Press release: Home Office report welcomed

The Home Office report has taken a year to compile and has been independently reviewed. Most of the allegations made by BUAV have not been substantiated. Importantly, in the case of the testing of botulinum toxin, the Home Office has found: “There is no evidence that there has been testing of cosmetic products or ingredients. All testing of botulinum containing products undertaken at Wickham Laboratories is in support of medicinal products…” (p5) The business of Wickham Labs is to help ensure the safety of products and medicines for the public. The use of animals is only a small part of such testing, and the company is proud of its high animal welfare standards (see attached briefing). The Home Office report has also confirmed that the animal testing carried out by Wickham Labs is entirely legitimate; (“the licence authorities granted to individuals at Wickham laboratories under the Animals (Scientific Procedures) Act 1986 were legitimately requested and appropriately assessed”.) (p6) The company accepts a number of recommendations made by the Home Office to improve practices and techniques. As part of its programme of continuing review and improvement Wickham Labs has already addressed many of the issues in the report through improved practices. In other cases, further clarification of international test guidelines is required. Chris Bishop, who has overall responsibility for animal care at Wickham Labs, said: “Wickham Labs is granted licences by the Home Office to use animals because of the vital importance of ensuring that products are safe for the public and for patients. We have taken seriously the issues raised in this report. Over the last year, we have improved our practices and we constantly strive to improve the care of our animals. We are proud of the contribution we make to the world around us and paramount to this is the welfare and care of our research animals”. Notes to editors In October 2009 a 50 page report was published by the British Union for the Abolition of Vivisection (BUAV) into the conduct of work at Wickham Laboratories. In November 2010 a Home Office report in response has published 12 key findings (points A to L on pages 4, 5 and 6). In eight out of these 12 key findings the allegations from BUAV were not substantiated (stated explicitly for points A, B, E, K and implicitly for points F, G, H, L). For some of these findings, however, room for improvement was suggested, and this is accepted by Wickham Labs. In four out of the 12 key findings, problems were identified. Not substantiated A. Use of LD50 test for botulinum toxin testing BUAV claimed that the LD50 test should not be allowed because alternatives exist. But the Home Office points out that the development and validation of alternatives "has not yet been completed". (p27) B. Licensing of rabbit pyrogenicity tests BUAV raised a similar concern about rabbit pyrogenicity tests. The Home Office view is that "the conduct of rabbit pyrogen testing at Wickham Laboratories is in support of the requirements of regulatory authorities for specific medicinal products". (p29) E. Licensing of death as an endpoint BUAV questioned the accuracy of answers to written Parliamentary Questions on the licensing of death as an endpoint in toxicity testing. The Home Office simply points out that "the authorised endpoint is appropriate observation and intervention by humane euthanasia”. (p5) F. Questioning of whether botulinum products are used for cosmetic purposes The Home Office found that "all testing of botulinum containing products undertaken at Wickham Laboratories is in support of medicinal products… there is no evidence that there has been testing of cosmetic products or ingredients”. (p5) G. Staff attitudes towards animal welfare The Home Office found that "the prevailing attitude of staff is one of appropriate care". H. Adequacy of Home Office inspections The Home Office considers that the 25 visits of inspection over a five-year period was a level of oversight “considered appropriate for an establishment of this size”. (p5) K. Staff practising injections The allegations that inexperienced staff were practising injections on live mice was “not substantiated” by the Home Office. (p6) L. Quality of housing and access to water The Home Office did not agree with concerns, and confirmed that “all housing and environmental conditions reviewed during the period were in compliance with accepted codes of practice”. (p6) Problems identified C. Humane endpoints for mouse bioassay A humane endpoint is the earliest indicator in an animal procedure of pain or suffering, at which stage the study can be stopped. The BUAV claimed that the tests were running for too long, and should be stopped earlier (by killing the animals). The Home Office seems to agree and believes "this may have caused additional unnecessary suffering to protected animals". (p4) This test does rely on professional judgment and the skill and competence of staff. It is impossible to eradicate suffering, but efforts are made to improve the mouse observations in an attempt to reduce