pharmacy tags

And now that I have your atten­tion, here’s the ans­wer straight from the mouth of Kenny Soe­joto, Chief Ope­ra­ting Offi­cer of the only North Ame­ri­can maker of desic­ca­ted por­cine natu­ral thy­roid pow­der (Ame­ri­can Labo­ra­to­ries): a firm NO!

“We have amply supply and so do the dis­tri­bu­tors for com­poun­ding phar­ma­cists”, unders­co­res Soe­joto when I chat­ted with him today.

He also added in res­ponse to the recent shor­ta­ges:  “We didn’t spare an expense to push it along”.  i.e  “Ame­ri­can Labo­ra­to­ries have caught up with all bac­kor­ders, with the excep­tion of one major com­pany which has tight spe­ci­fi­ca­tions, but they should be caught up by the first quar­ter in 2010″, explai­ned Soejoto.

So what about spe­ci­fic rumors we keep hearing??

1. My com­poun­ding phar­macy said they weren’t able to get it. Kenny explai­ned that a small com­poun­ding phar­macy often can’t afford the mini­mum order that Ame­ri­can Labo­ra­to­ries requi­res, nor does the sma­ller phar­macy want that much, which is an 110 lb drum of pow­der.  So, says Soe­joto, they need to con­tact their dis­tri­bu­tor, who is the middle man bet­ween a com­poun­ding phar­macy and Ame­ri­can Labo­ra­to­ries. “The dis­tri­bu­tor for com­poun­ding phar­ma­cies, ” explai­ned Kenny, “will buy the lar­ger amounts, make sma­ller pac­kets, and then sell those to the com­poun­ding pharmacies”.
2. Ame­ri­can Labo­ra­to­ries can’t be the only North Ame­ri­can makers of pow­de­red thy­roid because my com­poun­der told me a dif­fe­rent name. The dif­fe­rent name you heard is the middle man men­tio­ned above – a dis­tri­bu­tor for the thy­roid pow­der to the com­poun­ding phar­macy. But that dis­tri­bu­tor got their supply from Ame­ri­can Laboratories.
3. My regu­lar phar­macy said there is a supply issue for the brand I wan­ted. Again, Kenny explains there is no supply issue – they have plenty. Any phar­ma­ceu­ti­cal com­pany that makes desic­ca­ted thy­roid has to have ongoing cre­dit worthi­ness and docu­men­ta­tion before AI can sell to them. Also, we are simply expe­rien­cing con­ti­nued demand being grea­ter than supply, and it can take time to catch up.  i.e. there may be more to the story than you hear under any com­ment about a supply issue problem.

In conc­lu­sion, Kenny Soe­joto said they simply got into trou­ble from the growth of inte­rest in desic­ca­ted thy­roid the past few years, and they are much bet­ter pre­pa­red. Even Europe is inqui­ring more about it, he said. And my res­ponse to him?? Get ready, because you are doing millions of poten­tial thy­roid patients a HUGE favor by making it,  and we’re going to con­ti­nue to spread the world about natu­ral desic­ca­ted thy­roid. 

Check out posts below about other impor­tant issues, inc­lu­ding more from Erfa, plus the pro­blem of cellu­lose in com­poun­ded and regu­lar desic­ca­ted thyroid.

*HO HO HO! Have a STTM book sent to someone  you care about as a CHRISTMAS or HOLIDAY pre­sent. A card will be inc­lu­ded, and the book will be in an enve­lope with a red bow!! Save money the more you buy!

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.

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.

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I have been watching with inte­rest the past week about the jus­ti­fied ire of patients being expres­sed all over patient groups in the inter­net. And in case you’ve been too busy with school star­ting or end-of-summer acti­vi­ties, it invol­ves one of the nation’s lar­gest mail order phar­ma­cies as well as the lar­gest Phar­macy Bene­fits Mana­ger (PBM):  Medco.

In a sta­te­ment you can read right on their web­site, they state:

1)  there is a “nation­wide shor­tage of porcine-derived desic­ca­ted thy­roid“
2)  they are “uncer­tain about con­ti­nued avai­la­bi­lity.“
3)  “ask your doc­tor if a synthe­tic thy­roid medi­ca­tion, such as levothy­ro­xine is right for you.”

In Medco’s direct mes­sage to doc­tors, they state;

1)  desic­ca­ted thy­roid does not have the U.S. Food and Drug Admi­nis­tra­tion (FDA)  Fede­ral Drug appro­val“
2)  the FDA  “may remove any remai­ning unap­pro­ved pro­ducts from the mar­ket.“
3)  the shor­tage is due to this “uncer­tainty”.
4) “the Ame­ri­can Asso­cia­tion of Cli­ni­cal Endoc­ri­no­lo­gist recom­mends levothy­ro­xine over desicc­ca­ted thy­roid, lio­trix, com­bi­na­tion of thy­roid hor­mone, or triio­dothy­ro­nine (T3) for the treat­ment of hypothyroidism.”

Cla­ri­fi­ca­tion on their statements

If you are just now fin­ding out about this,  do note the following:

1) There is not a nation­wide shor­tage of all desic­ca­ted thy­roid. There is a shor­tage of Armour because of its 2009 refor­mu­la­tion. (See my blog posts below about pro­blems with the newly for­mu­la­ted Armour.)
2) Natu­reth­roid by RLC Labs con­ti­nues to be avai­la­ble. They are wor­king hard to keep up.  See my post on Natu­reth­roid.
3) Desic­ca­ted thy­roid was around long before the esta­blish­ment of the FDA, so they are grand­fathe­red in and still work with the FDA gui­de­li­nes.
4) There has been no sta­te­ments by the FDA that they are remo­ving desic­ca­ted thyroid.

