Ozempic, initially approved for Type 2 diabetes, has become a blockbuster due to its weight-loss potential. Its off-label use for weight loss led to shortages in the US as early as 2022. This shortage has made Ozempic a highly recognized and expensive drug, comparable to the Taylor Swift Eras Tour in its notoriety.
Compounded Medications: A Solution to Drug Shortages
In response to drug shortages, US pharmacies can create “compounded” versions. Unlike FDA-approved generics introduced post-patent expiration, compounded medications are custom copies made for specific reasons like shortages. These substitutes bypass normal approval processes, effectively legalizing “dupes” without waiting for patents to expire. Consequently, telehealth startups have entered the GLP-1 market, offering low-cost compounded drugs.
The Telehealth Marketplace Investigated
Over the past two months, WIRED investigated ordering compounded semaglutide—the active ingredient in Ozempic and Wegovy—from top US telehealth companies. The focus was on brands aggressively advertised on social media. The goal was to test the vetting process for potential patients and determine the documentation needed to purchase these drugs.
Findings
It’s surprisingly easy to get these prescription drugs, even without medical need. The investigation revealed that very few companies required lab work or medical records. Most didn’t require a short video conference or a simple phone call.
Intake Processes for Compounded Medications
Each company begins the intake process by asking health-related questions. These questionnaires are quick and easy to fill out. Alan Meds claims it only takes five minutes.
Some companies request full-body photos and copies of official IDs. All have healthcare providers review the answers, but only Henry requires a synchronous video conference. This brief interaction led to a treatment adjustment, steering towards the injectable version due to its higher efficacy.
State-Specific Protocols
According to WIRED, these processes were tested in Illinois. Some telehealth companies have different vetting protocols based on state laws. For example, Hims primarily offers asynchronous visits unless real-time video conferences are required by state law.
Testing Integrity
When filling out intake questionnaires, one weight detail was adjusted to ensure a BMI of 27, the threshold for FDA-approved semaglutide use for weight loss. This test aimed to see if companies would verify the information.
Company Responses
Hims didn’t offer GLP-1 meds despite accepting the exaggerated weight. It recommended a different drug combination and didn’t allow changes to the answers to qualify for GLP-1 meds. Get Thin MD accepted but declined the credit card repeatedly, so no medication was shipped. The other four companies sent vials of semaglutide without asking for proof of BMI or weight-related ailments. They provided instructions for safe injection, with Henry offering a clear visual tutorial.
Safeguarding Measures
When asked about measures to prevent exaggerating weights for medications, ReflexMD and Henry didn’t respond. Ro stated licensed providers review each online visit and may require a metabolic health lab test if necessary. Alan Meds emphasized adherence to FDA guidelines, assessing various factors to determine eligibility. They also ordered a metabolic lab test but didn’t require completion before shipping.
Circumventing Guardrails
WIRED’s experience suggests it’s easy to circumvent existing guardrails. People not meeting the criteria can still obtain these drugs with minimal difficulty.
Potential Market Size
Telehealth companies are coy about numbers. He reported thousands of visits since launching. The FDA doesn’t have data available. However, nearly 74% of US adults might benefit from these medications for weight management, diabetes treatment, cardiovascular health, or aesthetics.
Advertising and Market Trends
Telehealth companies advertise heavily on social media, emphasizing similarities to brand names and offering discounts. LegitScript has noted a spike in problematic GLP-1 ads, including false claims and ads from unlicensed pharmacies. A rise in telehealth providers and counterfeit drugs highlights the booming market.
Quality Concerns
Compounding pharmacies play a crucial role but have faced regulatory issues. Australia recently banned compounding GLP-1s citing safety concerns. The FDA advises caution as compounded drugs don’t undergo the same safety evaluations. Some compounding pharmacies have landed in trouble for practices, and the FDA has found issues with pharmaceutical companies too.
Future of Compounding
As demand for GLP-1 drugs remains high, shortages may continue. Telehealth companies might not pivot away from compounding even if shortages end, maintaining the supply of compounded medications to meet growing demand.
Conclusion
The booming telehealth market for compounded GLP-1 medications shows no signs of slowing down. With a vast potential customer base and high demand, the industry continues to grow despite regulatory and safety concerns.
Source: WIRED