Should Pharmaceutical Companies Sell Weight-Loss Drugs Directly to Consumers?

This story is part of a series called “Ozempic: Weighing the Risks and Benefits.” It was produced in part through a grant from the NIHCM Foundation.

Just a few months after Eli Lilly’s tirzepatide (Zepbound) was approved to treat obesity, the pharmaceutical company in January 2024 launched LillyDirect, a digital health platform for patients with obesity, diabetes, and migraine.

Pfizer — which is developing a once-daily weight-loss pill — followed this summer with PfizerForAll, a digital health platform for patients with migraine.

Both offer a connection with doctors right from their home page, albeit through third-party telehealth companies. These are the first two examples of pharmaceutical companies making quicker connections between their products and patients.

That has raised flags for some, including four U.S. Senators led by Sen. Dick Durbin (D-Ill.), who pressed Eli Lilly and Pfizer about their relationships with those telehealth companies, questioning whether the companies may be violating a federal anti-kickback statute.

In their letters to the companies, the Senators charged that the “arrangement appears to steer patients toward particular medications and creates the potential for inappropriate prescribing.”

Physicians interviewed by MedPage Today also raised questions about potential conflicts of interest inherent in these relationships.

Pharma Connects Patients With Doctors

Within just a few clicks, LillyDirect connects patients to independent telemedicine providers through Form Health or 9amHealth.

A spokesperson for LillyDirect told MedPage Today that these providers “are fully independent from Lilly, exercise autonomous clinical judgment in evaluating and making care decisions, are not incentivized to prescribe Lilly medicines, and do not provide any compensation to Lilly for referrals.”

The fact that patients don’t necessarily need to get a prescription through their existing medical team worries Osama Hamdy, MD, PhD, director of the obesity clinical program at the Joslin Diabetes Center and associate professor of medicine at Harvard Medical School in Boston.

“I don’t think it’s safe for patients to bypass their regular PCP or obesity specialist to get the drug through any channel,” he said. “We need to respect the safe medical pathway of patient-physician-pharmacy to monitor prescription of these medications.”

Conversely, Eduardo Grunvald, MD, medical director of the weight management program at UC San Diego Health, sees less of an issue as long as there is a legitimate prescriber. Some of his patients have found it easier to get access to tirzepatide during shortages using LillyDirect.

“I just don’t think that there’s enough of us obesity physicians or obesity specialists to handle the enormous amount of patients that could benefit from these drugs,” Grunvald said, adding that people wanting to see obesity specialists often face long wait times. “If it improves access, then I’m okay with it, as long as there is a responsible prescriber managing the medication.”

However, he acknowledged that when there’s less of an established relationship with a provider, it’s possible for patients to more easily lie about their symptoms to get access to the drug, which increases risks.

Hamdy added that weight-loss drugs can have serious, potentially dangerous side effects, like pancreatitis or significant muscle mass loss, and working with a primary care doctor or obesity specialist ensures someone is monitoring the patient’s health.

Conflicts of Interest?

Ateev Mehrotra, MD, MPH, of Brown University School of Public Health in Providence, Rhode Island, said this type of telehealth approach flips the traditional model of care on its head.

“When I went to medical school, we were told what we do is we interview the patient, we figure out what the problem is, make the diagnosis, and prescribe or push forward with the appropriate treatment,” Mehrotra said.

In some direct-to-consumer telehealth pathways, patients instead come in seeking a specific solution. The doctor’s role then is to screen the patient to see if they’re eligible, then prescribe the desired medication. “You’re starting at the end as opposed to the beginning,” Mehrotra said.

He also noted that the conversation operates under the assumption that having more Americans on weight-loss drugs is a net positive.

“As a society, we really want more people to be on these meds,” said Mehrotra. But the flip side of that perspective, he said, is that prescribers could be viewed as “just pill pushers, and they’re really just shoveling out the medications inappropriately.”

On its website, Lilly said it has “taken a vocal stance against the use of obesity medicine for cosmetic weight loss” and that it has a multi-step verification process to ensure only eligible patients get the drugs.

Christopher Robertson, JD, PhD, professor of health law at Boston University, said that while there are some checks in place, the duty to act responsibly ultimately comes down to physicians.

“Physicians using their judgement and ethics really … are the linchpins to make sure that we’re not just pillaging patients in terms of their pocketbooks and their health,” he said. “When the doctors just become a cog in this huge company that’s really designed to just sell product, then you get this conflict of interest, and ultimately a potential distortion of prescribing and potential risk to patients.”

Robertson did note that there are some laws that help curb overprescribing and limit how telemedicine and virtual health platforms advertise products. For instance, anti-kickback laws, which primarily apply to Medicare and Medicaid, prohibit financial or other incentives for prescriptions or referrals. Also, companies aren’t supposed to market their products beyond the labeled indication, even though doctors can prescribe beyond the labeling.

“At the end of the day, the U.S. healthcare system is terribly inefficient in the way it delivers care, and I’m excited when I see innovations that try to solve it,” Robertson said. “But the flip side of that coin … is it creates potential conflicts of interest.”