Show 1452: Why Is the FDA Planning to Ban Natural Desiccated Thyroid?

When the thyroid gland stops working efficiently, the effects resound throughout the entire body. That’s because this little gland controls metabolism in all our tissues. Before there was a treatment, thyroid disease was sometimes deadly. Doctors started prescribing natural desiccated thyroid derived from animals 130 years ago. This worked well. Synthetic levothyroxine (a thyroid hormone) was developed in 1970 and marketed aggressively. Now levothyroxine is one of the most commonly prescribed medications in the US. The FDA has announced that it plans to ban natural desiccated thyroid. What are the implications? We’ll check in with two experts to find out.

At The People’s Pharmacy, we strive to bring you up to date, rigorously researched insights and conversations about health, medicine, wellness and health policies and health systems. While these conversations intend to offer insight and perspective, the content is provided solely for informational and educational purposes. Please consult your healthcare provider before making any changes to your medical care or treatment.

How You Can Listen:

You could listen through your local public radio station or get the live stream at 7 am EST on Saturday, Nov. 15, 2025, through your computer or smart phone (wunc.org).  Here is a link so you can find which stations carry our broadcast. If you can’t listen to the broadcast, you may wish to hear the podcast later. You can subscribe through your favorite podcast provider, download the mp3 using the link at the bottom of the page, or listen to the stream on this post starting on November 17, 2025.

What Should You Know about Natural Desiccated Thyroid?

Thyroid extract from pigs contains two important thyroid hormones. Endocrinologists refer to them as T4, also called levothyroxine, and T3, known as liothyronine. The T4 molecule has 4 iodine atoms and is inactive. To activate it, the body uses an enzyme, deiodinase, that kicks off one iodine molecule resulting in activated T3 that does all the work in the tissue. When scientists discovered that T4 could be converted to T3, it opened the door to prescribing T4 alone, synthetic levothyroxine such as Levoxyl or Synthroid, to all hypothyroid patients.

That became standard practice not long after Synthroid was introduced. There was a hitch, however. Some patients did not feel well even though they were taking levothyroxine. Until fairly recently, doctors downplayed these problems.

Our guest, Dr. Antonio Bianco, helped conduct the research showing that some people have deiodinase enzymes that are less efficient at converting T4 to T3 (Current Opinion in Endocrinology, Diabetes, and Obesity, Oct. 2018). This enzyme activity seems to be under genetic control. As a result, endocrinologists may find it easier to understand why some patients don’t respond to prescribed levothyroxine as expected. They may need liothyronine in addition. This could be provided with a separate prescription. On the other hand, people get both T3 and T4 when they take natural desiccated thyroid.

We think that Dr. Bianco is one of the leading thyroid researchers in the world. Here is a very short video clip from our interview with him:

You will want to listen to the whole interview either live on Saturday morning or when it becomes available on this website Monday morning (11/17/2020). You can stream the audio by clicking on the white arrow inside the green circle under the photo of Armour Thyroid. You can also download the mp3 file by scrolling to the bottom of this article. Why not sign up for all our podcasts at this link so you will never miss another People’s Pharmacy episode again?

What Symptoms Do People Suffer Without Natural Desiccated Thyroid?

A majority of hypothyroid patients, perhaps 80 or 85 percent, are able to convert T4 to T3 well enough that they can use levothyroxine alone. The remainder, however, do not feel well on this regimen. They experience brain fog and low energy. They may also complain of other symptoms associated with undertreated hypothyroidism, such as difficulty with weight control, cold sensitivity and menstrual irregularities or fertility problems in women. An estimated 1.5 million Americans take natural desiccated thyroid. What will they do if the FDA bans this product? About half a million people take a combination of synthetic T4 and synthetic T3. That is one option, but some individuals prefer natural hormone.

What Will Happen to Patients?

We turn to patient advocate and activist Mary Shomon to learn about the patient perspective. She is concerned about the FDA’s announced plan to take natural desiccated thyroid (NDT) off the market in August 2026. (NDT is sometimes referred to as DTE, desiccated thyroid extract. They are the same thing.) It is not clear that the agency has considered what will happen to people forced to take a medicine that most of them have already tried without success, levothyroxine.

Rethinking Levothyroxine Treatment:

Mary Shomon points to recent research by Dr. Bianco and his colleagues suggesting that levothyroxine alone may not be quite as effective as most endocrinologists believe. In this analysis of medical records, hypothyroid people taking levothyroxine alone were twice as likely to die during the study period and had a 40% higher risk for developing dementia compared to people getting T3 along with T4 (Journal of Clinical Endocrinology, June 20, 2025). These new findings underscore the importance of information from the large number of patients in touch with Mary. As she says, there is enormous individual variation in which treatments help people thrive. She recommends that everyone who relies on natural desiccated thyroid should contact the FDA (as well as their Congresspeople) to let them know how banning these products would affect their lives.

This Week’s Guests:

Antonio Bianco, MD, PhD, is Senior Vice President of Health Affairs, Chief Research Officer and Dean of the John Sealy School of Medicine at the University of Texas Medical Branch at Galveston. Dr. Bianco is the author of Rethinking Hypothyroidism: Why Treatment Must Change and What Patients Can Do.

Mary Shomon is a patient advocate and author. Her books include the New York Times bestseller The Thyroid Diet and ten others. Her website is  https://www.mary-shomon.com
She is also a Paloma Health Advisor & Patient Advocate. Find her online at https://www.palomahealth.com/authors/mary-shomon
Her newsletter, Sticking Out Our Necks Hormonal Health News, is available on Substack. Here’s the link: https://hormones.substack.com/

The People’s Pharmacy is reader supported. When you buy through links in this post, we may earn a small affiliate commission (at no cost to you).

Listen to the Podcast:

The podcast of this program will be available Monday, Nov. 17, 2025, after broadcast on Nov. 8. You can stream the show from this site and download the podcast for free. This week’s episode contains additional discussion with Dr. Bianco of his research on the consequences of treating with levothyroxine alone. We also consider the FDA’s claim that natural desiccated thyroid suffers from inconsistent quality and dosing. Mary Shomon offers basic information on what the numbers from a thyroid test mean, especially the goals for T3 and T4. We also review the most common symptoms of hypothyroidism.

Download the mp3, or listen to the podcast on Apple Podcasts or Spotify.

Transcript of Show 1452:

A transcript of this show was created using automated speech-to-text software (AI-powered transcription), then carefully reviewed and edited for clarity. While we’ve done our best to ensure both readability and accuracy, please keep in mind that some mistakes may remain. If you have any questions regarding the content of this show, we encourage you to review the original audio recording. This transcript is copyrighted material, all rights reserved. No part of this transcript may be reproduced, distributed, or transmitted in any form without prior written permission.

Joe

00:00-00:26

I’m Joe Graedon.

Terry

00:01-00:05

And I’m Terry Graedon. Welcome to this podcast of The People’s Pharmacy.

Joe

00:06-00:27

You can find previous podcasts and more information on a range of health topics at peoplespharmacy.com. The FDA has announced a ban on natural thyroid extracts like Armour that will impact over a million people. This is The People’s Pharmacy with Terry and Joe Graedon.

Terry

00:34-00:44

Most people with under-active thyroid glands take synthetic levothyroxine, but many patients feel much better if they take a natural desiccated thyroid instead.

Joe

00:45-00:51

How will the FDA’s ban affect them? What could they do if their medicines were pulled off the market?

Terry

00:51-00:57

We speak with an endocrinologist and a patient advocate about the possible ways people might deal with this situation.

Joe

00:58-01:05

Coming up on The People’s Pharmacy, why is the FDA planning to ban natural desiccated thyroid?

Terry

01:14-02:28

In The People’s Pharmacy health headlines: the FDA has just announced a change to prescribing information for hormone replacement therapy. For many years, this treatment for menopausal symptoms like hot flashes and night sweats has carried a black box warning.

