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New therapies, advancements rely on dog research

Recently, Secretary of Veterans Affairs Robert Wilkie did something rarely seen in Washington, D.C., these days. He told the truth despite pressure from special interest groups to do otherwise. Mr. Wilkie explained that, like many other Americans, he is a dog lover. However, he also supports health studies in a limited number of canines to develop new therapies aimed at helping American veterans injured on the battlefield.

Animal research has improved the health of humans and animals alike through the development of countless medications and therapies. And while most research occurs in rodents, an incredibly small percentage of these breakthroughs require dogs. While speaking at the National Press Club, Mr. Wilkie highlighted past major advancements involving canines, including the heart pacemaker and a treatment for cardiac arrhythmias. Nowadays, dogs are helping us battle various forms of cancer. In addition, new therapies developed in dogs with a form of muscular dystrophy are now being tested in human patients.

Activists have been misleading Americans about animal studies for decades, falsely claiming they are no longer necessary. However, in many cases, there are simply no alternatives. You can’t model complex biological systems if you do not fully understand them.

It may be easy for some — including the PG editorial board — to accept animal rights fiction as fact (Nov. 17 editorial, “Put Him on a Leash: Dog Testing by Government is Wrong”). Thankfully, Mr. Wilkie did not make this mistake. He stood up for good, ethical science that benefits both veterans and animals. For that, he should be applauded, not criticized.

Paula Clifford
Washington, D.C.

The writer is the executive director of Americans for Medical Progress.

Clinical trials are commonly used during the development of drugs studied for approval by FDA for the use in animals.  Similar use in veterinary medicine has been increasing, but there are a number of interesting issues not considered in human clinical trials, where the individual involved in such trials is able to provide consent for inclusion in the trial.  Clearly, the animals that may be subject to such studies, cannot provide specific consent—their owner would have to do so on their behalf.  Those advocating for a change in status of animals as “property” to “persons” would be expected to object to such clinical trials, even if they benefit animals and people and help save their lives.

This issue was critically analyzed by veterinarians analyzing whether clinical veterinary studies must be reviewed by institutional animal care and use committees pursuant the Animal Welfare Act; the Office of Laboratory Animal Welfare for those studies funded by NIH; and/or reviewed and approved by a Veterinary Clinical Studies Committee established by a research entity, in a JAVMA published study, “Institutional animal care and use committee review of clinical studies.”

The study found

Determining whether activities conducted under the auspices of a clinical study are regulated by the USDA or OLAW, and thus require IACUC oversight, is not always a clear and simple issue. Institutions should develop their own guidance on how the IACUC oversees-or does not oversee-clinical trials.

Whether and to the extent certain clinical trials required review and approval by the IACUC pursuant to the Animal Welfare Act and/or OLAW requirements was dependent on whether the studying entities purchased the animals involved in the clinical trial and whether the proposed procedures would be required for the animal’s care, or were additional procedures only required for the purposes of the clinical trial.

The article presents 6 examples to help determine when USDA or OLAW oversight would be required.

Clearly, clinical trials, as utilized in human medicine, provide critical data related to the final approval of drugs and medical devices that will help prevent, diagnose and/or treat animals affected with life-altering diseases and conditions.

The New Jersey Senate Environment and Energy Committee unanimously voted to release the Homes for Animal Heroes Act (S2826) from committee.  The bill would requires institutions of higher education to offer cats and dogs for adoption when they are no longer needed for education, research or other scientific purposes.  During the hearing on September 13, 2018 the following nonprofit associations or individuals submitted slips or testified:

Best Friends Animal Society; Merck; Tom Leach and Cindy Buckmaster, Ph.D., and Karen Froberg, VMD from the New Jersey Association for Biomedical Research; and the National Animal Interest Alliance.

Homes for Animal Heroes, created by Cindy Buckmaster, Ph.D., and an initiative of National Animal Interest Alliance (NAIA),

is a product of the research community’s desire to find loving homes for their animals, as well as the need to educate the public on the real facts about our animal heroes, how they are cared for, and how they improve human and animal lives.

As stated on its website 

Homes for Animal Heroes (HAH) is a national program dedicated to rehoming retired research animals, mainly dogs, and sharing the facts about the critical role animals in research play in curing disease. HAH is building a network of dog experts that can effectively work with research institutions to rehome retired research dogs in every state across the country, one location at a time. Our goal is to permanently rehome these animal heroes into loving homes through a comprehensive foster-based program.

