Tag Archives: animal welfare

Research Roundup: Malaria vaccine, mouse sperm in space, animal welfare prizes, and more!

Welcome to this week’s Research Roundup. These Friday posts aim to inform our readers about the many stories that relate to animal research each week. Do you have an animal research story we should include in next week’s Research Roundup? You can send it to us via our Facebook page or through the contact form on the website.

  • New study finds that mouse sperm stored in space still functions on Earth. Increasingly in the news we read about the upcoming reality of commercial space travel (for example, here and here). Of course, with such advances there is caution with respect to feasibility — and of course imagination with respect to possibilities (e.g., colonizing Mars). With such goals on the horizons, these researchers investigated whether sperm that had been freeze dried, and transported to the International Space Station (ISS) and then back to Earth would be able to produce viable offspring. To accomplish this they used freeze dried mouse spermatozoa — which provided a unique advantage, as the addition of water — maintains the viability of the sperm to fertilize an egg and allows for the sperm to be stored at room temperature. Other sperm when freeze dried do not survive. Microinjection  of these “space” sperm into an egg on Earth — produced healthy viable  “space offspring”. Moreover, these offspring all grew to healthy adults and were able to produce offspring of their own. This study was published in the Proceedings of the National Academy of Sciences of the USA.

Space mouse and pups. Source: PNAS

Laboratory frogs. Source: University of Portsmouth

  • Modified experimental vaccine protects monkeys from deadly malaria. Researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, discovered that a modified version of an experimental malaria vaccine completely protected 4 of 8 monkeys from a malaria parasite, and delayed the first appearance of the parasites in 3 more monkeys. Scientists modified an existing malaria vaccine by including a particular protein, RON2L, so that it closely mimicked the protein complex used by the parasite to infect blood cells. Vaccination with the modified vaccine resulted in more neutralizing antibody, indicating a better quality response to parasitic infection. Additionally, the modified vaccine seemed to protect against other parasite strains that differed from those used to create the vaccine, suggesting that this new modified vaccine may protect against multiple parasite strains. This research will pave the way toward eventual human trials. The study was published in NPJ Vaccines.

A female Aedes mosquito. Source: NIAID.

 

 

 

 

 

 

 

 

 

 

 

  • Researchers at the University of Helsinki has found the lymphatic vessels extend into the brain – overturning 300 years of accepted wisdom. By genetically altering mice using the luminescent GFP gene, so that lymphatic vessels glowed under light, Aleksanteri Aspelund found that there were lymphatic vessels in the brain. The research was repeated by Karl Alitalo with the same results.  Other researchers have found evidence linking problems with the lymphatic and glymphatic systems to Alzheimer’s; one study in mice showed it could lead to the buildup of amyloid beta in the brain – a key sign of the Alzheimer’s. The study was published in the Journal of Experimental Medicine.

    Red fluorescence of the membrane protein aquaporin-4 in an individual with Alzheimer’s (left) and a healthy individual (right). Source: OHSU

  • Mice help researchers identify genes responsible for a severe congenital heart defect.  Congenital heart disease affect up to 1 percent of all live births. Hypoplastic Left Heart Syndrome (HLHS) is a rare congenital heart disease resulting in an inability to effectively pump blood  throughout the body.  Current treatment involves multiple complex surgeries during the first few years of a child’s life. For some, the surgical interventions improve heart function.  For others, it does not,  leading to heart failure and the need for heart transplants. It has been known that genetic risk factors play a role in HLHS but specific genes have been hard to identify.  Researchers at the University of Pittsburgh Schools of the Health Sciences used fetal ultrasound imaging to look for structural heart defects in genetically modified mice to identify HLHS.  Then by comparing the genomes of affected and non affected mice, and confirming using CRISPR technology they found that mutations in two specific genes that interact were required for HLHS.,   Dr. Cecilia Lo, a professor and the F. Sargent Cheever Chair in Developmental Biology at Pitt says, “Studying diseases with complex genetics is extremely challenging…By understanding the genetics and biology of HLHS, this can facilitate development of new therapies to improve the prognosis for these patients.” This study was published in the journal Nature Genetics.
  • The University of Bristol has awarded prizes in its first Animal welfare and 3Rs Symposium. The 3Rs, developed by Russel and Burch in 1954, have advanced the humane treatment of animals used in research by advocating for replacement (aiming to replace animals where possible, with alternatives), to reduce the number of animals used to the minimum required to answer and experimental question and and to refine their experiments to minimise any adverse effects experienced by the animals.These awards went to three research projects that have advanced the 3Rs in their various lines of research.

“The research project that won first prize has developed a refined method for producing aortic aneurysms in mice.  An aortic aneurysm is a bulge in a section of the aorta, which is the body’s main artery, and if the bulge ruptures it can cause sudden death. The research team has also developed a new human aortic aneurysm model in the laboratory, potentially replacing the need for animal models, using arteries taken from the discarded umbilical cord of newly born babies.

The second prize was awarded to a research team who has developed a method for giving oral drugs using solutions that mice and rats both like and which avoids the need for restraint and reduces stress in the animals. The research team found that liquid foods such as condensed milk, milkshake and fruit puree baby food are good solutions to use for giving a wide range of drugs.
The final prize was awarded to a research team who has developed photographic techniques that can be used in conscious animals.  This new technique has revolutionised preclinical eye research and has markedly reduced the number of animals needed for research studies.”

The 3Rs. Source: Bayer

Open letter: Private workshop on the “necessity” of monkey research does not represent broad public interests or the scientific community

This weekend there will be science marches around the globe. Scientists and science proponents will gather to provide a visible sign of support for work that benefits the public, the environment, and the world in innumerable ways. The march has been highly publicized  – rightfully so, because it serves as a reminder that scientific research and scientists can be threatened in a variety of ways that can have consequences with breadth and depth that should be of concern for society as a whole.

This week there will also be another event that has potential for consequences for science and public health. But it is neither a public event, nor one that has been publicized.

The private event is a workshop titled, “The necessity of the use of non-human primate models in research.” The workshop is supported by Johns Hopkins University and is organized by Prof. Jeff Kahn in the Berman Institute for Bioethics, with participants that include philosophers, bioethicists, a leader of the Humane Society of the US, veterinarians, and scientists– all by invitation only (see roster in workshop agenda below). Its stated goals and approach are: “To help address the issues of the use of NHPs in research, we are convening this working group to examine the science, ethics, and policy aspects of the use of NHPs in biomedical and behavioral research and testing, with the goal of identifying consensus findings, conclusions, and recommendations. The focus of the working group will be to evaluate the current and potential future uses of NHP models, drawing on the approach used in the 2011 IOM Report “Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity” (IOM, 2011).

The group lists as their objective: “The product(s) of the working group process will be a report or series of reports based on the working group’s expert analysis, which will include principles and criteria for assessing the necessity of the use of NHPs in research.” (emphasis added)

Detail is here: Animal Working Group Meeting 1 Briefing Book

In other words, the working group, privately convened, is intent on replicating the 2011 IOM process applied to chimpanzees in order to produce their own principles and criteria for assessing nonhuman primate research broadly. This process should cause grave concern for scientists and for the public who rely on research conducted with nonhuman primates.

The scientific community has publicly weighed in on the necessity of primate research. Most recently, the National Institutes of Health convened a working group to consider nonhuman primate research and concluded “that the oversight framework for the use of non-human primates in research is robust and has provided sufficient protections to date.” Similarly, a letter from over 400 scientists, including Nobel Laureates, rejected a claim from notable public figures that neuroscience research with non-human primates is no longer useful. The hundreds of scientists argued that, “primate research was still critical for developing treatments for dementia and other debilitating illnesses.” (https://www.theguardian.com/science/2016/sep/13/brain-experiments-on-primates-are-crucial-say-eminent-scientists)

Consideration of the ethical justification for research and of the care for animals in research occurs at many levels and in public space. Public health, including the interests of patients and of society as a whole, is integral to those decisions. The scientific community provides expert knowledge about what types of studies are needed for progress in the basic understanding of biology, brain, behavior, and disease and also about how to move forward with new prevention, intervention, and treatment to address health challenges. Funding agencies, such as the National Institutes of Health, are charged by the public to make decisions about science and do so through a process that involves multiple layers of expert review. Federal agencies also oversee research and standards of care for humans and animals involved in studies and provide opportunities for the public to comment on standards and to benefit from decisions.

