Weight loss companies WW and Noom have entered the realm of telehealth prescribing, and now drugmaker Eli Lilly is launching LillyDirect, a service that will link individuals in need of medication for obesity, diabetes, and migraines to virtual medical care and provide direct delivery of medications to their homes. This marks the first instance of a pharmaceutical company taking on such a significant role in coordinating care and delivering its own products, following the approval of its weight loss medication, Zepbound, by the US Food and Drug Administration in November.
CHICAGO, ILLINOIS - JULY 09: This photo illustration depicts Avkare metformin ER 500 mg tablets on July 09, 2020 in Chicago, Illinois. Avkare and several other distributors are issuing a recall for the medication, commonly used to treat individuals with type 2 diabetes, due to the discovery of elevated levels of N-nitrosodimethylamine (NDMA) impurities, a known carcinogen, in the tablets. (Photo Illustration by Scott Olson/Getty Images)
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CNN Exclusive: Older weight loss drugs are making a comeback as Zepbound, Wegovy remain out of reach for many
Lilly affirms that there are no financial ties with the telehealth providers it has teamed up with - 9amHealth, Forum, and Cove. Clinicians using the services have the freedom to prescribe any medications. However, if they prescribe particular drugs manufactured by Lilly, patients can have them delivered directly to their homes, ensuring continuous access, according to a press release from Lilly on Thursday. Additionally, Lilly's drug discounts will be automatically applied for those who qualify. Moreover, in addition to Zepbound, Lilly will make some types of insulin available through the service, as well as its migraine monoclonal antibody, Emgality.
Zepbound imitates the effects of two hormones that are released by the stomach after eating. It boosts insulin production and slows the digestion process, potentially extending the feeling of fullness. It also reduces appetite and cravings by affecting the brain. Clinical trials demonstrated that it led to an average weight loss of 20% over a year. The active components of Zepbound and a comparable drug, Wegovy, experienced a shortage in 2022 due to widespread discussions by celebrities about their weight loss while using the medications.
Zepbound is approved for adults with a BMI of at least 30 who are obese, as well as for individuals with a BMI of at least 27 who are overweight and have a weight-related medical condition such as high blood pressure or high cholesterol. On Thursday, Lilly stated that it opposes the use of its medicines for cosmetic purposes.
"Mounjaro and Zepbound are indicated for the treatment of serious diseases and should not be used for cosmetic weight loss," the company cautioned in a news release. It also warned about the safety risks associated with using compounded tirzepatide, the active ingredient in both Mounjaro, which is approved for diabetes, and Zepbound. Compounding involves mixing or altering drug dosages to create customized medications for individual patient needs. The US Food and Drug Administration permits compounding pharmacies to sell copycat versions of drugs in cases of shortages. Tirzepatide and semaglutide, the active ingredients in Zepbound and Wegovy, are currently listed as being in shortage in the FDA's database.
"Lilly is highly alarmed by the discovery that some of the tested compounded tirzepatide has been found to have significant impurities, and in one case, was merely sugar alcohol," the company disclosed.
FILE PHOTO: Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. REUTERS/Mike Blake/File Photo
Mike Blake/Reuters
Weight loss drug Zepbound is now available, Eli Lilly says
Wall Street responded positively to the LillyDirect announcement, but researchers and patient advocates had questions.
Dr. Peter Lurie, president and executive director of the Center for Science in the Public Interest and former associate commissioner for public health strategy and analysis at the FDA, expressed concerns about the potential conflict of interest when pharmacists and doctors exclusively promote Lilly products. He questioned whether patients' best interests would be prioritized if the recommended drug happened to be a non-Lilly product.
Lurie expressed interest in seeing the FDA's reaction, noting that the agency oversees drug marketing and considers medical conferences as part of its jurisdiction. On the other hand, the FDA avoids commenting on medical practices. Lurie also mentioned that LillyDirect appears to straddle the line between drug marketing and medical practice.
"From a practical perspective, I believe they would be hesitant," he stated. "It does appear to be on the edge, however."
The FDA states that when manufacturers, packers, distributors, or their representatives advertise prescription drugs to consumers and healthcare providers, it is mandatory for these communications to be honest, fair, and not deceptive. The agency mentioned that its regulations may also extend to telehealth providers and websites, depending on their activities and structure. States also have regulations governing the prescription and distribution of drugs.
Associate Professor Dr. Bree Holtz of Michigan State University, a specialist in telemedicine, acknowledges both the advantages and drawbacks of the innovative service. She believes that in rural areas, where accessing educators and specialists can be challenging, telemedicine could be beneficial. Drawing from her experience in diabetes research, Dr. Holtz notes the difficulty of finding an endocrinologist within a 50-mile radius, emphasizing the potential value of this additional resource.
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Holtz expressed doubts about the level of coordination in care that will be achieved. She raised concerns about the lack of seamless information sharing among electronic medical records systems. She questioned how the details of a new drug being prescribed would be communicated to the person's primary care provider. Additionally, she wondered if pharmacists would have access to patients' prescriptions to provide guidance on potential drug interactions, as well as how insurance coverage would factor into the equation.
Holtz expressed optimism about the idea, stating that she believes it will improve healthcare quality in the long-term by providing care to those who currently aren't receiving it.
CNN Healths Meg Tirrell contributed to this story.