareholder in the company.

Last night he denied that this represented a potential conflict of interest and said he was a professional.

Lab records seen by the BUAV investigator show that Cartmells weekly inspections sometimes took 15 minutes, with one visit in March this year lasting only eight minutes. He argued this was adequate to check that the animals were being treated well and not suffering.

The health status of the animals is at such a high level that the length of time involved is more than adequate, he said. The animals are under constant care unlike pet animals and farm animals.

Dysport, which is made from botulinum toxin, is licensed in Britain for medical use to treat conditions such as involuntary eye muscle contractions, facial twitches and muscle spasms.

However, it is also used legitimately off-label as an alternative to Botox for cosmetic treatments to eliminate frown lines and wrinkles.

Each batch has to be tested by law to ensure that it is safe and of the correct potency. Lab records seen by the investigator show that 41,088 mice were used in Dysport tests at Wickham between January and June this year.

The method used  lethal dose 50 (LD50)  is classed as a very severe test by the government. Mice are injected with the toxin. They suffer progressive paralysis and the film shows them lurching from side to side as they become unable to walk properly. Some appear to suffer severe breathing difficulties before dying.

Government regulations require suffering animals to be put out of their misery. Wickham Laboratories records indicate that far more mice died during the tests than were killed humanely.

Official guidelines allow mice to have their necks broken to ensure a quick death, and pens are often used to do this. But film shot at Wickham shows that some were left writhing after their backs were mistakenly broken by staff.

Alternatives to the LD50 test have been developed and are being used at other laboratories in Britain.

The official government laboratory, the National Institute for Biological Standards and Control, uses non-lethal methods to test Dysport. Ten years ago it developed a test of the toxin using a test tube. It also uses a far less severe test on mice that does not kill them.

The BUAV, which has eight months of footage from Wickham, said the treatment of many animals was appalling.

Sarah Kite, BUAVs special projects director, said: The fact that extremely sick mice end up in the hands of incompetent staff, to have their backs broken and suffer such an agonising death is totally sickening.

Our shocking findings show that crude, archaic and extremely cruel animal tests are still allowed in the UK even when an alternative test exists and animal testing is not required by official bodies.

The revelations about the testing at Wickham have shocked dermatologists who use Dysport. Nick Lowe, who is known as Dr Botox and has conducted research into the toxin, said he was surprised that the LD50 test was still being used.

Lowe, whose clients at his London clinic include Anne Robinson, the television presenter, said he was appalled to hear that animals were being allowed to suffer in tests on the drug.

I would like to know that all the drugs I prescribe for patients are evaluated in ethical ways. With my own range of skin-care products we do absolutely no animal testing. I am not in favour of that type of testing at all. I want the highest ethical standards, he said.

Ipsen Biopharm, which manufactures Dysport, said it took the allegations very seriously and would be following them up with Wickham. Animal welfare is of primary importance to Ipsen, and the approval of Wickham by the Home Office has been critical in Ipsens decision to work with this company, said a spokesman.

In no way would I, or any member of Ipsen staff, condone practices outside the approved procedures laid down for this type of test.

Ipsen said that it used the LD50 test because it was required to but was striving to replace the LD50 test as soon as suitable alternatives have been approved by worldwide regulatory authorities.

Chris Bishop, the technical director of Wickham Laboratories, said he could not comment on the footage but would seek opportunities to improve lab practice. He said the companys animal technicians undergo extensive training programmes.

We have a culture of seeking continuous improvement and if there are observations which indicate such opportunities, we shall gladly embrace them,  he said.

The company added: The welfare and care of our research animals is paramount.

Test rules

- The Home Offices policy is to license animal experiments only when there is no alternative research technique.

- Ministers say they will not license tests which cause severe pain or distress that cannot be alleviated or where the animals death is the end point.

- The government has banned the testing of cosmetics, such as make-up and face creams, on animals.

- Tests on animals rose to 3.7m procedures in 2008, up 450,000 on the previous year.

- Mice and rats are the most commonly used animals in tests. The government also allows dogs, cats, horses and primates. Last year 3,354 primates and 4,271 dogs were used in tests in UK labs.

