What's going on with natural thyroid? It's a question we've been asking since the spring, and it has been coming to a head this summer. Here's a recap. Armour Thyroid's manufacturer, Forest, which has been plagued by unexplained product shortages and back orders for the past two years, reformulated Armour product this past spring. While the drug was being reformulated, availability problems forced some patients to switch to the competing natural thyroid drug, Nature-Throid. When the newly reformulated Armour came back on the market, patients complained that the reformulated product was not working as well as before. Some of those patients again switched to Nature-Throid.
Despite the drop in demand for Armour Thyroid, Armour went into unexplained shortages and long term backorders again. At present, most pharmacies around the country do not have Armour Thyroid in stock. Forest, the maker of Armour, has not indicated any date when products will be back on the market.
Following right behind Armour, Nature-Throid and Westhroid, distributed by RLC Labs -- and until recently, manufactured by TimeCap Labs -- went into shortage and backorder. RLC has stated that the reason for the shortages is the increased demand the company has faced as patients switched from Armour to Nature-Throid. An additional factor, however, is that the Food and Drug Administration (FDA) initiated enforcement action against TimeCap Labs, indicating that the natural thyroid they were producing was an "unapproved drug" and subject to the FDA's ongoing "Unapproved Drugs Campaign." TimeCap Labs stopped all natural thyroid drug production. RLC is now working to reestablish production by other means.
At the same time, the Thyroid USP porcine desiccated thyroid that is the raw material for natural thyroid pills and compounded natural thyroid medications, which is made by only one company in the U.S., American Laboratories, was also in an unexplained short supply. The company has reportedly claimed that increased demand has caused their shortages.
Before I left on vacation on August 29th, I was able to obtain a formal statement from the FDA regarding the status of natural thyroid drugs. The statement was vague, but ominous, referring to "unapproved thyroid products," and referring to the FDA's "Marketed Unapproved Drugs --Compliance Policy Guide."
While I was away, the patient movement continued and expanded, and the Save Natural Thyroid Coalition has grown to more than 2000 participants, with ongoing discussions and strategies taking part on both the Save Natural Thyroid website and Save Natural Thyroid Yahoo listserv.
Since returning from my vacation on September 7th, I've been in discussions with physicians, pharmacies, drug companies, lobbyists, scientists, and government officials, etc. around the country -- and the world -- who are intensely focused on the natural thyroid issue, and developing behind the scenes strategies to help protect patient access to natural thyroid drugs.
This is a shifting situation however. Right now, as we all know, the "statements" and conversations from the FDA have been clear as mud. Every day, you get a different story. So we remain faced with several issues:
1. The FDA's Unapproved Drugs Campaign appears to have identified natural desiccated thyroid as an unapproved drug. I believe it's naive to assume, especially with FDA committee members who have direct financial ties to Abbott Labs (maker of Synthroid), and Sidney Wolfe -- a vocal opponent of natural thyroid -- on the drug safety committee, that the FDA would be planning to cherry pick only certain manufacturers for action, and leave the rest. Especially as the one official FDA letter declaring natural desiccated thyroid as an unapproved drug went to TimeCap, which was as noted, the subcontractor manufacturing RLC's Nature-Throid and Westhroid. Note that we do not know whether TimeCap -- or Biotech or Major for that matter -- was also producing Armour Thyroid under subcontract.
2. We don't have public information as to the behind-the-scenes negotiations going on with the two remaining companies, Forest and RLC, with the FDA. I believe we can safely assume they are going on, as these two companies have yet to receive any public enforcement letters from the FDA. This may be viewed positively, as it may suggest some willingness on the part of the FDA to avoid cutting off the majority of patients on natural thyroid going forward. But that's speculation at this point.
3. We do have RLC's commitment to continue making desiccated thyroid, and to return to the market within 90 days, and I believe they are doing their best to achieve that goal. Whether they will be able to do so, however, is the challenge they face themselves as a business, and depends on their acumen, personnel resources, manufacturing situation, financial resources, relationship with the FDA, etc.
4. We have no commitment from Forest regarding Armour Thyroid's future or availability. Forest has a history of a clear lack of interest and communication regarding Armour Thyroid. Given that they have been responsible for the majority share of the natural thyroid market, their lack of information or proactive interest is highly troubling. A number of years ago, in meetings I had with execs at Forest in NY, they made it clear to me that they allowed Armour to plod along because it wasn't a big market, and it sold itself anyway. They did not even have their sales reps discuss it with doctors, so as to avoid any conflict, given the controversy. They were not interested in putting money into marketing, and felt it was unnecessary to come to Armour's defense. I even specifically asked them to respond when Sidney Wolfe's Best Pills/Worst Pills attacked Armour, called it "cow thyroid supplement" and said that the only doctors prescribing it were unscrupulous diet doctors. They refused to make any public comment, and left it to me to defend THEIR product in letters to Public Citizen and Dr. Wolfe.
5. We do not have a verifiable explanation as to the shortage of porcine thyroid raw material. The raw material manufacturer, American Laboratories -- the only company that supplies Thyroid USP in the U.S. -- has issued assurances that they are working hard, and claim that increased demand triggered the shortage. But there are no statistics or evidence that the demand for natural thyroid drugs has exploded in 2009 to the extent that it would cause a shortage of raw material. And given that Armour Thyroid has been in limited production for most of 2009, this raises questions as to the nature of the shortage. Even more troubling is the fact that the shortage of Thyroid USP has occurred at the exact same time as the disappearance of several manufacturers, an FDA enforcement letter that shut down TimeCap Labs, and a nationwide shortage of drugs from the only two remaining natural thyroid manufacturers.
6. We have the FDA letter re: TimeCap, but we don't have enough information on the disappearance/shutdown of Biotech and Major's natural thyroid drugs. Second-hand information has suggested that these were the result of FDA action, but it's not confirmed.
7. We face the possibility that the FDA will take action against these companies, and that raises additional questions: When? Would the drugs remain on the market during an NDA (new drug application) process? Would RLC be able to pursue an NDA for their natural thyroid drugs? Would Forest be able to/interested in pursuing an NDA for Armour?
Answering these questions and exploring these issues definitively is an ongoing process.
What Can You Do?
