Tuesday, December 28, 2010

Why Animal Experimenters Should Be Vegetarians

By Joel Marks, Professor Emeritus of Philosophy at the University of New Haven and a Bioethics Center Scholar at Yale University.

When antivivisectionists protest the use of animals in biomedical research, they are commonly met with retorts like this:

“Our faculty members employ animals only when there are no alternative models for advancing their research; our laboratories comply with or exceed all federal regulations and independent accreditation standards. As we continue to advance modern medicine, and provide hope for millions of patients and their families, [our] scientists will sustain their commitment to the humane use of animals in research.” (Yale University press release, July 13, 2010.)

This press release is in line with the so-called 3Rs – replacement (of animals with nonanimal alternatives), reduction (in the number of animals used when their use is deemed essential), and refinement (in the treatment of animals so as to minimize their pain and distress) – the standard of animal research since the 1950s. Nevertheless, it is possible to question whether the use of animals in laboratories may not have been or at least no longer is crucial to medical advances. And even if it is, it does not automatically follow that it should be done or is even morally permissible.

Why not? Simply consider the human analogue. It would no doubt be even more useful to use human beings for the same sorts of medical research that animals are used for; after all, what could be a better “model” for human disease than a human being? But the contemporary consensus is that that would be unconscionable. But then utility, even to the point of “necessity” (for example, to find the cure for cancer as quickly as possible), does not by itself justify laboratory research on a sentient being.

But let us suppose that animal research were both useful for medical progress and morally permissible due to some relevant distinction between human and other animals. Apparently this is what the medical community itself believes, judging by its support for animal research. What I want to argue now is that it would follow that medical researchers should be vegetarians.
Much more ...

Sunday, December 26, 2010

The ABCs of Opinion

Robert Streiffer rightly argues that attributing beliefs to people based on their actions may lead one to false conclusions about their beliefs.
[I]f you are attributing beliefs to people on the basis of their actions, rather than on what they say their beliefs are, it must be kept in mind that the actions in question are not the product of people’s beliefs about the moral status of NHPs taken in isolation. Rather, the actions are the product of (a) their beliefs about the moral status of NHPs, taken in conjunction with (b) their beliefs about the harms of research and (c) their beliefs about the value of the research.
His comment was in response to my claim that those conducting harmful experiments on monkeys or those approving the research – as Streiffer does in his role as an ACUC member – must believe that monkeys have almost no moral status and that even a researcher’s whim is sufficient justification for using monkeys or other animals in ways certain to harm them.

Streiffer strongly denied that he holds such a position. My perception and explanation for why he and others support experiments on monkeys must therefore, he seems to imply, be erroneous.

Helpfully, Streiffer identified three key factors that may influence the opinions of those who engage in or otherwise support primate experimentation (and by extension, the use of all animals):

(a) their beliefs about the moral status of NHPs [nonhuman primates] taken in conjunction with
(b) their beliefs about the harms of research and
(c) their beliefs about the value of the research.

Strieffer seems to be arguing albeit implicitly that words should have precedent over actions when trying to divine a person’s actual beliefs. He has in the past pointed to the language in the regulations governing the use of some animals in some research that appear on the surface to imply some ethical weighing. In actual fact, ethical weighing occurs rarely in research using animals but is overt and required in research using humans. See my essay "The Ethics Underpinning Oversight" November 28, 2010.

People’s actual, operational beliefs about the moral status of monkeys (or any other belief, it seems to me) can be determined or gleaned much more accurately by their actions in settings that give them an option of behaving one way or another. No matter what someone claims, their actions are telling. No matter how honest one claims to be, if he or she repeatedly engages in fraud, theft, plagiarism, lying, etc., claims of honesty will ring hollow.

It is common to hear from the industry that those using animals “respect” them and consider it a “privilege” to use them and wish there was some other way. But how would researchers at a university or elsewhere behave if they genuinely respected the animals they used? At a minimum, it seems reasonable to expect that surgical suites would be kept clean, yet UW-Madison has been cited recently by the USDA for not keeping such facilities clean.

People’s operational, as opposed to their stated beliefs about the moral status of animals can be surmised by observing their actions. In circumstances where one’s beliefs could be expected to guide one’s behavior, that behavior will be a more accurate measure of a person’s beliefs than their public claims.

Streiffer seems to imply that in most instances researchers may believe that the harms to the monkeys and other animals are not very great. But if this is true then they must be ignorant of the use of monkeys on the whole because even monkeys not used in an experiment suffer from chronic diarrhea and signs of confinement-induced stereotypic behavior (pacing, spinning, odd postures, over-grooming, etc) and self-mutilation. Just keeping monkeys in the typical laboratory setting is clearly and demonstrably harmful to them. See for instance Stereotypic and self-injurious behavior in rhesus macaques: a survey and retrospective analysis of environment and early experience. Lutz C, Well A, Novak M. American Journal of Primatology. 2003.

But maybe they actually do recognize that the harm is great, which I believe even a casual observer would recognize. If the harm is great, it appears that only Streiffer’s third point could salvage his claim that vivisectors don’t consider the monkeys used to have a very low moral status:(c) their beliefs about the value of the research.

Presumably, if they believe the research has low value, then we are back to the conclusion that they must not have much moral concern for the monkeys’ lives and experiences. So Streiffer must be arguing that the researchers and those who approve their work believe that the research has high value. (It certainly has high monetary value to the researchers and even greater monetary value to the university, but I take it that he is thinking in terms of benefit to human society and those suffering or who will in the future suffer from some malady that might be ameliorated through the knowledge gained during the experiments.)

The industry and its shills are wont to claim that essentially every advance in healthcare is the result of experiments on animals and moreover, research using animals is a veritable fount of new treatments and cures.

A more sober look at the history of medicine and public health coupled with the current concern over the woeful lack of results (benefiting actual patients) from basic research suggests something much different.

A friend recently asked me for a good citation for my observation that sanitation and providing clean water are far and away the most significant advances in public health, ever. I hadn’t made quite this bold of a statement, but I am now confident in doing so.

At the time, I referred him to Roy Porter, The Greatest Benefit to Mankind, 1997. Norton. 426-427 passim, which I quote here:
Interpretations of the retreat first of epidemic diseases, and also of the increase in life expectancy, have been hotly debated. Some maintain the mass of the population was slowly but surely becoming less pauperized, and was enjoying better nourishment and hence improved health. Others argue that improving health was not due to rising prosperity but to better environmental salubrity due to public health measures, reducing the disease risks to which the hungry huddled masses were exposed.

Historians have distinguished between the retreats of epidemics in the eighteenth century and of endemic diseases in the nineteenth. Since plague was probably halted by the cordon sanitaire along the Habsburg border with the Ottoman empire, public health measures (‘medical police’) probably contributed to the reduction of epidemics. Smallpox vaccination from the early nineteenth century served to make epidemics less severe and frequent. The decline of plague and smallpox would thus have nothing to do with nutrition standards but some link with public health action. Endemic diseases such as tuberculosis and infant diarrhoea, by contrast, do seem to have been made more sever by under-nutrition. The reduction in such diseases might be linked to wage improvements. In either case little that personal physicians did was reflected in improved health.

Did public health measures actually do any good? The distinguished epidemiologist Thomas McKeown (1912 – 1988) maintained that reductions in deaths associated with infectious diseases (air-, water-, and food-borne diseases) cannot have been brought about by medical advances, since such diseases were declining long before effective means were available to combat them. Applying much the same argument to sanitary measures, McKeown concluded that resistance to infectious disease must have increased through improvement in nutrition. Overall he mapped out three phases: a rising standard of living from about 1770; sanitation measures from 1870; and better therapy during the twentieth century.

McKeown, however, underestimated the effectiveness of the public health movement. Changing public opinion, the labors of medical officers of health, the creation of filtered water supplies and sewage systems, slum clearance, the work of activists promoting the gospel of cleanliness, and myriad other often minor changes – for example the provision of dustbins with lids, to repel flies – combined to create an improving urban environment.
Porter’s observations are compelling to me, but I wasn’t fully satisfied that he presented the facts in a way that would lead an uncritical reader to the same conclusion as mine. As a consequence, I began reading a little more about the history of public health.

George Rosen’s 1958 A History of Public Health is a classic in the field. It was reprinted in an expanded edition by The Johns Hopkins University Press in 1993. With the expanded and helpful bibliographies (there are two) it is just over 500 pages in length. For those with an interest in this area of study, I recommend it; I have many pages marked and passages starred.

