Tag Archives: Synthroid

More Toxic Thyroid Supplements


During 2 decades of practicing endocrinology I had not encountered an instance of an over the counter product containing enough active thyroid hormone to make a difference in thyroid levels. In the last month I consulted on two new patients who appear to have developed toxic thyroid levels due to non-prescription products. The first involved a “Metabolic Complex” obtained from New Zealand. This seemed like a fairly random event in which a non-prescribing health practitioner was able to obtain an unregulated product which was passed on to the patient. Not likely to become a common issue. This second instance is more worrisome since it involves a product purchased directly by the patient from the internet, and supposedly “vegetarian” in nature.

Here is the story. A woman with a history of hypothyroidism for about one year taking synthetic prescription thyroid hormone decided to find a more natural solution to thyroid hormone replacement. She stopped the thyroid hormone replacement prescribed by her local physician and purchased a product via the internet advertised to improve thyroid gland “health”. Prior to starting the OTC product her thyroid blood tests indicated low thyroid levels, as expected. About a month after starting the thyroid supplement her thyroid levels were clearly above normal, entering the thyrotoxic range. Fortunately she returned to her physician who alerted her to the problem and asked her to stop the thyroid supplement and one month later she was back to being hypothyroid again. It was at this time I first consulted with her and found her to have the expected symptoms of fatigue, weight gain, poor memory, dry skin and water retention (edema). I restarted her on prescription thyroid hormone replacement.

I wanted to see the product bottle myself but was unable to obtain it. Instead I went on-line and tried to track down the product’s manufacturer and list of ingredients. It was a frustrating exercise since the names of the products and the manufacturers and distributors changed from one website to another. I narrowed my search to one product manufactured in California and another in Canada. Perhaps I will be able to get the original pill container and nail this product down but for now it remains a bit mysterious.

Members of metabolism.com have asked me to pass on the name of these products. Now come on…do you think I want to make this situation worse by giving the information away to juvenile delinquents? I am hoping government regulators will become more vigilante to what appears to be a growing problem. In the mean time I advise everyone to be on the alert to similar products being marketed to an unsuspecting public.

Gary Pepper, M.D.
Editor-in-Chief, Metabolism.com

Some of the details of this report have been changed to protect the identity of my patient. This information is for educational purposes only and is not intended as medical advice or therapy.

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What You can Learn from Sarah’s Struggle With Hypothyroidism


Every so often I like to bring attention to someone who has struggled to get properly treated for hypothyroidism. Not everyone shares the same dilemma regarding treatment of hypothyroidism because T4 by itself may be sufficient in many instances. But for those who continue to experience symptoms of hypothyroidism despite T4 treatment, adding T3 can be a life changing experience.

Here is Sarah’s story:

I was diagnosed with hypothyroidism in my early twenties and Synthroid did not help. I did not know at the time that many of my symptoms were due to hypothyroidism. After changing to my long time physician, I told her of my original diagnosis some years back. She did only the TSH and told me I was no longer hypothyroid! So for some 15 years after being in her care and continuing to feel crummy, then for the last 8 steadily gaining weight and feeling worse, I was not on any medication. I begged her for Cytomel several years back and was denied…she said she didn’t treat with that. When I finally was deemed hypo by her, she put me on the smallest dose of levothyroxine. It did not help. I finally went to see a shrink and he put me on 25 mcg of Cytomel. For the first time in my post pubescent life, I feel like living. My dose was upped to 50, and I felt even better but my thyroid levels were off, so we are now working on that and I am back to 25 mcg per day. If you can’t get Cytomel from your regular physician, you might get a psychiatrist to prescribe it. It changed my life and I finally feel alive. I’ve since switched primary physician because she wouldn’t listen to me, and she didn’t like that I was on Cytomel. I don’t know what it is about this medication that regular physicians don’t like and make them refuse to treat with it, especially when so many can benefit from it. I’ve lost only 12 lbs since being on it, but I gained nearly 35 unnecessarily while not being properly treated and was told to eat less and exercise more…I only ate about 1500 calories a day and walked my dog 2 miles each day, so I don’t feel it had anything to do with my diet!

