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                          CritCCicism suprises th soul

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A CRITICAL LOOK

AT ANIMAL

EXPERIMENTATION

Christopher Anderegg, M.D., Ph.D.

Kathy Archibald, B.Sc.

Jarrod Bailey, Ph.D.

Murry J. Cohen, M.D.

Stephen R. Kaufman, M.D.

John J. Pippin, M.D., F.A.C.C.

The Medical Research Modernization Committee (MRMC) is a non-profit

health advocacy organization composed of medical professionals and scientists

who identify and promote efficient, reliable and cost-effective research

methods. The MRMC focuses exclusively on the scientific merits

of different research approaches, even though some undoubtedly raise

serious and important ethical concerns. MRMC-sponsored activities include

research, publishing and student education.

To order additional copies of this booklet free of charge, for regular

Email reports and/or for more information about animal experiments,

contact:

• In the United States: Medical Research Modernization Committee,

P.O. Box 201791, Cleveland, Ohio 44120, U.S.A., Tel./Fax 216-283-6702,

Email: stkaufman@mindspring.com, www.mrmcmed.org

• In the United Kingdom: Europeans for Medical Progress, P.O. Box 38604,

London W13 0YR, U.K., Tel./Fax 020 8997 1265, Email: info@curedisease.

net,

www.curedisease.net

• In Switzerland: Association for the Abolition of Animal Experiments, Ostbuhlstrasse

32, CH-8038 Zurich, Switzerland, Tel./Fax +41 (0)44 482 73 52,

Email: ch.anderegg@freesurf.ch, www.animalexperiments.ch

Proponents of animal experimentation (tests, experiments and

«educational» exercises involving harm to animals) claim that

it has played a crucial role in virtually all medical advances.5,6

However, several medical historians argue that key discoveries in

such areas as heart disease, cancer, immunology, anesthesia and

psychiatry were in fact achieved through clinical research, observation

of patients and human autopsy.7-16

Human data has historically been interpreted in light of laboratory

data derived from nonhuman animals. This has resulted

in unfortunate medical consequences. For instance, by 1963 prospective

and retrospective studies of human patients had already

shown a strong correlation between cigarette smoking and lung

lung cancer in animals had failed. As a result, Clarence Little, a

leading cancer animal experimenter, wrote: «The failure of many

investigators to induce experimental cancers, except in a handful

of cases, during fifty years of trying, casts serious doubt on the validity

animal data failed to agree, this researcher and others distrusted

the more reliable human data. As a result, health warnings were

delayed for years, while thousands of people died of lung cancer.

By the early 1940s, human clinical investigation strongly indicated

that asbestos causes cancer. However, animal studies repeatedly

failed to demonstrate this, and proper workplace precautions

population studies have shown a clear risk from exposure to

low-level ionizing radiation from diagnostic X-rays and nuclear

1

studies have stalled proper

warnings and regulations.25

Likewise, while the connection

between alcohol consumption

and cirrhosis is indisputable

in humans, repeated efforts to

produce cirrhosis by excessive

alcohol ingestion have failed in

all nonhuman animals except

baboons, and even the baboon

data is inconsistent.26

Many other important medical

advances have been delayed

because of misleading information

derived from animal «models

». The animal model of polio,

for example, resulted in a

misunderstanding of the mechanism

of infection. Studies on

monkeys falsely indicated that the polio virus was transmitted via

resulted in misdirected preventive measures and delayed

the development of tissue culture methodologies critical to the

used for vaccine production, it was research with human cell cultures

which first showed that the polio virus could be cultivated

clogged arteries with the patient’s own veins was impeded

by dog experiments which falsely indicated that veins could not

We now know that kidney failure suppresses the immune system,

which increases tolerance of foreign tissues.

Nevertheless, society continues to support animal experimentation,

primarily because many people believe that it has been vital for

has been necessary or even beneficial to medical progress.

In 1971 the National Cancer Act initiated a «War on Cancer»

that many sponsors predicted would cure cancer by 1976. Instead,

this multibillion dollar research program has proven to be a failure.

