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The year of 2009 will long be remembered for two nightmares straight out of Twilight Zone for thyroid patients: 1) Armour desiccated thyroid by Forest Labs was reformulated with patients globally reported a return of symptoms and new frustrating ones, and 2) shortages of all US-made natural desiccated thyroid like Armour, Naturethroid and Westhroid occurred, as well as no more generics thanks to the FDA.

Additionally, as I write this, Naturethroid and Westhroid by RLC Labs are still hard to get–making too slow a return on pharmacy shelves which may not improve until 2010. You can read details and a good summary about this on about.com.

But there’s been a silver lining to this situation: Canada’s “Thyroid” by Erfa.

Many patients made a switch to this desiccated thyroid product, using online pharmacy websites and their prescriptions from their doctors. And overall, the experience of patients with Erfa’s Thyroid has been extremely positive.

I had a wonderful chat this week with Dr. Henri Knafo, the Director of Medical Affairs at Erfa Canada Inc.  My first and most important question: Is there enough Thyroid for all your patient customers?? And I got an unequivocal “Yes” from Dr. Knafo.  He explained there are no concerns with running out and they have plenty in stock, now and in the future. He stated that if their stock gets low from sudden demand, they can easily get more and quickly.

I also asked: Is shipping timely? Definitely yes, Dr. Knafo stated. But he also qualified that Erfa is overloaded with orders. And though they are keeping up, your prescription order can take time to process. But, he stated “Be Patient. It will arrive!”

What is going on with the FDA and Erfa? He underscored that the FDA is cooperating completely, and they see a good future with the FDA.  They are completely tolerant, said Dr. Knafo, because they seem to understand the shortages. Erfa’s Thyroid is also completely approved and regulated by Health Canada. As far as the future and the FDA, Dr. Knafo strongly feels that once the FDA is reassured about desiccated thyroid, things will only get better for US patients with brands and availability. He feels that issues with the FDA are far more positive than many thyroid patients and leaders seem to get or want to see.

Do you see changes towards opinion of desiccated thyroid?  Definitely, yes. Dr. Knafo recently attended a European medical conference with over 50 specialists and he saw many doctors not satisfied with Synthroid and noticing the better treatment with desiccated thyroid. “It’s booming in Europe”, he underscored about Erfa and desiccated thyroid  “Even Endo’s are noticing”.  He also said that Belgium was experiencing a huge medical trend away from T4 and towards desiccated thyroid.

Why has the cost of Erfa’s Thyroid gone up even more than 50%?? His explanation was three-fold:  it was first a financial decision, since they have never made much of a profit on desiccated thyroid. Second, Health Canada requires a lot of expensive testing from Erfa on products. And third, since they buy their powdered desiccated thyroid from Europe, an increase in Euros meant they needed to increase the price.

Any final comments? Dr. Knafo clarified: Erfa has been making Thyroid for 30 years and not only will that continue, they will not change the formula. He thinks the sugar in Thyroid is what makes absorption so good, and that will continue as an ingredient just as it is.  Nothing will change! To see ingredients of Erfa’s Thyroid and other brands, go here.

You can read more about Erfa from my September 2nd post.   Thank you to Dr. Knafo for being so candid and informative!

See my post below about my mother, who lived her entire adult life undertreated on T4 with depression and electric shock treatment and had no internet to compare notes. If you have a relative from the past with a similar story, add the story to the Comments.

*HO HO HO! Have a STTM book sent to someone  you care about as a CHRISTMAS or HOLIDAY present. A card will be included, and the book will be in an envelope with a red bow!! Save money the more you buy!

(This post garnered a lot of attention, up to FIFTY comments just a few hours after it went up. People are very interested in sharing their experiences in coping with the shortages! See below and add your own.)

This year will go down in history as shockingly miserable for enlightened thyroid patients on natural desiccated thyroid.

First came a reformulation in the most popular brand–Armour by Forest Labs. Patients worldwide in groups and forums reported a serious return of their hypothyroid symptoms on this product. A huge disappointment.

Second came the production shutdown of the two generic makers of desiccated thyroid: Time Caps Labs and Major Pharmaceuticals. It’s the first step in the FDA’s compliance plan to corral all grandfathered-in drugs (drugs already in existence when the the FDA was created in 1938) and make them each prove the efficacy and safety of their medication via very expensive clinical trials.  i.e. over 110 years of safe and effective use of desiccated thyroid is not enough for the FDA?? We are still waiting to see the outcome of that plan with RLC  and Forest Labs.–the two who were actually in existence before 1938.