The introduction is written by Elizabeth Fee, Ph.D., Chief of the History of Medicine Division, National Library of Medicine, NIH. In her introduction, she too mentions Thomas McKeown:
Rosen also asks whether the new scientific methods bore any relation to the actual decline in infectious diseases. This question was also to be addressed, and answered largely in the negative, in Thomas McKeown’s enormously influential book, The Modern Rise of Population, (1976.)
This citation first led me to Thomas McKeown and R. G. Record’s “Reasons for the Decline of Mortality in England and Wales During the Nineteenth Century.” Population Studies, Vol. 16, No. 2. (1962), pp. 94-122 which is an earlier less detailed account of McKeown’s thesis and includes some graphical data not in the later work. His thesis is more fully developed and a few potential errors corrected in The Modern Rise of Population.

McKeown’s work is not without its critics. Interestingly, and germane to the discussion here though, is the nature of the controversy. See for instance: The McKeown Thesis: A Historical Controversy and Its Enduring Influence. James Colgrove. American Journal of Public Health. 2002:
The consensus among most historians about the McKeown thesis a quarter century after it first stirred controversy is that one narrow aspect of it was correct—that curative medical measures played little role in mortality decline prior to the mid-20th century...

The ongoing interest in McKeown's ideas, not only among historians but also among policymakers addressing contemporary issues, is striking. What accounts for his work's remarkable durability? Why has the influence of the McKeown thesis persisted even after its conclusions were discredited? In part, his writing continues to generate responses because many scholars believe that although McKeown's analysis was flawed, his underlying ideas regarding the effects of poverty and economic well-being on health were essentially correct. More broadly, McKeown's influence has continued to be felt because his research posed a fundamental question that has lost none of its relevance in the decades since he began writing in the post–World War II era: Are public health ends better served by narrow interventions focused at the level of the individual or the community, or by broad measures to redistribute the social, political, and economic resources that exert such a profound influence on health status at the population level?

... Far from fading in prominence, the questions he raised have assumed new salience at the beginning of the 21st century, especially in debates about how best to confront health threats such as AIDS, tuberculosis, and malaria in the developing world. For example, commenting on the recent initiative to provide AIDS drugs in poor nations, a health activist based in Nepal summed up the 2 sides of this debate when he noted, “There has been an overemphasis . . . [on] drugs. The lack of drinking water is a much bigger priority in most countries than anti-retroviral treatments.”
McKeown argued that the dramatic decline in the death rate was due to the decline in mortality from infectious disease. On this point, there is wide agreement. The controversy arose because McKeown argued steadfastly that the largest share of this decline was unrelated to the work of the sanitary movement, but rather due to the decline in tuberculosis which he argued was the number one cause of death from infectious disease and that the decline was due largely to the improvement in diet.

The controversy is of absolutely no consequence to the well respected broadly acknowledged fact that there was a dramatic drop in the death rate from infectious disease prior to any accurate understanding of the cause of these diseases or effective treatments. Thus, experiments on animals played absolutely no role in the most dramatic drop in death rate in human history.

Readers of this blog will know that I am a fan of charts and graphs, and The Modern Rise of Population is full of them. Below is one that demonstrates the decline in deaths from whooping cough (Pertussis)

Keep in mind that the pro-vivisection organizations argue that essentially all medical progress is due to animal experimentation, and whooping cough is no exception. (Just google whooping cough animal research.) The whooping cough example has implications for the larger question at hand, namely the actual opinions of vivisectors vs their claimed opinions. I will come back to this below.In the meantime, consider the dramatic decline in mortality that occurred in the nineteenth century prior to any meaningful medical therapy or prophylaxis, or even knowledge of microorganisms, as a sort of bookend to the history of modern public health advancement, at the other end, is the modern critique of the basic research enterprise.

This second bookend is comprised of recent scientific papers and articles in the popular press such as:

Lies, Damned Lies, and Medical Science. David H. Friedman. Atlantic Monthly. 2010.

Where Are the Cures? Sharon Begley. Newsweek. 2008.

Comparison of treatment effects between animal experiments and clinical trials: systematic review. Perel P, Roberts I, Sena E, Wheble P, Briscoe C, Sandercock P, Macleod M, Mignini LE, Jayaram P, Khan KS. BMJ. 2007.

Translation of Research Evidence From Animals to Humans. Daniel G. Hackam, Donald A. Redelmeier, 2006, JAMA.

Why Most Published Research Findings Are False. John P. A. Ioannidis. PLoS Med. 2005.

Where is the evidence that animal research benefits humans? Pound P, Ebrahim S, Sandercock P, Bracken MB, Roberts I. BMJ.

Does animal experimentation inform human healthcare? Observations from a systematic review of international animal experiments on fluid resuscitation. Roberts I, Kwan I, Evans P & Haig S. BMJ 2002.

At one end of this tableau is the largest decline in mortality in human history - in the absence of animal research, and at the other end, the promised benefits of the modern basic (animal) research paradigm are apparently lacking.

Between these bookends lies the entirety of modern medical research. I am not implying here that no benefit has resulted from the use of animals. For instance, Robert Koch’s 1879 paper on the etiology or cause of infectious disease was based on his work with animals. While his work resulted in no immediate advance in treatment, it did explain the phenomenal results and gave more authority and impetus to the hygienic/sanitation movement’s efforts.

The point in calling attention to the dramatic progress that occurred prior to Koch is that it demonstrates the real and significant progress that is possible without the use of animals. This severely undermines claims that animal experimentation is necessary. The growing body of systematic reviews and reports questioning the overall results of basic research implies that the value of the research that is taking place is suspect.

This takes us back to Streiffer’s third point: That researchers and their supporters’ beliefs about the moral status of NHPs must be considered in conjunction with (c) their beliefs about the value of the research.

It seems to me that an informed unbiased observer would have to seriously question the value of research with monkeys (or any animals) in light of the history of public health and the crisis the basic research enterprise is facing. Claiming that the value of the research is high seems unreasonable and unsupportable.

Look again at the graph depicting the decline in deaths from whooping cough.

I believe that if there were no vaccine for whooping cough, that research using animals would be underway today in the effort to produce one. This is a hypothetical situation, but given the small number of people afflicted with some of the maladies being studied today, I think it is a reasonable assumption.

If it is, then we can look at the graph as a sort of measure of the actual sympathy and moral concern those who propose, approve, and engage in animal experimentation actually hold for the animals they use.

By the time the vaccine was generally available, the mortality rate had already collapsed. Yet someone asking for permission to use monkeys to develop a vaccine today, assuming there wasn't one, would – without any doubt – be given the go-ahead, even though the disease is no longer a major threat. That is, even a relatively insignificant gain would be deemed adequate justification to infect and kill monkeys.

If you think this is an unreasonable assumption, consider the very limited importance and value of UW-Madison primate vivisector Richard Wiendruch’s caloric restriction studies.

In summary, Robert Streiffer accurately I think observed that when attributing beliefs [about the moral status of monkeys] to people on the basis of their actions, rather than on what they say their beliefs are, it must be kept in mind that the actions in question are not the product of people’s beliefs about the moral status of NHPs taken in isolation. Rather, the actions are the product of (a) their beliefs about the moral status of NHPs, taken in conjunction with (b) their beliefs about the harms of research and (c) their beliefs about the value of the research.

Given the very real demonstrable harms and the information available regarding the questionable value of the research, it is fair and likely accurate to surmise that those using monkeys and approving their use have very little actual sympathy or moral concern for them, in spite of public pronouncements to the contrary.

Friday, December 24, 2010

"Animal usage is not a moral or ethical issue."

In the discussion under my post "The Structure of Cognition," Robert Streiffer asked for some examples of people who have explicitly endorsed the view that I claim is the operative norm within the animal research industry: animals (more specifically monkeys) do not warrant much moral concern from us.

One well-known example is the recently deceased primate head transplantation researcher (and one-time bioscience advisor to the Pope) Robert J. White, who wrote: “Animal usage is not a moral or ethical issue, and elevating the problem of animal rights to such a plane is a disservice to medical research and the farm and dairy industry.” (Hastings Center Report, 1990, Vol. 20, November-December, p 43.)

And then there is Stuart W.G. Derbyshire:
Those of us who research on animals or support that research have made a moral choice to put humans first. We should behave and argue with a conviction that is worthy of the choice. Animal experimentation is a positive activity that advances our appreciation of nature and disease, and defending animal research should be part of a moral campaign that celebrates human knowledge and understanding. Simultaneously advocating animal research while trying to apologize and introduce alternatives is a poor defense of animal experimentation. Successful promotion of animal research can only begin when we withdraw support for the three Rs. "Time to Abandon the Three Rs." The Scientist-Magazine of the Life Sciences. 2006.
And also from Derbyshire, this gem -- that seems to me to characterize an unspoken widely-held position of those within the industry (based on their actions):
In contrast to ourselves, animal behaviour is mechanical, driven by the dictates of nature and immune to the processes of reflective cognition that we take for granted. And it is a black, silent existence that is not conscious of its own processes. All their mental experience, if they have any at all, is diminished relative to ours and this includes all sensations including vision, hearing – and feeling pain. “Animal Experimentation.” Edinburgh Book Festival. 2002.
The passages below are all from Why Animal Experimentation Matters: The Use of Animals in Biomedical Research. Ellen Frankel Paul and Jeffrey Paul, Editors. 2001. While these passages are not as stark as White’s assertion, they do I think suggest strongly that the industry is well populated by those who do not believe that animals warrant much sympathy or moral concern.

