Tag Archives: animal research

Animal research successes spur growth in science…but PeTA can only complain

What do multiple myeloma, influenza, advanced breast cancer, atrial fibrillation, thyroid cancer, ear infection, advanced ovarian cancer and obesity all have in common? One commonality is obvious – they cause suffering, sickness and sometimes death in people around the world. Another commonality is less obvious – these are each conditions that are now being treated with new drugs just approved by the U.S. Food and Drug Administration (FDA) in the past three months alone. That’s right… in the period from Thanksgiving 2014 until now, new drugs that treat each of these conditions have become available, and these agents will be used to treat the illnesses that may affect millions of Americans. Eventually, they will likely have enormous worldwide impacts on these diseases. That’s something to be thankful for.

While some are thankful that the scientific progress is successfully tackling human suffering and disease, others cast doubt on the way that progress is achieved. In a newly published analysis entitled “Trends in animal use at US research facilities” [1], employees of People for the Ethical Treatment of Animals (PeTA) – a self-avowed animal rights organization – report that, amongst the largest research universities in the United States, the number of animals involved in research has grown by over 70% during the past 15 years. In their publication, the authors express alarm over the growing use of animals not covered by the Animal Welfare Act (AWA), mostly mice and fish, in biomedical research, without making any mention of the impact of this research growth.

This growth in animal research in the US is directly linked to an accelerating pace of scientific study and its benefits. A brief visit to the FDA’s “New Drugs at FDA page” makes it quickly apparent that the rate of approval of new medications is astounding. Where is this progress coming from? At least in part, it’s coming from the scientific discoveries that are pouring out of the research laboratories located in colleges and universities, institutes and pharmaceutical and biotechnology companies around the globe. A good example is the innovative BiTE antibody Blincyto (blinatumomab) which was approved for use in treating B-cell acute lymphoblastic leukemia in December 2014 (clinical evaluation against other cancers is ongoing); as we discussed in a blog post in 2008, animal research – particularly studies in mice – played a key role in its development and early evaluation.

Thanks to the researchers that occupy laboratories around the world, scientific discoveries are coming faster than ever, and all of us benefit. It’s not just that there is more research being done – it’s that the impact of the science is better than ever thanks to more advanced technologies, accumulating knowledge of how the body works and more advanced animals models, including ones that mimic human disease processes in increasingly sophisticated ways that promote new discoveries and new opportunities to develop novel drugs.

Why is the scale of animal research growing in the US? The answer is clear: scientific progress is cumulative. One discovery often enables multiple other lines of work. The discovery of the structure of DNA, for example, enabled thousands of efforts to find the genetic causes of disease. Because of this, successes build on successes and research grows.

What is the consequence of the growth in animal research? The answer is: new treatments, new cures, less sickness and longer, healthier lives.

In their paper, the PeTA employees fail to mention any of the following accomplishments, allow of which resulted from the growing scientific research efforts around the world:

But this isn’t the end. To these existing accomplishments, add the work that was started in the past 15 years and will yet unfold in the forthcoming decade AND the overwhelming progress in basic/fundamental research that will lead to new treatments and cures throughout the first half of the 21st century, and you have the recipe for a growing animal research infrastructure in this country.

As recent statistics from the UK indicate, the increase in the use of mice and fish in research is driven almost entirely by the increasing number of studies that involve the use of genetically-modified (GM) animals. In other words, the increase is driven by scientific and technological advances that had a profound impact on biomedical research over the past 15 years, rather than any desire to avoid using species regulated by the AWA (while mice and fish studied in Universities are not covered by the AWA, research involving them is regulated in multiple ways, including through the federal Office of Laboratory Animal Welfare which issues the PHS Guide for the Care and Use of Laboratory Animals).

“Recent statistics from the UK indicate, the increase in the use of mice and fish in research is driven almost entirely by the increasing number of studies that involve the use of genetically-modified (GM) animals.”

Growing study of GM animals has occurred because these models are enormously useful. To take just one example, the National Institute of Child Health and Development recently published an online article entitled “It’s in the DNA: Animal Models Offer Clues to Human Development”, discussing the role of animal models in helping to understand human development and developmental disorders. But this is far from the only example, studies in GM mice are key to many of the state-of-the-art emerging fields in biomedical research. These range from the very new areas of optogenetics – which uses light to control activation of individual cells – and gene editing techniques such as CRISPR that have the potential to cure genetic disorders, to new therapies such as cancer immunotherapy and treatments for rare genetic disorders such as progeria and Pompe disease which are being used to successfully treat patients for whom effective therapies were previously unavailable.

The rise in the numbers of zebra fish is also driven by their value as research models. As vertebrates they share over 84% of the genes that cause disease when defective in humans, while their rapid reproduction and transparent eggs make them ideal subjects for genetic and developmental studies. It’s not surprising that they are both an increasingly popular species in basic biomedical research, and in the preclinical evaluation of potential new therapies and of the environmental safety of chemicals.

In recent years zebra fish have become an increasingly popular species in biomedical research.

What the statistics presented by PeTA in their article don’t tell you is that, while the number of experiments and studies have increased, animal research increasingly involves Refined techniques that produce minimized harm to the subjects and Reduced numbers of animals per study. And of course, animal research directly led to the ability to Replace animals in some types of studies, altogether. The efficacy and efficiency of animal research is advancing, and individual discoveries are, on average, being made with fewer animals. That is a fact missed entirely by the PeTA article.