The age-adjusted total cancer mortality rate climbed steadily

In order to encourage continued support for cancer research

– now exceeding two billion dollars annually in the U.S. alone

– researchers and administrators have misled the public. In 1987

the U.S. General Accounting Office (GAO) found that the statistics

of the National Cancer Institute (NCI) «artificially inflate

the amount of ‹true› progress», concluding that even simple fiveyear

termed five-year survival a «cure» even if the patient died of the

cancer after the five-year period. Also, by ignoring well known

statistical biases, the NCI falsely suggested advances had been

made in the therapy of certain cancers.38

Commenting on the research program’s discouraging results

after 15 years, epidemiologist and program administrator John C.

Bailar III stated in 1986: «[We] are losing the war against cancer.

A shift in research emphasis, from research on treatment to

research on prevention, seems necessary if substantial progress

more than a decade later, Bailar reiterated in 1997: «The

more promising areas are in cancer prevention.»35

Why hasn’t progress against cancer been commensurate with

the effort (and money) invested? One explanation is the unwarranted

preoccupation with animal research. Crucial genetic,40

humans and other animals have prevented animal models from

serving as effective means by which to seek a cancer cure. Mice

Weinberg has commented: «The preclinical [animal] models of

human cancer, in large part, stink… Hundreds of millions of dollars

are being wasted every year by drug companies using these

«If you want to understand where the War on Cancer has gone

wrong, the mouse is a pretty good place to start.»45

Despite their extensive use since the early 1980s, animal models

have not contributed significantly to AIDS research. While

mice, rabbits and monkeys born with severe combined immunodeficiency

can be infected with the AIDS Virus (HIV), none develops

infected with HIV since 1984, only one allegedly developed symptoms

that chimpanzees, as members of an endangered species

who rarely develop an AIDS-like syndrome, are unlikely to

prove useful as animal models for understanding the mechanism

of infection or means of treatment.49

Other virus-induced immunodeficiency syndromes in nonhuman

animals have been touted as valuable models of AIDS, but

they differ markedly from AIDS in viral structure, disease symptoms

discussing anti-AIDS therapy, has acknowledged: «Candidate antivirals

have been screened using in vitro systems and those with

acceptable safety profiles have gone directly into humans with

little supportive efficacy data in any in vivo [animal] system. The

reasons for this are complex but certainly include … the persistent

view held by many that there is no predictive animal model

for HIV infection in humans.»51

AIDS researcher Margaret Johnston has concurred: «HIV/

AIDS [animal] models have not yielded a clear correlate of immunity

nor given consistent results on the potential efficacy of

clinical trial in humans in 1987, more than 100 clinical trials

have been funded by the U.S. National Institute of Allergy

and Infectious Diseases through mid-2006. Yet every one of the

more than 50 preventive vaccines and more than 30 therapeutic

vaccines that were successful against HIV/AIDS in primate

studies

has failed in human clinical trials.53

Human clinical investigation has isolated HIV, defined the

disease’s

tissue culture) research using human white blood cells has identified

both the efficacy and toxicity of anti-AIDS medicines, including

mandates misleading and unreliable animal toxicity testing.

Animal «models» in experimental psychology, which researchers

traditionally subject to painful stimuli in order to study their behavior,

have been strongly criticized in part because human psychological

problems reflect familial, social and cultural factors

disapprove of psychological animal experiments which

cause animal suffering.64

Harry Harlow’s «maternal deprivation» experiments in the

1950s and 1960s involved separating infant monkeys from their

mothers at birth and rearing them in total isolation or with «surrogate

» mothers made of wire and cloth. Their terror and subsequent

psychopathology, Harlow claimed, demonstrated the importance

of maternal contact. However, this had been shown

conclusively in previous human studies.65-68

Despite their conceptual shallowness, numerous maternal deprivation

studies continue, claiming relevance to human developmental

psychology, psychopathology and even immune and

hormone function.67-69

Experimental psychology continues to rely on painful research

on animals, despite clinical psychologists’ disregard for animal research

literature. A review of two clinical psychology journals revealed

that only 33 out of 4,425 citations (0.75 %) referred to animal-

research studies.70

Animal models of alcohol and other drug addictions are similarly

ill-conceived, failing to reflect crucial social, hereditary and

mental factors. Pharmacologist Vincent Dole has acknowledged:

damental insights into the causes of this self-destructive behavior

or even a convincing analogue of pathological drinking.»71

Scientists have located the genetic defects of many inherited diseases,

including cystic fibrosis and familial breast cancer. Trying

to «model» these diseases in animals, researchers widely use animals

– mostly mice – with spontaneous or laboratory-induced genetic

defects. However, genetic diseases reflect interactions between

the defective gene and other genes and the environment.

Consequently, nearly all such models have failed to reproduce the

transgenic mice carrying the same defective gene as people

with cystic fibrosis do not show the pancreatic blockages or lung

Numerous standard animal toxicity tests have been widely criticized

test – which determines how much of a drug, chemical or household

product is needed to kill

50 % of a group of test animals

– requires 60 to 100 animals

(usually rats and mice), most

of whom endure great suffering.

Because of difficulties extrapolating

the results to humans,

the test is highly unreliable.74

Also, since such variables as an

animal’s age, sex, weight and

strain can have a substantial

effect on the results, laboratories

often obtain widely disparate

data with the same test substances.

been validated to replace the

from the test guidelines of the Organisation for Economic

Cooperation and Development (OECD) in 2002.79

The Draize eye irritancy test, in which unanesthetized rabbits

have irritant substances applied to their eyes, yields results that

and rabbits differ in the structure of their eyelids and corneas, as

well as in their ability to produce tears. Indeed, when comparing

rabbit to human data on duration of eye inflammation after exposure

to 14 household products, they differed by a factor of 18

Animal tests for cancer-causing substances, generally involving

rodents, are also notoriously unreliable. When applied to human

cancer causation, Lester Lave et al. found the false positive

«Tests for human carcinogens using lifetime rodent bioassays are

expensive, time-consuming and give uncertain results.» The tremendous

economic costs of such research have recently been reported

in a study which examined over 500 rodent carcinogenicity

studies and concluded that rodent cancer assays are scientifically

invalid and fiscally indefensible.84

A combination of in vitro tests provides data that compares favorably

with existing carcinogenicity databases and costs far less

Institute (NCI) developed a panel of 59 human cancer cell lines

to screen compounds for anti-cancer activity, due to its «dissatisfaction

with the performance of prior in vivo primary screens

the NCI in 1990, by which time the agency had also adopted a

panel of about 100 human cell lines to screen compounds for

carcinogenicity.87

Animal tests for teratogens (drugs and chemicals that cause

birth defects) are equally misleading and unreliable. Jarrod Bailey

et al. conducted a comprehensive review of animal tests of 1,396

different substances and found that of those substances known to

cause birth defects in humans, animal tests indicated that almost

half were safe. Conversely, of those substances known to be safe

ous. And almost one-third of all substances tested yielded varying

differences in the physiological structure, function and biochemistry

of the placenta aggravate the usual differences in the absorption,

distribution, metabolism and excretion of drugs and chemicals

that exist between species, thus making reliable predictions

in pregnant women impossible.88

In vitro tests, such as the embryonic stem-cell test, the whole

embryo culture, and the micromass test, provide data that are considerably

more reliable and predictive and far less costly than animal

teratogenicity tests. While such in vitro tests currently utilize

cells and embryos derived from animals (thus rendering their

extrapolation to humans difficult), advances in human cell culture

technology should, in the future, permit a much closer in vitro

approximation of teratogenesis in humans.88

Animal laboratories are not necessary for teaching biological and

medical principles and skills to medical students, and 85 % of U.S.

