Over the past century, our society has witnessed an unprecedented increase in obesity. Given the plethora of comorbid conditions associated with obesity, medical professionals have begun to sit up and take notice of the need for new avenues of action. GLP-1 agonists represent a potentially transformative advancement in the battle against obesity. However, current data indicate a need for more intensive monitoring, not only of who prescribes these medications but also of how the consumer receives the product. This article draws attention to the dangers and ethical complexities of 3rd-party providers of GLP-1 medications.
Obesity In Our Society
According to a recent survey conducted by the San Francisco-based healthcare consultancy Omada Health, one in eight Americans currently use a GLP-1 medication, while an estimated 129 million meet the qualifications for semaglutide-based treatment. If this number seems surprising, it raises the question of whether GLP-1 medications have entered a “danger zone,” releasing a tidal wave of availability that could put the quality and purity of these products at risk.
Having proven themselves as a revolutionary force in today’s medical landscape, GLP-1 receptor agonists have had a dramatic impact in changing how physicians approach weight management and its comorbid conditions. Their proven efficacy has led to unprecedented demand; yet a significant accessibility hurdle often stands between these transformative treatments and the patients who need them. This tension between “medically possible” and “financially practical” seems to have woven a complex power struggle. We must ask ourselves: who ultimately steers the ship when it comes to GLP-1 prescribing— the primary care physicians, the pharmacy benefit managers behind the scenes, or the somewhat shady compounding pharmacies?
Telehealth and Patient Safety
Amid soaring patient demand for GLP-1 weight loss medications, primary care physicians report growing concerns regarding potential risks associated with third-party telehealth dispensing of these drugs. These concerns seem to have accelerated, as patients who seek telehealth or other third-party providers often do so without involving their primary care physicians.
The FDA remains vigilant that some patients and even some health care professionals may consider unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonist) drugs, including semaglutide and tirzepatide, as an option for weight loss. This health risk arises from the knowledge that unapproved versions do not undergo the FDA’s strict review for safety, effectiveness, and quality before they hit the market. Compounding pharmacies are the primary dispensers of many of these copycat GLP-1 medications. We will cover compounded medications later in this article.
The Food and Drug Administration Position
The FDA has received multiple reports of adverse events, some requiring hospitalization, related to dosing errors associated with compounded injectable GLP-1 products. These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug, and, in some cases, from health care professionals miscalculating doses.
Additionally, the agency received adverse event reports related to patients prescribed compounded semaglutide or tirzepatide products in doses beyond what the FDA approves. This could involve a number of scenarios: using more product in a single dose, taking doses more frequently, or increasing the amount more quickly (variations of a titration schedule). Some of these adverse events led to serious problems, and patients reported the need to seek medical attention for their symptoms, which included nausea, vomiting, diarrhea, abdominal pain, and constipation.
The principal objective of the FDA is to monitor the Internet for fraudulent or unapproved drugs. The agency investigates reports of suspected counterfeit drugs to determine public health risks and the appropriate regulatory response. The FDA remains vigilant in protecting the U.S. drug supply from these threats, which include medications prepared and dispensed by compounding pharmacies, since they lack proper FDA oversight.
Reputabilty in Question
Since many adults who could honestly use GLP-1 medications to help in their battles with obesity and potentially ensuing diabetes/heart disease/kidney problems lack sufficient financial means to obtain these drugs from reputable pharmacies, they often turn to the Internet in search of less costly products. These illegally marketed drugs, however, have their own unique set of problems:
- Potentially counterfeit
- Could contain the wrong ingredients or harmful ingredients
- Could contain too little, too much or no active ingredient at all
In a report entitled Primary Care Perspectives on GLP-1 Prescriptions, surveyors found that 67% of the 2,000 primary care physicians questioned believed that GLP-1 prescriptions by third-party telehealth providers pose a significant risk to patient health. These physicians cited concerns such as inadequate reviews of a patient’s medical history, insufficient patient monitoring, and the potential for overprescription.
Primary care physicians also underscored the role of lifestyle change in prescribing GLP-1s for weight loss; 53% reported requiring patients to try non-pharmacological approaches before dispensing GLP-1 medications. These two aspects alone should serve as a message to telehealth purchasers: most hands-on physicians who know a patient’s health history and current situation will most likely suggest alternatives to GLP-1 drugs. The same clearly does not hold true for Internet purchases.
