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FDA’s Safe Use Initiative–think they will listen to our cries about T4-only meds?

EarplugsAs a thyroid patient who was profoundly harmed by the use of Synthroid and Levoxyl in the treatment of my hypothyroidism, and as an activist who sees this same harmful truth with potentially millions of other patients, I find this recent news interesting.

But you gotta wonder if they will be wearing noise reduction headsets and ear plugs…or not…when it comes to the scandal of synthetic T4-only medications.  Will they?

Just today, the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) announced the Safe Use Initiative, “a program aimed at reducing the likelihood of preventable harm from medication use”.

Statements I gleaned from this initiative include:

1. Today, tens of millions of people in the United States depend on prescription and over‐the‐counter (OTC) medications to sustain their health–as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse.

2. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use.

3. Medications offer great benefit, but they come with risks. Whenever medications are not used optimally, risks of harm can increase significantly.

4. FDA proposes to identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm.

This initiative is actually far broader than what I gleaned above, and also involves self-abuse, exposure of dangerous medications to children, dire side effects, and more. Five areas are also specifically targeted:  Consumer medication information (CMI), Medication dosing devices, Acetaminophen toxicity, Alcohol-based surgical preps, and Medications in vials. You can read more in the fact sheet.

But if the FDA is going to do their job with this initiative, or do their job overall, you have to wonder if they will listen to and include the problems associated with being treated with a T4-only medication as experienced by millions of patients worldwide. Continuing symptoms of hypothyroidism while on this inadequate treatment is widespread and damaging for many, causing hands reaching deep in pockets to pay for numerous doctors appointments, besides antidepressants, anti-anxiety meds, blood pressure meds, statins, cortisol meds for adrenal fatigue, and other medications which we would have never needed, and would have been preventable, if we had been on natural desiccated thyroid like Naturethroid or Westhroid in the first place.

Many patients on thyroxine, T4-only medications will also report actual hospital visits due to the side effects of a poor treatment.

In other words, thyroxine aka levothyroxine aka T4 treatment has been an unsafe and harmful treatment, causing millions to suffer unnecessary injuries and side effects for over 50 years of its useless and popular use.  It fits the Safe Use Initiative. Or at the very least, it calls for the FDA to listen to patient experience with this lousy choice to treat hypothyroidism.

Listen to us, FDA. Listen and be wise.

P.S. See the blog post below about a genetic reason why so many do lousy on T4.

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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.

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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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** Join the STTM Facebook page for daily inspiration, tips and information. 

** 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/

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Thyroid patients say PHOOEY to new Armour formulation and Forest Pharmaceuticals

armourtabletsugh1 As the “newly” formulated Armour desiccated thyroid pills, made by Forest Pharmaceuticals/Laboratories, have been hitting the market, so are comments coming out from some thyroid patients…and they are not in the least complimentary.

The reason that Armour had been favored by so many thyroid patients among all the desiccated thyroid brands is the ability to take it sublingually.  Sure, Armour was never officially made to be taken sublingually, but it worked.

Sublingual refers to the administration of a medication via the millions of tiny capillaries that line your mouth and mucous membrane. The pill was placed under the tongue and allowed to dissolve–most of it entering the body directly via your sublingual glands, and only a small amount swallowed.

Some patients who switched from swallowing to sublingual noticed the difference, too.

But the beauty of sublingual has gone even farther than noticing anything different. First, it was always a known “baddy” to swallow any pills that might contain iron, estrogen or calcium at the same time we swallowed Armour or any other desiccated thyroid brand. Why? All three interfere with and bind a certain percentage of the thyroid hormones in our stomachs.  We were forced to take any of those hours apart from swallowing our pill. So doing the Armour sublingually allowed us to swallow the above pills, or drink milk, or eat high iron foods, at our own timing and not hours away.

