• Armour
• Big Pharma Pharmaceuticals
• fda
• forest labs

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℗(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.

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

*SALE! Stop the Thy­roid Mad­ness T-shirts are now 50% off just because I like sales. A great way to spread the word about our patient revo­lu­tion for the supe­rio­rity of desic­ca­ted thy­roid over T4-only meds. You’ll also see funny bum­per stic­kers. Also…when you order the STTM book and request it (i.e. you have to request it),  you get a Cal­vin peeing on….(you’ll see) bum­per stic­ker for FREE, and it’s a hoot.

Once again, I just appro­ved one more com­ment of someone who has had it with Armour, and is switching.   On the new Armour, she sta­tes she has a return of her for­mer hypo symp­toms: hair loss, joint pain, fati­gue, heart pal­pi­ta­tions, low body temps are back, etc.

And you see it hap­pe­ning all over thy­roid patient groups on the net.  Many folks are done with Armour.

It’s too chalky. It tas­tes terri­ble.  It doesn’t break into sma­ller pie­ces well any­more.  It’s lost the abi­lity to be done sublin­gually. And even worse, it has cau­sed a return of symptoms.

In case you are won­de­ring what this is all about, read the 40 current com­ments attached to the June 2^nd post Trying the Newly For­mu­la­ted Armour? Before that, you can read my May 7^th post Why the party is over with Forest Phar­ma­ceu­ti­cals and the current 37 com­ments.  And espe­cially power­ful is the April 28^th post Patients say PHOOEY to new Armour for­mu­la­tion and Forest Phar­ma­ceu­ti­cals with a current 57 posts.

So what’s their next step?

Right now, doc­tors of patients on Armour on being asked for a presc­rip­tion for Natu­reth­roid. Many report it wor­king won­der­fully; some state they need a little more to be as opti­mal as Armour. A small mino­rity aren’t sure about it yet. But ove­rall, the majo­rity are happy.

So let’s get an update of those who have switched: what pro­duct did you move to? Is the same amount giving you the same results? Did you have to more to a slightlyl higher amount, or lower amount? Was your phar­macy coo­pe­ra­tive for a dif­fe­rent brand?  Did you have to explain to your phar­macy that Natu­reth­roid can be drop-shipped directly to them?

P.S. Thy­roid patient Cheryl emai­led me and said she is sen­ding the above posts about Armour’s pro­blems to prac­ti­cally ever­yone on her email list, hoping they in turn will send it to their friends, and the word will get out.  If you want to do the same, this post is the most upda­ted, and inc­lu­des the links to the for­mer posts.

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

*Have depres­sion and you are on a T4 med like Synth­roid, Levoxyl, levothy­ro­xine, Eltro­xin, etc?? Read the blog post below.

If  you are, check out the com­ments on the May 7^th post or the April 28^th post, and add your own com­ment about the newly for­mu­la­ted Armour desic­ca­ted thy­roid by Forest Phar­ma­ceu­ti­cals.  Let’s keep a run­ning tab on experiences.

Funny how things work. I had been won­de­ring what the heck was going on with thy­roid patients in the UK after the Royal College of Phy­si­cians (RCP) came out with their February 6^th gui­de­line sta­ting that 1) thy­ro­xine was the only medi­ca­tion nee­ded for hypothy­roi­dism, 2) “natu­ral” medi­ca­tions were dan­ge­rous and 3) the only labs nee­ded are the TSH and T4.

All the above goes totally against the life-changing expe­rience of a gro­wing body of patients.

Equally a part of this B-grade horror movie is the stand taken by the Bri­tish Thy­roid Asso­cia­tion (BTA).  Read it. And UK-TPA thy­roid patient advo­cate Sheila Tur­ner began to go through her own hell when her Armour was taken away, which you can read about in the February 20^th blog post here.

And sud­denly, I get an email from Sheila, infor­ming me that the RCP stand is as bad as it was three months ago for her and other thy­roid patients.

Sheila sta­tes: This is abso­lu­tely unbe­lie­va­ble that out of the hun­dreds of refe­ren­ces we sent to the Royal College of Phy­si­cians to show their gui­de­line to be fla­wed, they have taken no account of one sin­gle one of them. They are publishing their pre­vious gui­dance without one since change. The world has gone mad.

