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An argument for ending the use of animals in biomedical research

The use of nonhuman animals in basic biomedical research should be halted immediately.

The research is not working

Support for the industry rests on the claim that basic biomedical research using animals is absolutely necessary for advancements in medical treatments. This claim is testable.

If the use of animals is a key factor in the progress of human medicine, then increasing the use of animals should accelerate medical advancements in a somewhat direct relationship.

In 1986, it was estimated that between 17 and 22 million animals were used in basic biomedical research in the U.S. and that between 55% and 88% of them were mice and rats. [U.S. Congress, Office of Technology Assessment, Alternatives to Animal Use in Research, Testing, and Education (Washington, DC: U.S. Government Printing Office, OTA-BA-273, February 1986). http://govinfo.library.unt.edu/ota/Ota_3/DATA/1986/8601.PDF ]

The number today is unknown, and vociferous resistance to counting them makes it unlikely that anyone will have more than a guess about the total for some time. But the skyrocketing growth in the use of transgenic and mutant strains of mice alone suggests that the number must be very large.

Has this increase in the use of animals yielded significant improvements or breakthroughs in the treatment of human illness?

In 2004, William Richard Rodriguez, M.D. Chief Medical Director, Veritas Medicine and Instructor in Medicine, Harvard Medical School had this to say [Rodriguez, WR Can biomedical research in the United States be saved from collapse? 2004 MebMD, Veritas Medicine http://tinyurl.com/l75kv]:

Exactly one year ago, the nation's most thoughtful and deliberative body devoted to translating the fruits of biomedical research into meaningful improvements in patients' lives … released a quiet, highly critical indictment of the biomedical research effort in the United States. [Sung NS et al. Central challenges facing the national clinical research enterprise. Journal of the American Medical Association . 2003;289:1278–1287.] Moreover, in an accompanying editorial, a leading neurologist, Dr. Roger Rosenberg of Tennessee, disparaged this group—the Clinical Research Roundtable of the Institute of Medicine (the “CRR”)—for not being critical enough. [Rosenberg, RN. Translating Biomedical Research to the Bedside: A National Crisis and a Call to Action. Journal of the American Medical Association 2003;289:1305-6. http://tinyurl.com/mtxfa]

“Lives are literally being lost daily because of inertia in the system to move promising research quickly enough to the patient in need,” wrote Rosenberg last year. “Publishing the report by the CRR is necessary and appropriate but not sufficient to mobilize national sentiment and resolve. A unified voice from the biomedical community must speak clearly and resolutely to emphasize that the CRR report amounts to a national crisis.”

Why a crisis? In effect, both Rosenberg and the CRR were saying publicly that the enormous sums of money invested in biomedical research—much of it taxpayer-financed—was being wasted because of inertia and disorganization. They specifically pointed to two stumbling blocks: difficulty in translating laboratory findings into results that actually make a difference to patients; and difficulty in taking proven, successful treatments out of the research setting where only a few patients can use them, and into the real world. Both stumbling blocks, they felt, were not inherent to the process of discovery, but were largely administrative problems that could and should be overcome by better organization and accountability.

Note the first of the two identified stumbling blocks: the difficulty in translating laboratory findings into results that actually make a difference to patients. Dr. Rosenberg observed:

There is an assumption that the recent exponential growth of scientific information about disease, as evidenced by the substantial increase in the numbers of published articles in biomedical journals, heralds a rapid move to improve human health.

This illusion is the subject of an intense analysis…. [emphasis added]

Note also that the CRR believes that the stumbling blocks are “not inherent to the process of discovery.”

Without some verifiable method to rule out factors that might be responsible for the difficulty in translating laboratory findings into results, any claim that a factor is not responsible for the difficulty is unscientific.

Given the likely large increase in the numbers of animals being used, the system's failure suggests that it may indeed be the process of discovery that has failed. That is, the acknowledged failure may be due to the assumption that what is discovered in an animal model of a human condition is translatable into human healthcare. This is the most parsimonious conclusion given the failure and the large increase in animal numbers.