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Wondering if t4 (Synthroid) Treatment of Hypothyroidism is the Answer


Prosanta asks metabolism.com if her thyroid blood test results indicate that treatment with t4 is required. I suspect that she is also wondering if other forms of treatment might be better (Armour Thyroid for example).

Here is what Prosanta writes:

Iamsuffering from Diabetes type2.recently on routine Blood test—
FT3(ECLIA) 2.33pg/ml
FT4 1.07ng/ml
TSH 9.32microIU/ml
AntiThyroid Peroxidase 37.02IU/ml
Do I need to take only Levothyroxine

In response to her question I offer my thoughts on whether someone beginning with thyroid hormone replacement therapy should start with t4.

Hi Prosanta

You know I can’t recommend medical therapy in this forum. I can make some general comments, however.

There is debate among endocrinologists about what level of TSH indicates a clinical degree of thyroid deficiency, but there is no doubt that a TSH of 9 is abnormally high. Since elevated TSH almost always indicates that the pituitary gland is releasing excessive TSH in response to thyroid hormone deficiency, unless there is a pituitary tumor (exceedingly rare), replacement therapy with thyroid hormone is indicated.

Thyroid hormone replacement therapy in the U.S. usually consists of taking a pure t4 product such as Synthroid or levothyroxine (generic t4). On this website you will notice extensive posting about treating hypothyroidism with alternative forms of thyroid hormone replacement, particularly desiccated thyroid products such as Armour Thyroid. An appropriate concern in a situation like yours is whether to take t4 only or to use desiccated thyroid or t4 plus t3 therapy.

If you are like most people in this country being treated with t4, you will wonder why someone might need alternative forms of thyroid hormone replacement. In the past year or so researchers have discovered that a portion of the population lacks the ability to normally metabolize t4 into the highly biologically active t3. This means that affected individuals may continue to experience symptoms of thyroid hormone deficiency when treated with conventional t4 therapy [http://www.metabolism.com/2009/11/07/breakthrough-discovery-thyroid-hormone-therapy-part-2/ ]. How does a person know if they won’t respond to t4? The simpliest approach is to try t4 and see how you feel. Then you and your doctor can decide whether you are a t4 responder or not.

You may be aware that Armour Thyroid and similar products are in very short supply in the U.S. Even if some advocates of desiccated thyroid therapy for hypothyroidism argue that only desiccated thyroid can result in a full return to normal, in my opinion the present shortage makes t4 therapy the clear initial choice. If symptoms of hypothyroidism persist even after a full course of t4 has been tried, then you may be forced to join the ranks of those struggling with the pharma industry to get desiccated thyroid products.

Please discuss these ideas with your own physician.

The disclaimer and terms of service of metabolism.com applies to this and all my posts on this website.

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Pharma Expert Examines FDA Moves on Restricting Armour


Hank Frier has been involved with the pharma industry for a long time and helps us see through the news blackout in regards to the FDA actions on Armour. He is also suffering the same fate as many others in the U.S., having been successfully treated with Armour for many years, now forced to switch to other alternatives.

Hank writes:

I too have been switched back to Synthroid after several successful years of being on Armour. At this juncture it is too early to tell how this will impact me. Luckily, my physician had the foresight to also put me on Cytomel after I suggested this from my readings. The combination of Armour and Cytomel seemed to work quite well for me without any adverse events.

This next is my opinion so take it as such. I believe the makers of Synthroid (Abbott Ross) in an attempt to increase their sales of Synthroid put pressure on the FDA to require the makers of Armour to submit an NDA. It is a devastatingly poor tactic by Abbott Ross but typical of this industry.

It is unfortunate that the FDA is caught in the middle of this since by statute and law drugs must pass regulatory muster. Where the FDA has failed is in their lack of looking at the long past history of Armour, its lack of adverse events and its benefit/risk for those individuals that have been using this drug. As opposed to demanding an NDA from Forest Pharma they should have sat with them and reviewed the long history of this drug, the number of scripts written for this drug and even contacting those physicians/endocrinologists that have been prescribing it for their patients.

