French health authorities have shut down a rogue and what they describe as an “in the wild” clinical trial involving 350 participants, conducted in a western French abbey. While running this illicit test of hormone-steeped skin patches on hundreds of Parkinson’s and Alzeheimer’s disease patients, the ANSM found out about the study, conducted an inspection and shut the study down. The quacks responsible are in serious trouble.
An unauthorized clinical trial was organized in the western French city of Poitiers with a focus on testing an unauthorized investigational product involving valentonin. The sponsor, Josefa Fund, received no authorization from ANSM. Bernard Celli, Director of Inspections at ANSM, reported that the discovery of such a trial was “very rare, the more so on such a scale.” He noted that it represented a “serious attack on the public health code and the penal code.” Health Minister Agnes Buzyn declared “It’s really a scandal. I think there will be legal action, we are taking it to a prosecutor.” The French government will possibly seek fines and even up to one year of prison time.
Who is the Josefa Fund?
Josefa Fund is a non profit organization also based in Poitiers France. They were founded by Jean-Bernard Fourtillan and Henri Joyeux, who actually was conducting the clinical trial. Mr. Joyeux is apparently known in French circles to represent part of the anti-vaccine movement but TrialSite News cannot verify that data. The Josefa Fund has a management and 15 advisory committee members—are they aware of what their organization was doing?
Mr. Joyeux reported to AFP that the trial was “nothing like a clinical trial.” He argued to a BFMTV broadcaster that it “is a preliminary scientific trial ahead of a clinical study which will be called for by year end. The ANSM knows that very well” Mr. Joyeux proclaimed. Moreover, he further commented that professor Jean-Bernard Fourtillan, the investor of the sleep hormone, valentonin, communicated with French authorities (ANSM) ahead of time. He claims that “either they did not read the letter or they read it wrongly. That’s all.”
If that was the case, why would the French authorities do an unannounced inspection? Why wouldn’t the quacks have the proof they secured the legal authorization in France to conduct a human study? Moreover, why would the trial organization tell the participants in the study not to disclose to their physician that they were participating in the clinical trial?
Josefa Fund Claims
The Josefa Fund claims on its website that they have developed a cure for Alzheimer’s disease in the form of a hormone infused patient—containing 400 micrograms of valentonin and 100 micrograms of 6-methoxy-harmalan. They make other unfounded claims that they can cure sleep problems and other central nervous system-based disorders.
Dr. Fourtillan has filed a patent application involving an “invention” relating to an adhesive transdermal therapeutic system containing, as an active ingredient, an association of valentonin (VLT) and 6-methoxyharmalan (6-MH).
Patients: Use Critical Thinking
Quacks and hucksters pray on the desperate and vulnerable. For example, for those that are sick and facing imminent decline with Parkinson’s, many patients are in a vulnerable position that are often exploited by medical fraudsters such as the Josefa Fund crew. Patients must think carefully—major biopharmaceutical companies spend hundreds of millions to billions on therapeutic areas such as Alzheimer’s disease and the race for treatments are still elusive. If the largest, best capitalized companies haven’t been able to find a cure then an obscure foundation in a small western city in France won’t have the elusive prize either.
Call to Acton: If you are a patient, absolutely never join a clinical trial unless your physician has reviewed and approved the participation. Clinical trials around the world must be authorized by the appropriate health authority. Be mindful that there are medical quacks running amok that seek your time and money.Source: France24