Moreover, there are theoretical reasons to explain this observed phenomena. Ray Greek, M.D., has offered this: 

Evolutionary biology predicts—and modern-day molecular biology confirms—that very small differences between species, on the genetic level, invalidate the historical notion that experiments on animals can lead to cures and treatments for human disease. http://www.curedisease.com

An examination of the assumptions on which the use of animals is based, and an explanation of the theoretical reasons for the failure of the current research model are deeply plumbed in Brute Science: Dilemmas of Animal Experimentation [Hugh LaFollette and Niall Shanks, Routledge 1996 (Philosophical Issues in Science) http://www.stpt.usf.edu/hhl/papers/brutes.htm]

To summarize, the Institute of Medicine at the National Academies of Science convened a Clinical Research Roundtable in 2000 to analyze the success of basic research. They reported in 2003 that there is a “disconnection between the promise of basic science and the delivery of better health.” And that unless new strategies are enacted, the “data and information produced by the basic science enterprise will not result in a tangible public benefit.” The Journal of the American Medical Association characterized the report as not worded strongly enough.

Simply, the massive increase in funding that has resulted in the likely large increase in the numbers of animals used has had little appreciable effect on human healthcare. The suffering of the millions of animals being used annually is not advancing medical care.

The oversight system is not working

When the public is asked about the use of animals in biomedical research a universal response is that the research should be well regulated, that there should be no unnecessary pain and suffering, and that the questions being researched should not be trivial.*

These caveats are based on the assumption and illusion that the use of animals in research is leading to meaningful advances in human healthcare.

But the use of animals is not well regulated.

The use of animals in biomedical research is regulated at the local and the national level. The Animal Welfare Act (the Act, 7 USC, 2131-2156) stipulates that all institutions using animals covered under the Act (all warm-blooded animals except purpose-bred mice, rats, and birds) must have a standing committee that reviews all animal use and certifies that all use is in compliance with the Act. These local oversight committees are called Institutional Animal Care and Use Committees (IACUCs) or just Animal Care and Use Committees (ACUCs).

In 2001, Plous and Herzog published the current definitive evaluation of the IACUC system of oversight. [Plous S, Herzog H. Animal research. Reliability of protocol reviews for animal research. Science. 2001 Jul 27;293(5530):608-9.]:

Over the past 20 years, the reliability of scientific peer-review judgments has been a topic of frequent debate and scrutiny. However, one area of peer review that has not received much empirical investigation is the system that protects animal subjects from research risks. At most research institutions, studies involving animal subjects must be approved by an Institutional Animal Care and Use Committee (IACUC). …

… [W]e conducted a study of randomly selected IACUCs from U.S. universities and colleges. Seventy committees were drawn from a master list of 916 IACUCs maintained by the U.S. Office for Protection from Research Risks. Of these 70, 50 agreed to participate in the study. Thirty-four IACUCs came from research or doctoral universities, seven came from master's colleges or universities, six came from specialized institutions (e.g., medical colleges), and three came from liberal arts colleges. In all, 494 of 566 voting members (151 females and 343 males), or 87% of those approached, took part in the study.

Each IACUC was asked to submit its three most recently reviewed protocols involving animal behavior, including the committee's decision on whether to approve the research in question. All information identifying the investigator or institution was then removed from the protocols, and each protocol was randomly assigned to be reviewed a second time by another participating IACUC. Voting members of the second committee were sent packets containing three masked protocols with a request to review the protocols and to send us a completed evaluation anonymously in a prepaid envelope.

Once we received reviews from individual committee members, the IACUCs were asked to meet as a group and render a final evaluation for each of the three protocols. Committees were asked to follow their standard operating procedures and to discuss the protocols as they would any other research proposal.

Protocol evaluations from the originating committee and from the second committee were not significantly related to one another…. This absence of a relation was found not only across the full set of 150 protocols, but for relatively invasive research involving procedures such as electric shock, food or water deprivation, surgery, and drug or alcohol research…; for protocols involving euthanasia …; and for protocols in which the reviewing IACUC expected animals to experience a significant amount of pain…. Thus, regardless of whether the research involved terminal or painful procedures, IACUC protocol reviews did not exceed chance levels of intercommittee agreement….

Compliance with the Act is monitored and regulated by the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service, Animal Care, usually referred to as APHIS-AC.

APHIS-AC is required to inspect institutions using covered species at least annually to judge whether the institution is in compliance. This includes an evaluation of the local IACUC's oversight duties as stipulated in the Act.