Furthermore, within the concept of refinement is the idea that researchers should use animals that will suffer less in a laboratory setting wherever possible [2]. So replacing a small number of “higher” mammals with a high number of “lower” animals is consistent with the 3Rs principles of animal welfare. PeTA neglect to mention that USDA statistics show a 40% fall in the use of AWA-covered species over the last 15 years, and it is likely that a small proportion of the rise in use of non-AWA covered species is due to technological advances that have allowed non-AWA species (e.g. GM mice) to replace AWA species (e.g. monkeys) in some studies, for example to develop new treatments for HIV/AIDS, in line with the principle of Refinement we have outlined.

Number of animals used annually for research in the US

“PeTA neglect to mention that USDA statistics show a 40% fall in the use of AWA-covered species over the last 15 years”

Through the implementation of these 3Rs, scientists ensure that they engage in socially-responsible and ethical work. What the authors of the PeTA study should do is to explain how achieving their end goal of a virtual end to animal research, which will reverse the trend of accelerating discovery and medical progress upon which it depends, is ethical or defensible.

  1. Goodman, J., Chandna A., and Roe K. 2015. Trends in animal use at US research facilities in: J Med Ethics. 0:1-3
  2. Richmond, J., 2014. Refinement Alternatives: Minimizing Pain and Distress in Allen, D. and Waters M. ed. In Vivo Toxicity Testing” in: Reducing, Refining and Replacing the Use of Animals in Toxicity Testing. Cambridge: RSC. pp. 133

David Jentsch

Implementing the 3Rs at the University of Oxford

This Guest Post is by Stuart Peirson, Associate Professor in the Nuffield Laboratory of Ophthalmology and chair of the 3Rs sub-committee at The University of Oxford. This article was originally posted on the website of the National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) and is reprinted with full permission. This article explains how Oxford is supporting the 3Rs, please read out page on UK research regulations and the 3Rs for more information.

Oxford imageThe University of Oxford is one of the world’s leading centres for biomedical research, with outstanding strengths in both basic science and its clinical application. The University’s Policy on the Use of Animals in Scientific Research outlines the University’s commitment to ensuring that all those involved in animal-based research are proactive in pursuing the 3Rs, engage fully in the ethical review process, and fulfil their moral and legal responsibilities for the care and welfare of animals.

Ethical review

Reflecting the enormous breadth of research across Oxford, the University currently holds over a hundred different project licences, with over a thousand personal licence holders. This poses a number of challenges for the coordination of ethical review as well as the dissemination of best-practice and advances in the 3Rs.

The critical element in this process is the Animal Welfare and Ethical Review Board (AWERB). All applications for project licences require the ethical approval of the University before they are passed to the Home Office. At Oxford, this involves a rigorous and objective process of ethical review that challenges scientists to justify their use of animals, and that requires them, where the use of animals is unavoidable, to minimise animal numbers and maximise animal welfare.

At Oxford the AWERB process consists of two principal elements. Firstly, a central Committee on Animal Care and Ethical Review (ACER) is responsible for setting policy, as well as reviewing applications involving the use of non-human primates, severe protocols or novel techniques. Secondly, Oxford also relies upon a network of Local Ethical Review Panels (LERPs), which consider all other project licence applications. All project licences are required to provide a written retrospective review for their LERP at two years and four years, providing a critical opportunity for the LERP to assess how project licences have applied the 3Rs in their research.

The 3Rs sub-committee

In addition to the ethical review process, the University also has a 3Rs sub-committee reporting directly to ACER, which receives copies of all retrospective reviews to identify key developments in the 3Rs across the University. These developments are combined to form a termly 3Rs newsletter, which also contains information on relevant workshops, lectures and courses, such as NC3Rs notifications.

In addition, the committee also recognises the achievements of particular groups in the application of the 3Rs, providing letters of commendation to those project licence holders who show particular commitment and dedication to the 3Rs.

Since the introduction of the University’s Policy on the Use of Animals in Scientific Research, all departments involved in such research are also required to have termly Departmental Animal Welfare meetings. These are attended by project and personal licence holders, vets, Named Animal Care and Welfare Officers (NACWOs) and animal care staff, and provide a valuable forum for discussion of advances in the 3Rs.

The relationships within the network of animal committees at the University of Oxford

Summary of the role of the 3Rs sub-committee within the ethical review process

The 3Rs sub-committee also arranges lectures and workshops in areas it has identified as being important. For example, in 2013 we held a workshop on ‘Developments in Transgenic Mouse Models’, involving speakers from both Oxford and MRC Harwell, covering subjects ranging from colony management and background strains to existing transgenic resources and developing new transgenic models.

Working together

Biomedical Services (BMS) is an independent University Department of the Medical Sciences Division. BMS provides world class animal facilities that provide accommodation and care for its animals, delivered by professionally trained staff. A central principle of the University’s policy is the commitment to a culture of care, encouraging a team approach to animal work that fosters good communication and collaboration between all those working with animals in scientific research.

To facilitate this, in addition to their role on AWERBs, BMS staff, (including vets and NACWOs), routinely attend Departmental Welfare meetings, providing an informal opportunity for project and personal licence holders to discuss their work. The regular interaction has encouraged BMS staff and academic scientists to work together to achieve both high quality research and animal welfare.

