A truly irreverant, impassioned, but quite eloquent reader shared her recent letter to Public Citizen...
"Thank you for your note and your humble retraction. That took courage and I appreciate your doing so. I thank you for taking my words to heart and digging for more of the facts.
I am sorry to say, however, that we are yet at odds.
My initial reaction is to ask you to provide a citation where I can examine the testing requirements of the FDA for dessicated thyroid. I'd also ask you to compare that with the requirements of the United States Pharmacopeia (USP)- the gold standard of American Pharmacology. I'd also be pleased to be provided any documented reports or studies of Armour Thyroid's efficacy, potency consistancy and consistancy issues as stated by you. In other words, may I see your sources?
Even if your pointed claims are true, the fact remains that if so, Forest Pharmaceuticals is following the requirements for product formulation consistancy standards as established by the USP, as is rather carefully pointed out on their web page FAQ.
http://www.armourthyroid.com/faq.html
An excerpt from this page states:
"QUESTION
What can you tell me about batch-to-batch consistency of ArmourR Thyroid?
ANSWER
ArmourR Thyroid is made from desiccated (dried) pork thyroid glands. The amount of thyroid hormone present in the thyroid gland may vary from animal to animal. To ensure that ArmourR Thyroid tablets are consistently potent from tablet to tablet and lot to lot, analytical tests are performed on the thyroid powder (raw material) and on the actual tablets (finished product) to measure actual T4 and T3 activity.
Different lots of thyroid powder are mixed together and analyzed to achieve the desired ratio of T4 to T3 in each lot of tablets. This method ensures that each strength of ArmourR Thyroid will be consistent with the United States Pharmacopoeia (USP) official standards and specifications for desiccated thyroid lot-to-lot consistency. The ratio of T4 to T3 equals 4.22:1 (4.22 parts of T4 to one part of T3)."
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
As I pointed out before, Armour Thyroid is formulated under USP standards, which are exacting and basic to the fundamentals of American Pharmacology. Even if the FDA merely requires the examination of iodine content, USP requires batch-to-batch consistancy of ingredients and their ratios.
What you are telling us might be true -to some small degree-. Trust me, I will be tracking this one down. But by ignoring these further standards of the USP and Armour Thyroid's requirement to maintain these standards, you give the erroneous impression that Armour Thyroid is an unsafe product.
You also ignore a couple of medical issues. Not all people convert T4 into T3 at the same rate. There are many, myself included, with T4-T3 conversion problems. The Resin T3 Uptake test is used to determine those exact issues.
Further, I was forced to endure a total thyroidectomy in December, 1997. Two months following surgery, while on Synthroid, my TSH level was 32.5. Within a few months, after numerous unsuccessful dosage adjustments, I was able to convince my doctor to switch me to Armour Thyroid. That was the day I found my soul after thirty years and remembered what it was like to wake up happy in the morning.
A normal thyroid produces T4 AND T3. Armour Thyroid is formulated to match the ratio of T4 and T3 that the thyroid gives to the body. If I take T4, along with my T4 to T3 conversion problem, WHERE do I get my T3!?!?!
I have yet to find any published study or report, or any scientific study that reports the consistancy problems for Armour Thyroid. I'm still looking and if you happen to know of any appropriate citations, please do forward them to me.
I did find one study that reported the consistency in -1977-
Metabolism. 1977 Nov;26(11):1213-8. "Triiodothyronine and thyroxine content of desiccated thyroid tablets. Rees-Jones RW, Larsen PR.