If you are looking to fill prescriptions for Armour or Nature-Throid, I suggest that you post to the Save Natural Thyroid website, where patients are sharing information on the limited number of pharmacies that may still have stocks of these drugs available.
If you are getting a new prescription for natural thyroid drugs, be sure your doctor writes it as broadly as possible for "natural desiccated thyroid" (and not by brand), and indicates a dosage in grains (not mg.) so that your prescription can be filled with any available product you can locate. For more information, see How to Get Your Natural Desiccated Thyroid Drug Prescription Filled.
If you are unable to get any of the prescription drugs, consider having your doctor write a prescription for compounded natural desiccated thyroid. Some compounding pharmacies still have sufficient supply of Thyroid USP to fill prescriptions. Patients are sharing information about these pharmacies at the Save Natural Thyroid Coalition website. A number of leading thyroid experts have shared their recommendations regarding compounded desiccated thyroid at How To Survive the Shortage of Armour and Nature-Throid Natural Desiccated Thyroid Drugs.
Some patients have been able to fill prescriptions with Canadian mail-order pharmacies. Note, however, that this is considered illegal in the U.S., though authorities typically have not enforced rules when individuals are getting 90-day or less supplies of medications for personal use.
If you are unable to get any natural thyroid medications whatsoever, you may wish to investigate combining synthetic T4/T3 medications, or use of over-the-counter glandulars, as an interim measure. Recommendations from leading physicians regarding these options are included in the article How To Survive the Shortage of Armour and Nature-Throid Natural Desiccated Thyroid Drugs.
In terms of the bigger picture, a national effort is now being organized behind-the scenes to strategize about how to protect thyroid patients' rights to natural thyroid medication. There is likely to be a time where patients will need to vocally speak out, take action, contact the FDA, legislators, media and others, as part of the national campaign strategy, so stay tuned here at the website, and also via participation in the Save Natural Thyroid Coalition.
At present, one thing you can do as a patient is to encourage your doctors to start writing up letters/case studies/patient profiles to document -- with data whenever available -- that support their decision to prescribe natural thyroid for you and other thyroid patients. For example, if you had a TSH of 35 no matter what dose of levothyroxine you were taking, but were able to become "euthyroid" (normal TSH) on natural thyroid, you should ask your doctor to write that up in a letter or brief case study. In the absence of journal research and published studies, this sort of testimony from practicing physicians will become critical.
MORE INFORMATION:
- The Armour Thyroid and Nature-Throid Shortage Information Center
- Save Natural Thyroid Coalition Website
- Save Natural Thyroid Coalition Yahoo Listserv
Image: clipart.com
Mary thank you for putting this update together. I know we all appreciate your efforts and for speaking on our behalf. I plan to print this update out to bring along to my next doctor visit. It will help me explain the situation and to get my natural desiccated thyroid filled when available.
Also read Janie’s blog for information not stated here.
http://www.stopthethyroidmadness.com/blog
I hope it’s resolved. I would not mind taking Cytomel for my T3, but I simply can’t afford it without insurance. I need the natural stuff plus a small amount of Synthroid.
Heartfelt thanks to you from me (and I’m sure everyone else who needs natural thyroid hormone).
Thank you SO much, Mary! I am so glad that someone more visible in the thyroid activist community is using logical analysis and is willing to step up to head off this potential disaster. People all over the USA (and now other countries too) are having trouble getting the prescriptions filled and we really must stick together and ensure we have access to this line of natural drugs. Your analysis, and fact sheet above, is really helpful for us to be able to explain this to others we seek help from.
Mary, you are the best! This was so clear and well written. Welcome back.
Mary, thank you very much for this very comprehensive and clear article regarding the threat to the natural thyroid hormone. We appreciate your leadership.
I can tell you sure put a lot of work into this article and it is really appreciated for those who don’t know the ins and outs. I was reading another thyroid blog and getting more confused by the minute, but your information clarifies a lot. Thank you.
Callie, that blog diverts attention away from needed action due to problems they have already caused with the FDA and Forest. See Internet Enabled Thyroid Hormone Abuse on pages 4-5:
http://www.annals.org/cgi/reprint/150/1/60-a.pdf
Les,
Thanks for posting that Annals of Internal Medicine article about Stop the Thyroid Madness. I thought I was the only one who ended up going to the hospital (I had bad atrial fibrillation) and became sicker than ever before, after following the advice I was reading at that Thyroid Madness site. But after reading this article, I see I wasn’t the only one. The madness that needs to be stopped is anyone listening to Janie Bowthorp when she says to buy dessicated thyroid pills without a doctor’s prescription, and then says to take these huge quantities. I wouldn’t be surprised if the people at the FDA read that medical article, and that may why they want to get rid of the Armour thyroid in the first place.
Stop the insanity! I was getting so tired of the lunatics on another blog. I am glad to see your level head chiming in on this. Thank you for your clarity and direction. What a wonderful article to wake up to.
I get useful information from Mary’s site plus the STTM site, however, if I followed the STTM’s site, I would be in the hospital with overmedication, but I know this, and I know my body so I don’t listen or follow their protocal. How can a one size fits all for thyroid medicine be healthy? I mean to assume that EVERYONE needs 3-5 grains of NDT is ludicrious and dangerous. I see it often on their site that they keep telling people to bump without waiting the 4-6 weeks that is necessary and they end up overmedicated. Gee, what a surprise!
Les, Who has caused what problems with Armour and FDA? I think you are mislead.
I am very grateful to Mary for this information. I could not get my prescription filled and my doctor has tried over 20 pharmacies. Mary pointed out it was not legal to get in Canada, but that is where I ended up having to go.
Les, Ginger, and anonymous, if you read the STTM site and her book, you would know she does not advise these high doses or doing anything without the doctor. Even so, some people cannot get what they need from their doctor and do it to save their lives. Did you read the patient’s comments? Even while she was in the hospital she complained her doctors don’t listen. Her desperation was likely why she went to such sites and didn’t follow what was said, but increased on her own in an attempt to try to get better after being ignored for so long. If you did the same, then you made your own choices and I would wonder why you would be following that site to begin with? I followed her site and book and got really good results, after 10 years of not getting help from my doctors. I finally found a good doctor. I have not seen Janie ever advocate above 3 grains and even then she cautions that you have to watch for symptoms as you slowly increase. Take some responsibility for your own actions and stop trying to create a divide.
