Yale researchers who conducted a "secret shopper" study were shocked by the lack of clinical oversight and the ease with which it was possible to purchase weight loss GLP-1 drugs online.
In many cases, all it took was “filling out a questionnaire, putting down a credit card and a driver's license, getting approved within a few hours and having a prescription show up outside of the doorstep one or two days later,” said Ashwin Chetty, a student at the Yale School of Medicine, and lead author of the paper published July 6 in the Journal of the American Medical Association.
The researchers created a patient profile of a 27-year-old man who was obese and pre-diabetic, shopping for a GLP-1 drug for weight loss. They reached out to 49 websites and received prescriptions from 45. Researchers said the ease of access raised red flags about patient safety.
Dr. Reshma Ramachandran, the study’s co-author, and associate professor of general medicine at the Yale School of Medicine, said multiple sites employed the same clinician, who prescribed the medication across different platforms — multiple times to the same patient.
“That is fairly egregious," she said, "especially for these medications when we know there’s side effects that can be pretty serious at certain doses."
Glucagon-like peptide 1 receptor agonists, commonly known as GLP-1s, were first approved by the U.S. Food and Drug Administration in 2005 for treatment of type 2 diabetes, and were later approved to aid with weight loss.
The drugs mimic naturally-occurring hormones which are released from the gut after meals.
According to the Mayo Clinic, GLP-1s boost the amount of insulin our bodies make to keep blood sugar within a normal range and provide the sensation of feeling full. People who take the drugs feel fuller after and between meals, think less about food and have improved glucose levels.
But many commercial insurers and most state Medicaid programs do not cover GLP-1s for weight management, citing costs. The undiscounted retail price for some brand-name GLP-1 drugs can be more than $1,200 per month without insurance, though some manufacturers now offer self-pay plans at lower rates. The Yale study found that the median monthly cost of GLP-1 drugs sold online by telehealth platforms is $217.33, without insurance.
The cost differential stems from the fact that several of these websites in the Yale study sold compounded, non-FDA approved medication. Compounded GLP-1s contain the same active ingredients but different inactive ingredients as brand-name drugs, according to the authors.
A previous study led by Chetty included a larger sample of telehealth websites selling GLP-1s. It found some websites did not disclose that the medications were compounded, and sometimes referred to the compounded version as the brand name option, Ramachandran said.
In the most recent study, researchers said the vast majority of websites did not ask for quantitative patient data prior to prescribing. “About a third asked for the patient to self-report some lab values if they had it on hand, but that wasn't required. Only two websites out of the 49 actually required lab work,” Chetty said.
Even FDA-approved medications come with side effects and contraindications.
“While GLP-1 medications have become a trend, they are not without risks,” said Dr. Vasanth Kainkaryam, a primary care physician in South Windsor. “There are significant side effects that we need to be aware of – pancreatitis, blindness, increased risk of thyroid cancer, gallbladder attacks, that all need to be monitored.”
Kainkaryam said the medications require patients to be engaged in a full program with clinicians who know how they work.
“For example, muscle mass loss is a real problem. You could land up losing weight, but losing healthy muscle mass puts you in a very metabolically unhealthy situation,” he said. “If your diet isn’t adequate with hydration and fiber, the constipation can be very serious, and sometimes the medications can stun your intestines and cause you to be hospitalized.”
The bottom line, he said, is that GLP-1 drugs have great potential for life changing and disease-modifying effects for the right people.
“But just like any drug, they require someone who knows how they work, how they are used in conjunction with lifestyle changes, and what to monitor,” he said.
