naturethroid tags

I have been watching with interest the past week about the justified ire of patients being expressed all over patient groups in the internet. And in case you’ve been too busy with school starting or end-of-summer activities, it involves one of the nation’s largest mail order pharmacies as well as the largest Pharmacy Benefits Manager (PBM):  Medco.

In a statement you can read right on their website, they state:

1)  there is a “nationwide shortage of porcine-derived desiccated thyroid”
2)  they are “uncertain about continued availability.”
3)  “ask your doctor if a synthetic thyroid medication, such as levothyroxine is right for you.”

In Medco’s direct message to doctors, they state;

1)  desiccated thyroid does not have the U.S. Food and Drug Administration (FDA)  Federal Drug approval”
2)  the FDA  “may remove any remaining unapproved products from the market.”
3)  the shortage is due to this “uncertainty”.
4) “the American Association of Clinical Endocrinologist recommends levothyroxine over desicccated thyroid, liotrix, combination of thyroid hormone, or triiodothyronine (T3) for the treatment of hypothyroidism.”

Clarification on their statements

If you are just now finding out about this,  do note the following:

1) There is not a nationwide shortage of all desiccated thyroid. There is a shortage of Armour because of its 2009 reformulation. (See my blog posts below about problems with the newly formulated Armour.)
2) Naturethroid by RLC Labs continues to be available. They are working hard to keep up.  See my post on Naturethroid.
3) Desiccated thyroid was around long before the establishment of the FDA, so they are grandfathered in and still work with the FDA guidelines.
4) There has been no statements by the FDA that they are removing desiccated thyroid.

An even more important revelation in this entire Medco scandal

There is actually an underlying message in the entire Medco fiasco that you should find even MORE disturbing: the continued  promotion of T4, aka levothroxine, as an adequate treatment of hypothyroidism.  And this is not just a faux pas of Medco, it continues to be the ignorant opinion of far too many doctors, medical schools and medical boards. All you have to do is look at what has happened in the UK with the Royal College of Physicians to see the idiocy abounding.

Over 100 years ago, desiccated thyroid was found to be an excellent treatment for hypothyroidism.  I give precise details about the first use of desiccated thyroid in Chapter 2 in the Stop the Thyroid Madness book. It worked!

But in the early 1960′s, the tide turned thanks to a batch of desiccated thyroid that turned out not to be what it said it was.  This is documented in the 1970 Pharmacological Basis of Therapeutics.  And pharmaceuticals, especially  Knoll Pharmaceuticals who first tableted levothyroxine aka Synthroid in 1955,  jumped to promote T4-only as a “new and modern medication”.  (See page 41 and 42 in the STTM book).  And doctors and medical schools fell for it hook, line and sinker.

And to this day, levothyroxine continues to be purported as an acceptable and logical treatment choice for hypothyroidism.  But patients all over the world beg to differ.  T4 medications like Synthroid, Levoxyl, Eltroxin, Oroxine and others simply leave all patients with their own unique amount and degree of lingering hypothyroid symptoms, no matter how high you raise it.

I also find it hugely disturbing to refer to AACE (American Association of  Clinical Endocrinologists) as if they are the grand poopah of knowing what’s right for thyroid patients. They are NOT.  Millions of thyroid patients who have switched to desiccated thyroid, T3, or a combo of T4 and T3 will tell them hands-down that they have gotten FAR better results, and most especially with desiccated thyroid like the “old” Armour, and now Naturethroid.

Visiting numerous thyroid patient groups will reveal how patients feel about Endocrinologists they have visited throughout the years.  Their experiences are far from flattering. In other words, with a few exceptions, thyroid patients are NOT impressed with Endo’s.

Medco’s statements are definitely a concern for patients and range from presumptous to unfactual.  But those statements only represent a far wider problem around the world in the medical community.  Clinical presentation and wisdom has been thrown out the window by doctors.  So patients have to continue spreading the word about the far superior treatment of desiccated thyroid, and their problematic experience with T4.

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

***50% off sale!! All STTM t-shirts are now on sale. I love sales. Not only do they help support this site, they are a great way to spread the word. Go here.   Did you know that Laughing Grape Publishing will send a STTM book directly to your doctor?

Numerous and ongoing comments to my blog posts below about the newly formulated Armour are shocking and despairing.