Triiodothyronine (T3) and thyroxine (T4) were measured by radioimmunoassay in Pronase hydrolysates of four lots each of 1- and 2-grain tablets of desiccated thyroid (Thyroid, Armour) and thyroglobulin (Proloid, Warner-Chilcott). The methodology used was verified by studies of tablets containing known quantities of T4 and T3. One grain of desiccated thyroid contained 12 +/- 1 and 64 +/- 3 microgram (mean +/- SD) of T3 and T4 per tablet, respectively (T4/T3 molar ratio, 4.3). A 1-grain tablet of thyroglobulin contained 16 +/- 2 and 55 +/- 5 microgram of T3 and T4, respectively with a T4/T3 ratio of 2.9. Two-grain tablets generally contained twice the quantity of T3 and T4 in the 1-grain preparations. The variation in T3 and T4 content between the four lots of each tablet strength for each product was 10% or less. These estimates of T3 and T4 content are 1.5- to 2-fold greater than those previously published. This difference probably results from the more sophisticated methodology now available which does not require chromatographic separation of T3 and T4 or iodometry. Using calculations based on published estimates of T4 and T3 absorption and of the T3/T4 potency ratio, it would appear that the T3 content of desiccated thyroid and thyroglobulin provide approximately 39% and 51%, respectively, of the thyromimetic activity of these two medications.
I have been unable to find ANY reference on the FDA website concerning product recalls or warnings or issues of any kind with Armour Thyroid.
HOWEVER, Synthroid HAS had -serious-, -ongoing- problems with potency and consistancy to the degree that they have been severely chastized by the FDA.
http://www.thyroid-info.com/articles/synthroidproblems.htm
An excerpt from this page states:
"III. Synthroid Has a History of Problems
According to the FDA,"...Synthroid has a long history of manufacturing problems...In August of 1989, Knoll initiated a recall of 21 lots of Synthroid tablets...because of a decrease in potency during stability studies."
The letter goes on to outline recalls in February 1991 affecting 26 lots of subpotent Synthroid, and a recall of lots of subpotent Synthroid in June 1991. An April 1991 inspection of Synthroid's manufacturing facility resulted in the firm being cited for two deviations from good manufacturing practices. Another manufacturing review in December of 1992 uncovered nine separate incidents of failure to follow good manufacturing practices.
As the FDA letter indicates, the problems continued. "FDA also found that the firm had continued to manufacture and distribute low dosage Synthroid tablets during 1990, 1991 and 1992."
"Although you claim that Synthroid has been carefully manufacturered, the violations of current good manufacturing practices discussed above indicate that Knoll has not always manufactured Synthroid in accordance with current standards for pharmaceutical manufacturing." -- United States Food and Drug Administration Letter to Synthroid Manufacturer, Knoll Pharmaceuticals, April 26, 2001
A 1994 review of the testing facility found additional problems with testing of product, and another recall in 1998 took place of subpotent product.
Says the FDA:
"The history of potency failures...indicates that Synthroid has not been reliably potent and stable. Furthermore, Knoll's use of an overage that has not remained consistent over the years suggests that Synthroid has stability, potency and consistency problem. Although you claim that Synthroid has been carefully manufacturered, the violations of current good manufacturing practices discussed above indicate that Knoll has not always manufactured Synthroid in accordance with current standards for pharmaceutical manufacturing."
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Based on your email, and applying your apparent standards to Synthroid - the major branding - I have to assume that Synthroid is much worse a product in your eyes. Will you go after that, next? Remember, if we remove the naturals, the dessicated and the synthetic from the market shelves - then quite simply, I die in a very black, nasty depression.
You've used badly flawed assertions that Armour Thyroid is a bad drug. You've used badly flawed references to indicate that Armour Thyroid is a bad drug. You have used flawed logic to concluded that Armour Thyroid is dangerous.
Yet you ignore those with the greatest problem?
Madam, it is my opinion that your credibility isn't in question, it's on -extended vacation-.
If Armour Thyroid were to be taken off the market, I'd be haunting slaughter houses and purchasing the butchered thyroids. I'd prepare thyroid and onions just like people make liver and onion. I'd measure by weight and titrate as necessary to feel healthy. But I am NOT going to go back on levothyroxine or Synthroid. You may not know how much T4 or T3 are in Armour Thyroid, but I'm content to read the PDR and the package insert and trust on my ability to tell the qualitative difference when I use or do not use it.