Finally, BMS also provides key central services, such as the University’s new online training and competency records and colony management systems. Furthermore, practical veterinary assistance is also provided, such as a recent series of workshops on aseptic technique.

The future

Whilst Oxford has made great progress in implementation of the 3Rs throughout its scientific research programme, more can still be done. For example, we are currently building a ‘3Rs Knowledge Bank’ containing key and up-to-date references and protocols relating to best practice in the 3Rs.

We are also currently working on a University Strategy for the 3Rs, based upon the NC3Rs publication ‘Implementing an Institutional Framework for the 3Rs’. This will ensure that the 3Rs are thoroughly embedded in the research activities of the University, and that when animal research is necessary, it is conducted to the very highest of standards.

Professor Stuart Peirson

Chimpanzee Retirement: Facts, Myths, and Motivation

How often have you heard the claim that chimpanzees who have moved to a sanctuary have felt “dirt and grass under their feet, sunshine on their faces” for the first time in their entire lives because they have come from laboratories where they have only known barren, concrete environments?

Yerkes chimpanzees

Chimpanzees at the Yerkes National Primate Research Center.

You may hear it pretty often if you follow the fundraising and publicity campaigns that are aimed at raising money to support facilities that care for animals retired from research.  Among many examples, are recent comments by Cathy Willis Spraetz, president and CEO of Chimp Haven. Chimp Haven is the US chimpanzee sanctuary supported and administered primarily by the National Institutes of Health (NIH) through public, federal funds that assure lifetime retirement care of research chimpanzees. Chimp Haven was founded in 1995 by behavioral scientist Dr. Linda Brent and a group of primatologists and business professionals.

In a recent presentation, Chimp Haven’s current CEO Spraetz said:

“Many of these chimpanzees have spent literally decades in laboratories. And so their experience has been concrete and mesh, not grass, not dirt. And so after decades of being there, coming to Chimp Haven is a novel experience and a very scary one. Many of them do not want to put their feet down on grass or dirt. …  We try to accommodate the chimpanzees and meet them where they are. The good news is that many of them, after a couple of years, actually can transition. But in the meantime, we give them a lot of different spaces so they can feel comfortable where they are.” [Emphasis added.]

Similarly, in a CNN story this weekend“Retired means to sanctuary. Labs are lots of things, but they are certainly not sanctuaries, and so it’s important that the chimps come here,” Spraetz said. She noted that some lab chimps have lived in cages for so long, they’re afraid of grass when they arrive at Chimp Haven. Gradually, they become accustomed to living in a more natural setting.”

The image and language resonate. They evoke emotional responses in compassionate people who care about animal welfare. But are they claims that are representative of the actual situation?

In many cases, they are not at all. For example, the picture below shows chimpanzees in four settings. In each, it is easy to see that the chimpanzees have dirt under their feet and sunshine on their faces.  Where are they?  Two are current research facilities, one is an NIH-funded sanctuary, and one is a publicly-funded zoo.

chimp housing [Autosaved]

Clockwise: Top – Yerkes National Primate Research Center, Atlanta, GA (Note: Yerkes’ chimpanzees are not NIH-owned or supported); Lincoln Park Zoo, Chicago, IL;  MD Anderson Keeling Center for Comparative Medicine, Bastrop, TX; Chimp Haven, Keithsville, LA.

In fact, the majority of research chimpanzees in the US live in settings that provide outdoor housing, including dirt and sunlight. They also provide extensive and complex climbing structures, opportunities for foraging and tool-use, toys, fresh produce and treats, bedding, interaction with expert and compassionate caregivers, and state-of-the-art medical care and facilities.

Are all the facilities equal in all aspects? No. But neither are the sanctuaries, zoos, and other settings that house chimpanzees in the US– more chimpanzees, in fact, than are housed in research facilities (Chimp Care).*  Furthermore, those research facilities are subject to more extensive standards, greater public oversight, and more public transparency than the zoos, sanctuaries, entertainment, and private homes that house chimpanzees.

Misrepresenting chimpanzees’ current housing and care is a problem.

There are a few explanations for why anyone would make the claim, or use partial truths, to encourage others to believe that most research chimpanzees live in barren concrete environments. One is simple lack of knowledge and experience. Another is a deliberate misrepresentation. Neither serves the animals or partnership with others in order to thoughtfully provide for the chimpanzees’ best long-term care. Nor does it serve the public.

It is likely that many members of the public may not be familiar with accurate representation of the conditions and housing of chimpanzees in NIH-funded primate centers.  That is not the case, however, for many involved in sanctuary efforts and who have first-hand knowledge of the dirt, sunshine, and enriched care that chimpanzees receive in many– if not all– research facilities.

Chimpanzees 2

Chimpanzees at the Yerkes National Primate Research Center.

The question isn’t whether there is room for continuing improvement in captive chimpanzee care and housing. No one would claim any captive setting is the same as the wild, or that any sanctuary, zoo, or research facility is beyond improvement. (The same is true for the wild, where chimpanzees are subject to many negative outcomes due to human influence and vital conservation efforts require more support.) But in reality, there is often more similarity than difference in chimpanzees’ actual care and housing between many of the best sanctuaries, zoos and research facilities in the US and in other countries. The question is how to identify best practices that balance animal welfare and the facilities’ purposes and then find workable solutions and funds to make them common practices.

