The transition was slightly trying, says Wendy. Her doc didn’t believe her that she shouldn’t be on a low dose for more than a couple weeks without upping it. So she  went hypo all over again. (See why here.)

But after successfully upping the dose, she will now shout that it’s been the BEST thing  in every way!  She tells folks that being on Synthroid was like having your hand amputated and replaced with a hook, while being on Armour was like have it replaced with a fully functional prosthetic.  Her skin is softer, hair is not shedding nearly as much, her mood has changed in a good way, memory has returned, fogginess has faded. She feels closer to her old self than she has in almost give years.

Now the bad news…

All this time, she only paid $15 for her Armour at the local Walgreen’s. But as of April 1st, it will be considered a Tier 3 drug under her insurance plan–United Healthcare.  Exclaims Wendy in outrage and sadness:  “This means that the natural drug I love, that has restored my in so many ways that the synthetic t4 only drugs never could, will now cost 85 bucks! Who can afford that?! ”

And here’s the awful irony: Synthroid, the worst medication ever thrust upon us in the treatment of hypothyroid, is Tier 2 (i.e. costs less), and generic T4-only is Tier 1 (costs even less).  i.e. if you are under this insurance, you have to pay big bucks to feel a thousand times better.  She has no clue why this is happening, but warns that it might start to happen across the board for others as well!

Here’s what happened: most insurance companies classify drugs under Tiers.  Tier 1 is generally generics.  And since the Acella “generic” brand of desiccated thyroid entered the market last November, her insurance company decided Armour is now a brand name, thus under Tier 3 and now $85 for Wendy. Seems a bit greedy when it could have risen to Tier 2….

But here is potentially good news for some of you. There is a bill to stop the Tier expense. You can read about it here. Unfortunately, tho, it “will not impact self-funded health plans which cover about half of all employees with health insurance. Federal legislation is needed to change that.”

Does your health insurance cover your desiccated thyroid?

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Canadian Pharmacy price updates for Erfa: See the latest prices here.

How medical journals affect the prescription practice of your doctor: An interesting article on this found here. And here’s an article about how the author of a medical article fails to state his association with the pharmaceutical of the product he is writing about–one more conflict of interest and influence on your doctor!

Ridiculous! Basing “normal” for Hashimotos patients by the TSH, a pituitary hormone, NOT a thyroid hormone: Read it here and weep.

Vit. D can help you stay sharp: So many benefits from optimizing your Vit D, and here’s one with your brain.

Need to talk to others? See all your alternatives here.

NOTE: they would be Lot #: 1077413 with an expiration of  9/30/2011  This is what your pharmacist would need to know.

PRODUCT

Armour Thyroid (thyroid tablets, USP), 1/2 grain (30 mg) , each tablet contains 19 mcg levothyroxine (T4) and 4.5 mcg liothyronine (T3), 100-count bottle, NDC 0456-0458-01. Recall # D-231-2011
CODE
Lot #: 1077413, Exp. 9/30/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals Inc., Earth City, MO, by telephone and letters on October 6, 2010. 
Manufacturer: Forest Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Labeling: Label error on declared strength; some bottles are mislabeled as containing 1/2-grain tablets but actually contain 1-grain tablets. The entire lot is being recalled even though some bottles are labeled correctly because bottles of 1/2-grain and 1-grain could be shrink-wrapped together.
VOLUME OF PRODUCT IN COMMERCE
31,172 bottles approx.
DISTRIBUTION
Nationwide, PR, Belgium and the United Kingdom

http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm242808.htm

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And the above quote is probably eggsactly what is going to have to happen for desiccated thyroid to finally become mainstream!  Stop the Thyroid Madness!

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HOW DIFFERENT BRANDS OF DESICCATED WORK FOR SOME, NOT FOR OTHERS: Many patients, for a variety of reasons, have switched from one desiccated thyroid brand to another.  I, for example, was on the pre-reformulated Armour from 2002 to 2009, and successfully treated. When I heard about all the horror stories from folks who picked up their “newly reformulated” Armour, I just let my old Armour run out, and I started on Erfa Thyroid from Canada. And it was an easy and successful switch for me.

For others, a switch has not been that smooth. One brand seemed to serve them well, while other brands caused them to tank.

What causes the switch problems? For many, it could be the adrenals/HPA dysfunction. On one product, they may have felt fine, yet due to an underlying adrenal issue they hadn’t caught, a different brand with that “something different” may have been the umpff that caused their adrenals to rebel.

