By Deborah Borfitz 

January 14, 2025 | Widespread misinformation about what obesity is and how it should be treated is finally getting the attention it deserves, according to one of the most vocal advocates championing changes across much of Europe, Jacqueline Bowman, founder of Third-i, a cause-based small- to medium-sized enterprise based in Brussels, and cofounder of the nonprofit Adipositas Pact Foundation for the Rights of Citizens with Obesity. The inconvenient truth, Bowman says, is that obesity is a series of diseases, and the underlying culprit is malfunctioning adipose tissue.  

But regulators, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have long since adopted body mass index (BMI) as the main surrogate marker of obesity, she says. This has created a negative “ripple effect” on clinical trials and exacerbated misunderstandings about glucagon-like peptide-1 (GLP-1) receptor agonists—a class of medicines with the active ingredients of albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, tirzepatide, or semaglutide—when specifically prescribed for obesity treatment and long-term management, Bowman says. This has led to shortages of GLP-1 drugs for patients with a valid obesity diagnosis and prescription who need the medicines and a high drop-off rate for those who take them. 

Regulatory authorities have been measuring the effectiveness of obesity drugs based on weight loss, rather than health status, and obesity drug manufacturers, notably in the U.S, have been heavily advertising them as such.  “It’s the blind leading the blind,” Bowman says. 

As a result of this systemic misinformation, individuals looking for a “beach body” (aka “cosmetic weight loss”) are going to great lengths at their own peril to obtain GLP-1 drugs. They don’t understand that the drugs are not for “weight loss per se,” she explains, but an artificial hormone severely lacking in people with obesity.   

Even for those validly prescribed, adds Bowman, the reported side effects are disproportionate to what should be happening if the drugs are properly compounded, delivered at the right dose, and patients are advised to adjust their eating habits and vitamin intake.  

A paradigm shift of opinion is getting underway in the European Union (EU) regarding the criteria for marketing approval of obesity medications, and thus the information that should be collected in trials, as well as the post-marketing studies needed to comprehensively assess long-term health outcomes, says Bowman. The FDA and EMA have often collaborated on many scientific and regulatory fronts, but it remains to be seen if this will be one of them, she adds.   

The FDA is not oblivious to problems with GLP-1 drugs, as evidenced by all the public information the agency has issued on the topic, including an alert about dosing errors associated with their compounding, a warning about the dangers of taking unapproved GLP-1 drugs for weight loss, and a preliminary finding that the drugs are not associated with suicidal thoughts or actions.  

The EMA has gone further by putting obesity in parity with type 2 diabetes when dealing with GLP-1 shortages, Bowman says. A year from now, she predicts, the EMA will have practical guidelines in place to mitigate shortages of GLP-1 drugs and an implementation protocol for national EU Member States to follow regarding the criteria for properly accessing them. A global-level framework on the prevention and management of obesity is also expected to receive the official nod in 2025 as part of a high-level meeting on noncommunicable diseases among member states of the United Nations, with whom incoming U.S. President Trump has threatened to disengage. 

Demand for GLP-1 drugs in the U.S. is high and continues to grow, and part of the fuel could come from a warning that nearly 260 million people could be affected by overweight (pre-obesity) or obesity by 2050 (The Lancet, DOI: 10.1016/S0140-6736(24)01548-4). The basis of the prediction is standardized BMI cut-off points.  

“Already, the U.S. has a different ICD [International Classification of Diseases] compared to the rest of the world,” says Bowman. “The U.S. version of the ICD only uses size to characterize the disease of obesity. This is a misnomer and not the ICD followed by the rest of the globe.” 

Driving Change

Since 1948, the World Health Organization (WHO) has classified obesity as a disease in its ICD, points out Bowman. “So, the whole conversation about whether it is a disease or not is more a case of smoke and mirrors at this point.” 

The definition, in layman’s terms, is “an abnormal or excessive accumulation of fat that may impair health,” she says. “You can be living in a large body or a tiny body at any given time. It doesn’t matter. The defining question is whether your adipose tissue is functioning or not.” As with cancer and diabetes, obesity is a disease “you have” and not a personal identity “you are.” 

