fda tags

As a thy­roid patient who was pro­foundly har­med by the use of Synth­roid and Levoxyl in the treat­ment of my hypothy­roi­dism, and as an acti­vist who sees this same harm­ful truth with poten­tially millions of other patients, I find this recent news interesting.

But you gotta won­der if they will be wea­ring noise reduc­tion head­sets and ear plugs…or not…when it comes to the scan­dal of synthe­tic T4-only medi­ca­tions.  Will they?

Just today, the U.S. Depart­ment of Health and Human Ser­vi­ces and the Food and Drug Admi­nis­tra­tion (FDA) announ­ced the Safe Use Ini­tia­tive, “a pro­gram aimed at redu­cing the like­lihood of pre­ven­ta­ble harm from medi­ca­tion use”.

Sta­te­ments I glea­ned from this ini­tia­tive include:

1. Today, tens of millions of peo­ple in the Uni­ted Sta­tes depend on presc­rip­tion and over‐the‐counter (OTC) medi­ca­tions to sus­tain their health — as many as 3 billion presc­rip­tions are writ­ten annually. Too many peo­ple, howe­ver, suf­fer unne­ces­sary inju­ries, even death, as a result of pre­ven­ta­ble medi­ca­tion errors or misuse.

2. Although FDA and many other sta­kehol­ders have been wor­king to improve how the health­care sys­tem mana­ges medi­ca­tion risks in the Uni­ted Sta­tes, it is widely recog­ni­zed that more needs to be done to pro­tect the public from pre­ven­ta­ble harm from medi­ca­tion use.

3. Medi­ca­tions offer great bene­fit, but they come with risks. Whe­ne­ver medi­ca­tions are not used opti­mally, risks of harm can inc­rease significantly.

4. FDA pro­po­ses to iden­tify, using a trans­pa­rent and colla­bo­ra­tive pro­cess, spe­ci­fic can­di­date cases (e.g., drugs, drug clas­ses, and/or the­ra­peu­tic situa­tions) that are asso­cia­ted with sig­ni­fi­cant amounts of pre­ven­ta­ble harm.

This ini­tia­tive is actually far broa­der than what I glea­ned above, and also invol­ves self-abuse, expo­sure of dan­ge­rous medi­ca­tions to chil­dren, dire side effects, and more. Five areas are also spe­ci­fi­cally tar­ge­ted:  Con­su­mer medi­ca­tion infor­ma­tion (CMI), Medi­ca­tion dosing devi­ces, Ace­ta­mi­nophen toxi­city, Alcohol-based sur­gi­cal preps, and Medi­ca­tions in vials. You can read more in the fact sheet.

But if the FDA is going to do their job with this ini­tia­tive, or do their job ove­rall, you have to won­der if they will lis­ten to and inc­lude the pro­blems asso­cia­ted with being trea­ted with a T4-only medi­ca­tion as expe­rien­ced by millions of patients world­wide. Con­ti­nuing symp­toms of hypothy­roi­dism while on this ina­de­quate treat­ment is wides­pread and dama­ging for many, cau­sing hands reaching deep in poc­kets to pay for nume­rous doc­tors appoint­ments, besi­des anti­de­pres­sants, anti-anxiety meds, blood pres­sure meds, sta­tins, cor­ti­sol meds for adre­nal fati­gue, and other medi­ca­tions which we would have never nee­ded, and would have been pre­ven­ta­ble, if we had been on natu­ral desic­ca­ted thy­roid like Natu­reth­roid or Westh­roid in the first place.

Many patients on thy­ro­xine, T4-only medi­ca­tions will also report actual hos­pi­tal visits due to the side effects of a poor treatment.

In other words, thy­ro­xine aka levothy­ro­xine aka T4 treat­ment has been an unsafe and harm­ful treat­ment, cau­sing millions to suf­fer unne­ces­sary inju­ries and side effects for over 50 years of its use­less and popu­lar use.  It fits the Safe Use Ini­tia­tive. Or at the very least, it calls for the FDA to lis­ten to patient expe­rience with this lousy choice to treat hypothy­roi­dism.

Lis­ten to us, FDA. Lis­ten and be wise.

P.S. See the blog post below about a gene­tic rea­son why so many do lousy on T4.

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.

With all the panic among thy­roid patients of the last seve­ral weeks, we are now seeing light at the end of the current tun­nel of desic­ca­ted thy­roid shor­ta­ges. More reports are coming in by patients that it’s appea­ring on shel­ves at their local phar­ma­cies, inc­lu­ding both Armour and Natu­reth­roid. Sure, it’s a tric­kle com­pa­red to the amount of US patients that need it. But it’s a sign of hope of more to come.

On the CDT (Coa­li­tion for Desic­ca­ted Thy­roid) yahoo group, where patients have been dis­cus­sing the shor­ta­ges and fin­ding pla­ces to get their desic­ca­ted thy­roid, patient Ele­nor gave just one more example:

“After losing “my” Wal-Mart’s last left-over bottle of Natu­reth­roid to some other thy­roid per­son (lucky him or her){wink}, I called around to pharms — and Sam’s Club Pharm two towns over had just got­ten ONE bottle of 60mg Armour in yes­ter­day. (I did also find a CVS that had a bottle and a half of the 90mg Armour — so there are some dribs-and-drabs left around… My doc wouldn’t write for me to get that too…) (YAY!) Emai­led my doc’s nurse beg­ging her to do it right away — which thank­fully she did, so they dis­pen­sed it “to me” and I can pick it up today! Down to three days left in my pos­ses­sion, so … WHEW!”

Ele­nor conc­lu­ded: Still gonna see my doc 5^th Oct and try to order 500 tablets from Canada. I do not EVER want to be scram­bling like this again — for ANY reason…

And we all agree with you, Ele­nor!

Clearly, our current shor­ta­ges were cau­sed by two fac­tors: demand being grea­ter than supply thanks to web­si­tes like Stop the Thy­roid Mad­ness (STTM), forums, groups and others, as well as the remar­kably poor timing by the FDA in cau­sing the only remai­ning gene­ric makers of desic­ca­ted thy­roid to cease production.

And in case you haven’t caught up with what’s going on, you can read a sum­mary of the his­tory about the FDA and regu­la­tions which will explain what we will have to face for desic­ca­ted thy­roid in the future, which is our real challenge.

**JOIN US TONIGHT for our weekly THYROID PATIENT COMMUNITY CALL hos­ted by Janie Bowthorpe. We’ll have an open topic night and perhaps a sur­prise guest (still wai­ting on con­fir­ma­tion on that). Let’s talk about the shor­ta­ges, ways to con­ti­nue trea­ting during this time, and more. NOTE that I have moved up the times by one hour. Just click on the link and you’ll see a count­down of when it starts: 6 pm Paci­fic, 7 pm Moun­tain, 8 pm Cen­tral and 9 pm Eastern.

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.