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Supplements, that fine line between communication and misleading advertising

Integratori, quel confine sottile tra comunicazione e pubblicità ingannevoleRome, 16 May - In times in which supplements and nutraceuticals are acquiring growing weight in the economy of community pharmacies, at least partially making up for the moonshine originating from the negative trend of contracted pharmaceuticals, the story of Trigno M, a supplement based on blackthorn and amino acids advertised as an adjuvant in oncological problems, certainly deserves to be brought to attention as a paradigm of how these products move in a sort of borderland where it is easy and far from infrequent that communication and misleading advertising become difficult to distinguish.

To deal with the product based on the extract Prunus spinosa, hit the headlines thanks also to a conference held at the end of June 2015 within the Milan Expo, during which its (alleged) anti-proliferative and anti-cancer properties were announced, which emerged after two years of research, is the site Today Scienceand with an article published on May 13 from one of his best-known columns, significantly entitled The buffalo park.

So what does he write TodayScience on the product obtained from a variety of wild blackthorn widespread in Molise? First, it contextualizes it, calling ainterview to an ISS researcher,  Andrew Savarino, author of a review published by Journal of Clinical Investigation on the (paradoxical) benefits of oxidative stress and the risks of antioxidants, to which preventive and therapeutic properties continue to be attributed, despite the National Cancer Institute US has already underlined how many randomized and controlled trials with a placebo have failed to demonstrate these (alleged) beneficial effects and, indeed, toSome of the larger clinical trials had to be halted because patients receiving antioxidants had a higher incidence of cancer than those who did not. 

Tracked the scope, Buffalo Park goes further and tells the story of the "legitimization" of the Molise blackthorn-based nutraceutical, starting from the end, i.e. a conference held just a few days ago in Milan, organized by Simeb, the Italian Society of Biointegrated Medicine and dedicated to the topic “New perspectives in Oncophytotherapy”.

Among the speakers of the appointment, the name of stands out  Stephanie Meschini, researcher of the Department of Technologies and Health of the Higher Institute of Health, who already in the past - in similar situations (the "oncophytotherapy" conferences, whatever the meaning of the term, have been taking place around Italy since April 2015 ) – had had the opportunity to illustrate the contents of one of his studies “being published in scientific journals, as reported also by launches of the Ansa agency.

What did Meschini say? Undoubtedly very relevant stories, such as that of having treated with the extract of wild sloe from Molise, during a "laboratory experimentation […] cancer cells from patients suffering from colon, lung and cervical cancer. We therefore observed that, alone, the extract had no effects, but added to a particular complex based on amino acids, minerals and vitamins, called Can, was able to reduce the survival of cancer cells and led to destruction among 70 and 78% of cancer cells in 24 hours”.

In short, a lot of stuff, even if – as the researcher underlined – the experimentation is only at the beginning and further studies are needed, first of all the transition ”to the animal testing phase, with the aim of producing a new anticancer drug within a few years".  

To reiterate the need for the utmost caution with regard to claims on the efficacy, on a clinical level, of the complex object of the research, thought Walter Ricciardi, now president and then extraordinary commissioner of the ISS, probably worried by the hype media that began to mount on the blackthorn of Molise capable of curing cancer:

On the other hand, the Biogroup company was decidedly less cautious, which collaborated in the study for the development of a supplement capable of improving the quality of life of cancer patients: although the research announced by Meschini had not (and has not) yet known the glories of publication, the integrator Trigno M was put up for free sale last October with the indication “targeted anti-neoplastic action”. Only a month later, in November, Franco Mastrodonato, iridologist-naturopath-homeopath president of the aforementioned Italian Society of Integrated Bio Medicine, announced that "about 2,000 patients affected by serious forms of tumours” they were already taking it sometimes with “amazing improvements”.

That's not all, according to what he says Buffalo Park: less than a month ago, on April 21, a committee of specialists (including Meschini herself) to fine-tune the scientific, logistic and regulatory details regarding the "in vivo" experimentation on humans of the Trigno M, experimentation which – strictly speaking – should therefore be close to the beginning.

Just this latest announcement has made the column suspicious TodayScience, whose curator (or "keeper", as she likes to call herself) Sylvie Coyaud, he immediately asked the ISS for guidance, writing to President Ricciardi and the press office. Coyaud's request is very simple: how is it that despite the fact that PubMed does not contain any reference to research on the reduction of tumors, relapses and metastases thanks to blackthorn and amino acids, an experimentation on humans is about to start? The ISS was able to provide some data confirming the alleged "targeted action" of the Trigno M What about Mastrodonato's statements?

The first response from the ISS press office was forthcoming: only the observations had been made at the Institute in vitro preliminary to an experiment live on the animals for which he was requesting the various authorizations. The study was not publishable because a patent extension had been requested and regarding claims of its efficacy in humans, "the institute is not aware of nor is currently participating in any study that demonstrates the efficacy or therapeutic role of the supplement in humans as part of a clinical trial protocol Trigno Min anticancer therapies.

In short, a substantial denial, unusually diligent. Which prompted Buffalo Park has raised another immediate question about the intentions of the ISS, once aware of the fact that the Trigno M it is in practice sold as an anti-neoplastic drug.

A question that also received a prompt response: the General Directorate of the ISS has already ordered the necessary measures. And indeed, on the Biogroup site about the supplement Trigno M the wording "targeted anti-neoplastic effect”, nor indications relating to the therapeutic use of the treatment of tumours.

Buffalo Park gives an account of the story, complimenting the ISS for the diligence shown on the occasion and wondering if it might not also be the case to ask about the Trigno M (but more generally on the "therapeutic" effects of other antioxidants, it being known that if these products "really drain the toxins - all of them, just to expand the market - they would also drain the real drugs") other subjects, starting from the Italian Medicines Agency, the Competition and Market Authority and consumer protection associations.

Ref Day 16 May 2016

Related news: Trigno M. The ISS specifies: "The anti-tumor action of this supplement on humans has never been supported"

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