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Tag: FDA-approved

Oh Jolly. Guess What the Endocrine Society Has Spouted This Time?

“A great deal of intelligence can be invested in ignorance when the need for illusion is deep.”  ~Saul Bellow

STTM ignorance graphicAnd here we go again.

On April 1st, 2016 (which is April Fools Day–how appropriate), out comes an article in the Journal of Clinical Endocrinology and Metabolism which presents the latest updated position statement of the Endocrine Society, titled Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement.

In other words, their last position statement on certain compounded medications came out in 2006, and this one trumps that one. And the implication is towards “increased regulatory oversight of all bioidentical hormones.”

Sounds innocuous enough, right? Certainly they are trying to be protective of us, right?

First, in case you don’t know much about the Endocrine Society, it’s existence began a century ago and is today the oldest “largest global membership organization representing professionals from the intriguing field of endocrinology.” Members come from 110 countries representing approximately 28,000 members, with 40 percent of them located outside the United States. They include scientists, physicians, educators, nurses and students. And you’d think that a society with such a vast array of members from 110 countries might have some innate wisdom, right?

Gulp.

The first gist of the article is first about compounded sex hormones…and here’s my summary of their position:

  1. There is no other rationale for compounding your sex hormones other than having an allergy or intolerance.
  2. Compounded hormones are risky.
  3. Compounded hormones are dangerous.
  4. Compounding Pharmacists, who are licensed professionals, are thus dangerous if their product is dangerous.
  5. Reported successful patient experiences (and their improved lab results) with compounded sex hormones has no validity; only “randomized, double-blind, placebo-controlled trials” have validity.
  6. Because there are no FDA-approved testosterone preparations for women, it should be completely avoided…so I guess the opposite logic applies?? i.e. that one should embrace FDA-approved medications like statins or the antibiotic Cipro with all their numerous side effects in all-too-many??
  7. Synthetic estrogen and synthetic progesterone is the way to go.
  8. Big Pharma products are the way to go.
  9. Give all your money back to Big Pharma

If you have a subscription to Medscape, here’s a good summary of what the Endocrine Society stated about compounded sex hormones, including DHEA, but I think my summary above says it all.

But here’s where it really gets nauseating for informed thyroid patients

Says the same Endocrine Society, as outlined in the Medscape article above (instead of my interpretation):

  • Levothyroxine (LT4) is bioidentical and a highly effective and safe therapy and is the treatment of choice for hypothyroidism. The complex tissue-specific deiodinase system converts T4 to T3 and supplies the proper amount of T3 to each of the body’s tissues according to its requirements.
  • Clinicians should evaluate patients with persistent symptoms (despite adequate LT4 therapy) for other causes of their symptoms and encourage patients to engage in healthy lifestyle measures.
  • Some of these patients may benefit from combination LT4/LT3 therapy, desiccated thyroid hormone, or compounded thyroid hormone, as long as symptoms and thyroid-stimulating hormone (TSH) (free T4) are monitored carefully.

Oh really??

To the contrary, millions of thyroid patients from the past 50+ years have noted and/or reported on the following while on T4-only:

  1. Unresolved or accumulating problems like depression, adrenal stress, anxiety, easy weight gain, difficulty losing weight, easy fatigue, poor stamina, easy sickness/slow recovery, joint pain, painful feet, hair loss, dry skin, rising cholesterol, rising blood pressure, heart problems, kidney problems, other mental health issues, and hundreds more as reported here.
  2. A poor conversion of T4 to T3 due to a myriad of real biological and normal life events which can negatively affect that deiodinase conversion of T4 to T3, such as aging, the normal stress of life circumstances, inflammation, low iron, and just plain bad genetics, to name a few. The body is not meant to live for conversion alone!
  3. Lousy outcomes from being held hostage to the dubious “normal TSH lab range” are rampant. The TSH is a pituitary hormone and can never discern if all our tissues and organs are getting enough thyroid hormone from conversion alone.

