Perhaps the COVID-19 pandemic will help us to question some of our outdated scientific practices as well as the obsolete regulations that still impose them.
SIGN HERE: Thank Researchers who are Rejecting the Animal 'Model'
“The Coronavirus pandemic is an important opportunity to reassess the way
we do medical research. Faced with this viral tsunami, scientists have not
had time to find one or more animal species to serve as a ‘model’ to study
this disease in the laboratory.
In the case of seasonal flu, doctors have well-known ways to lower rates of
infection, such as vaccines and antiviral drugs, which can decrease the
severity of symptoms and the duration of the disease. But faced with an
emergency situation, researchers decided to test new treatments directly on
patients. It should be noted that these are not untested medical drugs but
rather drugs used for other diseases, or else different combinations of
drugs already on the market.
This kind of human experimentation is called a ‘clinical trial’. Its purpose
is to assess the efficacy of a treatment following the approval by ethics
committees and the informed consent of the patient. A clinical trial is
normally preceded by several ‘pre-clinical’ steps to assess the toxicity and
efficacy of a new treatment. One of these steps is animal testing. This
regulatory requirement dates back to the Nuremberg Codes of 1947 and is
still the norm in national and international legislation today. Yet,
according to the US Food and Drug Administration, out of ten medical drugs
that have successfully passed the required tests on animals, nine will fail
in clinical trials involving humans (due to lack of efficacy or to side
effects not seen in animals). This represents a 90% failure rate or a 10%
prediction rate based on animal tests.
It is interesting to note that scientists closely involved in the search for
a treatment or a vaccine against COVID-19 also recognise the fact that
animal tests are unreliable to predict human reactions. Let us quote some of
them. According to Tal Zaks, medical director of Moderna, a successful
biotech company in the United States: “I don’t think proving this in an
animal model is on the critical path to getting this to a clinical trial”
(1). Barney Graham, director of the National Institute of Allergy and
Infectious Diseases (NIAID), also in the United States, notes that standard
laboratory mice do not catch this new Coronavirus, as humans do (2).
Finally, Karen Maschke, editor of the journal Ethics & Human Research,
pointed out that animal studies are often poor predictors of what will work
in humans (3).
Of course, making a new vaccine is not without risk. This is the reason for
using evidence-based technologies, as demonstrated by ‘personalised’
medicine and vaccines. Indeed, doctors and researchers note that we are not
all equal to the risk of infection by this virus. Why are children far less
susceptible than the elderly, for example? Crucially, the clinical
information that is being collected constitutes the best data to develop
personalised treatments and vaccines, more effective and with fewer side
effects than conventional treatments.
This is a golden opportunity to get rid of the ‘animal model’, a concept
that belongs to the 20th century, and to focus our efforts on the species in
question, namely humans. To try to reproduce a human disease in an animal is
a perversion of science, a complete misunderstanding of the complex system
that we are and of the different complex systems that make up our organism,
such as the immune system. Each animal species is a complex system and
therefore cannot serve as a model for another. Even among humans, there are
important differences between children and adults, men and women, in terms
of susceptibility to COVID-19. Rather than experimenting with ferrets,
monkeys or mice, it would be more intelligent – and far more scientific – to
invest in high-performance technologies of the 21st century.
One example is the ‘MIMIC’ (Modular Immune In vitro Construct). It is an in
vitro model of the human immune system (4). “The information you get from
this type of test is far and beyond what you’d get out of a mouse study,”
says Michael Rivard, vice president of corporate development at VaxDesign,
“both because it’s humans and because you can see the effect across a
spectrum of genotypes” (5).
Advanced in vitro technologies (such as MIMIC, ‘organs on a chip’ and
others) must aim for a prediction rate of 85 to 90 % in order to be accepted
at the regulatory level, whereas the ‘animal model’ achieves a prediction
rate of only 10% according to the FDA. A testing strategy based on a battery
of in vitro tests using human material would be far more relevant than
pursuing animal tests. It is time to change the current paradigm in
biomedical research if we want to preserve our health in the face of
emerging diseases of the 21st century. Perhaps the COVID-19 pandemic will
help us to question some of our outdated scientific practices as well as the
obsolete regulations that still impose them.”
REFERENCES
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