Adipose tissue is an organ in the body unrelated to the size of a person, Bowman stresses. But people are understandably confused because the primary criteria for regulatory approval of obesity drugs are weight loss together with a reduction in major adverse cardiovascular events (MACE). All people remember is the weight loss part, she adds. 

Patients on GLP-1 drugs end up with side effects that could have been managed had they taken a few evidence-based steps—e.g., taking in more vitamin B-6 to avoid nausea, not consuming liquids 30 minutes before or after solid food, and focusing on eating mostly proteins and vegetables—had their healthcare provider known to tell them, says Bowman. The muscle wastage known to occur with this class of drugs can be effectively counterbalanced by consuming the right kind and appropriate amounts of good quality protein as well as keeping an eye on resistance training to maintain muscle mass.  But none of these “services around the pill” are currently being fully integrated into clinical trials.  

The dark side of GLP-1 drugs, in this case Ozempic, was highlighted earlier this year in a story about reality TV star Sharon Osbourne. Oprah Winfrey, meanwhile, enthusiastically endorsed the drugs on national television as a treatment for obesity—even if the term was used interchangeably with weight loss. But there have also been growing concerns reported about the staggeringly high discontinuation rates of GLP-1 drugs, driven in part by fears of regaining lost weight after stopping use.  

Bowman knows of what she speaks both as an individual with obesity being treated with a GLP-1 drug and as the leading EU expert on getting the disease properly legislated and understood at the EU as well as in country. She underwent bariatric surgery in 2016 for endocrine obesity and when she became treatment unresponsive a few years later weight gain was only one of the many signs and symptoms, she says. 

Her professional background proved to be indispensable in “bringing obesity to the table” and ensuring the adoption of scientifically sound policies impacting the health outcomes of people with the disease. “I’m a lawyer by education, but I drive change,” says Bowman. “That’s my MO.” 

Over the past six years, running what she calls a “rebuttal campaign,” Bowman built out the entire policy function around obesity across 36 countries and international institutions as head of policy at the European Association for the Study of Obesity. She has also been involved with health systems transformation work since 2001, which she hopes to leverage in bringing a value-based healthcare approach to obesity. 

The scope of her work extends to the payer side of the equation and the different pricing and reimbursement models that might reasonably be adopted, she says. Healthcare systems will also need to consider the type of value-based budgeting model they can use to calculate the cost of not screening for obesity, as she is recommending. They likely lack the infrastructure for that because screening is currently focused entirely on diabetes. 

Righting the Wrongs 

Because of Bowman’s expertise in value-based healthcare, Third-i was tapped for a five-year EU project now concluding that aims to ensure obesity care provides “the right person with the right treatment at the right time.” She headed up development of a work package on shared value analysis, around which a “readiness to act” assessment tool is now being built, she reports. 

Separately, the Adipositas Pact foundation has been fighting for the legal rights of citizens with obesity in Belgium and beyond, who routinely face many unflattering biases and forms of discrimination. “We’re never seen as experts in our own right, we are supposed to be uneducated, [and] unable to express ourselves or hold good jobs,” says Bowman. “That’s not anybody I know... [and] that’s not me.” 

As such, Bowman has been bringing the voice of lived experience and citizens legal rights to the EMA in formal discussions on GLP-1 shortages In Belgium, the foundation succeeded in preventing people diagnosed with obesity “only,” versus people living with type 2 diabetes, from having their treatment denied from one day to the next, she reports. 

“We turned it around in 24 hours... [because] every patient in Europe has a legal right to continuity of treatment regardless of what the diagnosis is,” Bowman continues. “In the case of any pharmacological therapy, where there is a shortage, the [EMA] is obliged to find what is called a ‘suitable alternative’... but the reality has been that there are no alternatives for those validly prescribed a GLP-1 agonist.”  