So all of you who are esteemed members of the Endocrine Society, we as informed thyroid patients who live in our own bodies and have our own intelligence and wisdom,  challenge you to consider the following questions:

  1. Can you really call T4-only “effective and safe” in light of the myriad of continued hypothyroid symptoms that patients have noted or reported for 50+ years while on Synthroid, levothyroxine, Tirosent or any other brand of T4-only…sooner or later?
  2. In light of the fact that T4-only results in numerous organic and tissue problems like depression, a low metabolism, joint pain, high blood pressure, rising cholesterol and so much more…does it really meet the body tissues requirements?
  3. If T4-only meets all the body’s tissue requirements, why does nature cause a healthy thyroid to give not just T4, but also direct T3 and calcitonin?
  4. If all those continued and persistent hypothyroid symptoms on Levothyroxine are due to “other causes” or “unhealthy lifestyle choices”, why in the world do these same individuals see them all go away when they get on Natural Desiccated Thyroid and find their optimal dose (which has nothing to do with the TSH)??
  5. Why is it that when patients are held hostage to the dubious TSH range, they continue to have clear and/or rising hypothyroid symptoms?

JanieSignature SEIZE THE WISDOM

– Have you Liked the Stop the Thyroid Madness Facebook page? It gives you daily inspiration and informative information based on years of thyroid patient experiences and wisdom as record on the Mothership of Thyroid Patient Experiences: STTM!

– You can comment to the Endocrine Society as to their views right on their own Facebook page: https://www.facebook.com/EndocrineSociety/

– Check out this video by Hugh Melnick MD about the superiority of NDT over synthetic T4: https://www.youtube.com/watch?v=muorjvQ4DUE

– Share this blog post below. Let’s spread the word about this!

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Washington spits in your face, anti-depressant problem, and the STTM book is now in German and Swedish!

The US Government is going to confiscate your meds sent from overseas!

Fall is in the US, but as you were enjoying your summer, it happened in a flash:  last July, President Obama signed into law the FDA Safety and Innovation Act (S. 3187). And that Act includes a section that might negatively affect your life as a thyroid patient if you are among those feel forced to get your life-saving natural desiccated thyroid (NDT) or related medications from overseas (because your doctor was too clueless to either prescribe NDT or give you enough thanks to the medical stupidity about the TSH lab test).

i.e. in Section 708, the US government now has the authority to destroy a package of personally imported drugs at their point of entry to the United States…even if you badly need them. And this potentially includes NDT like Erfa coming to us from safe, reputable Canadian online pharmacies by prescription! Or your T3-only from other places. Both the latter are unclear, but it’s a possibility.

And do you know why they state they are doing this?? For your “SAFETY”.  Janie’s eyes rolling here.  Can someone tell me how they know if a thyroid med from somewhere else is “unsafe” simply because it wasn’t made in the US?? Are US-made drugs SAFE??? Give me a break. Ask that of folks whose lives paid big prices because of side effects from our FDA-approved medications like Synthroid and many other NON-thyroid related drugs pushed upon us. It’s all a bunch of Big Pharma-influenced, greedy hooey, say thyroid patients.

Now as far as we know, this isn’t going to affect anything really soon. The US Secretary of Health and Human Services has up to two years to decide how to make the new law a reality. But it may happen far sooner than later in that time frame and I would count on it.

Says Lee Graczyk, RxRights Lead Organizer, “It’s critical for people to stand up and get organized to fight against this harmful regulation!”

Anti-depressant use and your adrenals: not a helpful connection for some

Sure, having depression is not fun and it’s understandable if you want to do something about it. My own mother had depression so bad thanks to her lifelong use of Synthroid that she used anti-depressants her entire adult life. This was long before we, as thyroid patients, discovered the strong connection between low T3 levels in the brain and depression (and a connection which all too many doctors miss!)

She also had an extremely “emotionally apathetic” personality, which I assumed was solely due to the electric shock treatment she had while in her early 40’s in an attempt to reverse the depression. But turns out her impassive and flat personality could have also been from the nasty side-effects of my mother’s long-term antidepressant use. i.e. while they made her “happy”, they also made her more dull, flat and detached. This has been reported by all-too-many patients

But now we are seeing the problems that anti-depressant use can cause for your adrenals. A study done in September 2011 titled Antidepressant use and salivary cortisol in depressive and anxiety disorders reveals that

  1. Tricyclics* flatten your cortisol awakening response
  2. SSRI users** had higher evening cortisol levels
  3. Most antidepressants are associated with distinct alterations of the HPA axis (hypothalamus, pituitary and adrenal feedback loop)

*A common form of Tricyclics is Elavil (Amitriptyline).  **Common examples of SSRI antidepressant (Selective serotonin re-uptake inhibitors or serotonin-specific reuptake inhibitor) include Lexapro, Prozac, Celexa, Paxil, Zoloft, etc) 

The alternation of your HPA axis is a common finding when you peruse several research studies. And it’s even more obvious when thyroid patients with adrenal fatigue start using the T3 Circadian Method. i.e. it can take longer to get the right response from the T3. ***Please note that this is simply providing information in the name of being informed patients, not a recommendation to get off your antidepressant!  Talk to your doctor.

