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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.

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This is not the time to wield pitchforks and torches

The subject line of this post was just given to me in an email by a wise and cautious person. And I agree with it.

We have facts. We know that Time Caps Labs cannot make desiccated thyroid. We have read, without seeing the actual press release, that Major Pharmaceuticals has been told to stop. I’d sure like to see this release….

We know that Armour didn’t work well for most and became hard to find. We also know from RLC, makers of Naturethroid, that there is at least a 3 month backorder.

And, we know from American Laboratories that they are making the production of desiccated thyroid powder their #1 priority. Demand was greater than supply.

But beyond that as I write this, we know no more. And to speculate in only a negative direction can be a disaster. To march with our pitchforks and torches is only shining a spotlight in the direction of the FDA, and they may not be friendly.

There are positives. ERFA has allowed us to order their Canadian thyroid. There are other sources out there which I have mentioned below, as has health writer Mary Shomon.

And there are other facts: hundreds of thousands of us, if not into the millions, KNOW that desiccated thyroid really is safe and VERY effective. We KNOW that endocrinologists are totally wrong in their opinions.

So, what you can do is put emphasis on the latter FACT of effectiveness when it comes to you. Write your story.  Give a “”before on T4 and an “after on Desiccated thyroid”. Then send it to me for the Stories of Others page. IF…..and I say IF….something drastic happens from the FDA, we then start providing out testimonies and do what we need to do…one after the other after the other. That is our strength.  Facts, concern, but not panicking and carrying pitchforks and torches which may backfire on you. This is not yet the time, if it even passes.

Janie

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More good info on Canada’s “Thyroid” by Erfa

erfathyroidJust had a good conversation with Dr. Henri Knafo, the Director of Medical Affairs at Erfa Canada, Inc.

On my post below from yesterday, you will see hopeful information on getting this excellent Canadian desiccated thyroid. And below is more information you have been asking for as patients who know the efficacy of desiccated thyroid.

Erfa’s “Thyroid” comes in three strengths: 30 mg, 60 mg, and 125 mg.  Amounts you can order, and costs, are as follows:

30mg             500 tablets  $52.00 US;    100 tablets $18.00 US

60mg             500 tablets  $70.00 US;    100 tablets   $39.00 US

125mg          500 tablets  $100.00 US;   100 tablets  $ 50.00  US

Erfa will charge a 10$ handling fee (for first time users) and shipping is around $20 US.  Knafo states the prices are equivalent to Armour.

Erfa’s Thyroid has been in production for 30 years and they have 5000 Canadian patients on it.

Erfa’s Thyroid is approved by Health Canada (their equivalent to FDA).  Erfa spoke to the FDA, and in order for their desiccated thyroid to cross the US border, you have to fill out and sign the FDA patient study form which is mentioned below.

Erfa’s Thyroid is made in Europe with the raw materials, and they bought an excess of it. So there will be no problem getting it and they expect no shortages the rest of the year.

One canadian pharmacy you can use (and is not associated with Erfa) is the Canada Pharmacy Online.

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Good news! You can get good desiccated thyroid from Canada.

erfathyroid

NOTE: when this blog post was written in 2009, it was good news to mention the Canadian brand of NDT, made by the company called Erfa. But sadly beginning in 2014, it seemed to change in a negative way, as reported by numerous patients, even if some still used it. Complaints about symptoms returning fell on deaf ears. There have also been shortages. 

Unfortunately, patients who want to switch to desiccated thyroid from T4-only meds like Synthroid et al, or those already on desiccated thyroid who want to fill their next prescription, are going to find it difficult. There are widespread shortages in desiccated thyroid like Armour, Naturethroid and Westhroid. (see my posts below).

But there’s good news, and it comes in the form of “Thyroid”  by Erfa.

Erfa’s “Thyroid”  is an excellent natural desiccated thyroid product according to the experience of patients who use it. It contains:

  • Dried Thyroid
  • Mag­ne­sium Stearate
  • Corns­tarch
  • Talc
  • Sugar

**Note the “sugar”. Patients also report they are able to do this brand of medication sublingually! That is good news.

The Erfa website states you can obtain their desiccated thyroid medication outside of Canada via a special access program and follow their steps:

For patients outside Canada and the US:

1. Get a prescription from your local doctor (mention hypothyroidism on it).
2. Your doctor should fill in this simple document (not required for the UK)
3. Fax or e-mail us the documents at 1-514-931-7330 or info@ERFA.net

For patients in the US:

1. get a valid prescription of Thyroid from your local doctor
2. your doctor has to fill FDA form 1572 (e-mail us a request at info@ERFA.net
3. Fax or e-mail us the documents at 1-514-931-7330 or info@ERFA.net

Thank you Erfa from Stop the Thyroid Madness and thyroid patients all over the world who KNOW what a superior treatment desiccated thyroid really is!

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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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