Bowman says she is now in the process of getting the rest of Europe to follow the lead of Belgium. The discussion began at the EMA over the summer. 

Headlining Weight Loss 

The EMA meeting involved various medicines agencies, industry, health professionals, legal rights groups, and consumer bodies, says Bowman, and the outcome was highly encouraging. The agency publicly stated that people with diabetes and those with obesity should have equitable access to GLP-1 drugs.  

But it’s tricky, says Bowman, getting back to the problem of BMI being conflated with obesity and the erroneous belief that people of a certain size are more prone to cardiovascular events. The connection between BMI and how obesity is assessed “only historically applied to middle-aged men from the Flemish speaking part of Belgium.” For anybody else, other variables need to be applied and that’s not happening currently in clinical trials supporting regulatory approvals. 

The value of GLP-1 treatments, once they hit the market, are therefore headlined by their weight loss potential. Industry sponsors invest heavily to pass through phase 1 and 2 testing and are not financially motivated to invest extra effort and money into a redesign of their phase 3 and 4 studies, Bowman says. 

Widespread lack of awareness of what obesity is has meant real obesity markers and biomarkers aren’t being measured, she stresses. “BMI is not an individual clinical marker; it is quite far down the list.” The obsession with weight is in fact a major contributor to the shortage of not only GLP-1 drugs but other anti-obesity medications. 

Across the European region, there are 67 medicines approved for diabetes, 13 of which are GLP-1 drugs, says Bowman. Two of those 13 drugs are specifically approved, but not commercialized, for obesity—although the situation differs a bit country to country. In The Netherlands, for instance, people can still access the first-generation GLP-1 medication Saxenda (liraglutide) as well as the older and more widely available weight-loss drug Mysimba (naltrexone/bupropion) that is probably best reserved for people with binge eating behavior—a mental health condition that is distinct from but can coexist with obesity.   

Phentermine, a drug in an entirely different class of medications called anorectics that work by decreasing appetite, is also still being advertised as a treatment for obesity by some online providers. But again, Bowman says, “there’s a big difference between a weight-loss drug like phentermine and a [GLP-1] obesity management drug.” 

GLP-1 is a hormone that occurs naturally in the body and “people with obesity need five times more of it flowing through their system than [healthy individuals],” she continues. Given that GLP-1 drugs can’t be given to everybody, the EMA needs to find a way to prioritize who gets access. 

Bigger Than Cancer

For people with obesity, the legal means at present for getting a prescription for a GLP-1 drug is to show they also have type 2 diabetes or a cardiovascular condition, says Bowman. Never mind that obesity is often the cause of these and other diseases—more than 80% of the time for type 2 diabetes, 35% for heart failure, and 20% for preventable adult cancers.  

One of the generally accepted principles of obesity treatment and management is to catch it early via “personalized screening,” says Bowman. “But, yet again, the issue is that there is no standardized system in place for this to actually happen anywhere.” This is being addressed in the tool that Third-i is creating for the EU project IMI-SOPHIA, together with readiness of clinical trial sites to ask scientifically relevant questions. 

A “one-size-fits-all approach” will not do since obesity, like cancer, is not a single disease, she adds. “We need to start looking at the entire treatment pathway, so we see why people tend to come off the drugs [after a year] and what we can do to make sure they are getting the best out of their treatment.”  

Moreover, says Bowman, “we need to be looking at scientifically acknowledged biomarkers for obesity [e.g., cytokines and C-reactive protein levels] and the real-world evidence in terms of improvement of quality of life and psychotherapy.” The EMA already has a network for real-world evidence generation in oncology and a similar initiative might be launched for obesity because “there are more people with untreated obesity than there are people with cancer.” 

Her “Warren Buffet prediction” is that both the EMA and FDA will be changing up the markers of GLP-1 treatment outcomes, and thus the criteria for their marketing approval. “It is way beyond BMI—that’s already getting louder than a whisper from all stakeholders.” 