The program builds in successful outcomes by temporarily housing dogs with caregivers, trained “to acclimate former study” dogs to a home environment.  Potential adopters are also screened and interviewed for lifelong compatibility.

The program and the bill, do not require research facilities to place dogs with animal rescue organizations, many of which have not been trained to handle these animals, and most are nearly entirely unregulated.  Instead, the institutions and the staff who have worked closely with these dogs and cats, are able to place them in homes where they will have the best chance of remaining for the rest of their lives.

Americans for Medical Progress (AMP) “supports research involving animals when it is necessary to advance our understanding of biological processes.” and provides tools for “public outreach that builds understanding and appreciation for necessary and humane animal research.”

The latest tool in their toolbox is a video “designed to be a conversation starter about the importance of animals in research and the high standards of care they receive,” titled “Love, Care, Progress,” which you can view here.

The videp features

[r]esearch professionals, including a trainer, scientist, animal behaviorist, surgical manager, and veterinarian talk about caring for the animals in their charge, and their pride in the progress made possible in studies with these animals. Several dogs can be seen enjoying their time with technicians in a facility playroom.

Other associations that support animal research, including the National Association for Biomedical Research (NABR), also explain why “Animal Lovers Should Support Animal Research, Not Condemn It” as NABR President Matt Bailey explained on FoxNews :

Every year, 12 million cats and dogs in the United States are diagnosed with cancer. For their owners, that diagnosis is both emotionally and financially devastating. The initial cancer diagnosis alone can cost $2,000. Subsequent chemotherapy and radiation can run up to $10,000.

Fortunately, scientists are on the cusp of discovering treatments that could help pets with cancer at a much lower cost – if we let them continue the animal medical research needed to make those discoveries. But all over the country, self-professed animal lovers are lobbying for limits on – or even an end to – medical research involving animals.

That’s counterproductive, because animals are among the primary beneficiaries of such research. Consequently, animal lovers should be among the biggest supporters of animal medical research.

Matt goes on to describe how research has saved the lives of animals and humans.

While the use of animals in research remains critically important, efforts have long been employed to reduce, replace, and refine that use when possible.  In some states, like New Jersey, if there is an appropriate alternative testing method that can replace traditional animal testing methods, it must be employed “[w]hen conducting any product testing in the State . . .[but this does not] apply to any animal test conducted for the purposes of medical research.”  N.J.S.A. 4:22-59(a).  If animal testing is required to comply with other state or federal laws to ensure the health or safety of consumers, the requirement does not apply.

In time, we may be smart enough to develop reliable simulators and other tools that can replicate animal models, but until that time, researchers will continue to treat animals in their care humanely, while they work to save lives.

The “PUPPERS” Act, H.R. 3197, a bill that would prohibit the use of canines in biomedical research at the Veterans Administration by eliminating required funding, is misguided and, if enacted, would be harmful to both humans and animals.

Esteemed scientific associations (listed below) wrote to Congressional representatives, in opposition to H.R. 3197, explaining that while scientists embrace efforts to reduce the number of animals needed in research and to replace animals when possible, animal models are still required before drugs or devices are sufficiently proven to be both safe and efficacious for their intended use.  While the number of dogs involved in biomedical research has been reduced, their contribution remains critical in finding cures for certain diseases and disorders, like the previously incurable and fatal genetic disorder affecting skeletal muscles in both humans and dogs, called Myotubular Myopathy (MTM), recently described here.

Canines are currently playing a vital role in the moonshot to end cancer, aging and Alzheimer’s, heart disease, diabetes, and most recently the first FDA-approved artificial pancreas was brought to fruition because of work at the VA. Additionally, 22 of the 25 most prescribed medications were brought to patients’ bedsides thanks to research with canines.

