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Glad to see some reason creeping in with thyroid patient discussion!

IMG_2564If you have been keeping up with my posts, you’ll know that thyroid patients have been facing a shortage of desiccated thyroid for many weeks, probably due to sharp increased demand i.e. thyroid patients have been finding out how lousy T4-only treatment like Synthroid has been for them, and how much better desiccated thyroid is.

That demand became especially true after a reformulation of Armour by Forest Labs in 2009 drove patients to RLC’s Naturethroid and Westhroid. The “new” Armour caused a return of hypo symptoms plus new maddening ones, including palpitations and sleep problems never seen before.  As Julia Roberts said in the 1990 movie Pretty Woman: Big mistake, Big, Huge.

In addition, it didn’t help when Time Cap Labs, a pharmaceutical which made plenty of desiccated thyroid for other pharmaceuticals, stopped production after being contacted by the FDA. This action was probably in line with their aims to make long-term unapproved drugs become approved, even if the timing was incredibly stupid.

As all the above was happening, panic ensued!

We’ve heard all varieties of negative presumptions from thyroid patients about what caused the shortage, including an FDA conspiracy and an overt belief that desiccated thyroid is about to be removed.  Patients have threatened law suits, blamed pharmaceuticals, and/or sent numerous letters to FDA pleading to keep desiccated thyroid as if it was to be gone tomorrow. Even I, at first, fell in line wondering about the FDA.

But it started to dawn on me, as it has others, than we have been jumping the gun, not giving enough emphasis to facts and reason.

And finally, facts and reason are starting to appear on blogs and groups:

1) Yes, Forest Labs, the makers of Armour, and RLC, the makers of Naturethroid and Westhroid, state they have not been contacted by the FDA. We have no reason to disbelieve them!

2) Yes, RLC is working hard to catch up, as is American Laboratories, both state. We also have no reason to disbelieve them!

3) Yes, thyroid patients who know the superiority of desiccated thyroid have always been there to support them. Glad to see that recognition in blog and group postings.

4) Yes, as health writer Mary Shomon has stated, information-gathering, brainstorming, and communicating with our doctors is a good thing to be doing.  That is contrary to making panicky negative predictions about desiccated thyroid,  rallying for law suits, and feeding ideas to the FDA that may not be there in the first place.

5) Yes, we need to put energy in letting the world know about the superiority of desiccated thyroid treatment in our lives. That is where our power lies in the face of clueless Endocrinologists and their equally-clueless medical boards like AACE.

6) Yes, we need to listen to and support the pharmaceuticals and laboratories which give us the desiccated thyroid we need. It’s they who have to walk the line with the FDA. Let’s listen to their cautions and support them.

Strangely, there are still misconceptions being reported by patient blogs and posts:

1) That we don’t know what caused the shortage. But we do! Demand is as logical as it gets.  All of us have succeeded in getting the word out! That is exactly why I created STTM in the first place!  And by emails I get every week, it’s clear that it’s been working.

2) That groups like the Coalition for Desiccated Thyroid (CDT) have a wait-and-see attitude. That is as silly as saying STTM wants to ban T4 or encourages self-treatment. There are simply some thyroid patients who don’t agree with the extreme panic and negative presumptions that have been going on, and want more reason in our pro-activity!  Patients have been encouraged to spread the word in any way possible about the superiority of desiccated thyroid and how it’s changed lives, NOT to feed dire negative predictions which only end up giving ideas we don’t want to give! You are most welcome to join the Coalition above in addition to other groups.

Good for patients and advocates alike for putting more reason and fact in this situation.

I’m also glad to see some strategic, pro-active behind-the-scenes work going on as a just-in-case line of activism. That is the way it should have always been–a plan for action “just in case”, not dire predictions and fear mongering as if it all WAS going to happen.

We’ll get through this, folks. Here are options for thyroid treatment in the meantime. And if you want to talk to other patients, join our thyroid patient Community Call this Friday. Details are found in the September 7th blog post.