The only safety question in my mind is does Armour ingestion, a foreign protein, cause an immune response. This would have been reported by the medical profession if that were the case. Secondly, historically, large segments of the population have been eating pig and pig organ meats for generations without ill affects. The ingestion of a purified material from pig (Armour thyroid a protein) is probably benign. The FDA scientists should know this and counsel their legal staff as to the benign nature of the drug.

Hank

I too have been switched back to Synthroid after several successful years of being on Armour. At this juncture it is too early to tell how this will impact me. Luckily, my physician had the foresight to also put me on Cytomel after I suggested this from my readings. The combination of Armour and Cytomel seemed to work quite well for me without any adverse events.

This next is my opinion so take it as such. I believe the makers of Synthroid (Abbott Ross) in an attempt to increase their sales of Synthroid put pressure on the FDA to require the makers of Armour to submit an NDA. It is a devastatingly poor tactic by Abbott Ross but typical of this industry.

It is unfortunate that the FDA is caught in the middle of this since by statute and law drugs must pass regulatory muster. Where the FDA has failed is in their lack of looking at the long past history of Armour, its lack of adverse events and its benefit/risk for those individuals that have been using this drug. As opposed to demanding an NDA from Forest Pharma they should have sat with them and reviewed the long history of this drug, the number of scripts written for this drug and even contacting those physicians/endocrinologists that have been prescribing it for their patients.

The only safety question in my mind is does Armour ingestion, a foreign protein, cause an immune response. This would have been reported by the medical profession if that were the case. Secondly, historically, large segments of the population have been eating pig and pig organ meats for generations without ill affects. The ingestion of a purified material from pig (Armour thyroid a protein) is probably benign. The FDA scientists should know this and counsel their legal staff as to the benign nature of the drug.

Hank
hfrier@comcast.net
Hank Frier
1

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Breakthrough Discovery in Thyroid Hormone Therapy: Part 2


Treatment of hypothyroidism (low thyroid function) is accomplished by administering thyroid hormone by mouth in sufficient amounts to restore levels back to normal. At first glance this might seem like a simple goal to achieve. The truth is hormone replacement therapy is complex because there exists two very different thyroid hormones and because levels of thyroid hormone in the blood do not always reflect the amount of thyroid hormone within the cells where the hormone exerts its effects. In Part One of this blog I began to discuss how genetic differences among individuals could explain why some people need a complex mix of thyroid hormones to adequately treat hypothyroidism. In Part 2, I want to explain the nature of the differences between individuals and how it determines what sort of thyroid hormone therapy may be needed.

In May 2009 a group of researchers (Panicker, V. et al) in the UK published the WATTS study, the largest and most comprehensive study to date, of hypothyroid patients treated with combination t4 and t3. The goal of the study was to discover whether genetic differences in the population of hypothyroid patients accounts for some individuals needing t3 in addition to traditional t4 therapy. The researchers looked at 697 hypothyroid individuals and analyzed their DNA for differences in the portions controlling crucial enzymes which process thyroid hormones known as deiodinases. These enzymes are found widely distributed in the body including the thyroid, brain, muscle, liver, kidney and pituitary gland. As explained above, deiodinases convert t4 to the much stronger form of thyroid hormone, t3. At the same time the researchers measured patients’ mood and sense of well being on t4 alone and when t3 was added to the therapy.

Key findings of the WATTS study are that there is a substantial difference among individuals in the genes that make the deiodinases. In other words, due to genetic differences (mutations), there are differences in the way individuals make t3 out of t4. In a group of people, mutations in the genes that make a particular protein (in this case, the deiodinase), are called polymorphisms. The researchers discovered that a certain mutation in the deiodinase gene is associated with a poor sense of well being on t4 only therapy, and in the presence of this mutation a significantly better response to adding t3 can be found compared to those without this mutation. Of the group of hypothyroid patients studied in the UK about 16% possessed the faulty deiodinase gene. In other groups in other countries the percentage of people with this mutation could be higher or lower.