This warned women and their doctors that estrogen could increase the risk for endometrial cancer and could increase the risk for blood clots and cardiovascular problems. FDA Commissioner [Dr.] Marty Makary has expressed his belief that the boxed warning frightened women away from a treatment that could help them. He thinks that HRT might reduce the risk of bone fractures, dementia, and even heart disease in women who start taking it at menopause.

According to Dr. Makary, with the exception of antibiotics and vaccines, there may be no medication in the modern world that can improve the health outcomes of older women on a population level more than hormone therapy. Some critics are concerned that this action, which was not vetted by an official FDA advisory panel, may undermine the agency’s credibility. Apparently, the warning about the risk for endometrial cancer will remain for products that contain estrogen alone.

Joe

02:29-03:39

For years, cardiologists have warned patients with atrial fibrillation to avoid coffee. That’s because they worried that caffeine would aggravate heart arrhythmias. A new study titled DECAF, which stands for Does Eliminating Coffee Avoid Fibrillation, has produced surprising results.

The study published in JAMA recruited 200 coffee drinkers with AFib. Half were assigned to drink at least one cup of caffeinated coffee daily. The other half were required to abstain from coffee or any other caffeinated beverages. The study lasted six months. The results were unexpected. Coffee drinkers had a significantly lower likelihood of recurrent atrial fibrillation.

One possible explanation is that coffee has anti-inflammatory properties. Because some research suggests that chronic inflammation contributes to AFib, lowering inflammation might be beneficial. The authors conclude that one cup of coffee daily was associated with a lower risk of atrial fibrillation and atrial flutter recurrence.

Terry

03:40-04:47

Cardiologists have long known that low levels of circulating vitamin D may increase the risk for a heart attack. A study presented at the American Heart Association’s scientific sessions showed that people taking vitamin D supplements to raise their blood levels to at least 40 nanograms per milliliter significantly reduced their chance of a second heart attack. The study included 630 people who had suffered a heart attack less than a month before entering the trial. Such individuals are at risk for a second heart attack.

Investigators assigned them to a control group that received no vitamin D management or an intervention group that had regular measurement of vitamin D and adjustment of their supplements to reach the target blood level. When the study began, 85% of the volunteers were below target. Many required supplements of 5,000 international units of vitamin D3 daily to reach 40 nanograms per milliliter.

Those taking supplements were half as likely to experience a second heart attack compared to those not receiving supplements.

Joe

04:48-05:20

Metabolic syndrome is a cluster of three or more risk factors that increase the chance for cardiovascular complications such as heart attacks, strokes, peripheral artery disease, along with diabetes. Risk factors for metabolic syndrome include high blood pressure, abdominal adiposity, elevated blood sugar, and high triglycerides.

A new study has found that six months of lifestyle interventions to encourage new habits of healthier eating and greater physical activity led to long-term benefits.

Terry

05:21-05:53

Following a DASH diet rich in vegetables and fruits and low in processed foods can help lower blood pressure. But what about people who live in food deserts where fresh produce is not readily available?

A study compared home-delivered DASH-type groceries and dietary advice to monetary stipends for groceries. Three months of DASH grocery delivery lowered blood pressure and LDL cholesterol levels more than the $500 monthly stipends.

And that’s the health news from the People’s Pharmacy this week.

Joe

06:14-06:17

Welcome to the People’s Pharmacy. I’m Joe Graedon.

Terry

06:17-06:47

And I’m Terry Graedon. Hypothyroidism is surprisingly common, affecting over 20 million Americans. In this condition, the thyroid gland does not produce an appropriate amount of thyroid hormone.

This leads to a wide range of uncomfortable symptoms and some serious health consequences. Treatment is thought to be simple, but not everyone responds to the standard therapy.

What can people do if they still feel bad while taking their prescribed medication?

Joe

06:48-07:21

To help us understand the complexity of treating hypothyroidism, we turn to one of the country’s leading experts. Dr. Antonio Bianco is professor of medicine and a member of the Committee on Molecular Metabolism and Nutrition at the University of Chicago, where he runs a laboratory funded by the National Institutes of Health to study thyroid hormones.

Dr. Bianco is a former president of the American Thyroid Association and author of “Rethinking Hypothyroidism: Why Treatment Must Change and What Patients Can Do.”

Terry

07:23-07:26

Welcome back to The People’s Pharmacy, Dr. Antonio Bianco.

Dr. Antonio Bianco

07:27-07:29

Thank you. I’m glad to be here.

Joe

07:29-07:45

Dr. Bianco, a lot of your colleagues, endocrinologists, family practice physicians, internists, they think that thyroid disorders are easy to treat. Why is that a mistake?

Dr. Antonio Bianco

07:46-08:29

Well, the most common disease of the thyroid gland is hypothyroidism. And it is true that for the last 50 years, we have been treating patients with hypothyroidism with the daily tablet of what’s called levothyroxine.

And the dose is easily adjusted. And usually we tell patients, come back in six months, come back in a year. And this is sort of very straightforward to the point that it doesn’t have to be even treated by an endocrinologist. They can be treated by a primary care physician, a gynecologist, a geriatrician. I mean, most internists can treat hypothyroidism.

Joe

08:31-08:34

But you suggest it’s not as easy as that.

Dr. Antonio Bianco

08:36-09:54

That’s right. And that has been a mistake that we did in the last 50 years, again. We assumed that once we achieved the dose of this magical drug called levothyroxine, patients will feel without symptoms, would be relieved of their symptoms. And in fact, it is true for most patients.

We estimate that about 80%, maybe 85% of the patients are treated with this approach and they feel fine. However, we do have a substantial number of patients that it seemed small, 15%, but hypothyroidism is so prevalent. We have about 20 million people living in the U.S. with hypothyroidism. So if you estimate about 10%, 20%, we’re talking about 3 to 4 million people.

And for those individuals, treatment is not as straightforward. Even though the doctor thinks that the treatment is okay, it’s as it should be, they remain symptomatic. They still have symptoms.

Terry

09:55-10:48

Dr. Bianco, we have been hearing from people with hypothyroidism for decades ourselves. They write into The People’s Pharmacy or they call and they say, ‘I am taking Synthroid or Levoxyl, one of those T4 drugs, levothyroxine, and I still feel awful. I still feel tired, I still feel cold.’

Women still say, ‘I still am having problems with my menstrual cycles.’ Many people say, ‘I still can’t lose weight, in fact, I keep gaining weight even though I’m trying hard to lose it.’ They have many symptoms and they don’t feel good and they say, ‘My doctor doesn’t seem interested.’

Joe

10:49-11:03

Well, not only that, they say, ‘My doctor says I’m doing great. My TSH level, this monitor for my thyroid, is perfect. No problems, be happy, don’t worry.’

Dr. Antonio Bianco

11:04-11:40

In a nutshell, you capture exactly what the problem is. That’s exactly right. And so what we think is the problem is that these Synthroid or Levoxyl, they contain this molecule called levothyroxine, which is the thyroid hormone. And levothyroxine is not active, meaning when a patient takes a tablet of levothyroxine, levothyroxine by itself cannot relieve symptoms of hypothyroid. It just doesn’t do anything.

Terry

11:41-11:46

I think that’s a really important point. That isn’t adequately appreciated. Say it again, please.

Dr. Antonio Bianco

11:45-12:53

That’s correct. Yes. The substance contained in those tablets, either Levoxyl or Synthroid or any generic form of levothyroxine, it’s not active. It’s a dead molecule. And we rely on our body to take that molecule and activate, to process it, to transform it into a molecule that is biologically active, meaning can relieve symptoms of hypothyroidism. And some of us do their job very well.

Unfortunately, some of us don’t do that. And those individuals that remain symptomatic. We believe they have a sort of a problem in activating the molecule, the T4, to this other molecule called T3. And so they live in a state of chronic T3 insufficiency. And it so happens T3 is the molecule that relieves symptoms of hypothyroidism.

Joe

12:54-13:13

Perhaps we could take just a moment to review the physiology of the thyroid gland. Why is the thyroid, and in particular, that active form, T3, so crucial to every cell in our body?

