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.

16 comments:

Zeb said...

In conjunction with the remarks made by Eric Sandgren at the First Unitarian Society of Madison forum noted in this post, Sandgren stated that, for him, the ethics of animal experimentation depends upon drawing a line (or attempting to define a chasm) between human and non-human animals, humans being said to deserve ethical priority because of characteristics they have which other animals do not. The specific example he gave referred to the ability of humans to give conformed consent, something which non-humans cannot do. Sorry to go off on a bit of a tangent with regard the intent of your post, but I found this argument particularly irksome. We all know that animals used in experiments or living in laboratory settings will, in various cases, self-mutilate; vocalize their distress; physically resist experimental procedures; huddle in the back of cages when lab workers arrive to remove them; etc, etc. Give a monkey, chimp, cat, dog, rat, mouse or whatever, who has been fluid deprived, the choice between free access to a bowl or bottle of water or not, it's easy to guess what their choice will be - indeed, the very fact that they need to be so deprived in the first place indicates a working knowledge on the part of researchers that the animals, given a choice, would not choose to submit and perform as they are being asked to. The ability to consent or not consent is clearly indicated, but apparently, as far as Sandgren is concerned, because animals cannot discuss the issue in the complex, abstract, language-defined ways that humans can, any behaviors they exhibit which indicate autonomy of will and individual desire is emptied of all meaning. Thus his ethical argument, in this instance at least, amounts to nothing more than: "We have the right to experiment on other animals simply because they are not human." They cannot object as humans object, cannot refuse consent as we would, therefore it is acceptable to make use of them as we will. We do it because we can. Might makes right. With regard to his point about spaying and neutering dogs and cats without their consent, obviously this is being done for both their individual and their species benefit, something which does not apply with regard the vast majority of cases in which animals are used as experimental tools. Spaying and neutering pets without their consent but for their benefit not only does not support his argument, but refutes it: our ethical obligations to animals extends to making decisions which benefit them - not to using them for the sole purpose of benefiting us.

Eric Sandgren said...

Some corrections:

In the public forum, I said that people cannot believe what they hear on any side of the issue of animal use in research, because most of it is out of context. I said that anyone serious and honest about this issue would have to do a lot of hard work on his or her own to understand how science really works, and what it can (and can’t) tell us.

I do not believe that utilitarianism trumps rights. I believe that rights trump utilitarianism. If I said the former then I misspoke (where is the “elsewhere” you referred to?). I believe that humans have rights, and I do not believe that animals have the same kind of rights. That is why I say rights trumps utilitarianism for humans, but do not say the same thing for animals.

The statement of low “hit ratio” comparing scientific experiments to discoveries was made by someone else, not me. I do believe that translational studies, which will provide human benefit, should be much more common. That doesn’t negate the important role of basic animal studies.

The All Campus Animal Care and Use Committee DID address the question “Is experimenting on monkeys ethical?” The answer was “Yes”. Both written statements you cite “responded meaningfully” to this question; they do not beg it. They didn’t provide a detailed answer to each of the other dozen or so additional questions you now are asking, but they answered the question. We didn’t say, nor do we expect, that you would answer the question the same way, or even like our answer. Stop misleading the public.

Regarding the comment by Zeb, I do not believe, nor did I say, that we have the right to experiment on animals because they are not human. In fact, I avoided a detailed discussion of what makes animal and humans different with respect to rights because that is not my area of expertise. What I did say is that--once again--people need to look into this issue for themselves.

Anonymous said...

"I avoided a detailed discussion of what makes animal and humans different with respect to rights because that is not my area of expertise."

This seems whacky. You speak and act from a position of faith, not reason.

Zeb said...

Dr. Sandgren: Rick Marolt's question at the forum pertained specifically to the rationale applied to animal experimentation and its ethical framework. Prof. Webster, in his response, introduced the idea of the impossibility of using human subjects for the experimental purposes to which animals are put; you continued this thought in your own response, adding to it the concept of a variant degree of rights for humans and nonhumans. The inability of non-human animals to give informed consent (as humans can, in the form we can) was used by you as a central, explicatory concept defining the difference between humans and non-humans, and as central to the ethical framework you apply to the use of animals in experimental procedures (i.e. where you, personally, "draw the line" with regard the ethical viability of animal use). I do not see then how you can reasonably deny the assertion that you have posited, as at least as one prong of your argument in favor of using animals as experimental tools, that it is ethically permissible to do so because non-human animals cannot express themselves with regard consent in the same manner as humans can - i.e. that we can experiment on them because they are not human. That they may and do express a refusal of consent is apparently something you either refuse to recognize or refuse to give much credence to. I realize your response to Mr. Marolt was "off-the-cuff," nevertheless I see no reason not to take your remarks as being fairly representative of your view on the matter.

Rick Marolt said...

