Harmony Hub Health
Functional Medicine, Hormone Health and Weight Loss with Michele Postol, CRNP
Harmony Hub Health
Hormone Hogging: How Big Pharma Wants All the Bacon for Desiccated Thyroid Treatments
A century-old medication suddenly deemed unsafe? The FDA's unexpected crackdown on desiccated thyroid extract (DTE) has left 1.5 million Americans questioning their treatment options and wondering about the true motivations behind this regulatory move.
Desiccated thyroid extract—ground-up pig thyroid glands turned into pill form—has been helping patients feel human again since the late 1800s. These natural thyroid medications contain both T4 and T3 hormones, making them particularly valuable for patients who struggle with conversion issues. When synthetic options like Synthroid (which contains only T4) leave patients with normal lab results but persistent symptoms, DTEs have historically provided relief.
The FDA's recent letters to manufacturers reclassify these medications as biologics, placing them in the same category as vaccines and monoclonal antibodies. This move requires manufacturers to complete Biologics License Applications within just 12 months—a process typically costing over $100 million and requiring extensive clinical trials. For medications that represent only 6% of the thyroid market, this financial hurdle is effectively insurmountable.
The timing and nature of this decision raise serious questions. Why, after more than a century of safe use, is the FDA suddenly concerned about medications that have helped millions? Could the fact that 1.5 million DTE users would be funneled toward synthetic options produced by pharmaceutical giants be relevant? While the FDA cites concerns about standardization (DTEs are dosed in "grains" rather than micrograms) and purity, many patients and practitioners see this as a thinly veiled attempt to eliminate patient choice and competition.
As a functional medicine practitioner, I understand that thyroid health doesn't exist in isolation. Mineral balance, adrenal function, gut health, and toxic burden all play crucial roles in thyroid function. If you're currently using DTE, don't panic—work with a knowledgeable provider to develop a transition plan. Testing like Hair Tissue Mineral Analysis can reveal underlying factors affecting your thyroid health, allowing for targeted support as you navigate these changes.
Your body deserves more than a one-size-fits-all approach. Visit harmonyhubhealth.com to book a consultation and create a personalized plan that addresses the root causes of your thyroid concerns while navigating this changing regulatory landscape.
Welcome to Harmony Hub Health, where my mission is to provide comprehensive, affordable, integrative care that addresses the root cause of health issues. At the Hub, the focus is on individual patient journeys. I strive to optimize health, vitality and longevity, fostering a community where each person can thrive in body, mind and spirit. Today I'm going to talk about the world of desiccated thyroid extract, also known as DTEs. It's the old school pig derived thyroid medicine that's been helping people feel like humans again for over a century. But now the FDA has decided to crack down and the timing has me raising an eyebrow. Is this really about safety or is it just another move by big pharma to hog pun intended all the hormones and keep a monopoly on thyroid medications like Synthroid? We're going to dig in because the debate over pig pills, patient choice and profit margins is really heating up in my head.
Speaker 1:Desiccated thyroid extract, known as the DTEs think Armour Thyroid, np Thyroid, nature Throid. You know they all have roots stretching back to the late 1800s. They're made from dried and powdered animal thyroid glands, often porcine pig. It contains a blend of T4, t3, and some other thyroid components. Over time, synthetic levothyroxine, which is synthetic T4, and lyothyronine, which is synthetic T3, overtook DTE in popularity because of big pharma, but, despite its historical use, the majority of US patients now use synthetic hormone replacements. It's covered by their insurance. In 2024, about 94% of some 24 million thyroid replacement users received synthetic levothyroxine, while only about 1.5 million, or 6%, do rely on those DTEs.
Speaker 1:And you would think, after 100 plus years of helping people, desiccated thyroid extracts would be considered a safe bet. It's been over 100 years. It's literally the OG thyroid medicine pig thyroid ground up, turned into a pill. I know it doesn't sound very sexy at all, but very effective for millions of people. Absolutely, it is effective, and it has been for over a hundred years. But now, in 2025, the FDA, clutching their pearls, announces that these natural medications are unsafe and not approved anymore. They need to come off of the shells, and this is where I have to roll my eyes. For as long as I've been a prescriber which has been what the last 15 years um, armor thyroid has been a great treatment. It does mix um some natural T4 and T3, even some extras like T2 in some of these DTEs, and for many people it worked when synthetics like levothyroxine did not. I mean, these medicines have been used before women even had the right to vote. I have seen so many patients that have a conversion problem. They cannot convert T4 to T3. But the FDA is suddenly treating it like a sketchy new fad supplement that you'd find on TikTok. On August 6, 2025, the FDA issued letters to manufacturers, importers and distributors of unapproved animal-derived thyroid products. The agency states that these products lack FDA-approved biologics license application this is known as BLA and they pose a safety, purity, potency and consistency concerns. And I have to agree, you know, sometimes dosing isn't perfectly consistent, but neither is Starbucks coffee and we're all still addicted.