Dr. Antonio Bianco

13:14-15:17

The thyroid mostly makes T4, which again is this molecule that is not active. But T4 remains in the circulation, in the blood. A little bit of T4 goes into the cells. Most T4, it’s in the circulation. Now, once T4 gets into the cells and tissues and organs, T4 is rapidly activated in T3. So that inside that organ, T3 can act and relieve symptoms of hypothyroidism. Now, when doctors look at the TSH, and you mentioned TSH, TSH is this hormone that controls the thyroid gland. TSH likes to see T3 in the circulation within the normal range, so that if you have a healthy thyroid, the TSH controls the thyroid gland to the point that T3 in the circulation is normal.

Now, when a patient has hypothyroidism and we give the patient T4, only T4, and rely on the TSH to estimate how much T4 we should give, then the system gets confused because TSH regulates the T3 levels in the circulation, and yet we’re giving a lot of T4 to the patient. Yes, we can regulate TSH with T4, but it’s not the same as having an intact thyroid. And that has been the mistake we’ve done over the last 50 years.

We relied on TSH and treated patients with only one hormone. And all along, we needed two hormones to treat these patients. I mean, we believe that this T3 insufficiency should be fixed by adding a second hormone to the treatment.

Terry

15:19-16:10

Now, Dr. Bianco, a little bit of personal information here: I am one of those people with hypothyroidism. I have had it since 1974. I am part of your 80% of people who actually feel pretty good on T4 alone.

So I’ve been taking Synthroid all these years. When I go to my physician for a checkup and she orders a blood test to see how my thyroid is doing, the only thing she’s looking at is TSH. Is that a problem? When Joe gets his blood tested for his hyperthyroidism condition, his doctor is looking at T4, T3, all kinds of different thyroid hormone levels, not just TSH.

Dr. Antonio Bianco

16:11-16:49

That is a problem. And that is part of that, I think that’s a big part of the problem. We got used to just looking at TSH to adjust the dose of levothyroxine. And we were missing the big picture, which is a relative T3 deficiency that these patients experience.

And you’re right, some patients or most patients can cope with that. You know, they just don’t feel bothered by that. But there’s a small minority that those symptoms are really important.

Joe

16:46-16:48

Whoa whoa, Dr. Bianco-

Terry

16:49-16:51

15% is not a small minority.

Dr. Antonio Bianco

16:49-16:52

Oh, yeah. No, that’s right.

Joe

16:51-16:56

I mean, you’ve already, you’ve already said over a million, maybe as many as two or three million.

Dr. Antonio Bianco

16:55-16:56

No, that’s correct.

Joe

16:56-16:58

This is not a minority.

Dr. Antonio Bianco

16:57-17:06

Oh yes, absolutely. Percentage-wise, yes. Percentage-wise, yes, but it is a vocal and it’s a very important minority.

Joe

17:07-17:13

What else should doctors be testing for besides TSH?

Dr. Antonio Bianco

17:15-17:39

Uh, T4 and T3. They have to control… the purpose of the treatment of hypothyroidism has been to normalize TSH. And I advocate that we have to look at T3 levels because T3 is the hormone that relieves symptoms. T3 is the hormone that actually [does] things. And we should be looking at normalizing those levels.

Terry

17:41-18:07

You’re listening to Dr. Antonio Bianco, professor of medicine at the University of Chicago. He’s a member of the Committee on Molecular Metabolism and Nutrition there, and he runs a laboratory that studies thyroid hormones.

Dr. Bianco is a former president of the American Thyroid Association and author of “Rethinking Hypothyroidism: Why Treatment Must Change and What Patients Can Do.”

Joe

18:07-18:14

After the break, we’ll learn about the symptoms troubling some patients even though they’re being treated for hypothyroidism.

Terry

18:14-18:21

Low energy and brain fog are not very specific. What should make us suspect they could be due to thyroid problems?

Joe

18:21-18:28

Dr. Bianco is challenging the usual approach to hypothyroidism. How are his colleagues reacting?

Terry

18:39-18:42

You’re listening to The People’s Pharmacy with Joe and Terry Graedon.

Joe

18:51-18:54

Welcome back to The People’s Pharmacy. I’m Joe Graedon.

Terry

18:54-19:14

And I’m Terry Graedon. Today we’re analyzing the FDA’s plan to withdraw permission for natural thyroid extract, also referred to as desiccated thyroid.

What will happen to patients who rely on products like Armour Thyroid if they can no longer access the medications their doctors have prescribed?

Joe

19:15-19:36

We’re talking with Dr. Antonio Bianco. He is Senior Vice President of Health Affairs, Chief Research Officer, and Dean of the John Sealy School of Medicine at the University of Texas Medical Branch at Galveston.

His book is “Rethinking Hypothyroidism: Why Treatment Must Change and What Patients Can Do.”

Terry

19:38-20:38

Dr. Bianco, we really appreciate the overview and the history that we have gotten now. The reason we’re talking with you is that the FDA has announced that it is going to withdraw its permission from suppliers of desiccated thyroid extract. I’m not quite sure what the timeline is.

I think they suggested perhaps about a year from last August. But thyroid patients who are relying on desiccated thyroid extract to treat their hypothyroid condition are worried that they are going to be left out in the cold. And because they are hypothyroid, they are really going to feel that cold.

Can you fill us in on what the FDA has in mind, if you have any insight into that, and what people might be able to do?

Dr. Antonio Bianco

20:39-22:19

Yeah, well, that is a problem. I agree with you. We have 1.5 million patients taking this drug. And the FDA just announced that in 12 months, starting in August, that drug is not going to be available. And what the FDA is asking physicians is to switch those patients that are taking desiccated thyroid extract to take levothyroxine, which is the recognized standard of care.

But the problem is these patients are on desiccated thyroid extract most likely because they tried levothyroxine before and the levothyroxine was not sufficient to resolve all their symptoms. That’s why they were switched to desiccated thyroid extract. That’s the recommendation that the clinical professional societies are providing.

You start treatment with levothyroxine, and if that doesn’t resolve all the symptoms, you can try combination therapy for these patients, either with desiccated thyroid extract or synthetic combination of levothyroxine and liothyronine.

So these patients have tried levothyroxine, and levothyroxine failed them. And that’s why they’re happy on desiccated thyroid extract. So the idea that we should all move our patients to taking levothyroxine now, it’s a little bit concerning because it is my experience that these patients rely on that drug. Their lives are many times miserable without the desiccated thyroid extract or the synthetic combination.

Joe

22:19-22:49

Let me interrupt you right there. Again, Dr. Bianco, what do you think will happen if a million to a million and a half people are switched from desiccated or natural thyroid to levothyroxine, people who have failed in the past on levothyroxine?

What are some of the symptoms that they may encounter when they’re switched back to the pure synthetic levothyroxine?

Dr. Antonio Bianco

22:50-23:40

Yeah, the main symptoms include brain fog, the inability to function normally. And I had many patients that complained of brain fog, patients that lost their jobs because they couldn’t focus.

I have high school teachers that were functioning well. They were diagnosed with hypothyroidism, they were treated with levothyroxine, and by all accounts, they were okay, biochemically okay. The lab tests were okay, but they did not feel well. They had brain fog, they couldn’t focus, they lost their jobs.

I have countless, countless stories, and my colleagues do too. So I think that if they are forced to go back to levothyroxine, it will be a problem for their lives.

Joe

23:40-23:47

What are some of the other symptoms? Because we’ve heard of people who say, I just couldn’t lose weight on levothyroxine.

Dr. Antonio Bianco

23:47-23:48

That’s right. Yes.

Joe

23:48-23:49

And I feel cold.

Dr. Antonio Bianco

23:50-23:50

Yes.

Joe

23:50-23:52

And I’m constipated.

Dr. Antonio Bianco

23:53-24:22

Yes. All the symptoms. The symptoms are very similar to the symptoms of hypothyroidism in lesser intensity. So the second most common is low energy: patients feel very tired, no motivation to do things. And that is very helpful.