and Canadian medical schools have eliminated animal labs from

include lectures and written course materials, videos and interactive

virtual reality programs, mentored patient care encounters

and surgery participation, and lifelike programmable interactive

patient simulators. Comparative studies of simulation technologies

for many aspects of medical education (e.g. anatomy, physiology,

pharmacology, surgical skills, trauma management and invasive

procedures) have repeatedly demonstrated superior training outcomes,

fewer patient complications, greater trainee acceptance,

and more efficient use of educational time and resources.90-99

Further evidence of the emerging primacy of simulation-based

medical education is the American College of Surgeons’ (ACS)

to replace the use of animals and human cadavers for its Advanced

Trauma Life Support (ATLS) program. Furthermore, in 2006 the

ACS implemented a sweeping educational reform that incorporated

a wide variety of simulators to eliminate animal use in its

own conferences and educational programs, in addition to establishing

the Accredited Education Institutes program to achieve

the same goal in surgery training programs.100

Animal studies can neither confirm nor refute hypotheses about

human physiology or pathology; human clinical investigation is

the only way such hypotheses can be tested. At best, animal experiments

can suggest new hypotheses that might be relevant to

How valuable is animal experimentation? The Medical Research

Modernization Committee’s review of ten randomly chosen animal

models of human diseases did not reveal any important contributions

conditions in animals were given names analogous to the human

diseases they were intended to simulate, they differed substantially

from their human «counterparts» in both cause and clinical course.

Also, the study found that treatments effective in animals tended

to have poor efficacy or excessive side effects in human patients.103

Indeed, when MRMC physicians evaluate specific animal-research

projects, they consistently find them to be of little, if any, relevance

to the understanding or treatment of human diseases.104-110

MRMC’s reviews have revealed that, because animal models

differ from human diseases, researchers tend to investigate those

aspects of the animal’s condition that resemble features of the human

disease, generally ignoring or discounting fundamental anatomical,

physiological and pathological differences. Because most

disease processes have system-wide effects and involve many interacting

factors, focusing on only one aspect of a disease belies

the actual complexity of biological organisms.

In contrast to human clinical investigation, animal experimentation

involves manipulations of artificially induced conditions.

Furthermore, the highly unnatural laboratory environment

invariably stresses the animals, and stress affects the entire organism

by altering pulse, blood pressure, hormone levels, immunological

activities

For example, artifact from unnaturally induced strokes in animals

on over 4,000 studies demonstrating efficacy for more than

tested in human clinical trials failed to show any benefit.