Adrian R. Morrison writes: “Human beings stand apart in a moral sense from all other species ...”. (p 51.) To him, there does not appear to be a continuum; it's apples and ... hum, clouds?

Stuart Zola, currently the director of the Yerkes National Primate Research Center, argues that any use of animals is warranted as long as the experimental design is “good science.” He worries that any other criteria will necessarily be too limiting:
Another way to preserve research possibilities is to reconsider what is meant by “benefits.” For example, one could hold the moral position that while possible benefits to humans and animals are important, the advancement of scientific knowledge is itself a benefit as well. On the surface, this position appears to run the risk of justifying almost any research project. In reality, however, this is countered by the underlying assumption that a permissible project must be based on good science, that is, science that has been peer-reviewed and found to be of acceptable quality. With that caveat in mind, treating scientific knowledge itself as a benefit would seem to be reasonable for a variety of perspectives. .... Therefore, it might not be reasonable to preclude the possibility of carrying out a study simply because it has no obvious immediate relevance, either potential or real. (pp 85-86.)
Jerald Tannenbaum, Professor of Veterinary Science at UC-Davis, characterizes the “traditional approach” to morality and ethics in the lab:
British cancer researcher Harold Hewitt provides a succinct expression of the traditionalist approach. “My concern,” he states,
is really not with the number of animals [used in an experiment], in the sense that I should be more upset by having caused one animal to suffer by my neglect or ineptitude than I should be by administering euthanasia to fifty at the terminatiuon of an experiment in which none had been caused suffering. The question the prospective animal experimenter has to ask himself is whether he considers that the painless taking of an animal is itself an immoral act. For me it is not. (p 96.)
Baruch A. Brady, Professor of Biomedical Ethics at Baylor College of Medicine, writes:
What sort of greater significance are human interests given over animal interests in the U.S regulations?

In fact, this question is never directly addressed. This stands in sharp contrast to the U.S. regulations on human subjects in research. These regulations require the minimization of risks, but they also require that the minimized risks be “ reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.” Nothing like these strictures occurs in the U.S. principles and regulations governing animal research.

Something else can be inferred from the wording of the U.S. principles on animal research. Discomfort, distress, or pain of the animals should be minimized “when consistent with sound scientific practices.” The number of animals used should be minimized to “the number required to obtain valid results.” Unrelieved pain necessary to conduct the research is acceptable so long as the animal is euthanized after or during the procedure. What this amounts to in the end is that whatever is required for the research is morally acceptable. ... There is never the suggestion that the suffering of an animal might be so great – even when it is minimized as much as possible while still maintaining scientific validity – that the suffering might outweigh the benefits of the research. Even when these benefits are modest, the U.S. principles never morally require the abandonment of a research project. (pp 134 – 135)

... All European regulations assume that animal interests in avoiding the harmful consequences of being in a research project have enough moral significance – in comparison to human interests in conducting the research – that in some cases the proposed research is ethically unacceptable. All involve a balancing of animal interests against human interests in a way that allows the protection of animal interests to be given priority in some cases. In this way, they all reject the American pro-research position, in which human interests seem to have priority in all cases. (p 136)
Charles S. Nicoll and Sharon M. Russell, vivisectors associated with UC Berkeley, write:
From an evolutionary perspective, attempts to find moral justification for the use of animals on the basis of our “moral superiority” or otherwise are unnecessary, and the arguments against such justifications are nonsensical. (p. 167)
H. Tristram Engelhardt, Jr., Professor of Medicine at Baylor School of Medicine, who says that his opinion about animals comes from God’s covenant with Noah, writes:
[H]uman moral experience is not simply richer than that of animals: all of moral experience is placed within human culture. Thus, the significance of animals (and of their pains, pleasures, and experiences) can only be understood in the context of human concerns. (p 177)

As long as a project that involves animal suffering is not directed simply at harming animals, it will not involve malevolence. A hunter who acknowledges that the significance of animals is primarily achieved in their contribution to the delight and experience of humans acts benevolently when savoring not just the chase, but the kill. One can also recognize an important difference in kind between a bull dying at the hands of a matador and the ways one might leave various animals to die or be killed .... (p 187)

From these passages, coupled with the actual practices, it doesn't seem inaccurate to characterize the beliefs of those within the industry as not caring very much about the animals' experiences, or to claim that those in the industry and its supporters feel that animals do not warrant much moral concern from us.

Sunday, December 19, 2010

The Structure of Cognition

I recently participated in a public forum along with University of Wisconsin-Madison’s Research Animal Resource Director, Eric Sandgren, and John Webster, a UW-Madison professor of bioengineering who experiments on pigs. You can watch a video of the event here.

During the Q&A, Sandgren said that there are differences between humans and monkeys that justify or excuse our use of them. (See the video above at 1:01:54)

I asked him what those differences are and he replied that there is an “incredible literature” on this, and he referred me to that. I followed up with an email asking him if he would give me a title or two from that incredible literature. I cced UW-Madison bioethicist Robert Streiffer who had been in the audience. He chairs one of the university’s five or six Animal Care and Use Committees. (I say five or six because the previously top animal care and use committee, the All Campus ACUC, was recently decertified, disbanded, renamed, de-authorized or something, in some way, by some agency. I have to say some agency, because it’s hard to know as an outside observer just how to weigh the past few years’ multiple USDA Animal Welfare Act violations against the apparently serious complaints to the NIH Office of Laboratory Animal Welfare. One or the other or both led to a very rare joint inspection by the USDA and NIH. USDA has very recently had a large team of investigators at the university. Or, maybe the repeated serious biosafety violations and issues entered into the equation, or the Michele Basso fiasco, or even something the public doesn't know about. It’s hard to keep up.)

Sandgren never responded to my email, but Streiffer did, to both of us, and pointed to Michael Tomasello and Josep Call’s Primate Cognition. (Oxford University Press, 1997.) To his credit, Dr. Streiffer has been willing to engage in some debate and discussion on this matter, and I thank him for it.

Presumably, neither Sandgren nor Streiffer would argue that the extreme moral distinctions they make differentiating ethical treatment of humans and monkeys (and other animals) are based on gross appearance. Presumably, they would agree that the (extreme always-fatal) distinctions they make are based on mental characteristics.

Tomasello and Call made two lists of cognitive characteristics that distinguish cognition in all primates and cognition in humans. By placing them side by side and comparing these two lists one might be able to see or begin to tease out the salient characteristics of monkey and human cognition that to Sandgren and Streiffer explain the morally relevant differences they claim to see.

The claims and conclusions drawn by Tomasello and Call are sometimes controversial; other researchers have reached other conclusions. My personal experience with chimpanzees (and other animals) leads me to question some of their specific assertions. Tomasello and Call’s claims seem too conservative to me and somehow biased, but for the sake of trying to understand Sandgren and Streiffer’s position, and by extension, the position of others in the industry, we can accept them as written. I have left out the authors’ speculations on how these characteristics might have emerged. Blogger doesn't allow two columns. Here's a link to a readable .pdf of the image below.
Though the elements in each list might be fiddled with, the overall gist and fundamentals must be a fair statement of the reasons for the position held by those who claim that using monkeys in ways harmful to them is moral because of our mental differences.

Apparently, the animals described by the set of characteristics and abilities in the left-hand column are fair game for those described by the set of characteristics described on the right. To those with this belief, it must be that the non-human set of characteristics and abilities is insufficient to warrant much sympathy or moral concern.

In other words, a being with “the basic understanding of space and objects; the ability to discriminate, categorize, and quantify objects; the ability to recognize individual conspecifics and remember past interactions with them; the ability to communicate with and learn from conspecifics; the ability to create flexible strategies to deal with problems in both the physical and social domains based on both learning and insight,” doesn’t warrant much sympathy or moral concern.

I’m stymied. I can’t get past this point. What sort of moral system would exclude a being with the ability to create flexible strategies to deal with problems in both the physical and social domains based on both learning and insight?

The human cognition list waxes on at length about the power of human language, and how learning combines with the use of human language to help make us so cognitively advanced (smart, I would say, but Tomasello and Call specifically argue that intelligence is an inappropriate term to apply to nonhuman cognition. Humans can be smart. Animals are cognitively complex.)

