Allergan, a Botox producer in Ireland, have developed a non-animal alternative to the horrific and unreliable LD50 test on mice that is applied to each batch of Botox. Great news?!
For the LD50 test, groups of mice are injected with different doses of Botulinum toxin into the abdomen. Many of the mice suffer from paralysis, impaired vision and respiratory distress. After up to three or four days of suffering, if left, they die of suffocation. Undercover investigations by the BUAV reveal that, in practice, attempts by staff to intervene and kill the mice before they died this agonising death often fail, with many more mice dying from the effects of the toxin instead of being killed before that happens.
I’ve been providing policy advice to the Irish Anti-Vivisection Society, and we’ve discovered that, sadly, Allergan have not yet shared their humane testing technology, so other companies like Ipsen and Merz are still doing the LD50 test, as reported by the Irish Examiner on 5 September 2012. It seems like Allergan would rather force their competitors to spend money developing their own non-animal test, rather than share their technology.
Legislation says that animal tests must be replaced by non-animal alternatives where ‘reasonably and practically available’. In practice, this non-animal alternative is available in these terms to Ipsen and Merz, they just need to take action with Allergan’s cooperation. The public are given the impression that the animal testing industry and government bust a gut to save animals from unnecessary testing and that if alternatives are available they will be used instead of animals. This episode will shock the public when they see how commercial greed is allowed to take precedence and obstruct the sharing of lifesaving technologies (which also happen to be much better tests in terms of improving the safety of these products for humans), especially when a large proportion of these unnecessary animal tests are for cosmetic Botulinum products.
The Irish Government have been very complacent on this – though that seems to be standard practice for national governments generally. It is their legal and moral duty to bring Allergan and the other companies together to spare thousands of animals from unnecessary abuse.
I was very surprised to see a session at the Cheltenham Literature Festival on 10 October given over to naked, one-sided propaganda from a pharmaceutical industry-funded lobby group devoted to promoting painful and lethal experiments on animals – Understanding Animal Research.
For example, the synopsis implies that research has been moving away from animal experiments, when in fact a million more are being conducted every year in the UK compared to a decade ago. Moreover, their claim that animal research is boosting animal welfare – when it specifically involves the infliction of procedures that are likely to cause ‘pain, suffering, distress or lasting harm’ – is Orwellian doublespeak.
Indeed, it would appear that UAR have a deliberate policy of trying to conceal any pain and suffering involved in animal experiments. At a recent conference, a UAR spokesperson was candid enough to admit that when he gave school talks for UAR he didn’t bring up the central issue of the adverse effects endured by animals. This is important because polling data indicates that most people weigh up animal suffering against perceived potential benefits when deciding whether a particular animal experiment is acceptable. So evading the issue of animal suffering fundamentally distorts public understanding of animal research. Just like UAR’s vague spin about being reluctant to perform animal experiments (when their mission appears to be to defend animal experimentation in general as an institutionalised practice, come what may), the title of the organisation expresses an aspiration which, in my view, is diametrically opposed to their true intentions, particular in terms of their denial of the pain they inflict on animals. It seems like a tactic copied from the tobacco and fossil fuel industries in response to lung cancer and climate change respectively.
(I should say, I would love to be proved wrong and UAR start behaving in a more constructive and open manner, but I’m expecting any response to be snide and arrogant.)
It is unacceptable that no attempt has been made to encourage an informed, balanced debate on this issue of significant public interest. It’s a sad fact of life that any powerful lobby group, no matter how Machiavellian or unethical they are, will find it easy to gain a platform. But you would think that an event with pretensions to intellectual credibility would at least try to achieve balance? I’m not sure whether anyone is responsible for curating this festival or is it a case of who ever can afford to buy a slot can say what the hell they want?
But, then again, the related ‘Science’ Festival is sponsored by Pfizer, who have just had to pay out $60 million following bribery charges. In 2009, Pfizer had to pay out $2.3billion for mis-selling drugs. The whistleblower who exposed the fraud said: ‘At Pfizer, I was expected to increase profits at all costs, even when sales meant endangering lives.’ Yet law-abiding animal protection groups are the ones treated as pariahs while Pfizer’s PR budget seems to have a magical whitewashing effect for the festival organisers – or maybe they just aren’t bothered?
