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The gnarly man and what we can do in the face of this crisis

ogre

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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*Spread the word! STTM T-shirts are 50% off. I love sales.

Good news! You can get good desiccated thyroid from Canada.

erfathyroid

NOTE: when this blog post was written in 2009, it was good news to mention the Canadian brand of NDT, made by the company called Erfa. But sadly beginning in 2014, it seemed to change in a negative way, as reported by numerous patients, even if some still used it. Complaints about symptoms returning fell on deaf ears. There have also been shortages. 

Unfortunately, patients who want to switch to desiccated thyroid from T4-only meds like Synthroid et al, or those already on desiccated thyroid who want to fill their next prescription, are going to find it difficult. There are widespread shortages in desiccated thyroid like Armour, Naturethroid and Westhroid. (see my posts below).

But there’s good news, and it comes in the form of “Thyroid”  by Erfa.

Erfa’s “Thyroid”  is an excellent natural desiccated thyroid product according to the experience of patients who use it. It contains:

  • Dried Thyroid
  • Mag­ne­sium Stearate
  • Corns­tarch
  • Talc
  • Sugar

**Note the “sugar”. Patients also report they are able to do this brand of medication sublingually! That is good news.

The Erfa website states you can obtain their desiccated thyroid medication outside of Canada via a special access program and follow their steps:

For patients outside Canada and the US:

1. Get a prescription from your local doctor (mention hypothyroidism on it).
2. Your doctor should fill in this simple document (not required for the UK)
3. Fax or e-mail us the documents at 1-514-931-7330 or info@ERFA.net

For patients in the US:

1. get a valid prescription of Thyroid from your local doctor
2. your doctor has to fill FDA form 1572 (e-mail us a request at info@ERFA.net
3. Fax or e-mail us the documents at 1-514-931-7330 or info@ERFA.net

Thank you Erfa from Stop the Thyroid Madness and thyroid patients all over the world who KNOW what a superior treatment desiccated thyroid really is!

*Want to be informed of this informative posts? Curious what’s on Janie’s mind? Use the Notifications on the left at the bottom of the links.


*Need feedback from other patients? Go to the STTM Talk to Others page.

 

Why Forest Labs had gotten away with a “newly formulated” Armour that is causing so many problems

Armour tablets

 

This post was originally written in 2009, and gives you great history as to the disappointing change that happened to Armour as reported by patients. But it happened again in 2015, and you can read that here: //www.stopthethyroidmadness.com/2015/09/19/armour-and-unhappy-thyroid-patients/

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Numerous and ongoing comments to my blog posts below about the newly formulated Armour are shocking and despairing.

Additionally, thyroid patients are crying out about the loss of being able to do Armour sublingually. (Was Forest Labs not paying one hoot of attention to thyroid patients the last few years in their praise of Armour because of it’s sublingual effectiveness??) Sublingual administration was a godsend for thyroid patients who had digestive issues, including gluten intolerance and Celiac, as well as those who needed to take iron tablets (which you can’t do at the same time as you swallow desiccated thyroid, but could do with taking Armour subingually)

So how in the world did Forest Labs get away with reformulating and producing a product that so many patients are reporting to be problematic?

It’s not FDA approved. As many of you may know, Armour desiccated thyroid, even when it was produced by a pharmaceutical other than Forest Labs, was around far before the FDA (Federal Drug Administration) came into being in 1938.  That’s why it does not have the designation of  “FDA approved” as do those drugs which were created after the FDA existed. It’s called an unapproved drug, but Armour was presumed to be safe and effective already.

From the FDA: Under the 1938 grandfather clause (see 21 U.S.C. 321(p)(1)), a drug product that was on the market prior to passage of the 1938 Act and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that Act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.

Because it’s not “FDA-approved”, it does not have an NDA, aka New Drug Application. An NDA is used by the FDA to establish if the pharmaceutical product is safe,  EFFECTIVE, more beneficial than side effects, and has in-house  “controls” which maintain the quality, strength and purity of the product. (Thanks to “Ben” the pharmacist for reminding me of this.)

So…without that NDA, Forest Labs is, and has been, on their own, including with the latest introduction of a newly formulated Armour. So you might say, WE as patients were the guinea pigs.  And sadly, we’ve been squealing and it’s a muddy picture.

The most important fact to state: USP (United States Pharmacopeia) desiccated thyroid is an effective and important drug which is changing the lives of a huge and growing body of individuals around the world. That was evident before Armour was reformulated, and is still evident with products like Naturethroid or Westhroid, which many patients are switching to.  See my blog post about Naturethroid here, plus RLC Labs comment about Naturethroid here.

But something has gone terribly wrong with the reformulation of Armour, and patients appear to be leaving it behind in the dust in favor of another great and effective brand like Naturethroid. And whether it’s the fillers are not, Forest needs to take a new look at their reformulation of what was once a GOOD product, and hopefully this time, LISTEN TO PATIENTS.

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Why the party is over with Forest Pharmaceuticals, the makers of Armour

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Janie wrote the following in 2009 about Armour, and wouldn’t you know, 2015 sees another problem with Armour!

In 2002, when I first got on natural desiccated thyroid and it absolutely changed my life, it happened to be the brand name called Armour by Forest Pharmaceuticals.