The third one is difficulty managing body weight, that’s also a major problem. So this is going to be very inconvenient for those patients.

Terry

24:23-24:41

And that, I think, is why patients are really, I might say, alarmed at the prospect. Is there any possibility that a desiccated thyroid extract might actually be approved by the FDA?

Dr. Antonio Bianco

24:41-25:29

Well, yes, that would be terrific. So we have, I’m aware of about two or three pharmaceutical companies that are currently running clinical trials in communication with the FDA. They are in constant communication with the FDA.

The FDA knows about their results and they have these clinical trials that are ongoing and they are in the process of getting this drug approved. So it’s not that they’re doing it without the knowledge of the FDA. No, they know very well what they’re doing.

But of course, it takes time because it involves hundreds, sometimes thousands of patients that have to be studied on trial. So it takes time. It’s a long process.

Joe

25:30-26:41

Well, you know, I find it rather paradoxical that the overarching company that makes Synthroid, which is the best-selling brand name Levothyroxine, is AbbVie. And the same company, AbbVie, owns the company that creates the best-selling desiccated thyroid, Armour Thyroid.

So you have AbbVie with its tentacles, so to speak, in both the brand name synthetic levothyroxine and the natural combination of desiccated thyroid. And so presumably they have enough money, resources, and expertise to be able to run the clinical trials that you’ve described.

But the question is, will they be able to meet the timetable of the Food and Drug Administration? And what will patients do if for some reason, for example, they cannot access Armour or any other desiccated thyroid?

Dr. Antonio Bianco

26:41-27:41

Right. No, that’s quite interesting. You pointed to a very interesting thing by, you know, it was fate that levothyroxine was going to be manufactured and sold by the same company that makes desiccated thyroid extract. That’s quite interesting.

Now, they are running, they are one of the companies that are running clinical trials. They already have actually presented the results of their trial in the meeting of the American Thyroid Association two or three years ago in Montreal. And the results were quite satisfactory, meaning that following the guidance from the FDA, they were able to show scientifically that patients can effectively and safely be treated with desiccated thyroid extract. The results were presented in the American Thyroid Association meeting. Obviously, that’s the first step.

Now they’re working with the FDA into the second step of the study, which involves a much larger number of patients.

Joe

27:43-27:57

Dr. Bianco, perhaps you can give us an update on your latest research. We have been following you for a very long time, and we’d like to know what you have in the pipeline or what you have recently published.

Dr. Antonio Bianco

27:58-28:36

Yes, thank you. So this is, we got very interesting results. So recently I moved to the University of Texas in Galveston.

And here we have access to something unique, which is a computer network of electronic medical records. It’s called TriNetX. And once I moved here, I gained access to this network, which involves about 140 hospitals throughout the world, mostly in the United States.

And we have access to more than 100 million patients’ electronic medical records.

Joe

28:36-28:37

Wow.

Dr. Antonio Bianco

28:37-31:02

So obviously, yeah, that’s amazing. My first question is that let’s look at patients with hypothyroidism. And so we were able to identify 1.2 million patients with hypothyroidism that were being treated.

So we compared these patients with healthy patients that had a healthy thyroid. So we properly matched them for age, sex. We used about 20 variables to make sure we have two equivalent populations.

And much to my surprise, we saw that patients, even though they are being properly treated, They have a higher incidence of dementia, and they have a higher mortality. Mortality is almost double in patients that have hypothyroidism, even though they are being appropriately treated. So that was very concerning to us.

Now, the second question is, well, what if the patients were treated with combination therapy as opposed to levothyroxine? So out of these 1.2 million patients, we separated about 90,000 patients that were being treated with combination therapy. Half of them were taking desiccated thyroid extract, and the other half were taking synthetic combination, 90,000.

And then we matched those 90,000 patients with 90,000 patients only taking levothyroxine. And we looked at [them] retrospectively for 20 years, how did these patients do? So first, we were expecting, with all honesty, that patients taking the combination therapy, the therapy that contains T3, were perhaps not doing so well as the ones taking levothyroxine. After all, there’s some concern that combination therapy could not be a safe route. Even in the letter of the FDA, they say that desiccated thyroid extract is not safe.

So by looking at this population, seeing a very appropriate way of comparing combination therapy, desiccated thyroid extract or synthetic with levothyroxine. Much to our surprise, those individuals taking combination therapy, they had a reduction in mortality of about 30%.

Joe

31:02-31:02

Wow!

Dr. Antonio Bianco

31:02-31:48

They had a, yes, a reduction in the diagnosis of dementia over these 20 years. So not only the combination therapy were safe, but actually it showed to be slightly safer than levothyroxine alone.

And again, this is not one site study. This is not a study that was done here in Texas. No, this was done in more than 100 hospitals across the country. So this is really a multi-center study. It’s a retrospective study. It’s not a prospective study.

You can’t just follow 90,000 patients prospectively for 20 years. But even considering that is retrospective, the data is amazing.

Terry

31:49-32:21

Dr. Bianco, this brings up a question to my mind, a very personal question. I have been taking levothyroxine in the form of Synthroid since about 1974 or 1975. I don’t remember if it was the end of 74 or the beginning of 75 when I started on it.

But all this time, and I’ve counted myself as among that 80% of patients who do fine on synthetic levothyroxine.

Dr. Antonio Bianco

32:22-32:22

Right.

Terry

32:23-32:32

But what you’re suggesting is perhaps I could do even better if I also had a little bit of T3 in my treatment mix.

Dr. Antonio Bianco

32:32-33:43

That’s correct, absolutely. And I think that my research in the laboratory now shows that there’s some clues to why this is. I think that when we treat patients with levothyroxine alone, we do not restore thyroid hormone action in all tissues.

And it looks like the liver is one of the tissues that might remain slightly hypothyroid, even though the TSH levels are normal. Remember, the TSH is that hormone that doctors use to control the amount of the dose of levothyroxine that we give to patients. So the goal is to normalize TSH.

So it turns out that even though TSH is normal, the liver may remain slightly hypothyroid. And why do I say this? Because patients with hypothyroidism that take levothyroxine, they have slightly elevated levels of cholesterol. Even though the TSH is normal, cholesterol remains slightly elevated.

And you know what doctors do? They give statin.

Terry

33:43-33:45

Yes, I do know that.

Dr. Antonio Bianco

33:45-34:34

Exactly. So it turns out the number one co-prescription medication of levothyroxine is statin. Because, you know, you’re a doctor, you’re treating your patient, you’re giving levothyroxine, you normalize TSH, cholesterol remains elevated.

Okay, I’m going to prescribe statin now. So it seems that we are creating patients that have a liver that’s slightly hypothyroid. Statin helps, but statin does not resolve all the problems.

And therefore, that creates a risk factor for cardio-metabolic diseases. So these patients are dying of cardio-metabolic diseases. And I’m not surprised that when you use combination therapy, you actually improve a little bit.

Joe

34:34-34:37

Dr. Bianco, have you published this new research?

Dr. Antonio Bianco

34:38-34:44

Yes, it is published in the Journal of Clinical Endocrinology and Metabolism about two months ago.

Joe

34:44-35:12

Well, it seems to me that if you were to present this data to the Food and Drug Administration, that is to say that people actually are doing better on desiccated thyroid, natural thyroid, in the long run with regard to key factors that people really care about.

You know, they don’t care about lab values. What they care about is how they feel…

Dr. Antonio Bianco

35:12-35:13

That’s exactly right.

Joe

35:12-35:16

…and whether they’re living longer and healthier.

Dr. Antonio Bianco

34:16-34:16

Yep.

Joe

35:16-35:37

It seems like if you were to present this data to the Food and Drug Administration, they might say, ‘Oops, we just made a colossal mistake, we should be allowing natural desiccated thyroid on the market and maybe questioning the value of synthetic T4 levothyroxine.’