An even more impor­tant reve­la­tion in this entire Medco scandal

There is actually an underl­ying mes­sage in the entire Medco fiasco that you should find even MORE dis­tur­bing: the con­ti­nued  pro­mo­tion of T4, aka levoth­ro­xine, as an ade­quate treat­ment of hypothy­roi­dism.  And this is not just a faux pas of Medco, it con­ti­nues to be the igno­rant opi­nion of far too many doc­tors, medi­cal schools and medi­cal boards. All you have to do is look at what has hap­pe­ned in the UK with the Royal College of Phy­si­cians to see the idiocy abounding.

Over 100 years ago, desic­ca­ted thy­roid was found to be an exce­llent treat­ment for hypothy­roi­dism.  I give pre­cise details about the first use of desic­ca­ted thy­roid in Chap­ter 2 in the Stop the Thy­roid Mad­ness book. It worked!

But in the early 1960’s, the tide tur­ned thanks to a batch of desic­ca­ted thy­roid that tur­ned out not to be what it said it was.  This is docu­men­ted in the 1970 Phar­ma­co­lo­gi­cal Basis of The­ra­peu­tics.  And phar­ma­ceu­ti­cals, espe­cially  Knoll Phar­ma­ceu­ti­cals who first table­ted levothy­ro­xine aka Synth­roid in 1955,  jum­ped to pro­mote T4-only as a “new and modern medi­ca­tion”.  (See page 41 and 42 in the STTM book).  And doc­tors and medi­cal schools fell for it hook, line and sinker.

And to this day, levothy­ro­xine con­ti­nues to be pur­por­ted as an accep­ta­ble and logi­cal treat­ment choice for hypothy­roi­dism.  But patients all over the world beg to dif­fer.  T4 medi­ca­tions like Synth­roid, Levoxyl, Eltro­xin, Oro­xine and others simply leave all patients with their own uni­que amount and degree of lin­ge­ring hypothy­roid symp­toms, no mat­ter how high you raise it.

I also find it hugely dis­tur­bing to refer to AACE (Ame­ri­can Asso­cia­tion of  Cli­ni­cal Endoc­ri­no­lo­gists) as if they are the grand poo­pah of kno­wing what’s right for thy­roid patients. They are NOT.  Millions of thy­roid patients who have switched to desic­ca­ted thy­roid, T3, or a combo of T4 and T3 will tell them hands-down that they have got­ten FAR bet­ter results, and most espe­cially with desic­ca­ted thy­roid like the “old” Armour, and now Naturethroid.

Visi­ting nume­rous thy­roid patient groups will reveal how patients feel about Endoc­ri­no­lo­gists they have visi­ted throughout the years.  Their expe­rien­ces are far from flat­te­ring. In other words, with a few excep­tions, thy­roid patients are NOT impres­sed with Endo’s.

Medco’s sta­te­ments are defi­ni­tely a con­cern for patients and range from pre­sump­tous to unfac­tual.  But those sta­te­ments only repre­sent a far wider pro­blem around the world in the medi­cal com­mu­nity.  Cli­ni­cal pre­sen­ta­tion and wis­dom has been thrown out the win­dow by doc­tors.  So patients have to con­ti­nue sprea­ding the word about the far supe­rior treat­ment of desic­ca­ted thy­roid, and their pro­ble­ma­tic expe­rience with T4.

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

***50% off sale!! All STTM t-shirts are now on sale. I love sales. Not only do they help sup­port this site, they are a great way to spread the word. Go here.   Did you know that Laughing Grape Publishing will send a STTM book directly to your doc­tor?

To update again if you’re fee­ling panicky – Armour thy­roid, made by Forest Phar­ma­ceu­ti­cals, is not dis­con­ti­nued, con­trary to what your poorly-informed phar­ma­cist or Synthroid-loving doc­tor tells you.

What is going on is this: about a year ago, something went wrong in the pro­duc­tion of the higher grains, i.e. they didn’t work. Those who had been on Armour awhile and pic­ked up their new presc­rip­tions had their hypothy­roid returning!

And when a Phar­ma­ceu­ti­cal makes a mis­take, they have to jump through hoops with the FDA to correct their manu­fac­tu­ring pro­blem, and it takes a lot of TIME to get back to pro­du­cing their product.

What stop­ped being pro­du­ced this year, as a result of the pro­blem, were the 2, 3, 4 and 5 grain tablets (120 mg, 180 mg, 240 mg. and 300 mg). Ever­yone was now for­ced to use the sma­ller amounts, and the inc­rease in demand put a great strain on quan­tity in your local pharmacies.

Forest now pre­dicts that the lar­ger sizes will return in “late 2008″. So we’ll see. One gal has repor­ted that some of the lar­ger sizes did return to her phar­macy this week, but I’ll need con­fir­ma­tion before saying it’s a fact.

What do you do in the mean­time? Call phar­ma­cies to see what they still have, and expect to drive farther to a phar­macy which still has them in stock. Because many still do. If you don’t find any close enough with Armour, you can get your doc­tor to write out a presc­rip­tion for Natu­reth­roid or Westh­roid, both qua­lity desic­ca­ted thy­roid pro­ducts and very available.

To keep up with the latest from Forest about Armour avai­la­bi­lity, just call 866 – 927-3260 for a recor­ded mes­sage (which will be a repeat of some of the infor­ma­tion you have read right here.)

p.s. Think your doc is open-minded enough to read the STTM book?? You can have the publishing com­pany send one directly to your doc­tor. Click on the SEND A BOOK TO YOUR DOCTOR.