There’s a war brewing over blockbuster weight loss medications — and patients are now getting caught in the crossfire.
Last week, the Food and Drug Administration declared an end to the shortage of Eli Lilly’s tirzepatide, sold under the brand name Mounjaro for diabetes and Zepbound for obesity. The move was a clear warning to compounders that they can no longer make copycat versions of the drugs — a process that is only permitted when the medications are on an official agency shortage list.
On Thursday, Lilly, which has long warned about the risks of knockoff products, also ramped up its fight against compounders, reportedly sending hundreds of cease-and-desist letters telling them and telehealth platforms to stop making their versions.
At the same time, despite the FDA’s declaration, pharmacies are still having trouble getting Lilly’s treatment in stock. And even if they had supplies, many patients still can’t afford the branded drugs, which carry a list price of over $1,000 a month and are not widely covered by insurers. Lilly last month introduced what it called discounted vials of Zepbound, but they’re only offered at the lowest doses and some patients say they’re still too expensive.
“There’s a whole cohort of individuals who are finding success in using compounded tirzepatide to treat obesity, and those are the individuals who are at highest risk of losing those health benefits with the end of this shortage and the enforcement of the patent form of the medication,” said Beverly Tchang, an obesity medicine doctor at Weill Cornell Medicine. Tchang has not personally prescribed compounded products, but she’s an adviser for Ro, a telehealth platform that does.
Many patients, Tchang and other experts said, now face a near-impossible situation, with their access to both compounded and branded versions uncertain.
That could bring health risks if patients suddenly stop taking tirzepatide because they run out. Not only could they regain weight, but they could also see the return of conditions that had been addressed by the treatment — such as high blood pressure or blood sugar. Some research also suggests that weight cycling, the process of losing and then regaining weight, can in itself introduce health risks.
Experts also fear some patients may turn to dangerous alternatives. On online forums, users have indicated they may start stockpiling and rationing compounded supplies, which could present health risks if they use the treatments past their expiration dates. Some users have said that they plan to lose as much weight as they can before they run out of the drugs, but jumping to higher doses too quickly could lead to more severe vomiting and other gastrointestinal side effects than they would otherwise experience on the treatments.
Meanwhile, counterfeit drugs and what some websites have advertised as “research chemicals” that are not regulated, present further risk.
For now, the compounding of semaglutide, the scientific name of Novo Nordisk’s Ozempic and Wegovy, is still permitted, as the branded versions are still on the FDA shortage list. Some patients who have been using tirzepatide may be directed to use that drug instead. But it would take time for patients to get a new prescription, and semaglutide is not as potent as tirzepatide.
And as the current situation foreshadows, semaglutide could come off the shortage list at any time, leaving patients with even fewer options.
“A lot of people don’t understand how temporary those compounding allowances are,” said Erin Fox, a pharmacist at the University of Utah who tracks drug shortages. “It seems like people really started to rely on those products that were never — they were always kind of doomed.”
Supply of branded drugs still uncertain
Even though the FDA said the tirzepatide shortage has been resolved, pharmacies around the country say it’s still difficult to get ahold of the treatment. A drug shortage database managed by the University of Utah Drug Information Service still lists the medication in shortage, since it continues to get reports from pharmacies and patients, Fox said.
Mark Boesen, founding partner of the law firm Boesen & Snow, which represents compounders and traditional pharmacies, said that a pharmacy in Utah he represents tried to order several hundred doses of the branded product recently. But the pharmacy’s wholesaler, Cardinal Health, told them it would take six months to supply them that amount.
As of late Wednesday, the Cardinal distribution center with which the Utah pharmacy places its orders had in stock only a range of 29 to 67 boxes for each dose of Zepbound and a range of 88 to 308 boxes for each dose of Mounjaro, according to Boesen. One box contains just one patient’s one-month supply, and the distribution center covers pharmacies across multiple states — Utah, Nevada, Idaho, and Wyoming, Boesen said.
In Arizona, where Boesen is based, pharmacies are not allowed to order more than two boxes a day and more than 12 boxes a week. One of Boesen’s clients in the state orders from the distributor McKesson, which still has one of the higher doses of Mounjaro on backorder, he said.
For Boesen, it’s also a personal issue. He himself takes Zepbound, and over the past few months, he was able to get it since he knows all the local pharmacists.
The ongoing shortage of the weight loss drug tirzepatide, marketed as Zepbound, has left patients like Boesen in a state of uncertainty and fear. Despite the FDA’s announcement that the shortage had been resolved, pharmacies have been unable to procure the drug for him. Boesen, who has experienced significant health improvements since starting on the medication, is now concerned that all his progress will be undone if he can’t access the drug.
Boesen’s story is just one example of the challenges faced by patients trying to obtain Zepbound. The FDA’s approach to declaring the shortage resolved has raised concerns among healthcare professionals like Boesen, who believe the agency should ensure there is enough supply before removing a drug from the shortage list.
Dr. Tchang, an obesity specialist, shares this cautious approach, emphasizing the importance of a stable supply before prescribing Zepbound to patients. The unpredictability of the market and the potential for a surge in demand could lead to another shortage, undoing any progress made by patients.
Even if the supply issues are resolved, many patients may still struggle to access Zepbound due to its high cost. Insurance coverage for obesity drugs is often limited, leaving patients to bear the financial burden themselves. Lilly’s recent move to offer Zepbound in vials at a lower price may not make the drug more accessible to all patients, as higher doses and insurance coverage limitations remain barriers.
The availability of compounded weight loss drugs has provided an alternative for some patients, but it comes with its own set of risks. Compounded medications are not FDA-approved and may not undergo the same level of scrutiny as branded drugs. Telehealth providers have capitalized on the demand for compounded drugs, but questions remain about the quality of care provided through these platforms.
While regulated compounding pharmacies could provide a solution, the current system lacks standardization. Dr. Tchang acknowledges the role of compounding in filling a gap in the market but highlights the importance of ensuring quality and safety for patients.
As the debate over access to weight loss medications continues, experts like Joshua Sharfstein emphasize the need to balance innovation and affordability. While branded drugs offer the gold standard in treatment, their high cost can limit accessibility for many patients. Finding a solution that ensures both quality and affordability remains a challenge in the ongoing weight loss drug shortage. After careful consideration, it is clear that the most optimal solution to the issue at hand is to make authorized medicines more affordable. This statement highlights the importance of ensuring that essential medications are accessible to all individuals, regardless of their financial situation.
The cost of prescription drugs has been a major concern for many people, especially those who are struggling to make ends meet. High prices can prevent individuals from obtaining the medications they need to maintain their health and well-being. This is a serious issue that needs to be addressed in order to ensure that everyone has access to the treatments they require.
By making authorized medicines more affordable, we can help alleviate the financial burden placed on individuals and families. This will enable more people to get the medications they need without having to worry about the cost. Access to affordable medicines is essential for maintaining a healthy society and ensuring that no one is left behind due to financial constraints.
In order to achieve this goal, it is important for pharmaceutical companies to reevaluate their pricing strategies and prioritize the well-being of patients over profits. By reducing the cost of authorized medicines, we can make healthcare more accessible and equitable for all individuals. This will have a positive impact on public health and well-being, as more people will be able to afford the treatments they need to stay healthy.
In conclusion, the best solution to the issue of expensive authorized medicines is to make them more affordable. This will help ensure that everyone has access to the medications they need to maintain their health and well-being. By prioritizing affordability and accessibility, we can create a healthcare system that works for everyone, regardless of their financial situation. It is time to take action and make authorized medicines more affordable for all.
