This past Wednesday, August 26th, I contacted the public affairs division of the Food and Drug Administration (FDA), indicating that I was a writer and patient advocate looking into the status of natural thyroid. I explained that I had several straightforward questions:
- Is the FDA requiring ALL natural desiccated thyroid drugs to go through the new drug application (NDA) process, or only those manufacturers that have already been shut down?
- Is/will an NDA being required for the main drugs in the category: Nature-Throid, Westhroid and Armour Thyroid?
- If an NDA will be required for the drugs still on the market, will these drugs be removed from the market during the NDA process?
- If an NDA will be required for the drugs still on the market, and these drugs will be removed, WHEN would this be effective?
It took several days, but the FDA finally released an official "statement" in response to my question.
The Agency has not conducted a class action against unapproved thyroid products. As a policy matter, however, we do not discuss potential, pending, or ongoing actions except with the firms and individuals who are the subject of those actions. As information about enforcement actions becomes available it is posted on the FDA website.While we waited for the FDA's response, thyroid patients at the Save Natural Thyroid Coalition were themselves calling the FDA's consumer information line -- (888) 463-6332 -- and were being told a variety of things by FDA staff. Some staff at the FDA have said that all natural thyroid was going to be pulled from the market, others said that the FDA denied any involvement at all in natural thyroid, others have said that the measures are currently only applying to the companies already targeted.In June 2006 the Agency published the guidance "Marketed Unapproved Drugs --Compliance Policy Guide" (the CPG). This guidance outlined the Agency's enforcement policies which we believe are well-suited to protecting the public health without imposing undue burdens on consumers or unnecessarily disrupting the market. For additional information regarding the FDA's actions against unapproved drugs, please access our unapproved drugs website at the following link.
What's with all the contradictions? Officially, the FDA leaves the door open to do pretty much anything they want, but doesn't tell us anything that can actually help protect the health of thyroid patients. And then, in one-on-one conversations, their staff are offering all sorts of different scenarios.
Why is the FDA unable to provide clear, specific answers to thyroid patients about this critical issue?
And let's face it, we have a very troubling situation at present:
- Weeks ago, a major "big pharma" insider, Medco, sent a nationwide notice to doctors declaring that the FDA was taking all natural desiccated thyroid drugs off the market, and that doctors should switch patients to levothyroxine drugs
- We currently have an unexplained nationwide unavailability of Thyroid USP, the raw material that is used to manufacture natural thyroid drugs.
- Since the spring, production of three different natural desiccated thyroid drugs -- Biotech, TimeCapLabs and Major -- have been shut down. We know that TimeCapLabs was shut down in response to a publicly available notification letter they received from the FDA. The second-hand information is that Biotech and Major were also shut down by the FDA.
- We have the actual letter the FDA sent to TimeCapLabs, stating that natural desiccated thyroid requires a new drug application (NDA).
- Throughout the U.S., we have dwindling to non-existent supplies of Armour, Nature-Throid and Westhroid on the market, and most patients are now unable to get new or refilled prescriptions for these medications. Given the nationwide shortage of raw material, compounded capsules of natural desiccated thyroid is also unavailable to most patients.
- RLC is saying that it will be at least 90 days before they have any new product (Nature-Throid/Westhroid) to ship.
- Forest, which makes Armour, the most prescribed brand of natural desiccated thyroid, will provide no estimate whatsoever regarding when they expect to have any product available to ship.
Am I being overly suspicious or alarmist? It's possible. Am I, as one FDA person apparently told a caller, just "that lady who is stirring up trouble?" I guess that could be.
But given these highly unusual circumstances, can and should we trust that the FDA has our best interests at heart?
Given that the big drug companies -- who have undue influence the FDA -- stand to benefit financially by getting natural desiccated off the market, should we assume that the lack of a clear answer from the FDA is a positive sign?
Should we all just "wait and see" for three months or more if natural thyroid drugs again become available?
