Paris, January 20, 2016 – Following the clinical trial disaster of the experimental drug BIA 10-2474,
Antidote Europe has sent an open letter to the French Minister of Health, Mrs Marisol Touraine,
questioning the practice of recruiting healthy volunteers for drug trials (1).
Testing experimental drugs on healthy individuals is both scientifically and legally questionable.
From a scientific perspective, a healthy body is not a reliable model to test drugs intended for sick
people. In the same way that chemotherapy is not tested on healthy people, given the serious side
effects, we should not test new drugs in healthy individuals. The Phase 1 clinical trial is thus a
dubious concept as well as a dangerous shortcut as a means of obtaining human data.
Why ? Because the tests performed on animals (a rodent and non-rodent species according to
existing law) prior to the clinical trials are not predictive for humans. The animal tests are irrelevant
with respect to protecting human health. According to the US Food and Drug Administration, more
than 90% of experimental drugs found to be safe in animals, subsequently prove too toxic or
ineffective when tested in humans.
Animal tests persist because they are required by legislation that is 70 years out of date with current
scientific knowledge, such as the human genome. Regulatory authorities continue to demand animal
data whilst the submission of human data obtained through modern research methods, such as
pharmacogenomics, remains optional.
With regard to recruiting healthy individuals in Phase 1 trials, it is important to distinguish between
“legal consent” (the act of signing an informed consent document) and “valid consent”. Neither the
researchers, nor the healthy individuals taking part in a Phase 1 clinical trial, are aware of all the
risks associated with a new drug, which puts valid consent in doubt.
Whilst a sick person may have something to gain by taking an experimental drug, healthy
individuals stand to lose everything, including their lives. It is time to revise the legal framework
of early clinical trials.
Andre Menache 0044-7906-446889