Episode 62 of The Living Life Well Show: FDA Ban on Desiccated Thyroid Medications: Armour Thyroid, NP Thyroid, and Nature-Throid Explained
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Speaker 3: [00:00:00] Welcome to the Living Life. Well show the intersection of God's word, today's science and healthy living with common sense application, all based on the truth of the word of God. I'm your host, Dr. Jon Skelton. Now let's get straight to the truth.
All right. Welcome back to the Living Life Well Show Today. I'm excited to talk to you about the recent ban, the FDA has placed on armor, thyroid, np, thyroid, nature, thyroid, and as they refer to it, animal derived therapies. And so let's just jump right in. So. Armor, thyroid, np, thyroid, nature, thyroid. The FDA refers to these as biologics.
What they are saying is that they have [00:01:00] not gone through the proper certification to be in a prescribed format because they have not received the biologic certification that became necessary in 2009, 2010 kind of timeframe. Well, there obviously is a reason for that. It's very expensive. It's very cumbersome.
It's a long process to get that certification. And so for the last, , now 16 plus years. Apparently it hasn't been an issue. But recently what the FDA is citing is that they're citing quality control issues dating back to 2019 and 2020. They're saying that their inspectors went there inspected and they were being reported as adverse offense.
Events, meaning that patients were having adverse outcomes. Well, what were the primary adverse outcomes, either undertreatment or [00:02:00] overtreatment because as they report you are getting a biologic substance and then using that to treat humans, as you can imagine, a biologic substance. Can have varying levels of hormone associated with it.
So let, let's get right in. So what is a biologic substance in this instance? In this instance, it is primarily essentially. Porcine or pig thyroid gland. The thyroid gland is ground, and then it is dosed in something called grains, typically, and that is how we determine the dose when we are prescribing one of these combination biologic substances.
Well, why even prescribe this in the first place? Well, the reason is because for. Really decades back into the [00:03:00] 1950s when we treated thyroid, we treated with one form of thyroid hormone, the active form of thyroid hormone, T three or otherwise known as liothyroniine, which is the manufactured or synthetic form of thyroid hormone.
In your body, your body converts T four to T three. Well, back in the early two thousands, levothyroxine or T four was then produced synthetically and has been mass marketed and produced throughout the US to the tune of some 20 plus million people being on T four therapy. Well. Many people are having to escalate the dose on the T four therapy.
Plus they're also being placed on a synthetic, a laboratory derived substance. Many people don't like that. Many people don't respond to it well, historically, thyroid [00:04:00] hormone in the past was known to be. Different in brand name versus generic. We see that less and less nowadays, but it would be that you would switch somebody from the brand name to the generic and it would require an increasing dose to meet that same level of treatment, that same level of result, and increased energy.
You know, daily functions for every area of your body, your metabolic rate, all those things that we use a thyroid hormone for. So. In 2002, T four really hit the market and became the big, big thing that everybody prescribed and, and is still the most widely prescribed form of thyroid hormone today being just T four.
Well, now you have these. Biologics being armor, thyroid, nature, oid and [00:05:00] NP thyroid that really have been around in some form since about the same time as liothyronine the T three, if not even before that actually, because we were using it a long time before that and had been using it successfully. But.
What the issue is is that between the late 1960s yes, that's how far back this goes to these early 2020s. Now, there have been, quote, 500 adverse events that is a span of roughly five decades, 50 plus years, 500 adverse events. Those adverse events may have been underdosing or overdosing based on the thyroid concentration in the animal that it was derived from, and then packaged and prepared for human [00:06:00] consumption.
That is the vast majority of these. The other adverse events are reported viral transmission through this as well reported process and elemental related impurities, meaning it wasn't able to be purified to the standard that, that they've set, that they believe that it, it should be.
And while I believe. All those to be true. Really, when you look at the potential for underdosing or overdosing with thyroid hormone, it, it very well could be to the fact that there is a little bit of nuance when you are taking a thyroid from an animal and then using it to then treat a human issue.
And so. There, there can be issue with that. However, I'll also tell you there's an issue when you use synthetic [00:07:00] T four or synthetic T three as well. It is very easy to underdose or overdose. It depends upon how the patient takes it depends upon many other processes that are going on in their.
body. And so the same thing with underdosing or overdosing can occur with regular synthetic hormone that is prescribed by your doctor as well. Now, their specific report is, is that you can't rely on the concentration that is coming from the animal for accurate treatment for the problem.