The traditional treatment of hypothyroidism is to administer t4 (Synthroid, Levothyroxine, Levoxyl etc.). It is the conventional wisdom that inactive t4 is converted in the body to the active thyroid hormone t3 by “peripheral conversion” in sufficient amounts to restore normal thyroid balance. The recent breakthrough discoveries described in the WATTS study reveal for the first time that individuals differ in how their bodies process (metabolize) thyroid hormone. While some may convert enough t4 to t3 in the cells of the body to restore normal function, due to genetic differences some individuals will not be able to make enough t3 leaving them with persistent hypothyroid symptoms. Since the problem is a deficiency of t3 within the cells of the body, measuring thyroid hormone levels in the blood cannot adequately reveal the problem. T4 replacement treatment alone can result in thyroid levels that appear normal on blood tests so doctors conclude that persistent hypothyroid symptoms are not related to the hormone therapy.

Based on my personal experience and the documented experience of many of the members of Metabolism.com it is clear that endocrinologists and other physicians are often reluctant to consider combination therapy for hypothyroidism, either by using Armour thyroid or adding t3 (Cytomel, liothyronine) to t4 only therapy. With this new research in hand, hypothyroid individuals and their advocates can finally state with confidence that: Yes! There is a firm scientific foundation for combination t4/t3 therapy and; No! We are not just chronic complainers or kooks. If I had hypothyroidism and was going to request a change in my thyroid treatment I would say something like, “Due to polymorphism of the deiodinase gene I probably possess a defective D2 deiodinase and therefore my peripheral conversion of t4 to t3 is impaired. I need t3 added to t4 to compensate for reduced intracellular t3 levels which cannot be detected on blood tests. Without t3 I continue to suffer with cellular hypothyroidism which is the likely cause of my persistent symptoms.”

If you try this approach and your doctor looks bewildered hand them a copy of the study by Panicker et al in the Journal of Clinical Endocrinology and Metabolism, 2009, 94(5): 1623-1629.

Gary Pepper, M.D.

Editor-in-Chief, Metabolism.com

Notice: This article is for informational purposes only and does not substitute for the advice or treatment of your own physician. The disclaimer for all blogs at metabolism.com, applies.

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Tina Sends the NY Times a Heads Up Regarding the Armour Crisis


Tina has raised her pen (actually her keyboard) to bring greater visibility to the Armour Thyroid crisis. Tina addressed her comments to one of the editors at the NY Times who actually appears to have taken this seriously and passed the email on upward. Thank you Tina, from me and those who are struggling with this unwarranted interruption in their medical treatment.

Here is the email sent by Tina to the NY Times Editor

Dear Ms. Kolata: I am writing in regard to recent restrictions on the availability of alternative, though highly effective, medications for hypothyroidism. Dessicated thyroid generics (made from the thyroid glands of pigs), known as Armour or NatureThroid, help thousands of people who suffer from low-functioning thyroids. I was on Synthroid, a synthetic thyroid medication, for years, but still suffered from symptoms. It was only when I began using NatureThroid, which treats all four of the hormone levels affected by the thyroid (vs. Synthoid, which only treats one), that my symptoms cleared up. I can’t tell you what a relief it is to no longer feel agitated and inexplicably moody, nor to have my hair falling out, my skin dry, etc. But it is becoming harder and harder to find dessicated thyroid generics. Armour, which has been around for about 50 years, is virtually out of business. Apparently the shortage has to do with FDA documentation requirements (which is odd; why now?)!
. Meanwhile, the American Academy of Clinical Endocrinologists (AACE) is backing Synthroid, which makes big money for its manufacturers (i.e., Abbott Laboratories). I hope this captures your interest. I don’t know what I, or thousands of others who have found relief with dessicated thyroid generics, will do if they are no longer available. If you would like more information, it may be helpful to go to http://www.metabolism.com. Thank you very much for your attention, Tina Montalvo West Palm Beach, FL

ARTICLE REFERENCED (if any):
None

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Mele is Out of Armour and Out of Options