In 2005, the office of the Inspector General at the USDA issued an audit of the oversight system. [Audit Report APHIS Animal Care Program Inspection and Enforcement Activities . Office of Inspector General, Western Region, U.S. Department of Agriculture; Report No. 33002-3-SF; September 2005. http://www.usda.gov/oig/webdocs/33002-03-SF.pdf ]

It is not favorable:

Due to a lack of clear National guidance, AC's Eastern Region is not aggressively pursuing enforcement actions against violators of the AWA.

Discounted stipulated fines assessed against violators of the AWA are usually minimal.

Some VMOs [veterinary medical officers – APHIS inspection personnel] did not verify the number of animals used in medical research or adequately review the facilities' protocols and other records.

Some IACUCs are not effectively monitoring animal care activities or reviewing protocols. During FYs 2002 through 2004, the number of research facilities cited for violations of the AWA has steadily increased from 463 to 600 facilities. Most VMOs believe there are still problems with the search for alternative research, veterinary care, review of painful procedures, and the researchers' use of animals.

AC's Licensing and Registration Information System (LARIS) does not effectively track violations and prioritize inspection activities.

They recommend (among many things) that:

AC needs to emphasize the need for more detailed reviews of protocols, including those where animals are not present at the facility during the inspection. AC also needs to require research facilities to identify annually the number of protocols in their annual reports, and require the VMOs to verify the number of animals used in research.

To reduce the number of violations, AC needs to modify regulations to require IACUCs to conduct more frequent reviews of facilities identified as repeat violators (3 or more consecutive years with violations). We also recommend that AC require IACUCs to implement policies to fully train committee members on protocol review, facility inspections, and the AWA.

The oversight system did not fail overnight. It may never have been effective. [Enforcement of the Animal Welfare Act, Audit Report No. 33600-1-Ch.Office of the Inspector General, United States Department of Agriculture. 1995.]

To summarize: The use of animals in basic biomedical research is not producing the promised advancements in human medical care and the regulation and oversight of animal use is a failure.

The two claims discussed above: that animal research is beneficial and needed and that the use of animals is well regulated are clearly false. These assumptions are mere illusions.

Honest persons who base their support of animal research on these twin claims: we must do it, and it is highly regulated, must reverse their position. There is no other honest position available.

Mind

There is a third reason that animal research should be halted immediately and this is the fact that some of the animals being used are experiencing the world in a manner indistinguishable from the way that we experience the world. Our suffering is of a like kind.

Evidence to support this claim comes from a large body of scientific research. One recent example [Brosnan SF, Schiff HC, de Waal FB. Tolerance for inequity may increase with social closeness in chimpanzees. Proc Biol Sci. 2005 Feb 7;272(1560):253-8.]:

Economic decision-making depends on our social environment. Humans tend to respond differently to inequity in close relationships, yet we know little about the potential for such variation in other species. We examine responses to inequity in several groups of chimpanzees (Pan troglodytes) in a paradigm similar to that used previously in capuchin monkeys (Cebus apella). We demonstrate that, like capuchin monkeys, chimpanzees show a response to inequity of rewards that is based upon the partner receiving the reward rather than the presence of the reward alone. However, we also found a great amount of variation between groups tested, indicating that chimpanzees, like people, respond to inequity in a variable manner, which we speculate could be caused by such variables as group size, the social closeness of the group (as reflected in length of time that the group has been together) and group-specific traditions.

Few interested observers can be unfamiliar with the discoveries of Jane Goodall or the body of evidence supporting the claim that in chimpanzee society there is a cultural transmission of group knowledge. [http://culture.st-and.ac.uk:16080/chimp/]

Some animals and humans seem to see the world in a way that includes similar moral evaluations. This is demonstrated in the short paper, “Altruistic” behavior in rhesus monkeys [Masserman JH, Wechkin S, Terris W. Am J Psychiatry. 1964 Dec;121:584-5. http://www.madisonmonkeys.com/masserman.pdf ]:

1. A majority of rhesus monkeys will consistently suffer hunger rather than secure food at the expense of electroshock to a conspecific.

2. This sacrificial pattern is induced primarily by visual communication, remains characteristic for individual animals, and is enhanced by familiarity or previous experience of shock, but is not significantly related to relative age, size, sex, or dominance.

3. Such protective or “succorance” behavior, observable throughout the animal kingdom, deserves greater cognizance in psychiatric theory and therapy.

