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Tag: federal drug administration

What the recent Medco scandal is actually telling us–i.e. there’s more to this story

medcoI 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?

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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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