A recent post over at Adventures in Ethics and Science points to a rather fascinating anti-animal research screed by a cancer patient. This individual, after having taken advantage of a gignormous amount of animal research in the course of treatment is now regretful:
I have full-blown leukemia and the chemotherapy I'm taking doesn't seem to be working all that well. And even if it does kick into high gear soon, it's not a cure, only a brief delay of the disease's progression. One way or another, my odds aren't good.
-snip, reorder for clarity-
Throughout the past six years, I have felt terribly guilty about the drugs and procedures I've undergone because I know that so many animals have suffered in their development.
Still, I keep popping pills each morning and night, sitting for many hours each week with an IV in my arm, dealing with all the side-effects of treatment, hoping for a miracle. Some people may call me a hypocrite -- to take advantage of the benefits of animal research. Let me explain.
The "explanation" boils down to an argument that because animal research has not as yet provided a good cure for what ails the author, and because many things that may initially appear promising in animal models fail to work under clinical conditions in humans, this is evidence that we should not use animal models at all. The logic and ethical arguments are about equally tortured and there are many other bloggers who do a better job on this sort of nonsense. While we are awaiting some respectful insolence or whatnot [Update: didn't have to wait long; Orac notes that the author was previously Communications director for the PCRM ARA group] , I did have one thing I noticed that requires dissection.
On this one particular issue Janet Stemwedel booted the response* (just a bit) and that motivated this post. The regretful cancer patient stated:
...federal regulations are extremely weak and poorly enforced, and some species -- mice, for example -- are completely excluded from any protection.
This is an utter falsehood.
I had a couple of prior posts which outlined the fact that animal research in the US is indeed an activity that is highly regulated by the US Federal government. In that post I touched on the issue that is at the root of the above mentioned scurrilous distortion (which is very likely to be an outright lie).
I should note that "birds, rats...mice" were excluded from the provisions of the Act in 2002 via the "Helms Amendment". This most certainly does not mean that research on these species is not regulated and in fact the vast majority of the policies and procedures I will be discussing apply to these species as well because of regulation.
The claim that mice are "excluded from any protection" is presumably based on the Helms Amendment. It is indeed true that rats, mice and birds that are bred for research are excluded from the obligatory parts of federal law...but this does not mean that there are not other protections and oversight mechanisms in place that apply to these species. There are in fact many, some of the more important of which are detailed below.
In my initial series, I went on to introduce the local regulatory structure, the Institutional Animal Care and Use Committee, and pointed out the independent role of two necessary members of such committees. Admittedly I didn't get into the specifics of it but there is one very important concept for today's new item. Individual PI's have to have local IACUC protocol approval for each and every study they conduct with rats, mice and pigeons. There may be some slight differences in the way IACUC's deal with USDA-covered species and non-covered species but these are not substantive, especially when addressing the claim of "no protections". The essential elements in terms of defending the use of a species, justifying the numbers of animals to be used, the procedures, the refinements to minimize distress, the descriptions of housing/husbandry, etc...all of this has to be dealt with for rats, mice and pigeons.
The NIH Guide
I also described in a prior post that there are several established sets of guidelines for the treatment of laboratory animals that have come to have a power that approaches that of USDA regulation. The NIH Guide for the Care and Use of Laboratory Animals is one such set of guidelines, and a highly important one. Many journals with which I am familiar require a statement that the research has been conducted in a manner consistent with the NIH Guide prior to acceptance, for example. The Guide most assuredly covers the Helms Amendment species; in some cases the regulations are tighter in comparison with those for the USDA-covered species. It makes sense. For example, a mouse or rat has less tolerance for food, water, ambient temperature and/or humidity variation than does a larger bodied mammal such as a dog, monkey or even a rabbit.
The NIH Office of Laboratory Animal Welfare
Much of biomedical research which uses mice, rats or even pigeons is funded by the NIH and consequently local institutions must keep themselves on the right side of OLAW, lest they lose or fail to receive NIH grants. All NIH grants. Think about that. The contingencies are enormous, even if keeping in good standing with OLAW is not exactly a federal obligation (since there is no requirement under law to hold NIH funding). As you can tell from reading over the site, they promulgate law, policy, procedure and education on the appropriate use of laboratory animals and have investigatory powers to determine local institutional compliance. On the education and policy side, I'll draw your attention to two sets of research guidelines similar to the NIH Guide but with a more focused application- OLAW has the actual pdf's linked.
- National Academies Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research
- Recognition and Alleviation of Distress in Laboratory Animals
You will note that the Helms Amendment species are covered extensively in the activities of the OLAW. Again, it is the case that mice fall under appropriate oversight and protections when used in laboratory research. Suggestions that they do not are made out of willing ignorance, intentional malice or both.
Next we come to the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.
More than 770 companies, universities, hospitals, government agencies and other research institutions in 29 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC's program, in addition to complying with the local, state and federal laws that regulate animal research.
Although there are institutions which shun paying AAALAC for accreditation, most of the big research universities with which I am familiar do so. I see this on the facilities and/or Vertebrate Animals sections of grants all the time, which provides additional evidence. It has become a widely accepted (and therefore employed) seal of approval. In essence the body ensures that the local institution is using their laboratory animals in a manner consistent with a set of standards, most notably those described in the NIH Guide. They focus on animal care and use policies /responsibilities, the animal environment, housing and management, the veterinary medical care and the physical plant. In this process, the AAALAC deals with facilities for, and treatment of, rats, mice and pigeons just as it does for the USDA species.
The accreditation applies to an entire institution, so a University cannot, say, have accreditation for the USDA-species building and not for the Helms-Amendment-species building. It is a package deal and IME institutions take their accreditation very seriously. Heck, even for-profit contract research organizations (CROs) are starting to apply for, and receive, AAALAC approval because it gives them a competitive advantage. Therefore this process is another way in which the research species excepted by the Helms Amendment receive oversight and regulation for their use in research.
Now it isn't like the AAALAC does anything special on the ground. The standards that they promulgate and require for accreditation are sensible, modern, based on the NIH Guide and any institution can be using such standards regardless of certification. The important thing is that AAALAC is an independent body which has loyalty more to their brand (the accreditation) and to the collective pool of accredited institutions, than they do to any one local institution. Therefore, the certification should be viewed seriously and as an independent testimonial that an entire institution is committed to good laboratory practices.
Wrapping up there are other standards and guidelines that are promulgated for various uses. Standards established by professional societies of laboratory veterinarians are one such category. There may be other books or publications that have come to have the force of semi-official policy. One consistent theme is that the exception for rats, mice and pigeons that is represented by the Helms Amendment is essentially irrelevant when it comes to these other mechanisms for regulating the use of laboratory animals in research. Within these mechanisms, although exact standards vary by species as is appropriate, there is no evidence that particular mammalian species are somehow fair game for any-old, whenever-whatever research as has been suggested by the above linked article from the hypocritical cancer patient. None whatsoever. Assertions to the contrary are scurrilous lies.
*This reads to me as a tacit admission that the statement was correct. It is not.
Next, there is the question of whether the federal regulations are too weak. I'm guessing that most of Chaitowitz's readers at HuffPo have never read those regulations (for which you can find links here) and thus have no way to assess their strength or weakness. That mice are not covered species does not, however, mean that they are treated more cruelly in labs than they are in kitchens and basements where they are poisoned, stuck on sticky-traps, or gravely wounded by snap-traps.