I've said it before, I'll say it again, with a paraphrase of a cliche'.
"You can have my Armour Thyroid when you pry my cold, dead fingers off the bottle. I. Want. Armour. Thyroid."
Emphatically,
JR
California
"Thank you for your note and your humble retraction. That took courage and I appreciate your doing so. I thank you for taking my words to heart and digging for more of the facts.
I am sorry to say, however, that we are yet at odds.
My initial reaction is to ask you to provide a citation where I can examine the testing requirements of the FDA for dessicated thyroid. I'd also ask you to compare that with the requirements of the United States Pharmacopeia (USP)- the gold standard of American Pharmacology. I'd also be pleased to be provided any documented reports or studies of Armour Thyroid's efficacy, potency consistancy and consistancy issues as stated by you. In other words, may I see your sources?
Even if your pointed claims are true, the fact remains that if so, Forest Pharmaceuticals is following the requirements for product formulation consistancy standards as established by the USP, as is rather carefully pointed out on their web page FAQ.
http://www.armourthyroid.com/faq.html
An excerpt from this page states:
"QUESTION
What can you tell me about batch-to-batch consistency of ArmourR Thyroid?
ANSWER
ArmourR Thyroid is made from desiccated (dried) pork thyroid glands. The amount of thyroid hormone present in the thyroid gland may vary from animal to animal. To ensure that ArmourR Thyroid tablets are consistently potent from tablet to tablet and lot to lot, analytical tests are performed on the thyroid powder (raw material) and on the actual tablets (finished product) to measure actual T4 and T3 activity.
Different lots of thyroid powder are mixed together and analyzed to achieve the desired ratio of T4 to T3 in each lot of tablets. This method ensures that each strength of ArmourR Thyroid will be consistent with the United States Pharmacopoeia (USP) official standards and specifications for desiccated thyroid lot-to-lot consistency. The ratio of T4 to T3 equals 4.22:1 (4.22 parts of T4 to one part of T3)."
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
As I pointed out before, Armour Thyroid is formulated under USP standards, which are exacting and basic to the fundamentals of American Pharmacology. Even if the FDA merely requires the examination of iodine content, USP requires batch-to-batch consistancy of ingredients and their ratios.
What you are telling us might be true -to some small degree-. Trust me, I will be tracking this one down. But by ignoring these further standards of the USP and Armour Thyroid's requirement to maintain these standards, you give the erroneous impression that Armour Thyroid is an unsafe product.
You also ignore a couple of medical issues. Not all people convert T4 into T3 at the same rate. There are many, myself included, with T4-T3 conversion problems. The Resin T3 Uptake test is used to determine those exact issues.
Further, I was forced to endure a total thyroidectomy in December, 1997. Two months following surgery, while on Synthroid, my TSH level was 32.5. Within a few months, after numerous unsuccessful dosage adjustments, I was able to convince my doctor to switch me to Armour Thyroid. That was the day I found my soul after thirty years and remembered what it was like to wake up happy in the morning.
A normal thyroid produces T4 AND T3. Armour Thyroid is formulated to match the ratio of T4 and T3 that the thyroid gives to the body. If I take T4, along with my T4 to T3 conversion problem, WHERE do I get my T3!?!?!
I have yet to find any published study or report, or any scientific study that reports the consistancy problems for Armour Thyroid. I'm still looking and if you happen to know of any appropriate citations, please do forward them to me.
I did find one study that reported the consistency in -1977-
Metabolism. 1977 Nov;26(11):1213-8. "Triiodothyronine and thyroxine content of desiccated thyroid tablets. Rees-Jones RW, Larsen PR.
