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Tag: compounded

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!

50 replies

Survey on patient experience on the NEW Armour–not a pretty picture

It’s been about a year since Armour desiccated thyroid, a very popular prescription natural thyroid product on the market for decades, was reformulated. Forest Labs stated there were two changes: the raising of cellulose, and the lowering of sucrose.

Why did they do this? It could be strongly related to the fact that in late 2007 through 2008, patients who used the 3 grain tablets reported they were suddenly and entirely ineffective. So, many of us surmise that Forest was attempting to “improve” (cough) their product.

Says one of those patients:  I had switched to the 3 grain tablet months before to save money and I used my pill cutter to cut it in half.  Then around November, my work pants were getting tight and I would come home tired, achy and weak. It didn’t take me long to figure out that Armour in the 3 grain was now like a sugar pill!

In the meantime, Forest brought out the newly formulated Armour, & patients who finished their old batch started the new batch. And since then, it appears a large body of patients have run as fast as they could to Naturethroid, or compounded, or T4/T3 or Erfa. The reason: a return of former hypo symptoms on the “new” Armour.

I have completed an informal survey with 24 individuals responding, and asked the following questions. After each question, I give a summary of the answers.

  1. How long of doing well occurred on the newly reformulated Armour before you started to notice that you weren’t doing well?

    2. Most answers are in the area of 2-3 months, with three saying a month, one 4 months, and three stating a few weeks. And comparing this to comments we’ve been seeing for the past year on patient groups, it’s common to feel good at first, but to crash within that 2-3 months.

  2. What clued you in that you weren’t doing well on the new Armour?

    3. The answers are all over the map: fatigue and exhaustion, hair loss, brain fog, weight gain, sleeping problems, constipation, achiness, depression, hormonal problems, moodiness, dry skin/elbows/thumbs and cracking skin, flaking fingernails, heart irregularity, forgetfulness. Five report skin breakouts similar to poison ivy.  Fatigue and hair loss were the most common answers.

  3. Did you try raising it? What were the results?

    4. The majority tried raising it, and results were: no results; barely made any difference: more energy but skin was a mess. The majority said nothing happened. Two doubled it with no significant results.  Two developed fast heart rate with no improvements elsewhere. One had to lower it because of a very low TSH. One stated she raised it to get her labs back up to where they were before…with little improvements.  And one said it made her too hot to continue raising it.

  4. Did you try adding T3 to it? What were the results?

    5. All said no. One said she tested here RT3 ratio and it was 11, which is bad.  One stated she asked her doctor for T3; he said no. I’d sure like to find someone who did add T3 who could tell us the results.

  5. Did you do anything else to try and make the reformulated Armour work, and did it help?

    6. All reported nothing helped enough.  Many stated their doctors tested for other problems, ranging from heavy metals, low iodine, B12–the latter helped one gal’s tingling. One stated her doc put her on Aprotocol for the digestive tract which helped the constipation but nothing else changed. One added compounded desiccated thyroid to her Armour—it didn’t help. One gal tried Thyro-care, which helped. But she and two others report getting a poison-ivy like skin rash on the new Armour.

Currently, we see newly diagnosed patients put on the new Armour, and veterans can’t help but wonder what will happen to them.

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On my April 17th blog post, read 10 reasons thyroid patients are still frustrated, angry and sick. That is followed by the April 19th blog post Should thyroid patients avoid self-treatment at all costs, with an interesting and strong Guest Post by Sheila Turner of TPA-UK and a good followup to the former 10 reasons post.

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32 replies

Are we running out of desiccated thyroid powder???

And now that I have your attention, here’s the answer straight from the mouth of Kenny Soejoto, Chief Operating Officer of the only North American maker of desiccated porcine natural thyroid powder (American Laboratories): a firm NO!

“We have amply supply and so do the distributors for compounding pharmacists”, underscores Soejoto when I chatted with him today.

He also added in response to the recent shortages:  “We didn’t spare an expense to push it along”.  i.e  “American Laboratories have caught up with all backorders, with the exception of one major company which has tight specifications, but they should be caught up by the first quarter in 2010”, explained Soejoto.

So what about specific rumors we keep hearing??

  1. My compounding pharmacy said they weren’t able to get it. Kenny explained that a small compounding pharmacy often can’t afford the minimum order that American Laboratories requires, nor does the smaller pharmacy want that much, which is an 110 lb drum of powder.  So, says Soejoto, they need to contact their distributor, who is the middle man between a compounding pharmacy and American Laboratories. “The distributor for compounding pharmacies, “ explained Kenny, “will buy the larger amounts, make smaller packets, and then sell those to the compounding pharmacies”.
  2. American Laboratories can’t be the only North American makers of powdered thyroid because my compounder told me a different name. The different name you heard is the middle man mentioned above–a distributor for the thyroid powder to the compounding pharmacy. But that distributor got their supply from American Laboratories.
  3. My regular pharmacy said there is a supply issue for the brand I wanted. Again, Kenny explains there is no supply issue–they have plenty. Any pharmaceutical company that makes desiccated thyroid has to have ongoing credit worthiness and documentation before AI can sell to them. Also, we are simply experiencing continued demand being greater than supply, and it can take time to catch up.  i.e. there may be more to the story than you hear under any comment about a supply issue problem.

In conclusion, Kenny Soejoto said they simply got into trouble from the growth of interest in desiccated thyroid the past few years, and they are much better prepared. Even Europe is inquiring more about it, he said. And my response to him?? Get ready, because you are doing millions of potential thyroid patients a HUGE favor by making it,  and we’re going to continue to spread the world about natural desiccated thyroid.  🙂

Check out posts below about other important issues, including more from Erfa, plus the problem of cellulose in compounded and regular desiccated thyroid.

