Compounded weight-loss drugs raise serious patient safety concerns

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JEREMY MAGGS: The global boom in weight-loss and diabetes drugs like Ozempic has opened, I think, a lucrative gap in the market and compounded alternatives have rushed in to fill it. But right now, regulators are asking a far sharper question – are some of these cheaper versions exposing patients to products whose quality, dosage and safety cannot necessarily be guaranteed?

In that respect, I want to have a conversation with Charles Green, healthcare and pharmaceutical expert at the law firm Cliffe Dekker Hofmeyr, and I want to discuss the legal, clinical and commercial risks that seem to be coming to a head.

Charles, a very warm welcome to you. We’ve seen this extraordinary demand for GLP-1 drugs and it’s created a market, I think, where commercial appetite is maybe outpacing patient safety. Is that the case and what are your concerns?

Read: Meds regulator warns against ‘fake’ Ozempic-like products

CHARLES GREEN: Yes, thank you very much for having me. I think you’ve rightly alluded to the fact that compounded GLP-1s have found a massive increase of popularity amongst consumers worldwide, so much so that the supply and demand for it is actually lopsided.

The concern, and I think the main concern with compounded GLP-1s, is that they are not actually assessed or tested by the applicable regulators, so the FDA (Food and Drug Administration) in America and Sahpra (South African Health Products Regulatory Authority) in South Africa.

So there are risks to consumers who do consume compounded GLP-1s, and I think that’s the main risk with it right now.

JEREMY MAGGS: Now many consumers, and again just test my thinking here, would assume that compounded medicine is just a cheaper equivalent. You’re going to tell me, I think, that that is misleading or even dangerous, and t’s a very wrong assumption to make, right?

CHARLES GREEN: Yes, it’s the assumption many people make. In the context of cheaper medicine, you’re looking at generic medicines which are still Sahpra approved, they have to go through dossier testing. Their samples will go through clinical testing and then they will be registered by the regulator.

Compounding medicine is different. It serves a different purpose. Compounding medicine is used when there is no supply of the originally registered medicine. It’s just not there anymore.

So a pharmacist who is licensed to issue compounded medicine can issue compounded medicine to fill that gap, provided it meets certain requirements. So that’s essentially what compounded medicine is. It’s not actually registered under Sahpra. You won’t find a Sahpra licence for compounded drug.

Read: Aspen Pharmacare eyes Canada GLP-1 generic approval by September

JEREMY MAGGS: Sahpra, of course, is the regulator and it’s warned that some of these compounded products may be substandard or falsified. Tell us what that means, Charles, and in practical terms then, how real is that risk for patients?

CHARLES GREEN: Sahpra has issued, I think, two communications insofar as it concerns compounded GLP-1s and the first is that they’ve noticed an entry into the market of unregulated compounded drugs, so those are drugs where the actual active pharmaceutical ingredients are not registered with Sahpra. So they have no way of confirming the safety or the effects or what could happen to patients who take it.

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They’ve also noticed that it’s being sold by people who aren’t regulated, so those are not regulated or licensed pharmacists. They’ve seen it from online websites, you may see it from weight-loss practitioners and so forth, not actually doctors and pharmacists who are actually selling the product. So that’s their first concern.

Then later on, they released another communication to the market saying, look, we actually want to declare all compounded GLP-1s as undesirable, which means they can no longer be sold in South Africa due to the safety concerns with making these compounded GLP-1s.

JEREMY MAGGS: Charles, I’ve got two questions then. One is what is the volume that we’re talking about here in terms of these compounded products. Secondly, if the regulator were to declare certain products undesirable, I think you’ve used that word, could a significant portion then of the local market effectively disappear overnight?

CHARLES GREEN: Yeah, I think the main risk for compounded pharmaceutical companies is that the effect of the regulators saying your product is actually undesirable means that you can no longer sell it in South Africa. So your market is completely gone.

Sahpra hasn’t made a decision on it yet, it’s just issued a communication. So we are still yet to see.

But the volume of compounded medicine being sold, not only locally but globally, is absolutely massive.

It’s almost created its own market within pharmaceuticals, particularly with weight-loss drugs. So it’s absolutely huge.

JEREMY MAGGS: What kind of legal exposure then, do pharmacies or clinics or weight-loss businesses or practitioners face if they supply or facilitate access to products that regulators maybe later deem impermissible?

CHARLES GREEN: As it stands, currently, at least in the South African perspective, there are certain provisions that you have to meet to dispense compounded medicine. If you’re not meeting those provisions, then you’re in breach of the act, it’s unlawful, you can be met with a fine, you can be met with a criminal sentence.

Read: The appetite for GLP-1 drugs grows

But perhaps more importantly, and what we’ve seen in America, is that the people who are affected by taking your compounded drug, can submit a legal claim against you for any damages that occurred to them.

We’ve seen a lot of class actions in America against pharmaceutical companies, particularly with reference to compounded GLP-1s. So that’s also something that could happen to those practitioners.

JEREMY MAGGS: Does the regulator itself have enough capacity to either police or enforce this problem?

CHARLES GREEN: That’s a great question. Personally, I don’t think so. With anything where there’s a high demand and a lot of people can’t get it, people will find alternatives to it.

To know where it’s being sold, to know how it’s being sold, how people are taking it, if they’re taking it as prescribed or not, it’s very difficult. I don’t think Sahpra has that capacity right now.

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JEREMY MAGGS: The blunt question then that South Africans should be asking, and this is the last question to you, is not can I get this cheaper, but maybe more pertinently, do I know what I am being injected with?

CHARLES GREEN: Yes, 100%. Perhaps the public should be more cognisant of where they’re getting it from. You want to be going through regulated channels, proper pharmacists or doctors who registered under the Health Professions Act. You don’t want to be getting it from websites or from a weight-loss practitioner. You want to get it from the proper source to ensure that you actually are injecting something that is safe into you.

Read: Local insulin production could reshape diabetes care across Africa

JEREMY MAGGS: Yeah, I suppose that lesson applies to any medicine, really. Charles Green, thank you very much indeed, healthcare and pharmaceutical expert. He’s with the big law firm, Cliffe Dekker Hofmeyr. I appreciate your time.