PA) administered within three hours of stroke onset has proven

beneficial in reducing symptoms, but it was associated with ten

times as many intracerebral hemorrhages and did not increase

the answers to many of our questions regarding the underlying

pathophysiology and treatment of stroke do not lie with continued

attempts to model the human situation more perfectly in animals,

but rather with the development of techniques to enable

the study of more basic metabolism, pathophysiology and anatomical

imaging detail in living humans.»117

Since 1990, several hundred gene therapies that were successful

in animal studies have been tested on thousands of patients

worldwide. Yet only one gene therapy, for children with the severe

immune system disorder X-SCID, appears to have succeeded. Of

the ten successfully treated children, however, three developed

leukemia and one of them died of it – a side effect that animal experiments

failed to predict and that prompted the U.S. Food and

Drug Administration (FDA) to halt several gene therapy trials in

of hemophilia was discontinued in 2004 due to «safety problems

… in the human trial that weren’t predicted in animal studies»,

including liver damage.126,127

survival of rats with artificially induced heart failure, but humans

taking this drug experienced a 30 % increase in mortality.129

Fialuridine appeared safe in animal tests, but it caused liver failure

in 7 out of 15 humans taking the drug, five of whom died and two

to predict the dangerous heart valve abnormalities in humans

caused by the diet drugs fenfluramine and dexfenfluramine.131

Hormone replacement therapy increased women’s risk of heart

disease, breast cancer and stroke, but experiments with mice, rabbits,

widely prescribed arthritis painkiller Vioxx appeared safe and even

beneficial to the heart in animal tests, but was withdrawn from the

global market in 2004 after causing an estimated 320,000 heart

attacks, strokes and cases of heart failure worldwide – 140,000 of

and Medicine in the Office of Drug Safety at the FDA, described

Vioxx as the «single greatest drug safety catastrophe in the history

failed to predict the cases of partial or total blindness suffered by

mandatory, extensive animal testing, adverse drug reactions remain

the fifth leading cause of mortality in the United States, accounting

for more than 100,000 deaths per year.137

In London in March 2006, a new anti-inflammatory drug

called TGN1412 caused devastating reactions including multiple

organ failure in all six volunteers in phase 1 clinical trials, despite

«proof of safety» established by tests on monkeys who were

given 500 times the human dose. Many commentators noted that

the animal tests provided a false sense of security. The incident

prompted calls for an overhaul of drug safety testing requirements

and clinical trial design.138

In animal tests to evaluate the carcinogenicity of the artificial

sweetener saccharin, the weight-adjusted daily saccharin dose given

to rats was equivalent to a human consuming about 1,100 cans of

soda containing saccharin. Such massive dosing alone can result in

cancers, regardless of a compound’s actual carcinogenicity at typical

is further complicated by the observation that saccharin-induced

bladder cancers occurred only in male rats. It was later found that

male rats possess a protein in greater quantity than female rats

(and lacking in humans) that interacted with saccharin to form

irritating crystals in the male rats’ bladders, causing cancer. The

fact that some rats developed cancers did not (and cannot) clarify

whether or not saccharin causes cancer in humans.139

Similarly, despite almost 40 years of human consumption, its

use in more than 9,000 food and beverage products worldwide, and

aspartame is still being tested on animals, and regulatory authorities

continue to evaluate the results of such studies. Most recently,

an Italian study carried out in 2005 on 1,800 rats demonstrated

an increased risk for lymphomas and leukemias in rats fed aspartame

study involving 340,045 men and 226,945 women and reported

on at the 2006 meeting of the American Association for Cancer

bladder cancers from saccharin and female rats getting lymphomas

and leukemias from aspartame, no cancer risk from either

sweetener has been found for humans of either sex.

Scientists recognize that, even between humans, gender, ethnicity,

age and health can profoundly influence drug effects.142,143

Perhaps the most striking example of the specificity of drug effects

comes from the demonstration that even human monozygotic

twins display different drug responses and that these become

between species is much more hazardous than within a species.

Indeed, according to the FDA, a staggering 92 % of all drugs found

safe and therapeutically effective in animal tests fail during human

clinical trials due to their toxicity and/or inefficacy, and are

8 % of drugs which do gain FDA approval must later be withdrawn

or relabeled due to severe, unexpected side effects.148

In addition to squandering scarce resources and providing misleading

results, animal experimentation poses real risks to humans.

The mind-set that scientific knowledge justifies and requires

harming innocent individuals endangers all who are vulnerable.

Even after Nazi and Japanese experiments on prisoners horrified

the world, American researchers denied African-American men

syphilis treatment in order to assess the disease’s natural progression,

chemicals in order to determine safe levels of exposure to pesticides,

no chance of success, transplanted nonhuman primate and

pig organs into children, as well as chronically ill and impoverished

«science at any cost» mentality may have provided medical justification

for the Holocaust.154

Furthermore, through animal research, humans have been

exposed to a wide variety of deadly nonhuman primate viruses.

About 16 laboratory workers have been killed by the Marburg

virus and other monkey viruses, and two outbreaks of Ebola have

grown on monkey kidney cells exposed millions of Americans

to the simian virus 40, which causes human cells to undergo

malignant transformation in vitro and has been found in several

researchers transplanted baboon bone marrow cells into an

a large number of baboon viruses,

which the patient could

have spread to other people,

may have accompanied the

bone marrow. Indeed, animal

experimentation may have

started the AIDS epidemic.

HIV-1, the principal AIDS virus,

differs markedly from all

other viruses found in nature,

and there is evidence that it

originated either through polio

vaccine production using

manufacture in American laboratories,

where HIV-like viruses

were being produced by

cancer and biological weapons

researchers in the early

Failing to learn from the AIDS epidemic, many policy makers

and industrial interest groups support animal-to-human organ

transplants (from pigs and primates) known as xenotransplants.

