• Big Pharma Pharmaceuticals
• hypothyroidism

I have been watching with interest the past week about the justified ire of patients being expressed all over patient groups in the internet. And in case you’ve been too busy with school starting or end-of-summer activities, it involves one of the nation’s largest mail order pharmacies as well as the largest Pharmacy Benefits Manager (PBM):  Medco.

In a statement you can read right on their website, they state:

1)  there is a “nationwide shortage of porcine-derived desiccated thyroid”
2)  they are “uncertain about continued availability.”
3)  “ask your doctor if a synthetic thyroid medication, such as levothyroxine is right for you.”

In Medco’s direct message to doctors, they state;

1)  desiccated thyroid does not have the U.S. Food and Drug Administration (FDA)  Federal Drug approval”
2)  the FDA  “may remove any remaining unapproved products from the market.”
3)  the shortage is due to this “uncertainty”.
4) “the American Association of Clinical Endocrinologist recommends levothyroxine over desicccated thyroid, liotrix, combination of thyroid hormone, or triiodothyronine (T3) for the treatment of hypothyroidism.”

Clarification on their statements

If you are just now finding out about this,  do note the following:

1) There is not a nationwide shortage of all desiccated thyroid. There is a shortage of Armour because of its 2009 reformulation. (See my blog posts below about problems with the newly formulated Armour.)
2) Naturethroid by RLC Labs continues to be available. They are working hard to keep up.  See my post on Naturethroid.
3) Desiccated thyroid was around long before the establishment of the FDA, so they are grandfathered in and still work with the FDA guidelines.
4) There has been no statements by the FDA that they are removing desiccated thyroid.

An even more important revelation in this entire Medco scandal

There is actually an underlying message in the entire Medco fiasco that you should find even MORE disturbing: the continued  promotion of T4, aka levothroxine, as an adequate treatment of hypothyroidism.  And this is not just a faux pas of Medco, it continues to be the ignorant opinion of far too many doctors, medical schools and medical boards. All you have to do is look at what has happened in the UK with the Royal College of Physicians to see the idiocy abounding.

Over 100 years ago, desiccated thyroid was found to be an excellent treatment for hypothyroidism.  I give precise details about the first use of desiccated thyroid in Chapter 2 in the Stop the Thyroid Madness book. It worked!

But in the early 1960’s, the tide turned thanks to a batch of desiccated thyroid that turned out not to be what it said it was.  This is documented in the 1970 Pharmacological Basis of Therapeutics.  And pharmaceuticals, especially  Knoll Pharmaceuticals who first tableted levothyroxine aka Synthroid in 1955,  jumped to promote T4-only as a “new and modern medication”.  (See page 41 and 42 in the STTM book).  And doctors and medical schools fell for it hook, line and sinker.

And to this day, levothyroxine continues to be purported as an acceptable and logical treatment choice for hypothyroidism.  But patients all over the world beg to differ.  T4 medications like Synthroid, Levoxyl, Eltroxin, Oroxine and others simply leave all patients with their own unique amount and degree of lingering hypothyroid symptoms, no matter how high you raise it.

I also find it hugely disturbing to refer to AACE (American Association of  Clinical Endocrinologists) as if they are the grand poopah of knowing what’s right for thyroid patients. They are NOT.  Millions of thyroid patients who have switched to desiccated thyroid, T3, or a combo of T4 and T3 will tell them hands-down that they have gotten FAR better results, and most especially with desiccated thyroid like the “old” Armour, and now Naturethroid.

Visiting numerous thyroid patient groups will reveal how patients feel about Endocrinologists they have visited throughout the years.  Their experiences are far from flattering. In other words, with a few exceptions, thyroid patients are NOT impressed with Endo’s.

Medco’s statements are definitely a concern for patients and range from presumptous to unfactual.  But those statements only represent a far wider problem around the world in the medical community.  Clinical presentation and wisdom has been thrown out the window by doctors.  So patients have to continue spreading the word about the far superior treatment of desiccated thyroid, and their problematic experience with T4.

Want to be informed of these posts so YOU can be informed? Curious what’s on Janie’s mind? Use the Notifications on the left at the bottom of the links.

***50% off sale!! All STTM t-shirts are now on sale. I love sales. Not only do they help support this site, they are a great way to spread the word. Go here.   Did you know that Laughing Grape Publishing will send a STTM book directly to your doctor?

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.

*Want to be informed of these important blog posts? Curious what’s on Janie’s mind? Just use the Notifications to the left and below the links.

*SALE! Stop the Thyroid Madness T-shirts are now 50% off just because I like sales. A great way to spread the word about our patient revolution for the superiority of desiccated thyroid over T4-only meds. You’ll also see funny bumper stickers. Also…when you order the STTM book and request it (i.e. you have to request it),  you get a Calvin peeing on….(you’ll see) bumper sticker for FREE, and it’s a hoot.

