The FDA has spoken

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.

33 Responses to “The FDA has spoken”

  1. Jay

    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. 🙂

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  2. Jay

    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.)

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  3. Tami

    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?

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  4. Linda

    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.

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  5. Dawn

    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

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  6. Ruth

    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

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  7. John

    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?

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  8. Wynnell Nowell

    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

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  9. Sharan Devoto

    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.

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  10. Ginger

    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.

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  11. Cathy

    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.

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  12. Dia

    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?

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  13. kendra

    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.

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  14. Nancy

    ‘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.

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  15. Rainbow

    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!

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  16. Siobhan

    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.

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  17. Donna

    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.

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  18. Nikky

    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.

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  19. Bev

    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

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  20. S

    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.

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  21. SMc

    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.

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  22. Rob

    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

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  23. guiber_garcia

    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. )

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  24. Alice

    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.

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  25. David Jackson

    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.

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  26. Heidi

    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.

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  27. Elaine

    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.

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  28. Cynthia

    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.)

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  29. don carter

    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

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  30. Cathy

    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

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  31. Monika

    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…. 🙂

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  32. Susan M

    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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  33. Lisa A. Rodarte

    Janie,

    Since there are so many of us hypothyroids on here and on fb and in yahoo groups, how about going into http://www.change.org and start a petition about natural thyroid hormones and FDA and Insurances not covering them as every person that signs will send emails to all the people involved in FDA or can help in making changes with FDA etc…. Let me know what you think ….

    Reply

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