Second, the old formula was usually gone in our mouths within 30 minutes give or take. Now, patients who take their newly formulated pills sublingually (which now has less dextrose and more cellulose) despise the “chalky, pasty, gritty residue” left in one’s mouth.  It also results in Armour taking far too long to be properly absorbed.

Third, those with adrenal fatigue can find themselves waking up with nausea due to the morning low cortisol. And being able to take Armour sublingually bypassed the need to swallow a liquid to take a pill and promote more nausea.

Fourth, those with Celiac disease, and even those with standard low thyroid digestive issues, found sublingual administration to help their absorption of what desiccated thyroid offers, which they didn’t get well if they swallowed the pill.

All in all, the buzz around patient groups or on comments here  about the newly formulated Armour is not complimentary.  It doesn’t work well sublingually. It’s too chalky. It leaves a gritty paste in your mouth.  And patients are highly disappointed.  Let’s hope that one of the pharmaceuticals takes the ball and runs to create a sublingual desiccated thyroid.

What is your experience with the new formulation? Are you still trying to do it sublingually?  Have you found doing Naturethroid sublingually works? Are you switching to Naturethroid or Westhroid out of principal, as many are stating they are doing? Use the comment section and let’s talk.

*Express your opinion to Forest here: 1-800-678-1605, ext. 66297.

*Want to know what’s on Janie’s mind? Want to read the latest about desiccated thyroid and better treatment? Use the Notifications on the left at the bottom of the links.

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I met hundreds of millions of women today…in one woman

bunny Michelle, 40-or-50-something, came over to my house today to go over some paperwork. I hadn’t taken my Armour yet, and I said “Excuse me, I need to pop my thyroid meds under my tongue.”

“Oh, I take thyroid meds, too.  Synthroid” she explained as she was writing on the papers with her pencil.

Now when I hear something like that, being who I am, I’m like a bear in a china cabinet who suddenly smells honey.  So as not to overwhelm,  I casually say “Oh, I used be on Synthroid.” And after a long pause while we are going over the paperwork, I say “Did you know there’s a worldwide patient revolution going on against medications like Synthroid?”

At the point, she raises her head in curiosity.

I then stick my paw in the honey: “You and I and millions have been put on meds like Synthroid and then told we are “normal” because the TSH says so. But all of us have continuing symptoms of hypothyroidism.  It’s a lousy medication. “

And when I laid out what those continuing symptoms were, her eyes got as big as saucers and she was shaking her head up and down in recognition. “Depression, rising cholesterol and blood pressure, easy weight gain, fatigue, less stamina than others, dry hair and skin, feeling cold, etc”, I told her.

And the most profound aspect of Michelle? She lives her life like the Energizer Bunny, going and going and going. She told me she often doesn’t get home until 6 pm doing her job, and she clearly has a lot of professional responsibilities.

But does an active Michelle mean that Synthroid works and is just as good a thyroid treatment as desiccated thyroid? You know the answer. She revealed that she’s quite tired when she comes home, wishes she had more energy, and still has issues with her weight, even though she lost some when she got on Synthroid.

And reading between the lines, it was clear that Michelle is probably on an anti-depressant, a statin, and a blood pressure medication.  And…she clearly has an adrenal problem that’s only going to get worse. She has a terrible time falling asleep at night (high cortisol), and is very sensitive to light and noise (high or low cortisol).

Suddenly it dawned on me. I am sitting across hundreds of millions of women, and some men. I am listening to how millions live their lives–making a living, maintaining a home, loving their spouses and children, interacting with people.  But underneath it all, it’s not a pretty picture. They cope, and they cope again.  And they dish out their money for more medications to treat the very symptoms caused by an inferior medication. And as they age, they’ll pay each of their millions of prices, just as my mother did, and as I was headed.  Energizer bunnies with faulty batteries.

P.S. Barack Obama has a health care reform plan. Will it change the lives of those 50 million with thyroid disease in the US, or will it only continue this T4-only travesty and health care scandal?  Are we headed in the same insane direction as the UK when it comes to T4-only?  Express your opinion.

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