Open letter to the French Minister of Health

Mrs. Marisol Touraine
Minister of Social Affairs, Health and Women’s Rights
14, avenue Duquesne
75350 PARIS 07 SP

Paris, January 20, 2016


Dear Minister of Health,

The drama of the clinical trial in Rennes, was “an event of extreme gravity,” according to you. In
fact, this is just one more example – albeit highly sensational – of the tens of thousands of adverse
drug reactions seen in France every year. According to one of your predecessors, Mr Bernard
Kouchner, 1997 saw 20 000 deaths and 1.3 million hospitalisations in France due to the side effects
of drugs, all of which had been “successfully” tested on “animal models”. The one and only reason
for this carnage, including the drama in Rennes, is blind faith by a healthcare system that continues
to rely on animal data for human health.

The concept of such a “model”in biology, is pure fiction: no species is a biological model for
another. The proof lies in the very definition of what constitutes a species, in terms of its
reproductive isolation (male and female gametes cannot recombine if they do not come from the
same species). Since the genetic make up of every species is unique, each species will react to
illness or environmental factors based on its unique genetic make up, so there is no scientific reason
to expect a dog to react in the same way as a monkey to a new drug, nor for a dog or a monkey to
react in the same way as a human. We should heed this scientific evidence if we want to prevent
tragedies of the sort that made headlines in Rennes, in addition to the tens of thousands of
unannounced deaths every year, all victims of drug side effects. You are surely aware of the exact
number of deaths via your pharmacovigilance services, but we realise that these statistics are kept
secret from the public as our repeated requests to receive them have all been ignored.

So should we stop testing drugs? Of course not ! But the only valid way to study a human is
through the study of biological material of human origin. In addition, a Phase 0 trial should take
place before embarking on the clinical phases 1, 2, 3 and 4. The Phase 0 trial would consist of:

(1) pharmacogenomics using induced pluripotent stem cells obtained from healthy individuals (with informed consent) of different sexes, ages and from different ethnic groups, applied to the 243
human cell lines (representing all the different cell types in the human body). This test is a first
screen to indicate which organs may be affected, which genes may be deregulated by the candidate
drug, and which pathological pathways may be induced;

(2) the use of ‘mini organs” generated from induced pluripotent stem cells (mini brain, mini liver, mini kidney, etc.), whose reactions to the experimental drug would subsequently be analysed by
genomic studies as described above.

These are just two examples of preclinical tests that are relevant and valid for the human body as
well as quick, affordable, and widely used in some countries. Channeling more resources into this
kind of genuine scientific research, instead of wasting precious funds on so-called “animal models”
will greatly help to avoid the tragedies caused by side effects and the personal sacrifice of healthy
volunteers who trusted the words of the research clinicians. If the latter were so confident of the
safety of the experimental drug, why did they not agree to try the drug on themselves?

We should by now acknowledge the fact that “animal models” have no value in terms of protecting
human health and often lead to medical disasters. It is therefore your responsibility as Minister of
Health to end without delay the use of these so-called “models”. If you fail to take any action, you
will put yourself in the same position as a former Health Minister who was convicted in connection
with the tainted blood scandal.

Yours faithfully,

Claude Reiss
President Antidote Europe