Continued Responsible Oversight - Part 1

A look at the NIH workshop "Continued Responsible Oversight of Research with Non-Human Primates"

https://videocast.nih.gov/launch.asp?19835

Part 1.
The Back Story

The National Institutes of Health held a "workshop" on Wednesday, September 7, 2016, titled, "NIH Workshop on Ensuring the Continued Responsible Oversight of Research with Non-Human Primates." It was a sham.

Here's the reason for the NIH show: In 2014, in response to their public records requests, Peta received hundreds of hours of video footage from Stephen Suomi's lab at the NIH. They publicized some clips on their website and successfully lobbied some members of Congress to ask NIH to evaluate the ethics of using monkeys in its funded research.

Stephen J. Suomi had been the Director of the NIH Laboratory of Comparative Ethology and the Section on Comparative Behavioral Genetics for many years. Suomi's work has never helped anyone (not counting himself and his staff.) Suomi was trained by Harry Harlow who discovered and demonstrated repeatedly that infant monkeys taken from their mothers at birth and kept in a profoundly bleak environment were likely to go insane. Harlow began publishing in 1963, and worked with graduate students such as Suomi for nearly two decades devising endless ways to emotionally devastate baby monkeys.

A sampling of titles of papers documenting Suomi's earlier work:

1971 - Social recovery by isolation-reared monkeys.
1973 - Surrogate rehabilitation of monkeys reared in total social isolation.
1974 - Induced depression in monkeys.
1975 - Depressive behavior in adult monkeys following separation from family environment.
1976 - A 10-year perspective of motherless-mother monkey behavior.
1978 - Effects of imipramine treatment of separation-induced social disorders in rhesus monkeys.
1983 - Shuttlebox avoidance in rhesus monkeys: effects on plasma cortisol and beta-endorphin.
[Note: The shuttlebox is a device with two side-by-side compartments and a removable wall between them. The floor of each compartment is wire mesh which can be electrified. When the floor of the compartment holding the monkey is turned on, the monkey receives a shock and escapes by "shuttling" to the other compartment by jumping over the wall.

Once the monkey has learned that she can escape from the shock, the other floor is turned on and the first turned off. So now she learns that she can shuttle back to safety. The next step is to turn on both floors simultaneously. She will continue jumping from side to side hoping to escape. Finally, the clear plexiglass wall is placed between the compartments and the floor is turned on. After repeated tries she learns that she cannot escape and lies on the floor quivering and convulsing. She is now classified as "helpless."]

1983 - Therapy for helpless monkeys.
1991 - Nonhuman primate model of alcohol abuse: effects of early experience, personality, and stress on alcohol consumption.
1991 - Rationale and methodologies for developing nonhuman primate models of prenatal drug exposure.
1994 - Responses of free-ranging rhesus monkeys to a natural form of social separation. - Parallels with mother-infant separation in captivity.
1995 - Biobehavioral comparisons between adopted and nonadopted rhesus monkey infants.
1996 - A nonhuman primate model of type II excessive alcohol consumption. Part 1. Low cerebrospinal fluid 5-hydroxyindoleacetic acid concentrations and diminished social competence correlate with excessive alcohol consumption.
1998 - Crowding stress and violent injuries among behaviorally inhibited rhesus macaques.

And on and on. As recently as 2016 he was still publishing, for instance: OPRM1 genotype interacts with serotonin system dysfunction to predict alcohol-heightened aggression in primates. Driscoll CA, Lindell SG, Schwandt ML, Suomi SJ, Higley JD, Heilig M, Barr CS. Addict Biol. 2016 Aug 3.

In any case, the videos were evidence that much of what was going on in the NIH lab was beyond the pale, they exposed the sort things a certain sort of people in animal labs are doing to animals when they think no one is watching. NIH's knee-jerk reaction was to defend Suomi. (NIH defends monkey experiments. Director Francis Collins says the agency has changed how it conducts controversial studies, but argues the work is necessary. Sara Reardon. Nature. 28 January 2015. ) But the evidence of science gone mad was hard to dismiss; a little less than a year later in a transparently face-saving capitulation, NIH reversed its decision, but claimed that it was doing so for financial reasons. (Decision to end monkey experiments based on finances, not animal rights, NIH says. David Grimm. Dec. 14, 2015. Science.)

Unfortunately, Peta made a fatal tactical error when they (I assume) advised members of Congress to ask NIH to evaluate itself. They should have asked them to look for a less aligned third-party evaluation like the Institute of Medicine's evaluation of the use of chimpanzees. (See: Raising the Bar: The Implications of the IOM Report on the Use of Chimpanzees in Research. Jeffrey Kahn. Hastings Center Report.)

I think it very likely that the shut-down of the Suomi lab, the Congressional interest, and the NIH decision to put on a show for a few members of Congress, frightened the primate vivisecting community. I think it likely that they lobbied aggressively to be included in the "workshop" committee. But it had probably been intended all along to be exactly what it turned out to be.

Part 2: The Big IACUC

Continued Responsible Oversight - Part2

A look at the NIH workshop "Continued Responsible Oversight of Research with Non-Human Primates"

Part 2. The Big IACUC

https://videocast.nih.gov/launch.asp?19835

Institutional Animal Care and Use Committees are the cornerstone of the oversight system in the United States. They meet the requirements set forth by both the Public Health Service Policy on Humane Care and Use of Laboratory Animals (Frequently Asked Questions about the Public Health Service Policy on Humane Care and Use of Laboratory Animals) and the Animal Welfare Act (Animal Welfare Act Quick Reference Guides).

Institutional Animal Care and Use Committees (IACUCs or ACUCs) main, sometimes only role, is to verify that a project using animals is legal. In order to be legal, the project leader(s) must fill out a form that explains what they intend to do to animals and why. Among other things, they need to state the number of animals they want to use, the species, and what if anything they will do to address any pain or distress they imagine the animals might or will experience. They can do anything they choose to do so long as they explain their scientific reasons and the ACUC approves it. As long as the ACUC approves, they don't have to provide any pain relief or much of anything else.

In some cases, the University of Wisconsin, Madison is one example, researchers are provided with some of the text they need to enter on the form.

ACUCs apparently struggle at making sure an approved protocol will pass muster if a USDA inspector happens to looks at it. Inspectors sometimes respond to public complaints about specific projects and occasionally spot-check approved protocols if they see something odd, if they are one of the inspectors who happen to give a damn. But other than more or less assuring that the project is legal, ACUCs are not consistent, and are pretty haphazard and arbitrary in their decision-making. (See the only peer-reviewed evaluation of the system: Study Finds Inconsistency in Animal Research Reviews, 2001.)

So it comes as no surprise that the NIH workshop was such an abject failure with regard to meeting its charge of openly and honestly evaluating the ethics of primate vivisection. The workshop was just a very big IACUC. There were two public members, Tom L. Beauchamp, Professor of Philosophy and Senior Research Scholar, Kennedy Institute of Ethics, and Jeffrey Kahn, Director of the Johns Hopkins Berman Institute of Bioethics. From the video, it appears that there were about 30 people at the table. No roster has been produced. Other than Beauchamp and Kahn, it appears that everyone else was financially and professionally vested in the use of monkeys.

Generally speaking, regulations require a minimum of three people on an ACUC, an institution official, a veterinarian familiar with the use of animals in research, and a non-institution- affiliated member of the public. In practice, ACUCs are usually larger. One survey found that just half of all regulated institutions had 6 to 10 people on their committees, and only 10% had fewer. In every case I am aware of, larger committee have proportionally fewer non-aligned members. The added members are almost always institution employees and usually vivisectors.

It is no surprise that they rarely refuse to approve a project; almost everyone on the committees use animals in their own work or else are part of the institutional apparatus for hosting and supporting scientists using animals. The money that comes with the use of animals is the life blood of many if not all of the large universities.

So, either by design or out of willful ignorance, NIH chose to emulate the ACUC model as a means of examining the ethics of using monkeys in harmful usually fatal publicly-funded projects. In this case the ratio of those with a clear vested interest in the outcome to those with no financial interest in the outcome was about 28 to 2. The outcome was foregone.

Part 3. Some Interesting Bits and Pieces

Continued Responsible Oversight - Part 3

A look at the NIH workshop "Continued Responsible Oversight of Research with Non-Human Primates"

Part 3. Some Interesting Bits and Pieces.

https://videocast.nih.gov/launch.asp?19835

The "workshop" was kicked off with a greeting from NIH Director Francis Collins. He is certainly in the running for making the most outlandish comment. He said, "Looking around the room, I am impressed to see the diversity of expertise presented here...". It's true that there were people sitting around the table who were doing different horrible things to monkeys, but calling them a "diverse group" was laughable. He continued with the joke that "we need lots of perspectives from the various views that are represented around this table...." But there were only two views; one represented by 28-ish vivisectors and their crew and the other by 2 outsiders. Jeez.

Then we heard from the main moderator, Carrie Wolinetz, Associate Director for Science Policy at NIH. One thing she said was particularly interesting to me. (Quotations are in capital letters because that is how they appear in the closed captioning file. The paragraphing is mine.)