it. D. Poor practice in methods of killing mice BUAV objected to the way animals were killed through breaking their necks on the floor in the corridor (cervical dislocation), and through exposure to carbon dioxide. Wickham Labs accepts the Home Office finding that killing of mice is "inconsistent, at times incompetent and requires improvement". (p47) Changes have been made already. I. Areas for improvement Wickham Labs has already accepted that there were "a number of areas for improvement at the establishment". Many of these areas have been addressed internally already. J. Position, performance and independence of NVS Wickham Labs recognises the possible external perception of a conflict of interest with respect to the roles of the Named Veterinary Surgeon (NVS). The NVS undertakes regular weekly inspections and the records for each animal show a good level of health. However, the company has added the further support this year of a veterinary consultant specialising in laboratory animal work to review procedures and offer staff support. Notes for editors Wickham Laboratories Limited was founded in 1964 by veterinary surgeon William Cartmell. Today the laboratory has grown to a turnover of £4.5 million. Wickham Labs carries out contract testing and analysis. Its primary business is to test products for safety, including pharmaceuticals, medical devices, animal feed, human food and other consumer items. Wickham Labs will typically test over 100,000 product samples every year. Less than 1% of the tests use animals (approximately 900 tests), in all cases because it is a legal or regulatory requirement for toxicology (safety). The company is committed to applying the principles of reduction, refinement and replacement (the 3Rs) and the numbers of animals used in tests have fallen by 50% since the early 1990s. Most of the work is carried out in mice but rabbits, guinea pigs and rats are also used. The work of Wickham Labs is highly specialised and technical. The company provides employment for more than 90 people. It has a well-established culture of care when it comes to looking after the animals on the site, and is regularly checked by Home Office inspectors. For further information on Wickham Laboratories please visit https://wickhamlabs.co.uk/Home.aspx High quality images of laboratory animals are available from the Understanding Animal Research image library at; http://www.understandinganimalresearch.org.uk/resources/images_library/category/18/mice/Wickham Laboratories today welcomed the report from the Home Office into issues raised following an infiltration by an animal rights group in 2009 (the British Union for the Abolition of Vivisection (BUAV)). The Home Office report has taken a year to compile and has been independently reviewed. Most of the allegations made by BUAV have not been substantiated. Importantly, in the case of the testing of botulinum toxin, the Home Office has found: “There is no evidence that there has been testing of cosmetic products or ingredients. All testing of botulinum containing products undertaken at Wickham Laboratories is in support of medicinal products…” (p5) The business of Wickham Labs is to help ensure the safety of products and medicines for the public. The use of animals is only a small part of such testing, and the company is proud of its high animal welfare standards (see attached briefing). The Home Office report has also confirmed that the animal testing carried out by Wickham Labs is entirely legitimate; (“the licence authorities granted to individuals at Wickham laboratories under the Animals (Scientific Procedures) Act 1986 were legitimately requested and appropriately assessed”.) (p6) The company accepts a number of recommendations made by the Home Office to improve practices and techniques. As part of its programme of continuing review and improvement Wickham Labs has already addressed many of the issues in the report through improved practices. In other cases, further clarification of international test guidelines is required. Chris Bishop, who has overall responsibility for animal care at Wickham Labs, said: “Wickham Labs is granted licences by the Home Office to use animals because of the vital importance of ensuring that products are safe for the public and for patients. We have taken seriously the issues raised in this report. Over the last year, we have improved our practices and we constantly strive to improve the care of our animals. We are proud of the contribution we make to the world around us and paramount to this is the welfare and care of our research animals”. Notes to editors In October 2009 a 50 page report was published by the British Union for the Abolition of Vivisection (BUAV) into the conduct of work at Wickham Laboratories. In November 2010 a Home Office report in response has published 12 key findings (points A to L on pages 4, 5 and 6). In eight out of these 12 key findings the allegations from BUAV were not substantiated (stated explicitly for points A, B, E, K and implicitly for points F, G, H, L). For some of these findings, however, room for improvement was suggested, and