The private workshop has the appearance of being secretive while also directly opposing the processes in place for responsible public decision-making. As such, it appears to be yet another attempt to influence decisions about science without adequately representing either public interests or the breadth and depth of expertise in the scientific community. Without adequate scientific representation the workshop conclusions cannot be taken as adequately representative of the current state of scientific knowledge. Without adequate representation of the public agencies that safeguard societal interests in scientific and medical progress the workshop conclusions cannot be taken as representative of fact-informed, balanced consideration of research.

Finally, without consideration informed by understanding the fundamental characteristics of the scientific process, the workshop conclusions will only reflect an agenda biased to reach a particular conclusion. As it is framed, it appears that the question of “necessity” is one that cannot account well for the role of basic research, of uncertainty, and of the difference between decisions based in a particular set of values and decisions about the best scientific course of action to answer questions and advance understanding of human and animal health.

For all of these reasons, the reports emanating from this private workshop must be critically examined with healthy skepticism, rather than taken as an authoritative account. We remain concerned that the products of a workshop will serve to advance an agenda that is harmful to public interests in scientific research.

[Note:  If you would like to sign on to this letter please add your name to the comments].

Signatories,

Christian Abee, DVM, DACLAM, Professor and Director, Michale E. Keeling Center for Comparative Medicine and Research, Univ. of TX MD Anderson Cancer Center

Jeremy D. Bailoo, PhD, University of Bern

Allyson J. Bennett, PhD, University of Wisconsin-Madison (Member and former chair, American Psychological Association Committee on Animal Research Ethics)

Michael J. Beran, PhD, Psychology Department and Language Research Center, Georgia State University

James Champion, Morehouse School of Medicine

Julia A. Chester, Ph.D., Associate Professor, Department of Psychological Sciences, Purdue University

Linda C. Cork, D.V.M, Ph.D, Emeritus Professor of Comparative Medicine, School of Medicine, Stanford University  (Senior member of the National Academy of Medicine;  Diplomate of the American College of Veterinary Pathologists)

Robert Desimone, Ph.D., Director, McGovern Institute for Brain Research at MIT, Doris and Don Berkey Professor of Neuroscience

Doris Doudet, PhD, University of British Columbia

Marina Emborg, MD, PhD, Associate Professor, Department of Medical Physics; Director, Preclinical Parkinson’s Research Program, Wisconsin National Primate Research Center, University of Wisconsin-Madison

Lynn Fairbanks, PhD, Emeritus professor, Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA

Charles P. France, Ph.D., Professor, University of Texas Health Science Center-San Antonio

Patrice A. Frost, D.V.M, President of, and signing on behalf of, the Association of Primate Veterinarians

Michael  E. Goldberg, MD,  David Mahoney Professor of  Brain and Behavior in the Departments of Neuroscience, Neurology, Psychiatry, and Ophthalmology
Columbia University College of Physicians and Surgeons,  and Senior Attending Neurologist, New York Presbyterian Hospital. (Past chair, Society for Neuroscience Committee on Animal Research)

Katalin M. Gothard, MD, PhD, Professor of Physiology, The University of Arizona

Kathleen A. Grant, PhD, Professor, Oregon National Primate Research Center

Sherril Green, DVM, PhD, Professor and Chair, Department of Comparative Medicine, Stanford Medicine

Nancy L. Haigwood, PhD, Director and Professor, Oregon National Primate Research Center, Oregon Health & Science University

Keren Haroush, PhD, Assistant Professor, Department of Neurobiology, Stanford University

William D. Hopkins, PhD, Professor of Neuroscience, Neuroscience Institute, Georgia State University

J.David Jentsch, PhD, Professor of Psychology, Binghamton University

R. Paul Johnson, MD, Director, Yerkes National Primate Research Center

Joseph W. Kemnitz, Ph.D., Professor, University of Wisconsin-Madison

Robert E. Lanford, PhD, Director, Southwest National Primate Research Center, Texas Biomedical Research Institute

Kirk Leech, Executive Director, European Animal Research Association

Jon Levine, PhD, Director, Wisconsin National Primate Research Center; Professor of Neuroscience, University of Wisconsin-Madison

Alexander Maier, Ph.D., Assistant Professor, Department of Psychology, Vanderbilt University

Juan Carlos Marvizon, PhD, Adjunct Professor, David Geffen School of Medicine at UCLA

Earl K. Miller, Ph.D., Picower Professor of Neuroscience, The Picower Institute for Learning and Memory and Department of Brain and Cognitive Sciences at the Massachusetts Institute of Technology

John H. Morrison, PhD, Director, California National Primate Research Center, Professor, Department of Neurology, School of Medicine, University of California Davis

Michael Mustari, PhD, Director, Washington National Primate Research Center and Research Professor, Department of Biological Structure, University of Washington

J. Anthony Movshon, University Professor and Silver Professor, Center for Neural Science, New York University

William T. Newsome, Harman Family Provostial Professor, Stanford University, Vincent V.C. Woo Director, Stanford Neurosciences Institute
Investigator, Howard Hughes Medical Institute

Melinda Novak, PhD, Professor of Psychological and Brain Sciences, University of Massachusetts Amherst

Kimberley A. Phillips, PhD, Professor of Psychology and Co-Director of Neuroscience, Trinity University; Affiliate Scientist, Southwest National Primate Research Center, Texas Biomedical Research Institute

Peter J. Pierre, PhD, Behavioral Services Unit Head, Wisconsin National Primate Research Center, University of Wisconsin-Madison

Dario Ringach, PhD, Professor of Neurobiology and Psychology, University of California Los Angeles

Marcello Rosa, PhD, Professor of Physiology, Monash University, Melbourne, Australia

James Rowlett, PhD, University of Mississippi Medical Center (Chair, American Psychological Association Committee on Animal Research Ethics)

Mar Sanchez, PhD, Associate Professor of Psychiatry and Behavioral Sciences, School of Medicine; Yerkes National Primate Research Center, Emory University (Chair, Society for Neuroscience Committee on Animal Research)

Jeffrey D. Schall, Ph.D., Bronson Ingram Professor of Neuroscience, Department of Psychology, Department of Ophthalmology & Visual Sciences, Director, Center for Integrative & Cognitive Neuroscience, Department of Psychology, Vanderbilt University

Igor I. Slukvin, MD, PhD, Wisconsin National Primate Research Center, University of Wisconsin-Madison

David A. Washburn, PhD, Professor of Psychology, Georgia State University

Robert Wurtz, PhD, Scientist Emeritus, National Institutes of Health

 

The USDA’s removal of information about animal research is a step backwards for transparency

Speaking of Research has considerable concerns about the wealth of information that has been removed from the USDA website in the last week. The USDA has removed access to an online database that allowed the public to easily obtain documents involving the Horse Protection Act (HPA) and the Animal Welfare Act (AWA).This information includes the annual reports showing the number of animals used in research each year, and the animal welfare reports that are produced. [Direct links to annual reports were broken, but the reports still exist on the USDA website – Ed.]

According to Science Magazine, tens of thousands of reports have been removed, relating to around 1200 research labs and 6500 non-research facilities that are registered or licensed by the USDA. A statement from the USDA says:

Based on our commitment to being transparent, remaining responsive to our stakeholders’ informational needs, and maintaining the privacy rights of individuals, APHIS is implementing actions to remove documents it posts on APHIS’ website involving the Horse Protection Act (HPA) and the Animal Welfare Act (AWA) that contain personal information

No doubt many will see some irony in starting a statement about the removal of information with “Based on our commitment to being transparent”. That said, it is not yet clear if reports are being removed permanently or simply temporarily removed until they have been assessed for privacy issues. Though the previously public information will still be available through FOIA requests, the statement concludes by saying “If the same records are frequently requested via the Freedom of Information Act (FOIA) process, APHIS may post the appropriately redacted versions to its website”.

It is not just animal rights groups who have expressed concern. Matthew Bailey, President of the Foundation for Biomedical Research, said:

“I would certainly agree that protection of personal information is of utmost importance, especially given the rich history of targeting the individuals involved in animal research. However, this change also makes it more time consuming, although not impossible, for organizations like FBR to analyze trends in animal use in research.”