I’m currently finalising the manuscript for my new book, due to be published by Palgrave later this year, which will provide an unprecedented insight into animal experimentation and the myth of Britain’s ‘strict regulation’. It comes on the back of Uncaged’s publication of the leaked Imutran and Home Office documents which, among other things, showed clear breaches of ‘moderate’ severity limits when monkeys were ‘found dead’ or ‘in a collapsed state’.
Animals used in ‘moderate’ severity experiments are supposed to be put down before they suffer systemic illness or actually die as direct result of the ongoing experiment. Therefore, one would hope that researchers and the Home Office would admit that if an animal is ‘found dead’ because of the illness caused by the experiment, then their suffering exceeded the moderate severity limit. That’s if the regulatory system is meant to have any meaning at all.
Unfortunately, it turns out that such hope rests on the false assumption that the Home Office and the animal research industry are reasonably honest and law-abiding. Perhaps even more disturbing is the fact that bodies – such as the Ombudsman - who are meant to hold the Government to account, seem either too corrupt or too cowardly to do the right thing.
In December 2006, following a three year investigation hampered by staff absences* and, as explained below, an apparent difficulty in understanding the regulatory system, the Parliamentary and Health Service Ombudsman (PHSO or ‘Ombudsman’) laid before Parliament a final report that dismissed our complaint of maladministration in respect of the Home Office’s regulation of Imutran’s research. The term ‘whitewash’ doesn’t really do justice to the Ombudsman’s ruthless determination to give the Home Office a clean bill of health and discredit myself and Uncaged.
Uncaged’s complaint had argued that where procedures were allowed to continue until the point where the animals were found dead, instead of the animals being killed at or before the specified endpoint, then the endpoint and its corresponding moderate severity limit categorisation had been breached. In response, the Ombudsman stated:
‘In considering the explanations given by the Home Office, the Ombudsman’s staff have noted that death, in itself, does not appear to constitute a breach of the moderate severity limit within ‘The Guidance on the Operation of the Animals (Scientific Procedures) Act 1986′. This view is supported by the ‘Report of the cost-benefit working group of the APC’ which considered ‘The weight assigned to “death of an animal” in itself (i.e. in absence of suffering)’. Within that heading they weighed various arguments put forward on whether a humane death (that is one without suffering) should be included in the cost/benefit assessment. A number of indirect ‘harms’ were put forward, which could be caused by the death of an animal, and that might be considered within the cost/benefit assessment. The report observed, however, that ‘whilst these potential harms are important and should be considered within the cost-benefit assessment, they are not relevant to the question of whether death in itself is a harm’ (paragraph 13).
Where do you start? The basic problem was that the Ombudsman’s reasoning fundamentally misconstrued the complaint and the role of endpoints in limiting suffering. Uncaged’s complaint was not based on the argument that ‘death, in itself… constitute[s] a breach of the moderate severity limit’. Instead, the complaint was based on the fact that animals were allowed to suffer up until the point of death, i.e. that death was the de facto endpoint in some instances. Uncaged did not assert that ‘death in itself’ counted as harm in this regulatory context. On the contrary, we argued that the animals should have been killed earlier in the procedure in order to comply with the moderate severity limit. In reviewing their decision, the Ombudsman dismissed these submissions from Uncaged, claiming that they did not add to previous complaint submissions (despite the fact they were novel arguments in response the Ombudsman’s final report).
Concerns about the adequacy of the PHSO investigation were intensified by subsequent comments by the-then Ombudsman Ann Abraham to the House of Commons Public Administration Select Committee in February 2011:
We might [investigate], if there was a wider public interest. I am trying to think of an example that would help you, and most of the examples I can think of are where the wider public interest is in the possibility of the Ombudsman saying there was not maladministration. One of the cases we looked at some years ago was a complaint, again referred by many MPs and many complainants, about the regulation of the animal experimentation industry, and concerns that the regulation was not being carried out properly. There was a lot of outrage, a lot of concern, and a lot of distress about all this, and some very unhappy people. We did a very thorough investigation and we were satisfied that actually everything was being done reasonably, in accordance with the requirements of the regulatory regime. We produced a public report to say that. Now actually the wider public interest was in the Government Department concerned being able to say “The Ombudsman has looked at this, and this is being done properly.” So there are lots of circumstances in which we would say that it is worth us doing this.