What does the FDA know that they're not willing to tell us?
MORE INFORMATION:
Image: Mary Shomon, clipart.com
It’s time to rally. Let’s challenge ourselves to post as many ideas as we can to enable us to get clarity on this issue. Any MD’s reading this who believe in natural thyroid and prescribe it regularly, thank you for your continued advocacy. Any patients whose health will suffer terribly if natural thyroid is pulled from the market, please state your convictions. And for people like myself, who desperately want to feel better and are being denied the right to even try natural thyroid, please contact your local senator and congressperson. I know that is where I am going to start. There is strength in numbers. Let’s show the FDA what we’ve got!
You said it, Mary! You outlined the issues perfectly. Okay, I am going to try and make an appointment with my Congress person next week and also contact some of my doctor and health advocacy connections to get some ideas from them on strategy. Then it is conacting the Secretary of Human Services. They have to know that this money grab is going to kill people and we will not stand for it.
I am unable to get naturethroid in Reno, Nevada, however, I have a source in Idaho who says she has no problem getting Naturethroid there… gee, guess where I am taking my prescriptions? My doctor has no problem issuing an Rx for filling in Idaho.. if you have friends there on Naturethroid call them!
I agree with Mary and Suzanne, but think Congress-people should be added to the ‘list’. How many natural thyroid users are there in *every state in the US*? Including Alaska, Hawaii, and Puerto Rico and Guam even though they’re not states – yet.
Can Congress overrule the FDA? They created the damn bohemoth, I think it’s high time they rein them in. Yes they are all swimming in Pharma money, but can the really ignore hundreds of thousands of letters phone calls, faxes, etc – espeicially if coordinated (ie shut down the congressional phone lines..)?
The BHRT “co-alition” did something similar and got a Congressional “statement” to the effect that “whereas estradiol is a natural hormone, it should not be restricted” Not a law or even a Bill, and I’m not sure the FA backed off. Could we get them to do something similar here?
Are there any Congress-people or Senators who actually *use* natural thyroid (or could be persuaded by Mary and/or someone else sufficiently ‘visible’) to try a switch?
Discusted with the FDA – “F’ing Damned Incompentant!”
Thousands of phone calls are needed. I have a sign in my office now, asking my patients to call. I’ll be e-mailing my patients too. Each thyroid patient, ask your doctor to do the same.
What can we do to advocate for natural thyroid products? Who do we need to contact? I had a severe allergic reaction to Synthroid in March and am still recovering. I recently started on Nature Throid and am finally starting feel better and am thrilled. I CANNOT take Synthroid! I recently reported by reaction to the FDA and I would encourage anyone what has had problems with it but has not reported it, to do so now. What do you all think?
I know now might be a time where one who suffering from hypothyroidism could become discouraged and afraid and give up. We can’t give up however. If it takes thousands of letters/phone calls, that is what we need to do. And Mary can’t do that alone. She is busy at the moment doing research to keep us all informed. It is up to us to help in this process!
I am writing a rough draft letter to my Colorado congressperson and senator (and other relevant legislators and influentials). I will post it when I have finished, and I hope to get feedback to make it sound as articulate as possible. Can people either on or wanting to try natural thyroid in the other 49 states, Puerto Rico and Guam do the same?
Please, any patients of the ‘best thryoid doctors in the US “, use this forum to leave your thoughts, comments and advice. I know I will be contacting the Dr. I was going to see on October 1 to get my script of Nature-throid from, to see if he can help advocate.
We can’t give up hope. It is not over until it’s over. We have to make the best of our due process. There are so many beautifully spoken thyroid patients who truly understand the struggle. And there are so many wonderful doctors who have made a difference in their lives. It’s time to rally! It’s time to streamline! We have to fight for the best quality of life possible. WHO WANTS TO LIVE WELL?! Now let’s get going!