Triiodothyronine (T3) and thyroxine (T4) were measured by radioimmunoassay in Pronase hydrolysates of four lots each of 1- and 2-grain tablets of desiccated thyroid (Thyroid, Armour) and thyroglobulin (Proloid, Warner-Chilcott). The methodology used was verified by studies of tablets containing known quantities of T4 and T3. One grain of desiccated thyroid contained 12 +/- 1 and 64 +/- 3 microgram (mean +/- SD) of T3 and T4 per tablet, respectively (T4/T3 molar ratio, 4.3). A 1-grain tablet of thyroglobulin contained 16 +/- 2 and 55 +/- 5 microgram of T3 and T4, respectively with a T4/T3 ratio of 2.9. Two-grain tablets generally contained twice the quantity of T3 and T4 in the 1-grain preparations. The variation in T3 and T4 content between the four lots of each tablet strength for each product was 10% or less. These estimates of T3 and T4 content are 1.5- to 2-fold greater than those previously published. This difference probably results from the more sophisticated methodology now available which does not require chromatographic separation of T3 and T4 or iodometry. Using calculations based on published estimates of T4 and T3 absorption and of the T3/T4 potency ratio, it would appear that the T3 content of desiccated thyroid and thyroglobulin provide approximately 39% and 51%, respectively, of the thyromimetic activity of these two medications.
I have been unable to find ANY reference on the FDA website concerning product recalls or warnings or issues of any kind with Armour Thyroid.
HOWEVER, Synthroid HAS had -serious-, -ongoing- problems with potency and consistancy to the degree that they have been severely chastized by the FDA.
http://www.thyroid-info.com/articles/synthroidproblems.htm
An excerpt from this page states:
"III. Synthroid Has a History of Problems
According to the FDA,"...Synthroid has a long history of manufacturing problems...In August of 1989, Knoll initiated a recall of 21 lots of Synthroid tablets...because of a decrease in potency during stability studies."
The letter goes on to outline recalls in February 1991 affecting 26 lots of subpotent Synthroid, and a recall of lots of subpotent Synthroid in June 1991. An April 1991 inspection of Synthroid's manufacturing facility resulted in the firm being cited for two deviations from good manufacturing practices. Another manufacturing review in December of 1992 uncovered nine separate incidents of failure to follow good manufacturing practices.
As the FDA letter indicates, the problems continued. "FDA also found that the firm had continued to manufacture and distribute low dosage Synthroid tablets during 1990, 1991 and 1992."
"Although you claim that Synthroid has been carefully manufacturered, the violations of current good manufacturing practices discussed above indicate that Knoll has not always manufactured Synthroid in accordance with current standards for pharmaceutical manufacturing." -- United States Food and Drug Administration Letter to Synthroid Manufacturer, Knoll Pharmaceuticals, April 26, 2001
A 1994 review of the testing facility found additional problems with testing of product, and another recall in 1998 took place of subpotent product.
Says the FDA:
"The history of potency failures...indicates that Synthroid has not been reliably potent and stable. Furthermore, Knoll's use of an overage that has not remained consistent over the years suggests that Synthroid has stability, potency and consistency problem. Although you claim that Synthroid has been carefully manufacturered, the violations of current good manufacturing practices discussed above indicate that Knoll has not always manufactured Synthroid in accordance with current standards for pharmaceutical manufacturing."
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Based on your email, and applying your apparent standards to Synthroid - the major branding - I have to assume that Synthroid is much worse a product in your eyes. Will you go after that, next? Remember, if we remove the naturals, the dessicated and the synthetic from the market shelves - then quite simply, I die in a very black, nasty depression.
You've used badly flawed assertions that Armour Thyroid is a bad drug. You've used badly flawed references to indicate that Armour Thyroid is a bad drug. You have used flawed logic to concluded that Armour Thyroid is dangerous.
Yet you ignore those with the greatest problem?
Madam, it is my opinion that your credibility isn't in question, it's on -extended vacation-.
