Wednesday, September 29, 2010

Thyroid difficulties . . . and the U.S. government

I first wrote the majority of this post last October, but abandoned it when I felt it wasn't quite ready for publication.

Following my post about my encounter with the naturopath, however, I thought I should provide this as a kind of "background"--and, perhaps, as a wake-up call to those who are unaware of the issues I describe, and, finally, perhaps, as useful information for someone who is struggling with thyroid issues.
---The following text was written in October 2009---

I had my thyroid destroyed back in 1984 as a result of a hyper-hyper case of Grave's Disease. --The lab that did the tests said they had never seen thyroxine levels as high as mine; they were "off the charts."

So my doctor gave me the radioactive isotope Iodine-131 to destroy my thyroid gland . . . and a few months later I had none.

I have been taking thyroxin/thyroxine tablets ever since. For some time, now, I've been taking the "natural" stuff sold under the Armour® brand name by a company named Forest Phar­ma­ceu­ti­cals (what, in just the last few days, I found out are desiccated and pulverized pig thyroid glands formed into pills). Most of the time, however, I've been taking synthesized thyroxine sold as generic levothryroxine or a branded product like Synthroid®.

What's the difference between the two? I mean, physiologically . . . for the person like me who is ingesting the stuff?

I will confess that, for me, I haven't really been able to tell the difference. But then, I haven't been all that attentive to my physical condition until the last couple of years.

For many people, however, the difference between the two concoctions is dramatic, though the majority of doctors seem to believe the difference is all in hypothyroid sufferers' heads.

Happily, only one of my doctors has actively opposed my use of the Armour® tablets. But despite his opposition, I've been able to use the Armour® product for the past seven years or so.

This last year, however, I started bumping into supply difficulties. Back in January I was told the pharmacy didn't have 120 mg tablets (the daily dose I needed at the time). . . . Happily, they "simply" gave me the equivalent in the form of two 60 mg tablets per day. No big deal.

Last time I refilled, in late May, I still had almost a month's worth of pills left when I got a three-month supply of 60 mg tablets from our insurer's mail order pharmacy. . . . Then, only a few days after I got my three-month supply, I was told I should reduce my dose to only 90 mg--1½ tablets--a day. So in mid-October, I was just coming to the end of my supply.

Meanwhile, in mid-October I had another blood test to see how my thyroxine levels are.

My doctor wanted to run with the "standard" TSH-only (thyroid stimulating hormone-only) test. I said I believed we really needed the T4 and T3 levels measured as well. (Since then I have found some interesting data on the need for all three tests.)

TSH measures what your body "thinks" it needs in the way of thyroxine. T4 and T3 measure actual thyroxine levels in the blood--and, based on tests I've been having done throughout this past year on the direction of my longevity and vitality doctor, I know that one or more of these numbers can be "out" of range while TSH is "in" range.

My doctor relented.

The tests came back: TSH and T4 levels both indicated a significant deficiency, but T3 was slightly out-of-range on the high end.

"How about bumping your dose back up?" my doctor asked.

"Sounds reasonable," I said. (I had gotten the sense, somehow, that my body was slowing down a bit.)
But what should we make of the T3? Why is that so high?

Is it that kind of anomalous/strange number that got Armour's thyroxine in trouble, here, in the last year [so that it is unavailable for purchase]?

I still have a few weeks' worth of Armour left if I take it at 120 mg/day.
Meanwhile, I asked, "Is there any 'natural' thyroxine that can/will replace Armour while they are out of production?"

I thanked him for any help he could provide.

He replied:
1. I've been in touch with my pharmacologist. She states that since Armour is an animal product, the amount of T3 and T4 will vary from batch to batch which might explain the high T3 and low T4. Synthetic products like synthroid are more consistently dosed.

2. I don't think Kaiser has any of the other brands of the natural thyroid of any kind so we might have to get you to get it elsewhere during the shortage.
Somehow, I had this feeling the pharmacologist was misinformed. I can't imagine Armour/Forest Pharmaceuticals has been able to get away with inconsistent product quality for all these years.

So I did a little research. And then some more. And then a lot more.

I'm astonished at what I have found.
  • First--not terribly astonishing, but worth noting: The pharmacist really was "blowing smoke." Armour Natural Thyroid is carefully controlled for potency and purity:
    The amount of thyroid hormone present in the thyroid gland may vary from animal to animal. To ensure that Armour Thyroid tablets are consistently potent from tablet to tablet and lot to lot, analytical tests are performed on the thyroid powder (raw material) and on the actual tablets (finished product) to measure actual T4 and T3 activity.

