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As thyroid patients, we are continually seeking doctors who understand successful patient experience. It’s not always easy.  So when we do find a good doctor, we’re ecstatic. But little do we know the challenges a good doctor faces!  The following was sent to me by a progressive, open-minded MD, of whose name I have removed to protect him from his own medical board. Be appalled and amazed. I was.

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Janie, it is not infrequent that we are sent messages like this from Pharmacy Benefits Managers. Here is a typical letter with my reply.

Considerations for Your Review

1. Drug Safety Consideration: ARMOUR THYROID Use in Seniors  Our claims record suggests that your older patient is receiving ARMOUR THYROID. Thyroid hormones should be dosed cautiously in seniors due to a potential risk of cardiac effects. Desiccated thyroid products contain variable amounts of T3. T4 and other iodothyronine compounds. Because older patients have a high prevalence of occult
cardiac disease, the Beers criteria generally recommend transition to a safer alternative (e.g.. agents like levothyroxine with more standardized hormone content). Please consider the potential risks versus benefits of therapy for your patient.

Reference(s):
1. Thyroid Agents. In: McEvoy GK, ed. AHFS: Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2008:Sec 68:36.04.
2. Pick DM et al. Updating the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Archives of Internal Medicine. 2003; 163:2716-2724.
3. Semla TP et al. Geriatric Dosage Handbook. 13th ed. Hudson, OH: Lexi-Comp; 2007.

(And this brilliant doctor’s reply:)

Dear  xxxxxxx

Re: Armour Thyroid Products

I invite your attention to the P.I. (product information) in the PDR on levothyroxine (Synthroid). I quote:  PRECAUTIONS “Patients with underlying cardiovascular disease—Exercise caution when administering levothyroxine to patients with cardiovascular disorders and to the elderly in whom there is an increased risk of occult cardiac disease.”

DOSAGE AND ADMINISTRATION

“Caution should be exercised when administering SYNTHROID to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).”

I read your statement that says, “Desiccated thyroid products contain variable amounts of T3 and T4 and other idothyronine compounds.”  Forest Pharmaceuticals has stated their product is standardized as published in the PDR: “ One (1) grain or 60 mg of Armour contains by assay 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3).” I do not ever remember Armour Thyroid ever being recalled for stability or lack of standardization.

However, Synthroid and the other forms of levothyroxine have had significant problems.

SYNTHROID AND OTHER T4 PRODUCTS were subject to FDA NOTICE in the FEDERAL REGISTER: AUGUST 14, 1997 (VOL 62, NUMBER 157). These were the drugs that were not well standardized and were not stable. I quote from the report: “Some of the problems reported were the result of switching brands. However, other adverse events occurred when patients received a refill of a product on which they had been previously stable, indicating a lack of consistency in stability, potency, and bioavailability between different lots of tablets from the same manufacturer.”

Thank you for caring for the health of the patients receiving medications from your company. I request that you check your facts fully before issuing such flyers.

Respectfully,

xxxxxxxxx, M.D.

Cc: FOREST PHARMACEUTICALS

BRAVO TO THIS DOCTOR in the face of complete ignorance!!

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STTM HAS HIRED A PUBLICIST and YOUR HELP IS NEEDED!

Do you value what Stop the Thyroid Madness has given you??  Something has to be done to reach millions of individuals still lingering without a diagnosis due to the TSH, or suffering due to being on T4-only meds! You and I run into them DAILY and don’t even know it!  Or we have many family members in the TSH/T4 category. And the media does NOTHING about this scandal.  STTM has hired a publicist, and you can read about it here. But I can’t do this alone. If you value Stop the Thyroid Madness, please considering helping.

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TPA (Thyroid Patient Advocacy) STILL NEEDS YOU TO REGISTER 

Have you registered for the Counterexamples to T4-only?  So far, 1437 have, and Sheila Turner is determined to get that number to over 2000 at least. There were 900 participants on those flawed studies showing that T4/T3 combination worked no better than T4-only, and we have got to prove our point that this is wrong.  All you have to do is answer 3 very short questions.  http://www.tpa-uk.org.uk/register_of_counterexamples.php

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Even tho I saw this mentioned by a patient here or there on patient groups, and later saw it mentioned elsewhere on the net, I have been very hesitant to talk about it on this very widely-read website called Stop the Thyroid Madness.

Namely, there is a new US-made natural desiccated thyroid product out there. It’s considered generic, and is being actively substituted for Armour when patients go to pick up their Armour at the pharmacy.  It’s made by Acella Pharmaceuticals LLC in Alpharetta, Georgia, which was formerly Brookstone Pharmaceuticals. And I just found out that the inactive ingredients are listed as calcium stearate, dextrose monohydrate, maltodextrin and mineral oil.  Anybody see cellulose in there?? Neither do I. Very nice.