Speaker 1:One of the quirks of desiccated thyroid extract is how it is dosed. Unlike Synthroid, which comes in neat little microgram pills like 25 micrograms, 50 micrograms DTE is dosed in grains. So yes, it sounds like we're measuring rice at a health food store, but it is a little bit more precise. So one grain is about 60 to 65 milligrams of DTE. That typically contains 38 micrograms of T4, 9 micrograms of T3, give or take depending on the brand. So dosing can be anywhere from half a grain to several grains per day, depending on the brand. So dosing can be anywhere from half a grain to several grains per day, depending on that person's needs.
Speaker 1:And FDA is saying that grains aren't standardized enough. And okay, fine, grains do sound a little wild west compared to milligrams and micrograms. But let's not forget, millions of people have been dosing this way for over a century without spontaneously combusting. In fact, patients and practitioners often prefer greens because you can titrate these doses in small increments, like a quarter of a green, half a green, to fine tune how a patient feels. And DTE already contains T3. So people who don't convert T4 to T3, they can really feel the difference and the dosing flexibility often beats that one size fits all Synthroid script. So, yes, grains might not fit Big Pharma's shiny standardized pill chart, but for patients who finally got their energy, their metabolism and their sanity back, grains make perfect sense.
Speaker 1:The FDA is also saying that because it comes from pigs. You know there can be some impurities, but I don't see them pulling bacon off the shelf either. And then they're saying we don't have modern clinical trials. But all that translates to me is well, big pharma didn't pay to run billion-dollar studies. I think the biggest plot twist is now the FDA just reclassified these as biologics. This is the same category as vaccines and monoclonal antibodies. That means that compounding pharmacies can't even touch it. Big Pharma just pulled the rug out from natural thyroid and the FDA is holding the flashlight, since it's classified as a biologic. I mean, this is the same bucket as insulin.
Speaker 1:Okay, companies that make it would need to file for this BLA to keep it on the market, which sounds simple right, just fill out some paperwork. No, the BLA requires that you have extensive clinical trials. So companies would need to run large, modern studies proving safety, efficacy and consistency. And yes, even though this medicine has been used for 100 plus years, we're talking multi-million dollar studies that only big pharma can afford. But smaller DTE makers there's no way They'd have to prove every single batch is consistent in potency, purity and quality. That means super tight lab controls and reporting, which is very expensive. It would mean kicking out the grains and moving to milligrams and micrograms. They would have to modernize dosing standards that satisfy the FDA and they would have to collect ongoing safety data and report adverse effects long-term. But the FDA is only given 12 months for all of this to happen, and a BLA is not cheap. It's estimated to range from $100 million plus just to get a biologic through the pipeline.
Speaker 1:So for these medications like DTE, which already has a tiny share of the thyroid market. It is financially impossible. A company could get DTE FDA approved under a BLA, but you'll never be able to do that within 12 months, which is the timeline of getting it completely off the market, unless big pharma, you know, decides to bankroll it. This move basically pushes smaller thyroid manufacturers out of the game and this is why a lot of patients are calling foul, because it looks like a safety measure, but it really looks more like big pharma hogging the whole hormone trough. And I felt like before big pharma already had the monopoly.
Speaker 1:Think of 24 million Americans that take thyroid medications. 94% of those are taking levothyroxine. You know, that's Synthroid and all of its generics. 6% are on a DTE. This is what they've shown in 2024. And that's still 1.5 million people who actually feel better on pig thyroid. But if they take the DTEs off the market, that's also 1.5 million new customers funneled right into Big Pharma's Synthroid Monopoly. So if you're thinking, hmm, that's convenient, same me too.
