Brothers and Cousins

Statistics of the animal research done in Britain during 2016 have now been published. They show a decrease of about 5% or 206,000 in the annual total of ‘procedures’ (down, but not very far down, to 3.94 million). The Home Office press release announcing the statistics was headed with that notable news – notable not so much because the achievement is very great (after all, the 2015 figure had been the highest number of ‘procedures’ ever recorded), but because it represents only the second time in about fifteen years that the numbers have not gone up. And the total in 2016 is still larger than it was in 1986, when the present Animals (Scientific Procedures) Act was introduced with the aim and expectation (for a time actually realised) of pushing the numbers steadily down.

Now is a good moment to recall that aim, because the European Union’s Directive 2010/63, which has been co-ordinating the laws on animal research in all 28 member states, is about to be revised. Although the U.K. will probably not belong to the Union by the time any revisions come into effect, its own practice will certainly be influenced by them. In fact, because science is an internationally collaborative business, published in international journals, the rules and standards established in the Union are certain to have some influence in all countries where animals are used in research.

Article 58 of the Directive requires the European Commission (the E.U.’s executive) to “review” its contents no later than 10 November 2017. In doing so, the Commission must take into account “advancements in the development of alternative methods not entailing the use of animals, in particular of non-human primates”. Specifying OU primateprimates in this way, the Directive’s authors no doubt had in mind a ‘declaration’ which the European Parliament had adopted back in 2007, urging the Commission “to establish a timetable for replacing the use of all primates in scientific experiments with alternatives”. Anyway, by way of limbering up for the review, the Commission asked one of its advisory committees, the Science Committee on Health, Environmental and Emerging Risks (SCHEER), to set up a Working Group to study and report on “the need for non-human primates in biomedical research, production and testing of products and devices”. Under this same title, with its ready-made implication that such a need really does exist, SCHEER accordingly published its conclusions (formally an ‘Opinion’) a few weeks ago. These conclusions, on such an especially controversial aspect of animal research, may be taken as indicative of what animals have to hope for from the coming review.

We’re deep inside the E.U. machine here: a working group reporting to a standing committee commissioned to advise the executive on the revision of a parliamentary directive setting the parameters for (and here we at last come out into the open) actual laws in the 28 member states. And the advice itself frequently does have a machine-generated feel to it, of truth made out of words rather than real things, and all the more conveniently incontrovertible for that. “It is indeed important to consider the limitations of the NHP when choosing which species to use in a drug-safety test: the use of an appropriate species or combination of species/models is essential to obtaining the most reliable and translatable information.”[p.63] Has anything been said here that isn’t necessarily true? Is anyone arguing, for instance, that an inappropriate species would produce more reliable information? This key word ‘appropriate’, with its built-in wisdom, is much used in the authors’ proposals: “appropriate training”“appropriate standards”, and of course “appropriate use of NHPs”.

Another such passe-partout word is ‘robust’: the authors variously recommend “robust scrutiny”, “robust peer review procedures”, “robust study design”, and so on. One wonders why scientists hadn’t thought of the great merits of robustness before. Anyway, everything will surely be better in this robust and appropriate new world.

But not very much better. Distinctly this is a technical account of the subject: how to make things as they are work properly (the machine again). There are some good suggestions to that end, certainly. For instance the authors recognize, as one of the barriers to progress in animal-free research, the weight of professional habit and institutionalized practice; they advise that training courses for animal researchers should include “non-animal technologies”, so that transition is easier and more acceptable [p.64]. Also I must concede that, for all the tautologies and self-evident truths, there’s a 12-page bibliography to back up what the committee says. But the rationale for all this attention, why it matters whether there’s a ‘need’ for NHPs in science or not – in short, the morality of it – is almost untouched. Two pages (out of 66 in the main text) make a hurried tour of the topic, though it is of course alluded to from time to time elsewhere. But then all members of the Working Group were scientists. Accordingly, the page headed ‘Minority Opinion’, which looks rather promising with the whole of page 23 to itself in the table of contents, proves, when one reaches it, to be blank, apart from the word “None”.

The committee recognises, as a political fact, that “polls of the European public repeatedly show low levels of acceptance of the use of NHPs in research” [p.24]. Approval for the use of NHPs in the U.K., for instance, was about 17% when last canvassed (see, in this blog, ‘Animal Pains and Human Attitudes: the new Ipsos Mori survey’, 26 September 2016). However, there is at least “greater acceptance of animal research where animal use and suffering are minimised in line with the 3Rs principle” [i.e. Replacement, Reduction, Refinement: p.25]. This is no doubt true, although it’s a somewhat disingenuous way of putting things: where acceptance has not been ‘great’ in the first place, it shouldn’t really be said to become “greater”. And I suspect that approval would actually have been even lower if the respondents had known, as this SCHEER report records, that nearly three quarters of ‘procedures’ conducted on NHPs in the E.U. are for “regulatory use and routine production” [p.15].