Wolinetz: ... IT'S INTERESTING, HAVING READ SOME OF THE COMMENTS IN ADVANCE, TWO STRIKING THEMES THAT I THINK ARE RELATED TO THE STRUCTURE OF OUR WORKSHOP CAME TO ME. ONE, THERE WERE A LOT OF COMMENTS THAT SAID, WELL, YOU'RE TALKING TOO MUCH ABOUT THE SCIENCE, THEREFORE, THIS REALLY ISN'T A REVIEW OF THE ETHICS, AND THEN THERE WERE THOSE WHO SAID, YOU'VE GOT A SESSION ON ETHICS, THEREFORE, YOU'RE SOMEHOW COMPROMISING THE SCIENCE. AS IF THESE ARE TWO COUNTER VEILING FORCES, SCIENCE AND ETHICS, THAT ARE TOTALLY ANTAGONISTIC.

I THINK THAT IS SOMETHING THAT WE REJECT, THAT ETHICS AND SCIENCE REALLY GO HAND IN HAND, THE BEST SCIENCE IS INFORMED BY GOOD ETHICAL THINKING, AND AS WE THINK ABOUT PROTECTION OF ALL OF THE ORGANISMS USED IN RESEARCH, WHETHER IT'S HUMAN, ANIMALS, OR BACTERIA IN A PETRI DISH, CERTAINLY THAT IS INFORMED BY OUR BEST UNDERSTANDING OF THE SCIENCE OF THOSE SPECIES. THEY PROVIDE THE EVIDENCE BASE FOR MAKING SURE WE'VE GOT THE BEST WELFARE STANDARDS IN PLACE.

It isn't at all clear that ethics and science go hand-in-hand. The U.S. Declaration of Independence was a statement of an ethical position; the authors and signatories did not consult a biology text nor did they need to in order to proclaim that we are all equal. No amount of scientific benefit (that's code for any published paper) would be sufficient to tip the balance toward harmful experimentation on humans who do not consent, to breeding them, to keeping them in cages, or killing them to collect "needed" tissues. What science textbook should we consult to help us decide whether we should unleash more Josef Mengeles on unprotected populations?

The moderator for the first orchestrated section was UW-Madison primate vivisector David O'Connor who has recently cashed in on Zika. He has a track record of hitting NIH-paid jackpots. He currently has four funded projects together receiving over $3 million a year in NIH grants.

It is worth noting that the "workshop" lasted just over six and a half hours. The first part, moderated by O'Connor was a series of talks by vivisectors extolling their work and promising the world to those they imagined were tuning in, lasted for about 4 hours and 40 minutes. It concluded with a primate veterinarian promoting pro-vivisection trade groups and saying how supportive the Association of Primate Veterinarians is for the continued use of monkeys.

There was very limited discussion about ethics. Jeffrey Kahn makes a few comments at about 2:37:50, and continues briefly at about 2:41:36. Then, at about 5:10:00 into the program Tom Beauchamp spoke up. His entire comment is worth listening to, even if few others at the table understood him. He said, "... I CAN SEE FROM A NUMBER OF COMMENTS AROUND THE TABLE THIS MORNING THAT THERE'S STILL DEEPLY EMBEDDED [in] SOME FOLKS AROUND THE TABLE, THAT SCIENTIFIC NECESSITY IS THE KEY ISSUE. IF YOU CAN SHOW IT'S NECESSARY TO USE THE ANIMAL THEN IT'S JUSTIFIED TO DO THE RESEARCH. THAT'S JUST WRONG." A little later he gets into an interesting back-and-forth with Kathy L. Hudson, the Deputy Director for Science, Outreach and Policy at the National Institutes of Health, who says she thinks NIH is very open to change. She might have a career as a stand-up comic.

At about 5:15:00 into the meeting, the moderator of the section on oversight, Margaret (Mimi) Foster Riley asks how ACUCs assure that "ethical analysis" is represented on the ACUC? That's a crazy question from someone who ought to be well informed. (See my discussion Animal Research Ethics. 3/2012.)

Even crazier is the response from the top NIH watchdog, the Director of the misleadingly named Office of Laboratory Animal Welfare (OLAW), Patricia Brown (about 5:26:30): "SO FEDERAL AGENCIES THAT SUPPORT RESEARCH WITH ANIMALS, FORMED A WORKING GROUP IN THE LAST TWO YEARS AND HAVE PROVIDED JOINT FUNDING TO DEVELOP A NEW TRAINING PARADIGM USING ACTIVE LEARNING PEDAGOGY TO HELP DEVELOP IACUC TRAINING TO IMPROVE IACUCs SO THEY'RE THE HIGHEST FUNCTIONING IN TERMS OF ALL OF THE TOPICS THAT THEY ARE REQUIRED TO LOOK AT. NOT JUST FOCUSING ON THE ETHICS. BUT FOCUSING ON ALL THEIR RESPONSIBILITIES AS AN IACUC, BECAUSE IT GOES BEYOND JUST LOOKING AT IS IT ETHICAL TO USE THIS PARTICULAR MODEL OR THAT PARTICULAR MODEL."

One of the IACUCs at UW-Madison was chaired by an ethicist. He was hard pressed to point to an ethical evaluation of any proposed project that came before his committee. Pushed on the question he claimed that an ethical consideration perfuses the system, that it happens all along the way, from the initial application, to the NIH study section's deliberations, and throughout the ACUC's evaluation. But the minutes of his ACUC's discussions rarely included any record of such a consideration. The study sections certainly can't be relied upon because of members' clear biases. (See The "Best Science". November, 2009. See too: Animal Research Ethics. March, 2012.)

To her credit, Brown admits that the ACUC system hasn't been evaluated by NIH. But to the detriment of her credibility is the plain fact that OLAW could somewhat easily evaluate the ACUC system if or she cared to do so. USDA/APHIS inspection reports sometimes include citations for failures of ACUCs to meet the letter of the law. It would not be too difficult to quantify the reported ACUC violations and to sort them by type. The needed information is readily available to Brown; she simply doesn't look at it.

Jeffrey Kahn makes a few comments at about 2:37:50, and continues briefly at about 2:41:36. Then, at about 6:06:00, additional discussion with Kahn occurs, apparently because of on-line viewers questions, and runs more or less to the end of the session.

All in all, in the six-and-a-half hours, there were only a few minutes where the larger overarching questions were raised; the participants were primarily primate vivisectors and senior members of their federal support system. Peta has pointed out that in a workshop purportedly intended to address the ethics of using monkeys, a workshop filled with presentations about the claimed benefits of using monkeys, there was not a single presentation from an ethicist, a critic of any sort, nor from anyone who wasn't professionally or financially vested in the status quo. It is wildly far-fetched to imagine they might have had someone speak on behalf of the monkeys. In fact, in keeping with a common pattern, almost no monkeys were seen during the many hours of talks about using them. (See: "Forum" Keeps Details Hidden. October 2011. Particularly the observations by Susan Lederer.)

The general inability of the attendees to understand questions raised by Kahn and Beauchamp was the same sort of blindness or deafness that I have seen in other vivisectors. It appears to be a common characteristic. (One example, coincidentally also involving Jeffrey Kahn: Moral Similarities Continue to Confound Vivisectors. October, 2014.)

Bioethics at NIH

It seems that NIH supports a robust effort to ensure that human subjects being used in its supported research are treated humanely and in accordance with the spirit of documents like the Belmont Report. It also appears that NIH is alert to potential harm to human subjects that could arise from emerging technologies and works to ensure that the potential harms are identified and carefully evaluated. NIH seems to support ongoing work on the ethical side of its supported research with human subjects. But when the research involves the use of animals, nothing similar occurs.

Instead of being at the leading edge of research and thought on the ethics of hurting and killing animals for human gain, NIH is reactionary at best. This does not speak well for those in the NIH Department of Bioethics. Their near uniform silence on the matter suggests something less than should be expected from anyone claiming to be a bioethicist.

I wonder why ethicist is deemed insufficient? Maybe putting bio- in front of ethics is politically correct code for self-interest or maybe it just sounds more highfalutin. Maybe bio-ethics gives license to behave in ways that plain old ethics would deny? What isn't open to speculation is that when- and wherever NIH uses the term in relation to its funding of experiments on animals, ethics does not have its commonly implied meaning. In NIH's usage, the word in any connection to vivisection, refers only to its legality.

When NIH or one of its supported institutions or scientists say that their use of animals is ethical, all they really they mean is that it is legal. They seem to think that anything legal is ethical. Moreover, it has to be assumed that animals' pain and suffering is of such little concern or consequence to NIH's bioethicists that they need not even take notice of it.

This narrow meaning of the word has contributed to innumerable events that are universally thought of as having been profoundly immoral. (Slavery, state-sanctioned torture, and mass executions are just the tip of a very large mountain of examples. In many cases, philosophers -- the ethicists of the day -- defended the practices, or as today's NIH crew does, simply ignored them.) This narrow meaning of the word continues to shield immoral behavior and maintains barriers to moral progress on numerous important issues including how other animals are and should be treated by us. It seems that we never learn the lesson that legal and ethical should not be used interchangeably. It might have something to do with moral development. (See W.C. Crain. (1985). Theories of Development. Prentice-Hall. pp. 118-136. )

The NIH and its supported institutions and scientists tend to use ethics and ethical in ways that an unsuspecting reader would naturally and predictably interpret as meaning that the practices being discussed or defended are just or moral.