Speaker 1:So what do patients do now that there's only 12 months to figure out the next plan? And most thyroid warriors already know that thyroid doesn't live in a vacuum. So functional medicine does see thyroid function as a pillar of health that's deeply influenced by your minerals, your adrenals, your gut health toxins. So this is how I'm going to help my patients navigate what to do next. Because levothyroxine can normalize your labs, but it can also leave you feeling like a zombie. That's because many patients cannot convert T4 into T3, which is the active thyroid hormone and the DTEs. They bypass that issue because it already has that natural T3. And this is what makes patients feel so good.
Speaker 1:You often hear people say, oh, I'm on Synthroid. My doctor said my labs look good, but I don't feel good, I'm still exhausted, I still have hypothyroid symptoms On those DTEs. They feel like a functioning human again. So when the FDA says, oh, don't worry, just switch back to Levothyroxine, people are not buying it. Says, oh, don't worry, just switch back to live with thyroxine, people are not buying it, literally or figuratively. So how do we navigate the next 12 months and what would you do? Most people are already seeing a functional medicine provider because they did not want the synthetics. They did not want the synthroid. But maybe you haven't. Maybe this was just something because your doctor was really smart and put you on this because it's been around for over 100 years. But if you are a thyroid warrior, you already know that your thyroid doesn't live in a vacuum.
Speaker 1:Functional medicine does see this holistically that your thyroid function as a pillar of health.
Speaker 1:It's deeply influenced by your minerals, by your adrenals, by your gut health, by toxins.
Speaker 1:This is why I love that HTMA, which is the hair tissue mineral analysis test, and we use it to measure long-term mineral patterns and toxic metal loads. Usually I do find low selenium, which you need to convert T4 to T3, or I find high mercury that's blocking those thyroid enzymes. And guess what? Synthroid cannot fix that? It can't fix any of that.
Speaker 1:So what you can do to navigate this thyroid soap opera. Number one is talk to your provider, especially one who actually listens. That's where the hint comes. In Functional medicine practitioners, we are the listeners, because this transition plan really matters. It's how your whole metabolism, how your whole body, is going to function. If you are not seeing a functional medicine provider, I would love to see you at Harmony Hub Health. Number two is demand better options. Call your representatives. I've already seen multiple petitions going around. You can sign that to make some noise. Remember the squeaky wheel right Always gets oiled If enough patients push back. The FDA has been known to reconsider. So you can see a functional medicine provider to help support your thyroid naturally. You can see a functional medicine provider to help support your thyroid naturally. That would mean, you know, looking at your mineral balances, you know selenium helps convert T4 to T3. Zinc supports hormone production. Magnesium calms your adrenals and helps your thyroid enzymes and detox. So HTMA can reveal hidden heavy metals that slow your thyroid down.
Speaker 1:You want to think whole body health. You know thyroid health is so connected to the stress that you're living under, the gut health, your liver and how it detoxes, and even your sleep. So we need to fix the terrain, not just the lab number. The FDA says it's all about safety. Big Pharma says it's all about science. Patients say it's all about choice. So your body is not a business plan. If you feel best on DTE, you deserve access, I think, period. So is this really about protecting patients or is it protecting Synthroid's market share? Tell me. My eyebrow was raised because I'm really feeling suspect. If the FDA has you stressed out about your thyroid meds, please just take a big deep breath. You do have options, but you also need a plan. This is not the time to Dr Google your way through thyroid chaos.
Speaker 1:At Harmony Hub Health, I specialize in functional medicine, thyroid optimization. That means that I look just beyond your normal labs to get to the root the mineral balancing your gut health, your adrenal support and helping you navigate without the DTEs, even if it means synthetic transitioning. You don't have to stumble through this change alone. I can help review your current thyroid treatment and options. I can test deeper with HTMA, more thorough lab testing, toxins and a lot more. We can create a personalized plan that actually makes you feel like you again.
Speaker 1:So book your thyroid consultation today at Harmony Hub Health. You can go to wwwharmonyhubhealthcom. You can see me virtually or you can see me in person at Monarch Beauty and Spa in Manchester, maryland, so I can help you keep your thyroid and your life balanced, fda drama or not. You could even send me a email at Michelle. That's M I, c, h, e, l E at harmonyhubhealthcom. The information on this podcast is for educational purposes only and it's not intended as medical advice. Please do not start, stop or change your thyroid medication without talking to your healthcare provider. Everyone's health situation is unique and what works for one person may not work for another. And let me be clear please do not start raising your own pigs to DIY your own thyroid pills in your kitchen? No-transcript.