If patients begin experiencing adverse outcomes from improperly prescribed GLP-1 medications, the telehealth providers will likely notice a spike in medical negligence claims. These can cover a range of complaints, including the following:
- Inadequate medical oversight
- Failure to consider/monitor comorbidities and side effects
- Improper patient selection
- Drug interactions
- Inappropriate/abrupt discontinuation of treatment
Digital Weight Loss Services
Hundreds of telehealth companies, concierge medical practices, and so-called “med spas” have, over the last few years, built tremendously successful business models by offering compounded versions of popular GLP-1 obesity drugs during a period when brand-name versions were scarce. In more than 50 warning letters, the FDA called out these health providers and companies for false and misleading claims about the compounded products they sell to a public they have never met.
For individuals who lack reliable sources of GLP-1 drugs or whose physicians have refused their request, digital weight-loss services (DWLS) have emerged as a potential solution to the problem. Many DWLS utilize Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), either as a treatment by itself or in conjunction with lifestyle changes. Although randomized trials have shown these products to be both safe and effective in clinical settings, many individuals and medical professionals remain concerned about their use in real-world DWLS.
Key concerns center around the fact that DWLSs do not follow international guidelines in using GLP-1 RA treatment as a supplement to continuous lifestyle changes. They likewise seem to allow unsuitable patients to obtain such medications, risking either pharmacy dispensing errors or dosage errors. At present, both concerns seem very reasonable and a bit frightening. While the DWLS boasts a broad spectrum and contains several providers who offer GLP-1 RAs strictly as a supplement to lifestyle therapy, many services still appear to deliver GLP-1 RA prescriptions with little to no follow-up care. Either way, patients fail to get the FDA-rigorous protection from these medications.
In 2023, one study covered a 6-month period analyzing prescribing errors committed at Australia’s largest GLP-1 RA-supported DWLS. The analysis found that 4.4% of the 37,323 GLP-1 RA prescriptions contained errors. Most errors pertained to insufficient safety counseling (49.15%) and failing to sufficiently guard against potential contraindications with other medications (30.29%).
GLP-1 Drugs and Eating Disorders
We’ve encountered a particularly arresting situation over the past few years. Medical professionals report an uptick in patients seeking treatment for eating disorders related to the use of GLP-1’s. We cannot help but wonder if taking these medications without the guidance of a medical professional (as in the case of Internet purchases) might lead to either the development of an eating disorder or exacerbate existing eating disorders. How might responsible parties, employers, physicians, and health plans change course to ensure that individuals taking these medications receive appropriate clinical support and oversight?
The idea of abusing weight loss medications should not seem surprising. Diet pills, caffeine-laced products, and even laxatives have led to an array of disordered eating issues. In some instances, the use of GLP-1’s can create an obsession around food which previously did not exist, and can cause some individuals with a tendency toward disordered eating behaviors to further limit or restrict food intake to the point of endangering their overall health. Psychologists across the United States recently reported seeing increases in patients at their facilities taking prescribed GLP-1’s and exhibiting symptoms similar to anorexia nervosa.
In the face of such trends, one might hope that clinical industries and pharmaceutical companies would investigate these claims by conducting a deep dive into research studies and data-gathering surveys. Sadly, we see no evidence of published clinical trials, and very limited research, on the abuse of GLP-1’s to further weight loss and /or the development of eating disorders.