Consider the upcoming "NIH Workshop on Ensuring the Continued Responsible Oversight of Research with Non-Human Primates." (Wednesday, September 7, 2016, 9:00am to 5:00pm. It will be videocasted here: http://videocast.nih.gov.)

The NIH Office of Science Policy is organizing a workshop on September 7th, 2016, that will convene experts in science, policy, ethics, and animal welfare. Workshop participants will discuss the oversight framework governing the use of non-human primates in NIH-funded biomedical and behavioral research endeavors. At this workshop, participants will also explore the state of the science involving non-human primates as research models and discuss the ethical principles underlying existing animal welfare regulations and policies. NIH is committed to ensuring that research with non-human primates can continue responsibly as we move forward in advancing our mission to seek fundamental knowledge and enhance health outcomes.

The workshop is one result of PETA's successful lobbying effort that led to the closure of Stephen Suomi's lab at NIH. A few members of Congress were appalled by videos of some of the things being done to monkeys in the lab and complained to NIH Director Francis Collins (who not coincidentally is also a vivisector.) NIH followed the standard playbook and denied that the lab closure was due to the dust-up. Honesty is also implied by ethical when the term is used in its more commonly understood sense.

A bit of background about that case: copies of the videos were turned over to Peta in response to its public records requests. NIH could not resort to the usual claim that the evidence had been doctored by animal rights extremists; it was clear that the extremists were the NIH scientists performing cruel and macabre experiments on baby monkeys and their mothers. Suomi was the co-inventor of the infamous vertical chamber that made a name for UW-Madison as far as cruelty is concerned, or in the words of his teacher and co-inventor Harry Harlow, the "well of despair."

NIH has chosen not to name the participants in the workshop ahead of time -- the "experts in science, policy, ethics, and animal welfare." That doesn't seem too ethical to me. I'll wager right now that an overwhelming number of the experts will have obvious financial and professional interests in maintaining the status quo. The title of the workshop makes this even more likely "... Ensuring the Continued Responsible Oversight...". As if.

The workshop is actually just an appeasement to the members of Congress who were alarmed by the NIH's irresponsible sponsorship of Suomi's cruel and worthless very long career.

Given the background of the agency's leadership, it is unlikely that NIH would or even could convene a panel that might fairly evaluate the ethics surrounding the use of monkeys or any other animals in its funded research. An example of the agency's inability to grapple with this issue was seen pretty clearly during another NIH convened workshop, "The NIH Recombinant DNA Advisory Committee" meeting in June, 2014. See: "...an unbearable kind of suffering." (4-15-2016.)

It is interesting and germane to NIH's misuse of ethics and bioethics to note that if one visits the NIH homepage, and searches the site using bioethics, the first hit is The Department of Bioethics, which is part of the NIH Clinical Center. The Department of Bioethics provides an ethics consultation service for researchers, the Clinical & Research Ethics Services. Its stated purpose is to: "... improve the process and outcomes of clinical care and clinical research at times when ethical quandaries arise by addressing distressing concerns and questions, and assisting with identification and analysis of ethical issues."

Try as I may, I have been unable to find anything other than a topic on an obsolete list and a single name that even hints that the NIH Department of Bioethics has ever taken notice of any matter involving the use of animals. It is as if, no, that's not right, it isn't as if, let me say it plainly: Neither NIH at large nor the NIH Department of Bioethics, believes that the use of animals is an ethical concern. Maybe I'm wrong, but if so, they have hidden any evidence to the contrary.

But casual visitors might think otherwise. Under the section on Ethics of Clinical Research, among the five research areas listed is this: Research with Animal Populations. But after that mention, all reference to animals disappears.

The name I referred to above is David DeGrazia. But the chart has not been updated recently, and at least one of the people listed is deceased (Alan Wertheimer, PhD.) DeGrazia is the author of a number of academic articles on the ethics of animal research. [Nonhuman Primates, Human Need, and Ethical Constraints. DeGrazia D. Hastings Cent Rep. 2016 Jul;46(4):27-8; Necessary conditions for morally responsible animal research. DeGrazia D, Sebo J. Camb Q Healthc Ethics. 2015 Oct;24(4):420-30. And here.] His work related to animals does not seem to be mentioned or referred to on the NIH pages. If one searches his name from the main NIH page, there are multiple hits and some are for articles on the ethics of animal use. But these hits are links to PubMed which currently indexes over 26 million citations.

I contacted DeGrazia to ask whether he was still affiliated with Department of Bioethics; he confirmed that he is. (The inclusion of someone who had been dead for a while is what led me led to ask.) He has been a Senior Research Fellow in the department since July 2013. He was recommended as a participant for the "NIH Workshop on Ensuring the Continued Responsible Oversight of Research with Non-Human Primates," but told me that he was not invited. It seems to me that the failure to invite one of its own Senior Research Fellows in its own Department of Bioethics who has written and thought about the use of primates in biomedical research undermines the implication of the NIH's claim that they "will discuss the ethical principles underlying existing animal welfare regulations and policies." But maybe I'm wrong and there will be others included who are as qualified to talk about the ethics underpinning the use of monkeys. (I won't hold my breath.)

In any case, other than mention of DeGrazia's name and the single apparently obsolete listed topic name, there appears to be no mention or consideration of the ethics of animal use on the NIH Department of Bioethics webpages, the NIH site at large, or even a link to something elsewhere.

It seems to me that this absence on pages devoted to ethics, is telling. And then, there is the NIH Office of Laboratory Animal Welfare (OLAW). The word ethics does not appear on the homepage. If you click Useful Links, you are taken to an organized list of websites. This is the set of sites listed under Ethics:

1. Animal Ethics Infolink, Australia. Australia?

2. Guidelines for Ethical Conduct in the Care and Use of Nonhuman Animals in Research, APA. The American Psychological Association (APA) is a trade group with many members whose livelihoods are dependent on animal experimentation. Their Guidelines are simply a restatement of federal regulations and the urging of vivisectors not to break the law. It does not in any sense address the ethics of animal experimentation.

3. Information Resources for Institutional Animal Care and Use Committees 1985-1999: Ethics USDA. I thought this might lead to something substantive. On first blush, it seems to. Unfortunately, when drilling down from here, one hits one dead end after another. I was probably the first person to look at the page in a long time. The germane links in the pdfs refer one to the USDA's Animal Welfare Information Center, which in turn, directs users to various regulatory and policy documents. Again underscoring the misleading substitution of ethical for legal.

4. NASA Principles for the Ethical Care and Use of Animals. Right. NASA's history of animal use is the anathema of ethical.

5. National Health and Medical Research Council (NHMRC), Australia. Australia again?

6a. NIH Bioethics Resources on the Web This takes one to the Office of Clinical Research and Bioethics Policy mentioned earlier, which has no mention of animal use.

6.b Research Ethics, Laboratory Animal Care and Use. Which is a broken link.

7. On Being a Scientist: Responsible Conduct in Research, 1995, NAP. You can read the little booklet online. The word animal does not appear in the linked version. In a funny-ish twist, they point to the first edition of the booklet. The third edition is now in print. The third edition does mention animals somewhat frequently and always in connection with making sure that what is being done to them is legal. The ethics of animal use is not otherwise mentioned.

8. The Principles of Humane Experimental Technique, W.M.S. Russell and R.L. Burch, 1959, Johns Hopkins University, School of Public Health. This classic serves as the guide for all subsequent regulations and policies promulgated by vivisection trade groups, the industry, and the NIH. It is well worth reading and is available here. The work is only marginally on point however because it assumes and proceeds without explanation or argument that it is fitting and just to experiment on animals.

I don't think NIH is capable of convening a fair panel to discuss the ethics of animal experimentation. The agency is dominated by vivisectors and those with ties to the industry. See for instance, "It is Unethical for Carrie Wolinetz to be Involved in Any Policy Decisions Concerning the Use of Animals or Non-Human/Human Chimeras," and "Vivisectors at the Helm."

The upcoming "NIH Workshop on Ensuring the Continued Responsible Oversight of Research with Non-Human Primates" is probably going to be more of the same.

It is Unethical for Carrie Wolinetz to be Involved in Any Policy Decisions Concerning the Use of Animals or Non-Human/Human Chimeras

Within the past couple of days, according to Google, there have been about 140,000 news articles about the National Institutes of Health's announcement that it intends to start funding some human/nonhuman hybridization and allowing the creation of what are commonly referred to as chimeras.

NIH opened a 30-day window for public comment, but for those who might be opposed to this change in federal policy and choose to write them a thoughtful letter, they might as well shout their concerns into the toilet. (I still think you should write a letter.)

This is the sort of issue that should be debated in public and decided on by the public; 30 days is hardly enough time. So much for democracy.

