But in every individual, a thyroid also converts T4 to the inactive RT3 (reverse T3) as a way to clear out excess T4 that the body doesn’t need.  It’s natural and necessary. It will especially happen if you go through surgery or a diet.

Unfortunately, many thyroid patients make far too much RT3, and patients have been making cutting edge discoveries about this fact and how to treat it with their doctors.  High levels of RT3 can be found if you have high cortisol, low cortisol, low ferritin, low B12 and other undiscovered and untreated underlying issues that can go hand-in-hand with being hypothyroid.

Why is a high level of RT3 is problem? That excess RT3 is making itself lazily comfortable on your cell receptors, preventing T3 from gaining access to your body.  It becomes like a clogged up drain to your body. So you stay hypo and symptomatic, in spite of seemingly normal labwork.

This coming THURSDAY, NOVEMBER 19th (tomorrow as I write this) on the TALKSHOE THYROID PATIENT COMMUNITY CALL, we’re going to talk about the Reverse T3 problem with thyroid patient advocate Valerie Taylor. She not only owns the NTH Adrenals group (and is considered the most knowledgeable patient on adrenal fatigue in the world), she also created the RT3/T3  group on Yahoo, which you will find on the Talk To Others page.

We’ll talk about excess RT3, symptoms that can go along with it, how to do labwork to determine if you have this problem, how to treat it with T3-only, and more. There’s a Chat Box you can participate in while the show is going on. Audio will come directly out of your computer, and you can call in and ask Valerie or Janie a question. Times are 6 pm Pacific, 7 pm Mountain, 8 pm Central and 9 pm Eastern.

Want to read more? Thyroid patient Nick Foot, who also moderates the RT3/T3 group, has created an excellent Question and Answer RT3 website. This will make you even more informed before this Talkshoe event. Note that the website is still work-in-progress, so expect to see more as he works on it.

For those with the Stop the Thyroid Madness book, there is also more good detail in Chapter 12 called T3 is the Star of the Show, page 155. This is all good information to take into your doctor’s office.

Update: cellulose in our desiccated thyroid meds may be much more of a problem than we ever imagined. See my blog post below.

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*Want to be infor­med of these ‘fringe web­site’ blog posts?  Curious what’s on radi­cal Janie’s mind? Just use the Noti­fi­ca­tions on the left below the links.

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*Need options for thy­roid treat­ment during the current shor­ta­ges due to demand being grea­ter than supply? Go here.

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I confess that I hated my Chemistry class in high school, even if Mr. Bowen tried to make it interesting and favored the girls over the boys in class.  But lo and behold, one of those elements on the Periodic Table ended up having a significant role in all or our lives as thyroid patients: iodine.

Iodine can be found in every inch your body, but is especially prevalent in your thyroid, which makes it an interesting element for those of us with thyroid disease.  The active thyroid hormone T3 (triiodothyronine) is made up of three iodine molecules, and the storage hormone T4 (thyroxine) has four iodine molecules. In fact, without proper amounts of iodine, your thyroid wouldn’t even function well.

An optimal amount of iodine has also been shown to improve breast health, provide cancer protection, remove toxins like Bromide, fluoride, mercury etc…and in some cases, has helped thyroid patients either lower their dose, or even get off thyroid treatment. Thyroid patient Diana tells of getting off thyroid treatment due to iodine on the Stories of Others page.

***This Thursday evening on the Thyroid Patient Community Call on TalkShoe, we’ll have guest Stephanie Buist, owner of the Yahoo group Iodine and a 9-year thyroid cancer survivor who strongly feels iodine has been a huge factor.   We’ll explore how much iodine a person needs, the loading loading test, the best sources of iodine supplementation, whether you need iodine, as well as controversies with iodine use, including Hashimotos disease or bad reactions.  Times for the call are 6 pm Pacific, 7 pm Mountain, 8 pm Central and 9 pm Eastern. You can listen right on your computer, or call to talk directly to Stephanie and Janie. Join us!