It’s obvious that we are wildly smarter than any other species. But some people are much smarter than others. So what?

(Human) language is a common distinguishing characteristic appealed to in arguments defending the use of animals. But its presence does not seem to be a prerequisite for thinking. Helen Keller must have thought something before she learned to use sign language.

Monkeys don’t have our language ability, yet UW primate vivisector Ned Kalin has said that “[a]nimals do a lot of things instinctively…. But people – and probably monkeys – have the ability to think 20 steps into the future: ‘In the end I’m going to feel great, because I worked hard to get there,’ or ‘I’m going to get a lot of credit for this.’It’s the prefrontal cortex that brings those emotions into play and guides us in our behavior. If we didn’t have a sense of what would be wonderful or awful in the future, we would behave very haphazardly. "Wired For Sadness." Discover. April, 2000.

Imagine trying to plan even three or four steps ahead without some sort of internal dialog. There is either a dialog of sorts going on in a monkey’s head or else he or she is thinking in a mode unlike any I use regularly.

These two lists are interesting and could be the subject of much disagreement and conversation, but I can’t get past the implication that those who defend the use of monkeys in ways certain to harm them, often involving years and even decades of a severely reduced quality of life, and always death, must believe that those “with basic understanding of space and objects; the ability to discriminate, categorize, and quantify objects; the ability to recognize individual conspecifics and remember past interactions with them; the ability to communicate with and learn from conspecifics; the ability to create flexible strategies to deal with problems in both the physical and social domains based on both learning and insight,” simply do not warrant much concern.

It’s worth noting that the being described above by Tomasello and Call isn’t necessarily a monkey. These are what they term “general mammalian cognitive mechanisms.” Primates have additional “cognitive mechanisms.” So what? What is missing in the description above that gives license to our whims or holds up such beings for sacrifice?

Sunday, November 28, 2010

The Ethics Underpinning Oversight

It is common to hear from those within the vivisection industry that research with humans is considerably less constrained by regulations than research involving other kinds of animals.


The U.S. Department of Agriculture has set rigorous standards for the use of animals in research that are more stringent than those used for human studies." Our Commitment to Ethical Animal Care and Use. (p 7)
Johnson and Johnson
Even though the policies for protecting human participants have been strengthened, the requirements for human subjects investigators and IRB members remain less stringent than those of many other regulatory compliance boards, such as those overseeing radiation safety, biosafety, and animal research.

Regulatory Changes Affecting IRBs and Researchers
APS Observer. The American Psychological Society. Sept. 2001.
Is animal research regulated in any way?

Yes. All animal research is subject to strict federal regulations. The United States Department of Agriculture (USDA) has set forth federal regulations governing the care and use of animals in biomedical research that are considered more extensive than those covering human research subjects. The Animal Welfare Act sets these high standards of care for research animals.


If these claims were accurate they might suggest that American society cares less about humans than about other animals; or, if they were accurate, maybe these claims might mean that people experimenting on animals need the law explained to them in much greater detail than do those studying humans.

These claims do not reflect reality. These claims suggest that those within the industry worry about the potential results of the public’s concern and as a result either manufacture misleading claims or else, and probably more likely, have been duped by their industry’s propaganda. Such duping and willful ignorance – “faith” in the eyes of the believer -- or is a common phenomena throughout society and is discussed at length in Phillip Zimbardo’s The Lucifer Effect.

Previous posts and discussions here and elsewhere have addressed the question of whether or not ethics enters into the decision-making process regarding experiments using animals at the University of Wisconsin-Madison. This discussion has been narrowly focused for the most part on the university’s use of monkeys.

One of the many possible stumbling blocks in this discussion is the meaning of ethics. For some, apparently, ethics means compliance with rules and regulations. For others, like me, ethics in this context is synonymous with morality. When arguing that compliance with rules and regulations assures ethical behavior, it is claimed that ethics is built into the rules. This is sort of true, but it misses the point of the bigger question of whether or not we should use monkeys or other animals in the first place.

If we compare the regulation of the use of humans in biomedical and behavioral research with the regulation of the use of other animals we should be able to draw reasonable fact-based conclusions concerning the way these two enterprises are thought about and controlled.

We can look at the language used in the regulations and in the documents underlying the regulations. We can look at the paperwork required for each, and we can look at what is allowed.

The use of humans and other animals in research in the United States and its territories is regulated by the federal government. The use of humans and the use of other animals are each regulated by different laws and regulations, the differing regulations have different purposes, and the regulations each have different histories.

Human research subjects

Regulations controlling the use of humans grew out of the long history of scientists using humans in ways that they expected could or would harm or kill them. The most well-known and often cited example is the medical research conducted on humans in Nazi Germany. The result was "The Nuremberg Code", a set of ten guidelines written in 1949 by the judges presiding over the “Doctors Trial.”

The Nuremberg Code is a landmark document. It has been called the most important document in the history of the ethics of medical research. It is germane to note that the Nuremberg Code requires experiments on animals prior to experiments on humans but requires no initial consideration concerning the use of animals.

In 1964, the World Medical Association issued its Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, which begins with the clear statement of purpose and intent:
The World Medical Association has developed the as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.
The clear unambiguous intent of the Nuremberg Code and the Declaration of Helsinki is the protection of people used in scientific research. The Declaration of Helsinki includes the directive that if appropriate, experiments on animals should proceed human experimentations and that “the welfare of animals used for research must be respected.”

In the United States, the National Research Act of 1974 was passed as a result of the political embarrassment over the disclosure that men had been left untreated and had died as a result in the Tuskegee Syphilis Study which was halted in 1973.
SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research the produced the Belmont Report: Ethical Principles and Guidelines for the protection of human subjects of research. “The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations.”

In 1981, the Department of Health and Human Services and the Food and Drug Administration issued regulations based on the Belmont Report. DHHS issued the Code of Federal Regulations (CFR) Title 45 (public welfare), Part 46 (protection of human subjects).

In 1991, 45 CFR 46 Protection Of Human Subjects, Subpart A, known as “The Common Rule” was officially adopted by most federal agencies using human research subjects.

“The Common Rule” requires among many other things that an Institutional Review Board (IRB) review, approve, and oversee all research involving humans at each institution:
§46.107 IRB membership.

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
Repeated throughout the regulatory literature mentioned above is the underlying frequently repeated intent to treat human subjects with respect and to keep their individual safety and dignity paramount in any research design. “The IRB shall be sufficiently qualified through the experience and expertise of its members, ..., to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.”

For more on the regulation of human-based research see:

NIH Regulations and Ethical Guidelines

University of Nevada Las Vegas History of Research Ethics

Non-human research subjects

In the United States, laws governing the use of animals emerged directly from the theft of dogs and their sale to research laboratories. The first regulations were intended to protect the rights of pet owners rather than the animals themselves.

A “Legislative History of the Animal Welfare Act” is available on the National Agricultural Library website. It provides a useful bibliography and history.

Compare this summary of the meaning and intent of the laws and regulations governing the use of animals with the passages above regarding the use of humans:
All of these codes are the philosophical foundation for the development of laws that protect animals as property. They limit liability for the owner or for the animal. They set forth rules regarding the theft of animals, the use of animals in the punishment and execution of criminals or traitors, religious sacrifice, and provide for the legal standing of animals. The predominate rationale in these codes is based on the protection of property, the protection of the owner’s investment, and sanctions imposed by society for violating its notions of justice. These factors are not surprising if one considers the importance of animals to the early agricultural societies.
It is difficult to find among the large body of documents included in the “Legislative History of the Animal Welfare Act” any assertions similar to those found throughout the regulatory history of human experimentation.

There is no Belmont Report addressing the use of animals.

United States Code, Title 7, Chapter 54 § 2143 “Standards and certification process for humane handling, care, treatment, and transportation of animals,” creates the regulatory framework that controls the use of animals in laboratories. It also establishes the requirement of an Institutional Animal Care and Use Committee (IACUC) at each institution, a committee parallel in form to that of the IRB mentioned above:
(b) Research facility Committee; establishment, membership, functions, etc.
(1) The Secretary shall require that each research facility establish at least one Committee. Each Committee shall be appointed by the chief executive officer of each such research facility and shall be composed of not fewer than three members. Such members shall possess sufficient ability to assess animal care, treatment, and practices in experimental research as determined by the needs of the research facility and shall represent society’s concerns regarding the welfare of animal subjects used at such facility.
Notice that “The IRB shall be sufficiently qualified through the experience and expertise of its members, ..., to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects” while the IACUC “shall represent society’s concerns regarding the welfare of animal subjects.” One committee is charged with protecting the research subjects while the other is charged with representing society’s “concerns.” In practice, the results are grossly disparate.

