Products and medications that lead to weight loss are a complicated beast. 'Weight loss aids' available to buy are often touted as 'miracle cures' for what we're taught to hate about ourselves and they can range from utterly ineffective to dangerous. However, a new case is lifting the lid on how medication that caused weight loss, prescribed by doctors in France, may have caused years of untold suffering.
Today marks the beginning of a landmark trial in France, where Servier, one of the country's most powerful, privately owned laboratories stands accused of concealing the risks of Mediator, a drug used for weight loss. In turn, France's state drug regulator, The Agence National de Sécurité du Médicament (ANSM), is accused of taking too long suspend the drug. Servier denies all charges. The ANSM says it is cooperating with the trial.
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Mediator was an amphetamine derivative originally marketed to overweight diabetics to help them lose weight. Worryingly, according to The Guardian, it was also prescribed electively to "healthy women as an appetite suppressant if they wanted to lose a few pounds". The BBC reports that the pill was eventually prescribed "generally" and willingly given to those who were concerned about putting on a few pounds.
Up to 5 million people were given the drug between 1976 and 2009, even though it was suspected of causing heart and pulmonary failure. In 2010, the number of deaths linked to Mediator by the French drug regulator ANSM was 500. Another study puts the estimate at the number of deaths as a result of heart valve trouble from exposure to Mediator's active ingredient to be up to 2,000. According to The Guardian, thousands more are living with unanticipated and often debilitating health conditions, from being "unable to climb a flight of stairs" to "permanent cardiovascular problems that limited their daily lives".
The trial will focus on 91 victims, of whom four have passed away, of who lawyers believe they can show a link between their illnesses and the drug.
The alarm was raised in 2007 when Irène Frachon, a lung specialist, assessed patients' records and warned of a link between Mediator and serious health risks, particularly to the heart. The drug was not withdrawn from the French market for another two years, six years after it had been pulled in Spain and Italy. As a consequence, the ANSM is also on trial, accused of being too slow to act and not taking sufficient steps to check and control the drug.
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The UK's Medicines and Healthcare products Regulatory Agency (MHRA) tells R29 that "Mediator is not licensed for sale in the UK, according to MHRA licensing records."
The anti-obesity medications available on the NHS are entirely different to Mediator. In 2009, the prescription-only anti-obesity drug orlistat became available over the counter. Sold under the brand name Alli, this low-dosage version can be bought at a pharmacy by adults with a BMI of 28 or more. However, it is also accessible online, meaning people can easily bypass the need to be weighed by a pharmacist. Common side-effects of Alli relate to the gut and include oily or fatty stools, flatulence, bloating and frequent or urgent bowel movements. Orlistat also carries risks of headaches or upper respiratory tract infections.
Anti-obesity drugs like orlistat are not the same as weight loss aids. Orlistat is a prescription drug, whereas the flat tummy teas made famous by Instagram are everywhere. While both can be accessed fairly easily online, only the former will be regulated and prescribed by a medical professional to those they think are in need of it. According to the MHRA, many weight loss aids (like those teas) are "legally on the market as foods" – they only fall under MHRA jurisdiction if they are defined as a "medicinal product". In avoiding regulation, these products can be marketed to vulnerable, impressionable young women using empty, potentially damaging promises. Instagram itself is now banning them.
But for the women of France, the line may be a little more blurred. After three decades of being prescribed what was a regulated drug, today marks the beginning of a trial that could expose that regulation as invalid. And that's a hard pill to swallow.