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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.
Support the show
linktr.ee/harmonyhubhealth
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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.
Support the show
linktr.ee/harmonyhubhealth
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