Speaking of Research also has concerns. We believe the availability of data can foster an environment of openness and transparency about animal research. When information is hidden, particularly where it was once available, the public will naturally wonder why many stakeholders have cause for concern: the public wonders what is being hidden and why, and researchers must devote even more resources to combatting the public perception that they are not transparent.

USDA Statistics showing number of animas used in research

Speaking of Research uses the type of information that was available to help explain the realities of animal research to the public and media.

The USDA’s decision is also out of step with the direction of travel of many other countries. Approximately one month ago, after urgings from Speaking of Research, the EU website added a new page providing links to the annual statistical reports on animal research of member countries.

In our own commitment to openness, Speaking of Research has uploaded the Annual Reports of the USDA’s animal research to its website. They are available on our US Statistics page, or can be found below. We will be looking at what other information we can practically add in coming weeks.

Thousands of removed USDA documents have now been archived here.

Speaking of Research

Reigniting My Fire for Animal Research

lisa-headshotThis guest post is written by Lisa Stanislawczyk, a Veterinary Scientist at a pharmaceutical company. She plays a key role in ensuring the standards of animal care are always improving at her institution. Having been introduced to Speaking of Research through a committee member, Lisa kindly agreed to share her experiences. In this post, Lisa explains her passion for innovation in the field of animal welfare and her experiences, positive and negative, in delivering animal care at numerous institutions in the US. If you would like to write for Speaking of Research please contact us here.

When I started out after college working as an animal care technician at a contract research organization (CRO), I never thought I would want to perform the procedures I saw being done to the animals. I didn’t want to make them uncomfortable or scared. I loved animals and had always wanted to be a vet (like so many others in the field of animal research). While working at the CRO I began to see the care and attention that the technicians took in performing these procedures and how careful they were to make the animals comfortable and at ease. I realized they too cared for the animals as much as I did and we all wanted nothing more than to take the best possible care of these animals.

lisa-veterinary-scientist

Later, after 15 years in the animal research field, I found myself looking for a new role. I was always proud of what I did and left work each day with a sense of accomplishment. However, I was finding it difficult to find work, a common problem for so many in the world we live in today.

I realized that in order to stay in the field and get a good job I was going to have to move outside of my comfort zone, away from everything and everyone familiar. It was scary, but I moved to another part of the country, away from my family and all my friends, to pursue a new job. I was anxious and felt isolated. I came to the harsh realization that not everyone holds themselves or others to the same standards I had been taught, or was accustomed to. This realization almost made me stop doing the work that I had grown to enjoy and get a huge sense of accomplishment from.

I didn’t quite know how to deal with what I perceived as poor animal welfare in my new job. This feeling was not from the technicians doing the work, they were doing the best they knew how with what they were taught. There just seemed to be a lack of knowledge of the regulations which one should have working in a vivarium. It was the management that needed to be held accountable. I spoke with the Chair of the Institutional Animal Care and Use Committee (IACUC) in order get a better understanding of what I felt was just not good research. After our conversation, I still felt there was a lack of accountability from the IACUC Committee. I was at a loss and felt drained and hopeless because there continued to be mistakes and mis-steps which could have been avoided.

I spoke with the veterinarian and was told, “I didn’t understand the field that I was in and I was too soft”. I didn’t believe that. I believed I was there to be an advocate for the animals in my charge. I was told there was not a “magic ball” to know outcomes of certain studies, I knew there were humane endpoints that should be followed. I did my best to make things better. We began a better training program so the people performing the procedures had a better understanding of the Animal Welfare Act and the Guide. We updated procedures and SOPs (standard operating procedures.)

It took its toll. I found myself working long hours to make sure the studies I was to oversee were executed correctly and at the same time educating the personnel working with me. I was exhausted and overworked. So were my technicians. I began to become so emotional about some of the things I was seeing that I would spend what free time I had at home, crying myself to sleep. Just thinking about it now, makes my eyes water. We all began seeing things that we could not bear any longer and more people began to have concerns and fill out whistleblower forms. It was heartbreaking and I just didn’t feel like I could do it any longer. Then the day came, I was laid off. It was a blessing!

Thankfully my negative experience is not common and the facility I worked at was taken over by another company. I have heard that they are still overworked (many of us can sympathize) but that things regarding the animals have definitely improved.

Image of macaques for illustrative purposes.  Image courtesy of: Understanding Animal Research

Image of macaques for illustrative purposes.
Image courtesy of: Understanding Animal Research

I moved back to my family and friends. I needed the moral support from them. Still, I didn’t want to go back to it. I was burnt out. I worked at a home improvement contracting office fielding phone calls and organizing the office. It just wasn’t what I could see myself doing long term. I needed a challenge. I missed the animals. I held guilt for not doing more for them even though I still don’t know what more I could have done at the time.

A previous boss of mine who happened to be a veterinarian reached out to me about a job. Again it was a big pharmaceutical company. I was skeptical but I needed to give it one last chance and it was only a temporary position. It was great to experience the investigators working with the animal care technicians to communicate how the animals did while on study and this empowered everyone to know exactly what was going on with each and every animal on a daily basis. The communication between all the investigators, technicians and veterinary staff truly improved the welfare of the animals. The veterinary staff really cared for the animals and the animal care technicians knew every animal’s quirks, likes, and dislikes. Everyone would make sure the animals that were on study got some extra favorites whether it be food enrichment, human contact, or toys. The people there renewed my faith. I could see the ethical behaviors and integrity of each and every person there. It gave me the desire to stay in the industry. This was what I was accustomed to. I felt like I had a “place” again.

Once the temporary position was over, I moved to another company also working with the veterinary technical staff. There I was allowed to attend ILAM (Institute for Laboratory Animal Management). It is a 2 year program and the information, relationships, and contacts you come away with are immeasurable. I shared my story with others I met there (from all over the world) and I realized we all shared in the desire to deeply care for the animals. We go to work every day to make sure everyone does their best to take care of every need of all the animals in their charge. For some time, I have passively been in the industry, not really wanting to be a part of all the external committees and public outreach opportunities available. After attending ILAM, all that changed. Experiencing the love and desire to improve and do better within our industry and making connections and friendships with people with this common thread has re-ignited my passion for the industry. My company encourages people to innovate and strive for better animal welfare. I am so proud to be a part of a program that has refined techniques performed on multiple species to make it easier for both the animals and the technicians. This is how it should be. This is the industry we are in.  Change is key. Once again I am so proud of what I do and the program I am a part of everyday. I flourish when someone asks me what I do, instead of talking vaguely so they won’t understand or want to hear more about it. I am happy to explain why what we do is so important and necessary.

We make miracles happen and improve the lives of humans and animals every day! This is what we do for a living! This is why people and their pets are living longer, happier lives. This is the reason I am proud to be in animal research. I urge my fellow technicians to speak out, be proud, and get involved explaining what you do and why you do it!

Lisa Stanislawczyk

Confusing public agendas: Is it animal welfare? Or an absolutist campaign disguised as a call for “dialogue”?

A recent symposium at the joint meeting of The American Society of Primatologists and International Society of Primatologists focused on questions about the oversight and regulation of the housing, care, and treatment of nonhuman primates in research. Presentations of scientific research that primatologists conduct in order to inform animal care practices are a regular occurrence at ASP. This session, however, was billed as a call for dialogue. The organizers and participants included affiliates of groups and campaigns, including HSUS and PETA, that are often opposed to many types of primate research. ASP and ISP members conduct primate research in field, laboratory, zoo, and other settings across the world. The focus of this conference session appeared to be largely on laboratory  research, and particularly, that work funded by the US federal agency—the National Institutes of Health—that is charged with scientific research relevant to advancing public health.

Macaque. Photo credit: Kathy West. CNPRC.

Macaque. Photo credit: Kathy West. CNPRC.

Such research is a popular target for PETA and other groups opposed to the use of nonhuman animals in research, yet it remains a fact that the great majority of US facilities that house nonhuman primates are not dedicated research facilities (see graphic; summary illustration of data from USDA). As shown here, of the just over 1,000 US facilities that are either USDA-registered for research or USDA-licensed to house nonhuman primates for other purposes,  roughly 1/5th hold research registration. The majority are exhibitors. That includes zoos and other facilities that display animals to the public or engage in public interaction with the animals. In the US, the number of primates housed within each facility is reported annually for research institutions and is published by the USDA (for example, see here); however, the number of primates housed in licensed facilities is not easily accessible. This is similar to other countries.