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Sheila Turner of TPA-UK  (Thyroid Patient Advocacy-UK www.tpa-uk.org.uk) is starting the ball rolling on something very interesting:  they have contacted a lab in the UK who will do a qualitative analysis of the old Armour vs. the new reformulated Armour to get a breakdown of the ingredients, and potentially give us an idea WHAT is causing thyroid patients to have a return of their hypothyroid symptoms since Forest reformulated Armour in 2009.

However, says Sheila, this will cost in the region of £600 to £700 (approximately $1100).  Says Sheila, “If there are enough patients who are willing and able to help raise the funding required by giving whatever we can afford, we could finally get the answer as to which changes have been made in the new formula and whether this includes changes in the active (as some have suggested) and the inactive ingredients and put this baby to rest once and for all.”

You can contact Sheila at the above website and make a pledge.  As I write this, they have already have £100 pledged.

UPDATE: Stephanie above has agree to be the ‘Pledge and Money Collector’ for the lab work needed to analyze the old vs new Armour . She can be contacted at ladybugsandbees@sbcglobal.net

*Want to be infor­med of these ‘fringe web­site’ blog posts?   Curious what’s on radi­cal Janie’s mind? Just use the Noti­fi­ca­tions on the left below the links.

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*Need options for thyroid treatment during the current shortages. Go here.

And with our current shortage of desiccated thyroid via the tablets we were used to, compounding pharmacies are a good alternative in the meantime. Here’s what we learned from Mr. Voliva:

1) Different compounding pharmacies will use different fillers. Hooks Apothecary, for example, uses powdered acidophiles, the “active culture” which helps replace the good flora in your gut and improves digestion.

2) Compounded desiccated thyroid can be more expensive for two reasons: they acquire smaller amounts of the powder as compared to the huge amounts obtained by a pharmaceutical like Forest, and it takes time to compound it.

3) A good compounding pharmacy will give you the Certificate of Analysis right when you ask for it, and you should ask for it. This Certificate will tell you how much T4 and T3 is in one grain..and it’s not always simply 38/9 mcg.  It could be 35/8.6 or 39/8.5 per grain…for example.   Find out because there are allowed deviations of 10 mcg +-.  A really good pharmacy will shoot for an even better deviation and will also produce that Certificate right when you ask for it, not a day later. To not receive that documentation right when you ask implies they really weren’t paying much attention to the deviation.

4) A compounding pharmacy will get better deviations when they create a 65 mg grain of compounded desiccated thyroid than when they create a 60 mg grain.

5) Top notch Compounding Pharmacies will be accredited by, or be close to completing the steps towards, the Pharmacy Compounding Accreditation Board.

6) Compounding pharmacies can’t make a desiccated thyroid trouche because of the problems with heat in the processing of the trouche.

7) Mr. Voliva feels it would be too easy to overdose with transdermal (on the skin) desiccated thyroid.

8 ) Compounding pharmacies, via their 5-6 distributors, get the powder from American Laboratories.  But not all compounding pharmacies will be as diligent as others to make sure the deviation is closer to 5%.

9) If the compounding pharmacy is getting their powder via the distributor PCCA (Professional Compounding Centers of America), you can be assured you are getting a good product.  Ask the pharmacist where they are getting it.

10) Compounding pharmacies generally have plenty of desiccated thyroid powder.

My apologies to a group of callers whose chat questions I wasn’t able to see. I have sent a question about that to Talk Shoe’s Customer Support to find an answer before the next Community Call. But on the good side,  the audio worked on everyone’s computer.

Need alternatives during this shortage time? Here are options you can consider.

*Want to be infor­med of these fringe web­site blog posts? Curious what’s on unpro­fes­sio­nal Janie’s mind? Just use the Noti­fi­ca­tions on the left below the links.

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Dr. Mark Starr’s office team wanted to send over a portion of an article just written for an Arizona health magazine:

Desiccated thyroid from pigs is a bio-identical, complete hormone preparation, containing the entire spectrum of thyroid hormones including T4, T3, T2, and T1 that are in the human thyroid gland.

