• Armour
• desiccated thyroid
• fda

Just spoke with Diane Blecha, who ser­ves as a mode­ra­tor and patient advo­cate on the NTH groups.

She spoke with Lena Choe of the FDA. She is a phar­ma­cist in the Divi­sion of Drug Infor­ma­tion at the FDA.

Choe sta­ted that they are not taking current action with Forest Labs and RLC Labs in regards to Armour and Natu­reth­roid. Ins­tead, they will simply be requi­ring them to go through the New Drug Appli­ca­tion pro­cess, and they will require data. Data is pos­sibly refe­rring to the cli­ni­cal trials that both com­pa­nies will have to per­form to get results on the effi­cacy and safety of desic­ca­ted thyroid.

Choe sta­ted that the FDA is very aware of pro­blems with Armour and will be loo­king into that even­tually. The FDA takes prio­rity actions on medi­ca­tions based on con­su­mer complaints.

A com­ment which I found hope­ful from Choe was her know­ledge that desic­ca­ted thy­roid has already been used in humans since the 1962 amend­ment. That’s a good track record of 47 years, folks, that the FDA is refe­rring to. Of course, many of us also know that Armour had a good track record since the 1890’s.

1962 repre­sents the year the FDA esta­blished the “Drug Effi­cacy Amend­ment”, also called the Kefau­ver Harris Amend­ment. The amend­ment requi­res that phar­ma­ceu­ti­cal drug manu­fac­tu­rers pro­vide proof of the effec­ti­ve­ness and safety of their drugs before they can receive FDA appro­val, aka cli­ni­cal trials and the data that results. The amend­ment also requi­res accu­rate mar­ke­ting infor­ma­tion on side effects (think Bob and erec­tile dys­func­tion on those irri­ta­ting, nau­sea­ting commercials).

And again, it still appears as I sta­ted below that both Major and Time Caps were told to cease pro­duc­tion due to being “new” com­pa­nies since 1962 pro­du­cing desic­ca­ted thy­roid. That is a dif­fe­rent issue than RLC and Forest.

Hang onto hope, folks. Because by the limi­ted infor­ma­tion ever­yone gets when they call the FDA, it points to a good rea­son to feel posi­tive, not to think the worst…at least for me. Sure, it’s mad­de­ning they would shut down wha­te­ver pro­duc­tion was left of desic­ca­ted thy­roid. And it’s equally frus­tra­ting that we hang by threads as far as FDA com­mu­ni­ca­tion. But right now, as I also thought a few days ago, I don’t think the FDA is shut­ting down pro­duc­tion of RLC and Forest, or will during the NDA pro­cess. We just have to wait for supply to catch up, espe­cially with RLC. So we’ll see what pas­ses.

Hi Mary.

You know, I really don’t think this is a time for us to be sepa­rate, Mary, in our advo­ca­cies.   Seven years ago, I went a dif­fe­rent direc­tion that I felt was impor­tant, and still strongly do, as an acti­vist.  That will con­ti­nue because I believe in what I am doing. You don’t have to agree with my stance, but we can make the choice to work together in what is com­mon bet­ween us – sup­por­ting the use of desic­ca­ted thy­roid and hel­ping others with the shortage.

As I see it, Mary, we each have a won­der­ful legacy. You will always be appre­cia­ted for your work as much as many appre­ciate my work. That will never be taken away.

So why not be uni­ted in this fight, Mary, wor­king together to sup­port patients during this shor­tage.  Thy­roid patients need us.

Janie

We always talk about phar­ma­ceu­ti­cals who pro­duce our desic­ca­ted thy­roid medi­ca­tion pills like Forest Labs (Armour) and RLC Labs (Natu­reth­roid and Westh­roid). These are also the phar­ma­ceu­ti­cals who pro­vide these pills to the local phar­ma­cies we use. But there is another impor­tant link in the chain that pro­ceeds them: Ame­ri­can Labo­ra­to­ries, Inc. (ALI)

ALI is a small pro­ces­sing com­pany loca­ted in Omaha, Nebraska which was esta­blished in 1967 by Mr. Jack Jack­son and Mr. William Pha­len.  They have been making desic­ca­ted Por­cine Thy­roid Pow­der (which is an Active Phar­ma­ceu­ti­cal Ingre­dient, API) for over 40 years, as well as 200 natu­ral bio­lo­gi­cally deri­ved pro­ducts such as Panc­rea­tin and Pep­sin, both diges­tive enzy­mes. Their man­tra is “Buil­ding trust through qua­lity pro­ducts and service.”

