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Opinion: Why We Need Tighter Regulations for Weight Loss Drugs | Nov 2023

Published Date
Author McGraw Hill Higher Education

November 2023 | Volume 15, Issue 4

Note: This is an opinion piece written by Dr. Simon C. Cork, a senior lecturer in physiology at Anglia Ruskin University in the United Kingdom.

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

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 percent of Americans prescribed semaglutide in 2023, according to data from Epic Research.

 Research Regarding Semaglutide

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 percent 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.

Critical Health Questions

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 from 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 benefits of a slimmer body. Those who purchase these drugs without clinical supervision may find themselves developing potentially life-threatening complications that need urgent medical attention.

Guidelines Regarding Use

It is 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 U.S., 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.

UK Regulation

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.

The Author’s Position

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.

Discussion Questions

  1. Should weight loss drugs like Ozempic and Wegovy ever be available on a non-prescription (i.e., over-the-counter) basis? Why or why not?
    This is an opinion question, so student responses may vary. In your author’s opinion, such drugs should not be available on a non-prescription (i.e., over-the-counter) basis, since the risks of taking them should be subject to a doctor’s scrutiny and consultation with the patient.
  2. As mentioned in the article, the risk of developing pancreatitis from the use of semaglutide is around .5 percent. Is this statistically significant enough to warrant regulation of semaglutide for the purpose of weight loss? Why or why not?
    This is an opinion question, so student responses may vary. In your author’s opinion, yes, .5 percent is statistically significant enough to warrant the regulation of semaglutide for the purpose of weight loss. Even though the .5 percent statistic may appear on its face to be insignificant, if 30 million people took semaglutide for the purpose of weight loss, that would translate into 150 thousand of them developing pancreatitis from its use.
  3. Overall, do you believe that drugs like Ozempic and Wegovy should be subject to stricter regulation? If so, specifically what should those regulations be?
    This is an opinion question, so student responses may vary. In your author’s opinion, yes, Ozempic and Wegovy should be subject to stricter regulation. Specifically, your author favors more transparent and public disclosure of the risks of using these pharmaceuticals for the purpose of weight loss.