Number of facilities by type of USDA-registration or license. Exhibitors include zoos and other facilities with public interaction.

Number of facilities by type of USDA-registration or license. Exhibitors include zoos and other facilities with public interaction. (Note: Although not necessarily required by federal law, sanctuaries may choose to be licensed as exhibitors because there is no separate category for sanctuaries.)

We’ve written previously about the standards of care, external oversight, and public transparency of federally-funded research within dedicated research facilities in comparison to zoos, sanctuaries, breeders, dealers, and private owners of nonhuman primates (Bennett & Panicker, 2016). In fact, some of these comparisons are central to discussions in recent months about decisions to ensure the best outcomes and long-term care of retired chimpanzees (1, 2, 3, 4, 5).

The limited focus of the recent ASP/ISP conference session to nonhuman primates used in research in the US (18% of facilities) could have many explanations. We will return to consideration of these points, and to a fuller discussion of the session, in subsequent posts. To begin, however, we return to excerpts from a post we made in 2013, with points that are foundational and key to a fair dialogue.

*****

Macaque. Kathy West. CNPRC.

Macaque. Kathy West. CNPRC.

Fair partners in dialogue: Starting assumptions matter and they should be spelled out

The importance and need for civil, open dialogue about the complex set of issues involved in use of animals is among the points of agreement between members of the scientific community, the public, animal rights activists, and others. Speaking of Research, along with others, has consistently advocated for and engaged in such dialogue via a number of venues, including our blog, public events, conference presentations, and articles.

One of the important purposes of dialogue is to communicate diverse viewpoints and values on animal research and one key to understanding those viewpoints and values is consideration of the basic starting assumptions, or positions, from which they arise. However, such dialogue often takes place without clear specification of the starting positions held by the people engaged in the conversation. Speaking of Research has previously highlighted the problem with this approach– for example, see Prof. Dario Ringach’s posts on a series of public forums on ethics and animal research (here, here, here).

Image of mice courtesy of Understanding Animal Research

Image of mice courtesy of Understanding Animal Research

The basic position of those engaged in animal research is obvious in part by the nature of their work. Furthermore, the very structure of the current regulations and practices reflect– both implicitly and explicitly – a set of positions on the ethical and moral considerations relevant to the use of animals in research (*see below).

What are the positions of those who oppose laboratory animal research?

In some cases, these are clearly stated. In the case of absolutists, the position is that no matter what potential benefit the work may result in, no use of animals is morally justified. This extends across all animals – from fruit-fly to primate. Furthermore, all uses of animals, regardless of whether there are alternatives and regardless of the need, are treated identically. In other words, the use of a mouse in research aimed at new discoveries to treat childhood disease is considered morally equivalent to the use of a cow to produce hamburger, the use of an elephant in a circus, or a mink for a fur coat.

In this framework, the focus often excludes consideration of the harms that would accrue as a consequence of enacting the animal rights agenda. For example, the harm to both humans and other animals of foregoing research or intervening on behalf of animals. As a result, while the absolutist position is often represented as one that involves only benefits and no harms, this is a false representation. While some animal rights groups are clear about their absolutist position, others—to our knowledge—are not.

On the other hand are those who avoid identifying directly with an absolutist position, but instead focus on the need for development of alternatives to use of animals in invasive research. This is a goal that may be widely desired and shared. It does not, however, address the question of what should be done in absence of alternatives and in light of current needs that can only be addressed by animal studies. In turn then, this position is silent with respect to moral and ethical consideration of a broad swath of research and fails to offer a framework to guide current actions.

Pigtail macaques at the Washington National Primate Research Center

Pigtail macaques at the Washington National Primate Research Center

We believe that the goal of promoting better dialogue would be assisted by making these positions clear and we provide a starting place below. We welcome additions by individuals and groups, as well as clarification or correction if any are unintentionally misrepresented. (For additional groups see original post).

People for the Ethical Treatment of Animals: Offers clear statement of absolutist position. “PETA has always been known for uncompromising, unwavering views on animal rights. PETA was founded in 1980 and is dedicated to establishing and defending the rights of all animals. PETA operates under the simple principle that animals are not ours to eat, wear, experiment on, or use for entertainment.”

New England Anti-Vivisection Society: Offers clear statement of absolutist position. “Is NEAVS against all animal experiments? Yes. For ethical, economic and scientific reasons, NEAVS is unequivocally opposed to all experiments on animals and works to replace them with humane and scientifically superior alternatives that are more relevant and predictive for humans.”

Humane Society of the United States (HSUS): Does not, to our knowledge, offer a clear position on whether it is morally acceptable to use animals in research when there is no alternative. What they do say: “As do most scientists, The HSUS advocates an end to the use of animals in research and testing that is harmful to the animals. Accordingly, we strive to decrease and eventually eliminate harm to animals used for these purposes.”

Physicians Committee for Responsible Medicine (PCRM/Physicians Committee): Does not, to our knowledge, offer a clear position on whether it is morally acceptable to use animals in research when there is no alternative. What they do say: “We promote alternatives to animal research and animal testing.”

How is this relevant to building productive dialogue?

For those engaged in dialogue about the ethical and moral considerations related to the use of non-human animals in research, even this brief list makes clear that it is important to ask participants to begin by putting their basic starting assumption forward. Why? For one reason, because those assumptions are key to identifying whether there are potential areas of agreement or none at all.

For example, discussing refinement of laboratory animal care with an absolutist—someone fundamentally opposed to animals in laboratories—misses the point. No amount of refinement would make the work acceptable to them. In this case, the more critical questions for discussion would include consideration of the relative risks and potential benefits of failing to perform research for which there are currently no alternatives to animal-based studies. Consideration of species’ capacities and criteria for differential status– if any– would also be a useful starting point.

white-mouse-pair-in-cage-with-cardboard-tubeWhat about dialogue with those individuals and groups who do not provide a clear position? Does it matter?

Some would argue that it does not because the dialogue is only concerned with animal welfare and with reducing harm to nonhuman animals, or with pushing forward to develop non-animal alternatives for some types of research. In fact, framed in this way, most scientists are not only in the same camp, but are also the people who work actively to produce evidence-based improvements in welfare and development of successful alternatives.

The problem, however, is that real-time, critical decision-making about human use of other animals in research is not simple. It does require serious, fact-based consideration of the full range of risks and potential benefits, including consideration of the health and well-being of both human and nonhuman animals. It also requires clarity about alternatives, where they exist and where they do not. And it requires some understanding of the time-scales in which knowledge unfolds – often decades – and a basic appreciation for the scientific process.

It is easy to argue that developing non-animal alternatives for invasive research should be prioritized. But this argument does little to address the question of what to do now, what we do in absence of these alternatives, and what choices we should make as a society. Those questions are at the center of dialogue and the core issues with which the scientific community and others wrestle. To address them productively, and in a way that considers the public interest in both the harms and benefits of research, requires articulation of starting assumptions and foundational views.

Allyson J. Bennett

Excerpted from previous post “Fair partners in dialogue: Starting assumptions matter and they should be spelled out” 6/12/13

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*For example, in the U.S., the laws and regulations that govern animal research mandate that proposals for use of vertebrate animals (including rats, mice, birds) provide, among other things: 1) a justification of the potential benefits of the work; 2) an identification of potential harms and means to reduce them; 3) evidence that alternatives to using animals are unavailable; 4) the use of the least “complex” species necessary to answer that question; and 5) much detail about the animals’ care and treatment, including the qualifications and training of the personnel involved. Consideration of these issues occurs not only at the stage of IACUC evaluation, but throughout the scientists’ selection of questions and studies to pursue, peer review and selection of projects for funding (more here). Furthermore, the entirety of the project must proceed in compliance with a thorough set of regulations designed on the basis of the 3Rs – reduce, replace, and refine (for more about regulation see here, more about 3Rs, here).

