• fda
• shortages of desiccated thyroid

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.

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.

Hi Mary.

You know, I really don’t think this is a time for us to be sepa­rate, Mary, in our advo­ca­cies.   Seven years ago, I went a dif­fe­rent direc­tion that I felt was impor­tant, and still strongly do, as an acti­vist.  That will con­ti­nue because I believe in what I am doing. You don’t have to agree with my stance, but we can make the choice to work together in what is com­mon bet­ween us – sup­por­ting the use of desic­ca­ted thy­roid and hel­ping others with the shortage.

As I see it, Mary, we each have a won­der­ful legacy. You will always be appre­cia­ted for your work as much as many appre­ciate my work. That will never be taken away.

So why not be uni­ted in this fight, Mary, wor­king together to sup­port patients during this shor­tage.  Thy­roid patients need us.

Janie

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.

With the recent blog post by health wri­ter Mary Sho­mon con­cer­ning Dr. Sid­ney Wolfe’s new 4-year term with the FDA’s Drug Safety and Risk Mana­ge­ment Advi­sory Com­mit­tee, there has been much brooha and fear-mongering on thy­roid patient groups.

Why? Well look at it this way. This is a man of sta­ture. He is an MD, an Adjunct Pro­fes­sor of Medi­cine, the direc­tor of Public Citizen’s health research group which pro­mo­tes drug safety and public health, and edi­tor of the news­let­ter Worst Pills, Best Pills, and since August of  ’08, a mem­ber of the Drug Safety Com­mit­tee.  He also has a resume a mile long.

Yet in spite of his see­mingly caring acti­vism for our health and well-being, and his immense expe­rience and edu­ca­tion, he is clearly and com­ple­tely off-base about Armour and other desic­ca­ted thy­roid presc­rip­tion drugs.

For exam­ple, as as edi­tor of the Worst Pills, Best Pills news­let­ter,  Wolfe dec­la­red Armour desic­ca­ted thy­roid as a “Do Not Use” pro­duct because it is not ade­qua­tely gua­ran­teed to pro­vide appro­priate blood levels of thy­roid hor­mone and relia­ble alter­na­ti­ves are avai­la­ble”. (Gee, funny how our expe­rien­ces are com­ple­tely other­wise.…)

Then in the May 2003 issue (of which you have to have a paid presc­rip­tion to read), he wrote an article tit­led  “Do Not Use! Natu­ral or Desic­ca­ted Thy­roid (ARMOUR THYROID) For Thy­roid Hor­mone Repla­ce­ment The­rapy.” In that article, the clue­less Wolfe sta­ted that he sup­por­ted The Ame­ri­can Thy­roid Association’s sta­te­ment “There is no evi­dence that desic­ca­ted thy­roid, a bio­lo­gi­cal pre­pa­ra­tion, has any advan­tage over synthe­tic thy­ro­xine.” (I guess millions of us and our impro­ved hear­trate, sta­mina, cho­les­te­rol, depres­sion and more…aren’t evi­dence?)

He then pro­po­ses that Armour is mostly presc­ri­bed for weight loss, is a niche mar­ket for the unsc­ru­pu­lous, and conc­lu­des with “if you are offe­red natu­ral thy­roid hor­mone repla­ce­ment treat­ment for any rea­son, this is a red flag and you should get a second opi­nion.” In a let­ter to con­su­mers, Wolfe and Public Citi­zen state that that T3 is only nee­ded from con­ver­sion and is pre­dic­tably found from con­ver­sion, that the T2 and T1 also found in desic­ca­ted thy­roid has essen­tially no acti­vity, that desic­ca­ted thy­roid is an unpre­dic­ta­ble mix­ture, that is has no pre­dic­ta­ble bio­lo­gi­cal acti­vity…plus so many more com­plete and total inac­cu­ra­cies based on “inte­llec­tual head chat­ter” not on obser­va­tion and experience.

Thud.

Mary Sho­mon, in 2003, did a bang-up job trying to com­mu­ni­cate with Wolfe, Worst Pills, Best Pills, and Public Citi­zen about the inac­cu­ra­cies of their beliefs and statements…basically to no avail. The TRUTH is here, and in more detail in Chap­ters 1 and 2 in the STTM book which are enligh­te­ning those rea­ding it all!