Dr. Antonio Bianco

35:38-36:29

Yeah, I agree 100% with you. Including in the letter, the FDA says, we are unaware of any studies demonstrating the safety and effectiveness of desiccated thyroid extract, which is, I mean, absolutely incorrect.

There are several studies that have been published and are available on PubMed. There are two clinical trials that were done at the Walter Reed Medical Center, you know, in Washington. And, and uh, proving that this desiccated thyroid extract is effective and is safe.

And you don’t even need to look at this study that we just published. The study that we published is powerful because it involves 90,000 patients for over 20 years. So that is very important, I think.

Joe

36:29-37:00

I’m curious about your colleagues. I mean, you are one of the world’s foremost researchers in the field of thyroid physiology. Are other endocrinologists concerned about the FDA’s, shall we say, well, it’s just Joe speaking now, short-sighted decision to withdraw approval of desiccated thyroid?

Are you hearing from any of your colleagues who are a little bit worried?

Dr. Antonio Bianco

37:01-38:02

Yes. I think that I just recently went to the meeting of the American Thyroid Association in Arizona, and that was the conversation that we had with multiple individuals, colleagues of mine, very concerned. In fact, [AACE], the American [Association of] Clinical Endocrinology, put out a statement saying that they are supportive of the patients and they are stressing the FDA to reconsider and make sure that desiccated thyroid extract will remain available until the drugs are approved by the FDA. Because the companies are on track to get this drug approved by the FDA.

Also, the American Thyroid Association put out a statement saying that they support the availability of desiccated thyroid extract at the same time that they support the companies going through the approval process. So I think that professional societies and my colleagues are very concerned with this move by the FDA.

Joe

38:02-38:56

I do have one other question, and that has to do with quality. One of the concerns that the FDA has suggested is that, well, this natural thyroid stuff, this desiccated thyroid, it might be variable from one batch to another or from one company to another. And therefore, it might be unreliable.

And what has me concerned about that perspective from the FDA is that we have received an awful lot of complaints from people who say, you know, generic levothyroxine that may be made in China or India or Thailand or Brazil. We have some problems with that generic thyroid.

Terry

38:57-39:21

Well, the problem is that from one month to the next, when you get your prescription filled, you don’t know that the pharmacy is going to be using the same generic company to fill your prescription.

And we have heard from people who said it was fine for, you know, three or four months, and then I got switched, and it really was not the same.

Joe

39:22-39:42

So it seems a little, you know, I won’t say disingenuous of the FDA to be so worried about quality of the desiccated thyroid, but seemingly says, oh, all the generic levothyroxine is the same. Don’t worry. Everything’s fine and dandy when patients are saying it’s not.

Dr. Antonio Bianco

39:44-43:27

Yeah. So you touched on two important problems. One is the variable potency of desiccated thyroid. The other one is the consistency of exchanging levothyroxine formulations.

So the first one, it is true that desiccated thyroid extract was, there was this problem of inconsistency, but that was resolved in 1985. And if you look at the FDA letter, all the references that they quoted to support the idea that desiccated thyroid extract is inconsistent. They dated before 1985. I’m looking at the letter and it starts by 1978.

So what happened in 1985? The United States pharmacopoeia changed the recommendation for how this desiccated thyroid extract is standardized. And they moved from measuring just iodine in those tablets by measuring T3 and T4 by HPLC.

So now, since 1985, everyone, the pharmaceutical companies use HPLC to do this. And by doing that, the standardization became so much better, right? So the potency issue has basically been resolved.

Of course, there are recalls. Yes, levothyroxine is also recalled all the time. If you go to the FDA website, drugs are recalled. Lots of drugs are recalled, you know, different lots. Because, and actually I’m happy when I see a recall, because it means someone is looking at it, someone is actually measuring it, and making sure that whatever remains available for the public is within the recommendations. So, recalls are normal.

And I think that it means we are looking at, but if it’s not recalled, it’s consistent. It’s within the recommendations that we give by, that are given by the [USP], the United States Pharmacopeia.

Now, generic versus brand and multiple generic formats for levothyroxine. Yes, this is an issue that has been in discussion for a number of years. And I have to tell you that most publications, or at least two major publications that I know that have been published in JAMA, show that it is totally possible for patients to switch from one brand to the other, from one generic to the other, because they are all equivalent.

I know there are anecdotal reports by patients saying that they don’t feel well once they change, that might be because of the filler or the excipient that contain, [that] different formulations have. But as far as the hormones in the blood, the TSH, and as far, if you look at those, those drugs are interchangeable. So, and I, you know, this is, you cannot control that. That’s beyond our control.

We did recently a study in which we saw that about 40% of the prescriptions are switched at the pharmacy level within the first year that patients started taking levothyroxine. If you go to the next second year, the number is even higher. So the exchange happens no matter what because pharmacists are allowed to do that.

Joe

43:29-43:55

Now, for somebody who panics and they say, well, what will I do? They could ask their family physician or their endocrinologist to prescribe the synthetic versions. How different is it likely to be clinically if someone were to receive both levothyroxine and liothyronine?

Dr. Antonio Bianco

43:56-43:56

Right.

Joe

43:56-44:05

Two synthetic [hormones], the brand name, by the way, is Cytomel for that liothyronine T3. Just give us a clinical overview.

Dr. Antonio Bianco

44:06-45:42

Yeah. I mean, I think that from a clinical point of view, that would essentially be the best alternative available. The physician will, obviously, it’s not going to be a primary care physician because they will have to refer these patients to the endocrinologist.

I don’t think primary care physicians or family physicians will feel comfortable prescribing a combination of levothyroxine and liothyronine. So endocrinologists will be swamped with 1.5 million patients in this country that will be switching to synthetic combination of T4 and T3.

Now, this is totally feasible, and I think it’s going to resolve most of the problems if that’s the route. However, two drugs requires two copayments in most cases, and it requires taking two tablets. And some patients, they say that they don’t do well with synthetic levothyroxine. So they just prefer the natural thing.

They will tell you, my body does not accept the synthetic levothyroxine. Although I don’t see a scientific reason for that to be the case, the patients are adamant and they really feel the difference. So I’ve been wrong in the past, and I’d rather listen to what the patients are telling me and how they feel about it. And I would rather maintain them on the desiccated thyroid extract if that is the case.

Terry

45:43-46:18

Well, we know that there are a lot of patients who would prefer that route as well. I don’t know if this has any relevance for how people might feel, but I know that some versions of levothyroxine– Synthroid, for example– does contain lactose as a filler. And if people were extremely lactose sensitive, it’s a small amount, so they’d have to be very extra lactose sensitive, that might be a problem for them.

Dr. Antonio Bianco, thank you so much for talking with us on The People’s Pharmacy today.

Dr. Antonio Bianco

46:18-46:21

That was my pleasure. Thank you very much for having me back.

Terry

46:22-46:43

You’ve been listening to Dr. Antonio Bianco, Senior Vice President of Health Affairs, Chief Research Officer, and Dean of the John Sealy School of Medicine at the University of Texas Medical Branch at Galveston.

His book is “Rethinking Hypothyroidism: Why Treatment Must Change and What Patients Can Do.”

Joe

46:44-47:05

We turn now to patient advocate Mary Shoman to get some perspective from people who rely on natural desiccated thyroid for their treatment. She’s the author of The Thyroid Diet and 10 other books and a Paloma Health Advisor.

You can find her newsletter Sticking Out Our Necks: Hormonal Health News, on Substack.

Terry

47:06-47:09

Welcome back to the People’s Pharmacy, Mary Shoman.

Mary Shomon

47:10-47:12

Thank you so much. I’m so excited to be here.

Joe

47:13-48:02

Mary, we’ve just had an opportunity to talk with Dr. Antonio Bianco, and he shares with us that many of his colleagues who he has talked to, endocrinologists, are concerned about the Food and Drug Administration’s decision to, in a sense, eliminate the DTE, the desiccated thyroid extract, which is kind of shocking, I think, to a lot of us.

So both the endocrinology community and, I suspect, patients are kind of worried. What are you hearing from your colleagues, your patients, the people who have been following you for many years?