Quote from letter to Congressional representatives from:

  • American Academy of Neurology (AAN);
  • American Association for Laboratory Animal Science (AALAS);
  • American College of Neuropsychopharmacology (ACNP) ;
  • American Neurological Association (ANA);
  • American Society of Laboratory Animal Practitioners (ASLAP);
  • American Society for Pharmacology & Experimental Therapeutics (ASPET);
  • American Thoracic Society (ATS);
  • Americans for Medical Progress (AMP);
  • Associated Medical Schools of New York (AMSNY);
  • Association for Research in Vision and Ophthalmology (ARVO);
  • Association of American Medical Colleges (AAMC);
  • Association of American Universities (AAU);
  • Association of American Veterinary Medical Colleges (AAVMC);
  • Association of Public and Land-grant Universities (APLU);
  • Baylor College of Medicine California Biomedical Research Association (CBRA);
  • Coalition for the Life Sciences The College on Problems of Drug Dependence, Inc. Comparative Biosciences, Inc. Council On Governmental Relations (COGR);
  • Federation of American Societies for Experimental Biology (FASEB);
  • IACUC 101 Series Massachusetts Society for Medical Research (MSMR);
  • Michigan Society for Medical Research (MISMR);
  • National Animal Interest Alliance (NAIA) National Association for Biomedical Research (NABR);
  • National Association of Veterans’ Research & Education Foundations (NAVREF);
  • New Jersey Association for Biomedical Research (NJABR);
  • North Carolina Association for Biomedical Research (NCABR)
  • Northwest Association for Biomedical Research (NWABR);
  • Oregon Health & Science University (OHSU);
  • Pennsylvania Society for Biomedical Research (PSBR);
  • RxGen SNBL USA, Ltd. Society for Neuroscience (SfN);
  • Society for the Study of Reproduction (SSR);
  • States United for Biomedical Research (SUBR);
  • Texas Society for Biomedical Research (TSBR); and
  • University of California, Los Angeles University of Illinois Urbana-Champaign Washington University in St. Louis.

Our ability to study and find cures for many human and animal diseases and disorders would not have been obtainable without studies involving animals, including the following medical achievements:

  • the cardiac pacemaker;
  • the first liver transplant;
  • nicotine patch;
  • the discovery of insulin;
  • vaccinations against canine distemper, parvovirus, rabies, coronavirus, leptospirosis, Lyme disease, measles, and hepatitis;
  • prevention of canine intestinal parasitic diseases, fleas, ticks, mites and mange.

Like the entities listed above I look forward to a time when biomedical research does not involve animal testing, but we currently are not knowledgeable or scientifically advanced enough to entirely replace animals with other models.

Therefore, federally proposed bills, including H.R. 3197 and a similar amendment offered by Rep. Dave Brat (R-VA) to the Defense, Military Construction, Veterans Affairs, Legislative Branch, and Energy and Water Development National Security Appropriations Act, 2018, if adopted, would only serve to harm both human and animal health, and should therefore be opposed.

 

I recently attended the 2017 National Animal Interest Alliance (NAIA) Conference, titled “Animal Nation.”  There, I heard the remarkable, heart-wrenching but uplifting story about the life of Joshua Frase and the challenges he overcame with the support from his family who never gave up in their relentless search to find a cure for Myotubular Myopathy (MTM), a genetic disorder affecting skeletal muscle that Joshua was born with.

As described on the foundation’s website, children born with MTM “will often experience skeletal problems, gait problems, respiratory and feeding challenges, and fatigability along with poor muscle development . . . Statistically, 50% of these children do not live past their 2nd birthday.”

Joshua’s mom, Alison Rockett Frase shared her story at the NAIA conference:

On February 2, 1995, Alison gave birth to her son, Joshua—a baby so weak, he could only move his right hand.  The doctors said that he wouldn’t survive the day and, in a moment that defined the rest of her life, Alison said, “Let’s give him a chance.”  From that moment on, Alison became Joshua’s advocate. Before his first birthday, Alison determined that she would use her husband’s platform in the NFL to start a foundation that would one day find a cure or treatment for her son’s condition. I n 1996, together with her husband, she created the Joshua Frase Foundation.  Since that time, Alison has helped raise over $6 million to fund medical research, search for a cure and raise awareness of neuromuscular-related disorders.

During her search for a cure for this rare disease and to save her son and others similarly challenged, Alison, with scientists and researchers started unraveling the clues to a treatment and perhaps a cure.

After studying the use of gene therapy to restore normal function in mice with the same disorder, the search was on to find a larger animal model before the treatment could begin in humans.