‘Be Like Belgium’

Bowman says she is hopeful that the EMA will “be like Belgium” when prioritizing GLP-1 drug access in its forthcoming guidelines. The obesity society in Canada (Obesity Canada) has likewise successfully intervened to prevent people with the disease from being abruptly cut off.  

Excepting Belgium in the EU, “every country does not seem to have looked into the legalities of patient rights legislation directly applicable from the EU level,” she says. “As a result, most of them have been acting de facto breaching the legal rights of a substantial part of their national populations.” 

The anticipated stance in the EU is this: Anyone who has been diagnosed with obesity by an endocrinologist or obesitologist and—"because we’re still in the world of BMI”—has a body mass index of 35 or higher or 30 with weight-related complications, makes the priority list for obtaining the drugs, says Bowman. Complications such as osteoarthritis worsen with inflammation, which would take in many people with obesity since it is an inflammatory medical condition. 

“I’m now on combination therapy and I managed to check all the boxes, unfortunately,” Bowman says, noting that she developed a rare genetic condition that was aggravated by obesity. “There are lots of ways to check the box [on complications].” 

Sarcopenic obesity can present as muscle atrophy, a condition Bowman experienced after bariatric surgery during the COVID-19 lockdown. Although she still looked the same size, she in fact had a lot less muscle mass than is normal and healthy, she says. 

The added complexity in creating guidelines for GLP-1 drug access is their uneven availability across the EU. In Belgium, for instance, “we don’t have Wygovy, so we have to prioritize Ozempic,” says Bowman. “The compounding story [related to safety and dosing] has not hit Europe as of yet.” 

Given their history of cooperation, the EMA and FDA will likely be working closely on dealing with GLP-1 shortages, she adds. As it is, Mysimba is under Article 20 review due to concerns about potential long-term cardiovascular risk. An international solution will be needed if marketing authorization for Mysimba gets suspended or revoked, because so few options exist for people with obesity.  

Demand in the U.S. could get staggeringly high. A recent report finds that more than half of all U.S. adults are eligible for semaglutide therapy—a list that includes Ozempic, Wegovy, and Rybelsus—exceeding the number of adults eligible for statins (JAMA Cardiology, DOI: 10.1001/jamacardio.2024.4657).  

The peddling of GLP-1 medicines as weight-loss miracle drugs remains problematic, at least in the U.S., and needs a remedy, says Bowman. People looking to drop pounds quickly are being enticed to take what they think are “beach body drugs” and are ending up malnourished because they are effectively starving themselves of needed vitamins and minerals. 

GLP-1 drugs are also expensive and generally not reimbursed when prescribed solely for obesity treatment and management, let alone when used for cosmetic weight loss, but many people have come to associate them with “a day at the spa,” all to avoid being judged for their size, Bowman says. “[But] when you starve yourself, your brain doesn’t function properly... and your biology fights back. It holds onto any little bit of fat, good or bad.” 

Real-World Studies

Ideally, post-marketing “living lab" studies will emerge to assess the long-term prognosis of patients with obesity treated with marketed GLP-1 drugs, says Bowman, adding that even after bariatric surgery follow-up monitoring ends after two years. She advocates for the development of new standardized questionnaires that pose questions related to the actual disease of obesity, rather than the current sole focus on body image, size, and eating habits dating back to the 1980s. Attempts at working on new standardized outcome datasets would gain much “if the original surveys used could be aligned with the science.” 

Once people have obesity, they often start displaying depression because of inflammation, she cites as an example. “It’s a cycle. You may have nothing to be depressed about, but you will present as depressed because [among other things] you are not absorbing your iron and have low vitamin B-3 ... none of which are being tracked unless you have type 2 diabetes or had bariatric surgery.” 

Bowman’s dream scenario is to see people with obesity studied in real-world settings to assess the health service infrastructure in terms of providing easy access to treatment and properly informing clinical trial participants about how to mitigate the side effects of drug treatments—which will look different depending in part on the type of obesity an individual has as well as co-occurring medical and neurological conditions such as attention-deficit/hyperactivity disorder and autism.