37 replies

Another interesting reply to a patient by the FDA

fdaimageAs thyroid patients are not only in angst about a complete shortage of desiccated thyroid in the US, we all have questions and concerns about out future with no definitive answer.

For example, we wonder if the FDA may be  requiring clinical studies from pharmaceuticals who make desiccated thyroid to prove that it’s safe and effective (in spite of the fact that patients have been using it safely and effectively for 110 years.  Nope, we don’t count. Amazing, isn’t it?) And we wonder: if studies are required, will they be able to afford the studies, which are quite expensive? Will desiccated thyroid continue to be available while the studies go on? And more uncomfortable questions.

The FDA recently replied to a question by thyroid patient Catherine when she asked about the shortages and here’s their reply:

Dear Catherine:

Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research.

We understand your concerns regarding the availability of natural desiccated thyroid products.  FDA has NOT taken class action against unapproved thyroid products resulting in a shortage.  If a company discontinues manufacturing of an unapproved product, that is a business decision made by the company.

Please refer to the ASHP Shortages website for a listing of desiccated thyroid products that remain available:
http://www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/DrugShortages/GettingStarted/CurrentShortages/Bulletin.aspx?id=459

We have contacted the companies and RLC (manufacturer of West-Throid and Nature-Throid) is in backorder for all strengths and products for the next 90 days.

Major has the 60mg and 120mg available of their “generic” desiccated thyroid product.  They report increased demand as the reason for their backorder for the other strengths.

Forest reports they have the 120mg, 240mg, and 300mg strengths available for their Armour Thyroid products and they report increased demand as the reason for the backorder on their other strengths.

If you and your healthcare provider determine that one of these thyroid products is appropriate for you, you can provide the NDC numbers listed on the ASHP website for these products to your pharmacist so they can order for you.

Best regards,
Drug Information SH
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

The interesting thing about the above is that it implies that Major Pharmaceuticals is just on backorder, which goes completely against what patients have reported elsewhere.  What’s going on there? Are they using old knowledge? And the larger sizes of Armour? Is anyone finding that at the pharmacies right now? Very curious. Interesting the comment about RLC, the makers of Naturethroid.  And the link to shortages is interesting, though from the end of July.

Whatever the answers are, if you need a treatment to get you through this difficult time, here are options for thyroid treatment. And it still may be a very good idea to inform your congresspersons of our situation…just in case. See my blog post below.

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

*STTM t-shirts are 50% off! I love sales.

10 replies

The gnarly man and what we can do in the face of this crisis

ogre

There once was a gnarly, bottom-scratching and tuna-breathed man who terrorized a neighborhood as if he was above the law. He intimidated people, used threats to stop others from telling the truth about his actions, and he mooned his hairy buttamous to anyone he didn’t like. He brought other criminals into his large house, took bribes to do some of their own dirty work, and stole every single vegetable and fruit from all his neighbors gardens.

Finally, all the fearful, frustrated and hungry neighbors got angry, sick and tired of it all. So they sent him emails, letters and phone calls, asking him to stop what he was doing, and explaining how he was hurting their lives and well-being,  and speculated how he was going to do this or that.

And do you think he stopped doing what he always did?

Finally, the neighbors got wise. They reached out to the police, to local radio and TV stations, to the newspaper, and even to local political leaders.  They stated the facts as they knew them, how specific actions affected their lives, how they had speculations that they couldn’t prove but were quite uncomfortable…and they made sure everyone knew what was going on to get the help and support they needed. 

********************************

For over 100 years, thyroid patient lives have made a huge and positive turn-around on natural porcine desiccated thyroid, a superior, safe, and effective medication as expressed by all our lives for over a century.  But today, we face a crisis.

The most popular desiccated thyroid brand, Armour, was reformulated by 2009  and most patients reported a return of their hypothyroid symptoms. Then, the only other major pharmaceutical, RLC Labs, has their quality Naturethroid and Westhroid on backorder in August of 2009. The only North American makers of the desiccated powder, American Laboratories, is out.

