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What the recent Medco scandal is actually telling us–i.e. there’s more to this story

medcoI 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?

Patients and wise doctors continue to learn in leaps and bounds

IMG_2008 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.

Why Forest Labs had gotten away with a “newly formulated” Armour that is causing so many problems

Armour tablets

 

This post was originally written in 2009, and gives you great history as to the disappointing change that happened to Armour as reported by patients. But it happened again in 2015, and you can read that here: //www.stopthethyroidmadness.com/2015/09/19/armour-and-unhappy-thyroid-patients/

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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.

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Doctor questions if adrenal fatigue is real….so is it??

Screen Shot 2015-08-13 at 1.26.06 PM(This page was updated. Enjoy!)

In 2009, Louis Neipris, M.D., a staff writer who has written many fine articles for myOptumHealth.com, wrote one article titled Adrenal Fatigue: Is it for real?

It appeared on Upper Michigan News, TV 6 website on July 16th and made the rounds on other sites.

His answer to his own question?  “Not really”. He adds  “It’s not an accepted medical diagnosis.”

Oops. Thyroid patients and a growing body of informed medical practitioners beg to differ.

About the term “Adrenal Fatigue”

Patients in the earliest discussion groups were using the term “adrenal fatigue” right after the turn of the 21st century, probably because they saw it used so often on the internet, as well as referred to in certain books. And we did think that the adrenals became “tired” as a way to explain the low cortisol we outright saw in each other’s saliva results, as well as symptoms. The term “adrenal insufficiency” also fit.

Later, it became more popular with patients to identify the biological cause of our low cortisol as being rooted in a sluggish HPA axis, i.e. the messaging between the Hypothalamus to the Pituitary to the Adrenals. That messaging wasn’t as vibrant as it should be.

Fast forward to the 2014 book Stop the Thyroid Madness II, where the last chapter by Dr. Lena D. Edwards et al does a bang-up job explaining what might really be going on, and which they term “hypocortisolism”. They propose five brilliant and biologically valid reasons why we see low cortisol:

  • a developmental response to high stress
  • a corticotrophin-releasing factor (CRF) receptor down-regulation
  • inadequate glucocorticoid signaling
  • intrinsic adrenal gland dysfunction
  • an adaptive response towards infection or inflammation.

See Chapter 13, pages 291-292 for more details on each of the five. It’s a brilliant chapter on the subject within the STTM II book.

In other words, there are explainable and logical reasons why certain thyroid patients have low cortisol, and it’s very real, whether you call it adrenal fatigue, adrenal insufficiency or hypocortisolism.

The cortisol saliva test

One excellent method, we as informed patients, prove our low cortisol state is by the use of saliva testing. The important aspect of saliva testing has been two-fold: 1) it reveals our cellular level of cortisol, which we’ve noticed has always fit our symptoms (if the facility we use knows that they are doing, as do the ones listed on the Recommended Labwork page which do not need a doctor’s prescription), and 2) it tests us at four key times during a 24 hour period (which is important to see the fuller picture of what our adrenals are doing.)

We’re learned repeatedly, in comparison, that blood cortisol is not the way to go, since with blood, you are measuring both bound and unbound cortisol. And as informed patients, we have noticed that blood cortisol can look high, yet both saliva testing and our symptoms reveal we are actually low, cellularly. We’ve even seen blood cortisol measure low, yet saliva and our symptoms reveal high…even though it’s less common that the other way around. It’s uncanny! Also, with blood cortisol testing, a misinformed doctor will only do one test instead of the needed four.

What has been the impetus behind the low cortisol state of a large body of thyroid patients?

Two very clear reasons:  first, being held hostage to the TSH lab test, 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 the downwards spiral of adrenal fatigue/adrenal insufficiency/hypocortisolism.  On page 65 of the revised 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, Tirosent and other T4-only meds. Because of being forced to live for conversion alone, and missing out on the compliment of all five thyroid hormones, T4-only meds leave a high percentage of patients with their own brand and intensity of lingering symptoms of a poor treatment…sooner or later…forcing the adrenals to kick in for 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 and low cortisol, even without the diagnosis of Addison’s disease, and the need for physiologic doses of cortisol treatment, or the amount needed by each individual’s body to function correctly.  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 some medical professionals.  But today, there are a growing body of open-minded practitioners who recognize its reality as an acceptable diagnosis, and for which we are grateful.  Now our job as patients is to make sure our more open-minded doctors understand what we have on how to treat it! 

JanieSignature SEIZE THE WISDOM

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** Chapters 5 and 6 in the revised STTM book contain the best details about adrenals and treatment in any book. 

** Here’s a page on STTM listing a variety of symptoms related to a cortisol problem: //www.stopthethyroidmadness.com/adrenal-info/symptoms-low-cortisol/

Thyroid tidbit: interesting comment from makers of 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.