As the Olympic Games approach, a curious little piece of plastic has appeared on the bodies of athletes. A “painkiller” patch, to stick where it hurts. Called Initiv® and sold by Sanofi, this product has been everywhere in recent months. On the sweating shoulder blades of partner athletes, such as decathlete Kevin Mayer, footballer Amandine Henry or long jump athlete Arnaud Assoumani. In beautiful pharmacy displays, and even on billboards in the capital’s metro. With, each time, Paris 2024 written in huge letters, to remind you that the French laboratory is sponsoring the event.
Sold for around ten euros per box, the patch promises an analgesic effect, “without the use of medicinal active ingredients”. A godsend, as more and more patients demand gentle alternatives to chemical molecules. The secret of this “advancement”? A compendium of technology based on “bio-ceramic”, which would act in “synergy with the body” to “optimize its ability to respond to pain”, boasts the manufacturer. Such a compound would be capable of redirecting the infrared waves emitted by the body, which, in the words of an advertiser, would “increase the natural pain-relieving mechanisms” of the body.
Very good promises, except that they made a good number of scientists wince, worried by so much grandiloquence. The formulations used are, they say, closer to “pseudoscience” or “cosmetics” than to the medical arguments to which they are usually accustomed with the firm. The controversy took on a new dimension when a videographer specializing in demystification, G Milgram, took up the subject, relaying numerous unfavorable opinions. It was he, already, who had uncovered the big nonsense behind Guerlain’s so-called “quantum” cream.
A… light study
Pseudosciences at Sanofi, our French pharmaceutical champion, behind the discovery of numerous treatments? In fact, the company has not published any study to support its claims. Discussions are underway with a publisher, she indicates. But a poster was still posted online. A sort of appetizer for the scientific community, it details the method used by Sanofi to ensure the effectiveness of Initiv®.
© / Sanofi
To test it, Sanofi has launched a clinical study. But this is in reality “not able to scientifically demonstrate its interest”, indicates Didier Bouhassira, a leading French pain specialist, research director at Inserm and practitioner at the Ambroise-Paré hospital in Boulogne. Billancourt. The expert is categorical: “This work does not allow us to conclude that there is an effect against pain. It’s impossible to know if it works.”
In question, the methodology used: the manufacturer gave its patch to 100 people, and nothing to 100 others. Those who had the device were able to convince themselves that the pain had decreased, this is what we call the “placebo effect”. How do we know if that’s what makes them feel good, or if it’s the product? Impossible, as it stands. “To combat this trick of the mind, it would have been necessary to distribute a false patch to others,” confirms a second expert, Professor Mathieu Molimard, pharmacologist at Bordeaux University Hospital.
The “ultimate”, but no proof
Contacted by L’Express, the company assures that its study is the ultimate in what is done in medical devices. “The protocol of this study, carried out in Germany and Italy, corresponds to the most robust standards used in the field of pain assessment and was approved by the ethics committees supported by the health authorities of these two countries “, replies the industrialist, by return email, in the very controlled tone of pharmaceutical communicators, whose comments are subject to very strict rules.
There is nothing false in these statements: Sanofi has indeed carried out a very good study for a medical device. There lies, however, an important subtlety: for these products, which are not drugs, to access the market, their manufacturers do not need to carry out research as in-depth as that on pharmaceutical molecules. They must demonstrate their safety and “performance”, but not their effectiveness. “What Sanofi is showing with these clinical trials is only a proof of concept. We can see this as encouraging, but nothing more,” insists specialist Didier Bouhassira.
An inappropriate mix of genres
Even more surprising, some inconsistencies crept into the documents presented by the firm. We read in particular that the infrared rays supposed to be reflected by the patch would have an effect on pain. And to cite, as proof, two studies. Problem: these do not relate directly to this question, but to devices similar to its patch, tested by other teams. The height of irony is that neither of these two studies concludes that it is effective. It’s even the opposite.
On this subject, the company mentions “errors”, poor management of citations, which are the raw material for scientific argumentation. She promises to correct it. Internally, we even half-heartedly admit to “aggressive” marketing. And we remind you that these products are intended for people suffering from pain which disappears on its own. Understand: there is no issue, Initiv® is a little extra for Sunday athletes, not a cure for cancer.
Still, doctors are concerned that such big promises are kept by a pharmaceutical giant, for so little evidence of effectiveness. A priori, wearing a patch would be harmless and would at least have the advantage of triggering a placebo effect. It is rather the risk of seeing, due to such a great mix of genres, patients turning away from medicine, which is pointed out: “Disappointed hopes are what feeds distrust”, sighs the neurologist Didier Bouhassira. With or without a patch, Sanofi will therefore have to pass the pill.
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