Current FDA approved thyroid medications include Synthroid, Unithroid, Levoxyl, and Levothyroxine (all only contain T4), and Cytomel (only T3). These hormones are synthetic and contain only a portion of the thyroid’s hormones.

Dr. Mark Starr of Phoenix, Arizona, said patients have called him, frantic that desiccated thyroid is unavailable. “It is so key to my practice, I have enough for my patients. So far, it appears that when supply catches up with demand in a few months, the shortage will be over.”

Dr. Starr is the author of “Hypothyroidism-Type 2.” He said synthetic thyroid acts energetically differently in the body. “All living things have a right spin, and synthetic medications have a left spin. The desiccated thyroid is better tolerated.”

Dr. Broda Barnes did a study that revealed a relative intolerance to a synthetic thyroid product containing T3 and T4 (Thyrolar). One-fifth of the patients who had done well on desiccated thyroid developed rapid heart beats and palpitations when switched to Thyrolar. Dr. Barnes also did a major research study on desiccated thyroid that involved thousands of patients over 30 years; it showed a 94 percent reduction in the number of expected heart attacks. This study is the subject of the 1976 book “Solved: The Riddle of Heart Attacks.”

Lipitor is the best selling drug in the world. But for the first half of the 20th century, desiccated thyroid was the standard treatment for high cholesterol. Elevated cholesterol and triglycerides are one of the myriad symptoms of hypothyroidism. Dr. Barnes’ book included a chapter entitled “The Demise of the Cholesterol Theory.” Desiccated thyroid normalized cholesterol and triglycerides in 95% of the patients Dr. Barnes treated. The 5% who had persistently elevated levels had no increased incidence of heart attacks. Desiccated thyroid therapy also resolved a long list of other hypothyroid symptoms such as fatigue, cold intolerance, joint and muscle pain, dry skin, inability to lose weight, headaches, and menstrual problems. One of the most important benefits that Dr. Barnes demonstrated in studies on both animals and his patients was that desiccated thyroid increases immunity and allows the body to fight off infections. As we come into swine flu season, this is particularly important.”

Dr. Starr, I love the way you put it: “All living things have a right spin, and synthetic medications have a left spin. The desiccated thyroid is better tolerated.” And that’s exactly why the website Stop the Thyroid Madness exists–patients all over the world have found out what a far better “right spin” treatment desiccated thyroid has been for them!  So we present this information, hoping that more and more patients can learn from the paths walked before them, and take this right into their doctors offices.

And about Thyrolar, which is a combination of synthetic T4 and synthetic T3:  we’re glad it exists. But…there have been numerous patients over the years who tried the combination of synthetic t3/ synthetic T4, and who then switched to desiccated thyroid. And they identically report on the NTH thyroid group that they got far better results from desiccated thyroid. That is powerful information.

And yes, Dr. Starr, we are looking forward for supply to catch up, because natural desiccated thyroid is a godsend.

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Join the Thy­roid Patient Com­mu­nity Call on Talk Shoe this Friday. UPDATE: the President of Hook’s Apothecary, a compounding pharmacy that serves Illinois and Indiana, will be in the chat to talk about compounding desiccated thyroid.

Also check out the post below concerning possible hints that we are closer to seeing more desiccated thyroid on our shelves?

*Want to be infor­med of these fringe web­site blog posts? Curious what’s on unprofessional Janie’s mind? Just use the Noti­fi­ca­tions on the left below the links.

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Now I’m making no guarantees nor saying this is absolute fact…but because of emails I’m getting and other information, I’m seeing little drops of potential evidence that we may be seeing the beginning of a return of natural desiccated thyroid in our pharmacies. Are we?

For one, a patient called the Forest Hotline today (866) 927-3260, and it said that the 4 and 5 grain is available. Is that an old recording, or could that be a possibility at some pharmacy here or there? Granted, Forest states that the problem of backorders has been found in the “complicated steps in the supply line”, and “one factor is the supplier”.  But if the 4 or 5 grain tablet is available, is something getting through here or there?