Below, Mele describes her plight struggling to adjust to the disappearance of Armour from U.S. pharmacies. She discovered what was explained in my post, “Behind the Disappearance of Armour”. Forest Pharmaceuticals and Medicare are both responding in their own ways to the FDA decree that Armour Thyroid submit an application (NDA) as if it were any new drug seeking to come to market now. The FDA is charged with the responsibility to assure all prescription drugs in the U.S. demonstrate minimum levels of safety and efficacy. As a bureaucracy the FDA is unable (unwilling) to find a way to use the 50+ years of unblemished clinical experience unique to Armour, to satisfy this requirement. Rather than correct its own deficiency the FDA is forcing many thousands of hypothyroid patients on dessicated thyroid products to go through the difficult and potentially dangerous process of finding alternative thyroid hormone therapies. I am guessing that the FDA is receiving support for this policy from companies making synthetic t4 products and from medical organizations and their officers who receive funds from these same companies. Let’s not forget that Forest itself markets a generic t4 product, Levothroid, which will absorb some of the business lost by the withdrawal of Armour.

Mele submits her story to metabolism.com:

I’m just devastated. I could only get a seven day supply yesterday of Armour at Wal-Mart. They have no idea what the problem is and told me to come in Tuesday and they would have some again. I had no idea there was a problem again (last year’s nightmare made me assume everything would be ok after Forrest redid their manufacturinging plant) until I googled today.

I am 66 years old and have been on Armour Thyroid since I was 15 years old when I had a subtotal thyroidectomy for carcinoma. The only time I ever tried Synthroid was about 20 years ago when an endocrinologist convinced me that I was going to get osteoporosis if I continued using Armour. I only took it for two months, and when I walked into my family doctor’s office at the end of the two months, he took haveone look me and said “whWt is wrong? You are not you”. I wasn’t me anymore (and the blood tests he ordered confirmed that I was very low on T3 and barely in the normal range for T4). That was probably the most terrifying experience I have ever had. I had no idea how totally entwined my personality, and feelings of well being, are dependent on Armour. I still find it scary that “me” is a product of a drug I take and when I take a different brand, I am no longer me. I felt like a stranger in my own skin…weak, no sparkly, dramatic personality… instead dull feeling, acting and cobwebs in my brain. My family doctor said that he was putting me back on Armour immediately and slowly I began to feel like me again.

I’m terrified now. I am in the middle of trying to prepare for a very complicated (nothing is ever simple or easy medically for me) cataract surgery in another city that I have fly to repeatedly for the presurgical appointments. If I have to go on Synthyroid again…how can I deal with this other upcoming surgery? It can’t be put off as I can barely see to drive now.

Anyhow, I agree with others here that we have to organize and fight this. I find it very difficult to believe this is simply a shortage of the thyroid powder that Forrest is claiming is the problem. This is the FDA meddling, yet again, with patients very lives. I think I know an organization that will help us as they have fought bloody battles with the FDA for many years and have been victorious to a large extent. I am speaking of the Life Extension Foundation. I’ll be contacting them.

Two other things. For what it is worth, I have noticed no problems with the change in Armour but for the first time in many years, I have not done thyroid blood levels in two years. But I feel fine so I guess I don’t have the absorbtion problem some mention with the new formula. I have had hair breakage though which I have puzzled over and that could well be due to the formula change.

As for Medicare and Armour, I have had Medicare since a drunk driver hit me many years ago so I have had Medicare long before I turned 65. When Medicare Part D first appeared Armour was on the Medicare forumulary. That was in mid 2006. Armour was on the Medicare formulary in 2007 also. Beginning Jan 2008, Armour was removed from the Medicare formulary. My physician I did a lot of research, calling, letter writing, etc. about it. My drug plan was and still is from AARP/United Health Care. United Health Care is angry about the Armour situation. However, they cannot make a special exception to cover it when a physician asks them to do so (as mine did) because their hands are tied. They are required by law to allow ONLY drugs that are approved and on the Medicare formulary.