Mary Shomon

48:03-50:04

I am hearing a lot of confusion. As Dr. Bianco has said, there just is not enough information and that there is no real clarity coming out of the FDA and the Department of Health and Human Services. So it feels a little bit like a roller coaster for patients and for their providers, because we are in a situation where we have probably at least a million or more thyroid patients who rely on natural desiccated thyroid or DTE in order to treat their hypothyroidism.

Yet the FDA, which we thought was giving us till the end of the decade to get this NDT, DTE situation sorted out, has now narrowed the timeframe, declared this drug to be a biologic after a hundred and some years on the market and has basically left us wondering, are they going to pull it off the market with no approved alternatives for us, which would force patients either to go without medication or to take medication that for many of us, we have taken in the past and it has failed us. It has not worked for us to serve as a thyroid hormone replacement.

So it’s confusion on the part of the patients, the doctors and practitioners that prescribed for these patients are confused because they don’t know what to do to protect their patients’ continuity of treatment. And then we get mixed messages coming out of the FDA. You’ve got some of them saying, oh, we’re getting rid of it. We hate it. Dr. Tidwell apparently just can’t stand this, and he has made it very clear.

Then we’ve got Dr. Makary, and we have Robert F. Kennedy, the secretary, saying, ‘Oh, no, we’re going to save it. We’re going to keep it. We’re going to make sure it’s available.’ What’s the actual plan? Right now, we think it’s going off the market in about a year, and that’s what we know. And that is a frightening concept for most thyroid patients who rely on it.

Terry

50:05-50:21

Mary, I would like to just have you clarify for people who are listening and might not be aware of the abbreviations that we’ve been using, NDT and DTE, they’re really the same thing. Would you explain what those abbreviations mean?

Mary Shomon

50:21-51:18

Sure. NDT is the abbreviation for natural desiccated thyroid, and DTE is desiccated thyroid extract. They’re basically synonymous or equivalent, and they are referring to a form of thyroid hormone replacement that comes currently from porcine or pig thyroid glands that have been prepared and dried and created into a thyroid hormone replacement that contains both T4 and T3, the two primary thyroid hormones that are needed to replace missing thyroid hormone in the body.

They are different from the prevailing or most popular thyroid drug, which is levothyroxine, which is a synthetic form of only the T4 hormone, whereas the NDT or DTE contains both T4 and T3, but it’s coming from natural sources rather than synthesized.

Joe

51:19-51:33

And it’s my understanding, Mary, that if the FDA follows through on its plan, the natural or desiccated thyroid extract will disappear from the market August of 2026. Is that right?

Mary Shomon

51:34-52:38

Well, this is at least what the official statements have said. But we have posts on X, formerly Twitter, that suggest otherwise, that, oh, we’re going to ensure that patients still have access to their medication. But that has not been formalized with any releases or official guidance or official policy decisions that have come out from the FDA. So that’s all basically just a promise on social media, but nothing more.

Currently, I’m operating as if the policies that are issued by the FDA are the ones that are going to be honored, in which case we’re looking at NDT going off the market sometime next year, probably late summer, as you said.

Unless someone miraculously is able to get through the very onerous and expensive and time-consuming process of a biologic license approval to get the NDT approved as a biologic drug, which is what they are requiring for this drug to be able to be sold on the market and prescribed by doctors in the United States.

Terry

52:40-52:47

You’re listening to Mary Shoman, patient advocate and author of numerous books about thyroid disease. You can find her newsletter on Substack.

Joe

52:47-52:54

After the break, we’ll learn more about Mary Shoman’s 30 years as a patient advocate and her experience with Hashimoto’s disease.

Terry

52:54-53:01

Dr. Bianco said that people on levothyroxine alone don’t do as well as those on DTE in controlling their cholesterol.

Joe

53:02-53:07

Why hasn’t the endocrinology community taken that discrepancy more seriously?

Terry

53:07-53:12

We’ll find out what steps Mary Shoman is taking to advocate for all thyroid patients.

Joe

53:12-53:16

What about importing DTE from Canada? Is that feasible?

Terry

53:26-53:29

You’re listening to The People’s Pharmacy with Joe and Terry Graedon.

Joe

53:38-53:41

Welcome back to The People’s Pharmacy. I’m Joe Graedon.

Terry

53:41-53:58

And I’m Terry Graedon.

Joe

53:59-54:13

Many people who have done well on natural desiccated thyroid extract are worried that the FDA is planning to eliminate these products. Most have already tried synthetic levothyroxine with limited success.

Terry

54:14-54:17

What will they do if the FDA’s ban goes into effect?

Joe

54:18-54:34

Our guest is Mary Shoman. She’s a patient advocate and the author of “The Thyroid Diet” and 10 other books. Mary is a Paloma Health Advisor. You can find her newsletter, Sticking Out Our Necks: Hormonal Health News, on Substack.

Terry

54:35-55:08

Mary Shomon, you are widely recognized as an advocate for people with thyroid problems, especially hypothyroidism. Part of that is because you yourself have had a long-term personal experience with Hashimoto’s disease, which leads, can lead to hypothyroidism.

Would you recap for us briefly, please, some of the milestones of your 30-year journey with Hashimoto’s?

Mary Shomon

55:09-58:04

Absolutely. When I was first diagnosed with hypothyroidism and Hashimoto’s, it was really not very well known to me. I was in the process of getting married. I was engaged. I kept going for dress fittings. And every time I went for a fitting, instead of taking the dress in, as they often do, because brides are always eager to lose weight, they had to keep letting my dress out, which was unusual because I had always had a normal metabolism. I was fairly slender, I felt great, and all of a sudden, my dress is getting let out and I’m tired and I’m feeling kind of blue and depressed, which is not the norm for a bride to be.

So I went to my doctor and I told her what was going on. And luckily, I had a very good integrative physician who immediately decided to go ahead and check my thyroid. And it came back that I was slightly hypothyroid and had slightly elevated thyroid antibodies. And so she said, we’ll put you on some medication.

And I thought, OK, great. This is going to solve the problem because I really didn’t know anything about thyroid disease. She put me on the meds and things didn’t get better. I kept gaining weight, I was more depressed, my hair started falling out, I was tired and brain fogged and all of the symptoms that are characteristically associated with hypothyroidism.

And I eventually went back to her. We worked on this multiple times and really got to a place where we were able to start changing around, switching over. I started out by taking a T4, T3 combination drug that is not on the market at present called Thyrolar. That was a synthetic combo of the two hormones. Then we switched over to natural thyroid. And at that time I was taking Armour Thyroid and I started to feel better.

I also started to learn more, which back in those days, this is the very earliest days of the internet, was an adventure. There was not a lot of attention paid to thyroid. And doctors often said, oh, it’s easy to diagnose, easy to treat. Just take one pill every day. Don’t worry about it.

Well, I discovered after talking with other thyroid patients and connecting and forming community with them. Not the case. A lot of people still were struggling. And that was really the beginning of my journey into patient advocacy and writing books and articles and providing information and creating support groups and other components to really help empower thyroid patients to develop their own information, empowerment, and to seek out and work with the physicians who really understood hypothyroidism.

So it’s been a 30-year journey, and I’m still on it and still working to advocate for myself and helping others stay well because that’s really the goal is we want to feel well, we want to live well.

Joe

58:04-59:56

And you have done an extraordinary job educating not just patients, but also I think a lot of healthcare professionals. One of the things that Dr. Bianco shared with us just blew my mind, just to be honest with you. I was like, oh my goodness, that’s extraordinary.

He looked at this gigantic database that he has, and apparently he and his colleagues have just published this data a couple of months back. And it showed that people who are on standard levothyroxine, Synthroid and other products, they don’t do as well as the, I think, endocrinology community thought they were doing in terms of things like mortality, in things like dementia.