Furthermore, a closer comparison of the actual conditions at the federal sanctuary facility and those at the facilities in which the animals currently live is also key to serious, fact-informed evaluation of statements made about the NIH’s progress and eventual decisions about moving chimpanzees from their current homes to Chimp Haven.  In this weekend’s CNN story, the director of Chimp Haven makes a number of arguments in favor of increased funding and speeding the movement of chimpanzees to the Louisiana facility.  Many of those arguments revolve around whether, and how much of a difference there is between the different settings, and whether there is a difference to the animals’ well-being.

The quality of all of those evaluations depends on factual and specific comparison, as well as evidence for meaningful difference in the animals’ well-being.  The balance of benefit and harm includes the known stress to the animals that is caused by moving across country, into new situations, and into new social groups. Although movement to sanctuary may have benefits, it also has costs to the animals. For example, beyond relocation to unfamiliar housing, care practices and caregivers, the animals also face potential disruption of their social groups, introduction to new groups and upheaval in dominance hierarchies. The adverse impact of these stressors is of particular concern for elderly animals and for others who may be especially vulnerable to negative health effects of stress. Thus, consideration of those balances and comparison of different facilities must be taken together to inform decisions about investments that best suit the animals’ needs.

Bastrop chimps tool use

Chimpanzees at MD Anderson Keeling Center for Comparative Medicine, Bastrop, TX.

Federal public funding for retired chimpanzees
Over the past 15 years the US public, through federal legislation with overwhelming bipartisan support, has committed to an estimated $86 million to support the lifetime care, housing, and enrichment of retired research chimpanzees. In 2000, federal legislation (Chimpanzees Health Improvement, Maintenance, and Protection; CHIMP Act) established the first national chimpanzee sanctuary and committed life-time funding for retired NIH chimpanzees. As a result, in 2002, a $30 million public investment was made to build and fund Chimp Haven. Chimp Haven is the only federally-funded– though not the largest– US chimpanzee sanctuary.  (For more history and information see here: http://dpcpsi.nih.gov/orip/cm/chimpanzee_management_program)

By 2013, following NIH’s decision to retire the majority of its chimpanzees, additional funds were required for Chimp Haven’s ongoing support. Thus, the CHIMP Act Amendments of 2013 were passed by the US House, Senate, and President. Under new legislation, NIH may

“use already-appropriated funds to pay for care of chimpanzees housed in federal sanctuaries if doing so would be more efficient and economical for the NIH.”

An analysis by the Congressional Budget Office (CBO) in 2012 estimated an additional $56M cost to retire and maintain federally funded chimpanzees for a 5 year period (not the animals’ lifespan). The cost to support the entirety of the NIH’s ~500 chimpanzees may be roughly $8M each year; although the cost will likely vary significantly with increasing medical and care needs as the population ages. The CBO analysis also determined that there was no cost savings to moving federally-owned chimpanzees to sanctuary instead of research facilities.

US federal funds provide the majority of revenue for Chimp Haven and support the majority (~75%) of the cost of each NIH chimpanzee retired at Chimp Haven. Chimp Haven was built and funded primarily for retirement of publicly-owned research chimpanzees. However, it is also used for retirement of privately owned animals who are not supported directly via federal funds. In October of 2014, NIH reported an annual expenditure of $4.44M to Chimp Haven for the care of 191 NIH-owned chimpanzees and an average care cost of $63 per day per chimpanzee. The same report includes a range of $32-60 daily care cost for chimpanzees in other NIH facilities that house NIH-owned chimpanzees.

Chimp Haven photo from NAPSA

Chimp Haven, US federal chimpanzee retirement facility. http://www.primatesanctuaries.org/sanctuaries/chimp-haven-inc/

Federal support for chimpanzees goes beyond direct care of research animals. For example, NIH and NSF supported scientific research has produced new knowledge that continues to benefit chimpanzees in the wild and in captivity. Furthermore, federal investment in the nation’s primate research centers from the 1960s on supported continuing advances in chimpanzee housing, care, and enrichment that now drive best practices and chimpanzee health care in zoos, sanctuaries, and research facilities.

chimp haven 2

Chimp Haven, US federal chimpanzee retirement facility. http://www.primatesanctuaries.org/sanctuaries/chimp-haven-inc/

Is misrepresenting research facilities necessary?

It is unfortunate that some of those leading sanctuary publicity and fundraising efforts continue to base their appeals in claims that generally have little basis in current fact. It is also unfortunate that the many campaigns for fundraising for the federal sanctuary fail to let the public know that the NIH and US have, in fact, pledged lifetime support for federally-owned chimpanzees. This level of public support has not always occurred in those countries that have dismantled their chimpanzee research facilities.

Some of the current campaigns centered on US chimpanzees give the impression that NIH ended research and put the chimpanzees out on the street without a dime, leaving others to provide for their “rescue.” That is far from the truth.

Fundraising is required to meet roughly one-quarter of the cost for NIH-owned chimpanzees at Chimp Haven and the full cost for chimpanzees at other sanctuaries.  But for those that care about supporting the animals and decisions in the animals’ best interests, that fundraising should not require a storyline based in half-truth or deliberate misrepresentation of the conditions in other facilities or the efforts of others who care for chimpanzees.

