Tag Archives: Jeffrey Kahn

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

 

A Philosopher’s Dream

A moral philosopher had the following dream:

First Darwin appeared, and the philosopher said to him, “Could you give me a fifteen-minute capsule sketch for your support of medical research using animals?”

To the philosopher’s surprise, Darwin gave him an excellent exposition in which he compressed an enormous amount of material into a mere fifteen minutes,  ending with a warning to the philosopher that “I know that physiology cannot possibly progress except by means of experiments on living animals, and I feel the deepest conviction that he who retards the progress of physiology commits a crime against mankind. “ But then the philosopher raised a certain objection which Darwin couldn’t answer. Confused, Darwin scratched his head and disappeared.

Then Albert Sabin appeared.  He gave another detailed account of the importance of the work to the development of the Polio vaccine and concluded that “without the use of animals and of human beings, it would have been impossible to acquire the important knowledge needed to prevent much suffering and premature death not only among humans but also among animals.”  The same thing happened again, and the philosophers’ objection to Sabin was the same as his objection to Darwin. Sabin also couldn’t answer it at all, scratched his head and disappeared.

head-scratching

Then all the famous medical heroes of the past century paraded one-by-one to defend the work, and our philosopher refuted every single one with the same, singular objection.

After the last scientist vanished, our philosopher said to himself, “I know I’m asleep and dreaming all this. Yet I’ve found a universal refutation for all justifications of animal  research! Tomorrow when I wake up, I will probably have forgotten it, and the world will really miss something!”

With an iron effort, the philosopher forced himself to wake up, rush over to his desk, and write down his refutation. Then he jumped back into bed with a sigh of relief.

The next morning when he awoke, he went over to the desk to see what he had written.

It was,

“That’s what you say, but I am deeply skeptical.”

 

Jeffrey Kahn’s Odd Views on Animal Research

Professor Jeffrey Kahn visited UW Madison to discuss the use of monkeys in medical research.

He is the Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy and the Deputy Director for Policy and Administration at the Johns Hopkins Berman Institute of Bioethics.

Professor Kahn has participated in numerous federal panels and chaired the influential Institute of Medicine (IoM) committee on the Use of Chimpanzees in Biomedical and Behavioral Research, which recommended that the NIH phase out most biomedical research on chimpanzees.

Because he is respected and listened to by those in charge of making policy decisions on matters of important medical research and public health issues, his talk at UW Madison drew much attention.

During his comments Prof. Kahn raised several objections about how animal research is regulated in the United States that deserve closer scrutiny.

Unfair application of the principles of utilitarian philosophy

Professor Kahn objected to justifying research based on utilitarianism on the grounds that it is unfair to consistently harm one group (non-human animals) for the benefit of another (humans).

However, the notion that pure utilitarianism forms the basis for an ethical defense of biomedical research is incorrect.

For example, a pure utilitarian view would also call for doing invasive experiments in mentally disabled human beings whose cognitive capabilities are comparable to those of animals used in research, or demand we forcefully harvest the organs of a potential human donor to save the lives of several others.

Of course, we don’t do any of these things. So it was perplexing to hear him state that utilitarianism is “how the system is set up.” 

No, it is definitely not.

Medical research with human and non-human animals is not based on a pure, utilitarian view.  Instead, it is partly based on a graded moral status perspective that posits we owe moral consideration to all living beings, but not to the same degree that we owe consideration to the lives of fellow humans. It is also partly based in our mutual recognition of equal, basic rights for all members of the human family.

These ethical considerations are embedded in federal regulations and NIH guidelines that call for minimizing the number of animal subjects used in any one study, the amount of suffering involved, and require the use the “lowest” species that can be expected to yield meaningful scientific answers.  It is also reflected in specific federal programs aimed at developing alternatives to animal use and, of course, in protections for human subjects.

It is true that NIH has never made explicit the ethical and philosophical principles underlying its research.  Nevertheless, the ethical principles etched in these regulations should be clear to anyone who spend the time to become familiar with them.

A misguided notion of scientific necessity

Professor Kahn views the “scientific necessity” of the work as inextricably linked to the ethics. His views are aligned with the conclusions of the panel that he chaired on chimpanzee research.  Within this framework a project would be morally justified only if all the following three conditions were met:

  1. No suitable alternative is available
  2. The work cannot be performed ethically on human subjects
  3. The work is required in order to accelerate the prevention, control and treatment of life-threatening or debilitating diseases

A large class of studies readily meet the first two requirements. When we seek information about the cellular and molecular mechanisms in a living organism, the technologies available to us at the present are invasive, and the work cannot be performed ethically in human subjects. If we could observe and manipulate molecular pathways and cells in living humans without jeopardizing their well being, then the work would be done in humans. But we don’t yet have such tools. No computer simulation, no in-vitro system, no MRI, no organs-on-a-chip currently available, provide an adequate alternative to animal studies.

The crux of the matter then boils down to the third condition, and therein lies the rub. When you are talking about the process of scientific discovery, this third condition is meaningless when applied to individual scientific projects. Science, as Professor Kahn himself points out, is not necessarily a predictable linear path from point A to point B, because it involves the exploration of the unknown. Science cannot promise that any one experiment can lead to a cure, nor can researchers know ahead of time which specific experiment or line of research will lead to a breakthrough. In Professor Kahn’s own words, “we call it research because we don’t know what the answer is.”  Why does he not realize that demanding a specific outcome in advance is out of the question?  One can only evaluate outcomes in retrospect, as Peter Singer has done offering in his approval for monkey studies in Parkinson’s research. Unfortunately, scientists on NIH study sections do not have the luxury of an oracle that can guide their decisions.