This is absolutely incredible. A perfectly good solution that has been in existence for 100 years – Shame on you FDA and Big Pharma for causing such stress to already stressed thyroid patients – It’s time for a revolution – I for one have had enough of this.
Use The Freedom of Information Act to find out what is going on.
That the government is so obstructionist in its delivery of information on meds already being taken is dictatorial.
I used the mail order pharmacy from my health insurance for the first time this month – I was expecting a bottle of 60 mg tabs and got 120s. I thought the 120s were off the market – is it safe to take them?
The inside story (via my MD) is that there was a problem with the manufacturing of natural thyroid products which was out of the +/-10% potency limit, on the low side. The FDA investigated and found that several manufacturers have been selling thyroid products well below the 10% limit for potency. The FDA is now forcing these companies to stop the fraudulent sales or correct the problem. Additionally, since +/-10% is a huge medically-critical swing in potency, the FDA is making manufacturing companies re-submit applications with a +/-5% limit. I need Armour as much as many of the other’s commenting here, but I also do not like getting ripped off by these companies.
Daren,
Do you mean, resubmit applications as NEW drugs? And did your MD have any idea whether they’d let drugs still be produced in the meantime?
PS – Hasn’t anyone around here seen Animal House?
Walt, I had to ask my husband about your comment, but he explained, and I got it. Sorry, it’s my hypo head! I have written a rough draft letter but maybe it is premature to send it. I’m concerned about why the dilution of Armour happened in the first place. Will the FDA even allow dessicated porcine to be available so natural thyroid replacement can be made consistently and with minimal potency problems?
I have been glued to this site for about the past two weeks, when I was suddenly unable to get my Armour thyroid script refilled. Naive me — I thought the rumours of backorders were a thing of the past! I really appreciate the author of this site and have learned a ton from the fact-based information supplied here. I am, however, concerned that there is an overall bias against ‘big-pharma’ and the FDA that tends to be a bit hypocritical. The first information I came across seemed to blast Forest – manufacturers of Armour – for reformulating their product and causing this whole mess. The main sentiment was ‘how dare they do that and how on earth can they get away with this?’. It seems to me since they are not manufacturing FDA approved drugs they can get away with pretty much anything they want. The more I researched the issue however, the more the slant now seems to be on ‘how dare the FDA come down on these poor manufacturers – we’ve got to rally and stop the FDA from going out of control’. I’m confused, is the problem unregulated manufacturers doing anything they want, or is it the big bad bureaucrats at the FDA? If you recall back in the early days of Synthroid when these exact same things were happening, thank goodness someone (the FDA) stepped in and forced the manufacturer(s) to stabalize the product. Aren’t we looking for the same thing in the natural thyroid arena? I guess I’m an outsider here but it seems to me the answer is just what the FDA appears to be doing — forcing the natural thyroid manufacturers to follow some rules. I know it’s been around for 100 years and predates the FDA, but maybe someone should have explained that to Forest before they decided to fix what wasn’t broken.
This is in response to CF’s comments:
I, along with so many others coming to this site, went through some very tough experiences on our road to wellness. My body reacted negatively to synthetic thyroid medications and my concerns were met repeatedly with condescending endocrinologists who didn’t offer other options besides synthroid and who watched my immune system crash. They are the trained specialists but it was ME who had to insist on labs besides TSH, it was ME who despite ongoing below normal T3 results had to insist on T3 treatment, & it was ME who had to insist on armour when the T3 treatment wasn’t good enough. I go to physicians because I need help and I resent having to educate myself thoroughly on medical treatment/biochemistry just so I can advocate for my health needs.