Dear Sheila, Further to my email of 6 April, the com­ments and mate­rials recei­ved by the College have been revie­wed. This posi­tion sta­te­ment or gui­dance (not a gui­de­line) was pro­du­ced on behalf of the Royal College of Phy­si­cians, in par­ti­cu­lar its Patient and Carer Net­work and the Joint Spe­cialty Com­mit­tee for Endoc­ri­no­logy and Dia­be­tes; the Asso­cia­tion for Cli­ni­cal Bioche­mistry; the Society for Endoc­ri­no­logy; the Bri­tish Thy­roid Asso­cia­tion; the Bri­tish Thy­roid Foun­da­tion Patient Sup­port Group and the Bri­tish Society of Pae­dia­tric Endoc­ri­no­logy and Dia­be­tes and is endor­sed by The Royal College of Gene­ral Prac­ti­tio­ners. The Pre­si­dent has asked me to let you know that this review has not resul­ted in any chan­ges to that sta­te­ment.  It should be noted that it is about the treat­ment of pri­mary hypothy­roi­dism and does not prec­lude other treat­ments for excep­tio­nal cases by spe­cia­list endoc­ri­no­lo­gists who can make clear to patients any asso­cia­ted risks. Refe­ren­ces sup­por­ting the sta­te­ment are lis­ted below. Yours sin­ce­rely, Catha­rine Perry Admi­nis­tra­tor •   Diag­no­sis and treat­ment of pri­mary hypothy­roi­dism. BMJ 2009;338:b725 •   Vaidya B, Pearce S. A Cli­ni­cal Review of the mana­ge­ment of hypothy­roi­dism in adults. BMJ 2008;337:a801. This con­tains refe­ren­ces for 35 artic­les and sta­tes that Armour thy­roid is of no pro­ved addi­tio­nal bene­fit to levothy­ro­xine. • The Lan­cet Volume 363, Issue 9411, Pages 793 — 803, 6 March 2004.  This covers the his­tory, epi­de­mio­logy, pathophy­sio­logy, and cli­ni­cal diag­no­sis and mana­ge­ment of hypothy­roi­dism and is writ­ten by Caro­line GP Roberts and Paul Laden­son of Johns Hop­kins Uni­ver­sity School of Medi­cine, Bal­ti­more, USA.  This review, which refe­ren­ces 164 cli­ni­cal artic­les, sta­tes that the treat­ment of choice for hypothy­roi­dism is levothy­ro­xine sodium (thy­ro­xine) and does not refer to Armour thy­roid. •  Baloch Z, Cara­yon P, Conte-Devolx B, et al. Labo­ra­tory medi­cine prac­tice gui­de­li­nes. Labo­ra­tory sup­port for the diag­no­sis and moni­to­ring of thy­roid disease.Thyroid 2003;13:3 – 126. •  Asso­cia­tion of Cli­ni­cal Bioche­mists BTA, Bri­tish Thy­roid Foun­da­tion. UK Gui­de­li­nes for the use of thy­roid func­tion tests. http://acb.org.uk/docs/tftguidelinefinal.pdf •  Surks MI. Ortiz E, Daniels GH, et al. Subc­li­ni­cal thy­roid disease: scien­ti­fic review and gui­de­li­nes for diag­no­sis and mana­ge­ment. 2004;291:228 – 238.

And as your peruse the six refe­ren­ces above which they use to defend their tunnel-visioned, moro­nic posi­tion, you rea­lize that you, your words, and your positive-outcome expe­rience on desic­ca­ted thy­roid, as well as the use of far bet­ter labs, is about as impor­tant within the UK’s latest medi­cal pro­noun­ce­ment as is dirt on the bot­tom of a rus­ted buc­ket in the middle of an empty field in nowhere. Yup.

Or as Harold Ship­man sta­ted about the RCP’s gui­de­li­nes: What a bri­lliant wheeze.

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See below on the poten­tial impor­tance of potas­sium in your health and well-being. And on the May 7^th post about the party being over with Forest Phar­ma­ceu­ti­cals, com­ments con­ti­nue to come in about expe­rien­ces with the “new” Armour.

STTM’s Armour-vs-other-brands page now has infor­ma­tion on desic­ca­ted thy­roid in Den­mark, Ger­many and Italy: www.stopthethyroidmadness.com/armour-vs-other-brands Thanks go to Julia Hendryx for aler­ting me about the brand in Denmark!

If I need to add more info or correc­tions, please use the Con­tact Me form at the bot­tom of any page on Stop the Thy­roid Madness.

THIS PATIENT REVOLUTION for a bet­ter hypothy­roid treat­ment is wor­king! Desic­ca­ted thy­roid brands which were almost extinct from low use are now seeing a come­back. Another come­back?? PATIENT HEALTH!! T4-only meds do NOT work, unless an ele­va­tor which only goes to the 5^th floor of a 50 story building.…works. My quote; my words.

p.s. See the post below about the impor­tance of your potas­sium levels, and below that, how being hypothy­roid can affect your liver, and my opi­nion of that fact with T4 meds vs. desic­ca­ted thy­roid, which one com­ment disa­grees with.  For the May 7^th post, com­ments are still coming in about the “New” Armour. Express yours, and let’s hope that just rai­sing it will do the trick, in spite of the loss of being able to do it sublin­gually as easy as before – a sad loss.

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