Have I said that the ACUC did not answer the Question "Is experimenting on monkeys ethical?" I don't recall saying it. Maybe I did. But I agree that the ACUC answered the Question. In the future, I will make sure to say that the ACUC did answer the Question. I will also say that the ACUC declined a proposal to study the issues before coming up with an answer. Those are facts. Then I will give my opinion that the ACUC's answer was superficial, illogical, unsupported by evidence, corrupted by self-interest, and designed only to reinforce the status quo.

"Elsewhere" = Patricia McConnell's class last spring

Paul Kaufman made the comment about a low hit ratio in the public debate on March 15. I quoted him on public radio two days later, and you agreed with him. I would still like to know how the ratio of benefits to costs is maximized if there is a low hit ratio in translating costly research into actual benefits.

So rights trump utility for people, but utility trumps rights for non-human animals? But why? You're not explaining anything.

"I avoided a detailed discussion of what makes animal and humans different with respect to rights because that is not my area of expertise."

Eric, this sentence reveals the whole problem. To answer the Question meaningfully, the discussion that you are avoiding must take place. Your inability to explain your position is proof that the UW has not answered the Question in a meaningful way. You are a leader and a spokesman for a $200 - $300 million enterprise that causes much suffering and many deaths of non-human animals. You have an obligation to ensure that the work done is ethical and to explain to the public why it is ethical. Answering the Question meaningfully requires some study, some experts, some deliberation, some wrestling with difficult issues. Of course you and other committee members do not have the needed expertise. I made that clear when I proposed a study in which you would consult experts. I understand that committee members were taken aback when I spent most of my fifteen minutes explaining why the committee was not the right body to answer the Question. But then you went ahead, took a short-cut, and tried to answer the question anyway. And now you admit that you are not able to answer it satisfactorily because you lack the expertise.

The point is not that I disagree with the answer. The point is that the process that produced the answer was deeply flawed.

By the way, "begging the question" means assuming a conclusion instead of making an argument for it. When you state that different ethical standards apply to non-human animals and people but you cannot make an argument for that conclusion, you are indeed begging the question.

Rob said...

Rick, I agree with Prof. Sandgren that your account of the January meeting of UW’s All Campus Animal Care and Use Committee (ACACUC) is inaccurate and misleading on several points. So, in the spirit of “setting the record straight,” I wanted to clarify what I did and did not say.

I took up three main questions.

First, I asked what exactly you meant in asking UW to address the question of whether nonhuman primate (NHP) experimentation is ethical. On some interpretations, your request was puzzling. I made an analogy with asking the Vatican to clarify where it stood on whether God exists. What would be the point? Rather, I suggested that you were asking UW to initiate a robust process similar to the one it initiated regarding the ethics of human embryonic stem cell research, bringing together experts in relevant fields to meet several times and issue a report.

I think some of the back and forth between you and Sandgren has been the result of equivocation on this question. Sandgren did “take up the ethical issue of experimenting with monkeys”: he said that NHP research is ethical when it meets a utilitarian standard. Of course, you too are correct that there was no study, no public input, and no supporting arguments for many contested points. But has Sandgren claimed the contrary? Not to my knowledge.

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.

You mention someone who attended many IACUC meetings but who says that she has only heard them discuss ethics a few times; I’m sorry to hear that she has a mistakenly narrow understanding of the term “ethics.”

(Continued Below)

Rob said...

(Continued from above)

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:

“The use of nonhuman primates does raise significant ethical questions. We currently allow research that causes harm and premature death to sentient individuals capable of living long lives, capable of happiness and suffering, capable of agency and emotion. … I think that any reasonable view about the ethics of nonhuman primate research must acknowledge that these are significant costs, not to be imposed lightly. Such an important issue should be revisited periodically; it should be periodically reassessed in light of the latest scientific knowledge and ethical reflection.”

Rather, I argued that UW was not obliged to implement such a process because such a process has already taken place nationally, resulting in a detailed set of regulations that it is reasonable for universities to follow, thus obviating the need for them to individually reinvent the wheel. This does not amount to saying that "the status quo is fine" as there are other factors that contribute to the status quo; for example, how the regulations are interpreted and how effectively they are applied. These are large issues, which my brief remarks did not address.

So, my remarks were not intended to take up in a robust way the substantive ethical question regarding NHP research. But that was not what Chancellor Martin asked us to do. She asked us to "formally discuss your proposal," which I did. “Discuss” does not mean “comply with.”

Finally, I agree you should have received a written response. I even requested one at the time.

Robert Streiffer

Rick Bogle said...

Rob,

You wrote: "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?"

It goes without saying (funny phrase since we then go ahead and say it...) that it is hard or impossible to prove a negative. But, regarding the notion that ACUCs can't make ethical weighings, I refer you to The IACUC Handbook, Second Edition, Silverman, Suckman, Murthy eds. 2007:

"12:3 [pp 158-159 passim] Should the IACUC perform an ethical review of protocols?

