Armour tags

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.

The sub­ject line of this post was just given to me in an email by a wise and cau­tious per­son. And I agree with it.

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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Just had a good con­ver­sa­tion with Dr. Henri Knafo, the Direc­tor of Medi­cal Affairs at Erfa Canada, Inc.

On my post below from yes­ter­day, you will see hope­ful infor­ma­tion on get­ting this exce­llent Cana­dian desic­ca­ted thy­roid. And below is more infor­ma­tion you have been asking for as patients who know the effi­cacy of desic­ca­ted thyroid.

Erfa’s “Thy­roid” comes in three strengths: 30 mg, 60 mg, and 125 mg.  Amounts you can order, and costs, are as follows:

30mg             500 tablets  $52.00 US;    100 tablets $18.00 US

60mg             500 tablets  $70.00 US;    100 tablets   $39.00 US

125mg          500 tablets  $100.00 US;   100 tablets  $ 50.00  US

Erfa will charge a 10$ hand­ling fee (for first time users) and ship­ping is around $20 US.  Knafo sta­tes the pri­ces are equi­va­lent to Armour.

Erfa’s Thy­roid has been in pro­duc­tion for 30 years and they have 5000 Cana­dian patients on it.

Erfa’s Thy­roid is appro­ved by Health Canada (their equi­va­lent to FDA).  Erfa spoke to the FDA, and in order for their desic­ca­ted thy­roid to cross the US bor­der, you have to fill out and sign the FDA patient study form which is men­tio­ned below.

Erfa’s Thy­roid is made in Europe with the raw mate­rials, and they bought an excess of it. So there will be no pro­blem get­ting it and they expect no shor­ta­ges the rest of the year.

One cana­dian phar­macy you can use (and is not asso­cia­ted with Erfa) is the Canada Phar­macy Online.

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:

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!

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

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