In other words, while there is always room for continued improvement, the structure is designed to require that the major ethical and moral considerations relevant to animal research be addressed by those involved in performing and overseeing the work. This structure also incorporates explicit consideration of changes that arise from new knowledge. That includes evolving knowledge about different species’ capacities and needs, as well as the development of alternatives to animal-based studies for particular uses. It also includes advances in our scientific understanding that demonstrate the greater need for basic research that requires use of animals to address key questions.

Can we agree? An ongoing dialogue about where retired research chimpanzees should live

A couple of weeks ago we wrote about concerns for the health and wellbeing of chimpanzees moved from dedicated research facilities in the US to the only federally-supported sanctuary, Chimp Haven (“Do politics trump chimpanzee well-being?  Questions raised about deaths of US research chimpanzees at federally-funded sanctuary” 7/14/16). The impetus for this particular post was a compelling article written by Dr. Cindy Buckmaster (“Dr. Collins, please save our chimps! Lab Animal, Vol 45, No 7, July 2016). The article was about the deaths of 9 of 13 retired research chimpanzees who had recently been transferred to the federal sanctuary from the National Center for Chimpanzee Care (NCCC; University of Texas MD Anderson Cancer Center, Bastrop).

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Lab Animal article about relocated chimpanzees

There are, of course, other research facilities and other sanctuaries that house chimpanzees in the US. We, and others, have written previously about the broader picture, events, and considerations, including in posts here and in peer-reviewed articles in scientific journals (e.g., Facts must inform discussion of future of chimpanzee research, 8/12/11; Guest post: Efforts to ban chimpanzee research are misguided, 10/13/11; Where should US chimpanzees live, 12/5/15; Bennett, 2015; Bennett & Panicker, 2016).

Our recent post, like others on this topic, addressed some of the considerations that we believe should inform serious, fact-based public discussion of the different settings in which chimpanzees live in the US. The primary focus of the post, however, was on the federal sanctuary and the outcomes of transfer from a research facility to the sanctuary. There are several reasons for focusing on this case. Among them, are:

  • Providing the best possible care to ensure retired research chimpanzees’ health and well-being is the central ethical justification for continued public support of the animals.
  • Decisions about whether or not to transfer retired research chimpanzees to sanctuaries and zoos are ongoing and, presumably, will be informed by consideration of the outcomes for animals already relocated.
  • These chimpanzees are supported largely by federal funds, whether in dedicated research facilities or in the only federally-funded sanctuary. Chimp Haven is not the only, nor is it the largest, chimpanzee sanctuary in the US. It is, however, the only sanctuary in the federal sanctuary “system” and the only sanctuary that receives millions of dollars of federal support and a commitment to 75% of the cost to care for retired NIH research chimpanzees.
  • Similarly, federally-owned research chimpanzees are not the only chimpanzees in the US. Some research chimpanzees are the responsibility of private institutions. The retired chimpanzees transferred by NIH to Chimp Haven are chimpanzees that are owned by the federal agency. Thus, the ultimate decisions about the chimpanzees are under the direct control of the public agency.
  • While the focus here is on a particular subset of chimpanzees and a particular set of facilities in which they live, that does not mean that other chimpanzees and facilities are beyond the concern of the public and the research community. By contrast to NCCC and CH, however, chimpanzees owned by private institutions and transferred to private sanctuaries is largely not decided with public input or by public agencies. For example, this is the case for many of the chimpanzees slated for transfer from the University of Louisiana’s New Iberia Research Center (NIRC) to a new sanctuary, Project Chimps, in Georgia. It is also the case for chimpanzees at the Yerkes National Primate Research Center (YNPRC) that were transferred, with assistance from the American Zoological Association’s (AZA) Species Survival Plan (SSP), to a Tennessee zoo. In fact, the movement of chimpanzees between zoos in the US is a common occurrence and one that occurs with little public dialogue and input into decisions.

For all of these reasons, along with other more fundamental questions about the care of chimpanzees, the ethical justification for activities that they are involved in, and the roles that different types of facilities play, continuing discussion of the transfer of retired research animals to the federal sanctuary is of interest to many.

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Photo credit: Kathy West

Perspectives from experts across the communities that care for chimpanzees

A number of people with long history, expertise, and deep involvement in care for US chimpanzees commented on our previous posts to provide their perspectives and additional information that can inform others concerned with the situation. Among others, these comments were from veterinarians, scientists, and board members with direct experience at NCCC, the dedicated research facility from which chimpanzees that were the subject of the post were transferred, and Chimp Haven, the chimpanzees’ final destination.

What emerged from the comments appeared to be a consensus on a number of points, including universal agreement that the care and housing for chimpanzees at the research facility, the NCCC, in which the animals lived prior to transfer and many continue to live, is excellent. In addition, there were multiple calls for collaboration and setting aside differences across the different communities involved in decision-making and care for retired chimpanzees.

At the same time, members of the CH Board leveled some criticisms at the post. The chairman of the CH board and another member of the board felt that it was unfairly focused on their facility, wrongly attributed the stress of chimpanzees’ relocation as a critical factor in the animals’ deaths, and did not adequately represent CH’s care for those animals and its comparability to a research facility.

While the CH board members were critical of the discussion, members of the research community pointed out that sustained campaigns to demonize their own work, facilities, and care for chimpanzees have been a major factor that contributed to the decisions about chimpanzees, to public views, and to the current situation.

Chimpanzees 2Overall, we are encouraged by the response to this post and to the emergence of a public dialogue that goes beyond soundbites and entrenched positions in order to identify points of consensus and points that urgently need further consideration in order to inform ongoing decisions about captive chimpanzees. Providing an accessible space for serious, fact-informed discussion is a central goal of Speaking of Research and our blog. We are particularly encouraged that members of the research, sanctuary, and zoo communities have joined their voices to this particular venue for public dialogue. We appreciate their willingness to provide expert perspectives and to share their views.

While we encourage readers to review the full comments on the original post, we provide here a discussion of some main points and encourage continuation of the dialogue.

Points of apparent consensus:

That the care and housing for chimpanzees at the research facility, the NCCC, in which the animals lived prior to transfer and many continue to live, is excellent.

Dr. Elizabeth Magden, comments on the similarities between the research facility in which she works and the federal sanctuary. Magden is a veterinarian who cares for the chimpanzees at the Bastrop, Texas facility that is part of the University of Texas M.D. Anderson Cancer Center, now designated as the National Center for Chimpanzee Care (NCCC).

“Both Chimp Haven and the NCCC have large and enriching housing facilities for chimpanzees, with the goal of giving them the best possible retirement.”

The facility was also praised by Dr. Stephen Ross, an animal behaviorist who is both the chair of the Chimp Haven board and the Director of the Lester E. Fisher Center for the Study and Conservation of Apes, at Lincoln Park Zoo’s (LPZ) Regenstein Center for African Apes. As we’ve noted previously, Ross was also a member of the NIH Working Group on the Use of Chimpanzees in NIH-Supported Research whose recommendations informed the discontinuation of the majority of NIH chimpanzee research grants and the NIH decisions to retire and relocate its chimpanzees.

“Having worked at MDAKC [now NCCC], I concur that the chimpanzee management and housing there is the topline in the industry… I have nothing bad to say about Bastrop or the care they have provided to the chimpanzees that live there.”

Chimpanzees using tools at NCCC

Chimpanzees using tools at NCCC

That the focus of ongoing discussion should be on making future decisions that center on best protecting the animals’ health and well-being.

Many of the commenters articulated this point. As summarized by Professor Michael Beran, a scientist with extensive chimpanzee cognitive and behavioral research at Georgia State University’s long-standing Language Research Center (LRC):

“It is crucial to focus on the long-term needs of these and all chimpanzees and to accurately assess and anticipate what can happen when they are moved like this. Misperceptions about the “goodness” of sanctuaries and the “badness” of labs need to be addressed, but as you noted, this does not have to involve blame. Rather, the hope is that there can be a more careful consideration of what the real environments are like that these chimpanzees currently live in versus the misperceptions of “lab” housing, and also what the real implications might be from moving them elsewhere.”

Dr. Magden, NCCC veterinarian:

“I think we need to refocus this discussion on determining what is best for the animals. … The NCCC has been recognized by the Chair of the CH Board of Directors as a topline facility. Why move chimpanzees from a wonderful facility to a place they do not know, with people that are unfamiliar, and new animals that may (or may not) be friendly towards the newcomers? We all want to be surrounded by our loved ones in our twilight years. Don’t the chimpanzees deserve that too?”

