Animal Justice Project Open Letter to Medicines and Healthcare products Regulatory Agency 24 April 2017
Dear Dr Hudson, Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA) I am contacting you following an article published April 16 2017 in The Sunday Times, entitled ‘Pig organ transplant to save babies’ lives’ [1]. According to the article, the treatment will be used next year by doctors at Great Ormond Street Hospital in London on children born with severe cases of oesophageal atresia. The idea behind the treatment is to transplant an oesophagus obtained from a genetically modified pig. Also, according to the article, ‘before the first patient can receive a transplant, the treatment must be approved by the Medicines & Healthcare Products Regulatory Agency (MHRA)’ [1]. Hence this letter to you as MHRA Chief Executive. The use of animals as spare parts for humans raises both ethical and public health concerns, in addition to possible legislative issues. Ethical Concerns Pigs are highly intelligent mammals and subjecting them to medical procedures involving genetic manipulation may have deleterious consequences on their well being. In addition, the housing of these highly social animals under restrictive laboratory conditions related to increased hygiene will consequently impact on their natural behaviour needs and likely result in increased levels of stress and boredom. This, in addition to routine laboratory procedures, such as blood sampling and clinical examinations, all of which are known to increase stress levels in animals [2].
Public Health Concerns The use of animals as spare parts for humans carries health risks for the recipient and possibly for the wider population as well. The oft quoted example of implanting a pig heart valve inside a human as proof of principle is disingenuous as the pig valve is essentially a piece of dead tissue, having been sterilised beforehand. In contrast, transplanting living animal tissue (e.g. a pig oesophagus) carries the risk of host rejection and the risk of disease transmission, in the form of known and unknown pig microorganisms (including prions).
Xenotransplantation continues to be proposed but has yet to fulfil its promise due to concerns over long-term stability, immune system rejection and zoonoses. Despite recent advances in genome editing for xenotransplantation, there are still many challenges to overcome before organ transplant from animals becomes a commonplace [3].
Legislative Issues Directive 2010/63/EU on the protection of animals used in scientific procedures requires animals to be replaced wherever possible by other means [4]. In particular, clause 39 of the Directive states:
"It is also essential, both on moral and scientific grounds, to ensure that each use of an animal is carefully evaluated as to the scientific or educational validity, usefulness and relevance of the expected result of that use. The likely harm to the animal should be balanced against the expected benefits of the project. Therefore, an impartial project evaluation independent of those involved in the study should be carried out as part of the authorisation process of projects involving the use of live animals. Effective implementation of a project evaluation should also allow for an appropriate assessment of the use of any new scientific experimental techniques as they emerge." In addition, Article 4 of the Directive states:
"Member States shall ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of a procedure."
Concluding Remarks and Recommendations There are clear ethical and public health reasons against using pigs as spare parts for the human population, in addition to legislative imperatives covered under Directive 2010/63/EU. At a time when 3D bioprinting of human tissue is available, in addition to other advanced tissue engineering technologies, it surely makes more sense to invest our resources into refining these promising human based methods, rather than taking a leap in the dark by creating genetically modified animal organs. Reconstructing a functional human oesophagus is a complex technical challenge. Let us not compound the challenge by adding animal suffering and public health risks. Finally, I wish to inform you that this letter will be made available in the form of an Open Letter in the public interest.
Kind regards
Andre Menache BSc(Hons) BVSc Dip ECAWBM (AWSEL) MRCVS Animal Justice Project Science Advisor www.animaljusticeproject.com
REFERENCES [1] www.thetimes.co.uk/article/pig-organ-transplant-to-save-babies-lives-nm0r2zznv [2] https://www.ncbi.nlm.nih.gov/pubmed/15669134 [3] https://fibrogenesis.biomedcentral.com/articles/10.1186/s13069-016-0040-6 [4] http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0063&from=EN