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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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A un-brilliant double whammy by the FDA concerning a weight loss medication

alliThere’s an over-the-counter weight loss drug called Alli made by the huge pharmaceutical GlaxoSmithKline. You can see it on the shelves of most any Wal Mart or local drug store.  It’s also called Orlistat which is marketed under the trade name of Xenical by the pharmaceutical Roche.

It’s promoted as safe, and it works by limiting the absorption of fats from what you eat, which in turn reduces your intake of calories.  (What has always turned me off about Alli or Orlistat is that is creates oily and loose stools. Bleck. )

Medscape just today reported about an FDA warning: the Use of orlistat may decrease L–thyroxine (T4) absorption and lead to hypothyroidism. Clinicians are advised to administer levothyroxine and orlistat at least 4 hours apart…

Oh jolly. So now we have the FDA giving a warning about Alli causing problems with “thyroxine” use,  yet it’s the VERY “thyroxine” use that causes a certain large percentage of those using Alli to need to use it in the first place. You can see that reality in the questions about the hypo problem on the Alli forum.  i.e They are all on thyroxine!

Hitting my head against the wall.

P.S. Reported in Endocrine Today and from just a month ago, and article titled Hypothyroid patients required increased levothyroxine during pregnancy.  Zombie Endocrinologists. Zombies. That’s like having an article titled Sick patients need more blood-letting. i.e LEVOTHYROXINE SUCKS AND SHOULD BE IN THE PAST just as much as blood-letting.  WAKE UP ENDOCRINOLOGISTS!! WAKE UP!!

*Check out patient response to the newly formulated Armour below, and add your own comments.

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Thyroid Tidbit: Did ya notice that various Armour sizes are back??

armour-tabletsI can remember a few people the past year who proclaimed fervently that Armour was being discontinued because of the shortage.  And I chuckle about it.  Hopefully, my previous posts helped calm that fear.

But in case you haven’t heard, those larger sizes are back!  And you can keep track of what’s going via the Forest Pharmaceuticals customer product availability hotline: 1-866-927-3260  As of today, April 19, they state that the one grain tabs (60 mg) and 1 1/2 grains tabs (90 mg) are on backorder, and will catch up with production on April 20th, tomorrow as I am writing this.  We’ll see.

Unfortunately, the new formulation has made Armour lacking in sweetness, and it’s almost impossible to do it sublingually.  Sad. Maybe another pharmaceutical will get the hint. In the meantime, if you swallow your desiccated thyroid, make sure to avoid calcium, iron and estrogen at the same time. And if you’ve been doing it sublingually, and have to switch to swallowing, you may need a tad more.

Remember: if you have any issues with natural Armour desiccated thyroid in the treatment of your hypothyroidism, you can always ask your doctor for a prescription switch to Naturethroid or Westthroid, both fine FDA-approved, US Pharmacopeia standard prescription desiccated thyroid.

Janie

Want to be informed of my posts? Curious what I am raving about as a Thyroid Patient Activist? You can sign up for a Notification at the bottom of the links to your left.

P.S. If you haven’t bought the Stop the Thyroid Madness book yet, wanted to tell you that numerous patients are emailing me, stating they find the book even easier to refer to than this vast website (plus it has more details and information).  So if you want the ease of referral, the book may be the way to go.

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Getting the facts straight about Dr. Sydney Wolfe, and what YOU can do.

armourbottleWith the recent blog post by health writer Mary Shomon concerning Dr. Sidney Wolfe’s new 4-year term with the FDA’s Drug Safety and Risk Management Advisory Committee, there has been much brooha and fear-mongering on thyroid patient groups.

Why? Well look at it this way. This is a man of stature. He is an MD, an Adjunct Professor of Medicine, the director of Public Citizen’s health research group which promotes drug safety and public health, and editor of the newsletter Worst Pills, Best Pills, and since August of  ’08, a member of the Drug Safety Committee.  He also has a resume a mile long.

Yet in spite of his seemingly caring activism for our health and well-being, and his immense experience and education, he is clearly and completely off-base about Armour and other desiccated thyroid prescription drugs.

For example, as as editor of the Worst Pills, Best Pills newsletter,  Wolfe declared Armour desiccated thyroid as a “Do Not Use” product because it is not adequately guaranteed to provide appropriate blood levels of thyroid hormone and reliable alternatives are available”. (Gee, funny how our experiences are completely otherwise….)

Then in the May 2003 issue (of which you have to have a paid prescription to read), he wrote an article titled  “Do Not Use! Natural or Desiccated Thyroid (ARMOUR THYROID) For Thyroid Hormone Replacement Therapy.” In that article, the clueless Wolfe stated that he supported The American Thyroid Association’s statement “There is no evidence that desiccated thyroid, a biological preparation, has any advantage over synthetic thyroxine.” (I guess millions of us and our improved heartrate, stamina, cholesterol, depression and more…aren’t evidence?)