It sounds like you are not who you are presenting yourselves to be. That link that you posted only proves what lengths the medical establishment will go through to try to prevent people from getting well because of their own egos, and not relying on the patient to tell them whether they are getting better or not. The FDA was trying to shut down NTH long before Janie came on the scene. Mary was promoting it for a decade or more. Are you going to blame Mary next? Both these ladies have saved a lot of lives.
Ginger,
I have been on STTM many years and have never had anyone tell me to take high doses of any thyroid hormone NOR tell me to get that thyroid hormone anywhere but from a doctor. My doctor rx’s me 5 grains. That article is very misleading.
anonymous, They never say you HAVE to take 3-5 grains. That is an average. Average means that some need less, maybe even some might need more.
Excellent article, Mary. Thanks for explaining it so well.
Betty Jo, John Smith — thanks for bringing the issue to my attention, and hopefully it is now resolved.
Darla, the average of 3-5 grains is 4 grains. STTM refers people to more than one forum, and the one I was on clearly stated over and over that you need to ramp up to 3 grains before holding and then continuing (!) to raise. I protested over and over that some need only 1.5 -2.5 grain and were overmedicating themselves and was finally put on moderation.
Self-medication works if you’re intelligent and know what you’re doing. In a hypo brain fog, I don’t think those things are true.
thorina, You should only go to 3 grains if 3 grains is needed. If you do not need it don’t raise it. If I felt I didn’t need something I wouldn’t take it no matter what anyone else said.
Good post Mary.
I don’t see the point of this constant bickering between thyroid advocacy followers. At the end of the day, we are all working towards a common cause which is better diagnosis and treatment for thyroid disease and individualised treatment options for all patients.
And let’s face it. How often do we see endocrinologists writing up case reports in the Annals of Internal Medicine about patients who were failed by the advice of conventional endocrinology?
How many endocrinologists are giving poor advice on a daily basis to their patients, leaving them undiagnosed or with inadequate care?
How many patients have died prematurely as a result of poor treatment from their endocrinologists? A fair few I would imagine. But we don’t get to hear about that in medical journals do we?
Seemingly the authors of the case report saw fit to refer the woman to psychiatric care rather than get to the bottom of her thyroid issues. Doesn’t that tell us something important about the mindset of these doctors?
“thorina”, I am on many forums that I know STTM recommends, and those are individuals who might say that, not the “forum”. That’s why many of those forums state that comments made by individuals are not meant to be replacements for your doctor’s direction. I’ve read places where Janie says that some do need less than 3 grains. I would never be irresponsible enough to blame a forum of patients who are sharing if I chose to follow their advice. That is my problem if I get into trouble.
Janie has NEVER EVER EVER told everyone that they need 3-5 grains. She has said that on average many people need 3-5 grains. And you know what, that’s exactly what my doctor says as well, in his 40 years of experience of treating thyroid patients. Janie saved my life. Without her information, I wouldn’t just be in the hospital, I’d be long dead. She has saved many other people’s lives as well. She is a wonderful advocate, and the most helpful person to anyone who needs her help. Exactly like Mary Shomon is a thyroid patient advocate, so it Janie.
Mary, or anyone else in charge of this, please delete these untrue defamatory and inflammatory remarks about Janie. She would never stand to see Mary defamed in this way. To see Janie defamed and lied about in this manner is simply unconscionable to me.
We all have the same goal: we’d like to keep the medication that helps us on the market. Let’s keep the personal attacks out of it.
Nowhere on her websites has Janie advocated you MUST tke 3-5 grains and to keep raising willy nilly. She advocates waiting 4-6 weeks between raising once you are at 3 grains. The aim is to raise until syptoms abate. For some this is less than 3-5 grains
For me this is 6 grains.At 3 grains I was severely hypo with a TSH over 6.00.Thanks to an uninformed doctor and compounding chemist I thought it wasn’t working.
If not for Janie I wouls still be living in hypo-hell either on thyroxine or an inadeqaute dose of Armour.
Read STTM CAREFULLY and her book if you have it.
Thank you for your work, Mary. A few years ago on Synthroid I felt terrible and my hair was coming out in clumps. I went to a knowledgeable doctor who put me on Armour (thanks to advice I read on your site) and I feel like I got my life back. You do very important work and it is important that we work together to keep the naturals on the market.
Remember 6-9 months ago when the H1N1 flu (formerly known mostly as the SWINE flu) garnered national attention? Thousands and thousands of pigs were destroyed before all the hysteria died down and the medical community was able to straighten everyone out about the name of the flu. Could part of the desiccated porcine thyroid shortage have any correlation with the lack of pigs on the market for many, many months?
The people at the STTM site and some natural thyroid support groups have taken the bias against TSH to an all time high similar to traditional medicine with the opposite bias toward treating all patients to the all mighty TSH test with T4 only drugs. There needs to be a logical medium and unfortunately there are only a minority of health care providers in this area.
I was so hypo and had great insufficient brain cognation when I came to the internet that I followed a certain support group for natural thyroid’s advice as I was so glad to know I was not alone. At that time I was willing to do anything to stop my misery. However, I got into real trouble with being urged time and again all I needed was to take Cortef (HC) when, in fact, I really didn’t need it — so I became sicker. Also I was instructed to take too much Armour too quickly to the point of thinking I was having a heart attack and ended up in the ER. And I am not the only one because it’s documented that other people had the similar experiences. These people should not be practicing medicine without a license. Darned if you do and darned if you don’t! I know I wasn’t wise to be so gullible, but shouldn’t these people be held accountable for their portion?
I am sure many people come to the internet like I did because T4 only meds (and I tried most if not all of them) made me much worse. What are we to do when ALL doctors we go to don’t listen and then will only throw a T4 -Synthroid- and Prozac script at you and tell you it’s all in your imagination? These medical people keep some of us sicker to the point of new diseases developing like Chronic Fatigue and Fibromyalgia. This ignorance brings in the money for medical providers but leaves patients without any health quality whatsoever. My CF/FM disappeared after a short while on Armour. Why does modern medicine and the FDA listen to a few biased thyroid associations influenced by big drug companies? Could it be money, money, money and pushing drug’s for these companies? Who are the real criminals?
