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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.

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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.

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An open letter to Mary Shomon

shakinghands2Hi Mary.

You know, I really don’t think this is a time for us to be separate, Mary, in our advocacies.   Seven years ago, I went a different direction that I felt was important, and still strongly do, as an activist.  That will continue because I believe in what I am doing. You don’t have to agree with my stance, but we can make the choice to work together in what is common between us–supporting the use of desiccated thyroid and helping others with the shortage.

As I see it, Mary, we each have a wonderful legacy. You will always be appreciated for your work as much as many appreciate my work. That will never be taken away.

So why not be united in this fight, Mary, working together to support patients during this shortage.  Thyroid patients need us.

Janie

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.

More good info on Canada’s “Thyroid” by Erfa

erfathyroidJust had a good conversation with Dr. Henri Knafo, the Director of Medical Affairs at Erfa Canada, Inc.

On my post below from yesterday, you will see hopeful information on getting this excellent Canadian desiccated thyroid. And below is more information you have been asking for as patients who know the efficacy of desiccated thyroid.

Erfa’s “Thyroid” comes in three strengths: 30 mg, 60 mg, and 125 mg.  Amounts you can order, and costs, are as follows:

30mg             500 tablets  $52.00 US;    100 tablets $18.00 US

60mg             500 tablets  $70.00 US;    100 tablets   $39.00 US

125mg          500 tablets  $100.00 US;   100 tablets  $ 50.00  US

Erfa will charge a 10$ handling fee (for first time users) and shipping is around $20 US.  Knafo states the prices are equivalent to Armour.

Erfa’s Thyroid has been in production for 30 years and they have 5000 Canadian patients on it.

Erfa’s Thyroid is approved by Health Canada (their equivalent to FDA).  Erfa spoke to the FDA, and in order for their desiccated thyroid to cross the US border, you have to fill out and sign the FDA patient study form which is mentioned below.

Erfa’s Thyroid is made in Europe with the raw materials, and they bought an excess of it. So there will be no problem getting it and they expect no shortages the rest of the year.

One canadian pharmacy you can use (and is not associated with Erfa) is the Canada Pharmacy Online.