    Different lots of thyroid powder are mixed together and analyzed to achieve the desired ratio of T4 to T3 in each lot of tablets. This method ensures that each strength of Armour Thyroid will be consistent with the United States Pharmacopeia (USP) official standards and specifications for desiccated thyroid lot-to-lot consistency. The ratio of T4 to T3 equals 4.22:1 (4.22 parts of T4 to one part of T3).
  • Despite these statements by the manufacturer, you can still read claims such as this:
    Armour Thyroid was the only treatment for hypothyroidism for about 50 years, but it was found that the amounts of T3 and T4 varied greatly from batch to batch. Eventually, synthetic T4 (Synthroid) was being produced and widely used because it did not have similar problems of standardization in common with the naturally derived Armour Thyroid.
    And even stranger and more inaccurate information from the American Thyroid Association.

    But, as Mary Shomom notes in the Guide to Thyroid Disease, there may be good reasons for this kind of disinformation "from the top." Just follow the money--from Abbott Laboratories, maker of Synthroid, to the American Thyroid Association, for example. [Look toward the bottom of this article for the evidence.] --Or how about the payments from all the synthetic hormone manufacturers to the FDA in order to get their products approved in the early 2000s after virtually all of them were found to show "significant stability and potency problems"?
  • Armour REFORMULATED its thyroid product in the spring of 2009--changing its binders and excipients . . . and causing a bunch of problems for many patients.
  • Whether Armour thyroid is efficacious or not, it turns out there really is no source of natural thyroid in the United States as of this moment. And, it appears, the FDA may have actually outlawed--or may be in the process of outlawing--the manufacture of this product in the United States, a product that has been on the market and helping people like me for more than 100 years.

    The more I have read, the more disturbed I have become at this turn of events.
  • Despite the shortage here in the United States,
    Canada has a generic natural desiccated thyroid drug, referred to as 'Thyroid,' which is made by ERFA Drugs . . . [and s]ome of the foreign pharmacies that ship to the US may have some remaining stock of Nature-Throid, Westhroid, Armour Thyroid, or foreign brands of natural desiccated thyroid like Thyroid-S.
    It took a while, but eventually I discovered the natural thyroid preparation made by Greater Pharma of Thailand: a product that goes by the brand name Thiroyd and available in wholesale quantities at a wonderful price. I also found a Canadian source with very good prices of the ERFA Thyroid and in a wide variety of specific dosages.

    I had my doctor write me a highly "generic" prescription for natural thyroid along the lines of the following advice from the article:
    During the shortages, ask your doctor to write your prescription for desiccated thyroid as broadly as possible. For example, a prescription for 'desiccated thyroid, 1 grain' can be filled with Armour, Nature-Throid, Biotech, or a generic. But if they write 'Armour Thyroid, 60 mg' for example, you won't be able to get 'Nature-Throid.'
  • I should have learned these things years ago, but I just now discovered: the synthetic thyroxines normally prescribed by the medical profession supply only one form of thyroxine, "T4"--tetra­iodothyronine--commonly formulated as levothy­ro­xine sodium (a synthetic thyroxine molecule that contains four molecules of iodine bonded by sodium). Our bodies, however, use T4, T3 (triio­dothy­ro­nine--i.e., thyroxine with three iodine molecules), T2 (diiodothyronine--thyroxine with two iodines), T1 (monoiodothyronine), and something called cal­ci­to­nin, a hormone that participates in and/or regulates calcium loss from bone, calcium levels in the blood, and, possibly (proven in rats and monkeys; not yet demonstrated in humans), satiety.

    Not only do our bodies use all five of these hormones, when they are healthy, our bodies manufacture them. If--as happened to me via Iodine-133 therapy--your thyroid has been knocked completely out of commission, the only way you're going to get the T2, T1 and calcitonin is if you take natural thyroid. Yes, your body can convert some T4 to T3, but, I am given to understand, it cannot further break down the T3 to T2, T1, or calcitonin.
  • An article published in the February 11, 1999 issue of the New England Journal of Medicine (1999;340:424-429, 469-470) reports that treatment with thyroxine [T4--the commonly prescribed synthetic levothyroxine/Synthroid hormone] plus triiodothyronine [T3--rarely prescribed by American doctors, but available under the brand name Cytomel] improved the quality of life for most hypothyroid patients. Indeed, "Among 17 scores on tests of cognitive performance and assessments of mood, 6 were better or closer to normal after treatment with thyroxine plus triiodothyronine. Similarly, among 15 . . . scales used to indicate mood and physical status, the results for 10 were significantly better after treatment with thyroxine plus triiodothyronine [i.e., T4 plus T3]."