Alison described that search:

This may be the last chance to save my son Joshua. His health has declined dramatically and I am sensing impending danger. It is a miracle that Joshua is now 14, given the odds he would never celebrate his first birthday. It has been a tough and critical year physically for Joshua. We knew the gene replacement therapy success we were showing in the mouse model had to translate to a larger animal before we could even consider getting the FDA’s attention for human trials.

Miraculously, Alison found that animal model in a Labrador Retriever living in Canada named Nibs, who carried the genes for MTM.  Nibs’ puppies born with MTM have been successfully treated.  Nibs, who had been given to Alison to help find a cure for Joshua, was returned to her owner to live out the rest of her life back on the farm in Canada, running with horses.

On September 21, 2017, “Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases . . . announced it has commenced dosing of patients in ASPIRO, a Phase 1 / 2 clinical trial of AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM).”

Alison is hopeful that this treatment will save the lives of those afflicted with this devastating disorder.  Sadly, Joshua passed away in 2010.

If you are interested in learning more about Joshua, the Foundation, and this remarkable research that will help save lives of children and puppies, please visit the website to learn more.

On September 22, 2017, the New Jersey Association for Biomedical Research (NJABR) offered its 24th Annual IACUC Conference,  – “the region’s premier training conference for Institutional Animal Care and Use Committee members, lab animal veterinarians, animal welfare compliance specialists and lab animal research team members.”

As described, the conference focused “focus on opportunities to improve laboratory animal welfare, while reducing regulatory burdens, cutting red tape and creating efficiencies within institutions.”  Toward that end, presenters from NIH and USDA (Patricia Brown, VMD, MS, Director, NIH, OLAW and William S. Stokes, ACLAM, DACAW, BCES, FATS, Assistant Director, Animal Welfare Operations, USDA, APHIS, respectively) requested recommendations from the attendees to reduce unnecessary or redundant regulatory burdens to researchers.

Following morning presentations, discussed further below, the conference included the following workshop selections that attendees could attend:

AAALAC Perspectives on Occupational Health & Safety Programs

Presenter: Richard B. Huneke, DVM, Council Member Emeritus

Animal Care & Use Committee Scenarios: You Make the Call

Presenter: Pam Straeter, RLATG, Asst. Director, Research Integrity and Assurance, Princeton University

Legal Update: USDA, Animals and the Law                               

Presenter: Nancy Halpern, DVM, Esq., Attorney, Fox Rothschild

New IACUC Member – Double Session   

Presenter: Amy Salem, PhD, Associate Director of Operations and Training for Animal Welfare, Merck

Ask the Regulators                                                                    

Presenters:

Patricia Brown, VMD, MS, Director, Office of Laboratory Animal Welfare

Tonya Hadjis, DVM, Supervisory Animal Care Specialist, Northeast Area, USDA, APHIS, Animal Care

John F. Lopinto, DVM, Veterinary Medical Officer, USDA, APHIS, Animal Care

Ashley C. McIntosh, DVM, Veterinary Medical Officer, USDA, APHIS

Animal Reproducibility & Relatability of Animal Research to Human Research

Panelists:

Damir Hamamdzic, DVM, PhD, Research and Regulatory Affairs, Post-Approval Monitoring Compliance Administrator, Rutgers University

Sarah E. Robertson, PhD, Director, Sponsored Projects and Research, University of the Sciences

Laszlo Szabo, Esq., Director, Research and Regulatory Affairs, Rutgers University

Andrew Gow, Ph.D., Professor and IACUC Chair, Rutgers University

Elizabeth Dodemaide, BVSc, MA, MANZCVS, Director Comparative Medicine Resources, Rutgers University

Gregory Reinhard, DVM, Director, Animal Welfare, University of Pennsylvania

Strategies to Enhance Animal Welfare Compliance Monitoring

Presenters:

Pharmaceutical: Lisa Stanislawczyk, Bristol-Myers Squibb, CRO: Mary Ann Jacobs, Envigo

Academic: Greg Reinhard, MBA, DVM, University of Pennsylvania, The Role of the Statistician in Study Design, IACUC Protocol Preparation Data Analysis

Presenter: Alfred Barron, Associate Director, Nonclinical Statistics/TMEDS, Janssen Research & Development

The keynote speaker, Jim Welch, Executive Director of the Elizabeth R. Griffin Research Foundation, presented a phenomenal motivational talk about “the importance of safe work practices, biosecurity, and collaboration among organizations and institutions seeking to advance scientific discovery.”  It does not sound like a topic that would lend itself to a motivational talk, anyone looking for a keynote should consider Jim.

