• Coalition for Natural Desiccated Thyroid
• desiccated thyroid
• fda
• Thyroid treatment

Wish you could talk to others about relevant facts concerning the current shortage, the FDA’s actions with Time Caps Labs, DESI and the New Drug Application, clinical trials, and related concerns? Have important information to share?

A new group has just been created to work alongside other groups, including save natural thyroid. Smartly called the Coalition for Natural Desiccated Thyroid, it  represents unity of concern and is created for patients, advocates, medical professionals, representatives of pharmaceuticals who manufacture desiccated thyroid, or anyone with an interest in the four aims of this group:

1) Sharing of factual information concerning natural desiccated thyroid
2) Discussion of current issues related to desiccated thyroid
3) Unity among all concerned
4) Coordination of grassroots action where needed.

The discussion, support and action of this group does not limit itself to any one group, advocate, website or forum, and welcomes any mention of information from websites, advocates, medical professionals or etc. which/who post about or have the same concerns as the aims above.

Join the group here: http://health.groups.yahoo.com/group/CoalitionForDesiccatedThyroid

Just spoke with Diane Blecha, who serves as a moderator and patient advocate on the NTH groups.

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.

Hi 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

We always talk about pharmaceuticals who 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: American Laboratories, Inc. (ALI)

ALI is a small 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 40 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.”

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.

This morning, 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 the next few months, 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.

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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

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

*Like sales?? I do. And the STTM t-shirts are now 50% off. Spread the word!!

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.