And finally, the remaining two generic makers, Time Caps Labs and Major Pharmaceuticals, are told to cease production by the FDA.

We are now without desiccated thyroid other than the remaining 10 tablets there, or 5 tablets here. They will all be gone soon.

The facts we know are this: because of the 1962 “Drug Effi­cacy Amend­ment”, the FDA is suddenly demanding phar­ma­ceu­ti­cal drug manu­fac­tu­rers (with medications which have been used successfully for 80-110 years) pro­vide proof of the effec­ti­ve­ness and safety of their drugs before they can receive true FDA appro­val, aka potential cli­ni­cal trials and the data that results. i.e. 110 years of patient success, and a website like Stop the Thyroid Madness, and testimonies all over the net and in patient groups with desiccated thyroid…is somehow…just…not…enough.  What is obvious, is not enough.

In other words, they want proof of efficacy and safety of desiccated thyroid—a medication which has a safe and effective track record in a huge body of patients for 110 years…in the same way they give an FDA-stamp-of-approval on a whole variety of drugs which, in 2004, killed 783,936 individuals per year (according to the article Death by Medicine, co-authored by By Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD).

Does THAT make any sense to you?

And now, because there is hint that they may require RLC Labs to apply for a New Drug Application…and because we wonder if that will mean expensive and drawn out clinical testing to provide data…and because we wonder if they will allow RLC to continue manufacturing our only good supply of desiccated thyroid which saves our lives in a completely healthy way…we are left with a lot of uncomfortable and unanswered questions.

Of course, we can admit that all the above is pure speculation. We don’t know what will happen until it happens. But we are strongly uncomfortable with the unknowns, frustrated by the possibilities, and scared to death we might lose the only medication which has removed our lingering and debilitating symptoms while we were once on synthetic T4–aka Synthroid, Levoxyl, levothyroxine, etc.

And by the way, synthetic T4 is an FDA-approved medication which has left most of us sick or with lingering symptoms to our own degree and intensity for YEARS. Perhaps THAT is what you need to write the FDA about.

So do we email the FDA about this situation?? I am of the belief that writing/emailing the FDA is no different than asking the neighborhood ogre to change.  I could be wrong, but it is my deep suspicion. In fact, I am suspicious that the onslaught of communication with the FDA is going to do more harm than good…if it hasn’t already…just as writing and emailing the neighborhood ogre would probably cause him to laugh and do even MORE harm.

So what seems the best and most logical action to take with our current situation? Write/email your senators. Write/email your representatives. Write/email newscasters, talk show hosts, radio personalities, newspapers of merit, and anyone who has the power to spread the word. In my mind, we cannot expect to face what may be with power unless we inform the world of our plight ahead of time.

How to say what we need to say? I think, for our integrity in the eyes of whom we speak/email/write to, it’s important to state facts first and foremost. For me, if I need to mention speculation, I turn them into questions: Will RLC be able to afford clinical trials? Will the FDA stop all desiccated thyroid? You may not agree but that’s what seems wise for me.

I have compiled a list of particular congresspersons who just last year, made a resolution against the FDA. You will see a list of those supporters at the bottom of the page with their contact info. Email them.  You will also find links to contact each and every other political office. If I have missed something, let me know and I’ll add it.

I have also compiled a simple template letter you can use, or change exactly as you need it changed, for these emails.  It will not fit every single individual who uses it, so change it as you may. But keep it short and succinct. Too much to read will turn off the reader.

I have tried hard in this post to communicate my thoughts and intuition. I also still have some strong hope and faith that this IS going to work out, one way or the other. I’m just not into fear-mongering based on speculation.  Some of you may not agree with my sentiment, but that’s okay. And some of you may agree that it’s time to strongly communicate with our congresspersons, and I will hope you follow through. All of us need to follow through. I need to follow through. You need to follow through.

NEED OPTIONS FOR THYROID TREATMENT during this hard time? Go here. You’ll also find several Canadian Pharmacies to use with a prescription, as well, that is much easier than ordering directly from Erfa.

