This Non-Profit Organisation Conducted Illegal Clinical Trials On Over 350 Patients

This Non-Profit Organisation Conducted Illegal Clinical Trials On Over 350 Patients

At least 350 patients were illegally recruited by members of a non-profit called the Josefa Fund to test skin patches that deliver a melatonin derivative. The case has been brought before the courts.

This just might be the most surreal story of the year. In the Poitou region, several hundred Parkinson's and Alzheimer's patients were illegally recruited by members of a non-profit called the Josefa Fund to test a new melatonin derivative treatment. in a monastery. A patient told his doctor, who then alerted the ANSM, and the case was immediately brought to court. The Paris prosecutor's office's health unit is investigating the matter, according to Le Figaro.

A totally illegal treatment

"We discovered that at least 350 people were recruited to participate in an experiment to test skin patches that deliver valentonin, a derivative of melatonin, the sleep hormone. The aim of the experiment was to treat serious diseases such as Alzheimer's or Parkinson's. The trial was conducted without any authorization, illegally, and with no knowledge of the effects of these substances," explains Bernard Celli, the ANSM's inspection director. "A risk to the health of the participants cannot be excluded." Especially considering that the patients were asked to stop their usual treatment for the duration of the trial. "This can lead to serious complications," says Professor Philippe Damier, a neurologist at the University Hospital of Nantes.

Who conducted these experiments?

A non-profit called the Josefa Fund is at the head of this strange project. On its website, this rather mystical fund is described as a "spiritual foundation," and claims that neurodegenerative diseases like Alzheimer's or Parkinson's are caused by a "sleep/wake system." Hence the use of melatonin patches. "This is borderline charlatanism," warns the ANSM. Anne Josso, secretary-general of Miviludes (a government agency that detects sects), says that the task force that fights against sectarian deviances had already reported this fund's "disturbing" activities in December 2018.

The president of the fund is a "chemical engineer and pharmacist" (according to his online CV), Professor Jean-Bernard Fourtillan, 76. And the vice president is none other than professor Henri Joyeux, who is known for his controversial stance on vaccines.

Where did these experiments take place?

A part of these "informal" experiments took place in a monastery, the Sainte-Croix abbey in Saint-Benoît, near Poitiers. "Some patients stayed there overnight," says Bernard Celli. These patients were given the hormone patch in the evening, then had their blood drawn in the morning. The ANSM was able to trace back to this trial thanks to the recent investigation of a laboratory that collected the blood samples. Participants were reportedly asked to make a donation to the Josefa Fund. "We'll get to the bottom of this," says the ANSM.

Is the treatment effective?

The danger of these experiments lies mainly in the fact that this treatment is not at all certified, recommended or verified by the scientific community. "Neither the quality nor the effects nor the tolerance of the substances used (Valentonine and 6-methoxy-harmalan) are known," repeats the ANSM. "Tests have shown results on cell models but there is no scientific data on humans," says Philippe Damier. According to the neurologist, such practices "take advantage of the distress that patients who suffer from incurable diseases feel."

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What should the patients do?

But what about the patients who have undergone this treatment? The ANSM urges Professor Jean-Bernard Fourtillan to stop this trial and inform every participant of its prohibition. The foundation has eight days to provide evidence that it has informed those concerned. "Patients must stop using these patches," says Bernard Celli, director of inspection. They must promptly inform their doctor of the situation and get a check-up.

Nancy Youm
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