ALI, as a lea­ding manu­fac­ture and sup­plier of enzyme and natu­ral dried pro­ducts, is also pro­bably the only North Ame­ri­can com­pany to make desic­ca­ted thy­roid pow­der. And they will explain that it’s a long and dif­fi­cult pro­duct to make, but they are com­mit­ted to it.

This mor­ning, I spoke with Kenny Soe­joto, the Chief Ope­ra­ting Offi­cer. He explai­ned that supply and demand has been a cri­ti­cal issue, and ALI will be doing everything they can to pro­vide the qua­lity desic­ca­ted thy­roid pow­der to phar­ma­ceu­ti­cals that they always have. You’ll also see a Press Release come out later today from Kenny and ALI about the issue. I’ll add it below.

The supply and demand issue is outright due to the current patient revo­lu­tion, repre­sen­ted by STTM and other fine groups and web­si­tes,  against the sole treat­ment of hypothy­roi­dism with T4 meds like Synth­roid by too many doctors.…and in favor of desic­ca­ted thy­roid as a far bet­ter treat­ment. Demand has grown, and perhaps it caught them by sur­prise. (That is my com­ment, by the way, NOT ALI’s.)

Even RLC Labs sta­tes that demand for Natu­reth­roid (due to pro­blems with the newly for­mu­la­ted Armour) has qua­dru­pled in the past few weeks. And rightly so!  Thy­roid patients around the world KNOW FIRSTHAND how much bet­ter desic­ca­ted thy­roid treat­ment is over T4-only. And word is spreading.

So as we,  thy­roid patients on desic­ca­ted thy­roid, face a shor­tage the next few months, take heart that ever­yone is wor­king hard to bring supply back to us.  Also see my post below con­cer­ning the big­ger issue with Medco, and poten­tial alternatives.

*************************************

Here’s the Press Release below, and it should calm any fears or panic:

August 19, 2009

To our know­ledge, Ame­ri­can Labo­ra­to­ries, Inc. is the only manu­fac­tu­rer in North Ame­rica of Thy­roid Pro­ducts for use in Human Phar­ma­ceu­ti­cals as an Active Phar­ma­ceu­ti­cal Ingre­dient. We have manu­fac­tu­red our Thy­roid pro­ducts for over forty years, and we unders­tand the impor­tance they have to our cus­to­mers and ulti­ma­tely the con­su­mer patients. Today, as well as in the future, our Thy­roid pro­ducts will con­ti­nue to be a stra­te­gic part of our business.

Through the years, the world-wide demand for our Thy­roid pro­ducts, as well as our human nutri­tio­nal enzyme pro­ducts has inc­rea­sed dra­ma­ti­cally. Through care­ful plan­ning and strict adhe­rence to regu­la­tions set forth by the FDA, USDA and other govern­ment agen­cies, we have imple­men­ted plans to inc­rease our pro­duc­tion capa­ci­ties. In addi­tion, Ame­ri­can Labo­ra­to­ries’ is wor­king clo­sely with our sup­pliers to help ensure a con­sis­tent supply of qua­lity raw mate­rials. We hope that you unders­tand that the pro­cess to manu­fac­ture the active ingre­dient takes seve­ral months to complete.

Please be assu­red that we have pla­ced our Thy­roid pro­duc­tion as our num­ber one prio­rity so that we can meet the demands of our customers.

Ame­ri­can Labo­ra­to­ries, Inc
Omaha, Nebraska, USA

*Want to be infor­med of these blog posts? Curious what’ s on Janie’s mind? Use the Noti­fi­ca­tion on the left below the links.

*Like sales?? I do. And the STTM t-shirts are now 50% off. Spread the word!!

Just when you think we’re full of great infor­ma­tion for bet­ter thy­roid care, there’s still more to learn and find out.  Below is infor­ma­tion that you might find inte­res­ting on STTM.

ADRENALS: For those who dis­co­ve­red via the 24 adre­nal saliva test that they nee­ded cor­ti­sol sup­port, we have come to rea­lize that some can’t do the ram­ping up sche­dule from a small amount to a lar­ger amount without having pro­blems from the feed­back loop.

Ins­tead, many simply need to “start” on the higher amount, which would range from 20 – 30 mg. You can read about that on the How to Treat page, and you’ll note that not one mor­ning amount goes higher than 10 mgs.  With the excep­tion of men, higher than 10 mg seems to sup­press the ACTH and adre­nals too much.

A NEW LOOK: To make the STTM home page more unders­tan­da­ble to new­co­mers, the home page has bro­ken down the infor­ma­tion bet­ter into sepa­rate pages, and also has a new inte­res­ting way of using it.

LISTEN TO THIS INFORMATION: STTM has short audio clips you can lis­ten to, or send someone else to, to help unders­tand what this is all about.

