fdaimageJust 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.


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32 Responses to “The FDA has spoken”

  1. Jay said:

    Aug 28, 09 at 2:39 pm

    Des­si­ca­ted Thy­roid has been used suc­cess­fully for over 100 years.

    The ear­liest oral treat­ment for hypothy­roi­dism con­sis­ted of thy­roid extract. George Red­mayne Murray of the Uni­ted King­dom first desc­ri­bed treat­ment of myxe­dema with thy­roid extract in 1891, and published a desc­rip­tion of long-term suc­cess­ful treat­ment (28 years) of a patient with myxe­dema (severe hypothy­roi­dism) in 1920. His treat­ment was quickly adop­ted in North Ame­rica and Europe. The first recor­ded Ame­ri­can use dates to 1891 by a woman who was still taking it 52 years later at 84 years of age.

    http://en.wikipedia.org/wiki/Desiccated_thyroid_extract

    (From Janie: cough. I’m the one who put that on that Wiki thy­roid extract page. :)

  2. Jay said:

    Aug 28, 09 at 2:58 pm

    Sorry,

    But I would not say the “FDA has Spo­ken” here. When the Govern­ment speaks, they put out offi­cial let­ter rulings, regu­la­tions, or sends noti­ces to com­pa­nies that are usually published in newspapers.

    The FDA is a huge place.….they are wor­king on TONS of other issues besi­des thy­roid, and not ever­yone wor­king there knows Every detail of the thy­roid issue.

    I would be very sur­pri­sed to see Armour or Westh­roid go through a lengthy and costly new drug appli­ca­tion process.

    (From Janie: I agree about the offi­cial notice. This post just nee­ded good short sub­ject line since the mes­sage came from an FDA pharmacist.)

  3. Tami said:

    Aug 28, 09 at 3:07 pm

    This is very frus­tra­ting to me — I had to stop my meds to do the Uptake and scan back in April — by the time of the scan, was over 100 TSH and I didn’t res­pond well to the new Armour. I just switched to Naturth­roid and now can’t get anything. In addi­tion, because being so hypo, I am now seve­rely ane­mic and found that to correct one, I have to correct the other. How can I do this if I can’t get thy­roid meds?

  4. Linda said:

    Aug 28, 09 at 3:09 pm

    I really don’t see this as good news at all. If RLC and Forrest are requi­red to con­duct cli­ni­cal trials, they may decide that it is no lon­ger cost effec­tive to even con­ti­nue making it. Cli­ni­cal trials cost a lot of money. And it is just ludic­rous to sug­gest that a drug that has been safely used for over 100 years — and has tons and tons of docu­men­ta­tion during that time — would need cli­ni­cal trials. If the FDA wants to go after unsafe drugs, they need to go after those who pass out anti­de­pres­sants like candy. Or all the drugs adver­ti­sed ad nau­seum on TV every night that have LONG lists of side effects. To me, requi­ring cli­ni­cal trials is a very bad omen. I would like to hear what RLC and Forrest have to say about it.

  5. Dawn said:

    Aug 28, 09 at 3:17 pm

    I heard that it is hugely costly to go through this pro­ce­dure and sma­ller com­pa­nies might not find it worthwhile for des­si­ca­ted thr­yoid and may just cease to pro­duce it. That would be the worse case sce­na­rio pro­bably, howe­ver it is pos­si­ble.
    RLC labs MUST be still Grand­fathe­red surely?
    Will the vets still be able to get Westth­roid for dog­gies? Woof!

    lotsa luv
    Dawnx

  6. Ruth said:

    Aug 28, 09 at 3:31 pm

    I simply do not trust the FDA when it comes to their alle­gance to Big Pharma. The effi­cacy of des­si­ca­ted thy­roid is, as has been sta­ted, is shown in the num­ber of peo­ple using the pro­duct with sig­nif­cant suc­cess. When the FDA man­da­tes that com­pa­nies do research stu­dies for a pro­duct that does not drag in billions we can expect the pro­duc­tion to stop. That is what they want. Keep us on the synthe­tic T4, fat, tired, and sick. Then we will pas­si­vely let then des­troy all of us. UGH

  7. John said:

    Aug 28, 09 at 3:54 pm

    This word may not be the last word as others have said. There are many times that the FDA acts based on “Citi­zen peti­tions.” The rea­son for the quo­tes is because many times these peti­tions come from huge com­pa­nies. an exam­ple is wyeth making a citi­zen peti­tion against Bio iden­ti­cal hor­mone res­to­ra­tion. to me citi­zen peti­tions should come from a per­son who is a citi­zen. Did abbot put out a “citi­zen peti­tion” on this subject?