However, given the basic error at the heart of the Ombudsman’s exoneration of the Home Office and their repeated refusal to take Uncaged’s submissions seriously, these comments raise questions regarding at what point in the investigation did the Ombudsman decide there was a public interest in maintaining confidence in public institutions?
Relevant to this concern is the Ombudsman’s position on the issue of severity limit breaches in their draft decision letter issued on 4 May 2005, which differs markedly from their final report:
7. When considering complaints concerning decisions that are reliant on professional judgements, The Ombudsman would not normally seek to substitute her judgment for that of relevant expert. You will appreciate that there are many such decisions within this case, and this confines our legitimate interest to the overall process governing this area.
13. Whilst there would appear to be an element of subjectivity involved in the assessment of severity decisions about what severity limit to apply to the various procedures were a matter for the Inspectorate’s professional judgement and expertise. I do not see any basis upon which this Office could seek to question their assessment of the position (paragraph 7). In the light of that, and as I can see no evidence of administrative fault by the Home Office in their handling of this matter, I can see no grounds for the Ombudsman’s further intervention in the matter.
It is hard to reconcile the PHSO’s original decision to sidestep the issue of severity limits because it was deemed beyond their competency, with the subsequent assertion that they ‘did a very thorough investigation’ and were able to legitimately claim ‘The Ombudsman has looked at this and this is being done properly’. When considered in conjunction with the Ombudsman’s misrepresentation of the difference between the harm caused by ‘death-in–itself’ compared with ‘death–as-an-endpoint’ in the final report, it is hard to avoid the conclusion that the Ombudsman’s motivation for exonerating the Home Office had little to do with the facts of the case.
Rather it appears to confirm in stark terms the infallibility syndrome infecting the Westminster Village and the tribal loyalty exhibited by elite groups against justice and the interests of ordinary people.
*The PHSO’s draft decision letter dated 4 May 2005 stated: ‘[T]he investigation of the complaint has been interrupted on more than one occasion by illness, which has meant that the case has had to be considered by several different officers, which has led to significant delays’ (paragraph 2).
The UK Government’s implementation of a new EU Directive on animal experimentation threatens to weaken our already inadequate regulations. One area of acute public concern has been the question of whether experiments on stray/feral animals – including lost or stolen pets – will be permitted under the new regime. The answer to that depends heavily on the current rules, as the Directive allows countries to keep stricter existing measures, while hindering them from unilaterally passing new rules stricter than the Directive.
The Government is now desperately trying to give the impression that stray/lost pets will not be subjected to experiments, but is refusing to actually ban the practice. So what is going on?
Yesterday, Home Office Minister Lynne Featherstone issued a statement to the House of Commons which claimed that current UK legislation did not prohibit experiments on stray animals, and therefore the Government would have to ‘copy-out’ the relevant Article of the Directive into UK law. However, the Government could not ‘envisage’ allowing such tests and so there would be ‘effective prohibition’. A Home Office email to animal protection groups has sought to reassure us and they seem suspiciously keen to move on from this issue!
At first glance this all seems reasonable, until you compare this with previous Government statements. The problem is, Featherstone’s statement contradicts the interpretation stated in paragraph 64 of the Home Office June 2011 Consultation Document, which asserted:
“This [Article 11] is a relaxation of the provisions of Directive 86/609/EC under which their use was prohibited. ASPA 10(3)(a) and (b) implements this prohibition through its requirement under Schedule 2 for animals of relevant species to be purpose bred and limitations regarding the use of wild animals.
Question: Is there a case on animal welfare gounds for retaining the current UK prohibition on the use of stray and feral animals, as permitted by Article 2?”