This is because the Act has an escape clause unlke anything found in the regulations governing human-based research:
(6) (A) Nothing in this chapter—
(i) except as provided in paragraphs [1] (7) of this subsection, shall be construed as authorizing the Secretary to promulgate rules, regulations, or orders with regard to the design, outlines, or guidelines of actual research or experimentation by a research facility as determined by such research facility;
(ii) except as provided [2] subparagraphs (A) and (C)(ii) through (v) of paragraph (3) and paragraph (7) of this subsection, shall be construed as authorizing the Secretary to promulgate rules, regulations, or orders with regard to the performance of actual research or experimentation by a research facility as determined by such research facility; and
(iii) shall authorize the Secretary, during inspection, to interrupt the conduct of actual research or experimentation.
In other words, and in actual practice, anything is allowed to be done to animal subjects so long as it is approved by the IACUC and documented.

National Institutes of Health regulations governing the use of animals in research rely heavily on the Guide for the Care and Use of Laboratory Animals. The Introduction to the Guide makes its purpose clear:
The Guide is applicable only after the decision is made to use animals in research, teaching, or testing. Decisions associated with the need to use animals are not within the purview of the Guide,...
The NIH Office of Laboratory Animal Welfare is charged with ensuring that funded institutions and researchers are in compliance with the Guide. Additionally, NIH has promulgated a number of documents addressing the use of animals in the research it funds. One of these is the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

The "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" looks superficially like the Nuremberg Code. And, the "Principles" have been offered as evidence by researchers at the UW-Madison that ethical principles are built into the oversight committees’ deliberations. But a glance at each makes clear that one is intended to protect one group of subjects while the other is intended to govern how another group may be imprisoned, harmed, and killed.

If the "Principles" were cited as a guide to the use of humans no one would argue that meaningful ethical deliberation had occurred.

But everything above is academic. The scalpel meets the flesh at the paperwork required by federal law and regulation prior to using either humans or other animals and it is this regulatory burden and the resulting limitations and requisites therein that animal researchers seem to refer to when that they claim to be more regulated than scientists using human subjects.

The form researchers submit to their IRB is the “Application for Initial Review of Research Projects Involving Human Subjects.” The form researchers submit to their IACUC is the “University of Wisconsin - Madison Animal Care and Use Protocol Review Form.”

The Human Subjects form is twenty-one pages long. (The Human Subjects form was recently removed and replaced with a web-based form that is not accessible to the public.)
The Animal Care and Use form is nine pages long.

The Human Subjects form requires a “Submission Cover Sheet for Initial Review and Ongoing Studies,” which is five pages long.
It also requires a one page “Potential Financial Conflict of Interest Assessment Form.”
See too: University of Wisconsin-Madison Health Sciences Institutional Review Boards

Looking at the two forms, it seems clear that one expects the subjects to be seriously harmed and the other expects the subjects to be well protected from harm. The Human Subjects form asks about the length of stay required by subjects; the Animal Care and Use form leaves unsaid that the subjects are incarcerated for their entire lives.

Regulation of human use rests on the idea that the research is voluntary, that the subject can terminate their participation at any time, and that a subject’s best interests must prevail.

In actual practice, regulation of nonhuman use rests on the idea that animals are consumable commodities, that their use is justified by even the most remote and most unlikely possibility that some knowledge will be gained through using them.

All in all, it is difficult to find any evidence that regulations governing research using animals have more than a superficial similarity to the regulations governing research using humans.

It is difficult to find evidence that researchers using animals engage in formal discussions of the ethical issues associated with animal use or that there has ever been discussion and deliberation similar to that underpinning the regulation of human use.

Sunday, November 21, 2010

Marolt to Streiffer on Housing

Below is another post from Rick Marolt. I supplied the title. The 'Housing' bit is simply to tag it with a term that will distinguish it from other possible future related posts.



I have asked Rick Bogle to elevate this comment to a main post because 1) some issues raised in the discussion merit more visibility and 2) I want to encourage other people to participate in the discussion. Many people read this blog. What do you think of these issues? See the original post and comments here.

Rob Streiffer:
Second, I asked whether IACUCs have the authority to address ethics questions. I argued that they do and fail to understand your basis for saying that IACUCs "are constituted by law not to make ethical decisions." To which federal regulation are you referring? At any rate, it is misleading to say I made this claim "without providing evidence," as I cited examples of rules from the U.S. Government Principles which require IACUCs to frequently make ethical determinations about animal housing and about whether the value of the research justifies the harm to the animals. Perhaps you disagree with my argument here, but I did make one.

I cannot tell what statement of mine you think is misleading. I wrote: "The committee claimed, without providing evidence, that they make ethical decisions all the time." I think that statement is true. I see no such evidence in your statement or Sandgren's statement and I do not recall hearing such evidence at the committee meeting. Citing rules that require the ACUCs to do something, which you have done, is not evidence that they actually do it. Saying that the ACUCs do something, which Sandgren has done, is not evidence that they actually do it.

After the ACUC meeting last January, I asked Sandgren for evidence: minutes of meetings where specific experiments were approved, documentation of decisions not to approve an experiment because the benefits were not projected to exceed the costs, and evidence that benefits of completed experiments exceeded their costs. Sandgren was not able to provide such evidence.

Rick Bogle has responded to the point about ACUCs and ethics. Note also that the Animal Welfare Act, which contains the requirement of research organizations to have ACUCs, says: "Such members shall possess sufficient ability to assess animal care, treatment, and practices in experimental research ..." and the responsibilities listed have to do with assessing animal care, treatment, and practices. Members are not required to have expertise in ethics. The words "ethics" and "ethical" do not appear in the AWA. The AWA says nothing about larger ethical decisions such as whether or not experimenting on a given species is ethical, and those are the decisions that I am talking about.

ACUCs exist to ensure compliance with federal regulations concerning the treatment of non-human animals. They operate within a system that assumes that keeping monkeys in cages for their whole lives, giving them diseases, birth defects, and brain damage, and killing them are acceptable actions. (You might say that the ACUCs decide case-by-case when these things are ethical and when they are not. But the ACUCs have approved very many experiments of these kinds, and I am aware of no evidence that the ACUCs ever find such experiments unacceptable or unethical.) There is a deep, underlying assumption that treating monkeys in a certain way -- much differently from how we treat people -- is acceptable. The ACUCs do not question that assumption.

Let's imagine that UW-Madison keeps people in small cages their whole lives and conducts injurious and fatal experiments on them. I question the ethics of experimenting on people. You say "We make ethical decisions all the time about how to house the people and we approve experiments only when we think that the value of the research justifies the harm to the people." Most reasonable people would say that you missed the point. And you're missing the point about monkeys.

I did not mean to say that the ACUCs cannot or should not (or even do not) make ethical decisions, only that ACUCs are constituted primarily to make other decisions. My wording probably could have been better. And, yes, decisions about housing can have an ethical component. But what about a bigger question such as whether or not experimenting on a given species is ethical? That's the question that matters most. And you have argued that the ACUC should not even try to answer it. So all this talk about the ACUCs making ethical decisions is pretty minor quibbling and not very relevant to the bigger issues.

Except ... your statement includes this excellent paragraph:
IACUCs are required by law to prohibit any research that is not in compliance with what are referred to as the U.S. Government Principles. Principle VII requires that “the living conditions of animals should be appropriate for their species and contribute to their health and comfort.” It would thus be within the IACUC’s jurisdiction to prohibit research with a species if they concluded that appropriate housing conditions on campus could not be secured. (Imagine a researcher trying to bring chimpanzees onto a campus that can only secure funding for cages of the size typically used for macaques.) A decision about the appropriateness of housing conditions, which falls squarely within the jurisdiction of an IACUC, can amount to a prohibition on a certain kind of research. An even clearer, second, example comes from Principle II, which requires that “procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.” So if an IACUC finds that procedures involving animals do not produce sufficiently important knowledge, then it is within the IACUC’s legitimate authority to prohibit that research.
So let's ignore the bigger issues for a moment and just focus on housing, since you have brought it up. Both you and Sandgren have cited the U.S. Government Principles. Now, there is much evidence that monkeys suffer in their little cages, that they get chronic diarrhea, and that they mutilate themselves out of boredom and isolation. Some people say that the monkeys become neurotic or even go insane. A former UW-Madison veterinarian has written:
Each monkey was kept alone, in a cage that was so small that he/she could not take a few steps in one direction, let alone jump or run in monkey fashion. There was no companion to huddle, groom or play with.

It should be remembered that macaques are primates - just like us - who have an intensive need for social contact and social interaction. Solitary living conditions are similarly unbearable for them as it would be for us.

Most cages were completely barren, offering not even a perch that would have allowed the animals to make use of the arboreal dimension. In the wild, macaques spend most of the day in elevated sites - away from ground predators - and seek the refuge of trees at night.

