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Category: desiccated thyroid

Join us every Friday night for a STTM Community Call Talk Show

talkshoeOh boy! You are invited to a Thyroid Patient Community Call on your computer which will be held each and every Friday night for an hour with myself, Janie, as host. We had the first one last Friday and it was fun and informative. No, I didn’t announce it here because I wanted to work on any bugs in the system as we learned to use it.

Here’s a chance to ask questions about shortages of desiccated thyroid, options to talk to your doctor about to treat your hypothyroidism during this shortage period, how to find a good doctor, and more.

Times are 7 pm Pacific, 8 pm Mountain, 9 pm Central and 10 pm Eastern. Just go here: http://www.talkshoe.com/talkshoe/web/talkCast.jsp?masterId=62603&cmd=tc

You can make two choices: just listen to the Audio of the podcast talk show, or call in. Phone number will be right on the bottom. You can register with Talk Shoe and pick a user name, or come in as a Guest.

You’ll also note a chat box. The handy and beautiful gals Darla and Diane will usually be there to guide you. If you want to line up to talk in the queue, you’ll be asked the topic of your conversation in the chat box. As you wait for me to get to you, you’ll be able to hear the talk through your phone, and will need to MUTE your computer sound.

You’ll be seeing guests join us, as well, so watch for each Community Call announcement on the above link. And even without a scheduled guest, you just never know who is going to pop in and chat. 🙂

Come join us! And remember: we are all just patients chatting with patients. This is not to replace the relationship with your doctor in your treatment or for treatment advice. Stick with your doctor for that.

*Want to be informed of these blog posts? Curious what’s on Janie’s mind? Just use the Notifications on the left below the links.

* STTM t-shirts are half price! I love sales!

3 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

An open letter to Mary Shomon

shakinghands2Hi Mary.

You know, I really don’t think this is a time for us to be separate, Mary, in our advocacies. Seven years ago, I went a different direction that I felt was important, and still strongly do, as an activist. That will continue because I believe in what I am doing. You don’t have to agree with my stance, but we can make the choice to work together in what is common between us–supporting the use of desiccated thyroid and helping others with the shortage.

As I see it, Mary, we each have a wonderful legacy. You will always be appreciated for your work as much as many appreciate my work. That will never be taken away.

So why not be united in this fight, Mary, working together to support patients during this shortage. Thyroid patients need us.

Janie

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The only North American maker of desiccated porcine thyroid is working hard

Screen Shot 2015-09-21 at 11.27.57 AM(This page was originally written in 2009 but it has been updated to the present day and time.)

We always talk about pharmaceuticals which produce our desiccated thyroid medication pills like Forest Labs (Armour) and RLC Labs (Naturethroid and Westhroid).

These are also the pharmaceuticals who provide these pills to the local pharmacies we use.

But there is another important link in the chain that proceeds them–the laboratory that makes the actual porcine powder!

American Laboratories, Inc. (ALI)

ALI is a small and family-owned processing company located in Omaha, Nebraska which was established in 1967 by Mr. Jack Jackson and Mr. William Phalen. They have been making desiccated Porcine Thyroid Powder (which is an Active Pharmaceutical Ingredient, API) for over 47 years, as well as 200 natural biologically derived products such as Pancreatin and Pepsin, both digestive enzymes. Their mantra is “Building trust through quality products and service.”

Pertaining to their raw porcine powder, they state:

American Laboratories staff has been dedicated to the manufacture of active Pharmaceutical products for over 47 years, and currently follow all FDA cGMP (21 CFR) requirements or the safe and effective manufacturing of drug products or human consumption. Our stringent raw material quality requirements and highly defined manufacturing process control have aided us in providing category leading status for the drug products that we manufacture.

ALI, as a leading manufacture and supplier of enzyme and natural dried products, is also probably the only North American company to make desiccated thyroid powder. And they will explain that it’s a long and difficult product to make, but they are committed to it. ALI sells product to over 50 countries around the world, as stated below from them!!

Their website underscores:

American Laboratories, Inc. is a family-owned business founded nearly 50 years ago based on our knowledge of providing enzymes, proteins and flavors to various industries. Today, American Laboratories is proud to offer an extensive listing of over 300 products to the Food Processing, Pharmaceutical, Veterinary Health, Nutritional and Diagnostic industries in the United States and over 50 countries around the world. Through our high quality products and customer service, American Laboratories has become an industry-recognized supplier for the products we manufacture.

In August of 2009, I spoke with Kenny Soejoto, the Chief Operating Officer. He explained that supply and demand has been a critical issue, and ALI will be doing everything they can to provide the quality desiccated thyroid powder to pharmaceuticals that they always have. You’ll also see a Press Release come out later today from Kenny and ALI about the issue. I’ll add it below.