Additionally, thyroid patients are crying out about the loss of being able to do Armour sublingually. (Was Forest Labs not paying one hoot of attention to thyroid patients the last few years in their praise of Armour because of it’s sublingual effectiveness??) Sublingual administration was a godsend for thyroid patients who had digestive issues, including gluten intolerance and Celiac, as well as those who needed to take iron tablets (which you can’t do at the same time as you swallow desiccated thyroid, but could do with taking Armour subingually)

So how in the world did Forest Labs get away with reformulating and producing a product that so many patients are reporting to be problematic?

It’s not FDA approved. As many of you may know, Armour desiccated thyroid, even when it was produced by a pharmaceutical other than Forest Labs, was around far before the FDA (Federal Drug Administration) came into being in 1938.  That’s why it does not have the designation of  “FDA approved” as do those drugs which were created after the FDA existed. It’s called an unapproved drug, but Armour was presumed to be safe and effective already.

From the FDA: Under the 1938 grandfather clause (see 21 U.S.C. 321(p)(1)), a drug product that was on the market prior to passage of the 1938 Act and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that Act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.

Because it’s not “FDA-approved”, it does not have an NDA, aka New Drug Application. An NDA is used by the FDA to establish if the pharmaceutical product is safe,  EFFECTIVE, more beneficial than side effects, and has in-house  “controls” which maintain the quality, strength and purity of the product. (Thanks to “Ben” the pharmacist for reminding me of this.)

So…without that NDA, Forest Labs is, and has been, on their own, including with the latest introduction of a newly formulated Armour. So you might say, WE as patients were the guinea pigs.  And sadly, we’ve been squealing and it’s a muddy picture.

The most important fact to state: USP (United States Pharmacopeia) desiccated thyroid is an effective and important drug which is changing the lives of a huge and growing body of individuals around the world. That was evident before Armour was reformulated, and is still evident with products like Naturethroid or Westhroid, which many patients are switching to.  See my blog post about Naturethroid here, plus RLC Labs comment about Naturethroid here.

But something has gone terribly wrong with the reformulation of Armour, and patients appear to be leaving it behind in the dust in favor of another great and effective brand like Naturethroid. And whether it’s the fillers are not, Forest needs to take a new look at their reformulation of what was once a GOOD product, and hopefully this time, LISTEN TO PATIENTS.

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

*SALE! Stop the Thyroid Madness T-shirts are now 50% off just because I like sales. A great way to spread the word about our patient revolution for the superiority of desiccated thyroid over T4-only meds. You’ll also see funny bumper stickers. Also…when you order the STTM book and request it (i.e. you have to request it),  you get a Calvin peeing on….(you’ll see) bumper sticker for FREE, and it’s a hoot.

Louis Neipris, M.D., a staff writer who has written many fine articles for myOptumHealth.com, recently wrote one article titled Adrenal Fatigue: Is it for real? It appeared on Upper Michigan News, TV 6 website on July 16th and is making the rounds on other sites. His answer to his own question?  “Not really”. He adds  “it’s not an accepted medical diagnosis.”

Oops.

Dr. Neipris, thyroid patients all over the world beg to differ, as do a growing body of colleagues in your profession. Adrenal fatigue, aka low cortisol, has been discovered on the back of a huge body of thyroid patients, wearing them down with  irritability, anxiety, shakiness, feeling dizzy or lightheadedness, sleep issues, sweating, salt craving, nausea in the face of stress, and a host of other symptoms unique to each individual with adrenal fatigue. My personal observation, as a thyroid patient activist, is that up to 50% of millions of thyroid patients all over the world, may have adrenal fatigue, or at the very least, a sluggish feedback loop.

Even worse, the widespread occurrence of adrenal fatigue, especially in thyroid patients, has caused problems when they try raising a far superior thyroid medication called desiccated thyroid. Because cortisol is needed to facilitate the move of thyroid hormones from the blood to the cells, the direct T3 in desiccated thyroid pools in the blood, causing low-cortisol-induced hyper symptoms like a pounding heartrate and irritability. The first-pass treatment then has to start with hydrocortisone like prescription Cortef from their doctors.

Why have such a large body of thyroid patients found themselves with adrenal fatigue and its low cortisol? It’s clear. The TSH lab test sucks, giving one a “normal” reading for years in spite of obvious clinical presentation of hypothyroid symptoms, and pushing one’s adrenals into overdrive with high cortisol and adrenaline to keep the patient going, and ultimately leading to adrenal fatigue.  On page 65 of the Stop the Thyroid Madness book, you’ll read about a 44 year old woman who went 15 years with a “normal” TSH result, in spite of obvious clinical presentation of hypothyroidism, and which led to her own low cortisol. This is not uncommon.