this is accepted by Wickham Labs. In four out of the 12 key findings, problems were identified. Not substantiated A. Use of LD50 test for botulinum toxin testing BUAV claimed that the LD50 test should not be allowed because alternatives exist. But the Home Office points out that the development and validation of alternatives "has not yet been completed". (p27) B. Licensing of rabbit pyrogenicity tests BUAV raised a similar concern about rabbit pyrogenicity tests. The Home Office view is that "the conduct of rabbit pyrogen testing at Wickham Laboratories is in support of the requirements of regulatory authorities for specific medicinal products". (p29) E. Licensing of death as an endpoint BUAV questioned the accuracy of answers to written Parliamentary Questions on the licensing of death as an endpoint in toxicity testing. The Home Office simply points out that "the authorised endpoint is appropriate observation and intervention by humane euthanasia”. (p5) F. Questioning of whether botulinum products are used for cosmetic purposes The Home Office found that "all testing of botulinum containing products undertaken at Wickham Laboratories is in support of medicinal products… there is no evidence that there has been testing of cosmetic products or ingredients”. (p5) G. Staff attitudes towards animal welfare The Home Office found that "the prevailing attitude of staff is one of appropriate care". H. Adequacy of Home Office inspections The Home Office considers that the 25 visits of inspection over a five-year period was a level of oversight “considered appropriate for an establishment of this size”. (p5) K. Staff practising injections The allegations that inexperienced staff were practising injections on live mice was “not substantiated” by the Home Office. (p6) L. Quality of housing and access to water The Home Office did not agree with concerns, and confirmed that “all housing and environmental conditions reviewed during the period were in compliance with accepted codes of practice”. (p6) Problems identified C. Humane endpoints for mouse bioassay A humane endpoint is the earliest indicator in an animal procedure of pain or suffering, at which stage the study can be stopped. The BUAV claimed that the tests were running for too long, and should be stopped earlier (by killing the animals). The Home Office seems to agree and believes "this may have caused additional unnecessary suffering to protected animals". (p4) This test does rely on professional judgment and the skill and competence of staff. It is impossible to eradicate suffering, but efforts are made to improve the mouse observations in an attempt to reduce it. D. Poor practice in methods of killing mice BUAV objected to the way animals were killed through breaking their necks on the floor in the corridor (cervical dislocation), and through exposure to carbon dioxide. Wickham Labs accepts the Home Office finding that killing of mice is "inconsistent, at times incompetent and requires improvement". (p47) Changes have been made already. I. Areas for improvement Wickham Labs has already accepted that there were "a number of areas for improvement at the establishment". Many of these areas have been addressed internally already. J. Position, performance and independence of NVS Wickham Labs recognises the possible external perception of a conflict of interest with respect to the roles of the Named Veterinary Surgeon (NVS). The NVS undertakes regular weekly inspections and the records for each animal show a good level of health. However, the company has added the further support this year of a veterinary consultant specialising in laboratory animal work to review procedures and offer staff support. Notes for editors Wickham Laboratories Limited was founded in 1964 by veterinary surgeon William Cartmell. Today the laboratory has grown to a turnover of £4.5 million. Wickham Labs carries out contract testing and analysis. Its primary business is to test products for safety, including pharmaceuticals, medical devices, animal feed, human food and other consumer items. Wickham Labs will typically test over 100,000 product samples every year. Less than 1% of the tests use animals (approximately 900 tests), in all cases because it is a legal or regulatory requirement for toxicology (safety). The company is committed to applying the principles of reduction, refinement and replacement (the 3Rs) and the numbers of animals used in tests have fallen by 50% since the early 1990s. Most of the work is carried out in mice but rabbits, guinea pigs and rats are also used. The work of Wickham Labs is highly specialised and technical. The company provides employment for more than 90 people. It has a well-established culture of care when it comes to looking after the animals on the site, and is regularly checked by Home Office inspectors. For further information on Wickham Laboratories please visit https://wickhammicro.co.uk/ High quality images of laboratory animals are available from the Understanding Animal Research image library at; http://www.understandinganimalresearch.org.uk/resources/images_library/category/18/mice/