Dr. Steve Ross, CH BOD chair: “If we truly care about the welfare of these and other chimps living in labs and sanctuaries, then we have to spend less time demonizing through biased analyses and more time working together to make sound decisions.”

Chimp Haven photo from NAPSA

Unresolved points:

  • That the age and health status of retired chimpanzees is a critical factor to consider in weighing the risks of relocation; and, that the deaths of recently relocated chimpanzees merits serious concern and examination in order to reduce re-occurrence and risk to other animals considered for relocation.

While all of the commenters appear to agree that consideration of the chimpanzees’ health and welfare should be the primary factor driving decisions, there remains disagreement about whether relocation itself—or the care provided at CH—merit further review in light of recent chimpanzee deaths.  It was these recent deaths that were the focus of Dr. Buckmaster’s open letter to NIH Director Francis Collins and of recent media coverage.

For example, Dr. Elizabeth Magden, DVM, NCCC veterinarian, says:

“Our goals are the same, we love and care deeply for the chimpanzees we serve. That is why a 69% mortality in recently transferred animals is concerning. We need a joint commitment to look into what we can be doing better to help these amazing animals enjoy their retirement for as long as possible. Moving is stressful. Being introduced to new and unknown animals is stressful, can also lead to traumatic injuries, and some facilities have even experienced death.”

Members of the CH Board, including Ross, but also veterinarian Dr. Thomas Butler and Emory University and chimpanzee researcher Professor Frans DeWaal, provided personal testimonials about the quality of care at the facility. Overall, they appear to conclude that the recent deaths are only to be expected based on the animals’ ages. As summarized by Prof. DeWaal:

“Since we take in and house many individuals that have surpassed the median age at which captive chimpanzees die, we obviously expect mortality, but no reasonable expert would hold this against us. We are like an end-of-life care facility and have the death-rate to go with it.”

There is no doubt that many retired chimpanzees are aged or have health concerns, as we and others have quite clearly and repeatedly acknowledged as a critical factor that should guide decision-making. The specific question raised by the recent deaths at CH, however, is not whether it is reasonable to expect older animals to die. Obviously, it is.

The current question—and focus of Buckmaster’s article, our post, and discussion in the community— is whether the high number of deaths following the recent transfer should be met with sufficient concern to elicit an engaged response aimed at identifying whether everything that can be done is done to reduce future risk to chimpanzees and to ensure their best possible care. As captured by Professor William Hopkins, chimpanzee researcher at Georgia State University and Director of the Ape Cognition and Conservation Institute:

We can debate those facts [provided in the post] in terms of what caused the higher incidences of death but, as you indicate, there are no definitive data at this point in time. …[Steve Ross] ended … by stating that lab and Chimp Haven folks should be working together to make sound decisions about chimpanzee well-being. I agree with this entirely but, in retrospect, it seems clear that the decision to move these specific 13 apes was a poor decision. No blame is necessary but simply a recognition of this fact and a commitment to not letting it happen again.”

Prof. Hopkins’ comment, along with others, hits the central point.  It is promising to see members of the zoo and sanctuary communities vocalize agreement with the research community on the need to put chimpanzees’ health and welfare at the center of joint efforts.  At the end of the day, however, the question is how to move forward to best inform decisions.

And the question remains: Are the recent deaths are viewed only as the expected outcome of transfers, requiring no need for recognition? Or should they instead merit consideration as potential evidence that procedures, or relocation plans, should be adjusted?

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Chimpanzees at NCCC. Photo credit: Kathy West.

Dr. Ross, appears to argue that there is no cause for further reflection, nor for change, saying:

“As difficult as it is to discuss, death is very much a reality at an “end of life” facility such as a sanctuary. These chimpanzees may well have been well cared for by care and enrichment staff, but they have also been subjects of medical research which has in some cases has had very real health consequences. …objective readers of these facts must also realize the overtly misleading nature of comparing mortality rates of a small sample of aged chimps to overall death rates for a population. Chimpanzees that arrive at Chimp Haven are very often past the median life expectancy for the species (the average age of those chimpanzees from Bastrop that died at Chimp Haven was 42 years…. well over the median life expectancy for the species). These deaths were sad… and staff at both Bastrop and Chimp Haven mourned them. But they were neither the direct result of transfers nor were they completely unexpected given the demographic context of the species or the health status of these individuals.”

While his points about retired chimpanzees’ age are accurate, the implication that this set of chimpanzees were “subjects of medical research which has in some cases has had very real health consequences” is disputed by another commenter and remains unclear in absence of those animals’ records.

Thus, Ross’ implication—standing in contrast to his call for harmony and an end to “demonization”—was noted by other commenters. For example, Jennifer Bridges:

“I absolutely agree that we need to stop demonizing one another on this topic. Both facilities have a caring staff and the best intentions for their chimpanzees. However, in the same comment that you state that we should not be demonizing these facilities you also state that the 9 chimps that have died from the most recent transfer from the Keeling Center to Chimp Haven most likely had heath issues from use in research. In reality, many of those chimps were never used in medical research, ever. Implying that they were is further demonizing the Keeling Center which you have stated provides excellent, top of the line care. We all want what is best for these chimpanzees and hopefully we will be able to work together to do what’s best for them moving forward.”

Furthermore, as we’ve written previously, there is a long history of inaccurate statements about research facilities being used in promotional materials and arguments in favor of ending research and retiring animals. CH has previously engaged in exactly this kind of rhetoric (for example, here, here) and rarely acknowledges that research facilities such as NCCC can provide top of the line care for chimpanzees. Thus the irony of CH’s response to criticism was noted by other commenters as well. For example, veterinarian Dr. Thomas Rowell, who was the director of the NIRC for many years. Rowell reminds Ross that,

“The biomedical research community has for a long time been “unfairly characterized” when it comes to the care and use of chimpanzees and other animal models. There has been a lifetime of “demonizing” committed animal care givers and veterinarians who dedicate their life time to the profession and the animals under their care.

One can be sympathetic to commenters who react after having to endure statements such as “All invasive research is torture, and it’s not just the procedures. It’s the imprisonment. It’s being kept in a small space with no choice. You just are there. You’re powerless.” They use inflammatory statements like “chimpanzees have been infected with viruses, darted and sedated more than 100 times, and put through dozens of sometimes painful procedures”.

They describe a “better life” because of access to sun and grass for the “first time” when the reality is they have had access to the outdoors (including sun and grass) all that time. They mischaracterize there care by using descriptors for techniques of handling animals, that are common in zoos and sanctuaries, such as the use of “powerful and painful” dart guns and “frightening” squeeze cages for sedation. They do this so as to promote a political agenda and to misguide the public.

I agree with the last commenter. If we truly care about the welfare of these and other chimpanzees we should spend less time “demonizing”, on both sides.”

Chimpanzees in research, zoo, and sanctuary facilities

Chimpanzees in research, zoo, and sanctuary facilities

Prof. John Capitanio, a primate researcher at the California National Primate Research Center and a past President of the American Society of Primatologists, notes same frustration:

“A couple of years ago, I toured the chimpanzee facilities at MDAKC with one of the animal care people. I was totally blown away when she told me that, when animals were transferred from the Primate Foundation of Arizona to Bastrop several years earlier, she (and at least one other person) moved to Bastrop to be able to continue to care for the chimpanzees that had been under her care at PFA. That level of commitment is truly remarkable, and it really annoys me to have research institutions that obviously do a spectacular job of care, vilified in the way that they sometimes are, when they have people that are so dedicated that they will uproot their personal lives to move with their animals.”

What can we conclude?

In the end, none of the CH BOD provided acknowledgement, or any assurance, that the recent chimpanzee deaths had elicited sufficient concern to generate a new review of care procedures and decision-making about future transfers. Given that they appear to conclude the deaths are reasonable and expected, it seems possible that that they plan to simply continue the same course.

