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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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Again…Armour thyroid is not discontinued!

To update again if you’re feeling panicky–Armour thyroid, made by Forest Pharmaceuticals, is not discontinued, contrary to what your poorly-informed pharmacist or Synthroid-loving doctor tells you.

What is going on is this: about a year ago, something went wrong in the production of the higher grains, i.e. they didn’t work. Those who had been on Armour awhile and picked up their new prescriptions had their hypothyroid returning!

And when a Pharmaceutical makes a mistake, they have to jump through hoops with the FDA to correct their manufacturing problem, and it takes a lot of TIME to get back to producing their product.

What stopped being produced this year, as a result of the problem, were the 2, 3, 4 and 5 grain tablets (120 mg, 180 mg, 240 mg. and 300 mg). Everyone was now forced to use the smaller amounts, and the increase in demand put a great strain on quantity in your local pharmacies.

Forest now predicts that the larger sizes will return in “late 2008”. So we’ll see. One gal has reported that some of the larger sizes did return to her pharmacy this week, but I’ll need confirmation before saying it’s a fact.

What do you do in the meantime? Call pharmacies to see what they still have, and expect to drive farther to a pharmacy which still has them in stock. Because many still do. If you don’t find any close enough with Armour, you can get your doctor to write out a prescription for Naturethroid or Westhroid, both quality desiccated thyroid products and very available.

To keep up with the latest from Forest about Armour availability, just call 866-927-3260 for a recorded message (which will be a repeat of some of the information you have read right here.)

p.s. Think your doc is open-minded enough to read the STTM book?? You can have the publishing company send one directly to your doctor. Click on the SEND A BOOK TO YOUR DOCTOR.

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Bumper Stickers are coming! And they work!

***UPDATE: BUMPER STICKERS ARE HERE! You will also note a way to pay immediately for either bumper stickers or t-shirts, using a new, growing and SECURE site that transfers money from your bank to the STTM account on the site. This is a preferred alternative to PayPal with much less hassle. NOTE: IF YOU USE IT, you will need to use Contact Me to let me know the information on the Order Form.

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A gal suggested I also have bumper stickers in addition to the t-shirts, and I think she’s right. I have a bumper sticker on my car of Calvin peeing on a particular brand of T4 (I can’t sell those since I name the brand–lol). But it definitely catches attention! Just the other day, as we had parked our car in front of a Walgreens, a gal came up with her camera to take a photo of the bumper sticker. She laughingly explained that she works in the pharmacy and wanted to show it to the pharmacist.

And I have to wonder how MANY view that bumper sticker when I am sitting in line behind a red light, or parked somewhere. It has to create thought. And that is exactly what we ALL want–to create thought in this T4-obsessed, TSH-worshipping society.

You will see four different kinds of bumper stickers on this site before March, and I will announce them here. Three use good ole tongue-in-cheek humor. WE CAN MAKE A DIFFERENCE. YOU CAN MAKE A DIFFERENCE. Stop the thyroid madness!

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Oops. Let’s not blow this out of proportion!

A very overreactive rumor is being started as I type this about the FDA and Armour, and I think this whole topic needs to be leveled out. The rumor is as follows:

1) The FDA has stopped manufacture of all grandfathered drugs like Armour.
2) Armour will no longer be available at your local pharmacy

i.e. it’s being banned, discontinued, taken off the market, gotten rid off…you name it.

Now first let me clarify that all are totally and completely false. Forest Labs is still making Armour, and you can also find Armour at your local pharmacy, even if certain strengths are easier found than others.

Here is what is going on: In the January-February issue of the 2007 (i.e. a YEAR AGO) FDA Consumer Magazine, an article came out by Michelle Meadows titled The FDA Takes Action Against Unapproved Drugs. But this is NOT new news. This is based on the June 2006 release guidance by the FDA, called Marketed Unapproved Drugs–Compliance Policy Guide. What the FDA is doing is working to get unapproved drugs meet their approval guidelines.

What is an unapproved drug? For one, they are those drugs which were around before the FDA (Federal Drug Administration) came into existence in 1938, and these drugs were ‘grandfathered’ in with the subsequent FDA-approved drugs thereafter. (Armour is an example. Synthroid was too until it did what it took to be approved in 2002) Other examples, as explained in the January/February 2007 article, are when only one company may have approval to market a drug, but other companies are illegally marketing their versions of the drug without having gone through the FDA’s approval process. Another scenario is that a combination of ingredients is approved by the FDA, but a company is marketing a single ingredient without approval.

The article also clearly states: Before pursuing regulatory action against unapproved drugs, the FDA plans to consider the effects on the public health, including whether the product is medically necessary. The agency recognizes that some unapproved therapies offer benefits. An example is Phenobarbital, a drug used to control seizures. In some cases, FDA action requiring drug approvals will be gradual to avoid shortages of medically necessary products. In other words, whenever the day may come that Forest Labs is asked that Armour meet the regulations of the FDA, the process will be gradual and Forest will be given a fair deadline to do what it takes.

Kathy, a pharmacist with Forest Labs, reminds us that Armour has never been asked to go through that process (or they may not be admitting it yet so they can go through it in peace.). And if the day comes, they will do what it takes. Armour is a safe and life-giving product. And you bet your booties that even if it looked threatened some day, there would be a huge uprising from patients to stop it. But that’s not going to happen, just as it was for Synthroid where Abbott labs did what it took to be approved, and succeeded.

So, take heart: everything is fine. Armour is still being made. Your pharmacies still have it, even when some strengths are easier to come by than others. And I’ll keep you informed. And remember: I’ve always told you to stock up on your desiccated thyroid products anyway. 🙂

p.s. The root of the rumor comes from a recent recall by Forest Labs concerning its 3, 4 and 5 grain tablets, which had a 6-month potency problem, and a misunderstanding about it’s implications by individuals. Those tablets are currently scheduled to be out again by the end of January.

http://www.fda.gov/fdac/features/2007/107_drug.html
http://www.fda.gov/cder/guidance/6911fnl.pdf

***Want to spread the word and be your own thyroid patient advocate? Get your t-shirt here.

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