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American Laboratories continues to work hard at production.

ALIOn the August 19th blog post, you can read about the only North American manufacturer of natural porcine desiccated thyroid called American Laboratories (ALI). ALI sells to distributors who in turn pack it up in smaller quantities which go to those who create desiccated thyroid products.

I just got off the phone again from Kenny Soe­joto, the Chief Ope­ra­ting Offi­cer at ALI. And the news couldn’t be better. ALI is working hard to catch up and is currently shipping to all their customers. Yes, they are still in a backorder situation due to demand being greater than supply in 2009, but work is in progress, shipments are being made to all, and they hope to see some major catching-up in two months or so.

And his most important comment? “If we had FDA issues, we wouldn’t be producing”. i.e. everything is going fine. 🙂

In the meantime, there seems to be two areas of success right now with getting your desiccated thyroid prescription filled: from Canadian pharmacies, and from Compounding pharmacies. Hang in there. We’ll get past this.

Join us next Friday for our next thyroid patient Community Call via Talk Shoe. See the blog post right below this for information. Below that is information about the Coalition for Natural Desiccated Thyroid, an independent group working alongside Mary Shomon’s efforts, as well.

*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.

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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!

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Erfa’s Canadian “Thyroid” — more details

erfathyroidOn my August 26th blog post below, I reported good information about US patients being able to use their doctor’s prescription to order the Canadian version of natural desiccated thyroid called simply “Thyroid” by Erfa.

And here’s more:

In each Erfa 30 mg tablet embossed “ECI 30”, there is 18 mcg. of T4 and 4 mcg. of T3;

In each Erfa 60 mg tablet embossed “ECI 60”, there is 35 mcg. of T4 and 8 mcg. of T3;

In each Erfa 125 mg tablet embossed “ECI 125”, there is 73 mcg. of T4 and 17 mcg. of T3.

Erfa’s very friendly and helpful Medical Director, Henri Knafo, MD, states that they follow the USP (United States Pharmacopoeia) specifications. But I do see some slight differences. The USP specifications ratio for one grain that we are used to in the US is 38 mcg. T4 and 9 mcg T3, i.e 38/9. The above ratio is 35/8.

Likewise, US patients are used to 2 grains of 120 mgs having 76 mcg of T4 and 18 mcg of T3, i.e. 76/18. In Erfa’s medication of 125 mg, you will get a ratio of 73/17. I don’t know if this will make much of a difference but want you to be aware as you work to adjust Erfa’s desiccated thyroid to the treatment you were used to.

Knapo happily states that most all “Thyroid” is making it across the border to the states without issue. You will need your doctor’s prescription. And by the way, Erfa’s Thyroid is manufactured in Belgium, plus they have a huge supply of desiccated powder.

Erfa is also working with IDIS to get Thyroid to others. You can read about them here.

Need a doctor to work with who will provide a prescription for your needed desiccated thyroid? There are a growing body of good doctors out there. We also have a good list of Canadian pharmacies you can consider using during the current shortages.

I have also received word from a gal that the FDA document 1572, a federal form that FDA requires for over-the-border movement, has not always been used, and Erfa’s medication is arriving fine. i.e. the FDA may be tolerating it.

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

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American Association of Health Freedom has reported on this situation

AAHFBefore I post this, I want to remind everyone that as I am writing this, the FDA has not made an official statement concerning desiccated thyroid, and I want to avoid excessive fear mongering and undue speculation by underscoring that.

But with that being clarified, the American Association of Health Freedom (AAHF) has just today issued an article about the desiccated thyroid shortage that you might find of interest.

Concerning Time Caps Labs and being told to cease production, the article states: The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug. Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product. The purpose? Presumably to protect the profits of other, inferior drugs that have been FDA approved.

And I especially appreciate this comment: As famed physician Dr. Jonathan Wright observes: “Natural thyroid has never killed or severely harmed anyone since its first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.”