At the same time, Dr. William Satterfield, DVM, retired Keeling Center (now NCCC) veterinarian, called care practices at CH into question:

I personally visited Chimp Haven with a shipment of chimps that were being forced there by NIH from the Keeling Center. These animals had been provided state of the art behavioral and medical care at the Center were thrust into a minimal level care situations. They were unprepared at Chimp Haven to handle simple medical care that had been routinely provided at the Keeling Center. The supposed intent of NIH, doing the bidding of HSUS and similar organizations, to improve their care and save federal dollars, did neither, at the expense of the welfare of these animals. As a professional with over 30 years of caring for great apes, I had to hold my emotions and hope for the best for the animals. My worst fears have unfortunately become a reality for these animals.”

CH board members countered Satterfield and criticisms by others by pointing to their own experience with CH, as well as to its accreditation record with private agencies and its oversight by the USDA, a federal agency. Yet it remains true that the facts surrounding the recent deaths are largely unknown and not public. Nothing in the CH responses provided further illumination on those specific cases. From a reasonable public perspective, it appears that much remains unresolved with respect to confidence that examination of those cases can, and will, guide further decisions.

Summary:  Open questions for further consideration

1)  How should current experience inform decisions about future transfers?

2)  What are the other options for retired chimpanzees? Prof. Hopkins poses exactly this question:

Also, is it fair to ask everyone why it is the case that captive chimpanzees currently residing in labs cannot be retired in situ? If the sanctuary community acknowledges that some facilities provide excellent care (which is what I took from your piece), what is the financial and well-being rationale for moving them? For that matter, why is it that NIH has made the decision to only retire their chimpanzees to the Chimp Haven facility when other facilities, like ours in Des Moines, could accommodate some number of NIH-owned chimpanzees and provide excellent housing and care for them. None of these decisions make sense from a well-being and financial perspective. Let’s face the facts. Even in the best case scenario, given the retirement strategy that NIH has laid out, it will be many years before all their chimps are retired. So wouldn’t it better for chimpanzees, as a whole, if there were more options for their retirement rather than all the pressure to move them to Chimp Haven?”

We have addressed each of these questions in previous posts and articles and will continue to welcome dialogue on these points here, and in subsequent posts.

Speaking of Research

 

More at:

Bennett, A.J. (2015). The new era for chimpanzee research: Implications for broad ethical consideration and equitable treatment. Developmental Psychobiology, 57(3), 279-288.

Bennett, A.J. & Panicker, S. (2016). Broader impacts: International implications and integrative ethical consideration of policy decisions about US chimpanzee research. American Journal of Primatology, Epub ahead of print Jul 19.

Latzman, R.D. & Hopkins, W.D. (2016). Letter to the editor: Avoiding a lost opportunity for psychological medicine: Importance of chimpanzee research to the National Institutes of Health Portfolio. Psychol Med. Aug;46(11):2445-7. Epub Jun 10

Caveat Emptor

A current USDA case involving a major antibody producer underscores the need for the research community to demonstrate its commitment to high standards of animal welfare.

On August 18-20, 2015, Santa Cruz Biotechnology, Inc. (SCBT) went before Administrative Law Judge Janice Bullard in Washington to rebut charges of Animal Welfare Act (AWA) violations at its California antibody production site. The hearing was supposed to conclude on August 21. However, according to an account of the hearing posted by the Animal Welfare Institute (“Key Hearing in DC from August 18 to August 20”), the proceedings were suspended on the last day and the parties were given until September 30, 2015 to negotiate a settlement. As of this writing, no settlement agreement has been reached. Therefore the allegations against SCBT remain just that—allegations: Final judgment must be withheld until the legal proceedings are concluded. Nevertheless, the seriousness of the USDA’s charges against SCBT demands attention.

Why antibodies matter

Antibodies play an increasingly important role in both clinical medicine and research. The immune system generates antibodies when it detects a foreign protein. Antibodies are proteins that tag these “invaders,” enabling other immune cells to find and destroy them. Because each antibody targets a single protein, they also have many useful applications. Antibodies can be used to diagnose and treat diseases, such as cancer and autoimmune conditions including rheumatoid arthritis and inflammatory bowel disease. Just this past August the U.S. Food and Drug Administration approved the antibody-based drug Repatha (evolocumab), the second in a new class of drugs that can lower cholesterol dramatically by targeting a specific protein.

Antibodies are also widely used in research to detect specific proteins in blood or tissue:

Yates lab neurotransmitter photo

Antibodies “light up” a neurotransmitter in this sample of brain tissue. Yates laboratory, University of Pittsburgh

Antibody production is a multi-billion dollar industry, and SCBT is a major player.

Making antibodies

Antibody production starts by injecting animals with the protein to be tagged. One production method involves collecting blood from animals injected with the protein and then extracting the antibodies. This method produces polyclonal antibodies that are comprised of a collection of immune cells.

Another method uses hybridoma technology which produces monoclonal antibodies that consist of only one type of immune cell. This method also begins by injecting an animal with the protein to be tagged. The next step is to remove an initial batch of antibody- producing cells from the animal’s blood and fuse them with a harmless cancer cell to produce a cell line that can generate the desired antibody in the lab. César Milstein and Georges J. F. Köhler shared the 1975 Nobel Prize in Physiology or Medicine for developing this methodology.

When performed properly, the creation of antibodies using either of these methods causes minimal pain or distress to animals.

SCBT produces antibodies with various animals including goats and rabbits, species regulated under the AWA. The USDA sends inspectors at least once a year to visit all facilities that conduct research, teaching, or testing with regulated animal species to ensure their compliance with the AWA.

In a formal complaint filed August 7, 2015, the USDA accused SCBT of “repeated failures to provide minimally-adequate and expeditious veterinary care and treatment to animals” (2015 complaint, paragraph 5). USDA said further that the company had “demonstrated bad faith by misleading APHIS personnel about the existence of an undisclosed location” where goats were housed (2015 complaint, paragraph 6).

SCBT history of non-compliance citations

This was not the first time SCBT has been cited for AWA compliance issues. According to the August 7, 2015 complaint, in July, 2005, the company paid a $4,600 penalty to resolve allegations of AWA violations from 2002-2004 (2015 complaint, paragraph 7). Seven years later, on July 19, 2012, USDA filed a complaint against SCBT alleging the following:

  • SCBT failed to “establish and maintain programs of adequate veterinary care.” (2012 complaint, paragraphs III. B.-C based on findings from a July 13, 2010 inspection; 2012 complaint, paragraphs IV. C.-D, based on findings from a February 8, 2011 inspection; and 2012 complaint, paragraph VI. B. 5, based on findings from a March 6, 2012 inspection);
  • During the March 6, 2012 inspection, the inspector cited SCBT for not only having “failed to establish and maintain programs of adequate veterinary care under the supervision and assistance of a doctor of veterinary medicine,” but also having “failed to provide veterinary care to animals in need of care.” (2012 complaint, paragraph VI. A);
  • On July 13, 2010, the USDA inspector cited SCBT for animal care staff who were not properly trained. (2012 complaint, paragraphs III. A.-B. and E.1);
  • On July 24, 2007, the USDA inspector cited SCBT for improper handling of animals. (2012 complaint, paragraph II.D.1.-2).

The 2012 complaint also noted various shortcomings of SCBT’s institutional animal care and use committee or “IACUC.” According to the AWA, the IACUC is required to “assess the research facility’s animal program, facilities, and procedures,” including semi-annual inspections of the facilities that identify and report “significant deficiencies.” (9 C.F.R. section 2.31 (c) (1-3)) A significant deficiency is defined in 9 C.F.R. section 2.31 (c) (3) as a problem that “is or may be a threat to the health or safety of the animals.” The IACUC is also required to review and approve animal use protocols before the research commences, to review and approve significant changes to ongoing protocols, and to ensure that animal pain and distress are minimized.