(Speaking of mood issues, a study was done showing cherries help with mood. Who would’ve guessed. You can read about it here.)

The revised Stop the Thyroid Madness book is now in German and Swedish! 

You can read about the translations here and I included an autobiography of each translator!  Please do not comment asking if a particular language is coming. I’ll announce them when the day comes.  If you know someone in Germany or Sweden who could badly use the patient-to-patient information in this book, go here.

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The 2009 FDA Ombudsman report, and why you need to contact the FDA

Good or interesting news is kinda slack right now.

But last week, the ombudsman of the FDA’s  Center for Drug Evaluation and Research (CDER), came out with their 2009 report that I found interesting. The Ombudsman are those who receive and impartially look at any communications from patients to the FDA about medications.

On the fourth page, you find this under the heading Drug Shortages: Desiccated Natural Thyroid does not have FDA approval and it’s availability became quite limited in 2009. Many consumers complained to the ombudsman because of their preference of desiccated natural thyroid as thyroid replacement medication over the FDA approved synthetic versions.

Of course, the above gives a potentially false impression that the shortages were due to the lack of FDA approval–and reasons for this stupidity concerning “FDA-approval” are explained here.

To the contrary, last years shortages may be explained by production issues with the North American producer of desiccated thyroid powder, as well as demand being greater than supply thanks to patients finding out about the superiority of desiccated thyroid over T4-only meds like Synthroid.  The STTM website and book is working, as are numerous good patient groups and forums!

But the above reveals that they are hearing thyroid patients speak.

So with this being a somewhat silent period, waiting to see when the FDA will require RLC (Naturethroid) to do ridiculously expensive clinical trials to prove what patients have already known for 110 years–that desiccated thyroid is safe and effective–it can be a GOOD time to continue communication with the FDA. How? By reporting YOUR EXPERIENCE AND PROBLEMS with T4 for their 2010 report next year. i.e. it will serve to cement why so many did call to state their preference. Here’s how:

If you had depression or other psychological issues while on T4, report it.

If you have rising cholesterol, low ferritin, and/or low B12 because of T4, report it.

If you had dry skin or hair, digestive issues, or aches and pains, report them.

If the quality of your life was lowered on T4, report it, outline it, detail it.

If you got adrenal stress because of being on T4, underscore that lousy truth to them.

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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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Thyroid Tidbit: Did ya notice that various Armour sizes are back??

armour-tabletsI can remember a few people the past year who proclaimed fervently that Armour was being discontinued because of the shortage.  And I chuckle about it.  Hopefully, my previous posts helped calm that fear.

But in case you haven’t heard, those larger sizes are back!  And you can keep track of what’s going via the Forest Pharmaceuticals customer product availability hotline: 1-866-927-3260  As of today, April 19, they state that the one grain tabs (60 mg) and 1 1/2 grains tabs (90 mg) are on backorder, and will catch up with production on April 20th, tomorrow as I am writing this.  We’ll see.

Unfortunately, the new formulation has made Armour lacking in sweetness, and it’s almost impossible to do it sublingually.  Sad. Maybe another pharmaceutical will get the hint. In the meantime, if you swallow your desiccated thyroid, make sure to avoid calcium, iron and estrogen at the same time. And if you’ve been doing it sublingually, and have to switch to swallowing, you may need a tad more.

Remember: if you have any issues with natural Armour desiccated thyroid in the treatment of your hypothyroidism, you can always ask your doctor for a prescription switch to Naturethroid or Westthroid, both fine FDA-approved, US Pharmacopeia standard prescription desiccated thyroid.

Janie

Want to be informed of my posts? Curious what I am raving about as a Thyroid Patient Activist? You can sign up for a Notification at the bottom of the links to your left.

P.S. If you haven’t bought the Stop the Thyroid Madness book yet, wanted to tell you that numerous patients are emailing me, stating they find the book even easier to refer to than this vast website (plus it has more details and information).  So if you want the ease of referral, the book may be the way to go.

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