Then comes an email from a gal stating she was told by her large national pharmacy that Armour would be in stock by the middle of October.  That is similar to a comment on another blog post below.

Also, American Laboratories, the producer and supplier of desiccated powder, has always stated that they continue to make it–just not enough to meet the demands of larger pharmaceuticals all at once. i.e. perhaps some is getting through.

Little positive rain drops of clues? Maybe. I’m not sure what the near future holds. And there are unanswered questions, such as will Armour still be ineffective for so many in its reformulated state?  In what way, and when, will the FDA follow through on the 1960’s Drug Efficacy Study Implementation (DESI) to prove that desiccated thyroid is safe and effective (which still makes most of us want to ask  “Aren’t 110 years enough evidence?”)

In the meantime, there are options you can use for good thyroid treatment here. Just work with a good doctor if you use any of these options. But a caveat–a few Canadian pharmacies have doubled their prices!! Ouch. I find that very nasty and unethical. So check their prices on the website as compared to what was listed on this page. And GOOD NEWS: a German pharmacy will ship out its own brand of desiccated thyroid.  See it on the Options page.

There continues to be good feedback from patients that most compounding pharmacies have plenty of desiccated thyroid powder in stock.  The above link gives information on how to find a compounding pharmacy. I have used one before that mailed my order to me after my doc faxed the prescription.

Join the Thyroid Patient Community Call on Talk Shoe this Friday.

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And here’s more:

In each Erfa 30 mg tablet embossed “ECI 30”, there is 18 mcg. of T4 and 4 mcg. of T3;

In each Erfa 60 mg tablet embossed “ECI 60”, there is 35 mcg. of T4 and 8 mcg. of T3;

In each Erfa 125 mg tablet embossed “ECI 125”, there is 73 mcg. of T4 and 17 mcg. of T3.

Erfa’s very friendly and helpful Medical Director, Henri Knafo, MD, states that they follow the USP (United States Pharmacopoeia) specifications. But  I do see some slight differences.  The USP specifications ratio for one grain that we are used to in the US is 38 mcg. T4 and 9 mcg T3, i.e 38/9.  The above ratio is 35/8.

Likewise, US patients are used to 2 grains of 120 mgs having 76 mcg of T4 and 18 mcg of T3, i.e. 76/18.  In Erfa’s medication of 125 mg, you will get a ratio of 73/17. I don’t know if this will make much of a difference but want you to be aware as you work to adjust Erfa’s desiccated thyroid to the treatment you were used to.

Knapo happily states that most all “Thyroid” is making it across the border to the states without issue.  You will need your doctor’s prescription. And by the way, Erfa’s Thyroid is manufactured in Belgium, plus they have a huge supply of desiccated powder.

Erfa is also working with IDIS to get Thyroid to others. You can read about them here.

Need a doctor to work with who will provide a prescription for your needed desiccated thyroid? There are a growing body of  good doctors out there.  We also have a good list of  Canadian pharmacies you can consider using during the current shortages.

I have also received word from a gal that the FDA document 1572, a federal form that FDA requires for over-the-border movement, has not always been used, and Erfa’s medication is arriving fine. i.e. the FDA may be tolerating it.

But with that being clarified, the American Association of Health Freedom (AAHF) has just today issued an article about the desiccated thyroid shortage that you might find of interest.

Concerning Time Caps Labs and being told to cease production, the article states:  The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug.  Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product.  The purpose?  Presumably to protect the profits of other, inferior drugs that have been FDA approved.

And I especially appreciate this comment: As famed physician Dr. Jonathan Wright observes:  “Natural thyroid has never killed or severely harmed anyone since its first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.”

Kudos and appreciation from all thyroid patients go to Dr. Jonathan Wright, besides AAHF for giving acknowledgment of this issue!

