thyroid tags

Some­ti­mes there is a sil­ver lining with the storm cloud of bac­kor­de­red US desic­ca­ted thyroid.

Erfa, the makers of the Cana­dian ver­sion of natu­ral desic­ca­ted thy­roid, simply called “Thy­roid”, has recently announ­ced that the FDA is not requi­ring the exten­sive FDA Form 1572 from US citi­zens and their doc­tors when they fill their presc­rip­tions from Erfa directly. i.e. it’s now a lot easier to get your presc­rip­tion filled directly from them.

http://www.erfa-sa.com/thyroid_usa.htm

And those who have star­ted to use Erfa’s Thy­roid report being quite plea­sed. A cherry on top is that Thy­roid has that old sweet taste we used to all like with the old Armour, and it can be done sublin­gually as well! You can see the ingre­dients here.

Also, I am con­ti­nuing to get emails from patients that both Armour and Natu­reth­roid is star­ting to appear on phar­macy shel­ves, even if in small quan­ti­ties.  I’m per­so­nally not too exci­ted about Armour reap­pea­ring if Forest con­ti­nues to make the refor­mu­la­ted ver­sion. Just too many patients repor­ting a return of hypo symp­toms, even when they raise it, plus new symp­toms of under­treat­ment and/or cha­llen­ged adre­nals thanks to the refor­mu­la­ted ver­sion. Sad. Oh how we will all miss the old Armour.

In the mean­time, here are options for thy­roid treat­ment we all have until we see a good return of desic­ca­ted thy­roid, inc­lu­ding Natu­reth­roid and Westh­roid. They are all far, far bet­ter than being on T4 alone like Synth­roid, Levoxyl, levothy­ro­xine, et al. You’ll also note com­poun­ded thy­roid, which can be a good option, and you can read about on a recent blog post.  Aus­tra­lians hap­pily use com­poun­ded in their own country. Any option you and your doc­tor choose may mean a read­just­ment by your body, by the way.

Want to talk to other patients on how they are dea­ling with the shor­ta­ges? Join the Coa­li­tion for Desic­ca­ted Thy­roid.  Or if you simply need patient feed­back about your hypothy­roi­dism, go to the Talk to Others page.  Remem­ber that no patient group is meant to be a subs­ti­tute for your rela­tionship with your doctor.

**The next Thy­roid Patient Com­mu­nity Call will be held Thurs­day Oct. 8^th on TalkShoe, and our topic will be iodine and your thy­roid with patient expert Stepha­nie Buist. Come join us and lis­ten right on your com­pu­ter, or you can also talk live to Stepha­nie or Janie with your questions.

We had a great Thy­roid Patient Com­mu­nity Call Fri­day night on TalkShoe with John Voliva, RPh, the Pre­si­dent of Hooks Apothe­cary in Evans­vi­lle, Indiana. Hooks Apothe­cary is a compounding-only phar­macy that has been in exis­tence for ten years and is a small and high qua­lity family-owned business.

And with our current shor­tage of desic­ca­ted thy­roid via the tablets we were used to, com­poun­ding phar­ma­cies are a good alter­na­tive in the mean­time. Here’s what we lear­ned from Mr. Voliva:

1) Dif­fe­rent com­poun­ding phar­ma­cies will use dif­fe­rent fillers. Hooks Apothe­cary, for exam­ple, uses pow­de­red aci­dophi­les, the “active cul­ture” which helps replace the good flora in your gut and impro­ves digestion.

2) Com­poun­ded desic­ca­ted thy­roid can be more expen­sive for two rea­sons: they acquire sma­ller amounts of the pow­der as com­pa­red to the huge amounts obtai­ned by a phar­ma­ceu­ti­cal like Forest, and it takes time to com­pound it.

3) A good com­poun­ding phar­macy will give you the Cer­ti­fi­cate of Analy­sis right when you ask for it, and you should ask for it. This Cer­ti­fi­cate will tell you how much T4 and T3 is in one grain..and it’s not always simply 38/9 mcg.  It could be 35/8.6 or 39/8.5 per grain…for exam­ple.   Find out because there are allo­wed devia­tions of 10 mcg +-.  A really good phar­macy will shoot for an even bet­ter devia­tion and will also pro­duce that Cer­ti­fi­cate right when you ask for it, not a day later. To not receive that docu­men­ta­tion right when you ask implies they really weren’t paying much atten­tion to the deviation.