These have failed in the past and will most likely continue to fail

because of tissue rejection, the impossibility of testing animal tissues

for unknown pathogens, and the prohibitive expense.163-165

Similarly, the rapidly expanding field of genetic engineering

includes adding genetic material to animals’ cells to change the

animals’ growth patterns or induce the animals to produce human

proteins in their milk, meat or urine. Harvesting such proteins

poses serious human health risks, such as exposure to pathogens

ban on rBGH, a genetically engineered bovine growth hormone

that increases cows’ milk production.172

Typically, medical discovery begins with a clinical observation,

tend to highlight animal data that agrees with the previous

clinical finding, while discounting or ignoring conflicting animal

data (which is usually voluminous). Although animal experimentation

advocates routinely take credit for discoveries that actually

the primary role of human-based clinical research. Reviewing the

history of hepatitis, physician Paul Beeson concluded: «Progress

in the understanding and management of human disease must begin,

and end, with studies of man… Hepatitis, although an almost

‹pure› example of progress by the study of man, is by no means

unusual; in fact, it is more nearly the rule. To cite other examples:

appendicitis, rheumatic fever, typhoid fever, ulcerative colitis

and hyperparathyroidism.»11

based primarily on human clinical research and investigation.

Furthermore, clinical research is the only means by which effective

public health education and prevention programs can be developed

and evaluated.

In science, there are always many ways to address a given question.

Animal experimentation is generally less efficient and reliable

than many nonanimal methods, which include:

Medical research has always sought to identify the underlying

causes of human disease in order to develop effective preventive

and therapeutic measures. In contrast to artificial animal model

conditions that generally differ in causes and mechanisms from

human conditions, human population studies have been very fruitful.

For example, the identification of the major risk factors for

coronary heart disease, such as smoking, elevated cholesterol and

high blood pressure, which are so important for prevention techniques,

studies have shown that prolonged cigarette smoking from

early adult life triples age-specific mortality rates, but cessation at

the age of 50 reduces the danger by half, and cessation at the age

of 30 eliminates the danger almost completely.178

Epidemiology’s potential is illustrated by the growing field

of molecular epidemiology. Researchers can analyze cellular

and molecular

characteristics of those suffering from cancer or

birth defects, thereby elucidating the mechanisms and causes of

DNA damage and yielding effective prevention and treatment

approaches.179

The main source of medical knowledge has always been the direct

study of human disease by closely monitoring human patients.

For example, cardiologist Dean Ornish has demonstrated that a

low-fat vegetarian diet, regular exercise, smoking cessation and

based diets and medicines as needed arrests and often reverses

clinical investigation to develop techniques and operations

that have saved thousands of lives, including the Heimlich maneuver

for choking and drowning victims, the Heimlich operation

to replace the esophagus (throat tube), and the Heimlich

chest drainage valve.173,182

Modern noninvasive imaging devices such as CAT, MRI, PET

and SPECT scans have revolutionized clinical investigation.183-186

These devices permit the ongoing evaluation of human disease

in living human patients and have contributed greatly to medical

knowledge.

The autopsy rate in the United States and Europe has been falling

steadily, much to the dismay of clinical investigators who recognize

have been crucial to our current understanding of many diseases,

to the disease’s lethal stage, biopsies can provide information

about other disease stages. Diagnostic needle and endoscopic biopsies

often permit safe procurement of human tissues from living

patients. For example, endoscopic biopsies have demonstrated

that colon cancers derive from benign tumors called adenomas.

In contrast, colon cancers in a leading animal model appear to

(with intact capillaries) can be used as a tool before or during

clinical trials of new drugs and could have revealed the cardiovascular

risks of Vioxx, for example, before it was marketed.193

Thanks to advances in computer techniques, it is now possible to

keep detailed and comprehensive records of drug side effects.194

A central database with such information, derived from postmarketing

surveillance, enables rapid identification of dangerous

that unexpected beneficial side effects of drugs would be recognized.

