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ANIMAL TESTING FOR
PHARMACEUTICALS :
ETHICAL ISSUES
Siddhi Nath Paudel
Deepak Karna
Sanjay Ghimire
Sailesh Phuyal
Presented By:
08.02.2014
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INTRODUCTION
What is animal testing, why?
Use of non-human animals in experiments Galen, a physician in 2nd-century Rome,
dissected pigs and goats, and is known as the
"father of vivisection
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Need?
Drug safety
Biologically similar to humans
Animals like chimpanzees share more that99% of DNA with humans and mice share
more than 98% DNA with humans Animals are susceptible to many of the same
health problems as humans
Animals have a shorter life cycle than humans Environment around animals (diet,
temperature, lighting) can be controlledaccording to need
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CURRENT STATISTICS
Source - Alternatives to animal testing: current status and future perspectives
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Fig: Areas of animal use for scientific
purposes in EuropeSource - Alternatives to animal testing: current status and future perspectives
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Animal Rights: Where do you stand?
Idea that some, or all, non
human animals have rights of their own lives,
and that their most basic interests
Which animals deserve more moral
considerations, then?
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Argument: Do animals necessarily
need rights for moral action?
Need for human beings to behave morally canentirely outweigh need for animal rights
Causing pain and suffering ,morally wrong
whether victim is human or non-human Limitation: absence of cruelty is just one
ingredient for morality
It would be kind to give a relative a false excuse to stop
them from going to jail but it would also be morally wrong!
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Three Rs of animal research
eductionBy improving techniques , sharing
information
efinementUsing less invasive techniques,better
medical care and conditions
eplacementThrough alternative techniques
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Ethics of Animal Research
Experimenting on animals is alwaysunacceptable because:
It causes suffering to animals
The benefits to human beings are notproven
Any benefits to human beings that
animal testing does provide could beproduced in other ways
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Wasteful and Misleading
Poorly suited to addressing the urgent health
problems like heart disease, cancer, stroke,AIDS and birth defects
Even worse, animal experiments can misleadresearchers or even contribute to illnesses ordeaths by failing to predict the toxic effects ofdrugs
Physiological differences between animals andhumans make animal testing a poor model forhow drugs will interact and what adverseaffects might occur in humans
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Animal Tests Are Inapplicable
Important medical advances have beendelayed because of misleading results derivedfrom animal experiments
David Wiebers and his colleagues described astudy showing that of the 25 compounds thatreduced damage from ischemic stroke (caused
by lack of blood flow to the brain) in rodents,cats and other animals, none proved efficientin human trials
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During the 1920s and 1930s,
studies on monkeys led to gross
misconceptions that delayed the
fight against poliomyelitis
In a striking illustration of the
inadequacy of animal research,
scientists in the 1960s deduced
from numerous animal
experiments that inhaled tobaccosmoke did not cause lung cancer
(tar from the smoke painted on
the skin of rodents did cause
tumors to develop)
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Difficulties in extrapolation
Cancer research is especially sensitive to
differences in physiology between humans
and other animals
Vitamin C synthesis rate in mice and humans
The stress of handling, confinement and
isolation alters an animals physiology
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Carcinogenicity of 214 compounds on both ratsand mice agreed with each other only 70
percent of the time (Lester Lave of CarnegieMellon University, Nature that dual
experiments(1988))
The correlation between rodents and humanscould only be lower
David Salsburg of Pfizer Central Research has
noted that of 19 chemicals known to causecancer in humans when ingested, only seven
caused cancer in mice and rats using the
standards set by the National Cancer Institute
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FDA approval failureMilrinone
Raises cardiac output
Increased survival of rats with
artificially induced heart failure
This drug had a 30 percent
increase in mortality when usedin humans with severe chronic
heart failure
Flauridine
The antiviral drug caused liverfailure in seven of 15 humans
taking the drug
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Vioxx
An anti-inflammatorydrug, FDA (1999)
In mice, Vioxx reducedatherosclerosis
The drug was taken offthe market after it wasfound that it coulddouble the risk for heart
attack and stroke inhumans.