What these quotations illustrate is how the “3Rs principle” is seen by scientists as a sort of ethical machine labouring away to turn expediency into good conduct, rather as the “invisible hand” of the free market was supposed by Adam Smith to convert self-interested actions into social good. In this capacity, it’s expected to satisfy or at least placate opponents of animal research. That it does not do so, and that the whole managerial attitude to “ethical considerations” understates their seriousness, is evident in the consultation document which is published alongside the SCHEER report (but which came before it in time, of course).

I must say that this 234-page consultation document is conspicuous proof at least of the diligence and fair-mindedness of the committee, which here records in the left-hand column, and replies to in the right, hundreds of queries and comments. It wasn’t in the committee’s remit to deal with ethics except as a general premise, but at least the moral passion is now allowed printed expression in raw, ungentrified form: “cruel”, “inhuman”, “abhorrent”, “nearest cousins”, “brothers”, “freedom”. True, the committee makes little attempt to address this sort of complaint (there being plenty of other more strictly scientific representations). “Stop this insane abuse!!” says one contribution (well yes, two exclamation marks, but then, as the great Aneurin Bevan used to say, “In public life, those who would change things must shout to be heard”). To such, the committee can only reply with a slightly pompous set formula: “This is a personal opinion. The comment does not provide any suggestions for improvements of the scientific basis of the SCHEER preliminary Opinion and/or any scientific evidence.” Still, such remonstrations, earnest and unscientific, are at least recorded here. Thank you to those who did speak up with this authentic human indignation.

When it issued its previous ‘opinion’ on animal research, just prior to the making of the 2010 Directive, this same science committee was called SCHER. The second ‘E’, recently added, stands for ‘emerging’, and refers to novel or reappearing infectious diseases. It’s an ominous alteration for NHPs, because this is one of the areas of research in which the committee, so far from sketching out a diminution in their use, foresees an increase. NHPs, so SCHEER claims, “provide essential models for understanding and combatting (re)emerging infectious pathogens.” Thus, for recent research into whooping cough, “a new baboon model was developed” [p.47]. That rather euphemistic phrase actually means that research was conducted, for the first time, on juvenile baboons (from two to six months old): the opposite of the 3Rs, then. SCHEER justifies such retrogressions by speaking of “realistic dangers” [p.47]. Danger, which might properly be seen as a test and validation of our ethics, is evidently expected to frighten them away. And after all, even the great apes (gorillas, chimpanzees, orangutans, bonobos), whom the E.U. Directive in principle protects absolutely from scientific exploitation, may be used “in relation to an unexpected outbreak of a life-threatening or debilitating clinical condition in human beings” [Article 55.2].

So, shall a timetable be drawn up for ending the use of NHPs in European research, as the E.U. Parliament was dreaming ten years ago? SCHEER’s 12,000 word answer resembles the one being given in a famous Saul Steinberg cartoon from 1961. A well-fed manager of some sort, comfortably leaning back at his desk, addresses a petitioner with a mass of words, illegible but obviously full of patronizing civilities and bureaucratic reassurances. The words coalesce, above the petitioner’s head, into a giant ‘NO’.

 

Notes and references:

The 2016 statistics can be viewed here:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/627284/annual-statistics-scientific-procedures-living-animals-2016.pdf

These new statistics record about 3,600 procedures using NHPs. The SCHEER report uses the all-E.U. figure of 8898, which was the total in 2014. Note that the Home Office numbers don’t include Northern Ireland: i.e. they cover animal research in Great Britain rather than the U.K.

The 2007 Declaration of the European Parliament on primates in scientific experiments is published online at http://ec.europa.eu/environment/chemicals/lab_animals/pdf/fische_suite.pdf

The SCHEER report is at https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/scheer_o_004.pdf

The results of the public consultation are published at https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/followup_cons_primates_en.pdf

Aneurin Bevan is quoted in Michael Foot, Loyalists and Loners, Collins, 1987, p.36. Among other political achievements, Bevan was the Minister of Health from 1945 to 1951, therefore the man responsible for establishing the U.K.’s National Health Service.

