EvexiPEL Has It: The Patented Pellet
May 14, 2023
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The FDA has fought to have natural thyroid replacement removed from the market for many years, and now it seems they have gained traction. This would mean that individualized compounded batches of natural desiccated thyroid (NDT) would no longer be available to consumers. This is where you need to take action!
The FDA stated that NDT is to be classified as a “biologic”, which would make it ineligible to be compounded in a pharmacy. You probably wouldn’t even know this happened, because the FDA did NOT announce this decision publicly. Instead, they wrote it in a letter to the National Association of Boards of Pharmacy (NABP) and encouraged the NABP to share the letter with the state boards of pharmacy, hoping they would follow suit.
The removal of NDT from the market would obviously have a massive impact on the health of many patients. It has been estimated that roughly 30 million Americans have been diagnosed with a thyroid condition, while an additional 5 million Americans are struggling with an undiagnosed thyroid condition.
The real problem here is that not all patients with low thyroid (hypothyroidism) are the same. The body contains five different thyroid hormones. The FDA-approved synthetic thyroid options only contain one of these hormones (either T3 or T4) per compounded hormone medication. NDT (which comes from pig thyroid glands), on the other hand, can contain all of these hormones: T1, T2, T3, T4, and calcitonin.
The FDA is operating under the mainstream assertion that just taking the right amount of T4 should be enough, because the body can convert T4 into T3. They say that T1, T2, and calcitonin are not even needed. This is where putting all patients with hypothyroidism into the same box can do the most damage. Every patient with hypothyroidism is a little different. For some, taking only T4 could be sufficient. However, there are many patients with hypothyroidism that do not efficiently convert T4 into T3.
An integrative medicine practitioner can use your laboratory results and symptom history to measure and assess ALL of the thyroid hormones in your body. With the option to prescribe NDT, he/she can offer you a custom-compounded medication individually tailored to the needs of YOUR body.
As of right now, Armour and some of the other non-compounded NDT products are not on the chopping block, but that could obviously change as the FDA sees fit. These products are considered “grandfathered”, as they were in use before drugs were even required to be approved for safety and efficacy. However, the FDA has an “Unapproved Drug Initiative” to put these drugs through FDA approval.
So why would the FDA even go after NDT as they have for many years, despite the fact that studies show many patients prefer NDT to synthetic thyroid options? Not surprisingly, this comes down to money and competition. NDT competes directly with FDA-approved synthetic T4 drugs like Synthroid and Levothyroxine. Big Pharma makes a lot of money from these drugs; Levothyroxine has a market size of $2.3 billion and is expected to grow by an additional $1.2 billion in the next 5 years. It also came in at #2 in a list of the top 300 most prescribed drugs of 2020. Synthroid spent many years as the top prescribed medication in the US.
This isn’t expected to stop at NDT either. The FDA has had bioidentical hormone replacement therapy in its crosshairs for years, so they have made it very clear how they feel about customized, compounded medicine.
This is where you come in! Don’t let the FDA eliminate individualized treatments for hypothyroidism. Not every patient will respond positively to the one-size-fits-all approach of FDA-approved synthetic drugs. Write to the FDA and Congress to protect your right to use compounded natural thyroid.
The post TAKE ACTION NOW: FDA Attacking Natural Thyroid appeared first on EVEXIAS Health Solutions.