The 2012 complaint alleged these problems with SCBT’s IACUC:

  • The AWA requires the IACUC to determine that the principal investigator had considered alternatives to potentially painful procedures and failure to ensure that the animals’ pain and distress would be minimized by providing pain relieving drugs unless there was scientific justification to withhold them. (9 C.F.R. 2.31 (d) (1) (ii)) Alleged failures of the SCBT IACUC to do so were noted in the July 24, 2007 inspection (2012 complaint, paragraphs II. B.-C); the February 8, 2011 inspection (2012 complaint, paragraphs IV.A.-B); and the March 6, 2012 inspection (2012 complaint, paragraph VI. B. 2);
  • The AWA requires the IACUC to review and approve significant changes to an ongoing activity. (9 C.F.R. 2.31 (c) (7)) On March 6, 2012, the USDA inspector cited SCBT for an alleged failure of its IACUC to review significant changes. (2012 complaint, paragraph VI.B.1);
  • The AWA requires the IACUC to determine that animals are housed in conditions appropriate for their species. (9 C.F.R. 2.31 (d) (1)) On March 6, 2012, the USDA inspector cited SCBT for an alleged failure of its IACUC to ensure appropriate housing for animals at the facility. (2012 complaint, paragraph VI. B. 3)
Photo credit: Dan Coyro -- Santa Cruz Sentinel

Photo credit: Dan Coyro — Santa Cruz Sentinel

2014 hearing delayed

The 2012 complaint was to have been adjudicated in 2014, but the hearing was called off two weeks before it was scheduled to take place. According to a July 1, 2014 notice issued by Administrative Law Judge Jill S. Clifton, the hearing was cancelled to give SCBT and USDA “ample time to meet to further their attempts to settle the case.” However, no resolution to the allegations in the complaint was announced, and during subsequent visits, USDA inspectors identified more alleged AWA violations at SCBT.

On November 4, 2014, USDA filed a second formal complaint listing alleged violations found during 7 inspections between September 26, 2012 and April 22, 2014. The second complaint charged SCBT with having “failed to allow APHIS officials to inspect” a barn known as Lake Ranch/H7 “from at least March 6, 2012, through October 30, 2012.” (2014 complaint, paragraph III). This complaint also listed additional instances of failures to provide adequate veterinary care based upon findings from inspections of October 31, 2012 (2014 complaint, paragraph IV. B), December 18, 2012 inspection (paragraph V); and February 20, 2013 (paragraph VI).

The 2014 complaint also included these allegations:

  • The AWA requires the IACUC to ensure that the proposed activities or significant changes in ongoing activities “will avoid or minimize discomfort, distress, and pain to the animals.” (9 C.F.R. 2.31 (d) (i)) On September 26, 2012, the USDA alleged that SCBT’s had failed to execute this requirement. (2014 complaint, paragraph II. A);
  • The AWA requires the IACUC to “review and approve, require modifications in (to secure approval) or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities.” (9 C.F.R. 2.31 (c) (7)) Alleged failures of the SCBT IACUC to do so were noted during the inspections of October 31, 2012 (2014 complaint, paragraph IV.A); May 14, 2013 (paragraph VII); and April 22, 2014 (paragraph IX.A.-B);

The 2014 complaint further listed problems with the housing, food, and water provided to animals. These problems were noted in the September 26, 2012 inspection (cited in paragraph II. C. 1-4 of the 2014 complaint as alleged violations of 9 C.F.R. Sections 3.125 (a), 3.129 (a), 3.131 (a) and (d)); in the October 31, 2012 inspection (cited in paragraph IV.C. as alleged violations of 9 C.F.R. Sections 2.26, 2.100 (a), and 3.131 (c)); in the September 10, 2013 inspection (cited in paragraph VIII.1 as alleged violations of 9 C.F.R. Section 3.127 (a)); and in the April 22, 2014 inspection (cited in paragraph IX. C.1-3 as alleged violations of 9 C.F.R. Sections 3.56 (a), 3.54 (a), and 3.129 (a)).

USDA’s latest complaint

The third USDA complaint was filed August 7, 2015 and reported by the Santa Cruz Sentinel under the headline: “Santa Cruz Biotech faces third USDA complaint alleging animal mistreatment.” As noted above, this complaint asserted that the company had “demonstrated bad faith by misleading APHIS personnel about the existence of an undisclosed location where respondent housed regulated animals.” (2015 complaint, paragraph 6) It also alleged that SCBT had “repeated[ly] failure[d] to provide minimally-adequate and expeditious veterinary care and treatment to animals.” (paragraph 5) In support of this allegation, subparagraphs 8. a.-n. of the complaint describe 14 instances between 2011 and 2015 where USDA inspectors observed individual goats that appeared to be in poor health and lacking appropriate veterinary care. Several of these goats were thin, appeared anemic or seemed to be suffering from infections (subparagraphs 8 a., b., c., d., g., j., k., l., and m.), while others had wounds or other injuries (subparagraphs 8.e., f., and i.).

These were two of the most serious cases:

  • “Respondent failed to provide adequate veterinary care to a goat (#12267) that sustained a rattlesnake bite on April 28, 2012, and following initial treatment, the goat’s condition did not improve, and the goat was not given any further treatment until its death. Specifically, the goat developed a visibly swollen jaw and chest and draining lesion and experienced a 23% weight loss (24 pounds) between April 28 and May 9, 2012. By APHIS’s inspection on May 24, 2012, the goat was observed to be unable or unwilling to close its mouth, which, in conjunction with the goat’s other visible conditions, indicated that the goat was unable to eat normally. On June 10, 2012, the goat was observed to have labored breathing, but was not euthanized June 11, 2012.” (2015 complaint, sub paragraph 8.f.);
  • “Respondent failed to provide adequate veterinary care to a goat (#21135) that had been diagnosed with urinary calculi [kidney stones] and treated with ace promazine. On July 7, 2015, at approximately 10:30 a.m., APHIS inspectors found the goat in a depressed posture, unwilling to walk, and breathing heavily. Respondent had no veterinarian available to attend to this animal: the respondent’s ‘on-site’ veterinarian was on vacation, and respondent’s staff could not contact respondent’s attending veterinarian, or any other veterinarian who could provide emergency care. By 3:30 p.m., the goat was agonal [gasping for breath], suffering and in distress. Respondent failed to follow its own ‘Standard Operating Procedure’ for emergency goat euthanasia, which requires veterinary approval for euthanasia. As no veterinarian was available, respondent’s staff used a captive bolt gun alone (without a sedative or secondary euthanasia injection,) to effect euthanasia of the goat at approximately 4:15 p.m.” (2015 complaint, subparagraph 8.n.).

As of this writing, there has been no judicial resolution of the alleged AWA violations by SCBT. That is to say, neither a settlement between USDA and SCBT nor a continuation of the administrative hearing has been announced.

Animal welfare matters

On February 14, 2014, Cat Ferguson wrote in The New Yorker about alleged animal welfare problems at SCBT, “Valuable Antibodies at a High Cost”. On September 25, 2015, science writer Meredith Wadman published an opinion article in the San Jose Mercury News about the 4-day hearing the previous month. In “No excuse for cruelty to goats raised for medical research,” Wadman opined that researchers were “the only constituency that Santa Cruz cares about,” and urged them to “weigh in” using their purchasing power. According to Wadman, Matt Scott of the Carnegie Institution for Science and Pamela Björkman of the California Institute of Technology have stopped buying antibodies from SCBT. Wadman concluded by asking, “Is it too much to ask other scientists to follow suit?”

Testimony from USDA Veterinary Medical Officer Marcy Rosendale was reported in an account of the August 18-20, 2015 hearing posted by the Animal Welfare Institute. According to this report, Rosendale said she had not observed the same number of animal welfare problems she found at SCBT at other antibody production facilities she had visited.

There is growing recognition that to ensure the rigor of their work, scientists need more information about the antibodies they use actually, i.e., technical specifications such as the what part of the target protein the antibody binds to. Perhaps it is also time to pay more attention to how those antibodies are produced.

USDA inspections are a matter of public record, but meeting the requirements of the AWA should only be the beginning. Antibody producers should be encouraged to take additional steps to affirm their commitment to animal welfare, such as by seeking independent accreditation of their production facilities through AAALAC. The point is that researchers and antibody producers alike must find tangible ways to demonstrate a commitment to high standards of animal care.

Alice Ra’anan and Bill Yates

Previous posts about SCBT and antibodies:

https://speakingofresearch.com/2014/03/28/santa-cruz-biotechnology-bad-behavior/

https://speakingofresearch.com/2014/08/08/responsible-antibody-production/

USDA documents:

USDA – 1st SCBT complaint 19 July 2012

USDA – 2nd SCBT complaint 4 Nov 2014

USDA – 3rd SCBT complaint 7 Aug 2015