For others, the issues on the new brand could be from a sensitivity to one or more of the fillers. You can read about all fillers in each brand here.

And for still others, there is a mystery of why one didn’t work and another did.

What has been your experience? What did you switch from and to? Armour? Naturethroid? Erfa? Compounded? Thyroid-S? Let’s share.

HYPOTHYROID and/or ADRENAL WEIGHT GAIN: Have you ever heard of the gal who calls herself nonstickpam? I’ve known Pam for a good 8 years, and she has spent most of that time giving helpful advice on low carb eating and how to maintain your weight while dealing with thyroid and/or adrenal issues. Recently, she wrote an article for STTM about this very issue: http://www.stopthethyroidmadness.com/hypothyroid-and-weight-issues/

Have you found something that has worked for you in maintaining or losing weight? Let’s share our successes which might help others.

CANADA

I recently attended a lecture at a restorative medicine conference (kinda snuck in), and had a wonderful chat with a surgical nurse from Canada who is on Armour and didn’t even know about Erfa–the Canadian version of desiccated thyroid simply called “Thyroid”. She was thrilled to find out about it, but it was shocking to me that she didn’t know about a VERY good desiccated thyroid product right on her turf!

But even more concerning to me was being reminded that Canada has a severe shortage of doctors. Because that means it can be even harder for Canadians than Americans to find a good doctor when it comes to better thyroid treatment. It’s hard enough here: how it must be in Canada is chilling. And even if you do find one–because there are some there–the wait has to be long.

ARE 90% OF ALL MEDICAL STUDIES and CLINICAL RESEARCH WRONG?

Yes, according to meta-researcher and influential scientist Dr. John Ioannidi, and which was outlined in the recent issue of The Atlantic by David H. Freedman. Freedman states:  Much of what medical researchers conclude in their studies is misleading, exaggerated, or flat-out wrong.

AND DO THYROID PATIENTS EVER KNOW THIS TO BE TRUE!! How many studies are there that imply that T4-only medications work ever-so-brilliantly, yet our experience with T4-only has profoundly debunked that “research outcome”.

Patients have noted that much of what is achieved in research is to obtain money for those sponsoring the research, i.e via the sales of the product studied, like T4.  Even Freedman states:

This array suggested a bigger, underlying dysfunction, and Ioannidis thought he knew what it was. “The studies were biased,” he says. “Sometimes they were overtly biased. Sometimes it was difficult to see the bias, but it was there.” Researchers headed into their studies wanting certain results—and, lo and behold, they were getting them. We think of the scientific process as being objective, rigorous, and even ruthless in separating out what is true from what we merely wish to be true, but in fact it’s easy to manipulate results, even unintentionally or unconsciously. “At every step in the process, there is room to distort results, a way to make a stronger claim or to select what is going to be concluded,” says Ioannidis. “There is an intellectual conflict of interest that pressures researchers to find whatever it is that is most likely to get them funded.”

Hooray for Ioannidi!  Thyroid patients have royally suffered for over 60 years partly due to poor research outcomes favoring T4-only treatment, and we appreciate individuals like this man for exposing the truth! To read the entire brilliant article, go here.

IS ARMOUR CHANGING BACK…OR WHAT IS GOING ON?

Rumors often start on the patient groups, and I usually just note them, and do nothing. But one rumor which continues is that Armour tablets by Forest Labs seem to be back to the old formulation. One gal emailed me and said her bottle seemed to contain both the newly reformulated Armour (harder, unable to do sublingually) and the older version (softer, can be done sublingually.  What’s that about??  It’s odd.

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Namely, by either crushing your tablet with a mortar and pestle, or chewing it up in little pieces, patients are starting to report far better symptom relief!! i.e., this process is probably breaking down the ridiculous coatings and cellulose and allowing your body better access to the desiccated thyroid within.

And if you just can’t stomach the pulverized pill method, add a touch of honey to the powder, and lick it all up.

Let us know how it works for you!

Want to see the newest Question & Answer page on STTM? Go here.

PREVIOUS BLOG POSTS:

To read my Editorial Response, go here (or if you are reading this on the blog, right below)
To read my informal survey on the new Armour, go here.
To read UK Sheila Turner’s Guest post on those who criticize self-treatment, go here.
10 reasons thyroid patients are frustrated, angry and sick, here.

Why did they do this? It could be strongly related to the fact that in late 2007 through 2008, patients who used the 3 grain tablets reported they were suddenly and entirely ineffective. So, many of us surmise that Forest was attempting to “improve” (cough) their product.