Better treatment with Desiccated Natural Thyroid has been my main focus as a thyroid patient activist since 2003 and with great conviction.  I and millions of others whom this website and book represent know how GOOD this medication is and we definitely appreciate this kind of support.   Yes, millions of us have had our lives change ten-fold thanks to this safe and effective 110 year old medication. You can read just a touch of those changed lives on the Stories of Others page.

In their Overview, the AAHF explains:

The American Association for Health Freedom (AAHF), currently in the process of merging with the Alliance for Natural Health (ANH), is part of an international organization dedicated to promoting sustainable healthcare and freedom of choice in healthcare through good science and good law. We protect the right of natural-health practitioners to practice and the right of consumers to choose the healthcare options they prefer.  Since 1992, we have worked to shift the medical paradigm from an exclusive focus on surgery, drugs and other conventional techniques to an “integrative” approach incorporating food, dietary supplements and lifestyle changes. This is the way to improve health and extend lives while reducing the costs of healthcare back to a sustainable level.

You can read more on their Overview by clicking the link above. And if you need to communicate with anyone, provide facts and all your concerns to your congresspersons.   Here’s a template letter to use or change, and there are other good ones circulating in many good thyroid or facebook groups and forums out there.

P.S. Dr. John C. Lowe has also provided a very informative and well-reasoned editorial pertaining to our current shortages.

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There once was a gnarly, bottom-scratching and tuna-breathed man who terrorized a neighborhood as if he was above the law. He intimidated people, used threats to stop others from telling the truth about his actions, and he mooned his hairy buttamous to anyone he didn’t like. He brought other criminals into his large house, took bribes to do some of their own dirty work, and stole every single vegetable and fruit from all his neighbors gardens.

Finally, all the fearful, frustrated and hungry neighbors got angry, sick and tired of it all. So they sent him emails, letters and phone calls, asking him to stop what he was doing, and explaining how he was hurting their lives and well-being,  and speculated how he was going to do this or that.

And do you think he stopped doing what he always did?

Finally, the neighbors got wise. They reached out to the police, to local radio and TV stations, to the newspaper, and even to local political leaders.  They stated the facts as they knew them, how specific actions affected their lives, how they had speculations that they couldn’t prove but were quite uncomfortable…and they made sure everyone knew what was going on to get the help and support they needed. 

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For over 100 years, thyroid patient lives have made a huge and positive turn-around on natural porcine desiccated thyroid, a superior, safe, and effective medication as expressed by all our lives for over a century.  But today, we face a crisis.

The most popular desiccated thyroid brand, Armour, was reformulated by 2009  and most patients reported a return of their hypothyroid symptoms. Then, the only other major pharmaceutical, RLC Labs, has their quality Naturethroid and Westhroid on backorder in August of 2009. The only North American makers of the desiccated powder, American Laboratories, is out.

And finally, the remaining two generic makers, Time Caps Labs and Major Pharmaceuticals, are told to cease production by the FDA.

We are now without desiccated thyroid other than the remaining 10 tablets there, or 5 tablets here. They will all be gone soon.

The facts we know are this: because of the 1962 “Drug Effi­cacy Amend­ment”, the FDA is suddenly demanding phar­ma­ceu­ti­cal drug manu­fac­tu­rers (with medications which have been used successfully for 80-110 years) pro­vide proof of the effec­ti­ve­ness and safety of their drugs before they can receive true FDA appro­val, aka potential cli­ni­cal trials and the data that results. i.e. 110 years of patient success, and a website like Stop the Thyroid Madness, and testimonies all over the net and in patient groups with desiccated thyroid…is somehow…just…not…enough.  What is obvious, is not enough.

In other words, they want proof of efficacy and safety of desiccated thyroid—a medication which has a safe and effective track record in a huge body of patients for 110 years…in the same way they give an FDA-stamp-of-approval on a whole variety of drugs which, in 2004, killed 783,936 individuals per year (according to the article Death by Medicine, co-authored by By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD).

Does THAT make any sense to you?

