Opinion: Why we need tighter regulations for weight loss drugs

Opinion by Simon C. Cork

(CNN) — Weight loss drugs such as Ozempic and Wegovy are booming in popularity, and the companies that make them are ramping up supply to meet the demand. For many, these drugs are prescribed to help alleviate health issues associated with chronic obesity (such as hypertension, sleep apnea and type 2 diabetes), while others may turn to the drug as a tool to help them shed weight because they feel more comfortable in a smaller body for any number of reasons. But as more people have started using these drugs, serious side effects have come to light, throwing into question whether the weight loss benefits are worth the risks — and how best to regulate the drugs to ensure they don’t do more harm than good.

Semaglutide, more recognizable by the brand names Ozempic (for the treatment of type 2 diabetes) and Wegovy (for weight loss), works by mimicking a naturally-occurring, satiety-inducing hormone in the body called GLP-1. Semaglutide has been approved for the treatment of type 2 diabetes since 2017, but its use as a weight loss aid has more recently been popularized by celebrities, including the likes of Elon Musk and Amy Schumer. It’s no surprise, then, that prescription rates have skyrocketed over the past few years, with 1.7% of Americans prescribed semaglutide in 2023, according to data from Epic Research.

A study published this month highlights the risks associated with semaglutide when used specifically for weight loss. By studying a US-based database of patient prescriptions and diagnoses, researchers identified that semaglutide was associated with an increased risk of potentially life-threatening complications including pancreatitis, bowel obstruction and gastroparesis (stomach paralysis). On the face of it, this all sounds very worrying, but it’s important to place this in context.

Firstly, the incidence of these complications was very low – around 0.5% for pancreatitis, for instance. For the vast majority of people, these drugs are safe. However, when scaled up to the number of people who could be using these drugs, there is the potential for a significant number of people to develop serious complications.

Secondly, there are critical health questions to be assessed for each potential weight loss drug user: Do the benefits of losing weight to help minimize the risk of a health condition associated with being obese — stroke or cardiovascular disease, for instance — outweigh the risk of side effects from the drug? The answer will vary patient to patient.

But perhaps the most important factor to consider here is the risk associated with off-label prescriptions or for those who purchase these drugs without proper clinical guidance or monitoring. For those who are looking to shed pounds without a health reason that warrants a prescription, the risks associated with the drugs may outweigh the benefit of a slimmer body. And those who purchase these drugs without clinical supervision may find themselves developing potentially life-threatening complications that need urgent medical attention.

It’s therefore vital that the guidelines around who should access these drugs are adhered to, not only to ensure that only those who need weight loss drugs for health reasons are able to access them, but to protect those for whom the risk-benefit ratio may not be favorable. In the US, the Food and Drug Administration advises that semaglutide be used for weight loss only if a patient has a body mass index (BMI) of 27kg/m2 or more, in addition to at least one health condition related to their weight. If a patient has a BMI of 30kg/m2 or more, they do not need a weight-related health condition to warrant a prescription. Such guidelines are in place because they reflect the best evidence from clinical trials on the benefits and risks associated with these drugs.

Meanwhile, the UK’s independent regulator for pharmacists and pharmacies, the General Pharmaceutical Council (GPhC), introduced safeguards in 2019 to protect people from risks associated with purchasing drugs online that could be misused, including “making sure the prescriber proactively shares all relevant information about the prescription with their GP after seeking the patient’s consent.”

In the UK, like the US, there is room for these regulations to be tightened so that more patients are protected. More thorough guidelines should specify, for instance, that patients must be physically assessed prior to the prescribing of these weight loss medications. This is of particular importance when considering individuals with body dysmorphia or eating disorders, for whom weight loss medications may prove life threatening.

We need to be confident that only those who meet a clinical need for these drugs can access them and distributors looking to cash in on the Ozempic craze need to be held to account if found to be prescribing to those who do not. Without better regulation we risk a new wave of health problems, not caused by obesity, but by the very drugs used to treat it.

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