I have found ways to advocate my needs but it is a fight everytime I need to adjust my thyroid meds. Because of what I’ve been through, I simply don’t trust most docs and have become wary of of pharmaceutical companies, and yes, the FDA. The FDA could have avoided some problems by being up front. Obviously, they are aware of our concerns, but they’ve not put out any statements of reassurance or publicly addressed the shortage and rumors on their website. Add to this, rumors from our pharmacists (who say they are hearing it from their drug suppliers), Medco’s statement, & Major’s press release about discontinuation of desiccated thyroid. Why do these “rumors” keep circulating? And why would I trust the FDA when they have a webpage that says the only treatment for hypothyroid is T4 products, and the chairperson for their committee on endocrinology medication has a relationship with the makers of synthroid? I don’t understand why the FDA would take the desiccated products off the market now when armour has been having production problems. Where did they think consumers were going to get their product? Maybe they simply don’t understand that many of us can’t and won’t go back to synthetics.
I don’t know what to say about Forest. Armour saved my life. But don’t like the reformulation, I don’t like the stress of the shortage, and I do want to know that the pills I’m taking are consistent from batch to batch. (Armour, compared to the generics, has had a good reputation in their product’s stability an I’ve not had problems with fluctuating thyroid levels.) If Forest and RLC can’t afford to do the studies, and they are taken off the market, I (and scads of others) will be in trouble. We remember what life what like before going on desiccated thyroid and it’s frightening to think about going back to those days.
I too am a person whose life ‘has been saved by Armour Thyroid’. I had tried levoxyl for three years and then levoxyl plus Cytomel for one year. My lab values fluctuated quite a bit in that four year span, my hair fell out and what grew back was frizzy and dry and dull. And fell out fast. So I had short hair for years. I tried Armour in June 2005. The effects were nearly instantaneous. I could stay awake all day, I could think and do tasks and see them through. And my hair grew back thicker than it was when i was eighteen. I am now 54. I do not relish going back into hibernation and having no hair again. This is what I have to look forward to if I go back to levoxyl.
It seems to me the only things we can to while we are waiting for answers is to unite; create a GENUINE petition with names and addresses or at least zip codes to demonstrate how many of us need this medication, how many ARE there of us anyway? Secondly each one of use MUST call AND write our congressmen, and our senators. Telling our doctors would never be enough.
I know this is not an easy thing to do for those of us who are foggy-brained, sleepy, and slow-moving without our proper meds, like herding cats. But let’s try. All of us. Go to the Facebook site. Do what it takes.
Dr. Woliner,
Great idea! Have our doctors call their government representatives & ask their patients to do the same. With an attitude like yours, when I am in need of a new doctor, I’ll check you out! Thanks, JO
CF,
You are correct. If American Laboratories, Inc. (ALI), the only North American manufacturer of the active ingredient in prescription Natural Thyroid medications is going to have RCL (drug makers of Naturethroid & Westhroid) rejecting up to 50% of ALI’s product due to inadequate quality standards, then, yes, it would appear that stricter regulation is absolutely needed. We should all want a medication with dosage & potency which is consistent. However, the other question is, should the FDA eliminate the availability of a drug which many depend on while the “new drug approval process is completed? However imperfect the natural thyroid has been, for many of us, the synthetic is just not a medical option.
Dorothy,
Ditto on your story! Your “saga” sounds just like mine in so many ways. It’s maddening to know what has happened to my attitude toward medical professionals in general (and endocrinologist in particular) as a result of the arrogance of these doctors that we were unfortunate enough to encounter in our quest for wellness. Yes, we must educate ourselves, and advocate for what we need. I, too, refuse to go back to Synthroid…
When I first switched to Armour from levoxyl +cytomel, the improvement was immediate. But then I started feeling like the med, about the time of the reformulation, was not working as well, hair started falling out. So I switched to Naturethroid, and am still having the same problem.
My feeling is that there is definitely a problem with the manufacturing of the drug, and if the FDA is working on this, then it is a good thing.
Not sure if Medco or the other big pharma boys are trying to take natural thyroid off the market or not. They certainly are not trustworthy. Medco used to be my mail order pharmacy, but they lost the contract after it was announced on national news that they were throwing away prescriptions. Then Caremark got the contract and they were charging the insurance for brandname drugs while sending cheap generics. So the contract went back to Medco. Their track record is not good.