  8. Wynnell Nowell said:

    Aug 28, 09 at 4:01 pm

    I want to know what I am sup­po­sed to do until they get their cre­den­tials retur­ned to begin pro­duc­tion again? I will run out of my Armour in about 15 days and I have been told that I will not be able to obtain any until around Octo­ber. So what do I do? anyone have any ideas?
    Thanks!!!!!!! Wyn­nell Nowell

  9. Sharan Devoto said:

    Aug 28, 09 at 4:09 pm

    I vaguely remem­ber about 10 years ago synth­roid had to go through a new drug appli­ca­tion pro­cess too. At the time I was on synth­roid, fee­ling crappy, my doc­tor wouldn’t presc­ribe Armour and I was deligh­ted that synth­roid was in trou­ble. Howe­ver, synth­roid is still around. Hope­fully armour will have the same outcome.

  10. Ginger said:

    Aug 28, 09 at 4:40 pm

    Has anyone had strange symp­toms switching from Synthroid(.275)to Armour(135 mg.)? I have been very lethar­gic, emo­tio­nal and having heart pal­pi­ta­tions. Having labs next week but get­ting mixed sig­nals from my symp­toms as to whether I’m get­ting too much or too little thyroid.

  11. Cathy said:

    Aug 28, 09 at 5:19 pm

    Gin­ger – don’t panic, but do tell your doc­tor ASAP. I had to take it slow switching over to Armour (my body didn’t adjust imme­dia­tely to the T3 and I had rapid pulse, etc.). We knoc­ked down the dosage to a 1/4 grain (plus some synthe­tic T4) for awhile and after about 3 months we ram­ped it back up again with no problem.

    Wyn­nell – talk to your doc­tor and call around to some dif­fe­rent phar­ma­cies (espe­cially com­poun­ding ones). You may find a poc­ket of natu­ral thy­roid meds in stock somewhere that you can make work for you with your doctor’s gui­dance on dosage. If that doesn’t work try to get a presc­rip­tion for Cyto­mel (synthe­tic T3) along with some Synth­roid or other synthe­tic T4. Not ideal, but it should be bet­ter than the Synth­roid alone. Again, your doc­tor should be able to work out a plan with you that will work for the short term. There is a great article on Mary Shomon’s thyroid.about.com site that details what to do during the des­si­ca­ted thy­roid shor­tage. Goo­gle should turn it up for you.

  12. Dia said:

    Aug 28, 09 at 5:26 pm

    What about THYROID-S is from Sri pra sit Pharma Co., Ltd. in Thai­land .…might not that be an alter­na­tive until this mess is straigh­te­ned out? It’s natu­ral desic­ca­ted thy­roid and made by a repu­ta­ble company.

    Anyone tried it?

  13. kendra said:

    Aug 28, 09 at 5:36 pm

    Gin­ger
    you may be on the new Armour which is less effec­tive than the old. I have switched to Natu­reth­roid and it’s taken over a month to feel bet­ter and hope­fully as good as I felt on the old Armour! The bad news is that you cant get Natu­rethoid for another 3 months, Howe­ver you can get Efra and Thyroid-s at
    phar­ma­cies on line, you will just need your doc­tor to fax a prescription.

  14. Nancy said:

    Aug 28, 09 at 5:45 pm

    ‘If’ cli­ni­cal trials are requi­red, besi­des the cost, not ever­yone will be part of the trials or get­ting the real thing.. So that is still a huge pro­blem. If cli­ni­cal trials go on, then the hor­mone would not be avai­la­ble to the public until they ‘study’ the results and then decide if they want to approve the hor­mone or not.
    So if this is the case, this is not going to be ade­quate for those like myself that is depen­dant on the natu­ral thy­roid hormone.

  15. Rainbow said:

    Aug 28, 09 at 6:15 pm

    Since “the FDA takes prio­rity actions on medi­ca­tions based on con­su­mer com­plaints,” perhaps some con­tact infor­ma­tion could be pos­ted so that we can make our com­plaints known?