Reg: The AWA, AWAR, PHS Policy, and the Guide do not use the words 'ethical' and 'moral,' with the sole exception of the Guide's statement (p12.) 'Ethical, humane, and scientific considerations sometimes require the use or sedatives, analgesics, or anesthetics in animals.'
Opin. .... For the most part, the IACUC does not and cannot conduct this explicit ethical review. The IACUC is charged with reviewing the rationale (preferably statistical) for the animal numbers, but not whether a particular line of research warrants that number. Similarly, the IACUC evaluates a technical claim that nonhuman primates alone are likely to provide the sort of data sought, not whether a particular project ethically merits the use of primates. Because the IACUC does not have the tools (or the regulatory mandate) to conduct a thorough assessment of the scientific merit (i.e., the potential benefits) of a proposed project, it cannot make a thorough cost-benefit ethical analysis."

Rick Bogle said...

Rob,

It is, I think, worth mentioning that the University Faculty Senate committee that ruled against the All Campus ACUC's suspension of Basso, stated that the All Campus ACUC had insufficient expertise in the use of primates for it to come to a decision regarding her work.

It seems to me that if All Campus is not qualified to oversee Basso's use of monkeys then they aren't qualified either to make ethical decisions regarding the use of monkeys.

I think the Faculty committee was wrong on this point, but their conclusion indicates that many other reasonably well informed observers might agree that the limited consideration given to Mr. Marolt's question by the ACUC, was unqualified, even if as you (erroneously, I think) claim, it was the appropriate authority to do so.

Rob said...

Hi Rick B. In response to your 6:21 comment.

The Handbook is often helpful, but (a) even if correct, it doesn't support Marolt's claim that IACUCs are constituted by law not to make ethical decisions and (b) it isn't correct in this case.

I say (a) because the Opinion says "for the most part," implying that IACUCs sometimes can and do conduct "explicit ethical review." If so, then Marolt's claim is false.

I say (b) because even if a policy never uses the words "ethical" or "moral," implementing the policy could still allow or require making ethical decisions. For example, such phrases as "appropriate", "due consideration", "proper use", "adequate", "proper and humane care", appear in the regs and are ethically loaded terms. Making a decision regarding them requires making ethical decisions. The situation is similar, in my view, to the Constitution's requirement for "due process" and "equal protection": these don't use the terms "moral" or "ethical" but properly applying them requires making ethical decisions.

I would also say that the more important question here is not whether IACUCs can make ethical decisions, but whether the overall system supports ethical research while preventing unethical research. After all, even if the regs said "IACUCs may not allow any unethical research," that wouldn't satisfy Marolt because those who implement the regs are more permissive than he is. And even if the regs said "IACUCs shall not make any ethical decisions," that wouldn't bother Marolt if the regs required the IACUCs to make all of the relevant factual determinations upon which the ethics of the research depended. To see what I mean, suppose, just as a stupid, easy-to-work with example, that only research that involves dying an animal's hair is unethical. Since an IACUC can make that determination without making any ethical decisions, the regs could say “No hair dying!”, “No ethical decisions!” and still prohibit all unethical research.

I think in the case of IACUCs, it is a mix. On certain issues, an ethical decision was made up-front and parts of the regs were written so they could be implemented without any further ethical decisions. In other cases, it made sense to instruct IACUCs to make the ethical decisions. But the important ethical question is really whether the overall system supports ethical research while prohibiting unethical research, not how this particular division of ethical labor was settled.

Robert Streiffer

Rick Bogle said...

Rob,

I would find more merit in your argument if you would point to a specific section(s) of the Act or the PHS regs that you believe clearly empowers ACUCs to make the sort of ethical decision you say they can and do make.

I take the qualifier "For the most part," to mean something other than you do. You seem to give the phrase undue weight.

In 12:3 of Silverman, the authors conclude that ACUCs do at times act as ethical arbiters, and cite as evidence Dresser R, JAVMA, 1989; a 1994 doctoral thesis from The Netherlands; and the proceedings from a conference in Europe from 1994.

This "evidence" seems embarrassingly weak and weakly associated with US policy and practice. Dresser's study wasn't blinded. I find Plous and Herzog suggestive that ethical review is very uncommon and moreover, when it does occur, if it does, it has little reliability.

In any case, I would appreciate any citation of the Act or regs that you believe is evidence for your claim that ACUCs are empowered to make ethical decisions about the use of animals.

Rob said...

Rick.

