Thyroid, Armour, Westhroid, Naturethroid, T4, T3, T2, T1

Where Has all the Thyroid Gone?

Where Has all the Thyroid Gone?

I am constantly amazed by how much I don’t know . . . not in relation to topics that I have never pursued, but about subjects that I have studied for years and thought I had mastered. I am also surprised by how often I learn that what I believed to be an original discovery on my part was observed by someone else years before. Seeking the truth is often a humbling experience.

A decade ago I wrote about The Four Stages of Knowledge. I did so to address the question of why so few physicians are open to non-pharmacologic approaches to health challenges. I suggested that the reason is that physicians tend to believe that they have learned all that is known about sickness and health in medical school, residency training, and through continuing medical education courses. Simply stated, they think they know it all.

The first stage of knowledge is always the realization that I don’t know what I don’t know, the recognition that what I believe to be the whole picture may be, in fact, only the tip of the iceberg. It is accepting that when I look beneath the surface, or dig a little deeper into any subject I may discover that what I believed to be a complete understanding of the topic was only a façade, an impression that was nothing but a false front.

I set out to write this month about the strange disappearance of whole thyroid products from the U.S. marketplace. If you like a good mystery you should enjoy this article, in which I attempt to unravel several puzzles simultaneously.

When I began my research I thought I was an expert in the subject of hypothyroidism – the lack of adequate thyroid function. For over two decades I had been successfully managing the condition in patients who had not found help elsewhere. I had written about the advantages of using whole thyroid rather than commonly prescribed levothyroxine (T4) when thyroid support is needed, and I had explained why TSH and T4 blood tests are unreliable in detecting the need for or adequacy of thyroid support.

I thought I knew all there was to know about the thyroid gland and the role of thyroid hormones in the body, but I was wrong. In seeking to understand why pharmacists were no longer able to fill prescriptions for whole thyroid I discovered much that I did not know about thyroid function.

The story begins in the spring of 2008, when individuals taking certain strengths of Forest Laboratories’ Armour Thyroid began having difficulty refilling their prescriptions. In response to inquiries, Forest released the following statement:

“Forest is performing a process change to further enhance the quality of our product Armour Thyroid. The strengths currently involved in this change are the 2 gr (120 mg), 3 gr (180 mg), 4 gr (240 mg), and 5 gr(300 mg). If we maintain our current schedule, these strengths should be available in October. During this time, we will continue to manufacture the .25 gr, .50 gr, 1 gr, and 1.5 gr tablets. However, we may encounter short-term backorders on these strengths as a result of increase in demand.”

The statement gave no reason for the process change – the product had been performing satisfactorily – nor did it explain why they could not simply increase their production of the other strengths to compensate for the demand. Neither did it explain why Forest had not been able to anticipate the “process change” and increase inventories of the lower dosage strength tablets to compensate for the upcoming short-term shortfall in the larger dosage strength tablets.

In a separate release they acknowledged that the 1.5 gr(90 mg) tablets were backordered, but stated that shipments of the 1.5 gr strength were expected to resume on July 9, 2008. The anticipated release dates for the other strengths was October 2008.

Western Research Laboratories, the manufacturers of Naturethroid and Westhroid assured concerned consumers that they remained in full production of the products and had adequate stores to fulfill orders. A generic manufacturer, Time Caps Laboratories, was producing their product, Qualitest, and it was anticipated that this would provide a safety net if the production of Naturethroid and Westhroid were to fall behind the demand.

Fast forward a year to the spring of 2009. Pharmacies across the country reported that they were no longer able to obtain any whole thyroid product with which to fill their customer’s prescriptions. Not Armour. Not Westhroid. Not a generic. The supply of desiccated thyroid seemed to have been cut off.

Western Research contested the claims, stating that all strengths except the 3 grain tablet were fully stocked and that they were in full production, fully dedicated to assuring that there would be no interruption in the supply of natural desiccated thyroid medication.

Compounding pharmacies, which make up medications on-site, also issued press releases that they were able to meet the demand. The costs for a compounded product are higher, because the capsules must be filled individually rather than by machine automation, but patients were reassured that they would always have a way to obtain their medication.

By August, 2009, however, all assurances had failed. Western Research reported that they had been unable to maintain production because they had been unable to obtain desiccated thyroid from the only source, American Laboratories of Omaha, Nebraska. The same was apparently true for Forest Laboratories, as they finally stated in September that they had been able to obtain a supply of raw material and were in production. They were unwilling to give any anticipated release date, however.