    Per­so­nally, I’ve switched to T3 only medi­ca­tion (Cyno­mel — gene­ric of Cyto­mel) until pro­duc­tion gets back on track. I’ll do just about anything to stay away from Syncrap!

  16. Siobhan said:

    Aug 28, 09 at 6:31 pm

    There is no way these com­pa­nies will sur­vive an NDA. Forest will just give up, and RLC told someone else (pos­ted on the Face­book group) that it would be too expen­sive for them. So, I wouldn’t be too hope­ful yet. If they’re put­ting them this NDA pro­cess, it’s not good news — not to men­tion it’s VERY lengthy.

  17. Donna said:

    Aug 28, 09 at 6:32 pm

    I think Jay hit the nail on the head. The FDA can drag this out for years with a new drug appli­ca­tion and maybe even put these manu­fac­tu­rers out of busi­ness in the process.

    Ever­yone affec­ted should write to the FDA, their sena­tors and con­gres­sio­nal repre­sen­ta­tive. The wait and see approach will get us no where.

  18. Nikky said:

    Aug 28, 09 at 7:31 pm

    Is there a pos­si­bi­lity here that all of the com­plaints about how horri­ble the “new” Armour was trig­ge­red this reac­tion from the FDA? While horri­ble com­mu­ni­ca­tion is obvious, maybe they are just reac­ting how they should be with Armour’s new for­mu­la­tion cau­sing so many problems.

  19. Bev said:

    Aug 28, 09 at 9:38 pm

    Call the FDA now and let them know your con­cerns and need for desic­ca­ted thy­roid avai­la­bi­lity for your life and your health in the coming months and years. When Synth­roid was going through the new drug eva­lua­tion for seve­ral years, to be com­ple­ted in Octo­ber,.… they still were allo­wed to keep their pro­duct on the market.…why not desic­ca­ted thy­roid drugs?

    UK recently made synthe­tic thy­roid hor­mone the offi­cial drug and it looks like an attempt to do the same thing here with no other options. if you want another option to synthe­tic thy­roid hor­mone speak up now.

    888 – 463-6332

  20. S said:

    Aug 28, 09 at 10:45 pm

    Linda and Donna, those were exactly my thoughts. To me, the requi­re­ments for expen­sive and lengthy “cli­ni­cal trials” and new drug appli­ca­tions to sud­denly “prove” the effi­cacy of an inex­pen­sive drug that’s wor­ked for hun­dreds of years just pro­ves to me that the FDA is full steam ahead with its agenda to take this medi­ca­tion off the mar­ket. I am not sure how or why so many thy­roid patients are put­ting their faith into the FDA at this point. Any thy­roid patient who has read the rele­vant books, researched their con­di­tion, etc, knows that the FDA and Big Pharma pushes synthe­tic drugs through direct and covert means. This is just one of their covert tac­tics. They are slowly blowng the natu­ral des­si­ca­ted thy­roid mar­ket out. They know that Forest will not bother filing for an NDA. RLC will try to abide by requi­re­ments, but it will ulti­ma­tely turn out to be too costly and headache-inducing…in other words, not worth the invest­ment. With both major manu­fac­tu­rers out of the mar­ket, synthe­tics will then swoop in to see­mingly “save the day.” Now is the time to orga­nize. We do not have a choice if we want this drug to remain avai­la­ble to us. The FDA is coun­ting on us bur­ying our heads in the sand. There is no hope in this situa­tion if we simply wait for things to work them­sel­ves out. They have pro­ven, already, through their sto­ne­wa­lling (when peo­ple have been trying to get offi­cial com­ments from them regar­ding this fiasco) that they are simply buying time. And they will buy enough time as it takes to see that all Ame­ri­can natu­ral des­si­ca­ted thy­roid manu­fac­tu­rers go under.

  21. SMc said:

    Aug 29, 09 at 12:03 am

    While Con­gress is on break, it might be pos­si­ble to try to meet per­so­nally with your elec­ted offi­cials in Con­gress while they are sup­po­sedly home in their dis­trict and (sup­po­sedly) inte­res­ted in hea­ring from their cons­ti­tuents about health reform. IF they are sin­ce­rely con­cer­ned about health care, then they should be con­cer­ned about this.

    I think I still have a very long list of email addres­ses for many news sour­ces, inc­lu­ding tv, news­pa­per, inter­net sites, various repor­ters, alter­na­tive news, etc… that someone had put together when wor­king on another issue.