Kudos and appreciation from all thyroid patients go to Dr. Jonathan Wright, besides AAHF for giving acknowledgment of this issue!

Better treatment with Desiccated Natural Thyroid has been my main focus as a thyroid patient activist since 2003 and with great conviction. I and millions of others whom this website and book represent know how GOOD this medication is and we definitely appreciate this kind of support. 🙂 Yes, millions of us have had our lives change ten-fold thanks to this safe and effective 110 year old medication. You can read just a touch of those changed lives on the Stories of Others page.

In their Overview, the AAHF explains:

The American Association for Health Freedom (AAHF), currently in the process of merging with the Alliance for Natural Health (ANH), is part of an international organization dedicated to promoting sustainable healthcare and freedom of choice in healthcare through good science and good law. We protect the right of natural-health practitioners to practice and the right of consumers to choose the healthcare options they prefer. Since 1992, we have worked to shift the medical paradigm from an exclusive focus on surgery, drugs and other conventional techniques to an “integrative” approach incorporating food, dietary supplements and lifestyle changes. This is the way to improve health and extend lives while reducing the costs of healthcare back to a sustainable level.

You can read more on their Overview by clicking the link above. And if you need to communicate with anyone, provide facts and all your concerns to your congresspersons. Here’s a template letter to use or change, and there are other good ones circulating in many good thyroid or facebook groups and forums out there.

P.S. Dr. John C. Lowe has also provided a very informative and well-reasoned editorial pertaining to our current shortages.

*Want to be informed about my blog posts? Curious what’s on Janie’s mind? Use the Notifications on the left right below the links.

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Another interesting reply to a patient by the FDA

fdaimageAs thyroid patients are not only in angst about a complete shortage of desiccated thyroid in the US, we all have questions and concerns about out future with no definitive answer.

For example, we wonder if the FDA may be requiring clinical studies from pharmaceuticals who make desiccated thyroid to prove that it’s safe and effective (in spite of the fact that patients have been using it safely and effectively for 110 years. Nope, we don’t count. Amazing, isn’t it?) And we wonder: if studies are required, will they be able to afford the studies, which are quite expensive? Will desiccated thyroid continue to be available while the studies go on? And more uncomfortable questions.

The FDA recently replied to a question by thyroid patient Catherine when she asked about the shortages and here’s their reply:

Dear Catherine:

Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.

We understand your concerns regarding the availability of natural desiccated thyroid products. FDA has NOT taken class action against unapproved thyroid products resulting in a shortage. If a company discontinues manufacturing of an unapproved product, that is a business decision made by the company.

Please refer to the ASHP Shortages website for a listing of desiccated thyroid products that remain available:
http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=459

We have contacted the companies and RLC (manufacturer of West-Throid and Nature-Throid) is in backorder for all strengths and products for the next 90 days.

Major has the 60mg and 120mg available of their “generic” desiccated thyroid product. They report increased demand as the reason for their backorder for the other strengths.

Forest reports they have the 120mg, 240mg, and 300mg strengths available for their Armour Thyroid products and they report increased demand as the reason for the backorder on their other strengths.

If you and your healthcare provider determine that one of these thyroid products is appropriate for you, you can provide the NDC numbers listed on the ASHP website for these products to your pharmacist so they can order for you.

Best regards,
Drug Information SH
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

The interesting thing about the above is that it implies that Major Pharmaceuticals is just on backorder, which goes completely against what patients have reported elsewhere. What’s going on there? Are they using old knowledge? And the larger sizes of Armour? Is anyone finding that at the pharmacies right now? Very curious. Interesting the comment about RLC, the makers of Naturethroid. And the link to shortages is interesting, though from the end of July.

Whatever the answers are, if you need a treatment to get you through this difficult time, here are options for thyroid treatment. And it still may be a very good idea to inform your congresspersons of our situation…just in case. See my blog post below.

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

*STTM t-shirts are 50% off! I love sales.

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