AARP/United Health Care covers ALL drugs on the Medicare formulary and by law cannot cover any that are banned from the Medicare formulary. Armour was banned in 2008. I called Forest about it and was extremely puzzled by their lacksidasical response. My physician wrote Forrest also and they sent back a reply that had nothing to do with the question about Armour being removed from the Medicare formulary. My physician learned later that his, and my, suspicions were correct. It was removed because the FDA told Medicare that they could not cover a drug that had not gone through the NDA I believe it is called…where a new drug has to undergo extensive clinical trials as per FDA regulations. We learned that the FDA was requiring Forrest to do this if they wanted Medicare coverage for Armour. Well, that is not possible. Forrest charges very little for Armour. Where are they supposed to get the money for the many years of clinical trials that the FDA has demanded? The FDA knew that demanding this would effectively kill Armour and that was their intent.

So, since Jan 2008, I have had to pay for a Medicare Part D plan that I can’t use because the only drug I take (unless I need an antibiotic or something short term) is Armour. Wat is worse, most health insurance companies follow the Medicare formulary so if Medicare no longer covers Armour then most insurance plans will not cover it either.

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Behind the Disappearance of Armour Thyroid


After 50 years of exemplary therapeutic use and despite a large devoted following, Armour Thyroid and related dessicated thyroid generics have virtually disappeared from pharmacies in the U.S. An air of mystery with suggestions of conspiracy surround the shortage. The level of distress among Armour users confronted by their inability to obtain the medication, is extraordinary. Adding to the turmoil and confusion is the manufacturers’ continued reliance on flimsy and unconvincing explanations for their actions.

Several concerned individuals contacted the FDA for clarification of the Armour situation and received a prepared statement in response. A copy of the FDA’s letter explaining the government’s stance was posted to metabolism.com by an involved member. After studying the letter I believe I can offer a good explanation for the situation. The explanation, as I see it, is grounded in the fact that several thyroid medications such as Armour Thyroid but also including synthetic t4 medications like Synthroid, existed before the FDA was given full regulatory power. In 1973 the Supreme Court empowered the FDA to regulate the use of prescription medications in the U.S.. This meant that all prescription drugs would have to demonstrate to the FDA’s satisfaction, safety and efficacy for specific indications before pharmaceutical companies could promote the use of their drugs. Medications like Synthroid and Armour, already vital components of medical therapy for years before 1973 entered a grey area of legitimacy after that time.

Just a few years ago, I was astounded to hear from my pharmaceutical representatives that Synthroid faced being banned by the FDA since it never provided the FDA with the type of documentation of safety and efficacy that all modern medications had. After 30 years the FDA decided it wanted to rescind the right of the drug manufacturer to promote this medication which was considered safe and effective way before the FDA achieved regulatory power. What followed was a tense year during which the manufacturer of Synthroid went through the costly and bureaucratically intricate process needed for FDA approval, which it ultimately won.

What I believe is happening now is a similar scenario with Armour Thyroid and other dessicated thyroid products. What convinced me of this is the wording in the FDA letter which refers to Armour Thyroid as an illegal drug. The FDA has put Armour on its Most Wanted List and is intimidating the manufacturer (and prescribing physicians) by implying the law is being broken by continuing to make and use this drug. In the case of Synthroid, which enjoys the full support by the medical community and provides millions of dollars in annual sales the financial equation was a “no-brainer” in favor of putting the money into the process to gain approval.

Not so for Armour Thyroid which has been defamed by the American Academy of Clinical Endocrinologists (AACE) and who’s use is much more limited and far less profitable to the manufacturer. I can imagine that the pharmaceutical company has already done the math and decided that not making Armour makes more financial sense that to continue making the “illegal” product and going through the FDA gauntlet for approval.

Where does that leave the patients who depend on dessicated thyroid preparations and the physicians who prescribe it? With no way to force the manufacturer to make the drug or to make the FDA to back down on its stance my guess is that Armour and related products will simply cease to exist and alternative prescriptions will have to be written. Please remember, I am the messenger here and do not sanction or in anyway condone what I see as the most likely outcome of this predicament. Perhaps by recognizing the existing reality a strategy can be developed to prevent this outcome.

