An Opinion on primate experiments published this week by the EU’s Scientific Committee on Health & Environmental Risks1 (SCHER) has been heavily criticised by the Dr Hadwen Trust for Humane Research. The charity says SCHER has failed to take account of scientific evidence of the limitations of primate research and downplayed the potential of advanced alternative techniques. The Dr Hadwen Trust2, says it may be an ‘uncomfortable truth’ for scientists, but some adult primates have mental abilities greater than human infants3 so an EU-wide strategy to replace them with alternative techniques is a matter of moral as well as scientific urgency.An Opinion by SCHER was requested by the European Commission as part of the long delayed revision of Directive 86/609/EEC, Europe’s animal experiments law. A proposal to revise the law was published on Nov 5 20084. The Commission has been under intense pressure to examine the ethical and scientific case for an EU phase-out of primate research and testing. In September 2007 the European Parliament overwhelmingly voted in support of a Written Declaration demanding an end to research on great apes and wild-caught primates and establishment of a timetable for replacing the use of all primates with ethical alternative research techniques5.
Emily McIvor, Policy Director at the Dr Hadwen Trust for Humane Research, says despite being asked to produce a scientifically balanced and accurate assessment, SCHER’s Opinion is flawed from the outset because it assumes the credibility of primate research without unbiased scientific scrutiny.
“SCHER’s Opinion could and should have been a turning point in Europe’s bioethics, mapping out what needs to be done to achieve primate-free laboratories.” says Ms McIvor, “Instead it lacks both the scientific scrutiny and the necessary vision to do anything other than maintain the status quo. Its blind acceptance of the validity of primate research in areas such as neurology, stroke and AIDS, despite clear evidence to the contrary, suggests a level of bias or inaccuracy that would simply be deemed unacceptable in other areas of scientific enquiry.”
The Dr Hadwen Trust is particularly disappointed by the Committee’s assessment of non-animal alternatives. Whilst SCHER does “recognises that there are promising developments that have replaced non-human primate use6“, its assessment of alternatives is short-sighted. Where current replacement gaps do exist and primate ‘models’ are clearly failing, SCHER could and should have called for urgent priority funding.
“Almost 10,500 primates are subjected to experiments in Europe every year, despite many of them having cognitive abilities comparable to human babies.” says Emily McIvor, “That may be an uncomfortable truth for some scientists, but that makes strategy to replace primates a matter of moral and scientific urgency. Advanced techniques like human brain imaging, computer modelling and human cell culture are already replacing primates with studies more relevant to human patients. With further technology development, total replacement is achievable but SCHER seems to have ignored that path to progress.”
Primate research: failed treatments and new hope
- AIDS: Over 25 years, at least 37 animal-tested HIV vaccines have failed in human trials. Rhesus macaque monkeys are the favoured, but unsuccessful, ‘model’ but these could be replaced with a combined approach – population studies, in vitro cellular infection models including the newly launched ‘human immune system in a test tube’, molecular biology and computer modelling.
- STROKE: Ninety-five stroke drugs have passed animal tests but failed in human clinical trials. For over 170 years primates have been used but failed to yield safe, effective new drugs for people. Population studies, brain imaging, post-mortem brain analysis and in vitro multi-cell cultures would provide more useful data relevant to human stroke.
- MALARIA: 350-500 million cases of malaria occur worldwide, and over one million people die from malaria each year. Vaccines developed and tested in primates have failed in humans. In vitro human liver cell cultures could soon replace primates in identifying vaccine candidates and screening anti-malarial drugs.
- BRAIN FUNCTION: Research into human psychological processes such as memory and depression can involve surgically implanting electrodes in, or removing parts of, the brains of primates. Advances in non-invasive imaging now provide a range of cutting edge imaging techniques, including the creation of temporary ‘virtual’ lesions in the human brain. With these more relevant techniques available, the use of primates is scientifically superseded as well as being ethically inappropriate.
- HEPATITIS C: Despite decades of animal-based research there is still no definitive cure or vaccine. Mathematical modelling has already benefited hepatitis C patients by elucidating the virus’s dynamics and improving drug treatment. Human cell cultures for research and drug screening for this illness have also led to major developments in this area.
1 The need for non-human primates in biomedical research, production and testing of products and devices, SCHER scher_o_110.pdf
2 The Dr Hadwen Trust is the UK’s leading non-animal medical research charity funding exclusively non-animal techniques to replace animal experiments, benefiting people and animals. www.drhadwentrust.org www.scienceroom.org
3 Comparison of human infants and rhesus monkeys on Piaget’s AB task: evidence for dependence on dorsolateral prefrontal cortex. Experimental Brain Research 74 (1989)
4 Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Draft proposal http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52008PC0543:EN:NOT
5 Written Declaration 40/2007 “Urges the Commission, the Council of Ministers and the European Parliament to use the revision process of Directive 86/609/EC as an opportunity to: i. Make ending the use of apes and wild caught monkeys in scientific experiments an urgent priority; ii. Establish a timetable for replacing the use of all primates in scientific experiments with alternatives.”
6 The need for non-human primates in biomedical research, production and testing of products and devices, SCHER, 3.2, p21.
In the EU, 10,451 primates were used in 2005; the vast majority (7,000) were used for toxicology studies, 1,450 are used for basic medical research including brain research and 1,400 are used for pharmaceutical R&D. In the USA, 62,315 primates were used in 2006. In Japan, an estimated 2,802 primates were used in 2004. In Great Britain, 3,125 primates were used in 2007.