Comment // Coronavirus

Animal testing makes way for human testing

This article originally appeared in German and is translated and published with permission.

As reported by the prestigious journal Science, Congress has exempted the US Food and Drug Administration (FDA)—the world's trendsetter in this field—from the obligation to conduct animal experiments before testing drugs in humans.

Animal rights organisations are ecstatic. But what is behind the decision? And does this mean that humans can now legally be used as the proverbial "guinea pigs"? Unfortunately, it does. But let's take a closer look at the problem.

Clinical trials are human trials that are necessary to test pharmaceuticals for their efficacy and safety before they are approved and administered en masse to the human population. Pharmakon in ancient Greek means both "poison" and "remedy". From Paracelsus comes the aphoristic insight Dosis sola facit venenum: the dose alone makes for toxicity.

Thus, we need human trials to determine the correct dosage of pharmaceuticals and to study how they are distributed, metabolised and excreted or deposited in the body; how long they need to take effect (pharmacokinetics); how they work; and what undesirable effects they have (pharmacodynamics).

The process of studying pharmaceuticals in humans is roughly divided into three phases. Phase I serves to establish basic safety, the dose-response relationship and pharmacokinetics. Phase II is for the initial demonstration of an effect and further investigation of drug safety and aspects of pharmacokinetics. It is at this phase that most drugs are failed, owing to insufficient efficacy or toxicity.

Phase III serves to demonstrate efficacy and safety in larger samples and to generate empirical evidence to support the indications for using the drug. Animal trials serve to reduce the burden of human trials. That burden always consists of toxicity leading to the death of the subjects or chronic damage to them, taking such forms as destruction of the kidneys, chronic liver damage, heart muscle damage, damage to the nervous system or autoimmune disease—all forms of internal crippling.


The purpose of animal experiments

In this context, animal experiments have the task of modelling to anticipate pharmacokinetics and dynamics in humans. Of course, the models are not perfect, especially since it is chiefly mice, rats, fish and birds that are used for the experiments, with large mammals only accounting for just over 3 per cent of all experiments and 1.6 per cent of all fatal outcomes. From a pharmacological point of view, not using large mammals—especially prosimians and monkeys—is a problem, as it is the data developed in these models that most closely corresponds to the conditions in humans. We return to this problem below.

According to the Federal Institute for Risk Assessment, a total of 1.8 million animals were used for experimental purposes in Germany in 2021, and 644,000 were killed. This includes basic and pharmaceutical research—but a large share of the use of rodents, which combined account for 80 per cent of experiments and over 90 per cent of fatal outcomes, is certainly due to pharmaceutical testing.

So doesn't the abandonment of animal testing qualify as progress?

Animal experiments are used not only to determine the dose, the relationship of dose to effect, and the therapeutic range of pharmaceuticals, but also to determine pharmacokinetics and toxicity. If animal experiments are done away with, toxicity will only become apparent in humans, and more people will consequently be harmed by death or crippling in the trials in humans.

Yet Science claims in the aforementioned article that it is possible to avoid animal experiments by using computer models and what are known as organ simulation chips, in which cell cultures or clusters of cells (so-called micro-organs) are embedded in silicone apparatuses whereby they are supplied with nutrients and oxygen through artificial capillaries, and are thus supposedly even better at determining pharmacological parameters.

This is flat-out wrong. Currently existing methods are not capable of adequately and synoptically reproducing the complex system of the mammalian organism. Here, "adequate" means capable of meeting the requirements for the emulation—in this case, the transferability of the pharmacological results to the situation in the animal—and "synoptic" (literally meaning "whole view") refers to the comprehensiveness of the model.

That is to say that neither the simulation in the computer nor the emulation in the organ model can tell us what pharmacokinetics and dynamics will look like in the organism. How could they?


Renouncing pseudo-innovation

We know far too little about the complex pharmacology in organisms to be able to represent it mathematically in computer models. The available models cover very small areas of pharmacology, and only with rough approximation. And how is a silicon apparatus with pseudo-capillaries and cells grown in vitro supposed to capture how drugs are distributed and how they will affect the thousands of different cell types and hundreds of organs or organ function areas that exist in the body? That is an impossibility.

It is true that animal experiments are also only predictive for humans to a limited extent, especially because the mouse models [laboratory mice] that we use are highly overbred and genetically homogenised, so that their distance from human wild-type populations is significantly greater than that of real mice living in the wild. This is why toxic effects that have not been observed in animals will still crop up regularly in human trials.

The problem is not animal testing per se, but that the biopharma industry is dominated by testing and by the approval of agents that either show little to no clinical efficacy or are used in populations that could do without them (such as terminal cancer patients). Most of the agents that are approved as new drugs today started out in one of these groups.

If we dispensed with such pseudo-innovation and only sought to bring compounds into clinical practice that really do have a major clinical benefit, we could afford to test these drugs in monkeys, yielding results much more predictive for humans than tests in mice and rats are.

If, on the other hand, we omit testing on animals, then we are simply harming more people by killing or seriously injuring them in the human experiments that we call clinical trials.


The bigger picture

However, we now know something else: that regulators are not only willing to forego animal testing but also to ignore the deaths and injuries that occur in clinical trials with inadequate preparation. Even though Pfizer/BioNTech's, AstraZeneca's and Moderna's regulatory submissions for the SARS–CoV–2 "immunisations" had conclusively shown that the nucleic acid injections used for immunisation were harmful and clinically ineffective, they were nevertheless approved, ignoring the warning signals thrown up by the studies and the important drug safety systems at the CDC, MHRA and Germany's BfARM/Paul-Ehrlich-Institut.

Such practice continues to this day; the president of the Swiss Federal Commission for Vaccination Affairs, for example, knowingly lied again on 22 January 2023, asserting that the "vaccines" were safe and effective overall, despite severe side effects.

In other words, if the precedent set by the SARS–CoV–2 nucleic acid injections persists, our governments will be demonstrating their preparedness to abandon animal testing in drug research and thus to ignore the deaths and maimings that result from this practice—and to promote, pay for and advertise the mass administration of toxins.

How can this be explained? A new article in The Lancet gives us important clues. The renowned team of authors puts the medical needs of humans on a level with those of animals and seems to play down the special legal and moral position of humans which is anchored in our culture and is also the basis of human rights.

For the authors, animal and human welfare are of equal import. They call for the abolition of national regulation, for an end to the separation between human and veterinary medicine, and for the WHO's One Health programme to prepared the for further pandemics. This is to be done primarily through a massive expansion of vaccination programmes for animals and humans—to the advantage of the pharmaceutical industry, at the expense of human and animal health, which is exclusively harmed by nucleic acid therapies (see my response to a reader's query, point 4).

In doing so, they argue in the tradition of Peter Singer, whose 1975 book Animal Liberation was the first to call for the treatment of animals to be brought into line with that of humans and who first popularised veganism. The new legislation by Congress and the ideas of One Health seem to have taken up this view and radicalised it. But are they really serving animal welfare by doing so? I beg to differ; they are serving the good of the pharmaceutical industry, no matter how many human lives it costs. We are witnessing a demolition of human rights across the board.