    Of course, that is a dispassionate medical/scientific statement.

    A more partisan description comes from the StopTheThyroidMadness website:
    [I]n nearly ALL patients on T4 meds, the T4 does NOT convert into an adequate amount of T3, leaving you with symptoms that neither you OR your uninformed doctor realize are related to inadequate treatment—poor stamina compared to others, chronic low grade depression, thinning hair or outer eyebrows, feeling cold when others are warm, cholesterol problems, aches and pains, hard or small stools, easy weight gain, memory problems, foggy thinking, a diagnosis of Chronic Fatigue Syndrome or Fibromyalgia, difficulty conceiving . . . the list is long and pathetic. In other words, healthy thyroids are NOT meant to rely solely on T4-to-T3 conversion!
  • Despite the fact that the medical profession recently tightened the definition of "normal TSH" to no more than 3.04 mU/l (they used to say "normal" went as high as 5 mU/l), a 1997 article in the British Medical Journal concluded, "Thyroid stimulating hormone concentrations above 2 mU/l are associated with an increased risk of hypothyroidism." --And again the author at ups the ante:
    Around 1973, the TSH lab test was developed. Based on a sampling of several volunteers, a so-called “normal” range was established—.5 to 5.0 (recently lowered to 3.0). But volunteers with a history of family hypothyroid were NOT excluded, leaving us with a range that leans towards being hypothyroid! In fact, the TSH RARELY corresponds to how a patient feels [i.e. to actual hypothyroid symptoms]. There is a large majority of patients who have a “normal” TSH, even in the “one” area of the range, and have a myriad of hypo symptoms. There is a complete chapter on the TSH with more information in the Stop the Thyroid Madness book.
  • Nature-Throid and Westhroid have served many people well. But the Armour shortage--together with a shortage of USP desiccated thyroid powder--has now created a shortage of these alternatives.
---End of October 2009 Text---

Yesterday, as I spoke with my naturopath, I was surprised to hear him tell me that the desiccated thyroid products are now readily available in the US.

I have to confess, the mess last year kind of "converted" me away from US suppliers. After a while, when you get hassled every step of the way here in the US, and you find that their price is somewhere around $1 per per day, the easy access and 11- or 12-cent/pill prices of overseas suppliers become pretty attractive. So I hadn't even looked at U.S. suppliers in almost a year (since last I worked on the article above).

One last note: I thought I should at least check on what I wrote last October before simply posting it.

I found the following update in's Thyroid area:
A brief status update on "Current Drug Shortages" posted at the FDA website on March 2, 2010, states that, as of February 12, 2010:

"Forest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. This has been a long term shortage and any new information will be posted as soon as it becomes available. FDA approved levothyroxine products continue to be available from multiple manufacturers."
It's good to see that the FDA felt it necessary to include the brief statement that they have not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. This very likely reflects a concern on the part of the FDA that it not be perceived as taking action that can endanger the many thyroid patients who rely on natural thyroid drugs, and may be a response to thousands of inquiries by telephone, email and fax the FDA received from thyroid patients and practitioners regarding concerns about various FDA actions regarding natural desiccated thyroid drugs.

The FDA's statement does not address a critical issue for thyroid patients however. According to the natural desiccated drug manufacturers, the FDA has indicated that they still consider natural desiccated thyroid drugs "unapproved," and intend to call for a new drug application process for natural desiccated thyroid drugs.

This leaves us with several important questions:

  • When will the FDA requirement for new drug application for natural desiccated thyroid drugs be issued?
  • Will the FDA call for the faster (and less costly) abbreviated new drug application (ANDA) or the lengthier, costlier complete new drug application (NDA) process?
  • Will natural desiccated thyroid drugs be allowed to remain on the market during the ANDA/NDA process?

We still do not have answers to these questions, though manufacturers are still working behind the scenes with the FDA and with their own scientific experts, doing their best to ensure that natural desiccated thyroid drugs will continue to be available in sufficient supply to all patients who need them in the short term, and throughout a federally-mandated approvals process.

--Natural Desiccated Thyroid Drugs: An Update
March 2010 - - Where Are We Now?

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