And I swooned.

You could do it sublingually (even if it wasn’t made that way), and I praised Armour for that. So did other patients after we spread the word on patient groups, on the STTM website and in the Stop the Thyroid Madness book.

My fondness for Armour did not take away my praises for other prescription brands, though, including Naturethroid or Westhroid by RLC Labs.  I simply made a doe-eyed commitment to Armour for my personal treatment because you could do it sublingually. I have also used the name “Armour” interchangeably to represent all good desiccated thyroid products.

But because of a succession of three events, I think it’s time to give back my going-steady ring.

The first blow to my romance with Armour centered around the extreme tight-lipped secrecy from Forest when the reformulation of Armour began.

We can surmise the trouble begin in 2007 when patients were finding Armour in the larger sizes to be suddenly ineffective.  For the entire year of 2008, supplies were extremely limited and only the one grain size or lower could be found, if at all.  Patients were worried and unhappy.  I even supported Forest in my blog posts, assuring patients that everything would be fine.  But Forest said practically nothing. Why was and is Forest mum about why this was happening ?

The second blow to our courtship was the change to the “reformulated” Armour

Suddenly, patients find that doing Armour sublingually was a thing of the past. Now all we get is a never-ending chalky pasty residue under our tongues.  Additionally, many patients have been reporting that the amount of Armour that once removed all symptoms, was now bringing them back.  Huh?? In spite of an apparent drawback in some batches in 2007, why would Forest take an effective product and change it?

And the third and final straw to my affair of the heart?

I made a phone call to Forest using the same 800 number you all can use. That was Tuesday, May 5th. My intent was to ask about the word anhydrous which is now after the ingredient dextrose in the Armour ingredients listing. (It means that all moisture has been withdrawn, but I wanted to confirm the details for the brands page.) 

When I reached the representative for Forest, and after she asked my name and I gave it (oops),  the tune of the conversation changed.  She said she could not answer my question since I own a public website, and would have to inform the “Media group” from Forest, and they would call me back. When I asked when, the answer was a vague as Synthroid is in treating hypothyroidism i.e. she didn’t know. I even called back the next day to get the same dribble.   Why have representatives on the Forest hotline been instructed not to answer a simple question from someone like myself,  and I still have not received a phone call from Forest?

Sob.

Yup, breaking up is hard to do, but a gal can only take so much strange betrayal, tight-lipped silence…and ignoring a simple question from someone who has done a LOT to put money in their pockets out of extreme gratitude. Thank goodness there are other fish in the sea.

JanieSignature SEIZE THE WISDOM

Thyroid patients say PHOOEY to new Armour formulation and Forest Pharmaceuticals

armourtabletsugh1 As the “newly” formulated Armour desiccated thyroid pills, made by Forest Pharmaceuticals/Laboratories, have been hitting the market, so are comments coming out from some thyroid patients…and they are not in the least complimentary.

The reason that Armour had been favored by so many thyroid patients among all the desiccated thyroid brands is the ability to take it sublingually.  Sure, Armour was never officially made to be taken sublingually, but it worked.

Sublingual refers to the administration of a medication via the millions of tiny capillaries that line your mouth and mucous membrane. The pill was placed under the tongue and allowed to dissolve–most of it entering the body directly via your sublingual glands, and only a small amount swallowed.

Some patients who switched from swallowing to sublingual noticed the difference, too.

But the beauty of sublingual has gone even farther than noticing anything different. First, it was always a known “baddy” to swallow any pills that might contain iron, estrogen or calcium at the same time we swallowed Armour or any other desiccated thyroid brand. Why? All three interfere with and bind a certain percentage of the thyroid hormones in our stomachs.  We were forced to take any of those hours apart from swallowing our pill. So doing the Armour sublingually allowed us to swallow the above pills, or drink milk, or eat high iron foods, at our own timing and not hours away.

Second, the old formula was usually gone in our mouths within 30 minutes give or take. Now, patients who take their newly formulated pills sublingually (which now has less dextrose and more cellulose) despise the “chalky, pasty, gritty residue” left in one’s mouth.  It also results in Armour taking far too long to be properly absorbed.

Third, those with adrenal fatigue can find themselves waking up with nausea due to the morning low cortisol. And being able to take Armour sublingually bypassed the need to swallow a liquid to take a pill and promote more nausea.

Fourth, those with Celiac disease, and even those with standard low thyroid digestive issues, found sublingual administration to help their absorption of what desiccated thyroid offers, which they didn’t get well if they swallowed the pill.

All in all, the buzz around patient groups or on comments here  about the newly formulated Armour is not complimentary.  It doesn’t work well sublingually. It’s too chalky. It leaves a gritty paste in your mouth.  And patients are highly disappointed.  Let’s hope that one of the pharmaceuticals takes the ball and runs to create a sublingual desiccated thyroid.

What is your experience with the new formulation? Are you still trying to do it sublingually?  Have you found doing Naturethroid sublingually works? Are you switching to Naturethroid or Westhroid out of principal, as many are stating they are doing? Use the comment section and let’s talk.

*Express your opinion to Forest here: 1-800-678-1605, ext. 66297.

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