ANIMAL TESTING FOR

PHARMACEUTICALS :
ETHICAL ISSUES
Siddhi Nath Paudel
Deepak Karna
Sanjay Ghimire
Sailesh Phuyal
Presented By:
08.02.2014
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


Need?
Drug safety
Biologically similar to humans
Animals like chimpanzees share more that
99% 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 controlled
according to need
CURRENT STATISTICS
Source - Alternatives to animal testing: current status and future perspectives
Fig: Areas of animal use for scientific
purposes in Europe
Source - Alternatives to animal testing: current status and future perspectives
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?




Argument: Do animals necessarily
need rights for moral action?
Need for human beings to behave morally can
entirely 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!
Three Rs of animal research
Reduction
By improving techniques , sharing
information
Refinement
Using less invasive techniques,better
medical care and conditions
Replacement
Through alternative techniques

Ethics of Animal Research
Experimenting on animals is always
unacceptable because:
It causes suffering to animals
The benefits to human beings are not
proven
Any benefits to human beings that
animal testing does provide could be
produced in other ways

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 mislead
researchers or even contribute to illnesses or
deaths by failing to predict the toxic effects of
drugs
Physiological differences between animals and
humans make animal testing a poor model for
how drugs will interact and what adverse
affects might occur in humans

Animal Tests Are Inapplicable
Important medical advances have been
delayed because of misleading results derived
from animal experiments

David Wiebers and his colleagues described a
study showing that of the 25 compounds that
reduced damage from ischemic stroke (caused
by lack of blood flow to the brain) in rodents,
cats and other animals, none proved efficient
in human trials

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 tobacco
smoke did not cause lung cancer
(tar from the smoke painted on
the skin of rodents did cause
tumors to develop)
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

Carcinogenicity of 214 compounds on both rats
and mice agreed with each other only 70
percent of the time (Lester Lave of Carnegie
Mellon University, Nature that dual
experiments (1988))
The correlation between rodents and humans
could only be lower
David Salsburg of Pfizer Central Research has
noted that of 19 chemicals known to cause
cancer in humans when ingested, only seven
caused cancer in mice and rats using the
standards set by the National Cancer Institute
FDA approval failure
Milrinone
Raises cardiac output
Increased survival of rats with
artificially induced heart failure
This drug had a 30 percent
increase in mortality when used
in humans with severe chronic
heart failure
Flauridine
The antiviral drug caused liver
failure in seven of 15 humans
taking the drug




Vioxx
An anti-inflammatory
drug, FDA (1999)
In mice, Vioxx reduced
atherosclerosis
The drug was taken off
the market after it was
found that it could
double the risk for heart
attack and stroke in
humans.
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 tests
falsely suggested inefficacy or toxicity

ETHICAL ISSUES:SHOULD OR
SHOULDNT?
Experimenting on animals acceptable if
suffering minimized and human benefits
gained which could not be obtained
using other methods

Always unacceptable as it causes
suffering to animals, benefits to human
beings are not proven and benefits
obtained through animal testing can be
obtained through other ways


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

PENICILLIN
(1940,mice)
BLOOD TRANSFUSION
(1940,dogs )
POLIO VACCINE
(1950, monkey & mice)
TUBERCULOSIS
(Streptomycin ,1940,
guinea pigs)
MENINGITIS VACCINE
(mice)
ASTHMA
INHALERS(animal
research)
MAJOR ACHIEVEMENTS
INSULIN FOR DIABETES
(1923,dogs)
BREAST CANCER
(Animal research:
tamoxifen, herceptin
and other aromatase
inhibitors)
IMPLANTS FOR
PARKINSONS
DISEASE
(primates)
OPEN HEART SURGERY
Saves lives of 4440,000
people every year in US
alone
A routine procedure
Result of 20 years of animal
research
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
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 in
rabbits, 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 as
many patients who get infected with antibiotic-induced
colitis on a long-term penicillin therapy. Colitis infection in
both human and pigs caused by Clostridium difficile


Truth: no BASIC difference between
physiology of laboratory animals and humans

Unjust criticize: not identical to conditions in
humans

cystic fibrosis in mice may not exactly mimic
human condition but provide a way to
establish optimal method of gene therapy to
cure the disease


BLACK HOLE
OPPONENTS CLAIM
Although part in advances,
not essential and had they
been outlawed, forced to be
more creative and invented
superior technologies
Or more careful and
respected clinical and
cellular research
REALITY
A gaping hole present
No outstanding progress
until science followed
through empirical basis by
experiments on animals
Eg. Pasteur, William Harvey
(blood circulation) did not
chose animal experiment as
easy option
STANDARDS FOR USE OF ANIMALS
Strict in accordance with
present legislation
Housing, husbandry and
transportation of
animals be minimum
with approved standards
Transgenic animals be
used for experiments
when model justified
Alternatives to be used
when possible


CONTD
Health control be
supervised by experienced
veterinary officer
All precautions be taken to
reduce suffering and
distress
Procedures for monitoring,
evaluation and treatment of
the animals be
implemented
Records be kept updated on
the type of experiment,
animal species and number
of animals used in
accordance with authorities


TRENDS IN ANIMAL RESEARCH
THE PUBLICS VIEW

Who grew up on farms often see
animals as objects, whereas
those with pets tend to express
sympathy

Who are older or less educated
are more likely to see animals as
resources, whereas those who
are younger or more educated
tend to view animals with
compassion

If it hurts you, it probably hurts
the animals
THE SCIENTISTS VIEW

Taught as undergraduates not to
think of animals as other than
stimulus response bundles


Opposition to animal
experimentation is derived from
antiscience sentiments,
aggravated by poor public
knowledge of science

The dogma is you cannot credit
animals with feeling


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
USE OF ALTERNATIVES
For atherosclerotic heart disease, the risk factors include high
cholesterol 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 2
percent drop in risk for heart disease

Autopsy results and chemical studies added further links
between risk factors and disease, indicating that people
consuming high-fat diets acquire arterial changes early in life

THE STUDY WAS ENTIRELY BASED ON EXPERIMENTS WITHOUT ANIMAL USE!
CONTD
In vitro studies using human cells and serum allowed
researchers to identify the AIDS virus and determine
how 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 with
birth defects
Also, population studies linked lung cancer to
smoking and heart disease to cholesterol
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 of
multiplying 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!


In the animal experiment context, if the
experiment takes place, the experimenter will
carry out actions that harm the animals involved.

If the experiment does not take place the
experimenter will not do anything. This may
cause harm to human beings because they won't
benefit from a cure for their disease because the
cure won't be developed.

BUT, it is morally worse to do harm by doing something than to
do harm by not doing something


REFERENCES
Rowan, A. N. (1997); Forum: The Benefits and
Ethics 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]
THANK YOU!!!