Mary Beth,
You would have never ever been told to get on HC if you didn’t need it and if you didn’t show the results of a saliva adrenals test. Never. We do not respond to such requests for the just the reason you stated. We DO NOT want people on HC if they don’t need to be. How is practicing medicine. We only tell you what we personally do and what has worked for other people. You are responsible for your own decision. No one says Mary Beth you must do this or else. How can you hold anyone else responsible for your own actions. You yourself said, doctor leave us out to dry, to get sicker and sicker and sicker. You couldn’t stayed with that instead you we looking for other answers. Those answers are qualified by saying we are not doctors and we urge you to find a qualified doctor to help you, if you don’t then this is what others have done. I think it’s irresponsible to blame someone else. It was entirely your decision and if you were not “up to” doing that than finding a doctor would’ve been the right thing to do and again your decision.
I have read your post Mary Beth and then Birdy’s, and I agree with Birdy. I’m on a lot of those groups and I learned that these are patients (not doctors) expressing opinion, no matter how much brain fog I had. If I made a mistake based on what patients said to me, it was my fault not theirs, for taking that risk. I also made a point to visit STTM to find out more and that is where I saw that I needed to do the 24 hour saliva and not guess if I had low cortisol or not. I sympathize with you, but I would personally never blame patients for trying to help. Those groups are life savers to know I’m not alone and most of the time, they have helped me a lot!
I hope people from the Iodine yahoo group are reading this because a campaign is going on over there stating that the FDA is absolutely not behind any thyroid issues and they have nothing to do with the current lack of availability. When I asked the moderator, Stephanie, to provide a source for her statement, all hell broke loose. Apparently she doesn’t like being asked to back up her statements with evidence. I sent her a link to the letter the FDA sent, got accused of putting words in her mouth and spouting Mary’s “opinions.”
This was followed by several nasty private emails accusing me of not being rational and then she banned me from the group.
It is distressing to see the level of incompetence and fear of being wrong that some have to the extent that being asked to back up their statements with facts causing such drama.
Mary, your professionalism and intellect are sorely needed and appreciated. You are a wise and gifted researcher and talented writer. For many things, many thanks.
What about a letter writing campaign to the FDA, senators, congresspersons about the shortages and possible conflicts of interest. The Organic Consumers Association has a great method for signing prepared online statements, these can be edited if desired. The letters are then sent electronically to the pertinent persons.
The owner of the Iodine group is a well respected knowledgeable woman who has a lot of respect among the thyroid community. Having beat thyroid cancer herself, and having children who take thyroid meds, she knows a lot about the thyroid and thyroid research.
She repeatedly told you that RLC stated that the shortage in desiccated thyroid was not related to the FDA telling them to stop but was due to the backlog of manufacturing at ALI (maker of the raw thyroid powder used for the drugs). But you somehow wouldn’t take that as answer and continued to tell her that she was hiding something and the people had the right to know…There was nothing being hidden from you, there was no “Secret agenda” being held from you like you thought. There was simply a misunderstanding and miscommunication between you and the owner of the iodine group.
Stephanie, the owner of the iodine group, has helped me out SO MUCH and my family and she continues to help hundreds of others online for FREE!! So please think before you slander a great human being the way that you are doing right now.
Thank you and God Bless you,
Mia
I would advise that if people can’t get natural thyroid they get both a T4 synthroid such as Levoxyl, but also importantly a T3 based prescription such as Cytomel. I take 150 mcg Levoxyl and 25 mcg cytomel, a 6 to 1 ratio. My use is post thyroid removal (thyroid cancer) and it is very hard to get a prescription for Cytomel from endocrinologists. Ask your primary care if you have to in order to get the Cytomel. Adding Cytomel makes a ton of difference. It is easier to take a natural thyroid but if you can’t the alternative is both T4 and T3 synthetics. Hope that helps.
Mary, what would we all do without you? You are certainly the authority I turn to when I need to know anything about living with thyroid disease. Your tireless work is most appreciated. Thank you!
Thanks for summarizing the situation, Mary. I’ve been writing letters to my congressmen to make them aware of the situation and the need that many of us have for NDT. Others can do the same just to create awareness.
Concerning the derogatory link about STTM; I don’t think you can blame that on the Web site – the patient took the action out of desperation and ultimately, she did need NDT. If more doctors were willing to work with their patients and patient symptoms, less of this kind of thing is likely to happen.
Here is a link, I believe I found through Mary’s Web site: http://www.thyroid-info.com/articles/woliner.htm I think you will find that this supports a lot of what Janie has published and disputes the idea that a suppressed TSH causes bone loss if using NDT.
This is not the time to fight amongst ourselves, now, is the time to come together on what we agree on and save our NDT.
redplanet, Stephanie over at the iodine group is a saint. She has helped more people than I could ever imagine. Don’t mess with the saints.
Redplanet and others, you are not alone. Members who disagree (or have been harmed) are moderated/banned (their voices silenced); then hunted and shouted down the way you are seeing here. They are unwilling to listen. But you are far from alone.
RedPlanet
I wanted to publicly offer my apologies to you for your experience on the iodine group. I have been pulled in multiple directions and am realizing that I am not being effective in all I am trying to accomplish. My responses to you were quick and I did not pay as much attention to detail or how it may be perceived as I should have. As an attorney you are used to monitoring what is said and not said in various situations. This is not my background and I do not look at things under this microscope. I apologize for this miscommunication between us.
Hello All,
Today is Friday, September 11, 2009.
I placed my weekly call to the FDA, they are really an amusing lot. Thye are usually very pleasant until I start asking pointed questions. As usual, I got relatively NO information from them regarding RLC, shortages and NDAs. “we don’t discuss that unless you are with the company, but continue checking our website for updates, shortages, recalls, etc.” I did. Did you know that Listeria was found in Egoo waffles in Georgia? Nothing against them, just an fyi. There were all kinds of recalls, sweatshirts with drawstrings, tires, chunky soup… but no dessicated thyroid products. Shortages were not listed anywhere on there site.