I mean, so, you know, the stuff that people really care about, these patients weren’t doing as well, even though their thyroid levels seem to be, quote unquote, in the normal range. And Dr. Bianco then compared the outcome of these patients over a long period of time with people who were on desiccated thyroid extract, natural thyroid. And those people did better. They did better than the people on synthetic thyroid in terms of longevity, in terms of brain fog, in terms of just cholesterol levels in the liver.

And when I got done listening to him, I thought, wow, why hasn’t the endocrinology community recognized that there are long-term consequences in terms of general mortality rates and how people are feeling? And why hasn’t the FDA recognized what Dr. Bianco has discovered?

Mary Shomon

59:58-01:03:02

It’s a good question. And I have to say, I have the most incredible respect for Dr. Bianco because he has been out there for decades, really thinking outside the box from the endocrinologist standpoint, because endocrinologists tend to be fairly hidebound. They stick with what they know. They’re slow to change. They’re slow to move into new ways of thinking.

I mean, think about how it’s taken decades for the medical establishment to accept that blood sugar levels over 100 are problematic and that we need to watch those because people are on the way to potential type 2 diabetes. It used to be unless your blood sugar was over a certain level, you were fine.

Now we know there are gradations on the way to blood sugar problems. And I think it’s the same thing for thyroid. We are just now starting to see the endocrinology community accept that there is a subset of patients who absolutely need the two hormones rather than just the T4 hormone. The understanding was always, oh, patients get T4, their body converts it to T3. Everything’s great. We’re copacetic.

Now we do know that there are problems with genetic changes. There are incapacity to convert T4 into T3 that’s built in genetically in some people. And they’re just now starting to say, okay, well, that makes sense. It’s not just a patient preference issue. Well, they’re going to be moving slowly in this direction towards understanding that the T4-T3 combination therapy may in fact be better for the majority of patients.

But that said, my philosophy for 30 years has been the best thyroid medication or best thyroid hormone replacement for you is the one that works best and safely for you. And having been in touch with thousands and thousands of patients over the years, I can tell you that there is a patient for every possible permutation and combination where that has been the best choice for them.

For some, synthetic is perfect. For others, they need a particular brand of whatever drug they’re taking. Others do better on combinations. Some people need compounded mixtures. Some people like the T4 and T3. Others do well with T4. And we have a small subset that do better with just T3.

So safest and best relief of symptoms for you is ultimately the best option for patients. And the key for me is making sure that the medical world makes those options available to us and doesn’t take away options that we may need, at least a subset of us, me included, because I’m a desiccated thyroid patient. I use desiccated thyroid for my hormone replacement. Don’t take away options that work for me and for other thyroid patients. Make sure we have options and let us know what the different pros and cons are of the different options.

Terry

01:03:04-01:03:18

Mary, I wonder if you can tell us what you are doing as an activist to see if this action of the FDA, this proposed action, it can be counteracted.

Mary Shomon

01:03:19-01:05:17

Well, I have been talking with several of the drug manufacturers, number one, because they are all obviously quite interested in trying to, in some cases, they’re applying for their BLAs, but the biologic license applications for their formulations of natural desiccated thyroid. But that is going to be a lengthy process.

Some of them are already in progress, but it’s probably not going to come early enough if the FDA does in fact pull the medication off the market in a few months into the summer of 2026.

But what we’re doing is I’m talking with the manufacturers, we’re talking with the patient organizations, other patient advocates, and we’ve got patients reaching out to their representatives, to the FDA itself, writing in, making complaints, talking about and sharing their stories.

Because there are patients who have done every possible trial in the world on all of the different options, and natural desiccated thyroid is the only thing that has worked for them. And I’m an advisor with Paloma Health, which is a large medical practice that focuses on hypothyroidism, and our team of doctors have also been reaching out to explain situations, obviously without violating patient confidentiality, but saying, look, I have patients that will not survive if you take natural desiccated thyroid off the market because we’ve tried them on synthetics. We’ve tried them on every option and it doesn’t work for them. So I need this as an available option for some of my patients that rely on it for their very survival.

Because for those of us who are hypothyroid, thyroid medication is not an option. We have to have it in order to function for our body to function, all of our organs, tissues, glands, and cells.

Terry

01:05:17-01:05:39

Mary, I wonder if you could tell us a story about one or two of those people who are going to be just completely in terrible trouble if the FDA completes its action as proposed and the companies don’t yet have their biologic license in place.

Mary Shomon

01:05:40-01:07:32

Absolutely. I’m thinking of one patient that I know who’s also a friend of mine, and she’s in her early 70s. She’s a widow, and she has tried every possible thyroid medication. She got no response taking synthetics. The doctors haven’t really ever figured out why her body would not absorb them. We’re not sure if it was a malabsorption or ingredient allergy or sensitivity. But once she started taking natural thyroid, which was more than 10 years ago, she was able to get her thyroid levels under control.

The blood tests showed that the thyroid hormone was getting into her system, which it had not been doing on the Synthroid. It helped relieve depression, fatigue, exhaustion, brain fog, muscle pain, and weakness.

And she basically said to me, if they take my natural thyroid away, I think I’m just going to let myself die. She’s that depressed about the concept of having her medication taken away.

And I don’t blame her because it took her a long time. She went probably a decade or more trying to find something that worked and was dragging herself along, trying to function on a daily basis, barely.

Once she got the natural thyroid, it felt like her life had come back. And she’s like, don’t take my life away from me again. So she’s one of the people I know who has been most active. I think she has called every member of Congress, every one of her representatives multiple times. She’s talked with them multiple times.

She has sent letters to everyone at the FDA. She is a one-woman advocacy campaign unto herself because it’s so important to her. It is her life. And so I think she’s a good example of how passionate patients can be when we know that this is something we rely on. We cannot function without it.

Joe

01:07:33-01:08:09

Mary, I wonder if you would be kind enough to just run through some of the very confusing numbers that people need to know about when it comes to assessing their thyroid function, because a lot of times they get a lab report. It’s confusing to them. Their doctor may not explain it.

So what would you consider, based on all of your research and experience, normal or achievable goals for people who are using a natural thyroid, desiccated thyroid extract so that they feel well?

Mary Shomon

01:08:10-01:11:32

Well, typically, we want to look at, I think, four numbers. Most of the physicians that I have worked with over the last 35 years that are really knowledgeable about thyroid will focus in on four particular parameters. They’re going to look at the TSH, which is thyroid stimulating hormone. This is a brain hormone, not a thyroid hormone, but it is a messenger to the thyroid gland telling it to make more or less hormone. We’re going to look really carefully at the free T4 and the free T3. That’s free thyroxine and free triiodothyronine.

And there we’re looking at the actual available circulating amounts of thyroid hormone going through the bloodstream. And in many cases, because Hashimoto’s autoimmune thyroiditis is the primary cause of hypothyroidism in the United States, we’re going to look at Hashimoto’s antibodies or thyroid peroxidase antibody levels.

And so that set of four tests is really the basics. And for most people that are dealing with autoimmune Hashimoto’s or hypothyroidism, that’s going to cover most of the bases. We’re looking for a TSH that is going to be in the reference range. And the reference range, depending on the lab, typically runs from about 0.3 to 4 or 4.5, but with the understanding that the majority of the population is not walking around with a TSH at the high end of that range.

Most people feel best when it’s under 2.5 or under 2. The free T4 and the free T3, those are usually, we want to see those levels in the middle point or maybe a little bit higher of the reference range. But the free T4 can sometimes be a little bit lower in some people, the free T3 a little bit higher when they’re taking a natural desiccated thyroid because it does contain some extra T3 in it. So that helps to bump those T3 levels up a little bit.

And then the thyroid peroxidase antibodies or TPO antibodies, we typically are looking for those ideally to be in the reference range, which means there’s no active autoimmune disease, or if they’re elevated, we want to be watching them so that any dietary medication, thyroid treatment, lifestyle changes are bringing them down slowly and to a lower level.

I think the cutoff, it depends on the lab, but cutoff is like 32, 35. Anything above that is considered active evidence of thyroid antibodies. But as they creep up towards that cutoff point, that can sometimes be the indications that autoimmune activity is already starting to take place.