One of the articles that showed up in my newsfeed was "You Can Now Grow Human-Animal Hybrids, But You Can’t Breed ‘Em," from Wired magazine. The article relies in part on an apparent conversation with Robert Streiffer, a "bioethicist" at the University of Wisconsin, Madison who once chaired one of the university's Animal Care and Use Committees and with whom I have occasionally argued. Over time, Streiffer has inched toward a more ethical position on animal use, and even publicly criticized vivisector Ned Kalin's revival of maternally depriving infant rhesus monkeys.

To Streiffer's credit, he apparently told the article's author that animals used in research have less protection that humans used in research. While that simple observation should surprise no one, it is the opposite of the university's usual claim. R. Alta Charo, for instance, the Warren P. Knowles Professor of Law and Bioethics at the university, is on the faculty of the Law School and the Department of Medical History and Bioethics at the medical school. She has served on many federal commissions related to bioethics. In a public forum ostensibly about the ethics of using animals in research, she ridiculously said: "We have federal laws [to protect animals in the labs] that actually go further than the federal laws that govern human subjects research...".

There are two main things that caught my eye in the Wired article, the main one has to do with consciousness, which I wrote about here. The other was this:

After a nearly year-long ban, on August 4 the NIH said it would soon lift its moratorium and again start accepting grant applications from vivisectors who want to develop human-animal chimeras. “We thought it was good time to take a deep breath, pause and make sure the ethical frameworks that we have in place allows us to move forward and conduct this research responsibly,” says Carrie Wolinetz, associate director for science policy at NIH.

Whenever NIH funding for animal experimentation is mentioned in conjunction with ethics my BS-meter goes berserk. And so, I Googled Carrie Wolinetz. All I can say is holy shit.

It would be impossible I suspect to have found someone with more love for experimenting on animals than Ms. Wolinetz. This is the NIH director's announcement of her appointment, plagiarized from here, and published on my birthday. The links in the text were added by me to clarify the positions on animal use of some of the organizations she has worked for.

February 2, 2015

Appointment of Dr. Carrie Wolinetz as Associate Director for Science Policy, NIH
Carrie Wolinetz, Ph.D.

I am pleased to announce the appointment of Carrie Wolinetz, Ph.D., as the new Associate Director for Science Policy, NIH. This appointment is effective February 23, 2015.

Dr. Wolinetz has most recently been serving as Deputy Vice President for Federal Relations with the Association of American Universities (AAU). Her primary responsibility was to coordinate advocacy on funding and policy issues relating to the National Institutes of Health and biomedical research.

Outside of AAU, Dr. Wolinetz serves as current President of United for Medical Research, a leading coalition of universities, patient groups, and private sector companies advocating for sustainable funding for the National Institutes of Health. [Essentially all the coalition members are very pro-vivisection.] In addition, she is an Adjunct Assistant Professor at Georgetown University in the School of Foreign Service’s program on Science, Technology & International Affairs, as well as past Chair of the advocacy committee for the Association for Women in Science (AWIS). She has a B.S. in animal science from Cornell University, and she received her Ph.D. in animal science from The Pennsylvania State University, where her area of research was reproductive physiology. [She seems to have published a single scientific paper.]

Prior to joining AAU, Dr. Wolinetz served as the Director of Scientific Affairs and Public Relations at the Federation of American Societies for Experimental Biology (FASEB), where she worked on a portfolio of issues that included federal funding of research, the use of animals in research, cloning and stem cells, and biosecurity.

I would like to thank David Shurtleff most sincerely for serving as the Acting Associate Director for Science Policy over the last several months. His wise and gracious leadership kept this critical part of NIH on a steady and effective path.

Please join me in welcoming Carrie to the NIH leadership team, congratulating her on her appointment, and offering her your full support as she begins her work with us.

Francis S. Collins, M.D., Ph.D. [and vivisector]

So, the woman who is apparently involved at a senior level in determining national policy on the creation of animal/human hybrids is now and has been in the past, immersed in organizations lobbying for more money for animal experimentation, reduced constraints on their use, and publicly promoting vivisection.

It is unethical for Carrie Wolinetz to be involved in any policy decisions concerning the use of animals or non-human/human chimeras.

As I said above, please do write a letter.

The NIH Faith-Based Policy on Non-Human/Human Chimeras

This essay was motivated by the August 8, 2016 article in Wired magazine: "You Can Now Grow Human-Animal Hybrids, But You Can’t Breed ‘Em." The article relies in part on a conversation with Robert Streiffer, a "bioethicist" at the University of Wisconsin, Madison who once chaired one of the university's Animal Care and Use Committees. (I qualified bioethicist because I don't think the title or label has much meaning. I mention a few reasons I think that later on.)

There are two things that caught my eye in the Wired article, the main one has to do with consciousness, which I wrote about here. The other was the obvious bias of those involved in the NIH policy change which I wrote about here. For more about the biases at NIH see: "Vivisectors at the Helm." 11-1-2014.

I suspect that some of the ideas in the article about consciousness are indicative of some broadly-held notions by many people. But those ideas are more along the lines of superstition or urban myth than anything else:

Last year, though, the National Institutes of Health banned funding of animal-human chimeras until it could figure out whether any of this work would bump against ethical boundaries. Like: Could brain scientists endow research animals with human cognitive abilities, or even consciousness....

Human cognitive abilities, or even consciousness?

Most of the animals people think about when they use the word animal in this context already have "human cognitive abilities." Obviously they don't have the same cognitive abilities of every human, but neither do I. It is hard to see what cognitive ability could be inserted into a monkey, dog, pig, or mouse used in a lab that would make his or her suffering any worse.

The idea that animals would suffer more if they were slightly or a lot more like us is an echo of the assertions made by racists. Blacks don't suffer like whites was a common claim by pro-slavery writers in the South. Jews and Poles aren't as aesthetically sensitive as pure Aryans; or honest and generous. These claims of superiority are always spawned by those in the self-proclaimed better, more important and deserving group. This hatred or at least minimizing of others seems to be a sickness common to humanity.

And what I wonder the author means by consciousness. Surely he doesn't believe that animals are unconscious. I'm guessing from the context that he would say he meant "human consciousness." But the distinction has no basis in fact. Consciousness is a mystery. It is sometimes referred to as the hard problem. Since it isn't understood -- at all -- suppositions about differences between kinds of consciousness are complete and completely unsubstantiable speculation. There is no reason at all to assume that an elephant's sense of him or herself is any different than yours. And even if you think there is, your belief is nothing but a wild guess. And probably driven by the same innate propensity that has led us to demean and enslave others.

The author writes:

The boundary between human and animal is not just a philosophical debate. Human subjects in medical research have greater legal protections than laboratory animals, according to Rob Streiffer, assistant professor of bioethics at the University of Wisconsin-Madison.

This may be the heart of the actual matter. NIH is worried about where to draw the line; costs might go up. In some southern states, the "one-drop" rule was adopted to clarify the boundary between whites and blacks; in Nazi Germany, a test based on one's grandparents was devised to determine which side of the line one was on. How many uniquely human genes must an animal have before he or she ought not be treated like an animal? As history makes clear, such trivial distinctions have been ample license to commit atrocities, and in the case of animals, they still are.

“What it takes to cross a line is a contentious issue,” says Streiffer. For example, some people believe that a lot of animal testing is wrong, because many animals can feel pain and suffering. Others argue that any organism that displays uniquely human traits—things like autonomy, moral reasoning, and controlling one’s own behavior—ought to be excluded from research.

I don't know who was responsible for that obvious rhetorical error. No organism other than a human "displays uniquely human traits." The rub is delineating the set of uniquely human traits and then explaining why some subset of them gives us the right to hurt and kill other animals. No one to my knowledge has been able to convincingly do so. That's not to say that no one has found those weak and self-serving arguments convincing, but many people also found (and find) the arguments for white supremacy convincing as well.

The author also talked to Stanford University vivisector Sean Wu who wants to humanize animals, probably pigs or sheep (he uses sheep now, but the effort to grow transplantable hearts is generally confined to pigs.)

Still, Wu says some ethical concerns about human behavior or functions being transplanted into animals are in the realm of science fiction. “There’s a lot of concern and speculation and no data that anyone can offer.”

It is unlikely that Wu could delineate any human behaviors or functions that set our suffering above the suffering of other animals. I suspect money affects Wu's opinions on this matter. His 2015 NIH grant 5U01HL099776-07, was awarded $1,605,838.

The author concludes his article with this:

One way to avoid the consciousness-raising quandary is by deleting bits of DNA that are responsible for the development of certain parts of the human brain before implanting into a lab animal. That way, you could still study the origins of Alzheimer’s or other brain diseases without worrying about creating a human-like animal. “The science is moving very fast,” says Wu. The NIH just wants to make sure its standards can keep up.

It appears that both he and Wu believe that they have a "higher consciousness" than animals. But this is just an expression of faith. It's like saying that only the faithful will get into heaven. Animals already are human-like because we are all each-other-like.