Third came demand being greater than supply and shortages. Because of informative patient websites like Stop the Thyroid Madness,  Sheila’s TPA-UK, Lyn’s ThyroidUK, Stephanie’s Natural Thyroid Choices, some areas of about.com (and other good websites I don’t mean to miss here), plus many fine patient forums and groups,  patients found out why they had continuing symptoms on T4 thyroxine, and demand for natural desiccated thyroid grew exponentially.

STTM then created a list of options for all thyroid patients until the shortages resolved themselves, and also created CDT (Coalition for Desiccated Thyroid) where patients could discuss alternatives in a supportive and factual atmosphere.

And we’ve seen some interesting experiences and comments:

The new Armour: One grain tabs started to appear on some pharmacy shelves the past month.  Other pharmacies have still been waiting.  Many patients appear to have switched to other alternatives, though. One gal still on it feels she is finding success by adding T3 to the amount of new Armour she is on.  Time will tell if patients can ever find success with the newly formulated Armour, and most feel it’s a huge loss.

Naturethroid and Westhroid: Patients reporting on their switch to either of RLC Lab’s two identical products report doing well, having to raise it slightly or lower it slightly, or just not liking them at all. Others have had a hard time finding it on their pharmacy shelves, but have been seeing some appear in the last few weeks.

Erfa’s Thyroid from Canada: When it became clear that the FDA was allowing this excellent product to be shipped to patients, many switched and had their prescriptions faxed to a Canadian pharmacy. Prices at many of those pharmacy websites were doubled after prescriptions started to come in from the US. Most patient who stuck with it seem to love it, reporting you can do it sublingually, as well. A few haven’t been impressed, but were finding their former success by raising it.

Compounded desiccated thyroid: In spite of being a more expensive option, some patients found success with this. Others learned they preferred the filler to be Acidophiles.  If not the latter, Microcrystalline Cellulose was preferred over Methyl Cellulose–the latter which appeared to lessen the effectiveness of the compounded thyroid.

Synthetic T4 and Synthetic T3: some patients switched back to the synthetic combination, but many report that it hasn’t been as effective as desiccated thyroid was.

Other options: Patients moved to OTC products like Nutri-Meds, etc, which can be much weaker. Others sought desiccated thyroid from other countries and have found success.

So I’d like to hear from all of you.   Did you go back to synthetic T4?  What desiccated thyroid did you switch to? What worked and why? What didn’t work for you and why?  What product do you hope to switch to once you run out of your current meds?

As a thyroid patient who was profoundly harmed by the use of Synthroid and Levoxyl in the treatment of my hypothyroidism, and as an activist who sees this same harmful truth with potentially millions of other patients, I find this recent news interesting.

But you gotta wonder if they will be wearing noise reduction headsets and ear plugs…or not…when it comes to the scandal of synthetic T4-only medications.  Will they?

Just today, the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA) announced the Safe Use Initiative, “a program aimed at reducing the likelihood of preventable harm from medication use”.

Statements I gleaned from this initiative include:

1. Today, tens of millions of people in the United States depend on prescription and over‐the‐counter (OTC) medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse.

2. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use.

3. Medications offer great benefit, but they come with risks. Whenever medications are not used optimally, risks of harm can increase significantly.

4. FDA proposes to identify, using a transparent and collaborative process, specific candidate cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant amounts of preventable harm.

This initiative is actually far broader than what I gleaned above, and also involves self-abuse, exposure of dangerous medications to children, dire side effects, and more. Five areas are also specifically targeted:  Consumer medication information (CMI), Medication dosing devices, Acetaminophen toxicity, Alcohol-based surgical preps, and Medications in vials. You can read more in the fact sheet.

But if the FDA is going to do their job with this initiative, or do their job overall, you have to wonder if they will listen to and include the problems associated with being treated with a T4-only medication as experienced by millions of patients worldwide. Continuing symptoms of hypothyroidism while on this inadequate treatment is widespread and damaging for many, causing hands reaching deep in pockets to pay for numerous doctors appointments, besides antidepressants, anti-anxiety meds, blood pressure meds, statins, cortisol meds for adrenal fatigue, and other medications which we would have never needed, and would have been preventable, if we had been on natural desiccated thyroid like Naturethroid or Westhroid in the first place.

Many patients on thyroxine, T4-only medications will also report actual hospital visits due to the side effects of a poor treatment.