    This has not been repor­ted anywhere. It needs to be in the news, espe­cially since it can cause very serious health problems.

  22. Rob said:

    Aug 29, 09 at 12:06 am

    While the FDA might have some grounds for revie­wing the effi­cacy of Armour thy­roid or requi­ring a new appli­ca­tion, etc., the agency’s con­duct in this mat­ter is irresponsible.

    With thou­sands of patients depen­dent on this phar­ma­ceu­ti­cal, there is simply no jus­ti­fi­ca­tion for impo­sing a shut­down on its manufacture.

    Ins­tead, what is requi­red is that with only a sin­gle pro­vi­der of the raw mate­rial (Ame­ri­can Labo­ra­to­ries, Inc.), the FDA should have pro­vi­ded the com­pany as well as manu­fac­tu­rers such as Forest Labs, etc., a pro­vi­sio­nal license to con­ti­nue pro­du­cing Armour thy­roid sub­ject to cer­tain con­di­tions. This is a time-honored pro­ce­dure for brin­ging sole sup­pliers of a critically-needed com­mo­dity into com­pliance. To do other­wise is inexcusable.

    This issue needs to be imme­dia­tely brought before the gene­ral public and our repre­sen­ta­ti­ves in Con­gress. They should be urged to con­tact Health and Human Ser­vi­ces Sec­re­tary Kath­leen Sibe­lius and request that she ask the FDA to take more mode­rate steps and imme­dia­tely reo­pen the supply chain.

    I’ve already begun wor­king on it from this end.

    Rob in Arizona

  23. guiber_garcia said:

    Aug 29, 09 at 2:29 am

    I am sorry Jamie, but the hope you speak of is a ‘PASSIVE’ trus­ting hope that the pharmas/vetting agen­cies will do the moral thing. It is much the same hope that a gaze­lle has that a Lion will not eat it once the Lion has it in it’s clutches..Nothing per­so­nal, but this is a ‘fools hope’, the CODEX Ali­men­ta­rius pre­ci­sely intends to ‘slow cook’ away ALL natu­ral food sup­ple­ments, and esta­blish inter­na­tio­nal bor­der control..So at the very least all those on STTM etc..who had to bypass the dino­saurs in mains­tream medi­cine, and who order Armour freely WILL BE PREVENTED, AS IT IS ONLY THAT ARMOUR/IT’S ALTERNATIVES, HAVE BEEN USING THE ‘FOOD SUPPLEMENT’ (ANIMAL DERIVATIVE) LABEL to be sold/bypass bor­der controls..You WILL HAVE TO HAVE A DOCTORS CERTIFICATE, and Codex pre­ci­sely intends to shut down (rela­ti­vely small) health sup­ple­ment manu­fac­tu­rers, and (like­wise) armour manufacturers..So it’s 1.you’ll need a doc­tors cer­ti­fi­cate (a great no. of those on STTM couldn’t get this)
    2.Even with the doc’s cer­ti­fi­cate it’s likely Armour pro­duc­tion will be era­dic­ted due to the huge costs invol­ved, the big pharma inte­rest is purely with synthe­tics and they have the money to do ‘research’ (coo­king the books in fact is what they do).
    The time of PASSIVE HOPE HAS PASSED, GET REAL EVERYONE, GET ACTIVE AND FIGHT FOR YOUR RIGHTS, THAT IS THE ONLY CHANCE WE HAVE NOW!

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

    (From Janie: I think I’m being misun­ders­tood. We do have to fight. But to call for hope on my part was not also calling for passivity…because you are correct in your impli­ca­tion that we’d be eaten like a gaze­lle. I’ve been con­cer­ned about the “crowd men­ta­lity”, for lack of a bet­ter word, where the fear of one or two indi­vi­duals based on spe­cu­la­tion beco­mes blown into huge all-encompassing crowd fears that go in too many direc­tions and become irra­tio­nal panic – i.e. emo­tion and actions not based on facts of the moment, but emo­tion and actions dri­ven by nega­tive spe­cu­la­tion. The lat­ter can back­fire; the for­mer can be more pro­duc­tive. But that’s just my obser­va­tion, and in no way do I disa­gree with you that we all have to be proac­tive in this. )

  24. Alice said:

    Aug 29, 09 at 4:55 am

    Well from seeing how upset peo­ple were at Forest Labs for chan­ging Armour I can ima­gine hor­des of peo­ple calling the FDA and com­plai­ning so obviously they would take some type of action. I’ve seen com­ments from peo­ple all over the inter­net screa­ming for action to be taken against Forest for chan­ging Armour and not telling peo­ple, now unfor­tu­na­tely it has and has also affec­ted RLC Labs. Hope­fully the out­come will be posi­tive in that they can reins­tate their old for­mula and with an FDA appro­val and they can’t just change the for­mula again they way they have done.