Allyson J. Bennett


* An estimated 1,822 chimpanzees live in the US. The care for roughly half of the chimpanzees in the US, including most of the 206 chimpanzees retired to the federal sanctuary (Chimp Haven), is provided in large measure by federal public funds. According to Chimp Care, a census project from Lincoln Park Zoo, US research facilities house 625 chimpanzees, while a research reserve houses 172.  Private sanctuaries house roughly one fifth of US chimpanzees (N=318). Nearly one-quarter of the chimpanzees in the US live in zoos, both those accredited by a non-public agency, the American Zoological Association, (262) and facilities designated as unaccredited in Chimp Care’s data (174). Chimpanzees in the US are also kept in entertainment venues (14) or by private breeders and private owners who regard them as pets (51). Such private ownership of primates is opposed by leading scientific organizations including the American Society of Primatologists.

Students in Rome to rally for Prof Caminiti and future of science in Italy

Tomorrow students at the Sapienza University of Rome – Italy’s largest University – will join their Professors and members of the campaign group Pro-Test Italia outside the Department of Physiology and Pharmacology to show solidarity with Professor Roberto Caminiti, a leading neurophysiologist whose work is being attacked by animal rights extremists.

Tomorrow Pro-Test Italia will return to the streets of Rome, joining students and scientists in support of crucial research.

Tomorrow Pro-Test Italia will return to the streets of Rome, joining students and scientists in support of crucial research.

As with many recent instances of anti-scientific populism in Italy, the campaign against Prof. Caminiti began in earnest with a dishonest broadcast on the Italian tabloid TV news programme Striscia la Notizia which misrepresented the work being done by Pr0f. Caminiti and his colleagues. Prof. Caminiti responded to these false allegations in a video which you can watch here (in Italian with English subtitles)

Following the broadcast the European Animal rights Party (PAE) announced that they would be holding a demonstration Sapienza University of Rome, on February 5 2015, with the declared will to “free” the monkeys that are used by Pr0f. Caminiti and his colleagues. This has sparked concerns that the PAE – and the more extreme animal rights groups who will no doubt accompany them – will attempt to repeat the events of 20th April 2013, when five animal rights activists forced entry into the Pharmacology Department of the University of Milan, stealing hundreds of mice and destroying years of research.

There is, however, a major difference between 2013 and today; today scientists and students are ready to stand up and  defend their research. A group of neurobiology students at the Sapienza University of Rome have organized a counter-demonstration (see this Facebook event for details) tomorrow morning – February 5 – to show support for Prof Caminiti, defend their department, and speak up for the future of scientific research in Italy.

On Monday their stand received a boost when Professor Vincenzo Vullo, Head of the Faculty of Pharmacy and Medicine at Sapienza University of Rome, circulated an email to all scientists, staff and students to express support for Prof. Caminiti, and called on them to join him in defense of the research being undertaken at the Department of Physiology and Pharmacology:

Dear colleagues, dear students,

I transmit an open letter by Prof. Roberto Caminiti in defense of the unacceptable smear campaign underway against the scientific activity of the Laboratory of Behavioral Neurophysiology, Department of Physiology and Pharmacology of our University.

In this regard, I wish to emphasize the scientific value of Prof. Caminiti, an internationally acclaimed researcher whose research has made a significant contribution to the knowledge of the central nervous mechanisms of motor control. I also want to remember especially his human qualities, demonstrated in the constant respect and care with which he always treated animals necessary for his studies.

In expressing my personal solidarity with Prof. Caminiti, I ask for the support of all members of the faculty in defense of the scientific research conducted at the Laboratory of Behavioral Neurophysiology of our university.

Vincenzo Vullo”

The email also included a letter addressed to all staff and students from Prof. Caminiti:

Dear Colleagues, dear Students,
On December 18 2014 the TV show “Striscia la Notizia”, using images illegally shot in our animal facilities, broadcast a report with the aim of stirring in the public opinion a campaign condemning the scientific activity of the Neurophysiology of Behaviour Laboratory, in the Department of Physiology and Pharmacology of our Atenaeum, where other professors and I carry out our scientific activity, which started in the year1985.
To reply to the accusation of animal cruelty, as an act of absolute transparency of research towards the public, I posted online a reasoned reply, in which it is showed and commented on everything that is performed in our laboratories, thanks to several projects financed by MIUR (Italian Government research funder- Speaking of Research) and the EU, and according to experimental protocols regularly authorized by the Ministry of Health.
On January 23 2015, once again “Striscia la Notizia” returned to the topic, using the images we put online, to claim, with the help of a “flora and fauna” specialist (!) that our studies were useless and cruel, where it is unanimously recognized in the scientific community that our research, together with other work carried out in a select group of international laboratories, lead to the development of brain-computer interface in humans and to the cerebral control of artificial prostetics in patients with paralysis due to neurodegenerative or neurovascular diseases, just like similar researches lead to the development of deep brain stimulation in the treatment of Parkinson’s disease.
Exploiting the footage broadcasted by “Striscia la Notizia”, the European Animal rights Party (PAE) launched a national demonstration, set to take place on February 5 2015, in front of our Department, with the declared will to “free” the animals that we are working with, and together with the Antivivisection League (LAV) stated that they have submitted a complaint to the Prosecutor’s Office in Rome, to open an investigation aimed to the confiscation of the animals, and to open a criminal case against me for animal cruelty.
I call on you, confident that you believe in a country guided by reason, commitment and study, and not driven by obscurantism, just like the “Stamina” case, that you all well know (for more on the Stamina scandal see this recent report -Speaking of Research) . And I ask yo to defend, with the appropriate instruments, the scientific activity and the dignity of a Department of our Atenaeum.
On the morning of February 5, wearing a white lab coat and flower in the buttonhole, I will be in front of my Department to defend and reaffirm that ideal that drove us all to become MDs and researchers.
With best regards,
Roberto Caminiti

We congratulate both faculty and students at Sapienza University of Rome for taking this action in support of science, and wish them, Pro-Test Italia, and all friends of medical progress every success as they stand together in this noble cause.

