It’s time to humanize European health research with an action plan – POLITICO

European Transport Commissioner Adina-Ioana Vălean recently told the European Parliament that “the Commission is convinced that animal testing should be phased out in Europe”. MEPs agreed, suggesting that there is a broad consensus among EU institutions on the scientific and ethical benefits of replacing the use of animals in safety science and health research.

However, during this exchange, strong differences emerged as to how to achieve this goal.

MEP Katalin Cseh called for “a credible plan with measures and targets” to replace animal testing, to which the Commission replied that it “was working towards this objective notably by means of the directive on the protection of animals in science “and that this made” additional strategy documents and actions redundant “.

To this, MEP Tilly Metz replied that the 2010 European directive dealing with the protection of animals used for scientific purposes was “one of the strictest laws in the world”, but “it does not provide a clear strategy. for the transition to innovation without the use of animals. “

Our decline in animal use is so slow that at this rate around 1.3 million animals per year would still be used in the EU at the turn of the 22nd century!

The results of this lack of strategy are clear. EU statistical reports on animals used in scientific research published annually since 2015 show that our decline in animal use is so slow (around 2.3 percent per year) that at this rate, around 1.3 million animals per year would still be used in the EU at the turn of the 22nd century!

In September, Parliament will vote on a resolution asking the Commission to prepare an action plan to phase out the use of animals in experiments in the EU.

Such a plan is necessary because, despite all the progressive animal welfare language embedded in European legislation and impressive advances in science and technology, our product safety regulations and health research are still largely entrenched. in archaic approaches using millions of animals every year.

For example, in 2021, the most frequently performed animal tests in Europe are variations of the “50% lethal dose” procedure developed in 1927 which refers to the dose of a chemical given at one time that kills 50% of a group of test animals.

And current “state-of-the-art” animal models for testing the effectiveness of a new antidepressant drug involve forcing mice to swim or hang upside down by their tails. stop trying to escape.

With a system based on the 19th century presumption that mice and other animals are miniature humans who respond exactly like us to drugs and disease (history has shown this is often not the case), is- is it any wonder that over 90 percent of drugs that pass animal testing fail human clinical trials?

It is time to humanize European health research and safety science.

It is time to humanize European health research and safety science by making human biology, rather than rodent biology, the “gold standard”.

The toolbox of advanced non-animal technologies and predictive biology approaches ready to join the scientific and regulatory mainstream include:

  • microphysiological systems such as organ on a chip, to treat health problems such as lung and heart disease as well as personalized medicine;
  • 3D organoids that have been used, among other things, to study the effects of viruses such as Zika and COVID-19 on the brain and to test the effects of available drugs to accelerate the availability of existing treatments;
  • induced pluripotent stem cells which are widely used for everything from disease modeling to drug discovery to all kinds of chemical toxicity;
  • computer or in-silico models used to predict the physical properties of chemicals, such as genotoxicity and protein reactivity, metabolism and movement in the body;
  • integrated or “next generation” approaches that combine non-animal methods based on biological assumptions.

These methods focus on obtaining data based on human biology and, as such, have the potential to produce results that are more relevant to human health than animal models.

Better understanding the biology behind human disease and toxicity brings us closer to personalized medicine tailored to each patient’s specific genetic traits – or even using bioprinting to grow living human organs to from the cells of patients who need it.

The EU cancer plan provides a prime example of how we could make these technologies the preferred choice for public funding. In its communication, the Commission based its hopes of saving millions of human lives on “the remarkable potential of new technologies” – in particular computational approaches, in order to “better fight cancer along the disease pathway “.

The Commission’s Joint Research Center has published a series of reports on advanced non-animal models, including for breast cancer, stating that “breast cancer research currently relies heavily on animal models, which however have limits for capturing important cancerous traits “. One of the main approaches recommended by the JRC to improve this is the use of human-induced pluripotent stem cells (iPSC).

How close is European cancer research and testing to achieving this vision? In 2019, EU-based researchers authored or co-authored more than 5,700 academic papers on cancer research from animal experiments. Only 67 used iPSCs and 154 used organoids, while in silico the methods are doing a little better with 634 articles.

It says a lot about the current state of affairs that a rodent test devised over half a century ago is still the gold standard for assessing the carcinogenicity of chemicals, despite decades of evidence from tests on hundreds of chemicals that the current rodent-based test fails to predict human results.

To change the paradigm, we need to reverse the relationship of dependence of largely animal data to largely non-animal data.

To change the paradigm, we need to reverse the ratio of reliance on largely animal data to largely non-animal data, starting with a concerted effort to reorient research funding. We can do this by identifying and funding animal models that lack human relevance and clinical translation; invest more in new technologies; train research and regulatory staff in their use; reform regulations; and bring together experts from the scientific community, regulated industries, NGOs and Member States with EU institutions to advance our common goals.

Nothing less than a comprehensive EU regulatory and research action plan is needed to achieve a paradigm shift within an acceptable time frame. In the September plenary, MEPs can lead the way by voting for the resolution to “accelerate a transition to innovation without using animals in research, regulatory testing and education”.

This chance is too great to be missed, for animals as well as for humans.

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