Overall, it was another great conference.

 

Reports from two animal-related trade organizations provide insight into the current status and goals of animal rights organizations intent on eliminating the use of animals by humans, without regard to how humanely those animals are treated.

Based on these revealing comments from activists it remains vitally important that the public is exposed to the differences between animal rights activists and animal-related industries whose goals are to ensure that animals under the care of humans are treated humanely.

Members of the National Association for Biomedical Research and the Animal Agricultural Alliance attended the 2017 Animal Rights National Conference held on August 3-6 in Alexandria Virginia.

As advertised on the website

The Animal Rights National Conferences have been organized since 1981 by Farm Animal Rights Movement (FARM) with some breaks between 1987 and 2000, then every year since 2000. They are typically co-sponsored by more than a dozen national organizations.

Farm Animal Rights Movement (FARM) is a national non-profit organization working to end the use of animals for food through public education and grassroots activism. We believe in the inherent self-worth of animals, as well as environmental protection and enhanced public health.

Speakers at the conference talked about the “Power of confrontation in advancing animal rights,” and alleged abuses of animals used for all human purposes including: animals in Entertainment (circuses, rodeos, zoos, aquariums), animals in science (education, product testing, drug research),animals in Fashion, Companion animals, food Animals, and animals in the wild.

Kay Johnson Smith, Animal Agriculture Alliance president and CEO described this year’s conference:

The speakers at this year’s Animal Rights National Conference made their goals clear – ending all forms of animal agriculture, regardless of how well animals are cared for . . . Their persistent focus on pressure campaigns targeting restaurant, retail and foodservice brands is of great concern to the Alliance and our members. We encourage anyone with a vested interest in producing, processing or selling meat, poultry, eggs and dairy, to read this year’s report and hear how determined these groups are to eliminate food choices and make our society vegan.

The alliance reported that speaker encouraged attendees to protest and conduct rescues from farms without permission, and that “[b]reaking the law can often be a good thing to do.”

The Alliance also reported that one speaker, David Coman-Hidy with the Humane League encouraged attendees to damage the reputation of food companies.

Consistent with previous years, another key message from conference speakers was for attendees to focus efforts on eliminating farms of all types and sizes, not only the large-scale, modern operations (declared to be “factory farms”) that have historically been targeted.

National Association for Biomedical Research reported about the following speakers and their comments at the conference, intent on eliminating the use of animals in research:

  • Justin Goodman, lobbyist for the White Coat Waste project (WCW), an animal rights group that promotes itself as a fiscally conservative consumer watchdog group, spoke about WCW’s “defund” campaign to “take money away so [research institutions] can’t buy the animals to do the testing.” He continued to focus on making sure universities and other institutions that conduct animal research “don’t get their money.” 

  • Michael Budkie explained [Stop Animal Exploitation Now] SAEN seeks to end animal research by “hanging them with their own paperwork.” We understand this to mean the group attacks the reputations of research institutions and individual scientists by deliberately misusing or mischaracterizing written statements provided by the institutions to government agencies like the NIH and the USDA.

  • Speaking again on behalf of SAEN, Michael Budkie explained his approach to stopping animal research by targeting researchers: “We like to paint them as idiots. They are criminals. SAEN’s job is to let people know animal research is meritless. We will ruin their reputation and credibility. We are coming after them…It becomes news and we’re changing public opinion of what labs do.”

  • A celebrated figure in the animal rights world, Richard Couto conducts undercover investigations of factory farms and food enterprises that use animals. He gains access by working as an employee while filming and documenting abuse for later use in criminal prosecutions of his erstwhile employers. Joined by other so-called “undercover investigators,” they encouraged attendees to join their ranks by stating, “anybody in this room has what it takes to be an undercover investigator.”

Clearly, the goals of animal rights organizations, on display at this conference, should concern those who are involved in animal-related industries where animals are owned and cared for by humans.