On to American society of Health-system Pharmacists. Bingo! They have listed all of the shortages!!! Pretty amazing that the FDA missed ALL of these!
Next on my Friday morning call list – RLC. The very pleasant woman that answered their phone gave me the standard company line, in a very polite manner. She did empahtically deny the FDA requiring an NDA for either of their dessicated thyroid products. The company line is that the raw thyroid needed for production is not available. They are looking at full availabilty in December of 2009. She further re-iterated that their shortages are in line with the overwhelming demand for their product, not insufficient manufacturing. Simple supply and demand!!
I am crossing my fingers that something miraculous will happen between today and next Friday when again I make my weekly calls.
Good luck to all……..
Mary Beth, what are you complaining about exactly? Are saying is that you were dumb enough to follow something on a website without getting tested and you know it was your fault? Yet you want others to pay for your stupidity? If someone wrote on the internet you should light your head on fire, would you do that too? Did your endo or other docs ever give you guidance that made you worse? I don’t wish illness on anyone, but some of you people are too stupid to be even reading websites. The thyroid disease is not an excuse.
Bias against TSH: do you mean because it tells you absolutely nothing about what is going on in your cells? That seems like a legitimate bias to me. Don’t come on Mary’s site and insult her or her work if you can’t figure out what she is really saying. Your post makes no sense. First you bash those who criticize the TSH-only testing and T4 only drugs, then you go on to say your experience was just the same as those people; T4 only didn’t work for you and you need Armour. Make up your mind. People like you are going to get all medications, all supplements banned so that none of us have access to any treatments anymore.
I wish the cults would stop coming over to Mary’s website and trashing her, other sites, etc. Grow up people and focus on the issues we are dealing with.
Sue, your post was very useful. I looked up thyroid drug shortages based on what you posted and found this:
http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=459
There is a fourth company that was producing thyroid meds and is off the market: Thyroid (desiccated) tablets (Qualitest) – discontinued
Qualitest? Mary, do you know anything about that company?
“Reason for the Shortage
* Several thyroid (desiccated) products have been discontinued. The manufacturers would not provide a reason for the discontinuations; however these products are not FDA-approved.
* Forest states that the shortage of Armour Thyroid is due to a shortage of raw material.
* Major and RLC will not provide a reason for the shortage.”
On the desiccated thyroid shortage … isn’t it possible that some of the normal supply got used up in reformulated Armour that wasn’t benefiting anyone, was recalled, and likely destroyed, and that contributed to the shortage?
There was obviously some hording going on; folks getting several months supplies at one time out of fear of not being able to get NDT for awhile that contributed to seeming increased demand.
Available Thyroid USP then “stuck” at manufacturers who were told not to produce any more, Major, Biotech, etc. Supply at the wrong place unable to support the market demand.
Is it possible that the Thyroid USP shortage is truly all about supply and demand?
It is a hopeful scenario, but how would supply and demand explain the companies that the FDA made pull out? TimeCaps got a letter from the FDA, Major sent a press release saying it was due to the FDA. The FDA has definitely been at least part of the problem. The other troubling part is supply seems to be dwindling as less and less companies are making it (see Sue’s post).
American, the supplier of the raw material, has some issue that we aren’t being made aware of. Demand would not affect those issues. Read up on the face book page. You don’t have to join to read the posts and the people there put up lots of great information.
Mary sounds like she knows some people close to this issue and she said yesterday to stay the course. I am interpreting that as there is FDA and other governement involvement and we need to remain alert.
Mary – so many thanks from me. It would seem that Forest has a competing interest with Desicated Thyroid production. I hope to switch to Westhroid when it’s back.
As for STTM – I truly credit them with saving my life. They advocate TESTING, and avoiding sole reliance on TSH. Since my pituitary had not been producing TSH, education from STTM enabled me to experience VASTLY improved health, and to find smarter doctors who understood the hormonal downstream. To the complainers: I do not understand why anyone would not test, or who would take a large dose without education.
Concise article. A well written and up-to-date summary. I look forward to directions on further actions for all of us to take. Mary, thanks for your efforts.
I too was banned from Iodine group. To the newbie, it appears that all are in agreement there, but that’s because when we question the wisdom of the advice, or post adverse reactions, or try to post studies that repeatedly have shown over the years that iodine can cause problems for those with Hashi’s, we are shouted down and banned. Myself and others who no longer post there have gone hyper, two that I know of ending up in the ER with a racing heart. Not fun.
Mary you are a God send -Why don’t you contact Ben Beck at fox news about the special interests going on at the FDA-he may not be your choice politically ,but he is the only news personalty that has the guts to tackle the FDA or the big drug companies -My thyroid was removed 3 yrs. ago synthroid made my hair come out and fingernails brittle and ridge-also I felt my brain was numb-After switching to armor my hair grew back and I felt like my self again.I shudder to think I have to go through the synthroid nightmare again,
This was great info. I enjoyed reading it and it has peaked my interest in Armour and is it for me. I have been to 4 different endocrinologists in the past 15 years and they all have just looked at lab tests and tweaked my doses of Levoxyl and I walk out many dolars less and still feeling bad. I started just taking my Levoxyl and going in for my annual refill Rx and not complaining as I lost hope in the medical community as they did not seem to care that I still felt like crap and am a completely differet person with normal thyroid levels. My lethargy has increased over the years and I have two kids now and I feel like a horrible mom not being able to do the things with them that I want to. I finally just broke down and cried one day as I was so upset at my situation and my internist referred me to a rheumatologist as they thought bloodwork would find something that was unrelated to my thyroid making me tired. Nothing showed up —so she told me to goto a psychiatrist—are you kidding me I guess it was becasue I cried in the internist’s office?? I drive a freaking Bentley, have a great husband and kids –I am not about to kill myself. I just need something to give me some energy so I can enjoy and run after my kids. Not having energy makes me mad, not depressed. So, I am curious if people on Armour had the same symptoms I have had and it might be what I need and how soon when you take it do you normally know if it is working? This is great- thanks, ya’ll!
redplanet, just wanted to let you know I received the exact same treatment when I asked for evidence other than Brownstein’s and one or 2 other docs. The iodine brigade is pretty one-size-fits-all and all hell breaks loose if anyone tries to present valid studies or asks for proof. No dissent allowed–period.