And I, I would agree with that, but again, I, I say that potential to Undertreat or overtreat could be, could have been as simple as the patient not taking it as accurately as, as they should changes in the way or what they're taking it with will affect that, that level, that gets absorbed into your [00:08:00] body as well.
So, so. Those are the objections from the FDA to the manufacturer, Abb Vie for armor specifically, well, who, who is this really affecting? Well, it's affecting a, a, a little over a million people. About 1.5 million people are estimated to be on these medications, so not a small amount. I will tell you in clinical practice, I use these most commonly because what I see is an inability to convert T four to T three accurately in patients with thyroid disease, in patients with Hashimoto's thyroiditis or autoimmune thyroiditis patients that have reactivated mono that are affecting the thyroid.
Or patients with o other issues, maybe sleep apnea and, and other comorbidities that are contributing to thyroid disease. [00:09:00] So. When we look at treating the thyroid, many practitioners just focus on the TSH and the T four, and they stop right there. And so they look at these things and they say, okay, well that, that's good.
Some practitioners will go a little bit further in and look at T three. Those are gonna be most of the practitioners that will then start prescribing one of these biologics because. They realize that T three is the active form. It is what is really affecting your energy, your mood, your bowel habits, your skin, your hair, all your metabolic rate, your physiologic components.
It's the T three that is the most active in all of these areas. Well, so now we have one medication on the market called Cytomel or liothyronine. Is is the generic name which refers to T three. And it is good. It, it will, will help treat [00:10:00] your thyroid, however. Again, as I've said, usually it's a dual deficiency, a deficiency in T four and T three, there is not to my knowledge, a currently available combined product outside of going to a compounding pharmacy to make this product.
The issue with this ban that is occurring again 12 months from now. So for the people that are on armor or NP thyroid or, or naturethroid don't just get totally excited yet this doesn't mean that. We aren't gonna get a resolution between now and then Hopefully that will occur. Hopefully you can reach out to the FDA and specifically to Secretary Kennedy asking him to you know.
Give us a little bit more time on this ban. Explain this a little bit more thoroughly look into it [00:11:00] more in depth, because considering that, you know, we have so many millions of people on thyroid hormone throughout the country, in addition and in my estimation. Of that 22 million that's on the synthetics many of them are being undertreated in one of the categories, either T four or T three, and thus may be overtreated in one of the categories of T four, most likely because they are trying to raise the T four level such an amount so that the T three levels are higher.
Because they're not addressing the underlying inability of that particular patient to convert T four to T three. They're not looking at their iodine consumption, they're not looking at their selenium, they're not looking at the zinc that they are taking in. And so they are overtreating on the T four side to get the T three level.
Up [00:12:00] enough so that the patient doesn't suffer these consequences of hypothyroidism chronically. So for those of us that, that prescribe armor, that prescribe np, that prescribe naturethroid, what that means is a couple things. If this ban ultimately does go through and there is a year. For these companies to start meeting the FDA's demands, go through this certification process to get that done.
What I anticipate will happen is that Abb Vie will ultimately acquiesce and go through this certification process that most likely what will happen is that. They will the FDA will extend time in good faith that Abb Vie is attempting to go through this certification process to get certified as a biologic.
Now, once they do that, what I think is gonna happen is the price of armor and NP and [00:13:00] naturethroid, whoever does go through this process, is gonna increase dramatically because it is an expensive process to get certified as a biologic Now. Hopefully that won't be the case. Hopefully cooler heads will prevail and there will be a streamlined process that they can do this over a longer period of time without, as, as much need for these rigorous studies for a, a.
Medication that's been used for decades now with very, very minimal adverse events when you consider how long it's been in use and the amount of people that have been using it. But time will be time will tell. So what does that mean for us prescribing and us taking these substances well. Assuming that the band goes through.
What that means is that for those of us that have a T three need, you will have to be supplemented with liothyroniine, [00:14:00] the synthetic form of thyroid hormone. Again, it's been around since the fifties, again, considered to be very, very safe. But again, it's a synthetic, it's, it's, it's not a natural occurring product.
It was made in a laboratory. Same thing with the, the levothyroxine. Made in a laboratory. All of the patients that are on armor or NP or naturethroid. They need not only T four, but they also need T three because they don't generally have enough T four and they aren't converting the T four well to T three.
And so both level levels need to be supported. Well, what that means is currently in the current system, that means that you have to be on two medications. Or you have to get your medication compounded well. Insurance companies don't like paying for two medications, and insurance companies sure don't like paying for compounding.