I spoke to a representative of Western Research Laboratories just prior to sending this article to the publisher and was assured that they had been able to obtain desiccated thyroid from their supplier and were in production with an anticipated shipping date of mid-November 2009. With a two year history of failed promises I am only cautiously optimistic that supplies of whole thyroid will resume in the near future.

If, as it now appears, the reason for the shortfalls from both Forest and Western Research was an inability to obtain the active ingredient, raw desiccated thyroid from their supplier, there is yet another mystery. Why did supplies of dry desiccated thyroid suddenly disappear? For over a century desiccated thyroid has been obtained from the thyroid glands of animals slaughtered for food in the United States. Pigs continue to be sent to market. There have been no shortages of bacon, ham, or pork chops reported.

I believe I know the answer, but first I would like to explain why the inability to obtain whole thyroid medication is a serious challenge. Patients who have been taking whole thyroid medications are being advised to have their physician change their prescriptions to levothyroxin. Levothyroxine is the thyroid replacement preferred by most physicians, it is the only drug approved by the FDA for the treatment of hypothyroidism, and there has been no shortage of any of the levothyroxine brands on the market. Levothyroxine is readily available, but for most of those who have been taking whole thyroid it is not an acceptable option.

Many years ago I subscribed to a service that provided taped lectures from medical meetings. By listing to the tape of the month and completing a post-test I was able to obtain continuing medical education credits.

One month the taped lecture was on hypothyroidism (an underactive thyroid). Upon the completion of the formal talk the speaker invited questions from the audience. A physician stepped up to the microphone and asked the following question: “Every so often I inherit a patient from an older physician who has left practice. She is on Armour Thyroid. I try to bring her into the twentieth century by prescribing Synthroid, but she comes back in a month or two and tells me how rotten she feels. What’s happening?”

I shall never forget the response of the thyroid expert. She became unhinged and began shouting. “There are a lot of things you could give her that would make her feel good! You could give her morphine! You could give her codeine! You could give her amphetamines! She’s been feeling abnormally good for too long and its time for her to get a taste of reality!”

It was just the sort of scientific, logical, and compassionate response one would expect from a highly credentialed physician – or was it. It was more akin to an emotional outburst by a religious zealot who had just heard someone question one of the basic tenets of her faith.

I could identify with the questioner. For years I had been hearing similar reports from patient after patient.

The symptoms of inadequate thyroid hormone action in the body are many. They include tiredness, unexplained weight gain, constipation, sluggishness, depression, feeling cold to the bone, and difficulty with memory. Signs include dry scaly skin, thin brittle hair, thin brittle ridged nails, excessive snoring, loss of the outer third of the eyebrows, a low body temperature, a low pulse rate, sluggish reflexes, and walking with the thumbs pointing inward rather than forward.

When confronted with someone reporting a picture consistent with hypothyroidism I would order blood tests of two hormones, T4 and TSH. TSH stands for thyroid stimulating hormone. It is produced by the pituitary gland and its function is to stimulate the production of hormones by the thyroid gland. A normal thyroid gland responds by producing thyroid hormones, one of which is levothyroxine or T4. When thyroid hormone output is optimum the release of TSH slows and balance is maintained.

Unfortunately, many individuals with a classic hypothyroid picture had TSH and T4 levels within the normal range. Many whose test results confirmed the presence of hypothyroidism continued to report the same symptoms and display the same signs when their TSH and T4 levels were normalized with the use of levothyroxine.

The standard medical response to those with T4 and TSH blood tests in the normal range before or after treatment was and still is, “We don’t know what’s wrong, but at least we know it’s not your thyroid.” Many people in this situation are told that they are depressed and placed on an antidepressant medication. Few note any improvement.

As person after person continued to report symptoms and exhibit signs of hypothyroidism despite normal T4 and TSH test results it became apparent to me that something was missing in what was being taught about the diagnosis and treatment of thyroid disease.

Although the diagnosis of hypothyroidism was totally dependent upon finding a low T4 level in the blood and the only treatment acceptable to thyroid “experts” was levothyroxine, a second thyroid hormone was known to exist. The thyroid gland produced triiodothyronine (T3) as well as T4, but in smaller amounts. Thyroid experts acknowledged that excessive production of T3 could cause hyperthyroidism (an overactive thyroid condition), but the possibility that low levels of T3 could be responsible for the signs and symptoms of hypothyroidism was never considered.

A synthetic form of T3, liothyronine had been approved by the FDA in 1956, but due to its short duration of action it had not gained the level of acceptance enjoyed by levothyroxine.