For those who are interested I emailed the FDA and received this prompt reply. The word for word response from FDA follows: “Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.
Dessicated Thyroid product are on the market and available to consumers, even though they are not FDA-approved. FDA has not ordered all unapproved thyroid products off the market. Rather, FDA has urged all companies who market unapproved drug products, including thyroid products, to submit applications for approval. FDA is concerned that drugs marketed without required FDA approval have never been submitted to rigorous scientific evaluation, and therefore may not meet required standards for safety, effectiveness, quality, and labeling.
Regarding possible future action against unapproved thyroid products, as a policy matter we do not discuss potential, pending, or ongoing actions except with the firms and individuals who are the subject of those actions.
Some inquiries to FDA have cited reports of shortages of unapproved thyroid products. RLC (also known as Western Research, manufacturer of West-Throid and Nature-Throid) reports that they are currently in backorder for all Westhroid and Nature-Throid products. Major and Forest report they have some of their strengths available. The reason provided by the companies for the current unavailability of some presentations has been manufacturing delays.
Best Regards, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration”
Sometimes you are a hypochondriac. I live in the central Ohio area I took it upon myself to call over 30 pharmacies they all have armour thyroid in stock and have never had a shortage. You know the medical end but when you get into the political end of things get your facts straight and quit freaking people out.
Mary THANKS! For ALL you do! Keeping us all informed and providing a service so greatly needed. I am so thankful even today that you have a variety of balanced information about thyroid disease. Without natural desiccated thyroid I will die a slow miserable and paralyzing death.
Amy (post 51) you are not alone! My experience was similar to yours. I fell apart in an Endocrinologist’s office and she sent straight to the shrink after writing in my chart my thyroid was optimal but likely my crying was due to deep rooted psychotic problems. But, I would be in a grave now as I would have never been able to endure a T4 only life for 15 years. On Synthroid, Levoxyl, Levothroid and other T4 meds I got worse to the point of begging my husband to put me out of my misery. I was sent to various specialists and was even diagnosed with CFS & FM mostly because I was crippled after two years on the T4 meds. It didn’t seem to matter which T4 med I took. I remember being enraged because I couldn’t play with my kids, simply had no energy, forgetful, and the crippling pain –but not because I was lazy or depressed and suicidal. I felt stuck in a 90 year old woman’s body with a 35 year old’s mind.
The multitude of Endocrinologists I seen refused to test my Free T3/4. I was originally diagnosed by my children’s pediatrician because I passed all the TSH tests with flying colors, so doctors refused to look further.
Anyway, my hubby threw out all T4 and I improved a tiny bit and researched hypothyroidism and found Mary’s site. I called over 40 doctor’s offices asking if the provider was open to prescribing natural thyroid and finally found one, then made an appointment. Amazingly four hours after taking my first Armour pill (almost seven year ago), I knew I would prevail. I could walk again in a week and the Fibromyalgia and chronic fatigue disappeared within a month. I could, play with my kids again and go dancing with my hubby.
I did have some lingering problems until my Adrenals, vitamin and mineral deficiencies -Vitamin D, B-12, iron, zinc, magnesium, etc. – were fixed along with eliminating gluten and refined foods. My life is so much better now with a natural thyroid med and a healthier lifestyle. However, I’ll be a dead woman without my natural desiccated thyroid medication.
Amy, I hope this helps!
Wenda,
WOW! Did you miss a dose of your meds? Get your head out of the sand! There is a natural desiccated thyroid shortage and many patients are struggling to get their natural thyroid medications. Mary is doing a great service in updating us. If, in fact, your pharmacy has Armour it may behoove you to stock up.
Wenda,
Please list those 30 pharmacies you say have it available. We are all looking for pharmacies that have it in stock. Surely if you took the time to call 30 pharmacies, even after the first one had it available, you can share the name, address and phone number of those pharmacies. Thank you.
Just an fyi, a hypochondriac isn’t someone who raises, as you claim, a false alert. It is a person who has an excessive preoccupation or worry about having a serious illness.
SSTM members: Is it true a former SSTM moderator was prosecuted in Missouri for “practicing medicine without a license” at that forum?
While taking Synthroid for a number of years, I suffered with chest pains. Doctors performed a number of tests, one of which was invasive. Each one indicated my heart was fine so finally I asked my doctor about Armour Thryroid to which he agreed. I have been taking it for approximately ten years without any ill effects or chest pains.
Thank you so very much for this informative article. I went a month without thyroid medicine thinking it was a short term problem. It was only through this article and another one on the internet that the problem is becoming more clear. Please help us to know what the next step is for us in returning a natural thryoid medicine to the shelves.
dear mary
i sign up for your newsletter and i lear sooo much about my hypothyrodism.i have been taking one grain of armour thyroid for over 20 years.i am devasted needless to say.when i was first diagonosed with low thyroid,i was taking synthroid.it was terrible.i was sooo mentally not there and i could not perform my duties at the hospital.i was always in a brain fog.well im back to that point because i live in MI and cant get armour thyroid anywhere.i was not suprised when you said this is an fda issue,figures.please work with these other companies to get a t3 and a t4 drug thats natural.i dont think some people are understanding that our bodies produce t3 and t4.synthroid only has t4!(no wonder why i didnt lose weight on it).i did the best on armour.please help us all mary because i am only 42 and i feel so lousy every day.i need a mircle please.i am begging you.HELP
I’ve been on Armour for 14 years. Last week, when I got wind of this situation, I panicked because my doctor was on vacation. Yesterday (Sunday) I went to the pharmacy and asked if they had any Armour. They said they had 40 pills. This morning my doctor phoned in and I was able to get the remaining pills and by that time, they had found 80. So, I have enough for 3 months, but after that ????? I’m wanting to do something about this. Will keep checking, Mary, to get your advice on what to do. Thank you so much for being there!!
I sit here in Australia & read with amazement the animosity & disrespect shown on both this group & STTM to each other. I do not understand where it is all coming from but there’s obviously some history behind it all to which I am not privy to.