NEED A GOOD DOCTOR? Go here.

NEW TO DESICCATED THYROID? Here’s everything patients have learned.

*Want to be informed of this blog posts? Curious what’s on Janie’s mind? Use the notifications on the left below the links.

*Spread the word! STTM T-shirts are 50% off. I love sales.

13 replies

The FDA has spoken

fdaimage

This post was originally written in 2009–interesting that nothing has changed since then. 

Just spoke with a thyroid patient who spoke with Lena Choe of the FDA. She is a pharmacist in the Division of Drug Information at the FDA.

Choe stated that they are not taking current action with Forest Labs and RLC Labs in regards to Armour and Naturethroid. Instead, they will simply be requiring them to go through the New Drug Application process, and they will require data. Data is possibly referring to the clinical trials that both companies will have to perform to get results on the efficacy and safety of desiccated thyroid.

Choe stated that the FDA is very aware of problems with Armour and will be looking into that eventually. The FDA takes priority actions on medications based on consumer complaints.

A comment which I found hopeful from Choe was her knowledge that desiccated thyroid has already been use in humans since the 1962 amendment. That’s a good track record of 47 years, folks, that the FDA is referring to. Of course, many of us also know that NDT had a good track record since the 1890’s.

1962 represents the year the FDA established the “Drug Efficacy Amendment”, also called the Kefauver Harris Amendment. The amendment requires that pharmaceutical drug manufacturers provide proof of the effectiveness and safety of their drugs before they can receive FDA approval, aka clinical trials and the data that results. The amendment also requires accurate marketing information on side effects (think Bob and erectile dysfunction on those irritating, nauseating commercials).

And again, it still appears as I stated below that both Major and Time Caps were told to cease production due to being “new” companies since 1962 producing desiccated thyroid. That is a different issue than RLC and Forest.

Hang onto hope, folks. Because by the limited information everyone gets when they call the FDA, it points to a good reason to feel positive, not to think the worst…at least for me. Sure, it’s maddening they would shut down whatever production was left of desiccated thyroid. And it’s equally frustrating that we hang by threads as far as FDA communication. But right now, as I also thought a few days ago, I don’t think the FDA is shutting down production of RLC and Forest, or will during the NDA process. We just have to wait for supply to catch up, especially with RLC. So we’ll see what passes.

33 replies

This is not the time to wield pitchforks and torches

The subject line of this post was just given to me in an email by a wise and cautious person. And I agree with it.

We have facts. We know that Time Caps Labs cannot make desiccated thyroid. We have read, without seeing the actual press release, that Major Pharmaceuticals has been told to stop. I’d sure like to see this release….

We know that Armour didn’t work well for most and became hard to find. We also know from RLC, makers of Naturethroid, that there is at least a 3 month backorder.

And, we know from American Laboratories that they are making the production of desiccated thyroid powder their #1 priority. Demand was greater than supply.

But beyond that as I write this, we know no more. And to speculate in only a negative direction can be a disaster. To march with our pitchforks and torches is only shining a spotlight in the direction of the FDA, and they may not be friendly.

There are positives. ERFA has allowed us to order their Canadian thyroid. There are other sources out there which I have mentioned below, as has health writer Mary Shomon.

And there are other facts: hundreds of thousands of us, if not into the millions, KNOW that desiccated thyroid really is safe and VERY effective. We KNOW that endocrinologists are totally wrong in their opinions.

So, what you can do is put emphasis on the latter FACT of effectiveness when it comes to you. Write your story.  Give a “”before on T4 and an “after on Desiccated thyroid”. Then send it to me for the Stories of Others page. IF…..and I say IF….something drastic happens from the FDA, we then start providing out testimonies and do what we need to do…one after the other after the other. That is our strength.  Facts, concern, but not panicking and carrying pitchforks and torches which may backfire on you. This is not yet the time, if it even passes.

Janie

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

*Spread the word! STTM t-shirts are now 50% off.

22 replies