STORIES OF OTHERS: Indi­vi­dual real-life sto­ries con­ti­nue to come in, pro­ving over and over that this revo­lu­tion for far bet­ter care really does work.

FEEDBACK and MORE FEEDBACK: I get emails daily about lives chan­ged thanks to this patient revo­lu­tion. It’s won­der­ful to see peo­ple fin­ding out WHY they have depres­sion, less sta­mina than others, rising cho­les­te­rol and blood pres­sure, hair loss plus other lin­ge­ring symp­toms of  hypothy­roi­dism left untrea­ted because of the lousy TSH, or under­trea­ted because of the equally-lousy T4-only treat­ment like Synth­roid. I can’t begin to post them all, but STTM does con­tain a sam­pling of this feed­back.

DESICCATED THYROID BRANDS: Wow, the list is gro­wing for desic­ca­ted thy­roid brands around the world! We now have lis­tings for Den­mark, Ger­many, Italy and New Zea­land, as well as more detai­led infor­ma­tion on com­poun­ded thy­roid in Aus­tra­lia. Thanks to all who contributed.

KEEPING UP WITH ADDITIONS TO STTM: In case you didn’t know, there’s a page meant to inform you of what’s added to STTM. I may neglect to list a few addi­tions occa­sio­nally, but think I’m pretty close to get­ting most of them up there.

MEDICAL RESEARCH TO PROVE WHAT WE ALREADY KNOW: Did you know that STTM has a page which com­pi­les research and stu­dies which prove what we as patients already know? It’s not loa­ded with research yet, but it’s gro­wing. And if you have found more to con­tri­bute to that page, use the Con­tact Me form.

SITE MAP: And bot­tom line, you can always go to the Site Map, or review the infor­ma­tion more com­pactly in the book, which patients are taking into their doc­tors offices.

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

*Stop the Thy­roid Mad­ness T-shirts are now 50% off! I like sales, don’t you? And by wea­ring these shirts, you’ll never know what seed you put in the mind of someone wal­king past you who’s still on Synth­roid or any other T4 meds, and doesn’t know WHY they have depres­sion, rising cho­les­te­rol, easy weight gain, the need for naps, etc. You”ll also find humo­rous bum­per stic­kers which defi­ni­tely spread the word.

Armour desic­ca­ted thy­roid by Forest Phar­ma­ceu­ti­cals used to be easy to do sublin­gually, even if the offi­cial line was they didn’t make it that way.

And patients liked that sublin­gual abi­lity with Armour.  It allo­wed them to work around the pro­blem of swa­llo­wing desic­ca­ted thy­roid seve­ral hours from having swa­llo­wed iron, estro­gen or cal­cium – all which can bind some of the thy­roid hor­mo­nes in your stomach.

It also hel­ped those with diges­tive issues, glu­ten into­le­rance or Celiac (a com­mon pro­blem for some hypothy­roid patients) by bypas­sing the stomach.

But with the newly for­mu­la­ted Armour in 2009, it became dif­fi­cult. The pill is har­der with less dex­trose and more cellu­lose.  It now fell into the ranks of all other desic­ca­ted thy­roid pills, inc­lu­ding Natu­reth­roid and other good brands, as a more dense tablet.

But no mat­ter what brand you use (espe­cially the gro­wing group of patients who are having their doc­tors switch them to Natu­reth­roid), below are tips from patients on how to con­ti­nue doing your desic­ca­ted thy­roid sublin­gually. Let your doc know, too.

1) Try adding a touch of the con­tents of a Pixie Stix under your ton­gue. It’s fla­vo­red sugar in a straw, and the sugar seems to help the tablet dis­solve sublin­gually through tis­sues under the tongue.

2) If you are using sublin­gual B12 lon­zen­ges to treat low B12, try adding it under the ton­gue with your desic­ca­ted thy­roid. The action of the sublin­gual lozenge seems to move over to the thy­roid tablet.

3) Swish warm water in your mouth before you place the tablet under your tongue.

4) Crunch up the desic­ca­ted thy­roid tablet before any of the above and before pla­cing it all under your tongue.

Also note that you can swa­llow your desic­ca­ted thy­roid. You’ll just have to make sure you don’t also have a sto­mach full of iron rich foods or cal­cium, or estro­gen. Gene­rally, it’s best to take your tablet 4 hours from any of the for­mer. P.S. See com­ments below on the newly for­mu­la­ted Armour, and farther down, a post on Naturethroid.

*Have more sublin­gual ideas or expe­rien­ces? Share it in the Com­ments section.

*Want to be infor­med of my blog posts? Curious what’s on my mind? Just use the Noti­fi­ca­tions to the bot­tom left of the links.