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The U.S. General Accounting Office reviewed
198 of the 209 new drugs marketed between
1976 and 1985 and found that 52 percent had
serious post approval risks not predicted by
animal tests or limited human trials
Also numbers of drugs may have been
needlessly abandoned because animal testsfalsely suggested inefficacy or toxicity
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ETHICAL ISSUES:SHOULD OR
SHOULDNT?
Experimenting on animals acceptableifsuffering minimized and human benefitsgained which could not be obtained
using other methods
Always unacceptable as it causessuffering to animals, benefits to human
beings are not proven and benefitsobtained through animal testing can beobtained through other ways
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We have all benefited immensely from scientific
research involving animals. From antibiotics and insulin
to blood transfusions and treatment for cancer or HIV
2006 Report
virtually every medical achievement of the past
century has depended directly or indirectly on
research with animals
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PENICILLIN
(1940,mice)
BLOOD TRANSFUSION
(1940,dogs )
POLIO VACCINE
(1950, monkey & mice)
TUBERCULOSIS
(Streptomycin ,1940,
guinea pigs)
MENINGITIS VACCINE
(mice)
ASTHMA
INHALERS(animal
research)
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MAJOR ACHIEVEMENTS
INSULIN FOR DIABETES(1923,dogs) BREAST CANCER(Animal research:
tamoxifen, herceptin
and other aromatase
inhibitors)
IMPLANTS FORPARKINSONS
DISEASE
(primates)
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OPEN HEART SURGERY
Saves lives of 4440,000
people every year in US
alone
A routine procedure
Result of 20 years of animal
research
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COMMON MISCONCEPTIONS
Alleged difference between species in
physiology or drug response that
render animal experiments
redundant or misleading
These claims can be refuted by
proper examination literature
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CASE HISTORIES
Thalidomide Cited as a drug thoroughly tested on animals and showed
its teratogenic effect only in humans
Scientists never tested thalidomide in pregnant animals
Tests show that drug in fact cause fetal abnormalities inrabbits, mice, and several species of monkey
Penicillin Would not have been used in patients if first administered
to guinea pigs
Guinea pigs respond to penicillin in exactly same way asmany patients who get infected with antibiotic-inducedcolitis on a long-term penicillin therapy. Colitis infection inboth human and pigs caused by Clostridium difficile
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Truth: no BASIC difference betweenphysiology of laboratory animals and humans
Unjust criticize: not identical to conditions inhumans
cystic fibrosis in mice may not exactly mimichuman condition but provide a way toestablish optimal method of gene therapy tocure the disease
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BLACK HOLE
OPPONENTS CLAIM
Although part in advances,
not essential and had they
been outlawed, forced to bemore creative and invented
superior technologies
Or more careful and
respected clinical and
cellular research
REALITY
A gaping hole present
No outstanding progress
until science followedthrough empirical basis by
experiments on animals
Eg. Pasteur, William Harvey
(blood circulation) did notchose animal experiment as
easy option
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STANDARDS FOR USE OF ANIMALS
Strict in accordance withpresent legislation
Housing, husbandry and
transportation of
animals be minimum
with approved standards
Transgenic animals be
used for experimentswhen model justified
Alternatives to be used
when possible
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CONTD
Health control besupervised by experiencedveterinary officer
All precautions be taken toreduce suffering and
distress Procedures for monitoring,
evaluation and treatment ofthe animals beimplemented
Records be kept updated onthe type of experiment,animal species and numberof animals used inaccordance with authorities
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TRENDS IN ANIMAL RESEARCH
THE PUBLICS VIEW
Whogrew up on farms often seeanimals as objects, whereasthose with pets tend to expresssympathy
Who are older or less educatedare more likely to see animals asresources, whereas those whoare younger or more educatedtend to view animals with
compassion
If it hurts you, it probably hurtsthe animals
THE SCIENTISTS VIEW
Taughtas undergraduates not tothink of animals as other thanstimulus response bundles
Opposition to animalexperimentation is derived fromantiscience sentiments,aggravated by poor publicknowledge of science
The dogma is you cannot creditanimals with feeling
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ALTERNATIVES TO ANIMAL
TESTING Epidemiological studies
Clinical intervention trials
Laboratory testing using biochemistry
Human tissue and cell cultures Stem cells use
Autopsy studies
Endoscopic examination
Biopsy
Imaging methods
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USE OF ALTERNATIVES
For atherosclerotic heart disease, the risk factors include highcholesterol levels, smoking and high blood pressure(Framingham Heart Study)
Altered controlled human trials illustrated that every 1
percent drop in serum cholesterol levels lead to at least a 2percent drop in risk for heart disease
Autopsy results and chemical studies added further links
between risk factors and disease, indicating that peopleconsuming high-fat diets acquire arterial changes early in life
THE STUDY WAS ENTIRELY BASED ON EXPERIMENTS WITHOUT ANIMAL USE!