Instead, researchers understand that without animal studies we will not be able to develop new therapies and cures. Our expert scientific opinion is that were we to suspend animal research, most fields of biomedical research would come to a full stop. Meanwhile, patients and their families would pay the price of more human suffering.

Thus, the ethical question should be reframed as not whether one individual study is required but, in the case at the heart of this debate, whether the use of animal models is required to understand the molecular pathways underlying mental disorders so that we can  develop new treatments and cures for them.  Or more generally, if animals are required at all to advance medical knowledge and human health.  The scientific consensus in this matter, as indicated by a recent Nature magazine poll,  is overwhelming:

 

Bonus points should go to UW Professor Eric Sandgren who was nevertheless able to use Professor Kahn’s framework to explain, point by point, why he feels the studies under discussion can be justified. You may agree or disagree with his justification, but you cannot say he did not offer one. In contrast, Professor Kahn simply stated that he was “deeply skeptical” of the necessity of the work, despite acknowledging a lack of familiarity with the details of the study, nor bothering to explain the rationale for this view.

Given that the research at the center of this debate is aimed directly at anxiety disorders, a specific neurological condition that affects millions of humans, one might safely assume that Professor Kahn would express even graver doubts about basic research in animal subjects. He would have likely have rejected outright the research on olfactory cells that eventually allowed paralyzed people (and dogs) to walk again, among numerous advances in knowledge that have led to medical breakthroughs.

Professor Kahn ought to be reminded that the mission of the NIH is “to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability,” and try to understand better the inherent uncertainty and necessity of scientific research.

Do IACUCs and NIH study sections fail to evaluate scientific necessity?

Given his misguided view of necessity, it should not be surprising Professor Kahn believes that neither IACUCs nor NIH study sections are able to assess the scientific need for specific studies. He harshly criticized such committees for taking the claims of any one proposal at “face value.

That is a very strong statement… and a decidedly incorrect one, too.

First, the overall scientific direction of medical research in the country is established by our medical and scientific leadership. In the neurosciences, scientists are guided in their research by NIH’s Neuroscience Blueprint. Among the important scientific directions relevant to this particular discussion—ones that Professor Kahn should have known about—were the Blueprint Neurotherapeutics Network (to advance the development of new drugs for nervous system disorders) and the Blueprint Non-Human Primate Brain Atlas (to provide comprehensive data on gene expression in the rhesus macaque brain , from birth to four years old). Such work is expected to aid research on human brain development and its disorders.

Second, NIH study sections diligently assess proposals with an eye to which studies stand a better chance of advancing our knowledge of function and disease and therefore may have the greatest potential to lead to new cures or fundamentally advancing a field of study. In making their assessments, scientists who participate in study sections use their expertise to assess which research directions and pilot data look most promising. There is never a guarantee that any one study will produce a breakthrough. If there is any one premise it is that animal research has led to numerous advancements in knowledge and medicine that has benefited human and non-human animals alike. This is not taken at face value, rather, it is an indisputable fact of medical history.

Third, once the scientific merit of a proposal has been established, IACUCs provide an additional layer of local scrutiny and compliance oversight. It is perfectly reasonable for IACUCs to ensure the work at the institution maximizes the welfare of the animal subjects in each study, and NIH requires such an assurance for institutions that receive federal funding. (For the small minority of projects that have not yet received NIH review, the IACUCs seek local expertise to evaluate the scientific merit of the study.)

Is funding “unnecessary” research a waste of resources?

Another miscalculation derived from Professor Kahn’s flawed view of “necessity” is the claim that if research is “unnecessary” according to his definition, then it is also unethical, especially considering the limited funding resources we have available at the moment.

It is perfectly legitimate for a society to assess how it distributes its resources, but in doing so the entire budget ought to be considered.

One may ask, for example, how Professor Kahn feels about resources spent on drones for the military, the Hubble telescope, unmanned trips to Mars, funding for theoretical physics, game theory, or the Arts.

Or, more to the point, one could ask for a more detailed justification of why society should spend its resources on philosophers and bioethicists?

Should society prioritize the support of bioethics over the development of a vaccine for Ebola or a cure for cancer, Alzheimer’s or Parkinson’s?

Which is one more crucial to our social welfare and which is more “unnecessary”?

Who will direct medical research?

Scientists must participate more in public life because social policies need to be decided on the basis of rational grounds and facts. These include important issues ranging from climate change, to the goals of the space program, to the protection of endangered species, to the use of embryonic stem cells or animals in biomedical research.

When scientifically inaccurate statements emanate from someone who has demonstrable influence on public policy decisions, scientists have a duty to speak up and correct the mistakes.

Animal research poses a legitimate moral dilemma. Decisions to pursue different lines of research that are perceived as controversial — be it research involving animals subjects or embryonic stem cells — cannot be assessed fairly without the active participation of scientists, physicians, patients and their families, because all are stakeholders in the work.

Unless these stakeholders get involved in such debates, we may find that their interests are not taken into account when the future direction of medical research is determined.

Dario Ringach