by Sherri Thomas, DO and Raj Selvaraj, Pharm.D, R.P.
If it sounds too good to be true, it probably is. Though this saying may start to sound trite over time, it still carries wisdom. The claims being made about compounded semaglutide, and now tirzepatide, may be too good to be true and consumers, along with healthcare providers, need to be wary of this unregulated product.
Many of us have been able to see first-hand with our patients what was seen in the STEP trials – an average of 17% total body weight loss. The tirzepatide trial for Obesity had an average of 20.9% total body weight loss in patients receiving the 15mg dose. In our everyday practice, however, we most certainly are not able to get it for all our patients who qualify for it. It is safe to say that the cost and general inaccessibility of the GLP-1’s has been frustrating for all Obesity Medicine Specialists, Endocrinologists, PCPs, and many other providers. There has been no end to the prior authorizations, subsequent denials, medication shortages, adequate stock rumors, disappointment when it isn’t back in stock, and the drama has gone on and on. It has felt very much like the ups and downs of yo-yo dieting! It’s no wonder when compounding pharmacies showed up touting endless supplies of these game changing medication at a fraction of the cost, many jumped on board to prescribe or even dispense it to their patients.
However, that’s when we need to remember that while the practice of medicine is how we make our living, we first need to hold ourselves to a higher standard because that’s what our patients trust us to do. When something sounds too good to be true, we need to take a step back and examine the evidence to make sure that we honor the oath we took to first do no harm.
It is known for certain that the semaglutide being sold by compounding pharmacies is not being supplied to them by Novo Nordisk, the company holding the patent. In fact, Novo Nordisk has been issuing cease and desist letters to pharmacies claiming to compound semaglutide. So where are their wholesalers getting it from? Part of the approval process is releasing the polypeptide, so a skilled pharmacist or chemist would be able to produce it. But how does anyone know for sure that what they are getting from a wholesaler is the authentic product, the potency and the purity they claim it to be? How does oversight of the drug wholesalers work?
When a drug is generic and part of the US Pharmacopeia monograph, the products the wholesalers provide in bulk to the compounding pharmacies are submitted to a USP certified 3rd party to be verified. They are verified for 1. True Identity 2. Potency and 3. Purity. However, this cannot be the case with the compounded semaglutide being distributed. Either Ozempic and Wegovy are being diluted, or it’s being made with no FDA approved oversight. Stringent processes need to be followed in producing human medications and there is plenty of room for error. Even the FDA allows for 10% variance in potency. If this bulk semaglutide is not being controlled for quality, what is being disseminated without verification could easily vary even more regardless of having knowledge of the polypeptide.
Furthermore, many suppliers are selling the sodium salt of semaglutide. While some salts are considered by the FDA to be therapeutic alternatives (not therapeutic equivalents), this is not even the case with the sodium salt of semaglutide. All of this should be concerning to prescribers. Not only because the FDA has gone after manufacturers and prescribers dispensing products in this manner in the past, but also because of the ethical and safety concerns.
You would never give your child acetaminophen or even vitamins that had not been USP verified. Giving antibiotics that were not produced by an FDA approved manufacturer to a septic patient would be unconscionable. Many endocrinologists even prefer name brand Synthroid to generic levothyroxine because the variability in potency is too unpredictable between manufacturers. So why would we be ok with this kind of uncertainty in our patients with Obesity? These patients are already at high risk for being taken advantage of by the weight loss industry. We should not be surprised that many patients may be blinded to the risks of these compounded medications due to their inability to access it through appropriate avenues. We must have compassion for the bias and stigma they have no doubt experienced and understand the desire to utilize these medications. However, it is our job to educate them about the risk of infection, ineffective therapy, adverse effects, and drug-drug interactions. As prescribers, we should have no part in taking advantage of our patients or putting them at risk, and we should counsel patients against seeking these substances outside of our care.
In addition, much of the compounded semaglutide is being combined with carnitine or B12. This is not what was studied in the trials that were done with semaglutide. We have no idea how this affects bioavailability or efficacy.
If compounded semaglutide isn’t the answer, what is? With Wegovy we have a medication that resulted in at least a 20% total body weight loss in 50% of the patients who received it. That is approaching the efficacy of a gastric sleeve 2-3 years post-op and yet we can’t get it for our patients who need it. We know there are more medications in the pipeline that will be even more effective, but even then, access will likely continue to be an issue. And in the end, is the answer to the epidemic of Obesity truly to have 50% of the population on GLP-1’s indefinitely? The current situation with Obesity requires us to change what we are doing.
In this case, we need more providers to understand Obesity and what makes it a chronic disease that needs to be managed chronically. We need more providers to have early and compassionate conversations with patients about lifestyle modification. We need more providers to be better versed on the resources that exist within our communities that can help patients build healthier lifestyles. We need more providers to use evidence-based medicine to treat the appropriate patients with appropriate measures. We need more providers to advocate for patients to have access to all the tools in the toolbox. This does not mean that any given person should be prescribed all the tools. It does mean that all the tools should be available so that providers can decide what is appropriate for their patients, and from there patients can choose what is right for them. The same patient-centered, evidence-based approach that applies to every other disease needs to apply to Obesity.
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