However, we do want the manufacturing of natural dessicated thyroid to be done right, and I don’t think it is currently.
FDA hasn’t and won’t change . They treated Bextra patients in the same high handed manner as a group of money grubbing lawyers knocked off the market . I accused the FDA of thinking they are the God of medicine . Actually they re a selfish group along with the lawyers .Thyroid patients , give ‘em a fit !
Has anyone found out the safety/potency/quality issues with Armour 120’s?
I have recently been given the 120’s instead of taking 2 of the 60s every day. (As I have used for many years).
While I am currently receiving pain treatments and meds for my back, I have also noticed an awful change in my thyroid symptoms.
These could be manifestations of the pain issues with my back, but now I am not so sure. Especially given the fact that I have this “lump” in my throat.
Please let us know any info you may have on these Armour 120’s.
Thank you
When I was first diagnosed hypothyroid I spent one year on a synthetic thyroid prescription. I lost an inch of height and had severe joint pain. Carrying grocery bags was not fun! Checking urine ph revealed that I was losing minerals – turning that paper BLUE! I discovered a book by Dr. Broda Barnes and had to leave my endocronologist to get a prescription from a wise old GP. I’ve been using Armour Thyroid for 13 years with NO ill effects. FDA, wise up!
My whole problem with this is that they are yanking ANY medicine from the market without notifying the pharmacists and doctors and most of all patients.
I would be just as angry if they were discontinuing Synthroid, or any other medicine without notice, because it takes many months/years for us thyroid patients to get on the right dose of the right kind of medicine (whatever the brand), get stable, and start feeling better. To have to switch to another brand or type of medicine without enough notice to carefully wean ourselves off one medicine and abruptly forced to try another is unconscionable.
This information control game should be illegal. The FDA should be protecting patients! Give us the information we need so if we HAVE to switch, we know ahead of time.
I agree with #14 (CF). One has to question the motives of the natural thyroid manufacturers…..why did they make a formula change when there was nothing wrong with the product? My guess is greed….Armour was a good product until they started messing with it. I think we should have patience. Maybe the FDA IS looking out for the consumer. We won’t know the real story until the dust settles. We should let our congressmen know our distress about this situation. At the same time, I am making an appointment with an endocronologist so that he can help me make the adjustment to a synthetic (ugh) drug for now. We need to take care of ourselves.
For years I have taken Synthroid or Levoxyl but never feeling quite right. My doctor doesn’t like natural methods because she feels you can’t monitor them close enough. So without her knowing, I bought whole dessicated thyroid and supplemented my drugs with it, thinking I’m not getting the benefit of the t3/t4 conversion, and wow, what a difference in how I feel after a couple weeks of doing this. I’m starting to look and feel like my old self. My suspicions were correct. I do better with natural stuff. Synthroid doesn’t do crap for me. I’m writing my legislators…..
There is another way those who depend on Armour, can thumb their nose at the FDA. The FDA has no jurisdiction over shipments of Armour, NatureThroid, etc. to other countries. If you order Armour from Mexico (I know of one pharma website in Mexico which carries Armour), the FDA can’t do much. Customs might intercept 1 out of a few thousand packages, but that’s all that can happen. Armour might also be carried on Canadian pharma websites, but I haven’t checked.