Speaking of Research

American Society of Primatologists’ statement of support for NIH primate research

The nation’s largest primatological scientific society, the American Society of Primalogists (ASP), has posted a strong statement sent January 21 in support for the scientist and research under attack by PETA.  The statement can be found on ASP’s website: https://www.asp.org/index.cfm

ASP home page Jan 2015

In its entirety, the letter reads:

“Members of the Board of Directors of the American Society of Primatologists would like to add our comments to the discussion of the validity and effectiveness of non-human primate research as it pertains to human behavior and medicine. Non-human primate research (on monkeys and apes) has had widespread effect on improving the diagnosis and treatment of many adult and childhood diseases. Studies that have employed the judicious use of non-human primates as models for human illness have improved our understanding of such disorders as autism, childhood leukemia, cerebral palsy, and mental health.1 The long-term research of one scientist, Dr. Stephen Suomi, has been called into question as a result of inaccurate, misguided and inflammatory media accounts. Our comments will address Dr. Suomi’s work and the value of non-human primates in understanding human biology, illness and behavior.

Dr. Suomi’s research has focused on the influence of variable environments and genetics on infant development, and by extension variation in adult behavior2. He and his colleagues found that early changes in the degree of attachment between mother and infant have real biological, not only behavioral influences on adult social behavior3. If this finding seems intuitive, it is evidence that the benefits of research have permeated not only the scientific, but also mainstream media4 and literature. Infant subjects are either mother-reared or reared in same-aged groups of monkeys. Infants may undergo temporary isolation during the study5 to facilitate comparison among groups that are reared differently. The goal of much of this research is to mimic separation that every social animal, including humans, undergo during their lifetimes and to understand why individuals respond differently to separation. One such research focus is the development of risk factors leading to mental illness in humans.

The American Society of Primatologists supports research on non-human primates that is carefully designed and employs rigorous research protocols. Dr. Suomi’s research and consistent funding by the NIH attests to his adherence to prescribed protocols and regulations.

Before research can begin, proposals are thoroughly vetted by both their institutional ethical oversight board (in the United States these are called Institutional Animal Care and Use Committees or IACUCs) and by the review boards of granting agencies (e.g., NIH, NIMH, NSF). This very extensive process requires prospective researchers to respond to questions such as those raised in your letter, e.g., your concern about redundant research. Per both the Animal Welfare Act and Regulations (AWARs) and the Public Health Service Policy on the Humane Care and Use of Laboratory Animals (PHS Policy), research funded by federal and state governments, as well as private foundations, must demonstrate that the project they propose will advance knowledge in the field, be relevant to human biology or behavior, and will not duplicate the efforts of previous research. The number of animals used in experiments must also be justified as well as the conditions in which the animals are housed, the duration of the project, and the protocols implemented during experiments. The scientists employed by the NIH have been leaders in the development of safe, effective, and reliable research protocols whether the research is done on mice or monkeys.

Because of the close genetic relationship between humans and non-human primates, monkeys are important models for studying particular biological phenomena, including the research conduct by Dr. Suomi. Nevertheless, non-human primates are rare in laboratory populations making up < 1% of the laboratory animals used in research (Government statistics from 2010, cited in Phillips et al., 20146). Furthermore, species are carefully matched to proposed studies.

We appreciate your attention to this matter, and ask that you please send us a response letting us know the charge to the NIH Bioethics Review Board.

Respectfully submitted,
Marilyn A. Norconk, President; Justin A. McNulty, Executive Secretary; Kimberley A. Phillips,  President-Elect; Corinna N. Ross, Treasurer; Karen L. Bales, Past-President

 

Supporting science: NIH answers PETA

The National Institutes of Health released a statement Monday in support of a well-respected and long-standing primate research program within the NIH intramural program that has been the subject of an ongoing PETA campaign. The focus of the research program, under the direction of Dr. Stephen J. Suomi, is on:

“examining the behavioral and biological development of non-human primates. Primary objectives are to understand how genetic and environmental factors interact to affect cognitive development, as well as develop interventions that can alter developmental trajectories of individuals whose specific genetic and experiential background put them at risk for adverse developmental outcomes. These studies cannot be carried out in humans and require the use of animal studies to carefully separate experience, genetic, and environmental factors. Ultimately, these findings assist researchers in identifying humans most likely to suffer negative effects in at-risk situations and develop behavioral and drug therapies to improve negative outcomes early in life.”

The NIH statement notes the high value of the research program, as assessed by an external board of scientific experts who concluded that the program:

  “has achieved world class, enduring contributions to our understanding of the developmental, genetic, and environmental origins of risk and vulnerability in early life,” and “could be a truly remarkable point of departure for a unified theory describing the biological embedding of early social conditions and their developmental consequences.”