When kept in cages without a high perch, the animals have no way of retreating to a "safe" place during alarming events, such as when a staff member approaches them. Being cornered in this manner must, indeed, be a very distressing experience for a helpless monkey who associates people with painful and distressing handling procedures.

In order to accommodate as many monkeys in one room as possible, cages were arranged in double-tiers with one row stacked on top of the other. This condemned half of the animals to confinement in a permanently shady, cave-like environment. Needless to say, this was not a living quarter that was suitable for diurnal animals.

The conditions I witnessed were so depressing that most monkeys had developed stereotypic behaviors such as pacing, rocking, bouncing, somersaulting, swaying from side to side, biting parts of their own bodies, pulling their ears, tossing their heads back and forth, or smearing feces on the cage walls. (Viktor Reinhardt, "The Impossible Housing and Handling Conditions of Monkeys in Research Laboratories")
It's impossible to argue that the monkeys' housing is "appropriate for their species and contribute[s] to their health and comfort". (Please don't tell me that the little enrichment that the monkeys receive makes their housing appropriate for their species and contributes much to their health and comfort.) If the ACUCs make ethical decisions all the time about things like housing, when are they going to correct this situation? And if they cannot correct it, isn't it time for a "decision about the appropriateness of housing conditions" that "can amount to a prohibition on a certain kind of research"?

If your argument means anything, this topic will be on an upcoming ACUC meeting agenda and the committee will consult with experts before making a decision.

Let's talk about Principle II, which you brought up. If a utilitarian standard is used, only actual benefits matter, not just knowledge (unless you're going to argue that the satisfaction that a few people get from gaining and having knowledge justifies the suffering and deaths of monkeys). So I would revise your sentence: "If an IACUC finds that procedures involving animals do not produce sufficient benefits, then it is within the IACUC’s legitimate authority to prohibit that research."

Paul Kaufman and Eric Sandgren have said that there is a "low hit ratio" in translating basic science into health benefits, and one survey of 25,000 articles concluded that that hit ratio is just about 0% (W. F. Crowley, Jr., Am J Med 114, 503 - Apr 15, 2003), so there must be a lot of research that should be prohibited.

If your argument means anything, then the ACUCs will identify research that does not produce substantial benefits and prohibit it.

While I'm critiquing the ACUCs, I must note also that they are required to "represent society's concerns regarding the welfare of animal subjects". Evidence that many people and organizations in Madison have deep concerns about experimenting on monkeys became clear during discussion of Resolution 35 on the Dane County Board of Supervisors last summer. But UW-Madison declined, with the help of your statement, to study the ethical issue and it fought hard against Resolution 35. How and when do the ACUCs at UW-Madison represent society's concerns regarding the welfare of animal subjects? (If you, like I, distinguish the main ethical question from welfare issues, note that the scope of Resolution 35 included treatment of monkeys.) Please don't tell me that just having one or two ACUC members come from outside the UW takes care of this responsibility of the ACUCs.

Third, I asked whether UW was obliged to comply with your request. I argued that it was not. Not because I ignored "all the scientific and morally significant findings about monkeys that raise the ethical question," as you mistakenly say I did. To the contrary, I explicitly acknowledged them.
You did indeed mention some scientific and morally significant findings about monkeys. The committee then ignored the implications of those findings when it chose not to study the ethical issues.

The validity of most or all of your other points is clear and I have no disagreement with them. But they are not very relevant to the main issue.

Friday, November 12, 2010

Let's set the record straight

A guest post from Rick Marolt:

Eric Sandgren, who frequently serves as UW-Madison's spokesman for animal research, said in a public forum recently that local critics of experiments on animals are wrong when they claim that UW-Madison did not take up the ethical issue of experimenting on monkeys. In that public forum, Sandgren said more than once that people cannot believe what they hear because critics of experiments on animals make inaccurate statements.

So let's set the record straight.

In August 2009, I proposed to UW's top research oversight committee that the UW conduct a study to determine if experimenting on monkeys is ethical, and I requested a response to my proposal by a certain date.

That date came and went without any news, so I asked the chairman of the committee for an update. He told me that the committee had decided against my proposal. I asked him when the committee had made that decision. He said that the committee had discussed my proposal during the meeting that I attended, when I was out of the room. That was a lie. (And the committee probably violated the state's open meetings law by deliberating outside the meeting -- if they bothered to deliberate at all.) In any case, the committee declined to deal with the fundamental ethical question.

I shared this news with UW-Madison chancellor Biddy Martin because Martin had insisted that this committee was the appropriate body for answering the ethical question. Martin then instructed the committee to discuss my proposal formally and to give me a formal written response.

So that committee met again on January 8, 2010. The bio-ethicist on the committee presented a statement that concluded with a motion: "I move that the committee endorse the position that existing standards of veterinary care and applicable animal welfare laws, regulations, and policies provide a suitable and appropriate basis for determining when the use of nonhuman primates in research, teaching, or outreach at the University of Wisconsin-Madison is ethical."

Note that this motion does not respond meaningfully to my proposal and does not try in any way to answer my question. It says only that a basis for answering the question (or at least a similar question) exists. But the motion seems to assume that experimenting on monkeys, as it is done at UW-Madison, is at least sometimes ethical. I had asked the UW to question that assumption, not just to re-state it.

Sandgren presented his own written statement that the oversight processes ensure that experiments on monkeys meet a utilitarian ethical standard. But this statement only begs the main question and prompts a few more. Why should a utilitarian standard be applied to experiments on monkeys but not to experiments on people? (Sandgren has said elsewhere that "Utilitarianism trumps rights", which actually makes some sense to a principled utilitarian, which he is not, but still fails to explain why utilitarianism trumps the rights of monkeys but not the rights of people. And a deontologist would say that "rights trump utility".) What are the costs? What are the actual benefits to people? Where are the numbers, the evidence that a utilitarian standard is met? Why is it ethical for a powerful majority to exploit a powerless minority in pursuit of its self-interest? How do we know not only that the benefits of experimenting on monkeys exceed the costs but that experimenting on monkeys is the research approach with the greatest ratio of benefits to costs? How could it be if, as Sandgren himself has said in public, that there is a low "hit ratio" in translating experimental results into human benefits?

There was no study, no deliberation, no public input, and no testimony from experts, just statements that said, in effect: the status quo is fine. I wrote in a guest column in the Wisconsin State Journal after that:
The top animal research oversight committee at UW-Madison concluded recently that experimenting on monkeys is ethical. Here's what happened: a group of insiders who are constituted by law not to make ethical decisions but to ensure that the care of animals in labs meets a minimum standard, decided that the work that pays their salaries, funds their labs, and gives them a basis for tenure and promotion is ethical.

It was as if the Mississippi Slave Owners Association was asked in 1850 to determine whether or not slavery was ethical.

The committee ignored all the scientific and morally significant findings about monkeys that raise the ethical question: their advanced mental abilities, their strong emotions, their complex social relationships, and their profound similarity to you and me.

The committee confused the question about the ethics of experimenting on monkeys with the question of the treatment of the animals. They made the absurd claim that meeting a legal minimum standard of care ensures that the experiments are ethical. But if experimenting on monkeys is not ethical, then no standard of care can make it so.

The committee claimed, without providing evidence, that they make ethical decisions all the time. But years ago, when I heard someone ask one member [Sandgren] how ethical decisions were made, his only answer was "I will have to get back to you on that." And someone who has attended about fifty committee meetings tells me that she has heard committees discuss ethics only three or four times — and only because they seemed to be making a show of it.

Instead of wrestling with the ethical issue, the committee simply endorsed an answer that they like. I know from my interaction with some committee members that some of them do not even understand the issue. And the few who do understand it are afraid to speak openly.
So, did the UW take up the ethical question in any meaningful way? No. Sandgren should stop accusing concerned citizens of misleading the public.

By the way, I am still waiting for the formal written response to my proposal.

Thursday, November 11, 2010

Harlow, Responsibilty, and HIV

Meaningful discussion requires an attempt at honesty. We all make mistakes of course, and can unknowingly make false claims and hold unfounded opinions, but making things up, trying to mislead, and refusing to acknowledge plain facts is something altogether different.

Animals in Research and Testing seems like an effort to hoodwink the uninformed and unwary (or maybe just UW employees).

There are many silly claims on the site. Consider the statement below regarding the work of Harry Harlow on a page titled: “UW Animal Research Achievements. The Tangible Benefits of Animal Research.” This is matter-of-factly wrong.