  25. David Jackson said:

    Aug 29, 09 at 7:35 am

    Kno­wing how govern­ment regu­la­tion works and how the FDA tends to favor drug com­pa­nies, I would not at all be sur­pri­sed to hear that the two older com­pa­nies in ques­tion saw that NDT was on the rise and got the FDA to eli­mi­nate their com­pe­ti­tion for them. The big com­pa­nies ask for regu­la­tion to “pro­tect the repu­ta­tion of the industry” or “pro­tect the con­su­mer” and engi­neer the requi­re­ments such that new­co­mers are barred from entry and sma­ller com­pe­ti­tors can’t afford to meet the new stan­dard either.

  26. Heidi said:

    Aug 29, 09 at 8:06 am

    Hey folks, I have Crohn’s and went through MANY trials at Mass Gene­ral and the pro­cess to get something appro­ved takes a LONG time. I agree with Ruth com­ple­tely, “I simply do not trust the FDA when it comes to their alle­gance to Big Pharma.” she IS right!!

    My cou­sin is a top sales rep for John­son and John­son and he sells the One Touch Moni­tor for dia­be­tics. He has told me some of the sec­rets of Big Pharma and how doctor’s get kick­backs for pushing cer­tain medi­ci­nes, etc. I have to say that Donna, Jay, Nancy and Siobhan are all correct, howe­ver, “S”, SAID IT ALL through and through!!!!!

    hate to be con­si­pi­racy min­ded, but why do you think this shor­tage hap­pe­ned?? Was there REALLY a shor­tage or did the big pharma’s not like their loss in pro­fit and lean on them to “CREATE” a shor­tage?? Why do you think the refor­mu­la­tion hap­pe­ned? To MAKE peo­ple sick so they would be FORCED to go back to synthe­tic crap like Synthroid!!

    As the peo­ple above men­tio­ned, espe­cially “S” (Her post was right on!!) the FDA and govern­ment BOTH use direct and covert tac­tics and back­door s**t to get their agen­das pushed through. I think VERY SERIOUSLY, that the makers of Synth­roid and the other ones the ENDO’s push didn’t like the fact they were losing money because peo­ple were lea­ving them and like any good “mob” style tac­tic they lea­ned on them etc.
    Look at all the drugs like Vioxx and ALL kinds of other drugs that make MILLIONS (I’m being con­ser­va­tive here!) of dollars for the big pharma com­pa­nies that kill peo­ple!! They get “PUSHED” through by the FDA “because the bene­fits out­weigh the risks” My A** they do!! It’s ALL about profit!!

    Why do you think this web­site was crea­ted?? Thank you Janie !! :) Because peo­ple were not being trea­ted pro­perly because “DOCTORS” are GOD and THEY know best (God for­bid you ques­tion them or ask for something else they become so offen­ded!) and peo­ple were tired of fee­ling like crap and deci­ded I’m going the osteo­pathic way Holis­tic, alter­na­tive etc ) ins­tead of allo­pathic medi­cine ENDO’s mains­tream medi­cal etc. Doctor’s that are alter­na­tive or an Osteo­path treat peo­ple by symp­toms as well as tests, but do not put LAB results before how the patient feels. My doc­tor is a real MD but deci­ded to become more alter­na­tive because he saw how sick peo­ple were and how the drugs they were on were making them sic­ker. He does saliva tes­ting, food allergy tes­ting, etc etc and thinks the TSH is Bull***t!! He TRULY cares about his patients and thinks outside the box!!

    Howe­ver, he gets trea­ted like a pariah by the mains­tream medi­cal com­mu­nity because he doesn’t do things “their way”. When he took the “Hip­poc­ra­tic Oath” HE MEANT IT, most doc­tors are “Hypoc­ri­ti­cal” with their oath or are so naive that they think they are doing the right thing. This, like so many other agen­das will even­tually get pushed through and our hands will be tied.