And now, because there is hint that they may require RLC Labs to apply for a New Drug Application…and because we wonder if that will mean expensive and drawn out clinical testing to provide data…and because we wonder if they will allow RLC to continue manufacturing our only good supply of desiccated thyroid which saves our lives in a completely healthy way…we are left with a lot of uncomfortable and unanswered questions.

Of course, we can admit that all the above is pure speculation. We don’t know what will happen until it happens. But we are strongly uncomfortable with the unknowns, frustrated by the possibilities, and scared to death we might lose the only medication which has removed our lingering and debilitating symptoms while we were once on synthetic T4–aka Synthroid, Levoxyl, levothyroxine, etc.

And by the way, synthetic T4 is an FDA-approved medication which has left most of us sick or with lingering symptoms to our own degree and intensity for YEARS. Perhaps THAT is what you need to write the FDA about.

So do we email the FDA about this situation?? I am of the belief that writing/emailing the FDA is no different than asking the neighborhood ogre to change.  I could be wrong, but it is my deep suspicion. In fact, I am suspicious that the onslaught of communication with the FDA is going to do more harm than good…if it hasn’t already…just as writing and emailing the neighborhood ogre would probably cause him to laugh and do even MORE harm.

So what seems the best and most logical action to take with our current situation? Write/email your senators. Write/email your representatives. Write/email newscasters, talk show hosts, radio personalities, newspapers of merit, and anyone who has the power to spread the word. In my mind, we cannot expect to face what may be with power unless we inform the world of our plight ahead of time.

How to say what we need to say? I think, for our integrity in the eyes of whom we speak/email/write to, it’s important to state facts first and foremost. For me, if I need to mention speculation, I turn them into questions: Will RLC be able to afford clinical trials? Will the FDA stop all desiccated thyroid? You may not agree but that’s what seems wise for me.

I have compiled a list of particular congresspersons who just last year, made a resolution against the FDA. You will see a list of those supporters at the bottom of the page with their contact info. Email them.  You will also find links to contact each and every other political office. If I have missed something, let me know and I’ll add it.

I have also compiled a simple template letter you can use, or change exactly as you need it changed, for these emails.  It will not fit every single individual who uses it, so change it as you may. But keep it short and succinct. Too much to read will turn off the reader.

I have tried hard in this post to communicate my thoughts and intuition. I also still have some strong hope and faith that this IS going to work out, one way or the other. I’m just not into fear-mongering based on speculation.  Some of you may not agree with my sentiment, but that’s okay. And some of you may agree that it’s time to strongly communicate with our congresspersons, and I will hope you follow through. All of us need to follow through. I need to follow through. You need to follow through.

NEED OPTIONS FOR THYROID TREATMENT during this hard time? Go here. You’ll also find several Canadian Pharmacies to use with a prescription, as well, that is much easier than ordering directly from Erfa.

NEED A GOOD DOCTOR? Go here.

NEW TO DESICCATED THYROID? Here’s everything patients have learned.

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We have facts. We know that Time Caps Labs cannot make desiccated thyroid. We have read, without seeing the actual press release, that Major Pharmaceuticals has been told to stop. I’d sure like to see this release….

We know that Armour didn’t work well for most and became hard to find. We also know from RLC, makers of Naturethroid, that there is at least a 3 month backorder.

And, we know from American Laboratories that they are making the production of desiccated thyroid powder their #1 priority. Demand was greater than supply.

But beyond that as I write this, we know no more. And to speculate in only a negative direction can be a disaster. To march with our pitchforks and torches is only shining a spotlight in the direction of the FDA, and they may not be friendly.

There are positives. ERFA has allowed us to order their Canadian thyroid. There are other sources out there which I have mentioned below, as has health writer Mary Shomon.

And there are other facts: hundreds of thousands of us, if not into the millions, KNOW that desiccated thyroid really is safe and VERY effective. We KNOW that endocrinologists are totally wrong in their opinions.

