Right of reply of Professor Jean-Bernard FOURTILLAN
You will find below the official right of reply of Professor Jean-Bernard Fourtillan transmitted to the press and media on 22/10/2019.
Enjoy your reading.
"The JOSEFA FUND and I, who are its founder, were the object of a media explosion organized by the ANSM via the AFP, the day before the opening of the "MEDIATOR" trial in which she was seriously implicated.
The press as a whole used the terms "wild clinical trials", which were allegedly conducted by the JOSEFA FUND in an abbey, on patients suffering from sleep disorders, Parkinson's disease and Alzheimer's disease.
The press articles, including the one in this media, may have led them to believe that I had abused the weakness of the patients to inoculate them with products that were at worst dangerous, at best harmless, at best ineffective, by making them believe that they could relieve them of their suffering, all in order to determine them to make a financial commitment to the FUND over which I preside.
According to the press, patients were also told to hide the application of patches from their doctors and to stop their traditional treatment brutally (why not savagely?).
The "mystical accents" of the JOSEFA FUND website and the location of the "experiment" that almost suggested that patients would have been held against their will to undergo hazardous experiments finished painting the picture of the "horror and scandal" that the Minister of Health immediately afflicted herself on the air.
My attitude being dictated only by the fate of the patients, and noting that not a single journalist seemed to be interested in the scientific information given on the site, I initially preferred to let the media storm pass; it is now time to respond to the distorting allegations that have appeared, by explaining my discovery, and its applications.
My CV is easily accessible but it is necessary to remind you that I am a trained Chemical Engineer, Pharmacist, Hospital Pharmacist, Professor of Therapeutic Chemistry and Pharmacokinetics, at the Faculty of Medicine and Pharmacy of the University of Poitiers, and that I was for many years a Pharmacologist and Toxicologist Expert specialized in Pharmacokinetics (toxicokinetics) at the Ministry of Health.
Together with my wife, who is a pharmacist herself, I managed a biomedical research centre with a clinic and a bioanalysis laboratory that are among the world leaders in the determination of drugs in biological environments, by coupling gas or liquid chromatography with mass spectrometry.
It is undoubtedly these "transversal" skills that have enabled my discoveries.
While carrying out assay work on Melatonin in 1994, I discovered the hormone of sleep and night secreted by the pineal gland, which I named Valentonine (VLT), for which I filed patents.
Tested in nocturnal sleep animals, Valentonine has proven to be perfectly effective in triggering physiological sleep, having nothing to do with sleeping pills given very widely in France. To say how this hormone was not marketed at the time is not the purpose of this answer.
This "failure" allowed me to continue my research, and to discover the relationship of this hormone with 6-Methoxy-Harmalan (6-MH) and Melatonin (MLT).
The hormone 6-Methoxy-Harmalan (6-MH) was discovered in the pineal gland by American researchers in 1961 at a research centre that had discovered Melatonin (MLT) three years earlier. But the researchers did not then understand that it was actually the hormone of the day before and the day.
The three hormones produced by the pineal gland, Melatonin, 6-Methoxy-Harmalan and Valentonine, constitute a "biochemical cascade". They are formed successively from Serotonin by three successive enzymatic acetylations.
The two hormones 6-MH and VLT constitute the sleep-wake system that ensures the total regulation of the body's psychic and vegetative lives for 24 hours in all mammals and higher vertebrates. Until then, no one had ever been able to understand and explain the mechanisms by which people slept at night and woke up during the day.
From this discovery, I developed a patch that is used to transdermally release the two hormones VLT and 6-MH in a manner strictly identical to the secretion of the pineal gland during the night.
This patch is therefore used to treat patients with deficient pineal secretion and thus sleep disorders, nervous depressions, as well as neurodegenerative diseases of PARKINSON and ALZHEIMER.
In view of the results of the preclinical toxicokinetic studies confirming the total safety of transdermal patches that distribute natural hormones, I considered that, like Melatonin or many "comfortable patches" on the over-the-counter market, a Marketing Authorization from ANSM would not be required in the future, as these patches should be freely available.
I disclosed my discovery and its future therapeutic applications in a statement to the Academy of Pharmacy on December 2, 2015 with relative indifference, while it provides obvious solutions to diseases that have no cure.
By popularizing my discovery, many patients who understood it came closer to me in order to benefit from it, which I accepted. I informed them of the progress of the manufacture of the patch samples, the costs and the obstacles encountered, they know everything.
To the extent possible given the supply difficulties, the JOSEFA FUND has provided patches to a number of sick people. They are not presented as drugs and they are not regulatory, they are not for sale or open access.
Those who were able to benefit from sufficient samples, even over a limited period of time, have seen their condition change, I hope they will choose to testify, even if they have already done so anonymously on a website that we have dedicated to Valentonine. Others were waiting to benefit from a delivery of samples from the German manufacturer, now pending due to the decision of the ANSM.
It is the health of some and the hope of others that is being murdered, those responsible will take their responsibilities, at least morally I hope.
There is no "clinical trial" because there are no drugs but a natural substance that responsible people who have decided to take care of themselves have wished to take, there are no patches that would be sold "under the coat", there is no "wild trial" with ignorant guinea pigs in the hands of manipulative Professors, there is no "mistrust", there is no request to stop treatment or vow of silence, there is no room for MIVILUDES' statements.
There may be learned professors who do not know, and researchers who do not find, I am obviously at their disposal to explain to them, there is an urgent need for them to understand in the name of patient health.