So what that typically means for the [00:15:00] patient and the physician, it means that you end up having to fight for the dose that your patient actually needs to get coverage for both the T four and T three because now you're treating with two different medications.
That's two different prescription copays. That's two different pills that you're taking each and every day. And so, you know, from a patient standpoint, that's just not great. Right? From an insurance company standpoint, that's not so great either, right? You're, you're paying for, for two things. So what they will do is they will tend to err on the side of.
Paying for one, but not paying for the other. The other thing that we see is needing to be on both and wanting to have it in one pill. And that absolutely can happen and it typically is gonna happen through a compounded pharmacy Now. My understanding of how you get [00:16:00] a insurance company to cover that, is you have to have it required that you need a dose that isn't currently manufactured and made to be able to treat your thyroid.
So, for example, if it comes through that you need 30 micrograms of levothyroxine and you need, eight micrograms of T three, that would be a dose that isn't readily available in manufactured form. And so you could get that compounded through a compounding pharmacy and your insurance benefits would apply.
However, generally speaking, when you're talking about anything compounded, including the armor biologics and, and nature authority mp thyroid, usually the copay with those. Or higher. Usually they the insurance company is gonna put more patient [00:17:00] responsibility towards the cost for the drug. And that is no different with these compounded medications.
It's the same thing that we're seeing currently with these GLP one. With this compounding ban they again, they, they alleviated that ban for these GLP one medications in all dose forms when the manufacturer could not create keep up with the demand. Now the manufacturer is keeping up with the demand.
The compounding pharmacies can still make these substances. However, they have to make them in doses that are different and. Aren't commercially available, so that is most likely the route that this is gonna go. You're either gonna get on two medications with some hassle from insurance companies. And many of you that have been on armor, MP, thyroid or Naturethroid may have already had these hassles occur when you were initially being pre prescribed the medication.
However, I think it's gonna be [00:18:00] a bit more of a headache unfortunately, as we, we go through so. That being said, I, I think now is the time to not get excited about this. To not start stockpiling your meds or ask for extra medication to be considered, but to really have a conversation with your physician about, Hey, how can I best help my body convert T four to T three so that I can support myself.
As I go through to maybe even you know, reduce your dose of armor NP or naturethroid how can I take it more effectively so that it gets absorbed more easily and is used more readily? And then really looking at those things that support that, that conversion, the iodine, the selenium those things are gonna be important for anybody that has thyroid disease, regardless of whether it's an autoimmune condition, whether it's just a T four [00:19:00] deficiency.
Or a T three deficiency, keeping healthy levels of, of zinc and iodine and selenium as well as even vitamin D is, is gonna be important and vitamin A for that fact as well. So, with that being said, I, I don't want this all to be doom and gloom. There is. There is in my mind a possibility that these medications these vital medications won't go away.
That there will be some change or moratorium on this ban that will allow cooler heads to prevail and get this straightened out for all the people that, that really need this. So, that's it for, for this episode. I do wanna let you guys know especially if you're in the Lubbock area, I have a course that I taught last spring that I'm teaching again at Trinity Church this fall, starting September 3rd.
It'll run for nine weeks from six 30 to 7 45 on Wednesday evenings. There at Trinity Church and if that is something that you would be interested [00:20:00] in, we'll be discussing lots of things, things just like this. And then we'll really be getting into the truth of God's word, maybe some what seems to be even hidden truth, if you will about really being able to help ourselves in this modern society with what the Bible tells us is good and healing.
For our bodies and what we can do even today from a dietary standpoint from the way we approach life standpoint to, to really confer true wellness be it physical health, mental health, and of course spiritual health. And so we'll be touching on all those things. And really, I, I'm really excited about this because we have people reverse autoimmune disease in the, this last course.
And so. We've had amazing outcomes with, with weight loss, getting off of multiple prescription medications, all of these things just by going through this course. And this course is free, and so, space will be limited. If you're [00:21:00] interested I'd Rick you. Recommend you look up Trinity Church here in Lubbock.
We'll also have a link to it in the show notes here if you would like to, to sign up for that class. We would love to have you, so thanks and God bless.
Speaker: That's it for this episode of The Living Life. Well show if you like what you've heard and want to learn more or want to know how to put this into practice for yourself, go to live life well clinic.com. Until next time, this is Dr. Jon Skelton saying go out and live the truth so you can live life well.
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If you feel information presented in this show may apply to you, we [00:22:00] recommend you seek out the help of a qualified medical professional who can evaluate and treat your specific concerns.