Second, the risk of adrenal fatigue is high due to the inadequate treatment of T4 medications like Synthroid, Levoxyl, levothyroxine, Eltroxin and other T4-only meds. They all leave patients with their own brand and intensity of lingering symptoms of a poor treatment, forcing the adrenals to kick in too long for many.

Even William Mck. Jeffries MD., who wrote the medical classic Safe Uses of Cortisol around 1984, understood the preponderance of adrenal fatigue even without the diagnosis of Addison’s, and the need for physiologic doses of cortisol treatment, or the amount needed by each individual.  And he would certainly be amazed by the explosion of adrenal fatigue that has occurred since then in thyroid patients thanks to the lousy TSH and synthetic T4-only ‘affaire de coeur’ with doctors.

Adrenal fatigue may not be an “accepted diagnosis” by many.  But medical professionals and doctors who think it’s not real or an acceptable diagnosis will have to face a huge body of patients globally who DO have real live adrenal fatigue. And adrenally-fatigued patients can get realllllly hostile and angry because of low cortisol, and be very impatient when you deny their reality.  (You’re going to see a lot of comments to this post which I highly suggest reading.)

P.S. Even desiccated thyroid like Naturethroid and the pre-reformulated Armour are not considered to be the standard of practice for treating hypothyroidism, yet thyroid patients all over the world are having lives CHANGED thanks to it.

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

***Read below why thyroid patients are not happy with Armour and switching to brand names like Naturethroid.

The following comment by RLC Labs, a pharmaceutical which has made desiccated thyroid like Naturethroid since the 1930′s, was sent in a letter to a pharmacy. You may find it interesting as compared to problems so many have reported with Forest Labs and the newly formulated Armour:

We have never had any mandatory or voluntary recall of any of our thyroid medications due to inconsistency in dosages. Our formulation and preparation is able to stabilize the T3 and T4 hormones through its entire expiry period (3 years from manufacturing) providing additional assurance to both physician and patient alike in quality and consistency of our strengths.

Kudos for RLC Labs and Naturethroid! Patients whose lives have changed ten-fold thanks to desiccated thyroid need a good product. (And we’re going to hope down the line that “someone” will create desiccated thyroid in a sublingual form.)

P.S. If you don’t know what has happened to Armour and patient experiences with it, scroll down.

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

*SALE! Stop the Thyroid Madness T-shirts are now 50% off just because I like sales. A great way to spread the word about our patient revolution for the superiority of desiccated thyroid over T4-only meds. You’ll also see funny bumper stickers. Also…when you order the STTM book and request it,  you get a Calvin peeing on….(you’ll see) bumper sticker for FREE, and it’s a hoot.

Once again, I just approved one more comment of someone who has had it with Armour, and is switching.   On the new Armour, she states she has a return of her former hypo symptoms: hair loss, joint pain, fatigue, heart palpitations, low body temps are back, etc.

And you see it happening all over thyroid patient groups on the net.  Many folks are done with Armour.

It’s too chalky. It tastes terrible.  It doesn’t break into smaller pieces well anymore.  It’s lost the ability to be done sublingually. And even worse, it has caused a return of symptoms.

In case you are wondering what this is all about, read the 40 current comments attached to the June 2nd post Trying the Newly Formulated Armour? Before that, you can read my May 7th post Why the party is over with Forest Pharmaceuticals and the current 37 comments.  And especially powerful is the April 28th post Patients say PHOOEY to new Armour formulation and Forest Pharmaceuticals with a current 57 posts.

So what’s their next step?

Right now, doctors of patients on Armour on being asked for a prescription for Naturethroid. Many report it working wonderfully; some state they need a little more to be as optimal as Armour. A small minority aren’t sure about it yet. But overall, the majority are happy.

So let’s get an update of those who have switched: what product did you move to? Is the same amount giving you the same results? Did you have to more to a slightlyl higher amount, or lower amount? Was your pharmacy cooperative for a different brand?  Did you have to explain to your pharmacy that Naturethroid can be drop-shipped directly to them?

P.S. Thyroid patient Cheryl emailed me and said she is sending the above posts about Armour’s problems to practically everyone on her email list, hoping they in turn will send it to their friends, and the word will get out.  If you want to do the same, this post is the most updated, and includes the links to the former posts.

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

*Have depression and you are on a T4 med like Synthroid, Levoxyl, levothyroxine, Eltroxin, etc?? Read the blog post below.