In 2002, when I first got on desiccated thyroid and it absolutely changed my life, it happened to be the brand name called Armour by Forest Pharmaceuticals.  And I swooned.  You could do it sublingually (even if it wasn’t made that way), and I praised Armour for that. So did other patients after we spread the word on patient groups, on the STTM website and in the Stop the Thyroid Madness book.

My fondness for Armour did not take away my praises for other prescription brands, though, including Naturethroid or Westhroid by RLC Labs.  I simply made a doe-eyed commitment to Armour for my personal treatment because you could do it sublingually. I have also used the name “Armour” interchangeably to represent all good desiccated thyroid products.

But because of a succession of three events, I think it’s time to give back my going-steady ring.

The first blow to my romance with Armour centered around the extreme tight-lipped secrecy from Forest when the reformulation of Armour began. We can surmise the trouble begin in 2007 when patients were finding Armour in the larger sizes to be suddenly ineffective.  For the entire year of 2008, supplies were extremely limited and only the one grain size or lower could be found, if at all.  Patients were worried and unhappy.  I even supported Forest in my blog posts, assuring patients that everything would be fine.  But Forest said practically nothing. Why was and is Forest mum about why this was happening ?

The second blow to our courtship was the change to the “reformulated” Armour. Suddenly, patients find that doing Armour sublingually was a thing of the past. Now all we get is a never-ending chalky pasty residue.  Additionally, many patients have been reporting that the amount of Armour that once removed all symptoms, was now bringing them back.  Huh?? In spite of an apparent drawback in some batches in 2007, why would Forest take an effective product and change it?

And the third and final straw to my affair of the heart? I made a phone call to Forest using the same 800 number you all can use. That was Tuesday, May 5th. My intent was to ask about the word anhydrous which is now after the ingredient dextrose in the Armour ingredients listing. (It means that all moisture has been withdrawn, but I wanted to confirm the details for the brands page.)  When I reached the representative for Forest, and after she asked my name and I gave it (oops),  the tune of the conversation changed.  She said she could not answer my question since I own a public website, and would have to inform the “Media group” from Forest, and they would call me back. When I asked when, the answer was a vague as Synthroid is in treating hypothyroidism i.e. she didn’t know. I even called back the next day to get the same dribble.   Why have representatives on the Forest hotline been instructed not to answer a simple question from someone like myself,  and I still have not received a phone call from Forest?

Sob.  Yup, breaking up is hard to do, but a gal can only take so much strange betrayal, tight-lipped silence…and ignoring a simple question from someone who has done a LOT to put money in their pockets out of extreme gratitude. Besides, there’s another pharmaceutical courting me at my door:  RLC Labs. Thank goodness there are other fish in the sea.

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Recently, after we watched a semi-scary movie about being suckered, a friend brought up my blog post of last July where I described a terrifyingly-real horror movie.

The plot: stunningly convince hundreds of millions of individuals worldwide that what is obvious, isn’t. i.e. it’s all in your head, you are adequately treated on Synthroid, Levoxyl, Eltroxin, Norton, et al,  and not only that, we’ll bandaid your continuing problems with more medications.

A second plot: also completely hoodwink those with top notch higher medical educations and experience by churning out the the exact same poppycock, and reward their stupidity with gifts.

The central villian: Big Pharma, followed by the doctors who bought the lie

Exactly a year ago this month, Science Daily came out with an article, citing two York University researchers who estimated that the U.S. pharmaceutical industry spends almost twice as much on promotion as it does on research and development, contrary to the industry’s claim. In other words, the researchers estimated that $57.5 billion in US dollars was spent on pharmaceutical promotion in 2004–the year they were studying. Yes, I said BILLION.

Breaking that down, Big Pharma spent approximately $61,000 per physician in promotion of their products.  And they concluded that both figures were UNDERestimates.  In other words, they concluded that the US pharmaceutical industry is marketing-driven rather than “life-saving”.

And adding fuel to the fire: most doctors believe every thrust of that marketing. I recently participated in comments with other wonderful patients in response to a DO/Endocrinologist, Dr. Thomas Repas, who has clearly bought the Big Pharma marketing when it comes to levothyroxine. You can read his posts and our comments here, here, and here.   Dr. Repas is exactly the kind of doctor who has  starred in our horror movie, and the kind of doctor that patients have lamented about for years.  Read the  Give Me a Break list of comments made by doctors, as well as further comments on the January 1st blog.

But Dr. Repas is in good company. Doctors have believed the Big Pharma lie about T4-only medications, and against desiccated thyroid like Armour, Naturethroid, etc. for 50 years.  In the patient-to-patient  Stop the Thyroid Madness book, you can read about the first tableting of Synthroid in 1955 and the strategic and successful promotion of T4-only, in spite of the fact that T4 was known to be unstable for decades.

And today, more than 50 years later, very few of us have been untouched by the Big Pharma push for levothyroxine T4-only treatment.  My own mother was suckered, and I was suckered.  And until patients started to make a huge push for desiccated thyroid treatment the last few years, nearly every single doctor around the world had been suckered.

We still have a way to go. But we’ll get there, bit by bit.