Let me finish with a thought or two about our unfortunate propensity to look to authorities for guidance and to trust their proclamations. Of course, we have to rely on those with technical knowledge we lack. I can't fix my television, rebuild the engine in my car, or remove your appendix without killing you. I've learned to rely on attorneys on most legal matters. On many such things, I usually seek multiple opinions prior to making a decision. But on moral issues, there are no experts, in spite of professional titles that imply otherwise.

NIH is going to claim that an appropriate ethical weighing was conducted when it officially starts funding this new wrinkle in hurting animals in publicly funded laboratories. They will have put safeguards in place to assure that the animals being used are not too much like us. Like Jews weren't too much like the good Germans. The vivisectors will be happy. But it seems very clear that if the NIH doesn't readily recognize that it is unethical for Carrie Wolinetz to be involved in any decision concerning the use of animals, why in the world should anyone believe them or believe that they have done a good job?

UW-Madison Lied to Feds, Misled Public, Put Humanity at Dire Risk

Note: Over the past almost two decades I have learned that when it comes to universities' and university officials' statements about their care and use of animals, about the benefits that have resulted and that will result in the future as a result of the things they do to animals, that they lie easily and repetitively. This lesson has led me to look carefully and with much doubt about every assertion they make, but particularly so when money and animals are involved. This doubt and skepticism and my anger and sorrow over the things they do to the animals they use contributed to my close watch of UW-Madison's promotion and hype about the influenza research conducted by Yoshihiro Kawaoka, particularly his efforts to invent viruses more deadly than any yet encountered and to test their effects on ferrets and monkeys. I have written about it with some regularity.

Estimates of the number of deaths cause by the 1918 Spanish influenza epidemic vary from 20 to 100 million. John M. Barry, in his book The Great Influenza says:

Although the influenza pandemic stretched over two years, perhaps two-thirds of the deaths occurred in a period of twenty-four weeks, and more than half of those deaths occurred in even less time, from mid-September to early December 1918. Influenza killed more people in a year than the Black Death killed in a century; it killed more people in twenty-four weeks than AIDS has killed in twenty-four years.

Over half of those who died in the 1918 pandemic were in their 20s and 30s, in the prime of their lives, not the elderly.

--------------------------------------

Two years ago, I again called Madisonians attention to the grave risks associated with Yoshihiro Kawaoka's influenza research at the University of Wisconsin-Madison. ("Flu lab accident could leave millions dead within weeks." Jul 8, 2014.) University officials Tim Yoshino and Susan West fired back with the claim that my "alarmist" letter was "irresponsible," but they provided nothing in rebuttal other than simple ad hominems. ("Tim Yoshino and Susan West: Rick Bogle's flu lab column irresponsible." Tim Yoshino and Susan West. Jul 11, 2014.)

Yoshino and West must have known when they wrote their response that serious accidents had recently occurred in the Kawaoka lab and that federal regulators had ordered a halt. At the time of their letter, Yoshino was the "responsible official" for UW-Madison Select Agent Program, and West was the chair of UW-Madison's Institutional Biosafety Committee.

International concern over influenza research like that occurring in the Kawaoka lab led to the current international moratorium and much continuing international debate.

Following the initiation of the moratorium, the White House Office of Science and Technology Policy and the Department of Health and Human Services instituted their own review citing the grave risks of the research and the serious biosafey errors and accidents with highly infectious agents at top labs across the country. News of these accidents led USA Today to investigate. The resulting report, "Biolabs in Your Backyard," was recently awarded a Scripps Howard Award for public service reporting. That report includes many thousands of pages of documents and correspondence that were obtained through Freedom of Information Act requests. The documents compiled by USA Today include over 400 pages of biosaftey committee minutes, laboratory accident reports, and correspondence between UW-Madison officials and the National Institutes of Health concerning accidents and violations. Local media has not reported on the serious problems in Kawaoka's lab discovered by USA Today.

Kawaoka's influenza research is conducted in a BSL3+ laboratory built for him by the university in 2006 for $11.4 million after the University ran into trouble with the Centers for Disease Control (CDC) over its approval of Kawaoka's Ebola experiments without the required level of biosafety. The BSL3+ lab (sometimes referred to as a Biosafety Level-3Ag lab) has been repeatedly characterized in local media as being only "half a notch below the top level" of biosafety. ["Following controversy, UW researcher's findings on bird flu virus published." Wisconsin State Journal. May 2, 2012; "UW-Madison study: New bird flu in China could cause global outbreak." Wisconsin State Journal. Jul 11, 2013; "UW-Madison flu studies raise risk more than prevent it, biosafety panelist says." Wisconsin State Journal. Jun 29, 2014.]

The very top level of biosafety is provided in BSL4 laboratories. In a BSL4 lab, workers wear space suits. In the documents obtained by USA Today, it is apparent that the "half a notch" difference between a BSL4 lab and Kawaoka's BSL3+ is pretty big.

On November 9, 2013, barely six months before I warned readers about the risks associated with an accident in the Kawaoka lab and Tim Yoshino and Susan West said my alarmist op-ed was irresponsible, a worker in Kawaoka's BSL3+ lab dropped a stack of culture plates infected with two varieties of influenza viruses: HPAI (highly pathogenic avian influenza) and H5Nl. The plates broke and spilled the contents onto the floor and may have splashed the researcher's bare ankles. University officials have said that the mutations of H5N1 studied in Kawaoka's lab are very dangerous. [Susan West and Timothy Yoshino: UW flu research is important and safe. Wisconsin State Journal. Jul 2, 2014.] The university reported the event to the NIH, as they are required to do. In their report, they said that the researcher did not think that the material had come into contact with his or her exposed bare skin, but wiped their legs with disinfectant nevertheless. The doctor on call at the University hospital did not think there was a need for the researcher to take Tamiflu, but the person involved in the incident and others more familiar with the seriousness of the risk insisted.

The NIH chastised UW-Madison for allowing anyone to work in a BSL3+ laboratory with exposed skin. Essentially all biosafety accidents are the result of human error and institutional malaise. The potentially exposed researcher was not quarantined.

Kawaoka's influenza experiments have been of particular concern to public health officials outside Wisconsin due to his manipulations of the viruses' genes to produce new-to-the-world influenza viruses, or what some scientific reports have termed "novel potential pandemic pathogens" or PPPs. These are recombinant viruses; they are laboratory creations and worry many observers. These genetic recombinations can result in what is termed a gain-of-function, and are used in what is termed GOF research.

Genetic manipulations can make viruses more pathogenic and more easily transmitted. In GOF research, viruses with only limited virulence can be altered to be more dangerous. Kawaoka was making already very dangerous viruses even more dangerous. His work is a big part of what led to the current, perhaps temporary, international moratorium on this line of research. Kawaoka was one of only two researchers pursuing this supercharging of influenza viruses; the other was a scientist in The Netherlands. Kawaoka et al have reported that infected monkeys were euthanized after developing a high fever, were huddled in a corner of their cage, their hands and toes clenched, and were bleeding from the skin. [Itoh, Yasushi, et al. "Protective efficacy of passive immunization with monoclonal antibodies in animal models of H5N1 highly pathogenic avian influenza virus infection." PLoS Pathog 10.6 (2014): e1004192.]

On November 16, 2013, a worker in Kawaoka's BSL3+ laboratory stuck him- or herself with a hypodermic needle containing recombinant H5N1 containing genes from a strain of H1N1. It was an H1N1 strain that was responsible for the 1918 Spanish flu, the most deadly disease yet encountered. The seriousness of the exposure was recognized by university doctors, but the university's response put the public at risk. The use of the needle in and of itself was apparently a violation of University policy concerning activities in the BSL3+ laboratory.

But more troubling and much more worrisome from a public heath perspective is that the University appears to have misled federal regulators in order to get approval for these experiments.

In a December 16, 2013, letter to the University, included in the US Today documents, the NIH writes to Daniel Uhlrich, Ph.D., Associate Vice Chancellor for Research Policy, UW-Madison:

In follow-up conversations with you and Rebecca Moritz regarding your occupational health plans, you state that all exposures, including high risk exposures, would follow the same protocol, i.e. home isolation after removing the family from the house. Your decision was based upon consultation with your infectious disease experts and the state health department. You had rejected using a hospital room for quarantine because of the stress on the laboratory worker. This policy is not what was communicated to us in Dr. Kawaoka's application to perform research with mammalian transmissible strains of H5N1 that was provided to the Department of Health and Human Services. In a May 6, 2013, plan provided to NIH, Dr. Kawaoka indicated that he had access to a "designated quarantine apartment" in which researchers could be placed for 10-14 days in the event of an accidental exposure.

The University must find a dedicated facility outside of the individual's permanent residence in which (1) an individual can be safely isolated for up to 10 days, and (2) that can be decontaminated easily after the individual's departure. [This requirement and emphasis was contained in two separate letters from the NIH in response to the University's explanation of the accident.] An isolation room in a hospital would be appropriate. An individual's permanent residence is not appropriate due to the fact that many residences are in buildings with high occupancy that share air exchange and other infrastructure. Please provide revised SOPs that reflect an appropriate quarantine arrangement. No research with mammalian transmissible H1Nl stains may be carried out until this plan is operationalized. [Emphasis in original]

Contrary to what they had said they would do, the University simply called the researcher's family and told them to vacate their residence. Then, in an apparently unsecured vehicle, they took the accident victim home -- a potential patient zero for a global pandemic -- with a glove on their hand and wearing a mask without an exhalation vent -- and told him or her to stay there. There is no mention of any additional security.