Until more data becomes available related to the potential link between GLP-1 use and eating disorders, and to err on the side of caution, medical professionals should remain aware of the potential link. They might consider emphasizing ongoing emotional support, regular weight monitoring, education, and lifestyle changes if deemed necessary. This can include any of the following features:
- Carefully screen patients with history of an eating disorder, or eating behaviors that may render them prone to the development of eating disorders, prior to prescribing the drugs for weight loss
- Provide regular opportunities for re-screening of signs or symptoms of disordered eating while on a GLP-1 medication
- Educate patients on symptoms of common eating disorders associated with GLP-1 use
- Utilize a multidisciplinary team to connect with patients that includes mental health professionals
- Prioritize moderate weight loss, and educate patients on the importance of cultivating/maintaining lean body mass while on the GLP-1 drug
- Vigilant monitoring for appetite-related maladaptive responses, including food aversion and dehydration
Compounded Drugs
In an effort to sidestep traditional medical avenues, some patients seeking GLP-1 drugs resort to compounding pharmacies. These facilities create customized drugs, prepared by a pharmacist to meet an individual patient’s specific needs, when these needs, for whatever reason, cannot be met by commercially available, FDA-approved drugs. This can include changing dosage forms (e.g., turning a pill into a liquid), removing allergens, or providing custom dosages. Below we list some key features of compounded medications:
- Customization: tailored for specific needs
- Dosage Forms: change medications into forms easier to swallow or apply, such as lollipops, creams or gels
- Shortages & Discontinued Drugs: prepare medications currently in shortage or discontinued by manufacturers
- Not FDA-Approved: compounded drugs do not receive reviews by the FDA for safety, effectiveness, or quality prior to marketing
- Risks: since these drugs do not get mass-produced, they may carry higher risks of contamination or improper formulation
The FDA attempted to crack down on direct-to-consumer advertising of GLP-1 drugs. Over 50% of the letters written to this effect concerned providers of compounded drugs, which, as mentioned above, do not receive any oversight regarding safety, efficacy, or quality/quantity standards. Compounded drugs differ from generic medications because the latter always receive FDA approval before going to market. Overall, physicians believe that compounded GLP-1 medications are less regulated, less consistent, and, in general, less safe than branded medications.
As with any new “holy grail” weight-loss product hitting the market, individuals with genuine medical reasons for seeking these drugs often struggle to obtain them due to shortages and high costs. Concurrently, we often see wealthier individuals obtain them easily and use them solely for cosmetic weight loss. In addition to this problem, unregulated alternatives such as compounded injections and celebrity-endorsed supplements further complicate the process by introducing safety risks and misinformation. Physicians face the challenge of balancing evidence-based prescribing with resource allocation to ensure medications reach those in need. Patients considering such drugs have a responsibility to critically evaluate the information and make informed decisions.
As the use of GLP-1 agonists continues to rise, a collaborative approach, including ethical responsibility, patient education, and regulatory oversight, could go a long way towards preventing healthcare inequities while upholding the integrity of proper medical practice. This emphasizes those doubts regarding the potential for GLP-1 medications to drive long-term weight loss or make any real inroads on the obesity epidemic. Medical professionals cite the following concerns:
- Lack of sustainability
- Over-prescribing, when lifestyle approaches should serve as the first line of defense
- More oversight needed
- Unrealistic expectations
- Predatory pharmaceutical marketing practices
- GLP-1s will increase health inequities, negatively impacting disadvantaged individuals
- GLP-1s may grow exponentially while increasing healthcare costs
As the pharmaceutical industry continues to make these drugs available, perhaps the public can take it upon themselves to make informed decisions based on all the facts, including consideration of the risks involved.
References
https://www.sermo.com/resources/glp-1s-whos-in-control-doctors-or-pbms
https://www.medicaleconomics.com/view/the-risks-of-prescribing-glp-1-drugs-compounded-versions
https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss#:~:text=FDA%20received%20multiple%20reports%20of,of%20compounded%20semaglutide%20or%20tirzepatide.
https://www.mplassociation.org/Web/Publications/Inside_Medical_Liability/Issues/2025/Spring/Primary_Care_Physicians_Concerned_About_GLP-1.aspx#:~:text=The%20report%2C%20Primary%20Care%20Perspectives,through%20third%2Dparty%20telehealth%20providers.
https://www.omadahealth.com/resource-center/doctors-report-concerns-about-overprescribing-and-continuity-of-care-with-patient-access-to-glp-1-medications-through-third-party-telehealth#:~:text=The%20survey%20defined%20third%2Dparty,less%20safe%20than%20branded%20medications.
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https://journals.lww.com/psychopharmacology/citation/2024/03000/semaglutide_misuse_in_atypical_anorexia_nervosa_a.15.aspx
https://www.nationaleatingdisorders.org/glp-and-eating-disorders
https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s#:~:text=Press%20Announcements-,FDA%20Warns%2030%20Telehealth%20Companies%20Against%20Illegal%20Marketing%20of%20Compounded,over%20the%20entire%20preceding%20decade.
https://www.virtahealth.com/blog/glp-1s-for-weight-loss-are-overprescribed-and-unsustainable-per-new-virta-health-survey
https://www.fiercehealthcare.com/providers/primary-care-doctors-concerned-about-patient-risks-telehealth-prescribers-glp-1s-survey
https://pmc.ncbi.nlm.nih.gov/articles/PMC11144546
https://pubmed.ncbi.nlm.nih.gov/41219651