Given the Home Office’s equivocation on this issue – and in the absence of a clear explanation as to why the position has shifted – it is difficult to be confident about where the Government really stands.
If the Government sincerely wishes to ban the practice, why surreptitiously move the goalposts to give the impression that a ban can’t be implemented? The Home Office’s Consultation response (p.17, Article 11) last month gives a clue. It reveals that there was ‘limited support from the bioscience user sector for transposing Article 11 unchanged’.
So it appears that the Government has caved into demands by a small proportion of animal researchers to open the door to experiments on abandoned/stray dogs and cats, snubbing the call from just about everyone else (including many involved in animal research) to maintain the complete ban on such experiments.
There is a widespread and powerful commitment within the animal research sector to maximising their freedom to experiment on animals, by keeping the door open to all categories of experiment ‘just in case’ they want to perform them in the future, even if they and the Home Office can’t envisage it at the moment. Given stray animals are used in other developed countries such as the USA and Australia, UK animal protection groups are right to be wary of meaningless ‘intentions’ from a Home Office and their industry masters who are, in reality, facilitating such experiments rather than opposing them.
Yesterday (27 March 2012) the House of Commons had a half-hour ‘Westminster Hall’ debate about the implications of the new EU Directive on animal experiments which the Home Office is currently transposing into UK law. Six key factors were discussed:
- Will there be sufficient Parliamentary scrutiny of the Government’s draft legislation?
- Will there be legal protection for Great Apes?
- Will the Government define the term ‘debilitating clinical condition’, which the Directive says are the only conditions that might permit primate experimentation?
- Will the Government ensure reasonable transparency on animal experiments and their regulation?
- Will current licensing and inspection levels be maintained?
- Will current institutional ethical review processes be protected?
Nic Dakin, the Labour MP for Scunthorpe and Chairperson of the all-party FRAME group, opened the debate by raising concerns that the Government was seriously curtailing Parliamentary scrutiny, despite the enormous level of public interest in the new law. He then went on to highlight the Government’s reluctance to legally enshrine the long-standing administrative ban on experiments on Great Apes as a illustration of the Government’s willingness to lower UK regulations to those in the new Directive. The fact that experiments on Great Apes in the UK are to all intents and purposes practically impossible makes the Government’s desire to leave the door open to such practices all the more disturbing.
But in actual fact, this conforms to a deeply-entrenched pattern I’ve discovered in this area of Government regulation: the interests of the research industry – no matter how tenuous or self-serving – are almost always allowed to trump animal welfare. Indeed, it is this deeply biased approach to balancing animal protection and researchers’ goals – proven by evidence leaked from behind the wall of secrecy surrounding animal research – that fatally undermines the empty mantra that the UK has a world-leading strict and effective regulatory system.
I’ve been informed in no uncertain terms by an official from another EU country that the Home Office – acting on behalf of animal research interests – sees the transposition process as an opportunity to weaken UK regulation. In reality then, it is a case of a terrible situation getting even worse. Meanwhile, the Home Office has indicated its aim that no current research should be prohibited once the new Directive comes into force (see, for example, paragraph 52 of the Home Office Consultation Document). This exposes the professed commitment to the 3Rs as yet another PR-inspired sham.
One of the main problems is that animal research interest groups love the image of ‘strict regulation’ as a means of public manipulation, but abhor the reality. For example, while publicly expressing vague concern for animal welfare, behind the scenes they have lobbied to ensure that the legal restrictions on severe and prolonged pain are interpreted in a feeble way that will allow them to inflict such agony on animals, in pain research for example (see page 3 of this industry briefing, under heading ‘Upper threshold restriction’).
If animal research interests perceive that a regulation may constrain them, they and the Government (who basically act as their agents) always place the burden of proof on animal protection. Yet, providing unequivocal quantitative proof of animal welfare benefits of, say, larger cages, is intrinsically very difficult because these things are, by their very nature, hard to measure. As Dakin argued, the burden of proof should instead be placed on the research industry to prove that plausible measures to show a little mercy to animals would not actually work. Unfortunately, that would require reversing the power structure in animal research regulation that has enshrined industry domination since 1882.