Mary –
I think the only appropriate response to this crisis is LEGAL, and it’s time to consult with some attorneys. It’s time to look into the possibility for a massive class action lawsuit — the FDA’s actions are endangering those whose lives depend on natural thyroid hormone. This is criminal. The individuals at the FDA responsible for making these decisions should be held accountable. Another idea is a massive public campaign (perhaps this could be thousands of patients chronicling their deteriorating health on you-tube) to embarrass the FDA and create public sentiment against their recent actions. It’s unforunate strong tactics have now become necessary.
seems to me the reason they keep prescribing synthroid products is to keep the patients on this rollercoaster, that way both the doctors AND the drug companies make money..you see dr for feeling lousy, they prescribe the levoxyl/synthroid whatever, you still feel lousy so you go back to dr and over and over it continues..no wonder I feel so lousy all the time..if you are feeling well, then you don’t need to see the dr as often right..or is my hypo brain wrong on this theory
I CAN NOT WAIT……..I have no thyroid gland as it was removed 13 years ago because of Hashimoto’s disease that would not respond to any medications or treatments. I am now officially out of my meds and after going through pure Hades for over 8 years trying to get my levels normal with Synthroid, my doctor finally discovered that my body WILL NOT break down and convert the synthetic medication.
I can’t even begin to think about reliving the pain and unreal roller coaster ride of taking Synthroid again. Please fight for these medications to be released for production. Is there any advice you can give me to find any of this medication, even if from Canada, etc in order to keep my levels relatively in control? Thank you so much for your ongoing fight for thyroid patients.
Would any of this dilemma have to do with the sourcing of the porcine product which may come from large factory farms? There is pressure on the Agricultural Dept (mostly ignored by the new Secretary of Agriculture at this time) to close down these massive operations since they could be a major source for the H1N1 virus (swine flu)? Just a thought. There may be some bickering going on at the federal level among several departments;nevertheless, after reading the above comments I now wish to try the natural product. For 18 years I have had a hypo brain. I started with Synthroid and my insurance switched it to Levothyroxine about 8 years ago. Thanks to this site I added a bit of Cytomel and felt much better but certainly could use some zip and a clearer head.
I was on synthyroid for over 2 years & I remained ill. I also read the book by Dr. Broda Barnes which saved my life. I had to travel 3 hours to find a doctor that would understand my problems. I finally got Armour. I have continually argued with every new doctor due to relocation. I can not convert T4 to T3. I am extremely ill on sythroid. If we have a form letter to send to our congressmen, I would a appreciate a copy. WE CAN NOT STAND FOR THIS- irefuse to make myself sick taking synthetic thyroid.
I think we all need to inundate the FDA 1-888-463-6332 with phone calls!!!
Hi Mary-we need a clear plan. If Mary doesn’t have the time to do it (I can’t imagine how you would with everything else you have going on!), we need another person to step forward and offer to lead our efforts. I was recently involved with the Autism Speaks effort with trying to get autism covered for all children by the insurance companies (there is a loop hole that allows them not to cover). We would get updates daily with the list of congress people that we were supposed to call and would literally LIGHT UP their phone lines. They have people who answer the phones interns or something, you don’t get voice mail. We kept pounding them with calls until they have to make a public statement about where they stood on the autism issue. It would only take 15 minutes to call ten places. You give them your comments and move on to the next. Let’s do it quickly before we all slip into a hazy fog from lack of Armour and don’t have the energy to fight.
Erin,
Go to the Save Natural Thyroid Coalition at http://www.savenaturalthyroid.com — and in particular, check out the post at at
http://www.facebook.com/pages/Save-Natural-Thyroid/121680434089?v=app_2347471856&viewas=529245926 which outlines the latest plan.
Dorothy’s comments are exactly what I wanted to say! I have had Diabetes for 19 years and have never been able to control my blood sugars no matter what advice by dozens of endocrinologists over the years I was given. I tried everything, every possible scenario and nothing ever worked. It got to the point where I was giving up. First I was put on antidepressants and have been taking them for about 2 years now. And not only did I have trouble with my sugars but I had awful brain fog, body aches that made me feel like I was dying, and fatigue so overwhelming I had to have several naps a day and all I wanted was sleep. These symptoms got worse, so I went to my endocrinologists once again with my complaints. Her response was “How much antidepressants are you taking? Maybe you should increase the dose.” I have to say that every time I go I get more and more disappointed about the care I am getting, my trust is diminishing more and more.