We should keep in mind the fact that mind – animal mind or human mind – is a phenomenon about which we know next to nothing. There is no part of the brain that we can point to as the seat of consciousness. We have no testable biological theory to explain why we feel as if we are unique individuals. The phenomenon of a “self” remains a great mystery.

The neuroscientist Sam Harris writes in The End of Faith [Norton, 2004. 209.]:

And so, while we know many things about ourselves in anatomical, physiological, and evolutionary terms, we currently have no idea why it is “like something” to be who we are. The fact that the universe is illuminated where you stand, the fact that your thoughts and moods and sensations have a qualitative character, is an absolute mystery.

In light of this simple fact, claims that animals do not have similar thoughts, moods, or sensations are just unscientific speculation. We currently have no method that can delineate which animals do and which, if any, do not experience the sensation of “self.” The fact that our actions are condemning millions animals to much pain, suffering, and death should impel us to be more cautious.

To summarize:

  • the use of animals as models of human disease and drug response is not working; it is consuming much money and many human resources.
  • the regulation of animal use in biomedical research is not working; it is no more reliable than a coin toss.
  • at least some species used in research seem to perceive the world and act in ways that suggest that our suffering is of a like kind.

The use of nonhuman animals in basic biomedical research should be halted immediately.

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* Much of the research does appear to be trivial.

Consider these current examples [The System is Broken . AFMA newsletter. Spring 2006 http://tinyurl.com/fdh9m]:

Gayle G. Page's work at John Hopkins (Neonatal Pain, Adult Biobehavioral Responses to Stress. Grant Number: 5R01NR007742-05):

Animal studies have shown that repetitive painful stress or tissue damage in the neonatal rat can result in changes in nociceptive neuronal circuitry and altered responses to painful stimuli in adulthood. Given that repetitive nonpainful events in neonatal rats (e.g., maternal deprivation) have been shown to affect neuroendocrine and immune responses to stress in mature animals, it is possible that repeated painful stressors and the associated neurosensory alterations might lead to even more profound effects in the mature animal. The overall objective of the proposed study is to explore in the mature animal the biobehavioral consequences of repetitive neonatal pain.

C. Sue Carter's research at the University of Illinois at Chicago (Effects of Early Experience. Grant Number: 1R01MH073022-01A1):

The general goal of this research is to examine developmental influences on social behaviors and the neuroendocrine mechanisms of these influences. Using as a model the prairie vole, we have observed that apparently minor changes in the manner in which families are “manipulated” in early life can have life-long consequences. We propose to study the relationship between early experiences, including the influence of parental stimulation, and the later tendency to show social behaviors including alloparental behavior, the capacity to form a partner preference, the tendency to show same-sex aggression (possibly indicative of mate guarding), as well as reactivity to stressors.

Franz Goller's work at the University of Utah: Neuromuscular Control and Motor Integration of Birdsong. Grant Number: 2R01DC004390-06):

The goal of this research is to continue the investigation of motor coordination of song production in songbirds. The main focus will be on aspects of song production and modification that have received little or no attention to date. The various peripheral motor patterns will be studied in spontaneously singing birds with a set of well-established techniques, including recording of airflow and respiratory pressure, electrical activity of muscles and beak movements. To investigate the integration of beak movements into the motor control of song production, beak movements will be recorded during song development and again after song has become stereotyped. In addition, the role of the jaw muscles effecting these movements will be investigated for the first time. The dependence of beak movements on acoustic feedback will be studied by manipulating song output. The investigation into the detailed role of the muscle systems controlling the two independent sound generators will be continued by completing electromyographic recordings in two species. In addition to elucidating the role of syringeal muscles in the generation of various sounds, this research will allow the first assessment of whether different individuals can generate similar sounds using different combinations of muscle activation patterns or whether constraints dictate a certain pattern. Finally, the physiological and histological characteristics of the various muscles involved in sound generation and modification will be investigated for the first time.

Karen A. Seta's work at the University of Cinncinati: Secondhand Smoke and Cardiovascular Disease in Zebrafish. Grant Number: 1R21ES013817-01):

This proposal describes an experimental system that uses zebrafish as a model organism to study the direct effects of ETS [environmental tobacco smoke] exposure on embryo development and subsequent cardiovascular function, independent of the placental environment and maternal factors.

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Rick Bogle
December 2, 2006

 

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