Paris (AFP)

Molecules with unknown effects, tested on at least 350 Parkinson's or Alzheimer's patients, in an abbey and outside any legal framework: a "wild clinical trial" of a rare magnitude was banned Thursday by the French Medicines Agency (ANSM) ).

This "illegal" trial was led by a structure called the Josefa Fund, whose vice president is Pr Henri Joyeux, challenged by the medical community especially because of its anti-vaccine positions.

In addition to the ban, which falls under a health policy decision, "the ANSM has also seized justice," she said in a statement.

It is the health unit of the public prosecutor's office of Paris which has been seized, specifies with AFP Bernard Celli, director of the inspection with the ANSM.

Discovering such a "wild clinical trial" is "very rare, especially when of this magnitude", says Mr. Celli, according to which it is "a serious violation of the code of public health and the Penal Code".

"We are on the edge of quackery", he believes, judging that "the trust of these patients has been abused".

Joined on the phone by AFP, Pr Joyeux says that "it has nothing to do with a clinical trial", refusing to say more.

The experiment consisted in applying to patients patches containing two molecules, called valentonine and 6-methoxy-harmalan, in the hope of treating several neurological diseases (Parkinson's, Alzheimer's, sleep disorders ...).

According to the ANSM, these molecules are close to melatonin, a hormone frequently used to sleep better but not recommended for certain populations by the health agency ANSES because of side effects.

On the website of Josefa Fund, its founder, Professor Jean-Bernard Fourtillan, claims the discovery of valentonine, supposed to "protect our body and ensure the regulation of psychic and vegetative life".

"The quality, the effects and the tolerance of these substances are not known" and "a risk for the health of the participants can not be excluded", replica the ANSM.

The Agency asks the participants of these tests "to stop using these patches" and "to consult quickly (their) doctor to inform him of the situation, carry out a health check and ensure that the management of (their) illness is adequate ".

- Inspection inspection -

According to Mr. Celli, many patients were received in an abbey near Poitiers, the Abbey of St. Croix.

"It seems they spent one night there and they had a blood test in the morning," he says.

According to its website, the Abbey of St. Croix was founded in 552 in Poitiers by St. Radegonde, the Queen of the Franks, but the monastery was transferred in 1965 in the village of St. Benedict, 7 km away .

The community welcomes "hosts" to whom it offers activities and with whom they share "the French psalmody of the liturgy". The Benedictines live from the manufacture of hosts and the sale of local products.

According to Sister Martina, sister hotel of the monastery attached to the phone by AFP, "the abbey has about fifteen rooms and it's been about a year" they serve to accommodate patients of this clinical trial. Nine nuns live there.

Sister Martina assures that there was no search of the abbey.

Conducting a clinical trial without authorization is punishable by a fine of 15,000 euros and one year in prison, according to Mr. Celli, not to mention the possible penalties in the penal code.

The ANSM discovered this illegal test thanks to a control inspection conducted at the beginning of September in the laboratory where the blood samples were sent for analysis.

On its website, the Josefa Fund is presented as a "non-profit endowment fund", to which "the intellectual property rights of drug patents" have been transferred (...) based on the molecules tested at the time. illegal test.

It owes its name to a Spanish Catholic nun, sister Josefa Menéndez, who died in 1923 in Poitiers.

© 2019 AFP