Indeed, the anti-cancer properties of such medications as

through clinical observation of side effects.

Between the mid-1950s and mid-1980s, the NCI screened 400,000

chemicals as possible anti-cancer agents, mostly on mice who had

were effective against mouse leukemia had little effect on the

favored grafting human cancers onto animals with impaired immune

systems that do not reject grafts. However, few drugs found

promising in these models have been clinically effective, and

drugs with known effectiveness in humans often fail to show efficacy

in these models.204

By contrast, in vitro cell and tissue cultures have proven to be

powerful investigative tools. The NCI has now switched to 60

in vitro human cancer cell lines, a more reliable and much less

DNA can detect DNA damage much more readily than animal

tests.206

New drugs can be tested in human tissues. This could have

predicted the catastrophic reaction to the drug TGN1412 in the

and Asterand work exclusively with human tissue because, contrary

to animal tissue, the results obtained can be directly extrapolated

to humans.207

Regarding vaccines, researchers discovered already in 1949

more effective, safer and less expensive than vaccines produced

the serious danger of contamination with animal viruses.

have been replaced by far more sensitive and reliable cell culture

techniques.211,212

Microfluidic circuits provide the nearest thing to a human

body on a chip. They comprise tiny channels with cells from various

human organs and are linked by a circulating blood substitute.

Using these circuits, new drugs can be tested on a «whole

system», where they encounter human cells in the same order

as they would encounter them in the human body. Sensors

in the chip then feed back information for computer analysis.

Microfluidic circuits promise to deliver, early in the preclinical

phase, data of dramatically improved predictive relevancy to the

human organism.213

Computer modeling is now so sophisticated that scientists

can simulate in silico in minutes or hours experiments that would

take months or years to perform in animals. Drugs can be rationally

designed on computers and then tested on virtual organs

or in virtual clinical trials. Research teams around the world are

working on a «virtual human» which will predict human responses

more accurately than would ever be possible with any

animal model.214

Microdosing is a tremendously exciting breakthrough in drug

development based on the principle that the best model for man

is man. Human microdosing relies on ultra-sensitive analytical

techniques and permits the safe introduction of miniscule doses

(amounting to only 1 % of the normal full dose) of new drugs

into subjects in order to evaluate drug activity in the human

body. The technique has proven quite accurate, with the results

from microdosing studies showing a 70 % correspondence with

unreliable animal testing and become part of phase 0

preclinical trials for every drug. Both the FDA and the European

Agency for the Evaluation of Medicinal Products have endorsed

the use of microdosing to accelerate and improve the safety of

drug development.216

If animal experimentation is so flawed, why does it persist? There

are several likely explanations.

experiments provide an important legal sanctuary. In cases of

death or disability caused by chemical products or adverse drug reactions,

the responsible companies claim due diligence by pointing

out that they performed the legally prescribed «safety tests»

on animals and are therefore not accountable. As a result, the victims

or their families most often come away empty-handed after

suing for damages.14

2. Animal experimentation is easily published. In the «publish

or perish» world of academic science, it requires little originality

or insight to take an already well-defined animal model,

change a variable or the species being used, and obtain «new»

and «interesting» findings within a short period of time. In contrast,

clinical research, while directly applicable to humans, is

more difficult, expensive and time-consuming. In addition, the

many species available and the nearly infinite possible manipulations

offer researchers the opportunity to «prove» almost any

theory that serves their economic, professional or political needs.

For example, researchers have «proven» in animals that cigarettes

both do and do not cause cancer – depending on the funding

source.217,218

3. Animal experimentation is self-perpetuating. Scientists’

salaries and professional status are often tied to grants, and a critical

element of success in grant applications is proof of prior experience

and expertise. Researchers trained in animal experimentation

techniques find it difficult or inconvenient to adopt new

methods such as tissue cultures.

4. Animal experimentation is lucrative. Its traditionally respected

place in modern medicine results in secure financial support,

which is often an integral component of a university’s budget.