It also contains the same T4/T3 amounts we are used to in the 60 mg, one grain tablet: 38/9. Oh, and it’s still called an “unapproved drug”.

Now before you get all ticked off at me for NOT wanting to talk about it here as it has been done elsewhere, understand this: last year, we saw the FDA shut down ALL generic production of desiccated thyroid. The implication was that ONLY ones around since the 1930′s (Armour and Naturethroid) were allowed to exist, being an unapproved drug.  So…I worried that by mentioning it, we might give TOO much attention to a new one and see THIS ONE shut down.

But right now, I am seeing information about it on certain medicine website, including this one connected to our government.

Don’t ya just love the way things happen with a medication that turns lives around and we know NOTHING as to whythey are happening or when from the FDA?? Pitiful, typical…and sad.

***If you want to talk about this new generic version, which some patients are accepting in place of Armour and trying, go to the NTH (Natural Thyroid Hormones) yahoo group here.  It’s so new that there’s not a lot of feedback yet from folks, but I suspect we’ll start to see more and more.

P.S. If you have been through any long-term stress, you need to know that your cortisol will go high to help you cope, and in turn, it can drive your potassium and magnesium levels low. That happened to me this year as I went through prolonged stress from the economy.  So be sure and get those tested, and specifically the RBC (red blood cell) rather than serum. The RBC tests will show what your cells have.

HAPPY NEW YEAR, 2011!

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As we enter another wonderful year, the Stop the Thyroid Madness website couldn’t exist without your donations to the hosting fees, which have grown substantially due to the popularity of this patient-to-patient informational website. If you have benefitted from STTM, please consider donating to the fees here.  And thank you, since your donation assures that other will benefit as you have.

As the United States approaches Thanksgiving, it’s appropriate to offer our thanks as thyroid patients to the following:

THANKS go to the American Thyroid Association (ATA), who in their Nov. 10th email newsletter, had a NATURE-THROID desiccated thyroid ad right under their logo and gave us a great chuckle! Why? The ATA has always rigidly recommended T4-only medications and the TSH–both which have failed too many thyroid patients for sixty years. Loved your faux pas, ATA, in the name of making $$!! Are we going to see it again? Huh??

THANKS to Forest Labs, who though patients feel they ruined one of the oldest and best desiccated thyroid medications ever made when they reformulated it in 2009, gave thyroid patients the memory of a desiccated med far superior to press for from other pharmaceuticals in the future after the FDA gets their act together about the safety and efficacy of desiccated thyroid. (p.s. chew your Armour thoroughly before swallowing for better effectiveness, say patients)

THANKS to Erfa in Canada, who makes their own version of desiccated thyroid just like the old Armour, where we can do it sublingually and where it still has a touch of sugar to help with dissolution. Glory be to Erfa!

THANKS to the FDA, who had enough wisdom to allow thyroid patients to order Erfa desiccated thyroid from Canada–a far superior product than the lousy T4-only medications for a huge body of thyroid patients. We hope your wisdom continues.

THANKS to all the makers of important supplements–many which have played HUGE roles in the lives of thyroid patients trying to undo the damage done to us thanks to T4-only and the TSH lab test. They include high potency B-vitamins, selenium, minerals, sea salt, iodine, and so many more. We are behind you in the freedom to choose nutritional supplements without a doctor’s prescription.

THANKS to the growing body of doctors who have been listening to patient experience and email me of that fact. We bow to all of you who have LISTENED to the whole body of knowledge thyroid patients have learned, which is also Chapter 3 in the STTM book with more details.

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I am pleased to note that Mary Shomon of about.com,  who in her blog post on Thursday, April 22, 2010, has not only softened her wording about self-treatment by hypothyroid patients, but has also written expressively concerning surrounding issues. These are also issues which I presented in two blog posts earlier this week concerning the immense problem with doctors as expressed by patients, and self-treatment.

Good for Mary!

As witnessed by Sheila Turner’s excellent editorial towards those who criticize self-treatment, as well as angst expressed by many patients toward those who criticize,  self-treatment is an important issue and can’t be diluted down as simply “self-destructive” in our current medical climate.