He then proposes that Armour is mostly prescribed for weight loss, is a niche market for the unscrupulous, and concludes with “if you are offered natural thyroid hormone replacement treatment for any reason, this is a red flag and you should get a second opinion.” In a letter to consumers, Wolfe and Public Citizen state that that T3 is only needed from conversion and is predictably found from conversion, that the T2 and T1 also found in desiccated thyroid has essentially no activity, that desiccated thyroid is an unpredictable mixture, that is has no predictable biological activity…plus so many more complete and total inaccuracies based on “intellectual head chatter” not on observation and experience.

Thud.

Mary Shomon, in 2003, did a bang-up job trying to communicate with Wolfe, Worst Pills, Best Pills, and Public Citizen about the inaccuracies of their beliefs and statements…basically to no avail. The TRUTH is here, and in more detail in Chapters 1 and 2 in the STTM book which are enlightening those reading it all!

So we are left wondering, six years later, what his four-year appointment to this committee will mean. But let’s make a few things quite clear to contrast some of the fears going on and expressed on thyroid groups:

1) Armour is not being banned.
2) Wolfe is one of a current 9 members of this committee. Wolfe is not “the committee”.
3) Wolfe and seven others currently have voting rights. He is the only “Consumer Representative”.
4) There are still six more vacancies.
5) The committee is NOT the power. They simply make recommendations. And historically, the FDA can be slow to act on their recommendations, or doesn’t follow them at all (which is a GOOD thing when it comes to a SAFE and EFFECTIVE medication like desiccated thyroid).

So what can you do? I challenge you to follow and act on the below, which puts our energies into communication, not feeding the ego and power of a misguided man with our overtly expressed fears as if they have actually come to pass :

1) Remember 1-5 above. Armour is fully available. Keep the facts straight, and fear-mongering down.

2) STTM has a powerful and growing page of testimonies of those who switched to desiccated thyroid.  Are you in there? If not, you need to be. This website currently has a huge audience. It’s noticed by doctors all over the world, as is the STTM book, which is YOUR book of YOUR experiences,  which is also being ordered by doctors. Use the Contact Me form at the bottom of that page.

3) Tell your experience with Synthroid or other thyroxine medications at the following websites:  www.rateadrug.com,  www.drugs.com,  www.askapatient.com They don’t include any of the desiccated thyroid meds yet, but you can tell of the negative experiences with all the T4-only drugs, including adrenal fatigue if you fell into that, and all your lingering thyroid symptoms.  The above links will take you to their Synthroid page–you can search for the other T4 meds.  Remember to mention Armour or other desiccated thyroid meds and how they have helped you!! Update: thyroid patient Gina found the drugs.com Armour page: http://www.drugs.com/comments/thyroid-desiccated/armour-thyroid.html

4) Report your T4-only experience to MedWatch, the FDA’s  program for reporting problems.  You will see an Online Reporting Form to download. Don’t fail to mention which problems were removed or greatly improved when you switched to Armour, or the fact that you now have to deal with adrenal fatigue thanks to the inadequacy of T4-only treatment. You can also call 1-800-FDA-1088, but remember: your call is not to draw attention to Wolfe’s opinions! It’s to draw attention to how lousy a treatment T4 is as compared to how much better Armour has been.

5) Go to my article titled Synthroid Sucks: the Rallying Cry of Thyroid Patients vs. Clueless Doctors and comment on this article, including mentioning what Armour, Naturethroid or other desiccated thyroid did for you. Rate it as well. Both keep this article in the media and in the eyes of others.

6) Go to www.medications.com where patients ask questions and YOU can answer, mentioning YOUR experience and how much better desiccated thyroid has been. Clicking on that will take you to the Synthroid patient questions. Answer them. Be careful with links–they may not catch them at first, but will remove them if they do.  You can mention website names, tho, like Stop the Thyroid Madness.

7) Send people here to follow all these steps. Power is in numbers!

8 ) Use the following website to email or write your senators and representatives: http://www.visi.com/juan/congress/ THEY DO READ THEM. And they will remember this!  Here’s a template letter you can use:  www.stopthethyroidmadness.com/template-letter-to-your-senator-or-representive/

If you have other ideas and places to write or call, add your comment to this post. Remember,  put your power in communication! LOTS of communication.

P.S. Did you know that the American Thyroid Association, in cooperation with the American Association of Endocrinologists, together support January as “Thyroid Awareness Month”…which is supported through an unrestricted grant from Abbott Laboratories, the makers of Synthroid?? Major UGH.


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