In their response letter to NIH, dated December 20, 2013, the University promised that in the future, "Sharp needles will only be used for administering drugs to animals and drawing blood from animals. When either of these procedures are being done with reconstructed 1918 influenza or mammalian transmissible influenza viruses, two people will be required for the procedure."

On March 10-11, 2016, the National Academies of Sciences, Engineering, and Medicine held its second symposium on gain of function research. (National Academies of Sciences, Engineering, and Medicine. 2016. Gain of Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press.) Nothing was decided, but it is clear from the report that many scientists and public health officials remain very worried that GOF research with influenza viruses will be allowed to resume.

Tim Yoshino and Susan West called my letter to Madisonian's irresponsible and alarmist, probably because I observed that an accidental (or intentional) release of a modified influenza virus from the Kawaoka lab could result in millions of deaths within a matter of weeks. They claimed that I had not taken the time to learn about that which I was writing.

I believe that they each and together violated the public's trust; I believe that senior University of Wisconsin-Madison officials and local public health officials have violated the public's trust.

Very well informed and senior infectious disease experts have voiced their alarm. Yet, locally, little is reported, much is hidden. I believe that these violations of the public's trust were and are predictable because of the very large sums of money added to the University's coffers as a result of Kawaoka's research and the propensity of people to obey those they deem to be authorities. Added to this is the phenomena of conforming to the norm, which probably led public health officials to remain silent; after all, local media was not doing any significant or investigative reporting on these problems. Media's silence may have encouraged public health officials to get in line and to avoid a close observation of the situation and to go along with whatever the University experts told them to believe. Madisonians have largely been kept in the dark.

"Given historic estimates of influenza’s spread across the globe (∼24–38% of the world’s population), it is estimated that a pandemic of a highly virulent influenza strain, such as those created in GOF/PPP experiments, could cause between 20 million and 1.6 billion deaths." Evans, Nicholas Greig, Marc Lipsitch, and Meira Levinson. "The ethics of biosafety considerations in gain-of-function research resulting in the creation of potential pandemic pathogens." Journal of Medical Ethics 41.11 (2015): 901-908.

"...an unbearable kind of suffering."

NIH Recombinant DNA Advisory Committee - June 2014

After listening to about an hour of discussion concerning the housing and biocontainment methods required for nonhuman primates used in bio-safety level 4 (BSL-4) laboratories, the University of Wisconsin-Madison representative on the committee, Norm Fost, offered a comment. No one on the committee or any of the representatives from institutions with these high-containment laboratories using monkeys responded to him. But what could they have said? (Stick BSL-4 in the search window above for many essays and links concerning biosafety in these labs.)

Norm Fost is a Professor Emeritus, Pediatrics and Bioethics.

A video of the meeting is available here: https://videocast.nih.gov/summary.asp?Live=14300&bhcp=1 The discussion about monkeys begins at about 4:00:00; Fost's comments at about 5:00:00. This is my transcription of his oral comments, any errors are mine.

I apologize if anything I say offends any of the many investigators and lab personnel and others who I know care deeply about these animals and obviously about the scientific importance of the research, but I must say all of this I find very troubling.

We would obviously not put humans in any of these kind of cages or rooms or [undecipherable]

In fact its a reason it's a preferred method of torture because it constitutes an unbearable kind of suffering.

It's been now 40 years since Harry Harlow at the University of Wisconsin, his disciple Steve Suomi at NIH, formally at Wisconsin, and Deborah Blum, a Pulitzer prize-winning writer on the faculty at the University of Wisconsin wrote her famous book about all this.

It's been well established for 40 years that the way monkeys experience this kind of deprivation, isolation and so on is indistinguishable from humans. That is, any measures you can make: hormonal, behavioral, long-term psychosocial and behavioral problems, it's not possible to discriminate any difference in the way monkeys respond to these sorts of things from the way humans [do]. That's why they are such fabulous animals if you're studying at least psycho-scocial responses to stress and deprivation you can draw conclusions about interventions that would be highly likely to be replicable in humans, unlike rats or mice or other kinds of animals.

So, if we would never do this to a human, and we wouldn't say its justified by the enormous amount of benefit that would come out of it, its hard to come up with a reason for doing it to primates other than just sheer speciesism, just that we can do it, we have the power to do it.

So, this discussion about big cages versus small cages or big rooms versus little rooms is beside the point.

I find the whole enterprise very troubling, with complete respect for the dedication of the people who are doing this for very admirable reasons and for the benefits that hopefully come out of it.

Blue Ribbon Panel Announced

An April 4, 2016 news release from the National Institutes of Health (NIH) was titled: "Blue Ribbon Panel Announced to Help Guide Vice President Biden’s National Cancer Moonshot Initiative." It seems inevitable that their eventual recommendation will be dressed up with lots of words and will be widely ballyhooed when it is published, projected to be sometime in December 2016.

The ballyhoo has already begun with universities announcing the inclusion of their experts on the panel.

Distilled, it will be easy to understand: "Give us more money."

The Moonshot will apparently add an additional $1 billion to the cancer research public expenditure.

The National Cancer Institute's allocation in the 2016 Consolidated Appropriations Act is already $5.21 billion, an increase of $260.5 million over fiscal year 2015. Oddly, the NIH also reports that NCI is currently providing $7,215,203,202 in funding for 9,759 projects. NCI is the largest agency in the NIH, in terms of number of funded projects and expenditures.

The Chair and Co-Chair's research suggests that the Blue Ribbon Panel's recommendations are unlikely to deviate from the current norm; the biases inherent in normal science will guide the panel and probably led to the selection of the members.

The Chair is Tyler Jacks. His lab's webpage explains: "The Jacks Lab is interested in the genetic events contributing to the development of cancer. The focus of our research has been a series of mouse strains engineered to carry mutations in genes known to be involved in human cancer. We also study the effects of these mutations on normal embryonic development and use cells derived from mutant animals to study the function of these genes in cell culture models." Just more of the same dead-end lunacy.

The Co-Chair is Elizabeth Marion Jaffee. She has argued that what are needed are cancer vaccines and has already identified the sort of work that she will probably recommend for more funding, the majority of which use mouse models.


It appears that about a third of NCI's 9,759 funded projects involve vertebrate animals including 3,053 projects already involving the use of mice.

The use of the term moonshot was unfortunate. Vice President Biden explained it this way:

Fifty-five years ago, President John F. Kennedy stood before a joint session of Congress and said, “I believe we should go to the moon.”

It was a call to humankind.

And it inspired a generation of Americans — my generation — in pursuit of science and innovation, where they literally pushed the boundaries of what was possible.

This is our moonshot.

I know that we can help solidify a genuine global commitment to end cancer as we know it today — and inspire a new generation of scientists to pursue new discoveries and the bounds of human endeavor. [Italics in original]

The use of the term moonshot is unfortunate because it suggests that ending cancer is possible if we just commit enough resources to the problem; after all, it was just such a commitment that got us to the moon. But the two problems are not at all the same. Getting to the moon was essentially a technical problem while ending cancer is a scientific problem. Science and technology are not synonyms.

Science and technology frequently inform and contribute to advances in the other endeavor and there is much overlap. Better microscopes led to an increased appreciation and study of a previously unimagined part of nature. Technological advances are often the result of scientific discoveries like x-rays. But before the accidental discovery that the rays could pass through our bodies, no one imagined it ahead of time. The possibility was outside the paradigm. Prior to the discovery, no amount of money would have led to the development of x-ray machines.

There has been much written over the years about the lack of progress that has resulted from the use of animal models of cancer. Many voices have come from within the research community. Irwin D J Bross, head of research design and analysis at the Sloan Kettering Cancer Institute was consistent in his criticisms. Dr. Richard Klausner, director of the National Cancer Institute, famously told a Congressional committee that: "The history of cancer research has been a history of curing cancer in the mouse. We have cured mice of cancer for decades--and it simply didn't work in humans." Here's a list germane quotations.



All the money in the world will not lead to the end of cancer because the dominant paradigm leads to researchers being paid to keep doing more of the same. A huge industry rests firmly on the flow of money from the federal government to keep creating animal models of cancer. Huckleberry Finn told Tom Sawyer that the best way to get rid of warts was to take a dead cat to a graveyard where someone wicked was buried, wait until midnight for the devil to come, and then to throw the cat at the devil while saying, "Devil follow corpse, cat follow devil, warts follow, cat, I'm done with ye!" Neither method is efficacious.

Dave O'Connor: "Sad and heartbroken."

