Semaglutide (Wegovy), a weight management drug from Novo Nordisk, has been in prolonged shortage due to “unprecedented demand,” leading to heightened — and questionable — interest in compounded formulations of the drug, the doctors said.
Endocrinologists and obesity medicine specialists have sounded the alarm over what they say is contraband semaglutide, concerned about safety and quality as compounders offer lower prices and access easier. Doctors say they are asking more and more questions about the compound semaglutide, even as questions persist about how compounders can circumvent patent protections that are still in place.
“I can tell you that the consensus among legitimate obesity endocrinologists is to steer clear of this, because it’s just too unknown,” said Karl Nadolsky, DO, endocrinologist at Spectrum Health in Grand Rapids. , Michigan.
A simple internet search reveals what endocrinologists are up against. In a blog post, the Compounding Pharmacy of America states that it “combined high-quality semaglutide with L-carnitine, a fat-mobilizing amino acid. This creates a powerful symbiosis of weight loss mechanisms that help you lose weight at a steady rate… Just talk to your doctor to discuss your weight loss needs and determine if semaglutide is right for you.
An Ohio aesthetic medical center called Cru Clinic also promotes the compound semaglutide on its site, with photos of smiling patients on scales and in workout gear. It states that as an alternative to the more expensive semaglutide, “we have access to semaglutide from a compounding pharmacy for continued use” for $300 per month.
The compound semaglutide is described as “generic semaglutide” on other sites, and is sometimes mixed with vitamin B12. Many other websites offer similar locations.
But doctors remain skeptical about compound formulations of the drug.
Ricardo Correa, MD, EdD, director of endocrinology fellowship at the University of Arizona College of Medicine at Phoenix, said compounders “probably use the same pharmacologically active part [semaglutide]but when you combine things and add different excipients, the effectiveness – if you don’t measure it in a randomized controlled trial – won’t be the same.”
Fatima Cody Stanford, MD, MPH, obesity specialist at Massachusetts General Hospital in Boston, said, “I guess they make a close agent,” but “I can’t risk anything with my patients. I need to see data to support use.”
Physicians’ concerns about these products may also stem from memories of a 2012 outbreak of fungal meningitis linked to methylprednisolone acetate injections made by a compounding pharmacy that killed 64 patients in the United States and sickened nearly 800.
Under less stringent regulations, some said compounding pharmacies had become “de facto” small drug makers, so Congress then passed compounding reforms.
Yet compounding pharmacy groups say they are within their rights to use semaglutide in products – hypothetically speaking.
The Alliance for Pharmacy Compounding (APC) industry group wrote in an email to MedPage today that semaglutide probably meets the necessary criteria to be eligible for use in compound products, because it is not considered a “biologic”, which cannot be used in compound drugs, and it is a component of an FDA-approved product.
But APC has not acknowledged that compounding pharmacies actually use the same substance, protected by Novo Nordisk’s patents, in compounded substances.
“We didn’t say semaglutide powder was available to mix, or that pharmacies should compound semaglutide, just that it IS a peptide that meets the criteria,” the email reads.
A spokesperson for the FDA’s Center for Drug Evaluation and Research (CDER) also did not rule out the possibility, noting that under federal law, a drug used in compounding is exempt from normal approval. of the FDA if it is “manufactured using a bulk drug substance (active ingredient) that is a component of an FDA-approved human drug, provided all other conditions are met” , the spokesperson wrote. “Semaglutide is the active ingredient of an FDA-approved pharmaceutical product.”
APC also argued that the preparers were stepping in to fill a gap in Wegovy’s supply.
“The fact is, Wegovy has been out of stock by the manufacturer and is currently on the FDA’s Drug Shortage List – a distinction that means 503a preparation pharmacies MAY be able to compound it,” the statement reads. ‘E-mail.
However, the organization encouraged dispensing pharmacies to consult a lawyer.
The FDA also wrote that although the law restricts the preparation of drugs that are “essentially a copy” of commercially available pharmaceuticals, “we do not consider a drug to be commercially available when it appears on the FDA drug shortage list. Currently, we note that Semaglutide Injection (WEGOVY) is on the FDA drug shortage list.”
Despite the potential loophole, Novo Nordisk – which holds multiple patents protecting its semaglutide drugs, including the diabetes drug Ozempic – said in an email to MedPage today that entities selling products containing semaglutide “may infringe Novo Nordisk’s intellectual property rights and/or violate applicable laws. Novo Nordisk will take such actions as it deems necessary and appropriate to protect its intellectual property rights.”
Doctors also found it perplexing that compounding pharmacies could obtain the patented substance.
“Nobody knows how they get it,” Nadolsky said of compounding pharmacies. “Who makes it? Novo doesn’t give it to them. They own the rights to the molecule, so how can anyone get semaglutide?”
Jacob Sherkow, JD, professor of law and medicine at the Illinois College of Medicine, said MedPage today that most active pharmaceutical ingredients that a compounding pharmacy would use are not actually synthesized at the compounding pharmacy.
The substances are purchased outside the United States, where the chemicals are cheaper to manufacture, in countries like China and Ukraine, then mixed with inactive ingredients and put into syringes at the pharmacy, Sherkow said.
Even so, semaglutide that is “manufactured, used, sold, offered for sale, or imported into the United States is possibly an act of infringement, if Novo were to sue them, if they had a U.S. patent covering it all” , Sherkow said. A lawsuit, however, would cost time, money and be complicated by patents that could cover a “pharmaceutical formulation” – essentially a finished product – and not the active ingredient itself, he said.
Sherkow noted that compounding pharmacies play a crucial role for patients who need them, but they are not without risks.
“The vast majority of restaurants, with some – but minimal – oversight handle food that isn’t prepared properly and could easily poison us,” he said in an analogy. “And they do it every day, millions of times a day. A compounding pharmacy operates in a similar space.”
But endocrinologists and obesity specialists reiterated that they would not prescribe compound semaglutide. For them, the stakes are higher than food poisoning.
Stanford said for all of her patients, she wonders, “Would I be comfortable? And if I myself wouldn’t be comfortable receiving it, then I don’t need to prescribe it to anyone else.”
She added: “I understand that we are frustrated because we cannot obtain the GLP-1s. [glucagon-like peptide-1 receptor agonists, the drug class semaglutide falls into]but just because we live in desperate times doesn’t mean we use desperate measures.”
Correa added that a patient asked him about the compound semaglutide last week. But that without knowing exactly what it contains and how it works is simply too risky for the patient – and for him as a doctor.
“You treat 100 patients and all of them are doing well on a compound drug that you recommend. One develops a problem.” Correa said, in a hypothesis. “That’s it. It’s the end of your career.”