Armour tags

Surely most anyone who has been outside has felt a little drop here…then a little drop there…and you won­de­red:  am I get­ting ready to be rai­ned on?

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.

If you have been kee­ping up with my posts, you’ll know that thy­roid patients have been facing a shor­tage of desic­ca­ted thy­roid for many weeks, pro­bably due to sharp inc­rea­sed demand i.e. thy­roid patients have been fin­ding out how lousy T4-only treat­ment like Synth­roid has been for them, and how much bet­ter desic­ca­ted thy­roid is.

That demand became espe­cially true after a refor­mu­la­tion of Armour by Forest Labs in 2009 drove patients to RLC’s Natu­reth­roid and Westh­roid. The “new” Armour cau­sed a return of hypo symp­toms plus new mad­de­ning ones, inc­lu­ding pal­pi­ta­tions and sleep pro­blems never seen before.  As Julia Roberts said in the 1990 movie Pretty Woman: Big mis­take, Big, Huge.

In addi­tion, it didn’t help when Time Cap Labs, a phar­ma­ceu­ti­cal which made plenty of desic­ca­ted thy­roid for other phar­ma­ceu­ti­cals, stop­ped pro­duc­tion after being con­tac­ted by the FDA. This action was pro­bably in line with their aims to make long-term unap­pro­ved drugs become appro­ved, even if the timing was inc­re­dibly stupid.

As all the above was hap­pe­ning, panic ensued!

We’ve heard all varie­ties of nega­tive pre­sump­tions from thy­roid patients about what cau­sed the shor­tage, inc­lu­ding an FDA cons­pi­racy and an overt belief that desic­ca­ted thy­roid is about to be remo­ved.  Patients have threa­te­ned law suits, bla­med phar­ma­ceu­ti­cals, and/or sent nume­rous let­ters to FDA plea­ding to keep desic­ca­ted thy­roid as if it was to be gone tomo­rrow. Even I, at first, fell in line won­de­ring about the FDA.

But it star­ted to dawn on me, as it has others, than we have been jum­ping the gun, not giving enough empha­sis to facts and reason.

And finally, facts and rea­son are star­ting to appear on blogs and groups:

1) Yes, Forest Labs, the makers of Armour, and RLC, the makers of Natu­reth­roid and Westh­roid, state they have not been con­tac­ted by the FDA. We have no rea­son to dis­be­lieve them!

2) Yes, RLC is wor­king hard to catch up, as is Ame­ri­can Labo­ra­to­ries, both state. We also have no rea­son to dis­be­lieve them!

3) Yes, thy­roid patients who know the supe­rio­rity of desic­ca­ted thy­roid have always been there to sup­port them. Glad to see that recog­ni­tion in blog and group postings.

4) Yes, as health wri­ter Mary Sho­mon has sta­ted, information-gathering, brains­tor­ming, and com­mu­ni­ca­ting with our doc­tors is a good thing to be doing.  That is con­trary to making panicky nega­tive pre­dic­tions about desic­ca­ted thy­roid,  rall­ying for law suits, and fee­ding ideas to the FDA that may not be there in the first place.

5) Yes, we need to put energy in let­ting the world know about the supe­rio­rity of desic­ca­ted thy­roid treat­ment in our lives. That is where our power lies in the face of clue­less Endoc­ri­no­lo­gists and their equally-clueless medi­cal boards like AACE.

6) Yes, we need to lis­ten to and sup­port the phar­ma­ceu­ti­cals and labo­ra­to­ries which give us the desic­ca­ted thy­roid we need. It’s they who have to walk the line with the FDA. Let’s lis­ten to their cau­tions and sup­port them.

Stran­gely, there are still mis­con­cep­tions being repor­ted by patient blogs and posts:

1) That we don’t know what cau­sed the shor­tage. But we do! Demand is as logi­cal as it gets.  All of us have suc­cee­ded in get­ting the word out! That is exactly why I crea­ted STTM in the first place!  And by emails I get every week, it’s clear that it’s been working.

2) That groups like the Coa­li­tion for Desic­ca­ted Thy­roid (CDT) have a wait-and-see atti­tude. That is as silly as saying STTM wants to ban T4 or encou­ra­ges self-treatment. There are simply some thy­roid patients who don’t agree with the extreme panic and nega­tive pre­sump­tions that have been going on, and want more rea­son in our pro-activity!  Patients have been encou­ra­ged to spread the word in any way pos­si­ble about the supe­rio­rity of desic­ca­ted thy­roid and how it’s chan­ged lives, NOT to feed dire nega­tive pre­dic­tions which only end up giving ideas we don’t want to give! You are most wel­come to join the Coa­li­tion above in addi­tion to other groups.