In response the stand-in Minister, Damian Green, gave scant reassurance. On the question of sufficient time for parliamentary scrutiny, he merely expressed his ‘hope’ that would happen, which tends to be government-speak for ‘we would really like you to think we support the concept of Parliamentary scrutiny, but we’re not really bothered’. I hope I’m proved wrong, but don’t be surprised if the Government publishes the draft legislation as a last minute fait accompli. Green also said that the ‘best possible standards’ would be safeguarded. ‘Possible’ here is entirely subjective and, in reality, what the Government means is ‘whatever industry will tolerate’.
Green continued by asserting the ‘vital role’ of animal experimentation in health care and safety testing, without acknowledging the serious problems (or admitting any slight difficulties, for that matter) with translating animal research data into human beings, or the various studies demonstrating that most animal experiments do not lead to medical benefits (see here and paras 4.2.5, 4.3.5 of the Bateson review of primate experimentation). This rhetoric – standard Government fare for many years – confirms that they do not regard unnecessary cruelty to animals as anything intrinsically undesirable (and animal welfare isn’t directly incorporated into the Government’s Impact Assessment of the new law). It’s also a nice example of ‘the infallibility syndrome‘ that infects Government. As they have always given the impression that they are perfect regulators, they must therefore reject any suggestions for improvement – especially from the animal protection/democratic perspective.
Green also referred in passing to the Government’s two key policy pledges when they came into power – ending household product testing on animals and working to reduce the numbers of animal experiments. In fact the Government has already backed away from both promises.
The Minister let the deregulatory cat out of the bag when he professed a desire to rely on ‘good practice’ rather than legislation. Yet given every undercover investigation reveals a cavalier attitude to animal welfare and the law on the part of animal testers, the Government’s reluctance to give welfare protection legal backing indicates a worrying disregard for millions of vulnerable animals.
Another manifestation of the drive to undermine regulation was the intention not to define the term ‘debilitating clinical condition’ that would set new tougher limits on primate experimentation, in preference for a ‘case-by-case’ approach. This is another classic ploy with a long tradition in this field. By not pre-defining this key rule, it allows researchers much greater leeway to decide themselves (rubber-stamped by the Inspectorate) what experiments they want to perform, for whatever trivial or incoherent purpose, free from serious public concerns about painful experiments on primates.
The Minister did (sort of) promise that there would be a ban on Great Ape experimentation in the legislation, and indicated that the Government had changed its mind and now intended not to implement some controversial methods of killing permitted by the Directive, such as clubbing the heads of new-born puppies and kittens. While any positive steps are to be welcomed, in these cases the Government is merely reversing a previous intention to weaken current practice.
The Minister had nothing substantive to say to the issue of transparency. The obvious approach would be to rely on the Freedom of Information Act which incorporates protection on grounds of personal safety and commercial confidentiality. The fact that the Government still won’t commit to this approach suggests they are intending to maintain as much secrecy as they can get away with.
So, apart from the possible exception of Great Apes, the Government was unwilling to give a clear positive answer to the key concerns in the debate, reflecting this cosy policy clique’s attitude to animal protection and independent regulation for 130 years.
Just reading a fascinating paper by Dr Katy Wilkinson (Newcastle University) and colleagues on the politics of the Foot and Mouth outbreak in 2001. It shows how the National Farmers Union (NFU) largely dictated the Government response – led by the infamous Ministry for Agriculture, Fisheries and Food (MAFF) – to the FMD outbreak. Among other demands, the NFU called for countryside footpaths be closed, despite there being evidence from previous FMD events showing the walking public had no role in spreading the disease. I get the sense this deflected attention and blame from the farming industry. As a result, other sectors of the rural economy were unnecessarily decimated: between 2001–2005 it caused estimated £355 million loss to farming, compared with a staggering £2.1 billion loss to tourism.
The NFU vigorously opposed vaccination in favour of the mass slaughter of animals, the vast majority of which were not infected. This stance seems to have been motivated partly by financial considerations – it would be quicker to resume exports to Europe if culling was used. But there also seems to be a kneejerk reaction to simply kill animals whenever a problem arises.