In the forum I linked to at the bottom of the previous essay, you can hear Eric Sandgren saying that people should look up the facts themselves. Indeed, but people trying to do so have a reasonable expectation that information presented on a UW-Madison website is accurate, and they have an even stronger expectation that the information on the website is believed to be true by the authors. The public rightly expects that the state university will not knowingly mislead them. The problem is significantly compounded when publishing the false information is intended to benefit the institution itself. This is, I believe, an abuse of authority.
The importance of mom

Monkey research by Wisconsin’s Harry Harlow proved the importance of mother-child attachment to human development during the 1950s, when many psychologists discounted the relationship. In studies with a few animals, Harlow showed that food, water and medical care were not enough: young primates cannot grow into normal, healthy adults without contact with their mother. Harlow’s discoveries are widely applied in such settings as neonatal intensive care units.
This claim might not be recognizable as a lie if the actual historic facts had not been pointed out to the “author” of the “blog" associated with the university website, Eric Sandgren. But they have been, very clearly, and yet he – and by extension his employer – continues to make matter-of-fact false claims about Harlow’s work.

It is one thing to defend honestly one’s opinion that animals’ experiences and lives don’t matter very much, that scientists or ranchers or dog fighters should be able to kill them or hurt them in any way they choose, but it is an altogether different matter to present straightforward falsehoods as facts, and this seems to be a common tactic used on this University of Wisconsin-Madison website. Everyone acting as a university agent – everyone who produces copy for the site – has a higher than ordinary duty of honesty to the state’s citizens and Internet users everywhere.

Rather than repeat what I have written before regarding the actual facts surrounding Harlow’s work, I refer the reader to my essays: “Harry Harlow's Dark Shadow,” September 18, 2008, and “Monsters: Harry Harlow and Stephen Suomi,” web posted: August 29, 2010.

Repeating the Harlow myth isn’t the half of it. It’s not the tenth of it. Half-truths abound.
This university accepts responsibility for the stewardship of all animals under its care.
How would one go about judging the veracity or even determining the meaning of a statement like that? One way might be to look at how the university responds to citations for its violations of the Animal Welfare Act. If one took responsibility and acted responsibly, one wouldn't let things deteriorate to the point that a team of inspectors would be called in, or at least act responsibly and fix the problems pointed out to you.

USDA inspectors returned recently to the university and discovered that major violations like the university approving experiments even though researchers have not demonstrated that they have looked for alternatives to painful procedures, have gone uncorrected.
Because animal models are used only to answer questions that cannot be answered in any other way, experiments are not approved unless the lead investigator can show that no effective alternatives exist.
This is a half-truth because the animal models are themselves demonstrably ineffective.

Here’s a really misleading statement:
Nobel Prizes for Medicine or Physiology routinely recognize research that relied on animal models. The 2008 prize was awarded for discovering the human immunodeficiency virus, based on work with monkeys, chimpanzees and mice.
Like the false claim about the importance of Harry Harlow’s work, I believe the university’s claim that the discovery of the human immunodeficiency virus (HIV) was based on work with monkeys, chimpanzees and mice is factually incorrect.

The isolation of HIV was first reported and published in 1983, as explained below by Françoise Barré-Sinoussi in her Nobel acceptance speech.

UW-Madison professor and author Deborah Blum tells the story of the discovery of simian immunodeficiency virus (SIV) in “Not a Nice Death,” Chapter 9 of her 1994, The Monkey Wars, (which are still raging.)

She tells us that in 1976, a fatal epidemic swept through the stumptail macaque colony at the California Regional Primate Research Center at the University of California-Davis (now the California National Primate Research Center.) It turned out to be SIV, but at the time the cause of the disease was unknown. She quotes California primate center veterinarian Roy Henrickson: “They were suddenly dying, and whatever it was, it was a terrible death, a cascade of infections, cramming one on top of another, wearing the little monkeys out.”

In 1980, another wave of the same disease swept through the rhesus colony. A disease with the same symptoms broke out at the New England Regional Primate Research Center at Harvard University at about the same time. (The facility is in Southboro, a few miles from Boston.)

And this time, there was something similar spreading into the human population. A troubling illness was emerging, a disease that caused a lethal collapse of the immune system, crippling the body’s ability to fight off infection. The human disease was AIDS, Acquired Immune Deficiency Syndrome.

The New England scientists realized, and then the California researchers, that the monkey disease was almost a mirror of the human one....
The discovery of the human immunodeficiency virus, was not based on work with monkeys, chimpanzees or mice.

The opposite is true. The discovery of the simian immunodeficiency virus was based on work with humans. HIV was first described in 1983.

SIV was first described in 1985. See: Isolation of T-cell tropic HTLV-III-like retrovirus from macaques. Daniel MD, et al. Science.

Consider the beginning of Françoise Barré-Sinoussi’s Nobel acceptance speech.

Does this sound like monkeys, chimpanzees, and mice were used?
The Early Days

The story begins more than 25 years ago, when the initial clinical observations of a new alarming epidemic were made. In June 1981, clinicians in the United States first reported a number of cases of Pneumocystis carinii in homosexual men. Subsequently, the first cases of what would later be known as AIDS were observed in France. At the time, I was working at the Institut Pasteur with Luc Montagnier and Jean-Claude Chermann. In December 1982, we were contacted by clinicians in France who provided us with a biopsy of a lymph node from an AIDS patient, with the aim of isolating the etiological agent causing the disease.

The hypothesis at the time was that a retrovirus might be the etiological agent responsible for AIDS. The only human retrovirus known at that time was the human T-lymphotropic virus (HTLV), known to cause transformation of T cells, and arguably it would have been possible to culture the cells from the lymph node biopsy and simply observe for T-cell transformation. Luckily, we did not assume that HTLV was necessarily the cause of the disease, and we decided to sample the culture supernatant every three to four days to detect for reverse transcriptase activity. Indeed, we started to observe a reverse transcriptase activity, which decreased shortly after, in correlation with cell death. Initially we were concerned about possible toxicity related to tissue culture components, but following the addition of fresh lymphocytes and fresh components to the culture, the same cell-death phenomenon was observed, in correlation with the detection of reverse transcriptase activity. We thus realised that the virus itself was responsible for this phenomenon.

The isolation of this new human retrovirus (at the time known as LAV, lymphoadenopathy-associated virus) was first reported and published in May 1983. In this first report we described that LAV could be propagated on peripheral blood mononuclear cells and on cord blood lymphocytes. We also described the viral protein p25, and importantly we determined that there was no, or weak, cross-reactivity with HTLV-1 proteins, indicating that we were dealing with a new human virus. In the same report we demonstrated the presence of antibodies against LAV in a second patient affected by AIDS. The report of the virus was, however, just the beginning.

The isolation of the virus was not sufficient, however, to convince the scientific community of the implication of the virus in AIDS. It was, therefore, essential to further characterize the virus and establish a clear link between the virus and the disease to persuade the scientific community and the relevant authorities that the newly isolated virus was the etiological agent responsible for the emerging epidemic. In 1983, we decided to immediately halt all other research projects which were ongoing in the laboratory (including determining whether MMTV sequences could be associated with breast cancer—a hypothesis still valid today) and to mobilize a network of efficient collaborations with clinicians, immunologists, and molecular biologists. In order to determine whether this newly isolated virus was truly responsible for the disease affecting AIDS patients, we quickly developed a serological test to perform sero-epidemiological studies. Crucially this same test was subsequently used as a diagnostic tool for blood testing. The development of the diagnostic test was made possible by a strong and efficient partnership with the private sector, namely Sanofi Pasteur.
And the date of this paper also from Barré-Sinoussi:
Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune deficiency syndrome (AIDS). Barré-Sinoussi F, et al. Science. 1983.


A retrovirus belonging to the family of recently discovered human T-cell leukemia viruses (HTLV), but clearly distinct from each previous isolate, has been isolated from a Caucasian patient with signs and symptoms that often precede the acquired immune deficiency syndrome (AIDS). This virus is a typical type-C RNA tumor virus, buds from the cell membrane, prefers magnesium for reverse transcriptase activity, and has an internal antigen (p25) similar to HTLV p24. Antibodies from serum of this patient react with proteins from viruses of the HTLV-I subgroup, but type-specific antisera to HTLV-I do not precipitate proteins of the new isolate. The virus from this patient has been transmitted into cord blood lymphocytes, and the virus produced by these cells is similar to the original isolate. From these studies it is concluded that this virus as well as the previous HTLV isolates belong to a general family of T-lymphotropic retroviruses that are horizontally transmitted in humans and may be involved in several pathological syndromes, including AIDS.
Maybe the university’s writer is correct, maybe the discovery of HIV was dependent on experiments on chimpanzees, monkeys, and mice, but dates and statements from people who were there at the time strongly suggest otherwise.

I challenge them to provide clear relevant references for their claims. I don’t believe they can; I don’t believe they exist.