In 1991 Dr. E Denis Wilson published a book titled Wilson’s Syndrome: The Miracle of Feeling Well in which he reported success in treating individuals with normal T4 and TSH levels, but low basal body temperature and hypothyroid symptoms by using T3 in a sustained-release form. Sustained-release T3 must be prepared by a compounding pharmacist. It is therefore significantly more costly than mass produced medications. Wilson’s treatment also required titration, which required the mixing and matching of multiple capsule strengths. The cost and complexity of the treatment regimen made the program difficult to follow, but some of those who followed it were pleased with the results.

I subsequently learned that while T4 is the primary hormone produced by the thyroid gland, T3 is the primary active hormone in the body. T4 is the storage form of thyroid hormone in the body. It must be converted to T3 at the tissue level for normal thyroid activity to occur. This provided one answer to the dilemma faced by those who exhibited hypothyroid features in the presence of normal T4 and TSH blood tests.

The inability to convert T4 to T3 is quite common. In some instances this is due to vitamin and mineral deficiencies, but in many cases it is the direct result of physical or emotional stress.

The body not only has the ability to convert T4 to T3, the active form of thyroid hormone, but to reverse T3 (RT3), which is inactive. This allows the body to control the degree of thyroid hormone activity that is present. An example of a situation in which the body would choose to decrease the degree of thyroid activity present is when a famine is present. By shifting the conversion of T4 to RT3 rather than to T3 the body can slow its metabolic rate to conserve energy and increase the chance of survival.

Unfortunately, the RT3 conversion pathway can be triggered not only by famine, but by crash dieting, severe physical illness, injury or surgery, or other stress. When the initial stress is relieved, the body may not revert back to the T4 to T3 option. When this occurs the individual will experience all of the signs and symptoms of an underactive thyroid condition, but with completely normal T4 and TSH blood levels.

Another condition can also cause the normal blood test hypothyroid picture. Hashimoto’s thyroiditis is an inflammation of the thyroid gland that is usually triggered by iodine deficiency. When the thyroid becomes inflamed some of the hormone leaks into the surrounding tissues rather than being delivered into the blood stream. The body responds by creating antibodies that attack thyroid hormone. I discovered that normal T4 and TSH levels may be present for more than a decade following the initial episode of thyroiditis. Because a significant amount of thyroid hormone is being destroyed by the anti-thyroid antibodies these individuals also experience the characteristics of hypothyroidism.

I discovered that providing support in the form of whole desiccated thyroid brought almost immediate relief in those persons exhibiting a hypothyroid picture, but whose T4 and TSH levels were in the normal range. They were among the most grateful patients I have ever seen. Some of them had struggled needlessly for over a decade while being told by physicians “We don’t know why you are feeling this way, but we know it’s not related to your thyroid.”

The response, while clearly present, puzzled me. T4 alone was clearly not sufficient to restore normal thyroid function in many people. If T3 alone was the answer, why did people not achieve the same results when sustained-release T3 was prescribed? It is true that improvement was seen with the Wilson protocol, but massive doses of T3 were often required to achieve the desired result. Why did most people do better on the relatively small amounts of T3 found in whole thyroid products? It was as though the body needed to be exposed to T3 to remember what it was supposed to be doing with T4. If that were the case, however, why didn’t Thyrolar, a combination synthetic T4/T3 product did produce the results seen with desiccated thyroid?

It was not until I began researching this article that I discovered that T4 and T3 are not the only hormones produced by the thyroid gland. Two additional hormones, T2 and T1, are also present.

T2 and T1 have been almost completely ignored by the medical community. When they are mentioned in passing, which is so rare that I had not seen it in forty years of medical study, they are said to be inactive breakdown products of T4 and T3. I have learned that nothing could be further from the truth.

Nothing is known about the action of T1 in the body, but some research has been conducted on T2. The results provide incredible insight into the function of thyroid hormone in the body and go far in explaining the observed benefits of whole thyroid replacement therapy.

T2, like T3, activates energy production in mitochondria, the energy factories of cells. The mitochondrial response to T2 is much faster, however. It is though T2 is the spark that fires the engine and T3 is the accelerator that keeps the engine running. No wonder energy level improves so quickly when whole thyroid is provided. T2 effectively increases energy production in the liver, the heart, and in muscles throughout the body.

A second role of T2 appears to be that which I mistakenly credited to T3 – the catalyst that drives the conversion of T4 to T3! T2 has been found to stimulate activity of the enzyme that converts T4 to T3; T2 is critical to the T4 to T3 conversion process. I had found the answer to one of the mysteries surrounding the effective treatment of hypothyroidism. I now knew why only desiccated thyroid was able to restore normal thyroid activity in so many individuals who were experiencing hypothyroid symptoms. The mystery of the disappearance of whole thyroid products remained to be solved. (To be continued.)

© 2009 Wellness Clubs of


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