I’m reading this on the day the Government has signalled a return to the bad old days of MAFF with an extremely farmer-centric rural policy which, as history tells us (remember BSE as well?), could have catastrophic consequences for other parts of the rural economy, animal welfare and public health. The FMD fiasco has chilling echoes of the current NFU/Govt determination to slaughter badgers in the face of contrary scientific evidence.
However, there is one passage in the paper which very succinctly expresses the massive political problems faced by animal protection groups, which I think we must take heed of. Indeed, it reflects the thinking behind the formation of our new think tank and policy research organisation, the IASJ.
“The tactics employed by the NFU over the previous two decades in responding to the pressure from environmental groups critical of intensive agricultural practices demonstrate such anticipation and reaction. As Smith suggests, the NFU has capitalized on the poor resource base of many environmental groups which subsequently renders them unable to concentrate their efforts on a single issue for a long period of time; as a result, farmers need only resist pressure for a finite period of time before the pressure group and media spotlights turn elsewhere (1990a, p. 193).”
Wilkinson K. et al, (2010) ‘Beyond Policy Networks: Policy Framing and the Politics of Expertise in the 2001 Foot and Mouth Disease Crisis’. Public Administration Vol 88 pp331-345.
Smith, M.J. (1990a). The Politics of Agricultural Support in Britain: The Development of the Agricultural Policy Community. Aldershot: Dartmouth.
A recent statement by Home Office Minister Lynne Featherstone reveals that a staggering 9908 out of 9908 animal research licence applications were approved by the Home Office between 2008 and 2010. These include:
- personal licences authorising an individual to perform specific procedures on animals
- project licences – the most important – which specifically authorise a programme of experiments
- certificates of designation that authorise an establishment to be a location for animal experiments
The Minister claims that pre-application advice (a traditional Home Office line in relation to their high approval rates) effectively weeds out weak applications. But as I explain below, this cannot really account for this extraordinary phenomenon, as in practice Inspectors don’t have a great deal of time for pre-application discussion, so there’s no way on earth it could so effective. (I don’t think any pre-application advice process could be that effective!)
A look at Inspectorate resources provides clues to this 100% approval rate.
Pages 6 and 7 of the 2010 Inspectorate report is revealing. It refers to the Inspectorate providing advice on 44 project licence pre-applications that were not proceeded with. It doesn’t say why they were not proceeded with – so presumably not all were halted due to advice of likely refusal. Also, it doesn’t say how many pre-applications were advised upon in total.
Each Inspector (or full-time equivalent FTE) deals with an average of 394.5 licence applications and amendments per year. The Home Office states that a third of their time is spent on all licensing (personal, project and establishment) so that’s about 78 days per year – about 5 licence applications/amendments per day. The Home Office say project licence assessment is the most time consuming, so we’ll estimate half of licensing time is spent on project licences. These normally last 5 years and, I deduce from current figures, involve an average of 1354 animals per year (6771 over entire project). So these are major research projects, often involving several separate studies and the licence is supposed to provide lots of detail about scientific justification, likely adverse effects that the animals will suffer, and likely results/benefits to accrue. See here for some example – check out ND1 for instance. All this is supposed to be required so Inspectors can check the scientific validity, check if there are non-animal alternatives and conduct a cost-benefit assessment.
The Inspectorate report states each inspector dealt with 22.7 project licence applications and 72.5 licence amendments per year (this doesn’t include pre-application advice as they don’t provide a figure). If half their licensing time – 39 days – is spent on project licences, then on average they each approve about 2.44 applications/amendments per day. This equates to 3303 animals per day. Obviously they will spend more time on initial applications than amendments, but at best they are going to spend about a day and a half on each project licence application. In practice that will almost always be insufficient to thoroughly scrutinise them.
Coupled with targets for turning around licence applications within 35 days (which seems to be the Inspectorate’s principle goal) and the shared professional background of most Inspectors and researchers, and it’s easy to see why the licensing system is essentially a rubber-stamping exercise.