    Maybe just maybe, I think that the GOOD doc­tors and all of us need to com­plain to the FDA and be asser­tive and proac­tive, maybe not aggres­sive like how I can be, but I’ve HAD to be because some­ti­mes when they push you, YOU HAVE TO PUSH BACK HARDER!! Some­ti­mes they lis­ten some­ti­mes they don’t, when they don’t I DROP THEM and fast!! Whether it’s the FDA, Big Pharma, the Govern­ment and our elec­ted offi­cials, they don’t care what WE want, they care about them­sel­ves and their agen­das. Guiber_Garcia spoke the truth as well and was right on!!.

    I unders­tand Janie’s point though we need facts not nega­tive spe­cu­la­tion and the lat­ter can back­fire. If we all, inc­lu­ding doc­tors in large num­bers, com­plain and are asser­tive and firm, really firm, we might get somewhere. Howe­ver, I’ve seen the money making machi­nes get further than many voi­ces, so be rea­lis­tic but hopeful.

    P.S. Why do they need cli­ni­cal trials any­way, how about inter­vie­wing all of US and seeing our LABS and asking us how we feel on des­si­ca­ted thy­roid?? They don’t NEED to do cli­ni­cal trials, there are millions of us that can give them all the info they need. “Choe sta­ted that the FDA is very aware of pro­blems with Armour and will be loo­king into that even­tually.” Did you feel the smoke being blown up your a** cause I did!!!! Why do you think the pro­blems with Armour hap­pe­ned in the first place?? It’s really NOT cons­pi­racy min­ded to think this way, has anyone seen the movie OUTBREAK, this was based on true events with a little fic­tion thrown in. It’s true folks our govern­ment and the FDA are capa­ble of these things, and are in this for the money not to make us healthier. Sickness/illness are BIG money makers, why would they want something to cure us, then their money goes bye bye, think about it.

  27. Elaine said:

    Aug 29, 09 at 10:38 am

    So, I am curious.…besides DNT com­pa­nies having to prove effi­cacy and safety of their products.…what other presc­rip­tion drugs are being requi­red to go through this pro­cess? Your sta­te­ment doesn’t men­tion WHY the FDA deci­ded that this is neces­sary, only their deci­ded action.

    Perhaps it is to get all presc­rip­tion drugs in the same “cate­gory” so-to-speak? Just wondering.

  28. Cynthia said:

    Aug 29, 09 at 2:05 pm

    Janie,
    I’m not sure what your stand is on this? Are you angry with Forest because they aren’t knoc­king at your door to woo you? I unders­tand that you are one of the best advo­ca­tes for thy­roid patients and it is greatly appre­cia­ted. Howe­ver, for those of us who are gra­te­ful to have found Armour and quite frankly, are doing fine with it, it seems to me that you have a per­so­nal ven­detta out to see the demise of Forest Labs, hence an end to Armour. After all, it was you who sta­ted in your ori­gi­nal web­site that it was Armour which gave you your life back. Armour has been around long before you ever came into the thy­roid pic­ture. Millions are still alive today because of the incep­tion of Armour, when it was the only game in town. Long before Synth­roid or any others for that mat­ter. What is your agenda, if I might ask. Do you want Armour to go away? I’d just like a yes or no ans­wer. Not see­king a debate.

    (from Janie: huh??? Do you think I’d want Armour to go away when I need it as much as you? lol. Perhaps you are con­fu­sing my sta­te­ment about Armour’s refor­mu­la­tion resul­ting in a medi­ca­tion that doesn’t work as well as it used to. So I’d strongly recom­mend you read more on this web­site, becuz you’ll find out a lot about me, which isn’t at all what you describe.)

  29. don carter said:

    Aug 30, 09 at 12:34 pm

    everything i’ve read today is good infor­ma­tion and i am com­mit­ted to voi­cing my opi­nion “to the powers that be”, such as the FDA,etc. DOES anyone have a com­plete list of the companies/agencies that i could write to, and or phone. either pos­ted on this site or e-mailed to me? thanks…don

  30. Cathy said:

    Sep 02, 09 at 12:24 pm

    Can someone please tell us Ame­ri­cans over here in the UK if we have any hope of get­ting Armour (natu­ral desic­ca­ted thr­yoid hormones)outside the USA?

    Like many of you, I am fed up with 7 years of suf­fe­ring from hypo symp­toms and one year of Levothy­ro­xine which is not wor­king. I am des­cen­ding down a slip­pery slope.