So there’s this concept of the reference range or the normal range, but what most of the really savvy practitioners are using is what they consider the optimal range. So that would be the lower end of the reference range for TSH and the midpoint to the upper end of the range for the free T4 and free T3. And again, with antibodies, getting them down as low as possible.

Joe

01:11:32-01:11:41

And what would those free T3, free T4 levels be in general to be on the optimal side?

Mary Shomon

01:11:42-01:13:03

Well, it depends on the lab that you go to, but let’s see. I believe that free T4, if I’m remembering correctly, runs about 0.8 to like 2.2 at many range. That’s many labs have a range of that. And we’d like to see that like at about the midpoint there.

But typically with people taking natural desiccated thyroid, you would see levels maybe in the 1.2, 1.3 level. And with the free T3 levels, typically there we, I believe they run from like 2.2 to 4.3, give or take, depending on the lab. And there, a lot of people are walking around with 2.4, 2.5. They’re at the very low end of the range and they don’t feel well.

The people that feel the best tend to be 3.2, 3.3, 3.4, up in the upper half of the reference range, up to maybe about the 75th percentile. Too high of free T3, and you can start to feel like you’ve had too many espressos, and you can get jittery, you can feel nervous, your heart rate can go up, which is a sign that maybe there’s too much T3 on board. So we want people to be at a place where their T3 is good, but not that they’re getting over-medicated to a point where they’re feeling overstimulated.

Joe

01:13:04-01:13:14

And just to remind people, what are some of the most common symptoms of hypothyroidism, the people that you serve most frequently?

Mary Shomon

01:13:15-01:15:28

The most common symptoms are fatigue. And when we say fatigue, we’re not talking about, oh, I’ve had a busy day. I’m a little bit tired. We’re talking about having to go sleep in your car for 30 minutes at lunchtime to get through the rest of the day or having to have a nap when you come home because you can’t get up to make dinner. Uh, we’re talking about people that sleep 15 hours on the Saturdays, uh, mornings in order to get back to some level of energy after a busy week.

This is bone numbing fatigue for many people. Uh, we also see brain fog, cognitive changes, difficulty remembering things, wondering, oh my gosh, do I have Alzheimer? Why am I having so much trouble remembering a particular word or a particular thing? People often see some weight gain, especially if there’s no change to diet and exercise like I did when I was first diagnosed. Just no change, but all of a sudden gaining weight.

People will also have dry skin. They can lose hair. They can often lose, one of the most characteristic signs is the outer edge of the eyebrows will disappear, and they’ll have to be penciling it in. I always say to women, if you’re penciling in your eyebrows, I want you to get your thyroid checked.

Dry skin, constipation, feeling depressed, sometimes anxiety. People can have a lot of, their nails can break. Their nails become brittle, dry. They don’t grow, they break. And this is just the tip of the iceberg. There are dozens and dozens of other signs and symptoms.

For younger women, we can see fertility issues, menstrual changes. For women going into perimenopause, we can see issues with worsening perimenopausal symptoms. There’s a whole range of different types of symptoms.

For men, we can see low libido and women too, but low libido is often a complaint in men along with hair loss. So there’s a whole range. It’s essentially anything that slows down your thinking, your processing, your organs, tissues, glands, and cells can be a symptom of hypothyroidism because [the thyroid hormone] is helping to provide energy to all of those components of your physiology.

Joe

01:15:28-01:15:49

I’m wondering, Mary, if people will be able to access natural thyroid from Canada once the ban goes into effect. A lot of people do buy their medications from Canada online, and the FDA hasn’t prevented that. But in this case, what are you hearing?

Mary Shomon

01:15:51-01:18:23

Well, what I’m hearing is that there is a lot of confusion about it, but that because in the past, it was that the Canadian drugs were allowed to come in, the Canadian natural thyroid was allowed to be imported for personal use.

I believe that is the language that the cross-border medication issue was you can’t bring in giant volumes and truckloads of it, but you can bring in enough for your personal use and you can get it in Canada with a prescription.

But now that it is going to be designated as a biologic, unapproved, non-approved natural desiccated thyroid will technically be illegal. And so I’ve heard that there may be a crackdown on trying to import Canadian or potentially natural thyroid from other countries that might potentially try to fill the gap.

So it’s really up in the air. And that’s part of the big problem with this entire issue is what are they going to do? Are they going to enforce it in 2026? Are they going to let it slide? Are they going to keep us from importing meds from outside or from Canada? Or are they going to crack down and say, no, nope, or maybe say, yeah, we’ll let you do it until things change. It’s really a question mark.

And the question mark also goes into the motivations of the government, because we know that we have a new HHS secretary that’s focused on more natural approaches to things, a little bit of a battle with the drug companies to some extent that we’re seeing between the FDA and the HHS and the pharma industry.

And so I’ve heard some patients say, I don’t understand this. I thought they would like a natural, inexpensive drug that seems to work pretty well for us for over 100 years. Now they’re putting it in for this biologic status.

And frankly, that’s one of the other concerns I have is how much is it going to cost? Because biologic drugs in general are extremely expensive. These are the ones we see advertised on TV all the time. The Humira and Stellara and all these drugs that sometimes can cost thousands of dollars a month.

How much is natural desiccated thyroid, which most of us can get for $30, $40, $50 a month, how much is it going to cost once it’s gone through this big approval and becomes a biologic drug? Who knows? It could be many times the price that we’re paying now, or potentially it may be priced out to a point where it’s unaffordable for most people.

Joe

1:18:23-1:18:23

Right.

Terry

01:18:24-01:18:32

Mary Shoman, thank you so much for talking with us on The People’s Pharmacy today and for leading the charge.

Mary Shomon

01:18:32-01:18:40

Thank you so much and appreciate getting the word out because patients need to be informed in order to feel well and live well.

Terry

01:18:41-01:18:56

You’ve been listening to patient advocate Mary Shoman. She’s the author of “The Thyroid Diet” and 10 other books. She’s also a Paloma Health Advisor. You can find her newsletter: Sticking Out Our Necks: Hormonal Health News on Substack.

Joe

01:18:56-01:19:16

We spoke earlier with Dr. Antonio Bianco, Senior Vice President of Health Affairs and Dean of the John Sealy School of Medicine at the University of Texas Medical Branch at Galveston. He’s the author of “Rethinking Hypothyroidism: Why Treatment Must Change and What Patients Can Do.”

Terry

01:19:16-01:19:25

Lyn Siegel produced today’s show, Al Wodarski engineered. Dave Graedon edits our interviews. B.J. Leiderman composed our theme music.

Joe

01:19:26-01:19:33

This show is a co-production of North Carolina Public Radio, WUNC, with The People’s Pharmacy.

Terry

01:19:33-01:19:51

Today’s show is number 1,452. You can find it online at peoplespharmacy.com. That’s where you can share your comments about this episode. You could also reach us through email, radio at peoplespharmacy.com.

Joe

01:19:52-01:20:09

Our interviews are available through your favorite podcast provider. You’ll find the podcast on our website on Monday morning. The podcast this week has additional information we couldn’t squeeze into the broadcast with updates on Dr. Bianco’s latest research showing that people on natural thyroid live longer.

Terry

01:20:10-01:20:33

At peoplespharmacy.com, you could sign up for our free online newsletter to get the latest news about important health stories. When you subscribe, you also get regular access to information about our weekly podcast. We’d be grateful if you would consider writing a review of The People’s Pharmacy and posting it to the podcast platform you use.

Joe

01:20:34-01:20:36

In Durham, North Carolina, I’m Joe Graedon.

Terry

01:20:36-01:21:12

And I’m Terry Graedon. Thank you for listening. Please join us again next week. Thank you for listening to the People’s Pharmacy Podcast. It’s an honor and a pleasure to bring you our award-winning program week in and week out. But producing and distributing this show as a free podcast takes time and costs money.

Joe

01:21:12-01:21:22

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Terry

01:21:22-01:21:27

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Joe

01:21:27-01:21:40

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