Cover PNAS monkey pic 2For more about the research, the laboratory, and the animals, see:

NIH’s Response to PETA

NIH’s response to the PETA campaign was thoughtful, thorough, and transparent. The response includes a positive assessment of the value of the research in terms of human health relevance and advances in scientific understanding. It addresses why the research in conducted in monkeys and why it is not possible to use alternative methods, or to conduct the work in humans.

The response also includes a serious, fact-informed consideration of the animals’ welfare. Detailed responses from two of NIH’s Institutional Animal Care and Use Committees that conducted an extensive evaluation of the research address each element of the concerns raised by PETA and the scientists supporting them (including, Professors John Gluck, Psychology, University of New Mexico; Agustin Fuentes Anthropology, Notre Dame; and Barbara King, Anthropology, William and Mary College; Lawrence Hansen, Pathology, UC-San Diego).

Furthermore, in response to PETA’s complaint, the NIH undertook an exhaustive review via its Office of Laboratory Animal Welfare (OLAW). Comprehensive responses to each of the concerns raised by PETA are contained in the reports posted on the NIH website. For those who seek more information, facts, and substantive background to inform their consideration of the conduct of the research and the animals’ welfare, we encourage you to read the NICHD IACUC response posted here: NICHD 12.17.15 ACUC_Memo_2_121914

nih statement 01.28.15

Taken together, NIH’s responses provide a strong demonstration of a high level of care and consideration of animal welfare, as well as the risk and benefit balances that are inherent in the conduct of research with both human and nonhuman animals. The response clearly vindicates Dr. Suomi and provides welcome public acknowledgement by the NIH of the importance of his work.

As welcome as the NIH responses are, they are not, however, responses that will satisfy PETA’s absolutist goal of ending all use of nonhuman animals for any purpose, including animal research, but also food, companionship, entertainment, or other uses.

PETA’s complaint about this and other research included language about animal welfare and about alternatives to animal research in order to achieve the same scientific goals. In reality, however, PETA’s position—like that of all absolutists—is not centrally concerned with either viable alternatives to animal studies or with animal welfare. Rather, the position is that no human use of other animals—any animals, whether photogenic and appealing in popular campaigns, or not—is justified, regardless of the outcome or harms. (See here and here for additional discussion.)

As a result, it would seem that no response NIH could give to PETA would be satisfactory unless it was to end all animal research altogether. Or, in the case of a particular project or lab, the only response satisfactory to PETA or other absolutists would be to end that project, or close that lab. At some level then the question to ask may be about the cost: benefit of such responses.

By contrast to the absolute viewpoint, aspects of ethical consideration of animal research that matter to the majority of the broad public and to the scientific community are evidenced by their instantiation in the laws of a democratic society and  in regulatory and community standards, as well as in individuals’  own assessment. These include concern with significant public health challenges and appreciation for the critical role of basic scientific understanding as the foundation for a broad range of advances that benefit the public, other animals, and the environment. They also include acknowledgement of accomplishments and breakthroughs for human and nonhuman health that are accomplished via animal research. At the same time, they include selection of alternatives where possible, attention to animal’s care and welfare, continuing refinements of procedures in accord with evidence, risk and benefit justification, external oversight, and expert scientific evaluation.

In the case of the current NIH campaign and other campaigns against specific animal research there is a well-known pattern. A group like PETA focuses on a research project—usually one involving  animals such as cats, dogs, or primates that will capture broad public interest. The group then uses the highly responsive system of public institutions and government agencies to obtain information, call for investigation, and launch media campaigns to elicit public concern (and donations). The campaigns are typically based in some form of oversimplification and misrepresentation of the research, treatment of animals, availability of alternatives, or value of the science. In the face of public inquiry or media attention, public research institutions under attack typically offer a response focused on the scientific question, accomplishments, absence of non-animal alternatives, and on the animals’ welfare and oversight.

The problem with that pattern is that it ignores the fact that PETA and others’ campaigns are, in many ways, a reflection of a conflict between fundamentally different philosophical viewpoints. These differences cannot be resolved simply by ensuring scientific advances, careful risk and benefit assessment and balance, or high standards for laboratory animal welfare. All the care, training, accreditation, and external oversight in the world will not address the concerns of individuals or groups who are absolutely opposed to the use of animals in research and who believe that no matter the benefit, use of animals in research cannot be justified. Nor will such approaches address those who believe — wrongly, in most cases — that there are existing alternatives to the use of animals in research. Furthermore, each additional layer of oversight and regulation introduced in an attempt to appease those who cannot be appeased may well add substantial administrative hurdles and costs to the scientific effort without achieving meaningful improvements for animal welfare.

From that perspective, and in light of yet another PETA campaign that has resulted in a significant and extensive response from public agencies, the question becomes whether – and what – might be a better path forward. At present, the same path does not look like one that is productive to improving scientific research. Rather, the prediction would be that PETA and other groups will continue to use the transparency and responsiveness of public research institutions to lend steam to popular opinion campaigns that then target individual scientists, laboratories, and institutions. In turn, a great deal of time and energy will go into investigations, responses, and reports that are likely to yield little in terms of animal welfare, little public benefit, little progress to ending animal research, yet potentially high harm to science. At the very least these responses consume resources that would otherwise be devoted to scientific research or practical enforcement of regulations to protect animal welfare.