Many medical centers receive several hundred million dollars

annually in direct grants for animal research, and an average of

over 40 % more for overhead costs that are supposedly related

ing clinical revenues depend on this financial windfall for much

of their administrative costs, construction and building maintenance,

they perpetuate animal experimentation by praising it in

the media and to legislators.

clinical research. Researchers often assert that laboratory experiments

are «controlled» because they can change one variable at a

time. This control, however, is illusory. Any animal model differs

in myriad ways from human physiology and pathology. In addition,

the laboratory setting itself creates confounding variables – for example,

stress and undesired or unrecognized pathology in the animals.

Such variables can have system-wide effects, skew experimental

results, and undermine extrapolation of findings to humans.

efforts to avoid morality. For example, they «sacrifice» animals

rather than kill them, and they may note animal «distress», but

quickly learn to adopt such a mind-set from their superiors,

as sociologist Arnold Arluke explains: «One message – almost a

warning – that newcomers got was that it was controversial or

risky to admit to having ethical concerns, because to do so was

tantamount to admitting that there really was something morally

wrong with animal experimentation, thereby giving ‹ammunition

«Sadly, young doctors must say nothing, at least in public, about

the abuse of laboratory animals, for fear of jeopardizing their career

prospects.»224

Evidence indicates that many animal experimenters fail to acknowledge

– or even perceive – animal pain and suffering. For example,

sociologist Mary Phillips observed animal experimenters kill

rats in acute toxicity tests, induce cancer in rodents, subject animals

to major surgery with no postoperative analgesia, and perform

numerous other painful procedures without administering anesthesia

or analgesia to the animals. Nevertheless, in their annual reports

to the U.S. Department of Agriculture (USDA), none of the

researchers

acknowledged that any animals had experienced unrelieved

assured me that in their laboratories, animals were never hurt…

‹Pain› meant the acute pain of surgery on conscious animals, and

almost nothing else… [When I asked] about psychological or emotional

suffering, many researchers were at a loss to answer.»225

Similarly, a study published in the British Medical Journal found

that Canadian neurologists who spent a year of their training experimenting

on animals «had so hardened themselves to animal suffering

that they were no longer capable of recognizing suffering in their

patients for quite a while after returning to clinical work».226

Animal experimenters’ ethical defense of the practice has been

superficial and self-serving. Usually, they simply point to the supposed

human benefits and argue that the ends justify the means,227,228

though they rarely substantiate their claims with scientific evidence.

lacking certain attributes compared to humans, such as intelligence,

family structure, social bonding, communication skills and

altruism. However, numerous nonhuman animals – among them

rats, pigs, dogs, monkeys and great apes – reason and/or display

altruism. There is accumulating evidence that many animals ex-

20 21

mice have been shown to exhibit empathy with cage mates

sign language and to communicate with one another using signs

even without humans being present.234,235

The general public, which cares about animal welfare, has

been led to believe that animals rarely suffer in laboratories.

Animal experimenters often cite USDA statistics (derived from

researchers themselves) which claim that only 6-8 % of animals

used in animal experimentation experience pain unrelieved by

the United States constitute over 90 % of all animals used in animal

experimentation, receive absolutely no protection from the

Animal Welfare Act.237

The general public is clearly uneasy about animal experimentation.

In a 2006 poll in the United Kingdom, for example, 51 %

of nearly one million voters said they are not in favor of animal

the public and is financed largely with their taxes and charitable

donations, their concerns should be respected and addressed.

The tens of millions of animals used and killed each year in

American laboratories generally suffer enormously, often from

fear and physical pain, and nearly always from the deprivation

inflicted by their confinement which denies their most basic psychological

and physical needs.

The value of animal experimentation has been grossly exaggerated

by those with a vested economic interest in its preservation.

Because animal experimentation focuses on artificially created pathology,

involves confounding variables, and is undermined by

differences between human and nonhuman anatomy, physiology

and pathology, it is an inherently unsound method to investigate

human disease processes. The billions of dollars invested annually

in animal experimentation would be put to much more efficient,

effective and humane use if redirected to clinical and epidemiological

research and public health programs.

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