Re. Specific sections: The ethically loaded terms I cited in my previous post are from US Govt Principles (it’s only 1 page), as were the examples I gave at the January meeting of the ACACUC. And, to amplify on what I said at the January meeting, even if there was some esoteric reading of the regs that prohibited IACUCs from making ethics decisions, I don’t think that is how they work in practice, unless, again, you are understanding “ethics” in a mistakenly narrow way. Perhaps we could make some progress on the discussion here by approaching it from a different direction: Do you think Human Subjects Committees make ethical decisions? If so, in what way are their regs different from the IACUCs’ regs?

Re. the Silverman evidence being embarrassingly weak: I was not relying on the Silverman, and so I am not embarrassed. I merely pointed out that whereas you suggested that Silverman’s conclusion supported Marolt’s claim, in fact, Silverman’s conclusion contradicted Marolt’s claim.

Re. the Plous and Herzog: I don’t see how you interpret that study as being relevant to the question of whether IACUCs are allowed to and do make ethical decisions.

Robert Streiffer

Rick Bogle said...

Rob,

You asked how IRBs differ from ACUCs. I'm surprised by your question. Consider this from the NSF:

ETHICAL RESEARCH rests on three principles:

1. RESPECT for persons’ autonomy, meaning the researcher gives adequate and comprehensive information about the research and any risks likely to occur, understandable to the participant, and allows them to voluntarily decide whether to participate.

2. BENEFICENCE, meaning the research is designed to maximize
benefits and minimize risks to subjects and society.

3. JUSTICE, meaning that the research is fair to individual
subjects and does not exploit or ignore one group (e.g., the poor) to benefit another group (e.g., the wealthy). (cf: The Belmont Report)

National Science Foundation
http://www.nsf.gov/bfa/dias/policy/hsfaqs.jsp#overall

I didn't mean to suggest that you personally should be embarrassed by the evidence cited in Silverman that ACUCs engage in ethical decision-making, but that the evidence Silverman cited was old and mostly European in origin (and contrary to Plous and Herzog's findings that there is no reliability between decisions made by different ACUCs.)

Maybe you are suggesting that ethical decisions will be completely random between decision-making bodies?

Rob said...

Rick B., in response to your November 21, 2010 2:26 PM comment.

You are right about the content of the comments from the NSF FAQ. And yet the federal regulations (45CFR46) themselves only mention the word “ethics” in two contexts; first, in the context of suggested expertise for people serving on Human Subjects Committees; second, in the context of allowing (although not requiring) universities to include a statement of ethical principles in their federal assurance. It doesn’t explicitly mention “respect” in the moral sense, it doesn’t mention “autonomy” nor “beneficence,” nor “justice” (except for referring to the US Dept of Justice). So what the FAQ suggest to me, then, is that you can have a policy that is designed to conform to ethical principles, to support ethical research, and to prohibit unethical research without the policy itself using ethical language or explicitly instructing the oversight committees to make its decisions using that specific language. Rather, 45CFR46 requires human subjects committees, for example, to review research at “intervals appropriate to the degree of risk,” to ensure that “when appropriate, the research plan makes adequate provisions for monitoring the data collected,” to ensure that “risks to subjects are reasonable in relation to anticipated benefits,” and to ensure that there are “adequate provisions to protect the privacy of subjects.” The implementation of these requirements requires human subjects committees to make ethical decisions in a way very analogous to the way in which I was saying that IACUCs are required to make ethical decisions. So far as I can tell there is not a sharp difference on this point between the animal regs and the human subjects regs.

Re. Plous and Herzog: again, perhaps you can explain, but so far as I can see, it is one thing to say that committees come to different decisions about the same research and another thing to address the subject matter that the committees are deliberating about. They could be deliberating purely about factual questions and have high or low inter-committee consistency; they could be deliberating explicitly about ethical questions and have high or low inter-committee consistency. Studies similar to the Plous and Herzog study have been done in the human subjects area, but I don't see how their results would help you decide whether the regs explicitly ask human subjects committees to make ethical decisions either.

Rick Marolt said...

Rob Streiffer: "But the important ethical question is really whether the overall system supports ethical research while prohibiting unethical research, not how this particular division of ethical labor was settled."

OK. What's the answer?

Rob said...

Rick Marolt asked what the answer is to the question of whether the overall system supports ethical research while prohibiting unethical research.

I think the answer is that improvements are both needed and continue to be made on both counts.

To return to what I take to be the intent of the original posts by Sandgren and myself, making those improvements is unlikely to be best facilitated by perpetuating misleading and inaccurate characterizations of what people’s views are and of what people said. If you want to criticize us, criticize us for what we actually said. I expect you’ll still find plenty you disagree with.

Somewhat ironically, I do think that I understand better some of the context and reasoning behind some of the substantive remarks that Rick Marolt and Rick Bogle have made, and the exchange has prompted some constructive discussion of several questions that are much more interesting than the question of what Eric Sandgren and I did and did not say. That is all to the good, I think.