Keep going people & you will play right into the hands of Bigpharma, FDA & the Medical establishment!!! You will give them all the ammunition they need. Its a great tactic the old “divide & conque” & has worked well for many in times past.
I wouldn’t be surprised if some of the posters are ‘plants’ deliberately stirring up trouble. It’s been done before to great effect!! For example there is an earlier post on this thread supposedly made by “Lethal Lee”. It’s certainly NOT me so I wonder who that is? I have been using that name for some years now. Possibly there may be 2 of us but I certainly have never run across someone else using that name anywhere in the Thyroid & health forums, blogs & groups I frequent.
So COME ON people…stop bickering & pull together!!!!
BOTH Janie & Mary are amazing & have given & continue to give so much of their time & energy for the benefit of us all. There isn’t a “competition” between the Mary & Janie camp for goodness sake. At least there shouldn’t be.
Personally I don’t care what Thyroid med a person takes as long as it works for THEM. The point is to ensure that there remains a CHOICE so all can find their personal “optimal”.
Nor do I think that the responsibility for what & how much meds you take rests with ANYONE but yourself. It doesn’t matter how brain fogged you are it’s ultimately YOUR CHOICE. To pass the blame to someone else to whom you pleaded for advice/suggestions when you were let down by ‘conventional’ treatment is absolutely spineless IMHO.
I read on both sites & many more. The STTM recommendations are to increase meds gradually to elimination of symptoms. If you have no continuing Hypo symptoms you do NOT increase it’s that simple. Plus once you reach 2-3 grains you increase by ONLY 15mg every 6 weeks or so. You ensure other things that can impact on health are tested for & optimised. I can see little difference in the advice given both at STTM & this site? The advice also seems very sound to me. I do research all advice given regardless. If I chose NOT to do that & simply followed blindly both the consequences & the responsibility would STILL be mine.
I too find it hard to believe that the FDA is not going after Dessicated Thyroid albeit in a piecemeal fashion. Perhaps I’m just a cynic? Nor do I find the “its just a supply & demand problem” line at all plausible. Something’s happened at the “supply” end to which we are NOT being told the whole story. WHY should there be shortages when FOUR companies no longer produce their NTH product?
WHY does RLC need 90 plus days to bring ANY product “on line”? They must at least be getting SOME Thyroid USP. There’s also the fact that RLC was only a distributor. Timecaps made their product. FDA of course shut down the MANUFACTURER. Will they do the same to RLC if they actually do start to manufacture their own or to any other company they try to contract to do it for them?
WHAT is up with Forrest? Why no estimated date for Armour to be available again? Again they must be getting some Thyroid USP?
All I can say is I’m glad that in Australia i’ts all compounded Dessicated Thyroid more expensive but less scope for these types of shenanigans. We do use Thyroid USP for the Compounded NTH though so any shortages there will eventually affect us too as stocks run down.
It just makes me so sad to see folks playing into the blame & guilt game. All so counterproductive.
I’m always surprised to see any comparison of Bowthorpe to Mary Shomon. Shomon has advocated for thyroid patients since 1997 and is the editor of the popular and informative http://www.thyroid.about.com thyroid disease website along with several other thyroid-related sites. She is the author of a number of best-selling books on thyroid disease, has a newsletter for thyroid patients, and maintains several Internet forums inclusive of all thyroid patients. Mary Shomon actually does reach tens of thousands of patients globally while Bowthorpe imagines herself to reach hundreds of millions.
Bowthorpe has one self-published book, a small website with blog, and a small group of followers. I’m sure Bowthorpe has helped many people, as have many thyroid patients who take the time to reach out and help others on thyroid forums. Bowthorpe’s STTM website does contains some excellent information (as do many other personal thyroid websites); however the information is presented in a very unprofessional manner. STTM also has the reputation for promoting “self-treatment” which undoubtedly has given ammunition to those who want to see desiccated thyroid products removed from the market. Add this to Bowthorpe’s reputation for personal attacks on anyone who disagrees with her message/methods/presentation and it becomes clear why Bowthorpe is becoming ineffective.
Those thyroid patients who are seriously dedicated to natural thyroid as a superior hypothyroidism treatment need to take a close look at whether it is Shomon or Bowthorpe who is pro-active and taking every necessary step to assure not only that natural thyroid remains available to us, but perhaps in the future will become a more easily attainable hypothyroidism medication for all thyroid patients. “T4 meds suck” is not an effective strategy for what is needed.
Thank you, Mary. Good explanation of what is going on. I’m so worried about being able to continue taking Naturethroid.
I agree with Lethal Lee, we all need to work together to stop this. And whoever is doing the aliases here could be doing it to make Mary’s comment section look unreliable and false by then expressing indignation that someone is impersonating them. I’ve seen this happen elsewhere before.
Mary, it gives me some comfort to know that you are ‘on the job’ working daily to help us.
Wow, I am in such agreement with Lethal Lee. Thank you! And so what if Janie Bowthorpe has one book. She’s been a champion for all of since I think 2002. I see “both” Mary and Janie having great resumes of activity and action, and Janie especially with her focus on desiccated thyroid. And STTM is a massive website and I personally like her style. And I have never, ever seen Janie Bowthorpe attack anyone for disagreeing. I am so disappointed to see all the nasty comments here.
You know, I have never seen Mary or Janie say an unkind word about the other. We have no idea if they are working together or apart. It really doesn’t matter as we need all the help we can get and I am sure either together or apart they are working towards the same goal. Keeping us informed and dessicated thyroid in the pharmacies.
Rita…I’m with YOU! How can we get these people on this site organized enough to take ACTION and get something done to fix our problem, instead of leaving snarky comments and quibbling over details of who said what. Somebody needs to get this mess going forward and let the government know how we REALLY feel. Gather up what energy we have left and fight for what’s right!!
STOP IT!! I just read the bottom of the page (latest comments) and see the the bickering is still going on and stronger. You sound like a couple of babies…grow up and think about what you are saying and how destructive it is to our cause of wellness. Think about the people out there with no medication that works right now…depressed, tired, weak…baarly clinging to hope. They don’t need to hear you arguing. Think of the big picture. Obviously, you are losing it.