4) A com­poun­ding phar­macy will get bet­ter devia­tions when they create a 65 mg grain of com­poun­ded desic­ca­ted thy­roid than when they create a 60 mg grain.

5) Top notch Com­poun­ding Phar­ma­cies will be acc­re­di­ted by, or be close to com­ple­ting the steps towards, the Phar­macy Com­poun­ding Acc­re­di­ta­tion Board.

6) Com­poun­ding phar­ma­cies can’t make a desic­ca­ted thy­roid trouche because of the pro­blems with heat in the pro­ces­sing of the trouche.

7) Mr. Voliva feels it would be too easy to over­dose with trans­der­mal (on the skin) desic­ca­ted thyroid.

8 ) Com­poun­ding phar­ma­cies, via their 5 – 6 dis­tri­bu­tors, get the pow­der from Ame­ri­can Labo­ra­to­ries.  But not all com­poun­ding phar­ma­cies will be as dili­gent as others to make sure the devia­tion is clo­ser to 5%.

9) If the com­poun­ding phar­macy is get­ting their pow­der via the dis­tri­bu­tor PCCA (Pro­fes­sio­nal Com­poun­ding Cen­ters of Ame­rica), you can be assu­red you are get­ting a good pro­duct.  Ask the phar­ma­cist where they are get­ting it.

10) Com­poun­ding phar­ma­cies gene­rally have plenty of desic­ca­ted thy­roid powder.

My apo­lo­gies to a group of callers whose chat ques­tions I wasn’t able to see. I have sent a ques­tion about that to Talk Shoe’s Cus­to­mer Sup­port to find an ans­wer before the next Com­mu­nity Call. But on the good side,  the audio wor­ked on everyone’s computer.

On my August 26^th blog post below, I repor­ted good infor­ma­tion about US patients being able to use their doctor’s presc­rip­tion to order the Cana­dian ver­sion of natu­ral desic­ca­ted thy­roid called simply “Thy­roid” by Erfa.

And here’s more:

In each Erfa 30 mg tablet embos­sed “ECI 30”, there is 18 mcg. of T4 and 4 mcg. of T3;

In each Erfa 60 mg tablet embos­sed “ECI 60”, there is 35 mcg. of T4 and 8 mcg. of T3;

In each Erfa 125 mg tablet embos­sed “ECI 125”, there is 73 mcg. of T4 and 17 mcg. of T3.

Erfa’s very friendly and help­ful Medi­cal Direc­tor, Henri Knafo, MD, sta­tes that they follow the USP (Uni­ted Sta­tes Phar­ma­co­poeia) spe­ci­fi­ca­tions. But  I do see some slight dif­fe­ren­ces.  The USP spe­ci­fi­ca­tions ratio for one grain that we are used to in the US is 38 mcg. T4 and 9 mcg T3, i.e 38/9.  The above ratio is 35/8.

Like­wise, US patients are used to 2 grains of 120 mgs having 76 mcg of T4 and 18 mcg of T3, i.e. 76/18.  In Erfa’s medi­ca­tion of 125 mg, you will get a ratio of 73/17. I don’t know if this will make much of a dif­fe­rence but want you to be aware as you work to adjust Erfa’s desic­ca­ted thy­roid to the treat­ment you were used to.

Knapo hap­pily sta­tes that most all “Thy­roid” is making it across the bor­der to the sta­tes without issue.  You will need your doctor’s presc­rip­tion. And by the way, Erfa’s Thy­roid is manu­fac­tu­red in Bel­gium, plus they have a huge supply of desic­ca­ted powder.

Erfa is also wor­king with IDIS to get Thy­roid to others. You can read about them here.

Need a doc­tor to work with who will pro­vide a presc­rip­tion for your nee­ded desic­ca­ted thy­roid? There are a gro­wing body of  good doc­tors out there.  We also have a good list of  Cana­dian phar­ma­cies you can con­si­der using during the current shortages.

I have also recei­ved word from a gal that the FDA docu­ment 1572, a fede­ral form that FDA requi­res for over-the-border move­ment, has not always been used, and Erfa’s medi­ca­tion is arri­ving fine. i.e. the FDA may be tole­ra­ting it.

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.

*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.