Good for patients and advo­ca­tes alike for put­ting more rea­son and fact in this situation.

I’m also glad to see some stra­te­gic, pro-active behind-the-scenes work going on as a just-in-case line of acti­vism. That is the way it should have always been – a plan for action “just in case”, not dire pre­dic­tions and fear mon­ge­ring as if it all WAS going to happen.

We’ll get through this, folks. Here are options for thy­roid treat­ment in the mean­time. And if you want to talk to other patients, join our thy­roid patient Com­mu­nity Call this Fri­day. Details are found in the Sep­tem­ber 7^th blog post.

As thy­roid patients are not only in angst about a com­plete shor­tage of desic­ca­ted thy­roid in the US, we all have ques­tions and con­cerns about out future with no defi­ni­tive answer.

For exam­ple, we won­der if the FDA may be  requi­ring cli­ni­cal stu­dies from phar­ma­ceu­ti­cals who make desic­ca­ted thy­roid to prove that it’s safe and effec­tive (in spite of the fact that patients have been using it safely and effec­ti­vely for 110 years.  Nope, we don’t count. Ama­zing, isn’t it?) And we won­der: if stu­dies are requi­red, will they be able to afford the stu­dies, which are quite expen­sive? Will desic­ca­ted thy­roid con­ti­nue to be avai­la­ble while the stu­dies go on? And more uncom­for­ta­ble questions.

The FDA recently replied to a ques­tion by thy­roid patient Cathe­rine when she asked about the shor­ta­ges and here’s their reply:

Dear Cathe­rine:

Thank you for wri­ting the Divi­sion of Drug Infor­ma­tion, in the FDA’s Cen­ter for Drug Eva­lua­tion and Research.

We unders­tand your con­cerns regar­ding the avai­la­bi­lity of natu­ral desic­ca­ted thy­roid pro­ducts.  FDA has NOT taken class action against unap­pro­ved thy­roid pro­ducts resul­ting in a shor­tage.  If a com­pany dis­con­ti­nues manu­fac­tu­ring of an unap­pro­ved pro­duct, that is a busi­ness deci­sion made by the company.

Please refer to the ASHP Shor­ta­ges web­site for a lis­ting of desic­ca­ted thy­roid pro­ducts that remain avai­la­ble:
http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=459

We have con­tac­ted the com­pa­nies and RLC (manu­fac­tu­rer of West-Throid and Nature-Throid) is in bac­kor­der for all strengths and pro­ducts for the next 90 days.

Major has the 60mg and 120mg avai­la­ble of their “gene­ric” desic­ca­ted thy­roid pro­duct.  They report inc­rea­sed demand as the rea­son for their bac­kor­der for the other strengths.

Forest reports they have the 120mg, 240mg, and 300mg strengths avai­la­ble for their Armour Thy­roid pro­ducts and they report inc­rea­sed demand as the rea­son for the bac­kor­der on their other strengths.

If you and your health­care pro­vi­der deter­mine that one of these thy­roid pro­ducts is appro­priate for you, you can pro­vide the NDC num­bers lis­ted on the ASHP web­site for these pro­ducts to your phar­ma­cist so they can order for you.

Best regards,
Drug Infor­ma­tion SH
Divi­sion of Drug Infor­ma­tion
Cen­ter for Drug Eva­lua­tion and Research
Food and Drug Administration

The inte­res­ting thing about the above is that it implies that Major Phar­ma­ceu­ti­cals is just on bac­kor­der, which goes com­ple­tely against what patients have repor­ted elsewhere.  What’s going on there? Are they using old know­ledge? And the lar­ger sizes of Armour? Is anyone fin­ding that at the phar­ma­cies right now? Very curious. Inte­res­ting the com­ment about RLC, the makers of Natu­reth­roid.  And the link to shor­ta­ges is inte­res­ting, though from the end of July.

Wha­te­ver the ans­wers are, if you need a treat­ment to get you through this dif­fi­cult time, here are options for thy­roid treat­ment. And it still may be a very good idea to inform your con­gress­per­sons of our situation…just in case. See my blog post below.

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

*STTM t-shirts are 50% off! I love sales.

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. 

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

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.

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

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

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.