One of the most insidious accomplishments of the vivisection industry has been the corruption of science journalism. This happened because life science writing programs are housed at universities that benefit from having articles about their research published in mainstream media. Students have access to local scientists for interviews and practice their writing under the tutelage of accomplished writers who have already written favorably about the use of animals in research. The indoctrination is probably subtle, but the effects are seen everywhere one looks.

A recent example is NPR's report on David O'Connor's experimental infection of rhesus monkeys with the Zika virus, the disease de jure. The science writer seems to want her readers to have a good impression of O'Connor:

"O'Connor says that he can feel a moral need to do this kind of animal research and at the same time feel 'sad and heartbroken' at what the work entails. 'I don't think those two are mutually exclusive,' he says. And then she quotes him again: "I've come to the conclusion that there is an ethical and a moral imperative to study the most relevant animal model to get the most impactful and valuable data."

What a guy.

But O'Connor's lament and ethical justifications should be examined in light of his previous work rather than an appeal to a "public health emergency" during which, apparently, anything goes. That's pretty much the same excuse that was used to justify the torture at Abu Ghraib prison. In both cases, better, more useful information was and is available through less hideous means.

O'Connor says, according to NPR's science writer, that he feels "sad and heartbroken" about infecting monkeys with the Zika virus. He should have added that he feels that way all the way to bank. That would have been a little more honest. So far, in his Zika studies, O'Connor seems to have infected three young males and one pregnant female. At the same time, public health officials and medical doctors have been studying hundreds, maybe thousands of women and their babies. The history of medicine gives a good notion of which body of research is likely to provide benefit.

Looking at O'Connor's publishing history on PubMed, it appears that he has been using and killing monkeys since at least 1999; I suspect even he may not know how many monkeys he has infected and killed, but his career rests squarely on their corpses. Over the ensuing years he has made millions of dollars infecting and killing monkeys. This is his (partial) NIH grant history while at UW-Madison. They all use monkeys:

2009-2013: DEFINING THE IMPORTANCE OF CD8+ T CELL BREADTH IN SIV/HIV PROTECTIVE IMMUNITY. Total project funding amount: $3,241,340.

2011: NHP MHC GENE DISCOVERY AND TYPING TECHNOLOGY DEVELOPMENT. Total Funding: $6,569,785.

2005-2013: IMMUNOGENETICS OF PRIMATES USED FOR BIOTERROR RESEARCH. Total project funding amount: $4,406,491.

2006-2007: SIV-SPECIFIC CD8+ T-CELL IN MAURITIAN CYNOMOLGUS MACAQUES. Total project funding amount: $507,040.

2008-2015: ADOPTIVE TRANSFER OF IMMUNITY ELICITED BY ATTENUATED HIV VACCINES. Total project funding amount: $5,433,316.

2009-2013 EXPLORING IN VITRO AND IN VIVO T CELL IMMUNITY TO SIV WITH MHC-IDENTICAL MACAQUES. Total project funding: $1,694,161.

2016: DEFINING SOUTH AMERICAN ZIKA VIRUS SUSCEPTIBILITY AND PATHOGENICITY IN ADULT AND NEONATAL NONHUMAN PRIMATES. $263,233. This project is a subproject of his 2015 grant GBV-C-MEDIATED PROTECTION FROM AIDS IN HUMANS AND GBV-C/SIV CO-INFECTED MACAQUES which received $665,879. Total funding for the grant in 2015 and 2016 was $929,112.

2014-2015: IDENTIFYING COMMON T CELL RESPONSES TO MAJOR PATHOGENS IN RHESUS MACAQUES. Total project funding: $1,354,157.

On top of that, he also receives $186,311 in salary from the university.

If you visit his lab's website, you'll see that he loves selfies. He does not appear to be someone wracked with sadness or suffering from a broken heart. No, he seems quite happy, giddy even at times, which makes sense given the fact that in his line of work, the only thing that matters is getting papers into journals -- no matter the actual low value of the information in the papers for the purported beneficiaries, taxpayers. Check out the videos on his website.

Postscript, after posting this, O'Connor got rid of the his selfies and and completely revamped his website.

Watch the video here.

Responding to Another Pile of VS* from UW-Madison

One way to tell whether or not your criticisms are having an impact is to consider the response from those you criticize. Using that measure, it is clear that Dr. Ruth Decker's criticisms of UW-Madison psychiatrist Ned Kalin's experiments on baby monkeys and her criticisms of publicly-funded experiments on monkeys across the country is having a significant impact on vivisectors at the University of Wisconsin Madison. They seem to be pooping their pants.

The UW primate vivisectors' knee-knocking response to Dr. Decker's new petition is understandable. Her first petition was a large factor in forcing the university to (slightly) modify the cruelty to the infant monkeys being used in one of Kalin's richly-funded projects. He was forced to abandon his use of maternal deprivation. Dr. Decker's new petition casts a much wider net, putting the university's tax-dollar gravy train in some jeopardy.

I have included a link to their tiresomely long effort to defend themselves and discredit Dr. Decker below. (The university did not include a link to Dr. Decker's petition.) Here, I am going to make some observations about a few of their claims. Keep in mind that the university's new chief vivisection propagandist, a likely co-author of the university's unattributed essay, is Allyson Joy Bennett, a primate vivisector with close ties to Stephen Suomi, the co-inventer of the diabolocal "vertical chamber" or "Well of Despair," as his co-inventor Harry Harlow liked to call it. Bennett is a leading member of the pro-vivisection anything-goes extremist cult "Speaking of Research," a branch of the pro-vivisection anything-goes extremist cult "Pro-Test," started by a 14-year-old boy in England.

The title of the university's essay is "Responding to another Ruth Decker change.org petition," which makes it pretty clear that she has their attention. I wonder how the authors' time to write this essay was billed? Whenever the university has to respond to a public records request they always make claims about the labor costs of having to do so. I don't wonder about the billing too much though, they are being paid by taxpayers to hoodwink taxpayers; what a job.

The university starts out with their most stinky bit of VS and says that they "appreciate and share the concern for animals that leads people to add their names to the petition." They share the same concern for animals that leads people to ask them to stop hurting and killing animals? Up is down.

The university's anonymous authors say that Dr. Decker's petition piles up mistakes, myths, exaggerations, omits important information, and tells people with "little understanding" of "real science" to speak out. The authors expound on what they imply is the evidence of Dr. Decker's purported failings and say that those failings are unfair to the people who signed the petition, are unfair to Kalin and Suomi, to other vivisectors, or to the millions of people suffering from mental illness.

It must be reassuring for the vivisectors to believe that most of their critics are simple bumpkins who don't understand science. But in fact, the vivisectors either don't understand science or else know that what they are doing isn't good science and simply don't care. It's apparently easy not to care when you are getting rich by doing so.

You may think that my statement about the lack of good science in the animal labs is hyperbole or simple rhetoric, but it's not, and the problem has been recognized and written about in mainstream science journals for a fairly long time now which makes its continuation all the more troubling, particularly when those being paid for conducting the junk science, like the university's vivisectors, keep telling the public that they are doing important work.

The most recent example (as of 2-16) was the June 9, 2015 paper, "The Economics of Reproducibility in Preclinical Research." The authors lead off with this matter-of-fact observation:

"Low reproducibility rates within life science research undermine cumulative knowledge production and contribute to both delays and costs of therapeutic drug development. An analysis of past studies indicates that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28,000,000,000 (US$28B)/year spent on preclinical research that is not reproducible—in the United States alone."

("Preclinical" includes all animal-based biomedical research outside of veterinary research on the species of animals the research is looking at, like studying FIV in cats by using FIV-infected cats.)

The authors go on to say that. "Flawed preclinical studies create false hope for patients waiting for lifesaving cures; moreover, they point to systemic and costly inefficiencies in the way preclinical studies are designed, conducted, and reported." It is exactly this false hope and fear that the vivisectors cultivate as they prey on the public; a public misled by the vivisectors into thinking that what they are doing is "real science."

A foundation stone of real science is reproducibility. If no one working in another lab can reproduce another scientist's work then it is of no merit. The vivisectors' work largely fails on this point alone. But equally damning is the very poor applicability or translation rate of the preclinical studies. This problem too has been written about ad nauseam. In response, using a tactic seeming out of Orwell's 1984, the bloated research universities fell all over each other rushing to establish this and that "Center for Translational Research," (be sure to use a grandiose intonation) as if saying that they were doing "translational research" would magically transform junk data from animal experiments into wonder drugs for humans.

Again, you may think that my statement about the overall failure of the science in the animal labs is hyperbole or simple rhetoric, but it's not. Here's a passage from the June 5,2014 BMJ that provides a nice summation:

Ten years ago in The BMJ Pandora Pound and colleagues asked, “Where is the evidence that animal research benefits humans?”(doi:10.1136/bmj.328.7438.514). Their conclusions were not encouraging. Much animal research into potential treatments for humans was wasted, they said, because it was poorly conducted and not evaluated through systematic reviews.