I think that this post’s comments area has seen more than enough back and forth that doesn’t really have to do with the task at hand: ensuring that patients and practitioners have legal access to natural desiccated thyroid drugs in the U.S. and beyond. Anyone who is interested in that is welcome to continue the discussion at the list or web page for Save Natural Thyroid, http://www.savenaturalthyroid.com
Thanks — Mary
Folks, I agree with Lethal Lee (the real one), that we need to not fall into the trap of the “divide and conquer” that is taking place both here and elsewhere. We need to STOP the corrupt FDA from eliminating this natural product that helps millions! We need to be willing to do what it takes to stop this takeover (not just of natural thyroid medication but all the supplements they are trying to eliminate). Call, call, call, and call again – Congressmen, newspapers, whoever. Keep fighting!
Just one more reason why we can’t let the government take over healthcare (more than they already have).
I am now 63. My thyroid was removed when I was 20 because it was producing toxic output. I was also hyper and my neck was big from goiter. I was put on Armour Thyroid and have lived a pleasant and totally normal life in good health. For about 5 months I have been mostly unable to obtain Armour and my doctor prescribed synthroid. I did (and do) not feel as good, have experienced some mysterious chest pains and muscle aches. I recently abtained a month supply of Armour and it seems I am returning to normal. Hope so.
I’ve been riding the thyroid roller coaster for years, and just recently found a wonderful Dr. who prescribed Armour Thyroid for me. What a difference that has made!
My last prescription refill, Armour was substituted with Nature-throid; leaving me to wonder what I can expect next month. I’m keeping my fingers crossed, that everything with the FDA will get straightened out and we can all stop worrying about this.
Aren’t there more important issues the FDA could focus on?
Mary, Thanks for great simmary overview!
RE: FDA RESPONSE
Hey Stella O, I too emailed the FDA on 9/19/09 and received my reply 09/30/09 not timely. My response is similar and somewhat a repeat of yours. However, in the last Paragraph, they mention Thyrolar. ALSO FILED THE SITUATION WITH MY CONRESSMAN AND AWAIT RESPONSE.
MY FDA RESPONSE: PS LINKS WERE EMPTY! ! !
Thank you for contacting the Division of Drug Information, in the FDA’s
Center for Drug Evaluation and Research.
You have inquired about dessicated Thyroid products. These products are
on the market and available to consumers, even though they are not
FDA-approved. FDA has not ordered all unapproved thyroid products off
the market.
Rather, FDA has urged all companies who market unapproved drug products,
including thyroid products, to submit applications for approval. FDA is
concerned that drugs marketed without required FDA approval have never
been submitted to rigorous scientific evaluation, and therefore may not
meet required standards for safety, effectiveness, quality, and
labeling. In addition, marketed unapproved drugs have been associated
with numerous serious adverse events, including 23 infant deaths related
to the use of unapproved carbinoxamine, 93 deaths related to the use of
unapproved quinine sulfate, and 23 deaths related to the use of
unapproved colchicine injectable products. Marketers of drug products
in the U.S. have an obligation to the public to ensure through the FDA
approval process that their products meet modern standards for safety,
efficacy, quality, and labeling.
Regarding possible future action against unapproved thyroid products, as
a policy matter we do not discuss potential, pending, or ongoing actions
except with the firms and individuals who are the subject of those
actions. Class actions against unapproved drugs are made in accordance
with the priorities discussed in FDA’s Compliance Policy Guide on
Marketed Unapproved Drugs,
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati
on/Guidances/UCM070290.pdf. Information about enforcement actions
against classes of unapproved drugs is posted on the FDA website. For
additional information regarding unapproved drugs, please access our
unapproved drugs website at the following link:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Enforce
mentActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.
htm.
Some inquiries to FDA have cited reports of shortages of unapproved
thyroid products. RLC (also known as Western Research, manufacturer of
West-Throid and Nature-Throid) reports that they are currently in
backorder for all Westhroid and Nature-Throid products. Major and
Forest report they have some of their strengths available. The reason
provided by the companies for the current unavailability of some
presentations has been manufacturing delays.
We advise you to talk to your doctor about possible alternatives if you
are unable to obtain your usual thyroid medication at this time. Please
note there are several approved levothyroxine products available.
Examples include Synthroid, Unithroid and Levoxyl and also Thyrolar (a
T3/T4 product), which also remains available as an approved product.
Please let our Drug Shortage program know if you have difficulty
obtaining one of these alternatives listed above. The Drug Shortage
e-mail account is drugshortages@fda.hhs.gov.
Best regards,
Division of Drug Information LC
Center for Drug Evaluation and Research
Food and Drug Administration
For up-to-date drug information, follow the FDA’s Division of Drug
Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an
informal communication that represents our best judgment at this time
Thanks Mary, great update.
Hello Lethal Lee, YOU ARE SO RIGHT!!! Wish you lived here. I have a formal letter with supporting data on file with my Congressman. I have also contacted FDA and got a confusing reply. Unfortunately, I just read an article whereby 200 of their investigators admitted to pressure to change their findings to suit Big Pharma. No doubt, US is in big trouble.
Well I just keep trying and am in touch with Legislators who do get things done. Unfortunately, our current administration has an agenda against the earnst, honest citizens.
Thanks again, Mary
Hey Stella, I too received a reply from FDA and tried to put it on this Website but it is not posted. The point is, it is similar to yours but does recommend the synthetics in the last paragraph, in particular, Thyrolar for T3.
They also had two links that yielded 0, zilch nothing.
Please, please get your family and friends involved in our fight. 12 years of being a “good patient” and listening to Drs has given me NO LIFE that is worth living. Thyrolar and Armour Thyroid began to change that with my Rx for it only 3 months before the “shortage”… I would rather die then live like this just so the Drug companies in collusion (sp) with the FDA can profit from it. Do you want your loved one to feel as I do? It is MY life, my health and it should be MY choice of treatments.
What I find suspicious is why did Forest decide to reformulate Armour? If they hadn’t they would not be subject to the FDAs regulations as the drug would have been grandfathered in. The reformulation made it vulnerable to FDA attack. Were they warned about this before they made the change? Or did they want Armour to just go quietly away given that they also make a synthetic thyroid pill? Just how far up the ladder does this conspiracy go? Who is in whose pocket?