Gary Pepper, M.D., Editor-in-Chief. Metabolism.com

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Armour Thyroid Shortage a Nation Wide Problem


Samantha, Nurse Practitioner in New York reports on the effect the national shortage of dessicated thyroid products is having on health care in her area. My own experience is that the situation is getting worse here in Florida, as well. Nature Thyroid and Westhroid which we had hoped would replace Armour in this practice has also become unavailable. At this very minute our office administrator is calling every pharmacy and pharmaceutical mail order companies we have used, trying to locate a source of these products for this practice (8 endocrinologists who serve a large portion of South Florida). Switching people back to T4 because the desired dessicated thyroid medication is unavailable, seems unacceptable in the “best health care system in the world”.

I thought Samantha’s comments were vital to see:

Samantha writes:

I’m a nurse practitioner in NY, and find that our patients generally do better or Armour Thyroid than on the usual T4 products. As for Cale, it sounds as if he’s in love with BigPharma, but many conservative practitioners and dispensors abound, so take what he says with a grain of salt. I, several MDs and NPs and a DO of my acquaintance all use Armour Thy. ourselves, but have noticed a slight decrease in effectiveness since the reformulation. The real frustration is having to convert our patients back to Levothyroxine and Cytomel which many do not find nearly as helpful. Other brands such as wes-throid and nature-throid are now out of stock, (in our area) and so there is no real alternative. Some of our patients have even tried getting stocks from Canada, to no avail. When I last checked with Forest they had stocks of 120 and 360 dosages available, but most of our patients require much less. While I will still use Armour and prescribe it, when we can get it again – as will my colleagues mentioned above – we are thoroughly annoyed at Forest for the reformulation. Most people tolerated the product very well. Patients should not have to have their effective medication routines switched out from under them. No one wants to change horses mid-stream.

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Researcher Comments on the Lack of Studies Comparing Synthetic Thyroid and Armour.


I noticed this very interesting post from Sarah who is a non-medical researcher. She has discovered what other contributors to metabolism.com have, that a serious lack of research exists comparing Armour thyroid to synthetic thryoid hormone in treatment of hypothyroidism. How is it then that the community of endocrinologists who pride themselves on their scientific approach to the practice of medicine, or who claim they follow “evidence based” medical decision making, are so uniformly opposed to the use of Armour thyroid or similar dessicated thryoid products?

Sarah, I believe the vast majority of contributors to metabolism.com including myself, are as astonished and troubled as you are by this apparent lack of insight by the policy makers in the field of endocrinology, in regards to this issue.

Sarah posts the following comments to metabolism.com:

It was very interesting to read these posts. I have never posted to a site such as this but I wanted to contribute my perspectives on this topic. I am a researcher by trade (in a very different line of research). I have been reading general “google” information for years on the controversy between synthroid and Armour. I have had trouble with mild symptoms at 88 mcg (synthroid) but 100 mcg brought my TSH to .4. My doctor was not comfortable with a TSH that low. For a number of years I have requested to try Armour and been denied. My main argument for trying Armour has been that if there are not risks with Armour (beyond the typical risks seen with any thyroid meds) why should I not try it. He has responded that the literature does not support Armour or the use of T3. I sat down for a few hours yesterday and looked at primary research articles and was very surprised. First of all there is a serious lack of research with autoimmune related thyroid disease. Second the few clinical trials that looked at Armour vs synthroid products were very poorly designed. Very small sample sizes with high variability in sample populations. The samples involve wide age ranges, multiple ethnicities represented and both genders. These variables would be important to consider but statistically inappropriate with small sample sizes. Of a greater concern was that in many of the studies most of the patients were being treated for hypothyroidism post surgical removal of the thyroid and then had only two patients with autoimmune related hypothyroidism mixed into the sample. They even noted that with the two patients with autoimmune hypothyroidism there were trends toward more positive outcomes related to the Armour. You will not find statistical significant with these kinds of research design (if being responsive is specific for the autoimmune variety) even if differences exist. If anyone could please provide the references for well designed research studies (either pro or con for Armour) I would really appreciate it.

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