The photograph is of a rhesus macaque monkey in Oxford University’s Biomedical Sciences Building, and is used here by permission of the University’s Public Affairs Office.

 

 

 

 

Home Office statistics: numbers, words, and euphemisms

The Home Office has now published its statistical report on the animal research done in Great Britain (i.e. omitting Northern Ireland) during 2015. It shows that 4.14 million ‘procedures’ were completed last year. This is the largest number ever recorded under the 1986 Act, and tends to confirm that the promising drop in the numbers during 2014 (3.87 million) was the result of under-reporting in that year, rather than a sudden change of direction. The new system had just been introduced, whereby the research projects are counted when they finish rather than when they begin, and not everyone seems to have understood it. So the Home Office advises that the new figures should be compared with 2013 rather than 2014 (for VERO’s comment on the 2014 figures, see http://www.vero.org.uk/events.asp.). In that case, there has been a slight increase of 1% or 21 thousand in these ‘procedures’. This in turn means that the real numbers have been rising in every year since 2001, except 2009, which came after a notable jump the year before. During this whole period, the numbers have increased by about 58%.

This new Home Office report makes an exhaustive summary of every countable aspect of the nation’s work as vivisector in 2015. Its own two-page précis can be found at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/538556/scientific-procedures-living-animals-2015snr.pdf. There are other useful and more critical summaries to be found on the web-sites of the Fund for the Replacement of Animals in Medical Experiments and Cruelty Free International. These notice, for instance, the rise in numbers of primates used in research (from 3,220 to 3,600), and the continuing use of dogs in toxicology studies, one of the most unpleasant areas of research. There’s also a review on the web-site of Understanding Animal Research, which is the promotional arm of the animal research industry. At the end of it the Chief Executive, Dr Wendy Jarrett, is quoted as saying “today’s statistics will help people to find out more about the reality of animal research in the 21st century.”

Yes, on the face of it the statistics ought to help in that way, but I doubt that they will help much. Quite apart from the varying interpretations which statistics notoriously allow, they address a part of the mind (the numerate) which is completely unrelated to the part where ethics or empathy live. What can one feel about this great torrent of numbers? It’s a crowd scene with no foreground. Every now and then, a detail will catch the dazzled attention. For instance, under the category ‘regulatory testing’ (p.49), the astonishing fact emerges that the LD50 and LC50 tests (= the Lethal Dose or Lethal Concentration that kills 50% of the test animals) are still in use. These true products of the mind as computer, giving a specious accuracy to toxicology tests at the cost of human decency, accounted for 8898 animals in 2015 (mice, rats, and fish).

Nearby, now that one’s eye is adjusted to such detail, it seems that something very like the Draize test (listed as “eye irritation/corrosion”) also survives: 173 rabbits went that way. But what: only 173? In most of the categories, that number would simply have disappeared in the ‘rounding down’ of untidy decimals (see User Guide to Annual Statistics, pp.9-10). On the other hand, you’d certainly hate to see the test done to a rabbit you knew, and you’d be quite properly liable to prosecution for cruelty if you did it yourself. And by the way, that’s a useful reminder that the Home Office is wrong to define the Animals (Scientific Procedures) Act in its preamble as “an animal protection measure” (p.5): the Act is also, and much more successfully, an animal-user’s protection measure.

Anyway, such details as the ones mentioned are generally invisible in the glare of the huge numbers. The whole dazzling parade of facts, so competently put together by the Home Office’s statisticians, is therefore a kind of euphemism, tending as much to hide as to show the “reality of animal research in the 21st century”.

A rather more informative source, and a necessary complement to the Annual Statistics, are the ‘non-technical summaries’ of proposed research which the Home Office also publishes (at https://www.gov.uk/government/policies/animal-research-and-testing). There you can see the research in detail, admittedly as presented by its partisans, but in the format required by the Home Office, with answers to questions about purpose, method, the 3Rs, and so on. The animals appear in more comprehensible numbers (150 pigs, 200 chickens), and their kind is more accurately identified (crows, rainbow trout, opossums, voles). What happens to them is more or less picturable, and the scene can be bloody and squalid, even where no suffering is involved: “In parallel to in vivo experiments, we will also carry out in vitro experiments using sheep uteri and ovaries collected from an abattoir” [God, what have we become?]. You get some idea of how scientists may have judged the pain levels which are later to be recorded in the statistics: “The expected adverse effects are the development of skin wounds, inflammation and cancer. In most cases the severity will be mild. However, in some situations, such as tumour development, the severity will be moderate.” [Excellent! Cancer is evidently not as bad as we feared.]

