About NAMs !
get to learn more about alternatives to animal testing with Altertox first video content !
episode 2: Replacing rabbits and horseshoe crab in pharmacopeia: the “human pyrogen testing”
Medicines intended to be injected in the human body need to be sterilized to prevent dramatic reactions of the immune system, such as septicemia. To ensure that products are not contaminated with bacteria, pyrogen tests used to be performed on about 400 000 rabbits per year world-wide up until 15 years ago. ( source: “The human whole blood pyrogen test – lessons learned in twenty years”, by Thomas Hartung, in Altex, May 2015).
In the EU at that time, some 170,000 rabbits per year were used for pyrogen testing, a figure that exceeded the number of all animals used for industrial chemicals or pesticide (Source: ”Pyrogen Testing Revisited on Occasion of the 25th Anniversary of the Whole Blood Monocyte” by Thomas Hartung, in Altex January 2021).
One alternative to the use of rabbits for pyrogen test is the blood of horseshoe crab or Limulus, a 500-million-year-old invertebrate which is released in the ocean after blood collection. An estimated 10% of horseshoe crabs unfortunately die when bled and this alternative was not enough to impact the number of rabbits used in pyrogen tests. (Source: Idem supra)
In the EU28+Norway, the number of rabbits used for pyrogen testing dropped by 80% between 2008 and 2018 to reach 30 450 rabbits thanks to the development of a 100% animal-free alternative: the “MATs” (Source: Alure, the EU statistics database on the use of animals for scientific purposes.
According to Prof. Thomas Hartung who led the validation study of the MATs, this New Approach Methodology is cheaper, faster, and more reliable than the rabbit pyrogen test or the Limulus test. Easy to use as the cells can be frozen, MAT variants can be applied for chemotherapeutics and other products that cannot be tested in rabbits. The MATs are also a proof that alternatives to animal testing can be commercially interesting, as this test has a turnover of around half a billion dollars per year. (Source: Marketsandmarkets, 2020)
The European Pharmacopoeia Commission announced in June 2021 that they will end all pyrogen testing on rabbits in five years, thanks to the MATs. (Source: Council of Europe). There is hope that the Limulus test will be replaced too, putting an end to animal suffering while improving product safety.
episode 1: introducing NAMs!
Each year, an estimated 115 million animals are used for research and testing purposes worldwide. (source: Humane Society International).
However, faster, more accurate and ethical technologies exist to replace animal testing (photo: NASA; source: Source Tox 21 NIEHS ).
Aristotle was among the first to perform experimentation on living animals in IVth Century BC.
Nowadays, animal models are mainly used to study human diseases, develop drugs and treatments, but also to assess the safety of chemicals before they enter the market.
Every year in the EU, about 10 million animals are used for the first time in research facilities (source: European Commission).
Transgenic animals are even bred to study gene functions or the contribution of genetic alterations to the development of diseases.
Highly criticized by citizens and animal protection activitists, animal models often fail to accurately predict risks to human health due to interspecies differences (source: EU Barometer 2016).
A new drug can take 10-15 years and billion € to be developed, yet, 92% drugs that pass animal tests fail in human (source: US National Institute of Health)
This represents a tremendous waste of public money, time and hope for patients, and unnecessary animal suffering and killing.
New Approach Methods (NAMs), non-animal models are revolutionizing toxicology and healthcare.
NAMs include sophisticated tests using human cells and tissues, organoids, multiphysiological systems and organ-on-a-chip (in vitro methods) and advanced computer-modeling techniques (in silico models).
Able to mimic the functioning of an organ or an organism, such as this beating mini hearth (source: Science; photo: The Mendjan Lab), these models allow to better predict risks and benefits to human health.
These human centric approaches also allow to study genetic variation between humans to accelerate precision medicine and toxicology.
NAMs promise to advance towards precision toxicology by accelerating and improving the identification of harmful chemicals and by bridging the gap between humans and other species.
And as we still need to study animals, NAMs can also be created to replicate animal organ-on-a-chip.
NAMs can not only be used to safeguard human health, but also to protect animals and the environment.