*HO HO HO! Have a STTM book sent to someone  you care about as a CHRISTMAS or HOLIDAY present. A card will be included, and the book will be in an envelope with a red bow!! Save money the more you buy!

12 replies

How are YOU doing with the current desiccated thyroid shortages?

Pills Spilled Shortages

(This post garnered a lot of attention, up to FIFTY comments just a few hours after it went up. People are very interested in sharing their experiences in coping with the shortages! See below and add your own.)

This year will go down in history as shockingly miserable for enlightened thyroid patients on natural desiccated thyroid.

First came a reformulation in the most popular brand–Armour by Forest Labs. Patients worldwide in groups and forums reported a serious return of their hypothyroid symptoms on this product. A huge disappointment.

Second came the production shutdown of the two generic makers of desiccated thyroid: Time Caps Labs and Major Pharmaceuticals. It’s the first step in the FDA’s compliance plan to corral all grandfathered-in drugs (drugs already in existence when the the FDA was created in 1938) and make them each prove the efficacy and safety of their medication via very expensive clinical trials.  i.e. over 110 years of safe and effective use of desiccated thyroid is not enough for the FDA?? We are still waiting to see the outcome of that plan with RLC  and Forest Labs.–the two who were actually in existence before 1938.

Third came demand being greater than supply and shortages. Because of informative patient websites like Stop the Thyroid Madness,  Sheila’s TPA-UK, Lyn’s ThyroidUK, Stephanie’s Natural Thyroid Choices, some areas of about.com (and other good websites I don’t mean to miss here), plus many fine patient forums and groups,  patients found out why they had continuing symptoms on T4 thyroxine, and demand for natural desiccated thyroid grew exponentially.

STTM then created a list of options for all thyroid patients until the shortages resolved themselves, and also created CDT (Coalition for Desiccated Thyroid) where patients could discuss alternatives in a supportive and factual atmosphere.

And we’ve seen some interesting experiences and comments:

The new Armour: One grain tabs started to appear on some pharmacy shelves the past month.  Other pharmacies have still been waiting.  Many patients appear to have switched to other alternatives, though. One gal still on it feels she is finding success by adding T3 to the amount of new Armour she is on.  Time will tell if patients can ever find success with the newly formulated Armour, and most feel it’s a huge loss.

Naturethroid and Westhroid: Patients reporting on their switch to either of RLC Lab’s two identical products report doing well, having to raise it slightly or lower it slightly, or just not liking them at all. Others have had a hard time finding it on their pharmacy shelves, but have been seeing some appear in the last few weeks.

Erfa’s Thyroid from Canada: When it became clear that the FDA was allowing this excellent product to be shipped to patients, many switched and had their prescriptions faxed to a Canadian pharmacy. Prices at many of those pharmacy websites were doubled after prescriptions started to come in from the US. Most patient who stuck with it seem to love it, reporting you can do it sublingually, as well. A few haven’t been impressed, but were finding their former success by raising it.

Compounded desiccated thyroid: In spite of being a more expensive option, some patients found success with this. Others learned they preferred the filler to be Acidophiles.  If not the latter, Microcrystalline Cellulose was preferred over Methyl Cellulose–the latter which appeared to lessen the effectiveness of the compounded thyroid.

Synthetic T4 and Synthetic T3: some patients switched back to the synthetic combination, but many report that it hasn’t been as effective as desiccated thyroid was.

Other options: Patients moved to OTC products like Nutri-Meds, etc, which can be much weaker. Others sought desiccated thyroid from other countries and have found success.

So I’d like to hear from all of you.   Did you go back to synthetic T4?  What desiccated thyroid did you switch to? What worked and why? What didn’t work for you and why?  What product do you hope to switch to once you run out of your current meds?

107 replies

FDA is not requiring form when you order Erfa’s Thyroid

CloudSilverLiningSometimes there is a silver lining with the storm cloud of backordered US desiccated thyroid.

Erfa, the makers of the Canadian version of natural desiccated thyroid, simply called “Thyroid”, has recently announced that the FDA is not requiring the extensive FDA Form 1572 from US citizens and their doctors when they fill their prescriptions from Erfa directly. i.e. it’s now a lot easier to get your prescription filled directly from them.

http://www.erfa-sa.com/thyroid_usa.htm

And those who have started to use Erfa’s Thyroid report being quite pleased. A cherry on top is that Thyroid has that old sweet taste we used to all like with the old Armour, and it can be done sublingually as well! You can see the ingredients here.

Also, I am continuing to get emails from patients that both Armour and Naturethroid is starting to appear on pharmacy shelves, even if in small quantities.  I’m personally not too excited about Armour reappearing if Forest continues to make the reformulated version. Just too many patients reporting a return of hypo symptoms, even when they raise it, plus new symptoms of undertreatment and/or challenged adrenals thanks to the reformulated version. Sad. Oh how we will all miss the old Armour.

In the meantime, here are options for thyroid treatment we all have until we see a good return of desiccated thyroid, including Naturethroid and Westhroid. They are all far, far better than being on T4 alone like Synthroid, Levoxyl, levothyroxine, et al. You’ll also note compounded thyroid, which can be a good option, and you can read about on a recent blog post.  Australians happily use compounded in their own country. Any option you and your doctor choose may mean a readjustment by your body, by the way.

Want to talk to other patients on how they are dealing with the shortages? Join the Coalition for Desiccated Thyroid.  Or if you simply need patient feedback about your hypothyroidism, go to the Talk to Others page.  Remember that no patient group is meant to be a substitute for your relationship with your doctor.

**The next Thyroid Patient Community Call will be held Thursday Oct. 8th on TalkShoe, and our topic will be iodine and your thyroid with patient expert Stephanie Buist. Come join us and listen right on your computer, or you can also talk live to Stephanie or Janie with your questions.

30 replies