In other words, thyroxine aka levothyroxine aka T4 treatment has been an unsafe and harmful treatment, causing millions to suffer unnecessary injuries and side effects for over 50 years of its useless and popular use.  It fits the Safe Use Initiative. Or at the very least, it calls for the FDA to listen to patient experience with this lousy choice to treat hypothyroidism.

Listen to us, FDA. Listen and be wise.

P.S. See the blog post below about a genetic reason why so many do lousy on T4.

Sometimes there is a silver lining with the storm cloud of backordered US desiccated thyroid.

Erfa, the makers of the Canadian version of natural desiccated thyroid, simply called “Thyroid”, has recently announced that the FDA is not requiring the extensive FDA Form 1572 from US citizens and their doctors when they fill their prescriptions from Erfa directly. i.e. it’s now a lot easier to get your prescription filled directly from them.

http://www.erfa-sa.com/thyroid_usa.htm

And those who have started to use Erfa’s Thyroid report being quite pleased. A cherry on top is that Thyroid has that old sweet taste we used to all like with the old Armour, and it can be done sublingually as well! You can see the ingredients here.

Also, I am continuing to get emails from patients that both Armour and Naturethroid is starting to appear on pharmacy shelves, even if in small quantities.  I’m personally not too excited about Armour reappearing if Forest continues to make the reformulated version. Just too many patients reporting a return of hypo symptoms, even when they raise it, plus new symptoms of undertreatment and/or challenged adrenals thanks to the reformulated version. Sad. Oh how we will all miss the old Armour.

In the meantime, here are options for thyroid treatment we all have until we see a good return of desiccated thyroid, including Naturethroid and Westhroid. They are all far, far better than being on T4 alone like Synthroid, Levoxyl, levothyroxine, et al. You’ll also note compounded thyroid, which can be a good option, and you can read about on a recent blog post.  Australians happily use compounded in their own country. Any option you and your doctor choose may mean a readjustment by your body, by the way.

Want to talk to other patients on how they are dealing with the shortages? Join the Coalition for Desiccated Thyroid.  Or if you simply need patient feedback about your hypothyroidism, go to the Talk to Others page.  Remember that no patient group is meant to be a substitute for your relationship with your doctor.

**The next Thyroid Patient Community Call will be held Thursday Oct. 8th on TalkShoe, and our topic will be iodine and your thyroid with patient expert Stephanie Buist. Come join us and listen right on your computer, or you can also talk live to Stephanie or Janie with your questions.

With all the panic among thyroid patients of the last several weeks, we are now seeing light at the end of the current tunnel of desiccated thyroid shortages. More reports are coming in by patients that it’s appearing on shelves at their local pharmacies, including both Armour and Naturethroid. Sure, it’s a trickle compared to the amount of US patients that need it. But it’s a sign of hope of more to come.

On the CDT (Coalition for Desiccated Thyroid) yahoo group, where patients have been discussing the shortages and finding places to get their desiccated thyroid, patient Elenor gave just one more example:

“After losing “my” Wal-Mart’s last left-over bottle of Naturethroid to some other thyroid person (lucky him or her){wink}, I called around to pharms — and Sam’s Club Pharm two towns over had just gotten ONE bottle of 60mg Armour in yesterday. (I did also find a CVS that had a bottle and a half of the 90mg Armour — so there are some dribs-and-drabs left around… My doc wouldn’t write for me to get that too…) (YAY!) Emailed my doc’s nurse begging her to do it right away — which thankfully she did, so they dispensed it “to me” and I can pick it up today! Down to three days left in my possession, so … WHEW!”

Elenor concluded: Still gonna see my doc 5th Oct and try to order 500 tablets from Canada. I do not EVER want to be scrambling like this again — for ANY reason…

And we all agree with you, Elenor!

Clearly, our current shortages were caused by two factors: demand being greater than supply thanks to websites like Stop the Thyroid Madness (STTM), forums, groups and others, as well as the remarkably poor timing by the FDA in causing the only remaining generic makers of desiccated thyroid to cease production.

And in case you haven’t caught up with what’s going on, you can read a summary of the history about the FDA and regulations which will explain what we will have to face for desiccated thyroid in the future, which is our real challenge.

**JOIN US TONIGHT for our weekly THYROID PATIENT COMMUNITY CALL hosted by Janie Bowthorpe. We’ll have an open topic night and perhaps a surprise guest (still waiting on confirmation on that). Let’s talk about the shortages, ways to continue treating during this time, and more. NOTE that I have moved up the times by one hour. Just click on the link and you’ll see a countdown of when it starts: 6 pm Pacific, 7 pm Mountain, 8 pm Central and 9 pm Eastern.