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Dr Gérald Kierzek (Medical Director of Doctissimo)
A new molecule, retatrutide, is presented as the “new ozempic” for weight loss. Sold in Britain for around two euros per injection, counterfeit versions endanger users. The opinion of Dr Gérald Kierzek, emergency doctor and medical director of Doctissimo.
After Ozempic® and its derivative, Wegovy®, two drugs manufactured by the Danish pharmaceutical laboratory Novo Nordisk and intended for the treatment of type 2 diabetes and weight loss, the craze is now focused on retatrutide.
Retatrutide is manufactured by the American pharmaceutical giant Eli Lilly, which already produces the weight loss drug Mounjaro® (tirzepatide). But the molecule is in the testing phase and is not yet approved. However, unscrupulous resellers offer counterfeit injections based on retatrutide, at a ridiculous cost, accessible online.
An online sale without any guarantee
Chinese companies, but also European laboratories, are believed to be behind the manufacturing of these fraudulent injections, available for purchase online. The “medicine” would be presented as a “weight loss supplement” with bottles bearing indications such as “not intended for human consumption” Or “search only“. A ploy to try to protect themselves from the fact that it is an unapproved drug, for the moment.
Encouraging first trials on retatrutide
These lax companies are riding on the success of the molecule. The drug, still in clinical trial development, has been nicknamed “triple G” because it targets three different hormones involved in the process of regulating the amount of food we eat. In comparison, ozempic® and Wegovy® target one, and Mounjaro® targets two.
Furthermore, initial trials of patients taking retatrutide experienced weight loss of up to 24.2% of their body mass after 48 weeks. This is the highest figure reported after taking an anti-obesity drug. For the record, with wegovy, the loss is 15% and with mounjaro, 22.5%.
But bringing this molecule to market will likely take years, with clinical trials currently underway not expected to end before 2026.
A molecule without marketing authorization
According to Dr Alison Cave, head of safety at the Medicines and Healthcare products Regulatory Agency (MHRA), the English medicines regulatory agency, interviewed by the DailyMail, explains: “Retatrutide is currently in clinical trials and has not been approved for use in the UK. This means that it has not yet been shown to meet our standards for safety, quality and effectiveness.”.
It also warns the general public against purchasing such medicines from online sellers. “Purchasing any medicine such as semaglutide or a product labeled as retatrutide from suppliers trading illegally online significantly increases the risk of obtaining a product that is either falsified or not authorized for use in the country. United Kingdom” she indicated.
“Buying from illegal suppliers means there is no guarantee that the products meet our quality and safety standards, and taking such medicines can put your health at risk.” she insists.
NO to diets, YES to WW!
Several steps are necessary before a drug is placed on the market.
A warning shared by Dr. Gérald Kierzek, emergency physician and medical director of Doctissimo. “Placing a medicine on the market in Europe, including in France, is a regulated and rigorous process that involves several stages.” he recalls. We count:
- Preclinical development: Before a drug can be tested on humans, manufacturers must conduct preclinical studies to evaluate the drug’s safety and effectiveness. This may include laboratory and animal testing.
- Clinical research: clinical trials, that is to say the first trials in humans, are conducted to confirm the safety and effectiveness of the new treatment, most often compared to the reference drug or a placebo, as part of a double-blind study (neither the patient nor the prescriber knows which compound he is receiving/delivering, so as not to influence the result).
- An authorization request: Once promising preclinical data has been obtained, manufacturers can submit a marketing authorization application (MAA) to the European Medicines Agency (EMA). This application contains data on the quality, safety and effectiveness of the medicine.
- An assessment by the EMA: The EMA reviews the application and the data provided to determine whether the medicine meets the required standards of quality, safety and effectiveness. The EMA may request additional information or additional studies if necessary.
- A marketing authorization: If the EMA is convinced of the quality, safety and effectiveness of the medicine, it issues a marketing authorization (MA) which allows the medicine to be marketed throughout the European Union.
- A national procedure: Once marketing authorization has been obtained at European level, the medicine can be marketed in all EU member states, including France. However, some countries may have additional requirements for marketing within their territory, such as post-authorization studies or specific pricing.
In France, the National Agency for the Safety of Medicines and Health Products (ANSM) plays a key role in the regulation and monitoring of medicines. It monitors the safety and effectiveness of medicines after they are placed on the market, and can take regulatory action if necessary to protect public health.
“Generally speaking, it is absolutely not recommended to buy medicines online abroad. In France, the online pharmacies must have a pharmacy with a storefront“advises the doctor.”And never buy on social networks, ebay or anything else!” he concludes.