Says one of those patients:  I had switched to the 3 grain tablet months before to save money and I used my pill cutter to cut it in half.  Then around November, my work pants were getting tight and I would come home tired, achy and weak. It didn’t take me long to figure out that Armour in the 3 grain was now like a sugar pill!

In the meantime, Forest brought out the newly formulated Armour, & patients who finished their old batch started the new batch. And since then, it appears a large body of patients have run as fast as they could to Naturethroid, or compounded, or T4/T3 or Erfa. The reason: a return of former hypo symptoms on the “new” Armour.

I have completed an informal survey with 24 individuals responding, and asked the following questions. After each question, I give a summary of the answers.

1. How long of doing well occurred on the newly reformulated Armour before you started to notice that you weren’t doing well?

Most answers are in the area of 2-3 months, with three saying a month, one 4 months, and three stating a few weeks. And comparing this to comments we’ve been seeing for the past year on patient groups, it’s common to feel good at first, but to crash within that 2-3 months.

2. What clued you in that you weren’t doing well on the new Armour?

The answers are all over the map: fatigue and exhaustion, hair loss, brain fog, weight gain, sleeping problems, constipation, achiness, depression, hormonal problems, moodiness, dry skin/elbows/thumbs and cracking skin, flaking fingernails, heart irregularity, forgetfulness. Five report skin breakouts similar to poison ivy.  Fatigue and hair loss were the most common answers.

3. Did you try raising it? What were the results?

The majority tried raising it, and results were: no results; barely made any difference: more energy but skin was a mess. The majority said nothing happened. Two doubled it with no significant results.  Two developed fast heart rate with no improvements elsewhere. One had to lower it because of a very low TSH. One stated she raised it to get her labs back up to where they were before…with little improvements.  And one said it made her too hot to continue raising it.

4. Did you try adding T3 to it? What were the results?

All said no. One said she tested here RT3 ratio and it was 11, which is bad.  One stated she asked her doctor for T3; he said no. I’d sure like to find someone who did add T3 who could tell us the results.

5. Did you do anything else to try and make the reformulated Armour work, and did it help?

All reported nothing helped enough.  Many stated their doctors tested for other problems, ranging from heavy metals, low iodine, B12–the latter helped one gal’s tingling. One stated her doc put her on Aprotocol for the digestive tract which helped the constipation but nothing else changed. One added compounded desiccated thyroid to her Armour—it didn’t help. One gal tried Thyro-care, which helped. But she and two others report getting a poison-ivy like skin rash on the new Armour.

Currently, we see newly diagnosed patients put on the new Armour, and veterans can’t help but wonder what will happen to them.

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On my April 17th blog post, read 10 reasons thyroid patients are still frustrated, angry and sick. That is followed by the April 19th blog post Should thyroid patients avoid self-treatment at all costs, with an interesting and strong Guest Post by Sheila Turner of TPA-UK and a good followup to the former 10 reasons post.

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(This post garnered a lot of attention, up to FIFTY comments just a few hours after it went up. People are very interested in sharing their experiences in coping with the shortages! See below and add your own.)

This year will go down in history as shockingly miserable for enlightened thyroid patients on natural desiccated thyroid.

First came a reformulation in the most popular brand–Armour by Forest Labs. Patients worldwide in groups and forums reported a serious return of their hypothyroid symptoms on this product. A huge disappointment.

Second came the production shutdown of the two generic makers of desiccated thyroid: Time Caps Labs and Major Pharmaceuticals. It’s the first step in the FDA’s compliance plan to corral all grandfathered-in drugs (drugs already in existence when the the FDA was created in 1938) and make them each prove the efficacy and safety of their medication via very expensive clinical trials.  i.e. over 110 years of safe and effective use of desiccated thyroid is not enough for the FDA?? We are still waiting to see the outcome of that plan with RLC  and Forest Labs.–the two who were actually in existence before 1938.

Third came demand being greater than supply and shortages. Because of informative patient websites like Stop the Thyroid Madness,  Sheila’s TPA-UK, Lyn’s ThyroidUK, Stephanie’s Natural Thyroid Choices, some areas of about.com (and other good websites I don’t mean to miss here), plus many fine patient forums and groups,  patients found out why they had continuing symptoms on T4 thyroxine, and demand for natural desiccated thyroid grew exponentially.

STTM then created a list of options for all thyroid patients until the shortages resolved themselves, and also created CDT (Coalition for Desiccated Thyroid) where patients could discuss alternatives in a supportive and factual atmosphere.

