Presented as a powerful drug for non-diabetic obesity, Retatrutide is actively advertised and prescribed in the United States, including licensed doctors, according to a CBS News investigation. The substance is still considered experimental and has not been approved for sale by the Food and Drug Administration (FDA).
The active substance retatrutide is an agonist of three receptors – glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and glucagon receptor (GCGR). By comparison, semaglutide (the active ingredient in popular drugs such as Ozempic and Wegovy from the Danish company Novo Nordisk) is a GLP-1 agonist only.
RTVI.US reported that the study revealed the safety of Retatrutide back in January last year. However, the drug has not received official certification since then.
Retatrutide is produced by the American company Eli Lilly. It is called a new generation of drugs based on GLP-1, a natural hormone that is produced by cells of the small intestine in response to food intake. It is involved in the regulation of blood glucose levels and affects metabolism, and therefore weight.
CBS News claims to have identified dozens of clinics across the country staffed by licensed doctors and nurses who openly advertise the drug, the sale of which is not yet authorized by the federal New Drug Act.
“No person shall import or supply for importation into interstate commerce any new drug unless such drug is subject to an authorization,” the regulation states.
In total, the TV channel found more than 120 websites selling or advertising Retatrutide, including over 50 clinics staffed by licensed doctors and nurses. When CBS News reached out for comment, at least 21 clinics “abruptly removed” the drug from their websites or changed their wording to say they do not offer it for treatment.
Other clinics defended prescribing Retatrutide, saying they had “reasonable confidence in the clinical trial results” conducted by Eli Lilly that they “do not need to wait for independent and rigorous review” by the FDA. By the way, the department emphasizes the inadmissibility of prescribing such drugs.
“Retatrutide and cagrilintide cannot be used with a prescription under federal law. In addition, they are not components of drugs approved by the FDA and have not been found to be safe and effective for any disease,” the regulatory agency clarifies.
In May, Eli Lilly announced that participants in a large clinical trial who took the highest dose of retatrutide lost an average of 28% of their body weight over 80 weeks. Side effects, including nausea, diarrhea, constipation and vomiting, were comparable to those of similar drugs, the company said.
The manufacturing company claims to have discovered “thousands of illegal publications and advertisements about retatrutide.” Eli Lilly is calling on social media companies to “stop disseminating them immediately.” On social networks, users often test the drug on their own and show the results, but this directly threatens their health, many doctors note.
The Department of Justice is investigating two cases, in Utah and Florida, involving the sale and prescription of retatrutide. The Ohio Board of Pharmacy has fined several pharmacies and clinics selling the drug, and last month the Alabama Board of Medicine warned doctors against prescribing the experimental drugs.
However, a spokesman for the Medical Board of California told CBS News that state law “does not prohibit a physician from prescribing or giving a patient a drug that is not approved by the FDA.” Those who have tried retatrutide purchased through unlicensed channels told CBS they do not consider the lack of government approval to be a “barrier to purchase.”
As ex-FDA employee Peter Lurie told CBS News, the spread of unlicensed drugs is facilitated by bloggers “who do not think about the consequences,” as well as the actions of the US Department of Health and Human Services (HHS) led by Robert Kennedy Jr.
“This movement rejects almost a century of experience in regulating the circulation of medicines under the pretext of so-called medical freedom, but medical freedom has already led us to very sad consequences,” Lurie emphasized.
According to the American Society for Metabolic and Bariatric Surgery (ASMBS), obesity can weaken the body's immune system, cause chronic inflammation, and increase the risk of many other diseases and conditions, including cardiovascular disease, stroke, type 2 diabetes and some types of cancer.
The risk of mortality with excess body weight ranges from 7% to 300%, depending on its degree. Moderate obesity shortens life expectancy by about three years, and severe obesity by 10 years. The prevalence of the disease in the United States is 40.3%, and its critical form is 9.4%, ASMBS notes.
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