- Labs have a legal duty to keep animal suffering to a minimum. There are strict standards for humane killing, animal care, housing and health. 
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* BUAV: Undercover investigation exposes shocking animal cruelty and major failings by the UK government *

The BUAV, one of the worlds leading organisations campaigning to end animal experiments, has today revealed graphic disturbing evidence of the cruelty and suffering inflicted on thousands of animals every year in UK research; including for the first time, the appalling suffering inflicted on mice for the worldwide craze of using botox products to temporarily reduce facial lines and wrinkles.

The BUAV has also accused the Home Office, which regulates animal experiments in the UK, of breaking the law in several ways including not enforcing the use of non animal alternatives and failing to minimise the suffering inflicted on animals.

The BUAV placed an undercover worker in Wickham Laboratories in Hampshire for 8 months to the end of October 2009. She secretly filmed the appalling suffering inflicted on thousands of animals inside the facility. The laboratory carries out poisoning tests on thousands of mice every month for a product called Dysport ® (manufactured by Ipsen), which contains the deadly botulinum toxin. Botulinum toxin is licensed in the UK for some relatively rare medical conditions  and the Home Office claims it only allows the animal tests for these purposes - but is increasingly being used off-label in cosmetic clinics for purely cosmetic purposes where it is commonly referred to as botox.

In practice it is impossible for the Home Office to ensure that the Dysport ® tested at Wickham on an industrial scale does not end up in cosmetic clinics. The Government has banned animal testing for cosmetics since 1997.

The test used is the archaic poisoning test LD50 (lethal dose 50 - this is the dose at which 50% of the mice would be expected to die when injected with the toxin), one of the cruellest and most controversial tests carried out on animals. Even the Home Office classifies it as substantial severity.

Wickham also uses rabbits in pyrogenicity (fever) tests where a test substance is injected into an ear vein to detect contaminants. The rabbits are restrained by their necks in stocks with a temperature probe deep in their rectum for many hours at a time, with no access to water. According to the laboratory, damage to the ear and rectum can occur as well as damage to the rabbits backs from struggling in the stocks. Rabbits can be starved for up to 30 hours and are re-used repeatedly in further pyrogen tests, adding to their distress.

Key findings:

The UK government is failing in its legal obligation to enforce the use of the 3Rs (Replacement, Reduction and Refinement) principle for non-animal alternatives where they exist and to ensure that, if animals are used, then it should be the minimum number and with the minimum amount of suffering.

The appalling suffering inflicted on thousands of animals in cruel, crude and archaic tests. Animals kept in small, virtually barren cages that failed to meet their behavioural and social needs.

The total inadequacy of measures to intervene before death with the LD50 poisoning tests - far more animals died an agonizing death than were euthanased.

Mice crudely killed by having their necks broken on a corridor floor with a ball point pen. Some staff breaking the backs of mice rather than their necks resulting in excruciating additional suffering.

Some animals suffered in tests that are no longer required by national and international regulations. This destroys the often made claim that companies have to do animals tests because regulators require them.

A glaring conflict of interest by the statutory Named Veterinary Surgeon, responsible for advising on the animals welfare. He is a director of Wickham and with his wife owns virtually all the shares. Recorded weekly visits by him often lasted just for a few minutes.

Tests such as the LD50 test for botulinum toxin and the pyrogenicity test have valid in vitro alternatives and it is outrageous that they are not being implemented. The Limulus amoebocyte lysate assay (LAL) is an in vitro method that can often be used for detecting bacterial pyrogens and is recognized by regulatory authorities in both Europe and the USA as an alternative to the rabbit pyrogenicity test. Indeed, European guidelines stress the alternative is often more reliable..

The SNAP-25 assay, a method that does not use live animals but instead measures the activity of the toxin in a test tube, can be used to replace the botox mouse LD50 tests. The BUAV believes that under UK law this test should be used. Furthermore, this test has been validated by an official UK government laboratory, the National Institute for Biological Standards and Control (NIBSC), and has been used by them since 1999, specifically for Dysport ®. Inexplicably, the UK Home Office is not insisting on this test even after all these years.

BUAVs Director of Special Projects, Sarah Kite states: Time and time again the government and animal research community claim that animals are only used as a last resort for vital medical research and that animal suffering is kept to a minimum. This BUAV investigation has blown those claims wide open. Our shocking findings show that crude, archaic and extremely cruel animal tests are still allowed in the UK even when an alternative test exists and animal testing is not required by official bodies.

For further information, images and video footage, please contact: Sarah Kite

[email protected]

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