Mrs. Marisol Touraine
\nMinister of Social Affairs, Health and Women’s Rights
\n14, avenue Duquesne
\n75350 PARIS 07 SP<\/p>\n
Paris, January 20, 2016<\/p>\n
OPEN LETTER The drama of the clinical trial in Rennes, was “an event of extreme gravity,” according to you. In The concept of such a “model”in biology, is pure fiction: no species is a biological model for<\/em> So should we stop testing drugs? Of course not ! But the only valid way to study a human is (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 (2) the use of ‘mini organs\u201d generated from induced pluripotent stem cells (mini brain, mini liver, mini kidney, etc.), whose reactions to the experimental drug would subsequently be analysed by
\n<\/span>
\nDear Minister of Health,<\/p>\n
\nfact, this is just one more example \u2013 albeit highly sensational \u2013 of the tens of thousands of adverse
\ndrug reactions seen in France every year. According to one of your predecessors, Mr Bernard
\nKouchner, 1997 saw 20 000 deaths and 1.3 million hospitalisations in France due to the side effects<\/em>
\n of drugs<\/em>, all of which had been “successfully\u201d tested on \u201canimal models\u201d. The one and only reason
\nfor this carnage, including the drama in Rennes, is blind faith by a healthcare system that continues
\nto rely on animal data for human health.<\/p>\n
\n another<\/em>. The proof lies in the very definition of what constitutes a species, in terms of its
\nreproductive isolation (male and female gametes cannot recombine if they do not come from the
\nsame species). Since the genetic make up of every species is unique, each species will react to
\nillness or environmental factors based on its unique genetic make up, so there is no scientific reason
\nto expect a dog to react in the same way as a monkey to a new drug, nor for a dog or a monkey to
\nreact in the same way as a human. We should heed this scientific evidence if we want to prevent
\ntragedies of the sort that made headlines in Rennes, in addition to the tens of thousands of
\nunannounced deaths every year, all victims of drug side effects. You are surely aware of the exact
\nnumber of deaths via your pharmacovigilance services, but we realise that these statistics are kept
\nsecret from the public as our repeated requests to receive them have all been ignored.<\/p>\n
\nthrough the study of biological material of human origin. In addition, a Phase 0 trial should take
\nplace before embarking on the clinical phases 1, 2, 3 and 4. The Phase 0 trial would consist of:<\/p>\n
\nhuman cell lines (representing all the different cell types in the human body). This test is a first
\nscreen to indicate which organs may be affected, which genes may be deregulated by the candidate
\ndrug, and which pathological pathways may be induced;<\/p>\n
\ngenomic studies as described above.<\/p>\n