The following are differences in how this is viewed, though, with one common thought:

• Is self-treatment one  of the “most controversial” issues with thyroid patients? The answer is “only to those who make it so”. Far more troubling to thyroid patients is a medical establishment which worships a medication which has left millions undertreated, and which makes a pituitary hormone lab called the TSH as if it’s from God Almighty. Equally as troubling to patients are doctors whom they report as condescending, close-minded, robotic, and/or ignorant about issues that keep thyroid patients sick–low ferritin, adrenal fatigue, and more. Self-treatment is only the symptom of a much larger, more controversial problem.
• Does self-treatment have “obvious drawbacks” for thyroid patients who feel forced to do it? The answer is “yes”, but no different and probably far less than the “obvious drawbacks” patients face with clueless doctors.  The comments on my blog posts are bloated with patients who have been left sick, or made sicker, by one doctor, after another doctor, after one more.  It’s not a pretty picture.
• Is there a “risk of undertreatment” for thyroid patients who self-treat? Yes, but probably far less  than the huge number of patients who report being left “undertreated” by doctors who are blind to the problems of T4, or doctors who remain clueless about the inadequacy of treating by the TSH.
• Is the “greatest concern” about self-treatment the problem of being “over-medicated”? You betcha. But in the vast majority of these unfortunate cases with patients who choose to self-treat, the problem is undiagnosed or undertreated low cortisol and/or low ferritin, which results in thyroid hormones pooling in the blood and creating hyper-like symptoms.  This is a risk for self-treatment.
• Have “dozens of thyroid patients” ended up in emergency rooms due to over-medication? “Dozens” is speculation.  It may be more realistic to state that “some”, yes, have stated this unfortunate outcome when they made the choice.  But research and comment all over the internet shows anyone that hundreds of thousands of all patients can end up in the emergency room due to poor doctoral decisions, or bad reactions to pharmaceutical medications which doctors love to prescribe. Ending up in an emergency room is not solely connected to self-treatment.
• Do “patients face many major obstacles that prevent them from getting accurate and effective thyroid diagnosis and treatment?” Yes! That is where Mary is in agreement with me with her six excellent  points, including the tragic situation in the UK. And here are 10 reasons patients are frustrated, angry and sick.
• Has one negative journal article about someone who self-treated “resulted in desiccated thyroid  getting greater scrutiny by the FDA?” The answer can easily be:  no worse than the body of patients who were made fearful that the FDA was banning desiccated thyroid, and who followed a strong campaign to contact the FDA about desiccated thyroid. I was also personally told by two pharmaceutical representatives that this action to contact the FDA made the pharms very uncomfortable and put too much attention on desiccated thyroid. Time will tell, but it’s not helpful to blame anything.
• Does “actively promoting self-medication” with natural desiccated thyroid “work against thyroid patient interests”. The answer to this loaded question resides in who you ask. Whether “actively promoted” or simply “read about”, there seems to be a body of patients who report that finding out about desiccated thyroid, and feeling forced to self-treat because of not finding any doctor to help them, was one of the best decisions they ever made.

And to the last comment above, and since there have been “implications”, I want to underscore (and ad nauseum) that the patient-to-patient Stop the Thyroid Madness was not created as a self-treatment site, nor does it “actively promote” it.  STTM is a site with a goal to educate patients who can, in turn, take that information into their doctors offices and push for change. And it’s been working, one doctor at a time, as witnessed by patients who report those doctors on patient groups, and by emails I get from some of those doctors.

But it’s also clear that those who self-medicate may be using STTM, as well as many other websites and books out there by doctors, advocates and non-professionals alike, to help them. So at least there is education out there to help those who choose this, even if none was created for that purpose.

Summary

There are important differences in opinion, and much more to the story as I outlined above.

But the bottom line is this: for up to 60 years, hundreds of millions of thyroid patients around the world have been subjected to

1. a medication called thyroxine which has left a heap of lingering hypothyroid symptoms,
2. a new debilitating condition like adrenal fatigue,
3. a lab test (TSH) which has delayed diagnosis for years or kept patients undertreated, and
4. too many doctors who aren’t up to speed about most any of this, and have left patients frustrated, angry and still sick.

And all the above is a far worse scenario which only pushes some patients to self-treat as a side-effect. But if  you aren’t totally wiped out financially and emotionally in trying to find an informed doc, two suggestions: http://www.stopthethyroidmadness.com/how-to-find-a-good-doc as well as posting your city/state in the subject line of patient groups here: http://www.stopthethyroidmadness.com/talk-to-others

P.S. Please note that you will never see this blog, or this website, knowingly allow non-professional,  negative, nasty, false, abusive and/or profound slander about a colleague, as has been done elsewhere.

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:

• Call or fax them and report what happened to you on T4: 1-800-332-1088
• Fill out their form: http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf and fax or mail to MedWatch; 5600 Fishers Lane; Rockville, MD 20852-9787
• Contact the FDA rep for your state: http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm

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.