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Tag: Time Caps Labs

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

American Association of Health Freedom has reported on this situation

AAHFBefore I post this, I want to remind everyone that as I am writing this, the FDA has not made an official statement concerning desiccated thyroid, and I want to avoid excessive fear mongering and undue speculation by underscoring that.

But with that being clarified, the American Association of Health Freedom (AAHF) has just today issued an article about the desiccated thyroid shortage that you might find of interest.

Concerning Time Caps Labs and being told to cease production, the article states:  The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug.  Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product.  The purpose?  Presumably to protect the profits of other, inferior drugs that have been FDA approved.

And I especially appreciate this comment: As famed physician Dr. Jonathan Wright observes:  “Natural thyroid has never killed or severely harmed anyone since its first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.”

Kudos and appreciation from all thyroid patients go to Dr. Jonathan Wright, besides AAHF for giving acknowledgment of this issue!

Better treatment with Desiccated Natural Thyroid has been my main focus as a thyroid patient activist since 2003 and with great conviction.  I and millions of others whom this website and book represent know how GOOD this medication is and we definitely appreciate this kind of support. :)  Yes, millions of us have had our lives change ten-fold thanks to this safe and effective 110 year old medication. You can read just a touch of those changed lives on the Stories of Others page.

In their Overview, the AAHF explains:

The American Association for Health Freedom (AAHF), currently in the process of merging with the Alliance for Natural Health (ANH), is part of an international organization dedicated to promoting sustainable healthcare and freedom of choice in healthcare through good science and good law. We protect the right of natural-health practitioners to practice and the right of consumers to choose the healthcare options they prefer.  Since 1992, we have worked to shift the medical paradigm from an exclusive focus on surgery, drugs and other conventional techniques to an “integrative” approach incorporating food, dietary supplements and lifestyle changes. This is the way to improve health and extend lives while reducing the costs of healthcare back to a sustainable level.

You can read more on their Overview by clicking the link above. And if you need to communicate with anyone, provide facts and all your concerns to your congresspersons.   Here’s a template letter to use or change, and there are other good ones circulating in many good thyroid or facebook groups and forums out there.

P.S. Dr. John C. Lowe has also provided a very informative and well-reasoned editorial pertaining to our current shortages.

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

4 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. 

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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.

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13 replies

Major Pharm told to stop making thyroid–more to this story

FDA2

I have been receiving emails this afternoon from concerned patients about the latest blog post by health writer Mary Shomon. Her post states that Major Pharmaceuticals has received a notice from the FDA to stop making desiccated thyroid.  And Shomon questions:  is this the beginning of the end?

I think it’s important to mention something that I remember reading, but can’t right now put my finger on, that the FDA can stop production of desiccated thyroid if a company has started making it AFTER the FDA came into existence, and require it to file a New Drug Application, since it is “new” to that company.  Forest Labs and RLC do not fall in that classification. They were around before the FDA came into existence.

I did find this article about Morphine, which implies that as long as a drug (like desiccated thyroid) has not changed since it’s inception, it can avoid the New Drug status. It states:

Under a grandfather clause, a drug marketed prior to the 1938 Federal Food, Drug, and Cosmetic Act, and labeled with the same conditions of use as prior to the Act, was not considered a new drug. These drugs did not require an approved new drug application, but many thought tacit FDA approval was implied. It’s the drug company’s burden to prove an assertion that its product is grandfathered. But FDA believes few drugs are entitled to grandfather status because many differ from previous versions in some respect (e.g., formulation, strength, dosage form, route, indications, intended population).

The above statement makes you pause about Armour, which WAS changed by Forest Labs. But I’m not at all sure RLC’s desiccated thyroid has changed at all, which can be good news for all of us.

Check out page 332 of Good Manufacturing Processes for Pharmaceuticals by Joseph D. Nally which also outlines the above issue of grandfathered drugs.

All in all, it’s downright MADDENING and INEXCUSABLE how the FDA would tell these generic pharmaceuticals–Major and Time-Cap Labs, to stop producing the medication when we already have a shortage.

Here is what the FDA states in their 2006 Compliance Manual, Section 7132c.02 titled Marketed New Drugs Without Approved NDA’s and under A: Reason for This Guidance, please note what I have italicized in their statement:

Manufacturers of drugs that lack required approval, including those that are not marketed in accordance with an OTC drug monograph, have not provided FDA with evidence demonstrating that their products are safe and effective, and so we have an interest in taking steps to either encourage the manufacturers of these products to obtain the required evidence and comply with the approval provisions of the Federal Food, Drug, and Cosmetic Act (the Act) or remove the products from the market. We want to achieve these goals without adversely affecting public health, imposing undue burdens on consumers, or unnecessarily disrupting the market.

To the contrary, the FDA has IN FACT adversely affected public health and has imposed undue burdens on consumers by these ridiculous actions!! A large body of those now on desiccated thyroid will tell you that being on anything BUT desiccated thyroid ruins their health and well-being. I am one.

Under III. FDA’s Enforcement Policy, they define two areas of concern: drugs with potential safety risks, and drugs that lack evidence of effectiveness. You and I know very well that the latter has been stated ad nauseum by the FDA and certain individuals, and yet THE EVIDENCE IS IN HUNDREDS OF THOUSANDS OF US who have switched to desiccated thyroid is ignored, as it the continuing symptoms representing lack of effectiveness in T4 meds!

You can continue reading this FDA Guidance policy and use the Comments to see what hits you, as well.

I have compiled the above fairly quickly, so if I have left anything out, or you can offer more clarification, use the Comments.

P.S. A recommendation: if you are very optimal on your current desicccated thyroid, I would recommend trying to decrease your dose every other day. For example. 4 grains, 3 1/2 grains, 4 grains, 3 1/2 grains, etc.  Not everyone can do this, but if you can, it will help draw out the amount of desiccated thyroid you do have without adversely affecting you. Again, this may only work for those who are quite optimal, and without adrenal fatigue or other issues.

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

15 replies