Like many other animal-related businesses universities, researchers, pharmaceutical companies, their suppliers, associated businesses and non-profit trade associations, are facing increasing scrutiny by the public who seemingly object to the use of animals in research, even though research benefits animals as well as humans.

To address these issues and concerns head on, the New Jersey Association of Biomedical Research recently hosted one of the most significant efforts to promote biomedical research advocacy, the “Biomedical Research Summit,” presented by Bristol-Myers Squibb, also sponsored by Covance, Charles River Laboratories, s-tune software, Inc., Marshall BioResources, and Allentown, Inc. 

Representatives from interested state and national advocacy and professional organizations who are involved in the lab animal research community, as well as representatives from research institutions, including pharmaceuticals, academia and CRSOs, to find common ground and come together on key issues.

Vice-Chair of the NJABR Board of Directors, Laura Conour, DVM, DACLAM facilitated the discussions during the two-day event, encouraging participants to

find ways to enhance the public’s understanding of the critical work undertaken by the biomedical research community and to provide a strong support network for all members in our community, regardless of geography.

The Summit was a huge success, bringing together not only the biomedical research community but also other animal-related sectors under similar attack by animal rights activists.

The following needs and gaps identified include:

  1. A centralized approach for advocacy of biomedical research;
  2. A compelling, consistent, proactive national communication plan;
  3. A comprehensive and effective education effort to address society’s negative perception and lack of understanding about animal research;
  4. There is a lack of an organized and cohesive advocacy effort;
  5. There is a lack of a constituency (a group that support or offers authority and representation) interconnecting with all stakeholders to create a larger network of interests to build and establish effective education efforts; and
  6. Resources are needed to effectuate these goals.

The future of biomedical research advocacy requires a coalescence of all those involved with the humane use of animals for human and animal benefits to educate the public about, not only the necessity of animal use, but also that the animals are treated humanely, and with the understanding that as science advances, the treatment of animals is always evolving to ensure that animals are treated humanely.

Others in the global biomedical research community have launched campaigns in the U.S. and overseas to increase transparency and public education about the special care animals receive in research as well as the incredible importance of their contribution to animal and human health.  For example, as previously discussed, Americans for Medical Progress launched a virtual website “Come See Our World,” where visitors learn about the important role animals play in medical progress.  

Also, the non-profit “Understanding Animal Research” launched a new online tool that allows anyone interested to visit four research facilities in the U.K., through digital video tours.  Participating facilities include the MRC Harwell Institute, The Pirbright Institute, the University of Bristol, and the University of Oxford. 

Understanding Animal Research explains:

why animals are used in medical and scientific research. We aim to achieve a broad understanding of the humane use of animals in medical, veterinary, scientific and environmental research in the UK. We are funded by our members who include universities, professional societies, industry and charities.

 In addition to the virtual lab tours, Understanding Animal Research hosts another website “Concordat on Openness on Animal Research” for “Universities, charities, commercial companies, research councils, umbrella bodies and learned societies [that] have all committed to help the public understand more about animal research.”

Stay tuned for more information about these important developments.

American for Medical Progress (AMP),[1] “a nonprofit organization dedicated to protecting society’s investment in biomedical research,” just launched an important new educational tool for the public to see and understand the truth behind modern animal research.  “Come See Our World”  is a digital invitation into the world of “essential animal research,” that provides all those interested and concerned a behind-the-scenes glimpse into world of animal research, with a front seat to view the care that research animals receive.  Without this important research, medical advances in human and animal health would not be possible.

AMP invites you to “[j]oin us for a journey into our world of medical progress and discover the animals that help save lives,” including the following examples:

Mice have long been a model for human disease. Zebrafish provide insights into embryological development as well as human disease.  Dogs and Pigs were integral in the development of insulin treatments for diabetics.  Sheep have provided life-saving advancements for those with cardiovascular disease.  People with diseases like cancer and AIDS now have hope because of research with nonhuman primates. Our pets live long healthy lives thanks to vaccinations and many of the same treatments developed for humans.

From rodents, to primates, dogs and cats, farm animals, aquatic and other animals, this website provides more than pictures of well-cared for animals, it also educates the reader about what each animal contributes to the health of others-humans and animals alike.

I encourage you to visit the website and recognize the heroes these animals have been and continue to be.

[1] The author serves on the Board of Directors of AMP.