So, what you can do is put emphasis on the latter FACT of effectiveness when it comes to you. Write your story.  Give a “”before on T4 and an “after on Desiccated thyroid”. Then send it to me for the Stories of Others page. IF…..and I say IF….something drastic happens from the FDA, we then start providing out testimonies and do what we need to do…one after the other after the other. That is our strength.  Facts, concern, but not panicking and carrying pitchforks and torches which may backfire on you. This is not yet the time, if it even passes.

Janie

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I have been receiving emails this afternoon from concerned patients about the latest blog post by health writer Mary Shomon. Her post states that Major Pharmaceuticals has received a notice from the FDA to stop making desiccated thyroid.  And Shomon questions:  is this the beginning of the end?

I think it’s important to mention something that I remember reading, but can’t right now put my finger on, that the FDA can stop production of desiccated thyroid if a company has started making it AFTER the FDA came into existence, and require it to file a New Drug Application, since it is “new” to that company.  Forest Labs and RLC do not fall in that classification. They were around before the FDA came into existence.

I did find this article about Morphine, which implies that as long as a drug (like desiccated thyroid) has not changed since it’s inception, it can avoid the New Drug status. It states:

Under a grandfather clause, a drug marketed prior to the 1938 Federal Food, Drug, and Cosmetic Act, and labeled with the same conditions of use as prior to the Act, was not considered a new drug. These drugs did not require an approved new drug application, but many thought tacit FDA approval was implied. It’s the drug company’s burden to prove an assertion that its product is grandfathered. But FDA believes few drugs are entitled to grandfather status because many differ from previous versions in some respect (e.g., formulation, strength, dosage form, route, indications, intended population).

The above statement makes you pause about Armour, which WAS changed by Forest Labs. But I’m not at all sure RLC’s desiccated thyroid has changed at all, which can be good news for all of us.

Check out page 332 of Good Manufacturing Processes for Pharmaceuticals by Joseph D. Nally which also outlines the above issue of grandfathered drugs.

All in all, it’s downright MADDENING and INEXCUSABLE how the FDA would tell these generic pharmaceuticals–Major and Time-Cap Labs, to stop producing the medication when we already have a shortage.

Here is what the FDA states in their 2006 Compliance Manual, Section 7132c.02 titled Marketed New Drugs Without Approved NDA’s and under A: Reason for This Guidance, please note what I have italicized in their statement:

Manufacturers of drugs that lack required approval, including those that are not marketed in accordance with an OTC drug monograph, have not provided FDA with evidence demonstrating that their products are safe and effective, and so we have an interest in taking steps to either encourage the manufacturers of these products to obtain the required evidence and comply with the approval provisions of the Federal Food, Drug, and Cosmetic Act (the Act) or remove the products from the market. We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market.

To the contrary, the FDA has IN FACT adversely affected public health and has imposed undue burdens on consumers by these ridiculous actions!! A large body of those now on desiccated thyroid will tell you that being on anything BUT desiccated thyroid ruins their health and well-being. I am one.

Under III. FDA’s Enforcement Policy, they define two areas of concern: drugs with potential safety risks, and drugs that lack evidence of effectiveness. You and I know very well that the latter has been stated ad nauseum by the FDA and certain individuals, and yet THE EVIDENCE IS IN HUNDREDS OF THOUSANDS OF US who have switched to desiccated thyroid is ignored, as it the continuing symptoms representing lack of effectiveness in T4 meds!

You can continue reading this FDA Guidance policy and use the Comments to see what hits you, as well.

I have compiled the above fairly quickly, so if I have left anything out, or you can offer more clarification, use the Comments.

P.S. A recommendation: if you are very optimal on your current desicccated thyroid, I would recommend trying to decrease your dose every other day. For example. 4 grains, 3 1/2 grains, 4 grains, 3 1/2 grains, etc.  Not everyone can do this, but if you can, it will help draw out the amount of desiccated thyroid you do have without adversely affecting you. Again, this may only work for those who are quite optimal, and without adrenal fatigue or other issues.

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