So we are left won­de­ring, six years later, what his four-year appoint­ment to this com­mit­tee will mean. But let’s make a few things quite clear to con­trast some of the fears going on and expres­sed on thy­roid groups:

1) Armour is not being ban­ned.
2) Wolfe is one of a current 9 mem­bers of this com­mit­tee. Wolfe is not “the com­mit­tee”.
3) Wolfe and seven others currently have voting rights. He is the only “Con­su­mer Repre­sen­ta­tive”.
4) There are still six more vacan­cies.
5) The com­mit­tee is NOT the power. They simply make recom­men­da­tions. And his­to­ri­cally, the FDA can be slow to act on their recom­men­da­tions, or doesn’t follow them at all (which is a GOOD thing when it comes to a SAFE and EFFECTIVE medi­ca­tion like desic­ca­ted thyroid).

So what can you do? I cha­llenge you to follow and act on the below, which puts our ener­gies into com­mu­ni­ca­tion, not fee­ding the ego and power of a mis­gui­ded man with our overtly expres­sed fears as if they have actually come to pass :

1) Remem­ber 1 – 5 above. Armour is fully avai­la­ble. Keep the facts straight, and fear-mongering down.

2) STTM has a power­ful and gro­wing page of tes­ti­mo­nies of those who switched to desic­ca­ted thy­roid.  Are you in there? If not, you need to be. This web­site currently has a huge audience. It’s noti­ced by doc­tors all over the world, as is the STTM book, which is YOUR book of YOUR expe­rien­ces,  which is also being orde­red by doc­tors. Use the Con­tact Me form at the bot­tom of that page.

3) Tell your expe­rience with Synth­roid or other thy­ro­xine medi­ca­tions at the follo­wing web­si­tes:  www.rateadrug.com,  www.drugs.com,  www.askapatient.com They don’t inc­lude any of the desic­ca­ted thy­roid meds yet, but you can tell of the nega­tive expe­rien­ces with all the T4-only drugs, inc­lu­ding adre­nal fati­gue if you fell into that, and all your lin­ge­ring thy­roid symp­toms.  The above links will take you to their Synth­roid page – you can search for the other T4 meds.  Remem­ber to men­tion Armour or other desic­ca­ted thy­roid meds and how they have hel­ped you!! Update: thy­roid patient Gina found the drugs.com Armour page: http://www.drugs.com/comments/thyroid-desiccated/armour-thyroid.html

4) Report your T4-only expe­rience to Med­Watch, the FDA’s  pro­gram for repor­ting pro­blems.  You will see an Online Repor­ting Form to down­load. Don’t fail to men­tion which pro­blems were remo­ved or greatly impro­ved when you switched to Armour, or the fact that you now have to deal with adre­nal fati­gue thanks to the ina­de­quacy of T4-only treat­ment. You can also call 1 – 800-FDA-1088, but remem­ber: your call is not to draw atten­tion to Wolfe’s opi­nions! It’s to draw atten­tion to how lousy a treat­ment T4 is as com­pa­red to how much bet­ter Armour has been.

5) Go to my article tit­led Synth­roid Sucks: the Rall­ying Cry of Thy­roid Patients vs. Clue­less Doc­tors and com­ment on this article, inc­lu­ding men­tio­ning what Armour, Natu­reth­roid or other desic­ca­ted thy­roid did for you. Rate it as well. Both keep this article in the media and in the eyes of others.

6) Go to www.medications.com where patients ask ques­tions and YOU can ans­wer, men­tio­ning YOUR expe­rience and how much bet­ter desic­ca­ted thy­roid has been. Clic­king on that will take you to the Synth­roid patient ques­tions. Ans­wer them. Be care­ful with links – they may not catch them at first, but will remove them if they do.  You can men­tion web­site names, tho, like Stop the Thy­roid Madness.

7) Send peo­ple here to follow all these steps. Power is in numbers!

8 ) Use the follo­wing web­site to email or write your sena­tors and repre­sen­ta­ti­ves: http://www.visi.com/juan/congress/ THEY DO READ THEM. And they will remem­ber this!  Here’s a tem­plate let­ter you can use:  www.stopthethyroidmadness.com/template-letter-to-your-senator-or-representive/

If you have other ideas and pla­ces to write or call, add your com­ment to this post. Remem­ber,  put your power in com­mu­ni­ca­tion! LOTS of communication.

P.S. Did you know that the Ame­ri­can Thy­roid Asso­cia­tion, in coo­pe­ra­tion with the Ame­ri­can Asso­cia­tion of Endoc­ri­no­lo­gists, together sup­port January as “Thy­roid Awa­re­ness Month”…which is sup­por­ted through an unres­tric­ted grant from Abbott Labo­ra­to­ries, the makers of Synth­roid?? Major UGH.