• Coalition for Natural Desiccated Thyroid
• desiccated thyroid

Oh 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.

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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

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