Unauthorised trials, partly conducted in a French abbey, of hormone-steeped skin patches on hundreds of sufferers of Parkinson's, Alzheimer's and other neurological diseases, were on Friday condemned as "a scandal" by the country's health minister who promised legal action.
France's ANSM medical watchdog on Thursday urged participants who took part in the unauthorised trial to stop using the patches immediately, saying the suitability of the tests was unknown. It urged them to visit their doctor for a health check and slammed the trials as "illegal practices."
"It's really a scandal. I think there will be legal action, we are taking it to a prosecutor," said Health Minister Agnes Buzyn, after news emerged of the medical trials at an abbey near the western city of Poitiers.
The "in the wild" clinical trials were performed on some 350 patients the ANSM declared them illegal and is itself taking legal action.
The tests were conducted by a body called the Josefa Fund, whose vice-president, medical doctor Henri Joyeux, is known in the medical community for his anti-vaccine stance.
ANSM director of inspections Bernard Celli said Friday the discovery of such a trial was "very rare, the more so on such a scale." He added that it constituted a "serious attack on the public health code and the penal code".
- Authorities 'were told' -
Joyeux, 74, told AFP that the trial was "nothing like a clinical trial." Rather, he told broadcaster BFMTV, it "is a preliminary scientific trial ahead of a clinical study which will be called for by year end. The ANSM knows that full well."
Joyeux added that "professor Jean-Bernard Fourtillan, who discovered the sleep hormone, valentonin, wrote on June 22 to the ANSM to tell them. Either they did not read the letter or they read it wrongly. That's all."
The Josefa Fund, on its website makes the unfounded claim that: "The causes and the treatment of Alzheimer's disease have finally been discovered". It says its patch containing 400 microgrammes of valentonin and 100 microgrammes of 6-methoxy-harmalan "should improve sleep and cognitive skills if it is not too late."
It makes similar claims for Parkinson's disease, an array of sleep disorders, depression and "psychotic states".
The site describes valentonin as "the night and sleep hormone" and 6-methoxy-harmalan as "the daytime, wakefulness and consciousness hormone".
On Thursday, the ANSM stated that the two molecules were closely related to melatonin, a hormone that can be prescribed to aid sleep. But it is not recommended for certain groups of people due to possible side-effects.
Professor Fourtillan says on the website of the Josefa Fund -- which describes itself as "a non-profit endowment fund" that valentonin "protects the body and ensures the regulation of the psychic and vegetative lives"
But the ANSM warned Thursday that "a risk to the health of the trial participants cannot be excluded" and urged them to keep their discarded skin patches for analysis.
The health ministry meanwhile alleged trial organisers had told participants not to tell their doctor that they were taking part in the test.
Celli stressed that carrying out such tests without authorisation carried a possible 5,000 euro ($16,500) fine and a year in prison.
ANSM discovered the tests following an inspection in early September of the laboratory where the blood samples were sent for analysis.
Unauthorised trials, partly conducted in a French abbey, of hormone-steeped skin patches on hundreds of sufferers of Parkinson’s, Alzheimer’s and other neurological diseases, were on Friday condemned as “a scandal” by the country’s health minister who promised legal action.
France’s ANSM medical watchdog on Thursday urged participants who took part in the unauthorised trial to stop using the patches immediately, saying the suitability of the tests was unknown. It urged them to visit their doctor for a health check and slammed the trials as “illegal practices.”
“It’s really a scandal. I think there will be legal action, we are taking it to a prosecutor,” said Health Minister Agnes Buzyn, after news emerged of the medical trials at an abbey near the western city of Poitiers.
The “in the wild” clinical trials were performed on some 350 patients the ANSM declared them illegal and is itself taking legal action.
The tests were conducted by a body called the Josefa Fund, whose vice-president, medical doctor Henri Joyeux, is known in the medical community for his anti-vaccine stance.
ANSM director of inspections Bernard Celli said Friday the discovery of such a trial was “very rare, the more so on such a scale.” He added that it constituted a “serious attack on the public health code and the penal code”.
– Authorities ‘were told’ –
Joyeux, 74, told AFP that the trial was “nothing like a clinical trial.” Rather, he told broadcaster BFMTV, it “is a preliminary scientific trial ahead of a clinical study which will be called for by year end. The ANSM knows that full well.”
Joyeux added that “professor Jean-Bernard Fourtillan, who discovered the sleep hormone, valentonin, wrote on June 22 to the ANSM to tell them. Either they did not read the letter or they read it wrongly. That’s all.”
The Josefa Fund, on its website makes the unfounded claim that: “The causes and the treatment of Alzheimer’s disease have finally been discovered”. It says its patch containing 400 microgrammes of valentonin and 100 microgrammes of 6-methoxy-harmalan “should improve sleep and cognitive skills if it is not too late.”
It makes similar claims for Parkinson’s disease, an array of sleep disorders, depression and “psychotic states”.
The site describes valentonin as “the night and sleep hormone” and 6-methoxy-harmalan as “the daytime, wakefulness and consciousness hormone”.
On Thursday, the ANSM stated that the two molecules were closely related to melatonin, a hormone that can be prescribed to aid sleep. But it is not recommended for certain groups of people due to possible side-effects.
Professor Fourtillan says on the website of the Josefa Fund — which describes itself as “a non-profit endowment fund” that valentonin “protects the body and ensures the regulation of the psychic and vegetative lives”
But the ANSM warned Thursday that “a risk to the health of the trial participants cannot be excluded” and urged them to keep their discarded skin patches for analysis.
The health ministry meanwhile alleged trial organisers had told participants not to tell their doctor that they were taking part in the test.
Celli stressed that carrying out such tests without authorisation carried a possible 5,000 euro ($16,500) fine and a year in prison.
ANSM discovered the tests following an inspection in early September of the laboratory where the blood samples were sent for analysis.