And now, with these and other Home Office publications about animal research to hand, you begin to realize that the word ‘procedure’, the key word in the Animals (Scientific Procedures) Act (ASPA) and the one on which you have to rely if the statistics are to make any sense, is itself a euphemism. Having myself been misled by this word, I shall try to show what’s wrong with it.

For the purposes of the Act, a “regulated procedure” is defined (see the User Guide, p.10) as “any procedure applied to a protected animal for an experimental or other scientific purpose, or for any educational purpose, that may have the effect of causing an animal pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.” The breeding of a genetically altered (GA) animal is quite properly counted as one such procedure under the Act, and we’re told in the 2-page summary that about half of those 4.14 million procedures “related to the creation/breeding of genetically altered animals that were not used in further procedures.” That seems to make good sense. The breeding would be one procedure. Those GA animals for whom that turned out not to be a sufficient contribution to science would become part of other (“further”) procedures, counted as such.

But in fact we know that this isn’t what’s being done. It would mean that there’d be many more procedures than animals in the total count, whereas we’re specifically told that the two numbers are always more or less the same, and that in the rare cases where the number of procedures is higher than the number of animals used “this is due to a re-use of animals” (User Guide, p.9). ‘Re-use’ is a term always meaning ‘used in a different project of research’, which is actually by no means a common practice. And for this purpose, GA breeding apparently doesn’t count as a different project. So the real situation is this: animals which have undergone the GA procedure, and are then used in “further procedures”, still count for only one procedure each.

All right, but even apart from the GA question, ‘procedure’ has a very elastic meaning, which seems to include its own plural. It may just mean an injection, such as the one which is the model for what minimally constitutes a regulated procedure as defined in the Act. On the other hand, it can mean a whole “series of regulated procedures”: that’s the phrase which the Home Office Use, Keeping Alive, and Re-use Advice Note (p.9) uses when reviewing the experience of an animal during one research project, and advising on its suitability for ‘re-use’. The User Guide explains (also p.9): “Each procedure (which may consist of several stages) for a given purpose on an animal is counted as one returnable procedure.” ‘Procedure’, it emerges, is a collective noun, but what exactly it may have collected in any particular instance there’s no way at all of discovering from the statistics.

I don’t know whether I’ve been able to make things clear; probably not, because this key-word in ASPA is not used clearly and consistently even in the official documentation. To summarise, then. A ‘procedure’ is an animal’s whole career of procedures within one research project. If it’s a GA animal, that career will include the procedure which brought it into being, and may or may not include others. In short ‘procedure’ is a term so elastic as to be almost meaningless. The number 4.14 million, therefore, really means 4.14 million multiplied by an unknowable n.

This ambiguity must affect every aspect of the published statistics. For instance, the rule for deciding the painfulness or severity of a ‘procedure’ is that it should be put in the severest of the four classes (sub-threshold, mild, moderate, or severe) which it reaches at any point during the research. But you will see that the meaning of a severity class is itself obscured by the vagueness of the term ‘procedure’. A procedure classed as ‘severe’ may have been a brief torment constituting the whole of an animal’s part in modern science, or it may have entailed that ‘severe’ pain together with a succession of other ‘severe’ or ‘moderate’ or ‘mild’ interventions covering the full period of a research project. It makes a great difference to our understanding and (lest we forget) to the animal concerned, but the difference cannot be indicated in the Home Office statistics.

It’s no wonder, now I come to think of it, that Understanding Animal Research has been content to present the Home Office statistics on its web-site as the “reality” of animal research. In truth, they’re a mixture of understatement, euphemism, and unintelligibility. Despite all the varieties of show and tell that the animal research industry now agrees to, the essential secrecy remains. And I should say that outsiders will never really know what’s going on until we get the number of ‘procedures’ down to nought.

 

References:

For Oxford University’s part in the 2015 numbers, see ‘Multitudes, multitudes’ in this blog (posted 24 April).

The Home Office’s Annual Statistics of Scientific Procedures on Living Animals, Great Britain 2015 can be seen at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/537708/scientific-procedures-living-animals-2015.pdf 

Its User Guide to Annual Statistics of Scientific Procedures on Living Animals  is at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/538549/guide-animal-procedures.pdf

Use, Keeping Alive and Re-use (dated October 2015) is at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/470008/Use__Keeping_Alive_and_Re-use_Advice_Note.pdf .

Other references are to be found on the relevant web-sites.