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Saturday, September 10, 2016

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.)