If Armour Thyroid were to be taken off the market, I'd be haunting slaughter houses and purchasing the butchered thyroids. I'd prepare thyroid and onions just like people make liver and onion. I'd measure by weight and titrate as necessary to feel healthy. But I am NOT going to go back on levothyroxine or Synthroid. You may not know how much T4 or T3 are in Armour Thyroid, but I'm content to read the PDR and the package insert and trust on my ability to tell the qualitative difference when I use or do not use it.
I've said it before, I'll say it again, with a paraphrase of a cliche'.
"You can have my Armour Thyroid when you pry my cold, dead fingers off the bottle. I. Want. Armour. Thyroid."
Emphatically,
JR
California
I am now convinced to switch to armour thyrod. Thanks so much.
I’d like to know how to compare the dosages between the two drugs. I have been on as much as 25 mgs of Synthroid at different times over the last 15 years, with the most recent dose being 10 mg and I felt that was too low, so
my doctor sent me to an endocrinologist, who ran more tests, and did an ultra sound of my thyroid. He told me it was “all shrivaled up and no longer produced any hormones at all,” yet his bloodwork showed T3 and T4 levels that seemed to indicate I was hyperthyroid since the reading came back .03!
I said then why is my hair so dry and falling out& breaking off (I get it trimmed monthly) why are my nails constantly breaking, and my skin so dry? Why am I always freezing cold? Why am I so tired to the point that I can barely function anymore and had to go on medical leave mid year last year? (I’m a teacher and could no longer keep up the necessary pace.)
So he first put me on 75 mg once a day of Armour Thyroid, then later dropped it to 60 mg a day. When He dropped it I slowly started gaining weight.
He has never told me how the two drugs compare dosage wise, and no one else seems to be able to do so.
I’m trying to find out if I’m on a high or low dose of Armour Thyroid. I
I’m concerned because I also have a seizure disorder which was diagnosed a few months before the thyroid condition. For 13 years I took Dilantin and synthroid together with no problems, then my gums began bleeding, and my dentist told me to switch to a different anticonvulsant, since bleeding gums is a known side effect of Dilantin.
Making that change, to Topamax, caused all hell to break loose in my life. It took me 8 months to eventually make the change–very hard on my body–hated side effects of topmax–and it seemed like from that point on, I started having problems with my synthroid blood tests, and my doctor started cutting my dosage and I just became more and more tired over the next two years, until I could no longer work.
I think something was keeping me from properly metabolizing the synthroid, but my doctor just kept looking at the the numbers on the bloodwork and lowering my dose until it got to the point that I was trying to write out report cards and my arm literally froze and refused to move! A job that normally took me 6 hours took 3 days, and I knew I couldn’t do it any more. It shouldn’t have to get to that point before a doctor starts to listen! It’s been almost 9 months now, and I’ve been to 5 specialists, and still don’t have the problem completely solved…
I have hashimoto disease. Natural thyroid products are very important to me and I am sure to many others who have this disease and related thyroid issues.
My question is this: Why did Forest Laboratories change the way they make Armour Thyroid? It isn’t the same and I can no longer take it. Many other people say the same thing. You keep on recommending this product, however, it is not what it use to be.
I cannot find a natural thyroid hormone on the market today that is sufficient as Armour use to be.
Can you tell me the name of the manufacturer of Armour before Forest Labs was making it?
Maybe they can help. Proloid is not being made either and people with thyroid cancer absolutely need that medication. It is life and death for them. Why isn’t anything being
done. It doesn’t seem fair that the government doesn’t step in and say someone has to make effective natural thyroid products. If they use to be made, why is it changing and why can’t the government step in and say something has to be done before people get sicker and sicker?
Please understand that Armour is no longer a good product. You keep recommending it and it is not anything what it use to be.
Also, they stopped manufacturing Proloid. Why? I don’t understand what is going on with the pharmaceuticals companies today. I think they only care about money and not people.