And we’ve seen some interesting experiences and comments:

The new Armour: One grain tabs started to appear on some pharmacy shelves the past month.  Other pharmacies have still been waiting.  Many patients appear to have switched to other alternatives, though. One gal still on it feels she is finding success by adding T3 to the amount of new Armour she is on.  Time will tell if patients can ever find success with the newly formulated Armour, and most feel it’s a huge loss.

Naturethroid and Westhroid: Patients reporting on their switch to either of RLC Lab’s two identical products report doing well, having to raise it slightly or lower it slightly, or just not liking them at all. Others have had a hard time finding it on their pharmacy shelves, but have been seeing some appear in the last few weeks.

Erfa’s Thyroid from Canada: When it became clear that the FDA was allowing this excellent product to be shipped to patients, many switched and had their prescriptions faxed to a Canadian pharmacy. Prices at many of those pharmacy websites were doubled after prescriptions started to come in from the US. Most patient who stuck with it seem to love it, reporting you can do it sublingually, as well. A few haven’t been impressed, but were finding their former success by raising it.

Compounded desiccated thyroid: In spite of being a more expensive option, some patients found success with this. Others learned they preferred the filler to be Acidophiles.  If not the latter, Microcrystalline Cellulose was preferred over Methyl Cellulose–the latter which appeared to lessen the effectiveness of the compounded thyroid.

Synthetic T4 and Synthetic T3: some patients switched back to the synthetic combination, but many report that it hasn’t been as effective as desiccated thyroid was.

Other options: Patients moved to OTC products like Nutri-Meds, etc, which can be much weaker. Others sought desiccated thyroid from other countries and have found success.

So I’d like to hear from all of you.   Did you go back to synthetic T4?  What desiccated thyroid did you switch to? What worked and why? What didn’t work for you and why?  What product do you hope to switch to once you run out of your current meds?

She spoke with Lena Choe of the FDA. She is a pharmacist in the Division of Drug Information at the FDA.

Choe stated that they are not taking current action with Forest Labs and RLC Labs in regards to Armour and Naturethroid. Instead, they will simply be requiring them to go through the New Drug Application process, and they will require data. Data is possibly referring to the clinical trials that both companies will have to perform to get results on the efficacy and safety of desiccated thyroid.

Choe stated that the FDA is very aware of problems with Armour and will be looking into that eventually. The FDA takes priority actions on medications based on consumer complaints.

A comment which I found hopeful from Choe was her knowledge that desiccated thyroid has already been used in humans since the 1962 amendment. That’s a good track record of 47 years, folks, that the FDA is referring to. Of course, many of us also know that Armour had a good track record since the 1890′s.

1962 represents the year the FDA established the “Drug Efficacy Amendment”, also called the Kefauver Harris Amendment. The amendment requires that pharmaceutical drug manufacturers provide proof of the effectiveness and safety of their drugs before they can receive FDA approval, aka clinical trials and the data that results. The amendment also requires accurate marketing information on side effects (think Bob and erectile dysfunction on those irritating, nauseating commercials).

And again, it still appears as I stated below that both Major and Time Caps were told to cease production due to being “new” companies since 1962 producing desiccated thyroid. That is a different issue than RLC and Forest.

Hang onto hope, folks. Because by the limited information everyone gets when they call the FDA, it points to a good reason to feel positive, not to think the worst…at least for me. Sure, it’s maddening they would shut down whatever production was left of desiccated thyroid. And it’s equally frustrating that we hang by threads as far as FDA communication. But right now, as I also thought a few days ago, I don’t think the FDA is shutting down production of RLC and Forest, or will during the NDA process. We just have to wait for supply to catch up, especially with RLC. So we’ll see what passes.

No, they are not ceasing to make desiccated thyroid. They just weren’t prepared for the high demand due to the reformulation of Armour and problems it caused.  And they aren’t keeping up and won’t for several months.

So, if you can’t last with your current prescription for several months, you will probably need to talk to your doc about getting a generic version by Major Pharmacy, or get some over-the-counter like NutriMeds, or even the “Hypo Support Formula” made by RLC Labs, but expect to take much more of either.  Many patients are also mentioning Thyroid-S by Greater Pharma as a backup until RLC catches up.  But it’s by mail order and will take a few weeks to arrive.  Google any of the above. Finally, you can move a slight step backwards and talk to your doc about doing synthetic T4 and synthetic T3.  It’s not going to be quite a good as being on desiccated thyroid, but it’s certainly better than being on T4 alone, don’t you agree?? Keep connected to your doc.  And hang in there. This will pass.