As we welcome the NIH’s support for Dr. Suomi we must also ask ourselves a question:  How many more cases like this will there be before the leaders of the scientific community take action to prevent the regulatory system from becoming primarily a tool of the animal rights propaganda machine?

Speaking of Research

American Psychological Association supports NIH primate researcher Stephen J. Suomi

Research conducted within the National Institutes of Health (NIH) intramural program has been the focus of a PETA campaign over the past several months. Elements of the campaign mirror tactics PETA has used elsewhere to generate media coverage, fundraising, and emails or phone calls to the NIH. The campaign recently reached beyond newspaper, bus, and metro advertisements to include a congressional request to NIH to provide a review of the research.

The American Psychological Association (APA) responded on January 22 with strong statement of support for the scientist and research under attack by PETA.

APA 01.22.15

APA’s letter to the congress members, in its entirety, reads:

“In December 2014 you were one of four members of Congress who sent a letter to Dr. Francis Collins, Director of the National Institutes of Health (NIH), requesting that his office commission a bioethics review of a research program directed by the world renowned researcher, Dr. Stephen J. Suomi. On behalf of the American Psychological Association and its Committee on Animal Research and Ethics, I am writing to provide a broader scientific perspective on this research. As you are likely aware, the request you received was a part of a sustained and well publicized campaign against Dr. Suomi’s laboratory by the organization, People for the Ethical Treatment of Animals (PETA), in support of its mission to put an end to research with nonhuman animals.

Your letter stated that prominent experts have raised concerns about the scientific and ethical justification for these experiments. We believe that the facts do not support PETA’s public statements about this research. Over the past three decades, Dr. Suomi and his collaborators have made significant contributions to the understanding of human and nonhuman animal health and behavior. Dr. Suomi’s work has been critical in understanding how the interactions between genes and the physical and social environments affect individual development, which in turn has enhanced our understanding of and treatments for mental illnesses such as depression, addiction, and autism.

Dr. Suomi and colleagues found that like humans, monkeys share similar variants of genes that make an individual more vulnerable to mood and personality disorders; however, genetics interact with experience in determining such disorders, and mother-infant dynamics in particular have a large influence on later development. Dr. Suomi has successfully produced monkey models of depression and excessive alcohol consumption and his studies provide insight into modes of treatment. Through his work on neonatal imitation, Dr. Suomi discovered potential early signs of atypical social development in monkeys, which has informed the search for screening methods and treatments for autism in human children. Further, through his work on the development of attachment behavior to a caregiver, which is crucial for infant survival in both humans and other animals, Dr. Suomi’s research has had a tremendous impact on the standards for the welfare of nonhuman animals in captivity.

Cover PNAS monkey pic 2

The specific study targeted by PETA was designed to investigate the long-term effects of fluoxetine (Prozac) in children. Given that drugs are typically tested only on adults, the effects of this commonly prescribed anti-depressant on children were unknown. Thus, in response to overwhelming concern raised by parents, physicians, and others involved in child and adolescent health about the safety of this medication for children, Dr. Suomi and his colleagues began a study with baby monkeys to elucidate the effects of fluoxetine in children. Contrary to PETA’s repeated claims that animal research has not improved human health and that modern non-animal research methods are more effective, there are, in fact, no viable non-animal alternatives for identifying the causes of and treatments for disorders that affect the brain and behavior. Studies with a wide variety of nonhuman animal species have been and continue to be integral to basic and applied research on health.

Laboratory animal models generally provide the most scientifically rigorous means of studying normal and abnormal behaviors in order to better understand their underlying mechanisms and to remedy disorders. Monkeys are the ideal model for the work that Dr. Suomi does, because they share approximately 93% of human DNA, they live in social groups with similar mother-infant dynamics as humans, and they develop more quickly than humans. Moreover, the monkeys in Dr. Suomi’s studies are treated humanely, following strict guidelines set forth by the Animal Welfare Act and overseen by numerous entities including the NIH Office for Laboratory Animal Welfare (OLAW), the United States Department of Agriculture (USDA), the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC), and institutional animal care and use committees. And given that Dr. Suomi is an intramural researcher at NIH, you can be certain that his research animals receive premier quality of care.

I understand that it may sometimes be difficult to weigh the qualifications and varying conclusions of “dueling experts,” but let me assure you that Dr. Suomi is a highly regarded member of the APA and the psychological science community at large, as well as a highly sought-after expert in the field of pediatric medicine. In addition to providing information to the U.S. Congress, Dr. Suomi has testified at the World Health Organization and addressed the British House of Commons about the implications of his scientific findings.

Based on the conviction that research with nonhuman animals is a necessary component of basic and applied research on health, APA strongly supports humanely conducted, ethically sound, and scientifically valid research with nonhuman animals. For nearly 100 years, through its Committee on Animal Research and Ethics, APA has promoted informed, serious, and civil dialogue about the role of nonhuman animal research in science. If you should be asked to take further action against Dr. Suomi, I hope you will make it a point to seek out additional information before making a decision. My staff stand ready to provide you with additional information, including assembling experts for a staff briefing or assisting you in any other way on this issue.”

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The complete statement can be found here:  APA Suomi-letter 01.22.15