    Is it pos­si­ble to buy it off the Inter­net or from an ex-US manufacturer?

    Thank you
    Cathy

  31. Monika said:

    Sep 08, 09 at 9:01 pm

    I agree with Janie’s com­ment about “how” we approach the FDA and medi­cal com­mu­nity about our fight for NDT. It took me three years to con­vince top doc­tors (i.e. Mayo Cli­nic) that I was hypo even though TSH was within range. I finally rea­li­zed that I had to use LOGIC (not emo­tion and crying in their office) to con­vince them I was right. Last year my cho­les­te­rol was 273 (in my 30s) and per their recom­men­da­tion, I went to nutri­tio­nists to get on a diet plan which I found insul­ting since I have been a size 2 most of my life and never nee­ded to diet (mode­ra­tion was my daily lifestyle). It was the nutri­tio­nist that said I was eating too well to have a cho­les­te­rol that high. Still I took all fat out of my diet — even the good fat.

    This year, I went to another top hos­pi­tal and they belie­ved me and put me on Synthy­roid. It did help ini­tially until I got a reac­tion to it 3 weeks into it. Then I went to Armour (my Endo does pre­sen­ta­tions on behalf of Synth­roid but he is great and does not force it on you — I am hoping he tells Abbott Labs [makers of Synth,] that many don’t have a choice and NEED Armour). Anyhow, 2 months on meds and my cho­les­te­rol went from 240 in May to 170 in July?! There was no change in diet or exer­cise. My Endo now belie­ves my symp­tom com­plaints over the phone vs. having me take lab tests to believe me. He is even willing to write my a presc­rip­tion for Thy­roid meds from Canada (him being Cana­dian helps, but he knows I would use Synth IF it worked).

    This is what I don’t get??!! I would hap­pily use Synth IF it wor­ked for ME. But it doesn’t. I am sooo exhaus­ted loo­king for a repla­ce­ment. Armour was AWESOME (I was on the new for­mula — ima­gine what the ori­gi­nal one would have done form me). The Natu­reth­roid did not work for me — the fati­gue came back ins­tantly. So pharma com­pa­nies need to back off and let the patients decide what works for them. I do agree with many of you who think there is a cons­pi­racy. Of ALL the meds I have taken through out my life, local drug sto­res have NEVER called me on why I have stop­ped taking something. Yes, wouldn’t you believe it, last week CVS called me as a “cour­tesy” to see why I have NOT filled my Synth­roid medi­ca­tion. Do you think they called me about the Armour shor­tage and not being able to fill my future presc­rip­tion?! Hell no!! I told the pharma asst. (not her fault, she is just the mes­sen­ger and pro­bably doesn’t know the whole con­tro­versy) that she nee­ded to tell her bos­ses this was an inap­pro­priate call and that the Armour filled AFTER Synth. was an obvious indi­ca­tion that Synth did NOT work for me. So, I DO belie­ved Abbott is out to make money, I do think they want to bump off the com­pe­ti­tion and I do believe the drug retai­lers like Medco, CVS have been bought in. Howe­ver, I think Forest chan­ged the Armour for­mula for cost savings and it back fired. If you read about them in About.com, Forest has been in costly trou­ble with other drugs they make. I think Armour chan­ges was a bad deci­sion and now it has come under the FDA scru­tiny. This is what I have conc­lu­ded based on I what I have read.

    Anyhow, I plan on calling the FDA tomo­rrow to let them know the ORIGINAL Armour works and they have millions of users to pick from for evi­dence. They need to focus on making Forest con­ti­nue to pro­duce the ori­gi­nal drug. If anything, FDA needs to inves­ti­gate why the aggres­sive push for Synth by drug retai­lers and doc­tors? Shouldn’t they be neu­tral? I am care­ful NOT to bash Synth as it works for the other half of hypo patients. I don’t want my expe­rience to impact them. Anyhow, I wish you all best during this shor­tage. I NEVER thought in a million years I would be facing this once my diag­no­sis was correct. Part of me wants to cry and the other laughs about this irony.… :)

  32. Susan M said:

    Sep 19, 09 at 6:46 am

    Where’s a list of con­tacts so maybe peo­ple can be hel­ped SOON? (From Janie: Susan, not sure which list of con­tacts you are refe­rring to?)


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