Janie

P.S. I’ll be adding more information to this post tomorrow. Check back.

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Below is the actual release by RLC Labs:

For any patients experiencing difficulties in attaining either Nature-ThroidTM or WesthroidTM through their pharmacy, RLC Labs, Inc, asks these individuals to have their pharmacy contact us directly at 877-797-7997 to place an order, or have their pharmacy request a drop-shipment through their wholesale supplier.

RLC Labs’ products are only available through wholesalers, pharmacies and or their doctors; thus all confirmations and/or tracking information will only be available through the wholesaler, pharmacy, or doctor’s office that placed the order.

RLC Labs is experiencing a substantial increase in orders for Nature-ThroidTM and WesthroidTM. The recent unexpected influx has inundated our customer service and shipping departments, thus causing delays and depleting our current stock. We are working around the clock to fulfill all current orders; however, we cannot guarantee that
any future orders will be fulfilled until our stock is replenished.

RLC Labs will continue to accept orders from our customers, however as of Friday August 14th, we are backordered on all strengths of Nature-ThroidTM and WesthroidTM. Shipment is expected to resume within 90 days.

We regret to inform you of this situation; however, we can assure you that we are working diligently to replenish our stock and will resume shipping as soon as possible. Please accept our sincerest apology for any inconvenience.

We do understand how much of an impact this has as most of us employed @ RLC Labs, are hypothyroid and take our own product. Thus, we know and understand how important it is to get product back into the market place. We are grateful for your continued patience, patronage and support!

Feel free to contact our customer service department with any questions concerning this matter @ 877-797-7997.

Thank you from all of us @ RLC Labs, Inc.

Numerous and ongoing comments to my blog posts below about the newly formulated Armour are shocking and despairing.

Additionally, thyroid patients are crying out about the loss of being able to do Armour sublingually. (Was Forest Labs not paying one hoot of attention to thyroid patients the last few years in their praise of Armour because of it’s sublingual effectiveness??) Sublingual administration was a godsend for thyroid patients who had digestive issues, including gluten intolerance and Celiac, as well as those who needed to take iron tablets (which you can’t do at the same time as you swallow desiccated thyroid, but could do with taking Armour subingually)

So how in the world did Forest Labs get away with reformulating and producing a product that so many patients are reporting to be problematic?

It’s not FDA approved. As many of you may know, Armour desiccated thyroid, even when it was produced by a pharmaceutical other than Forest Labs, was around far before the FDA (Federal Drug Administration) came into being in 1938.  That’s why it does not have the designation of  “FDA approved” as do those drugs which were created after the FDA existed. It’s called an unapproved drug, but Armour was presumed to be safe and effective already.

From the FDA: Under the 1938 grandfather clause (see 21 U.S.C. 321(p)(1)), a drug product that was on the market prior to passage of the 1938 Act and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that Act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.

Because it’s not “FDA-approved”, it does not have an NDA, aka New Drug Application. An NDA is used by the FDA to establish if the pharmaceutical product is safe,  EFFECTIVE, more beneficial than side effects, and has in-house  “controls” which maintain the quality, strength and purity of the product. (Thanks to “Ben” the pharmacist for reminding me of this.)

So…without that NDA, Forest Labs is, and has been, on their own, including with the latest introduction of a newly formulated Armour. So you might say, WE as patients were the guinea pigs.  And sadly, we’ve been squealing and it’s a muddy picture.

The most important fact to state: USP (United States Pharmacopeia) desiccated thyroid is an effective and important drug which is changing the lives of a huge and growing body of individuals around the world. That was evident before Armour was reformulated, and is still evident with products like Naturethroid or Westhroid, which many patients are switching to.  See my blog post about Naturethroid here, plus RLC Labs comment about Naturethroid here.

But something has gone terribly wrong with the reformulation of Armour, and patients appear to be leaving it behind in the dust in favor of another great and effective brand like Naturethroid. And whether it’s the fillers are not, Forest needs to take a new look at their reformulation of what was once a GOOD product, and hopefully this time, LISTEN TO PATIENTS.

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*SALE! Stop the Thyroid Madness T-shirts are now 50% off just because I like sales. A great way to spread the word about our patient revolution for the superiority of desiccated thyroid over T4-only meds. You’ll also see funny bumper stickers. Also…when you order the STTM book and request it (i.e. you have to request it),  you get a Calvin peeing on….(you’ll see) bumper sticker for FREE, and it’s a hoot.