The supply and demand issue is outright due to the current patient revolution, represented by STTM and other fine groups and websites, against the sole treatment of hypothyroidism with T4 meds like Synthroid by too many doctors….and in favor of desiccated thyroid as a far better treatment. Demand has grown, and perhaps it caught them by surprise. (That is my comment, by the way, NOT ALI’s.)

Even RLC Labs states that demand for Naturethroid (due to problems with the newly formulated Armour) has quadrupled in the past few weeks. And rightly so! Thyroid patients around the world KNOW FIRSTHAND how much better desiccated thyroid treatment is over T4-only. And word is spreading.

So as we, thyroid patients on desiccated thyroid, face a shortage in 2009, take heart that everyone is working hard to bring supply back to us. 🙂 Also see my post below concerning the bigger issue with Medco, and potential alternatives.

*************************************

Here’s the Press Release below, and it should calm any fears or panic:

August 19, 2009

To our knowledge, American Laboratories, Inc. is the only manufacturer in North America of Thyroid Products for use in Human Pharmaceuticals as an Active Pharmaceutical Ingredient. We have manufactured our Thyroid products for over forty years, and we understand the importance they have to our customers and ultimately the consumer patients. Today, as well as in the future, our Thyroid products will continue to be a strategic part of our business.

Through the years, the world-wide demand for our Thyroid products, as well as our human nutritional enzyme products has increased dramatically. Through careful planning and strict adherence to regulations set forth by the FDA, USDA and other government agencies, we have implemented plans to increase our production capacities. In addition, American Laboratories’ is working closely with our suppliers to help ensure a consistent supply of quality raw materials. We hope that you understand that the process to manufacture the active ingredient takes several months to complete.

Please be assured that we have placed our Thyroid production as our number one priority so that we can meet the demands of our customers.

American Laboratories, Inc
Omaha, Nebraska, USA

JanieSignature SEIZE THE WISDOM

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23 replies

Patients and wise doctors continue to learn in leaps and bounds

IMG_2008 Just when you think we’re full of great information for better thyroid care, there’s still more to learn and find out. Below is information that you might find interesting on STTM.

ADRENALS: For those who discovered via the 24 adrenal saliva test that they needed cortisol support, we have come to realize that some can’t do the ramping up schedule from a small amount to a larger amount without having problems from the feedback loop.

Instead, many simply need to “start” on the higher amount, which would range from 20-30 mg. You can read about that on the How to Treat page, and you’ll note that not one morning amount goes higher than 10 mgs. With the exception of men, higher than 10 mg seems to suppress the ACTH and adrenals too much.

A NEW LOOK: To make the STTM home page more understandable to newcomers, the home page has broken down the information better into separate pages, and also has a new interesting way of using it.

LISTEN TO THIS INFORMATION: STTM has short audio clips you can listen to, or send someone else to, to help understand what this is all about.

STORIES OF OTHERS: Individual real-life stories continue to come in, proving over and over that this revolution for far better care really does work.

FEEDBACK and MORE FEEDBACK: I get emails daily about lives changed thanks to this patient revolution. It’s wonderful to see people finding out WHY they have depression, less stamina than others, rising cholesterol and blood pressure, hair loss plus other lingering symptoms of hypothyroidism left untreated because of the lousy TSH, or undertreated because of the equally-lousy T4-only treatment like Synthroid. I can’t begin to post them all, but STTM does contain a sampling of this feedback.

DESICCATED THYROID BRANDS: Wow, the list is growing for desiccated thyroid brands around the world! We now have listings for Denmark, Germany, Italy and New Zealand, as well as more detailed information on compounded thyroid in Australia. Thanks to all who contributed.

KEEPING UP WITH ADDITIONS TO STTM: In case you didn’t know, there’s a page meant to inform you of what’s added to STTM. I may neglect to list a few additions occasionally, but think I’m pretty close to getting most of them up there.

MEDICAL RESEARCH TO PROVE WHAT WE ALREADY KNOW: Did you know that STTM has a page which compiles research and studies which prove what we as patients already know? It’s not loaded with research yet, but it’s growing. And if you have found more to contribute to that page, use the Contact Me form.

SITE MAP: And bottom line, you can always go to the Site Map, or review the information more compactly in the book, which patients are taking into their doctors offices.

*Want to be informed of these blog posts? Curious what’s on Janie’s mind? Use the Notifications on the left at the bottom of the links.

*Stop the Thyroid Madness T-shirts are now 50% off! I like sales, don’t you? And by wearing these shirts, you’ll never know what seed you put in the mind of someone walking past you who’s still on Synthroid or any other T4 meds, and doesn’t know WHY they have depression, rising cholesterol, easy weight gain, the need for naps, etc. You”ll also find humorous bumper stickers which definitely spread the word.

2 replies