At this visit, she examined my thyroid and found nodules (apparently are common?!?). I had one of them tested (too big) and the tests were fine but this sequence of events started me on my research. I found that I had every symptom of Hypothyroidism (even though the T4 tests came back fine??). It was my brother who found Armour. I started taking it about 6 weeks ago and I cannot believe the difference in how I feel AND my blood sugars have leveled!! What?? After 19 years I am finally able to control my sugars? Hmmm??? I am very suspicious. My aches are completely gone, I haven’t had a nap since the first day I started taking Armour and My head is CLEAR!! I can think! I haven’t had a job for nine months because I could barely function. And now I am hearing that the FDA is going to take my miracle away?? NO WAY! I have NEVER felt better and now this. I am extremely upset and no, I don’t trust the FDA, yes I think they are hiding information and of course they want us to continue taking synthetics (harmful chemicals for the human body!), why??? Money! Unless the FDA gives us some real answers, I will be suspicious. Although, don’t get me wrong, I am sure that the FDA is stopping a lot of dangerous drugs from being sold to the public but why this? Especially when it is helping so many people. I AM ONE OF THEM. I will swear by Natural Thyroid. My life has been leveled because of my health and now this. I agree, lets not stand for this!
The FDA is created to control the drug production in america for americans. But dessicated thyroid is a natural product that comes from animals and has essentially proven to be a natural “supplement” that outperforms the latest synthetic drugs produced by labs.
In fact this natural supplement product has been used successfully for over 100 years with significantly less risk than the synthetic drugs produced today.
Nature is much more complicated than science and should be respected as such. The FDA should respect the fact that dessicated thyroid has been a historical remedy for hypothyroid conditions that predate the inception of the FDA and related regulations. Thus this “supplement” should benefit from a grandfathering clause of sorts.
If its been in use for 100 years and has been successful for it’s intended purpose, then it’s NOT NEW!!! If the manufacturer cannot benefit from a patent, then it is not new and should not be forced to undergo new drug application.
The suggestion that comes to mind is for the dessicated thyroid companies to go to court to protect their ability to continue to produce this valuable product.
If they need their patients to assist them, I’m sure they can line up thousands of patients who will testify to the benefits of natural dessicated thyroid over the synthetic drugs. My wife recently had her thyroid removed and we are new to the T4/T3 thryroid replacement remedies.
I am sure and certain that this family would gladly pay a premium on top of the price of the product specifically dedicated towards covering legal costs associated with obtaining the court’s judgement that natural thyroid replacement remedies (dessicated thryoid) should be exempt from NDAs…and should be permitted to continue to service the millions of patients who opt for a natural remedie over a synthetic drug! I wonder how many others would be prepared to participate in something like that? If everyone organized behind one or both producers and as a group flooded congress and found a way to reach the President and sought court support…light would shine at the end of the tunnel.
I think it’s pretty darn crazy and irresponsible for any government to discourage the use of natural working remedies in lieu of synthetic drugs that either don’t work or marginally work.
MM
I am aghast after reading these posts. I’ve been using Armour for 5 years after a disaster with Synthroid. I do not know what I will do if I cannot get the drug (fly to Canada with my prescription?). I plan on writing my Sentaor and Congressman and asking them to query the FDA and get some straight answers. In the meantime, between the H1N1, terrorism and now this, it’s kind of hard to sleep at night. Doesn’t the FDA have better things to do than yank this drug w/o notice and w/o a reasonable substitute available?
Now Ive had it. after 6 mos + without natural thyroid and being prescribed sythetic t4 & t3, my tsh has been creeping up- , now 3.8 and just had an episode of Atrial Fib -dehydration related. buut they tried to blam my thyroid I am pointing to a too low dose of t4/t3. and being forced to take synthetic. Do we need to suffer heart problems due to ignorance and other factors? Any hope for the return of natural thyroid?