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CONTD In vitro studies using human cells and serum allowed
researchers to identify the AIDS virus and determinehow it causes disease
Research into the causes of birth defects has relied
heavily on animal experiments
HOWEVER, these have typically proved to be
embarrassingly poor
Epidemiological studies are needed to trace possible
genetic and environmental factors associated withbirth defects
Also, population studies linked lung cancer to
smoking and heart disease to cholesterol
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BASIC ETHICAL ARITHMETIC The harm that will result from not doing the experiment is
the result of multiplying three things together: the moral value of a human being
the number of human beings who would have benefited
the value of the benefit that each human being won't get
The harm that the experiment will cause is the result ofmultiplying together: the moral value of an experimental animal
the number of animals suffering in the experiment
the negative value of the harm done to each animal
GOOD DONE TO HUMAN BEINGS OUTWEIGHS THE HARM DONE TO ANIMALS!
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In the animal experiment context, if the
experiment takes place, the experimenter willcarry out actions that harm the animals involved.
If the experiment does not take place the
experimenter will not do anything. This maycause harm to human beings because they won'tbenefit from a cure for their disease because thecure won't be developed.
BUT, it is morally worse to do harm by doing something than to
do harm by not doing something
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REFERENCES
Rowan, A. N. (1997); Forum: The Benefits andEthics of Animal Research; Scientific American,
Inc. through
www.indiana.edu/acoustic/s685/Rowan-
1997.pdf[Accessed: 6/3/2014]
Animal ethics: Experimenting on animals through
http://www.bbc.co.uk/ethics/animals/using/expe
riments_1.shtml#h3[Accessed: 5/26/2014]
http://www.indiana.edu/acoustic/s685/Rowan-1997.pdfhttp://www.indiana.edu/acoustic/s685/Rowan-1997.pdfhttp://www.indiana.edu/acoustic/s685/Rowan-1997.pdfhttp://www.indiana.edu/acoustic/s685/Rowan-1997.pdfhttp://www.indiana.edu/acoustic/s685/Rowan-1997.pdfhttp://www.bbc.co.uk/ethics/animals/using/experiments_1.shtmlhttp://www.bbc.co.uk/ethics/animals/using/experiments_1.shtmlhttp://www.bbc.co.uk/ethics/animals/using/experiments_1.shtmlhttp://www.bbc.co.uk/ethics/animals/using/experiments_1.shtmlhttp://www.bbc.co.uk/ethics/animals/using/experiments_1.shtmlhttp://www.bbc.co.uk/ethics/animals/using/experiments_1.shtmlhttp://www.indiana.edu/acoustic/s685/Rowan-1997.pdfhttp://www.indiana.edu/acoustic/s685/Rowan-1997.pdfhttp://www.indiana.edu/acoustic/s685/Rowan-1997.pdfhttp://www.indiana.edu/acoustic/s685/Rowan-1997.pdfhttp://www.indiana.edu/acoustic/s685/Rowan-1997.pdf8/12/2019 Animal Experimentation Ethics
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THANK YOU!!!