Since then, as Pound and Michael Bracken explain this week (doi:10.1136/bmj.g3387), the number of systematic reviews of animal studies has increased substantially, but this has served only to highlight the poor quality of much preclinical animal research. The same threats to internal and external validity that beset clinical research are found in abundance in animal studies: lack of randomisation, blinding, and allocation concealment; selective analysis; and reporting and publication bias. The result, said Ioannidis in 2012, is that it is “nearly impossible to rely on most animal data to predict whether or not an intervention will have a favourable clinical benefit-risk ratio in human subjects.”

Such wastage is as unethical in animal as in human research. Poorly done preclinical research may lead to expensive but fruitless clinical trials exposing participants to harmful drugs. And of course there is the unnecessary suffering of the animals involved in research that brings no benefit.

Again, the fact that animal-based studies are usually worthless, frequently misleading, and usually altogether forgotten isn't a secret. Anyone the least bit tuned in to the debate about the use of animals knows about these problems, the junk science, the waste of public dollars. And yet, university vivisectors continue to sing the same siren song -- all medical progress relies on animal experiments. That's wrong. If they know it, and say otherwise, as the authors of the university's attack on Dr. Decker do, then they are liars who have no concern for the people suffering from the ailments and maladies putting their trust in the decision-makers at the university and the NIH. It appears to me to be wholly immoral.

The authors go on to say that the truth doesn't matter to "activists" trying to stop the vivisectors. But as the evidence above makes clear, it is they who deny the plain facts as reported in the mainstream science journals.

The authors then attempt further wool-pulling by ginning up some nonsense that they believe will fool the average reader.

They claim that the "scientific and medical leadership of our country have determined that animal research plays a fundamentally important role in scientific studies that advance the health of the nation." But that's far afield from the actual facts. Taxpayer dollars are used to fund the NIH's lobbying efforts. The senior scientists at the NIH are for most part vivisectors who have gained positions of power. When they send a letter or meet with a member of Congress, it is understandable that they are believed when they say that NIH is making good decisions. We tend to believe those we deem to be authorities. This is what the university and the NIH bank on -- all the way to the bank.

Then the authors make the claim that experiments on monkeys are "critical" to scientific research and as evidence they provide a list of serious ailments that are understood, prevented, and treated they say, as a result of experiments on monkeys. They are in good company. In 2000, NIH/NCRR (a defunct branch of the NIH) endorsed an expansion of primate-based biomedical research in the "Full Scale Evaluation of the Regional Primate Research Centers Program—Final Report (Office of Science Policy and Public Liaison, National Center for Research Resources/NIH. 2000), saying that experiments on monkeys and chimpanzees were "crucial" to the study of the most frightening diseases. I looked into their claims in 2003, and found them to be as silly then as the university's are now. See the accompanying article here.

The university's authors say, "Although the petitioners may believe that animal research supported by NIH is a waste, there is no evidence that the majority of the American public concurs." But they are again being misleading, which they must realize. The Pew Research Center wrote in 2015 that: "The general public is closely divided when it comes to the use of animals in research. Some 47% favor the practice, while and a nearly equal share (50%) oppose it. Support for animal research is down somewhat since 2009, when 52% of adults favored and 43% opposed the use of animals in scientific research." They went on to report that 62% of women are opposed to vivisection.

The authors then make the wild assertion that they have the moral high ground! "... failing to engage in and support research that is ethical, humane, and well regulated would be an abdication of our moral obligation...". Wow. Torturing baby monkeys will never be seen as the moral high ground.

Then they say that Kalin's and Suomi's career-long torture of young monkeys is valuable and ethical and calls them "two of the nation’s leading scientists." While they could be among the richest and while Suomi must be one of the tallest, they lead only those who conduct similarly worthless, non-replicable, cruel experiments. The university then claims that Kalin's work must be good and important because it was "reviewed and supported by panels of scientists at the National Institutes of Mental Health (NIMH)."

But again, they know full well that the majority of the scientists serving on the panels that approved Kalin's cruelty are themselves vivisectors. Again, the authors seem intent on hoodwinking their audience.

They appeal to authority rather than facts when they write that Tom Insel, director of NIMH until November 2015, claimed that the Ebola outbreak proved the importance of animal research. The authors fail to mention that Insel is a past Director of the NIH's Yerkes Primate Research Center, a mega-lab at Emory University in Atlanta infamous for its cruelty to monkeys and to chimpanzees, or that Insel was an outspoken proponent of the use of chimpanzees in HIV studies, a completely discredited line of research. His opinions on any matter having to do with the ethics of animal experimentation are biased at best.

And, Insel's claim that animal research had any impact whatsoever on the course of the recent Ebola outbreak is far afield from reality, but hey, as we've seen already, facts hardly matter to those whose incomes are dependent on bamboozling the public. The World Heath Organization is hopeful but says clearly that, "At this time, there are no vaccines to protect against EVD [Ebola virus disease] licensed for use in humans."

The authors repeat Kalin's debunked claims about the importance of his experiments on monkeys, blowing more spoke up the behinds of those they hope don't understand science or take the take the time to do a little research on their own. That's the sort of thing charlatans count on.

And the VS just keeps coming. The authors -- and let me remind you that Allyson Joy Bennett is a past co-author with Suomi -- claim that because Suomi published over 500 papers and that because he has been cited over 10,000 times that his work must be important. But there are a lot of citations of various claims made in all sorts of matter-of-factly wrong reports. I hate to say it, but no one has risen from the dead -- no matter how many times it is claimed otherwise. Sillier still is their claim that because professional associations of vivisectors defended Suomi after it was announced that the NIH was shutting his lab down, that his work was important. The assertion simply underscores the fact that they assume their readers are ignorant, wowed by big numbers and too stupid to see through their fiction.

The claim that publishing many papers proves someone's work is important is just another example of the authors not really understanding science. Quantity and quality have little to do with each other. In case you think being published in a science journal means that someone's work is important, consider this: "Why most published research findings are false." (John Ioannidis. PLoS Med, 2(8), e124. 2005.)

The authors claim that the decision to use animals to study human psychiatric disorders (or for any other reason, presumably) is not made lightly, and they are right. It is made only after one learns that they can get rich doing so, regardless of the results.

And then, heaping absurdity upon absurdity, they state that "consideration of viable alternatives to research with live animals is a basic ethical principle that undergirds the conduct of all research with nonhuman animals." What a sad joke on the animals. Ethics and the use of animals have nothing in common. They are opposites. If it were otherwise, lifetimes would not be spent moving from animal experiment to animal experiment as so many vivisectors do.

The authors claim that Dr. Decker and those who have signed her petitions may not be aware that there is a regulatory system in place that is supposed to assure that animals are used only when necessary and only as humanely as possible. They claim that "the petitioners" ignore this "to further their agenda." But the authors are in a position to know full well that the regulatory system does not work. They are in a position to know that the university violated Wisconsin's anticruelty statutes for years while killing sheep in decompression experiments and staging fights between mice. They are in a position to know that researchers have hidden expired medications from federal inspectors, have paid no attention to dogs suffering after surgeries, have let cows die of starvation, allowed slipshod surgical procedures on monkeys's brains to continue for years, let hundreds, maybe thousands of animals die of thirst, to mention just a few of the problems that have come to light while operating under the "stringent regulatory oversight system" they claim should put everyone at ease.

It is possible that the authors simply can't recognize suffering when they are so enmeshed in the system that causes it.

The authors write: "Research animals are treated humanely. Research conducted with animals is highly regulated at the local, state and federal levels. The No. 1 priority for UW–Madison’s scientists, veterinarians, animal care personnel and institutional animal care and use committees is ensuring the welfare and humane treatment of animals used in ethically and scientifically sound research. In addition to honoring their ethical obligation, scientists maintain the highest standards of animal care to ensure that research results are scientifically valid."

I don't think one single assertion in that statement is correct. Not one. This would have been much closer to the truth: "Research animals are treated like the tools they are. Research conducted with animals is not regulated at the local or state level and is only nominally regulated at the federal levels. The No. 1 priority for UW–Madison’s scientists, veterinarians, animal care personnel and institutional animal care and use committees is cashing their pay checks. They have no ethical obligation to maintain anything other than the most minimal standards of animal care and get angry when someone says otherwise. They all know that their research publications pretty much meaningless."

Publicly-funded scientific research with animals receives no meaningful review; career scientists receive rubber stamp approvals. Proposals for research undergo scientific review from other vivisectors who know that their own proposals will be treated similarly. The importance of the research questions don't matter too much, the quality of the research approach and investigators, and the likelihood of the project’s success is of little account. Senior researchers get long-term funding even though everyone knows or should know that nothing of value will result from their tortuous experiments.

The authors conclude with the hollow observation that oversight at the university is the obligation of committees that include veterinarians, members of the public, scientists and others; but they fail to mention that these committees have been handmaidens to all the regulatory and legal violations that have occurred at the university over the years. They must have forgotten to say that.

Here is a link to Dr. Ruth Decker's petition, I urge you to add your name to it: https://www.change.org/p/members-of-congress-stop-wasting-tax-dollars-to-torture-and-kill-monkeys-for-bad-science

The university's VS: https://animalresearch.wisc.edu/responding-to-another-ruth-decker-change-org-petition/

* VS is much stinkier than plain old BS.