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Category: Armour

About Canada, 90% flawed medical research, and is Armour changing?

(Though this post was written in 2010, it’s been updated to the present day and time where needed. Enjoy!)

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.

UPDATE: Erfa started to cause problems for patients, which I first reported about twice in 2014, and the most informative post is here. Even into 2016, some patients continued to have problems, but they were lessened.

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.

UPDATE: In 2014, Forest Labs was bought out by Activas, and in 2015, thyroid patients once again reported a return of symptoms and a change in the pills. Armour also tripled in price. Not everyone was experiencing the return of hypothyroid symptoms (perhaps they were still using the Forest made Armour), but enough were they many started to change to other brands. That continued into 2016. Even the tripling of price was enough for patients to say “NO MORE!” Read about it here. .

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65 replies

How to make reformulated Armour and Naturethroid work!

Screen Shot 2015-11-28 at 8.05.11 PMThis was written in 2010, but can apply when a pharmaceutical changes a tablet, such as has happened again to Armour in 2015.

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In case you are missing comments on my previous posts, there is a potential solution to the problems encountered with both the reformulated Armour by Forest Labs, and the reformulated Naturethroid by RLC.

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.

153 replies

Survey on patient experience on the NEW Armour–not a pretty picture

It’s been about a year since Armour desiccated thyroid, a very popular prescription natural thyroid product on the market for decades, was reformulated. Forest Labs stated there were two changes: the raising of cellulose, and the lowering of sucrose.

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?

    2. 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?

    3. 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?

    4. 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?

    5. 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?

    6. 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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32 replies

How are YOU doing with the current desiccated thyroid shortages?

Pills Spilled Shortages

(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?

107 replies

The FDA has spoken

fdaimage

This post was originally written in 2009–interesting that nothing has changed since then.

Just spoke with a thyroid patient who 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 use 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 NDT had a good track record since the 1890’s.

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

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

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

33 replies