Wednesday, November 10, 2010

Symposium Addresses Ethics

Symposium Addresses Ethics, Standards, Beneficiaries of Research

Madison, Wisconsin - Drawing on issues raised by this year's Go Big Read selection, a fall symposium at the University of Wisconsin-Madison will address responsible conduct and ethical decision-making in research.

The Integrating Research Ethics and Scholarship (IRES) is an initiative, sponsored by the Graduate School, that offers both novice and seasoned researchers and scholars educational opportunities and resources that reflect best practices in ethics education and scholarly integrity.


A public evening session, "Who Decides and Who Profits: Research at UW-Madison," will feature a panel discussion about the decision-making and administrative processes behind campus research. The panel will include a mix of researchers, research administrators and deans.

"We are hoping to put an open, public face on how we, as an institution and as individuals, go about the process of research," says William Mellon, professor of pharmacy and associate dean for research policy, who will moderate the discussion. "In general, researchers are interested in producing results that will benefit people. Most researchers are motivated by making a difference."

Discussion topics will include the costs and benefits of research, research oversight and infrastructure at UW-Madison, how the public can influence the research agenda, how federal and state money is spent and why basic science research is done.

"To the general public, the nature of how research gets done - the organization and administration - is not transparent and so complex. There are many misconceptions," says horticulture professor Irwin Goldman, one of the panel members.

I attended the evening panel discussion held on November 4, 2010. The event was video-recorded; when it becomes available, I’ll link to it here.

The moderator was William Mellon, the Associate Dean for Research Policy. The participants were Susan Ellis Weismer, Associate Dean in the College of Letters and Science, Professor, Communicative Disorders; Sharon Dunwoody, Interim Associate Dean for Graduate Education, Evjue-Bascom Professor of Journalism and Mass Communication; Eric Sandgren, Director, Research Animal Resources Center, Associate Professor, Experimental Pathology; Nichelle Cobb, Director of the Health Sciences Institutional Review Board; Richard Moss, Senior Associate Dean for Basic Research, Biotechnology, and Graduate Studies, School of Medicine and Public Health, Professor of Physiology; Irwin Goldman, Professor of Horticulture; and Jill Sakai, University Communications.

The event was interesting in a geeky sort of way though it did not answer the questions posed in the advertising. I enjoyed it and came away with some new insight. One thing that struck me was the gigantic chasm between oversight of human-based research and animal-based research.

The event grew out of the university’s Go Big Read campus-wide book circle’s first selection (a play on the university’s Go Big Red athletic slogan): The Immortal Life of Henrietta Lacks, by Rebecca Skloot. http://www.gobigread.wisc.edu/

Before, via email, and during the panel discussion, the audience was invited to submit questions. These were vetted and edited by Associate Dean Mellon, and no follow-up was allowed.

Nichelle Cobb, Director of the Health Sciences Institutional Review Board, the committee responsible for oversight of human-based experiments answered questions read by Mellon concerning human experimentation. She said that even the use of tissue left over from surgery is highly regulated, and that informed consent is expected and required in certain cases.

It is apparently common and accepted practice in hospital admissions to include a generic approval clause in the fine print granting permission for the use of incidental tissue residues. These tissues are apparently not associated with a patient’s identity and apparently may be used generically in research. On the other hand, if a researcher has a specific desire for certain types of tissues from certain patients, then informed consent is required, and if there is a profit motive behind the collection of specific tissues, then the request, according to Cobb, would be almost certainly denied.

This sensitivity to the use of leftovers from surgery on humans is at distinct odds with the de facto rubber-stamping of nearly any requested use of whole live animals. Yet we hear repeatedly by industry spokespersons and other vested parties that the oversight of experiments on animals is more stringent than oversight of experiments on humans. For instance:

The U.S. Department of Agriculture has set rigorous standards for the use of animals in research that are more stringent than those used for human studies. Our Commitment to Ethical Animal Care and Use. (p 7) Johnson and Johnson
I had not previously looked into these claims and had merely assumed that they were false, but as a result of the panel discussion, I did a little research. I can say now, and support it with evidence, that such a claim – that animal-based research is more highly regulated than human-based research is absolutely ludicrous. I imagine that those who make such claims are either repeating falsehoods they’ve heard or else are making them up themselves.

I submitted two questions to the panel, neither of which was asked fairly by Mellon.

The first one had to do with the ever-growing body of research demonstrating through meta-analyses and retrospective reviews that clinical care of human patients is not being appreciatively improved as a result of basic biomedical research using animals.

When a protocol comes before an Animal Care and Use Committee for approval, there is a near certainty that the research results will provide no new knowledge that will lead to an improvement of human patient care. [See for example, Lindl T, Völkel M & Kolar R. 2005 and 2006.] Yet the public is told that the oversight committees weight the costs to the animals against the potential benefits to humans. But the costs to the animals are a lifetime of being caged in bleak tight confinement, often-serious discomfort, stress, and almost always death, and the benefits to humans are nil.

Thus, in every approved project, and generally all projects are approved, the ethical weighing that occurs is this: no likely benefit to humans vs. certain suffering and death to the animal = an approved project.

How could an informed honest person argue that this system is ethical?

One of the panelists, Irwin Goldman, Professor of Horticulture, was a spokesperson in the university’s strong efforts to host the Department of Homeland Security and USDA jointly sponsored BSL-4 laboratory, the National Bio and Agro-Defense Facility (NBAF).

The university argued vigorously that the NBAF would be perfectly safe and should be built in the Town of Dunn, a few miles from Madison, and successfully cajoled some local politicians to get behind their effort. [See my essays: "regrettable consequences" July 30, 2009; UW Experts Dead Wrong, again. July 28, 2009; Are UW Vivisectors Anti-Knowledge? June 8, 2007. NBAF Fiasco Reveals Idiocy of UW Decision-Makers. May 10, 2007; Wanna buy a bridge? March 12, 2007.]

But the Government Accounting Office reported in 2009 that the lab would pose unnecessary risks if it were built anywhere on the mainland. The GAO reported that the Department of Homeland Security’s analysis of the risks was flawed in a multitude of ways. See: Observations on DHS’s Analyses Concerning Whether FMD Research Can Be Done as Safely on the Mainland as on Plum Island. United States Government Accountability Office. Report to Congressional Committees. 2009. http://www.gao.gov/new.items/d09747.pdf

So I asked whether it was ethical for the university to ask the Department of Homeland Security to build the facility here and to tell the public that there was no appreciable risk, without first seeking an analysis of the risks from experts at the university?

Apparently the university had conducted no independent analysis of the risks; instead, they merely argued that the facility would be an economic boon to the community and that any concern over safety was mere hand wringing by uniformed or misinformed Luddites. Mellon twisted this question, like my question about the ethical weighing of costs and benefits of experiments on animals, into something nearly unrecognizable.

There was no discussion with the audience. There were no follow up questions.

A couple interesting tidbits:

Associate Dean Mellon started out by saying that the panel, or maybe IRES, was: “[O]ur initial foray into this area.” Public discussion about ethics is apparently a new idea at the university.

Mellon “read” a question that asked what the university was doing to counter the negative press about its use of animals. There was much hemming and hawing, but Jill Sakai of University Communications said she was aware that a recent telephone opinion poll by a group named CURES or C.U.R.E.S. or something like that, there was no opportunity for follow-up questions, had found great support for university research.

As far as I can tell, there isn’t an organization by this name. I contacted Ms. Sakai (twice) and asked her for a reference or a link, or any information whatsoever she might have about this survey, but she said she knew nothing, had nothing, and could point to nothing about it. This seems odd to me given her significant “knowledge” of it at the panel.

Associate Dean Mellon had told me in an email that the panel would not address animal research, but of course, with two vivisectors (Moss and Sandgren) on the panel, it did. Mellon also told the audience that the university is planning a series of “forums” specifically addressing the use of animals. The “forums” were proposed by the university as part of their successful efforts to defeat Dane County Resolution 35, though Mellon didn’t mention that. As of this writing, as far as I am aware, the “forums” planning committee has met only once. If the IRES symposium can be used as a indication of the substance and value of these promised “forums,” they may be more form than substance.

P.S. and a little aside: I recently participated in a genuine forum with actual discussion with the audience at the First Unitarian Society of Madison, Wisconsin. One of the other two panelists was Eric Sandgren. You can watch it here. Sandgren told the audience [beginning at about 16:08 and then again at 1:10;15] that he had opposed Resolution 35 because it had a fatal flaw, the committee proposed by the Resolution created would decide for the County whether experiments on monkeys are ethical. The actual text reads:
BE IT FURTHER RESOLVED that the Panel’s “Final Report” will include a recommendation to the Dane County Board of Supervisors either to officially endorse or officially oppose experimenting on monkeys in Dane County.
Eric may need some reading remediation. He should look up the meaning of recommendation.