www.savenaturalthyroid.com

Started by Mary Shomon to address the concerns NTH users have regarding continued manufacture & supply of our life-saving medication.
The latest worry is that the FDA is trying to shut down production.

I have been assured that in that event, PCNZ will do its best to keep us all going, even if they have to compound their own mixture!

To: Save-Natural-Thyroid@yahoogroups.com
Date: Wednesday, 9 September, 2009, 3:58 PM


I posted earlier today, but wanted to check in, and share more indepth about my perspective on what's going on. I understand that some of the other groups that are involved in the natural thyroid issue view the current situation as simply a manufacturing shortage, and have decided to take a wait and see approach. That is certainly their prerogative, but from my perspective, strategic, proactive planning and networking is essential at this time, and that's where my focus is now and will continue to be.

I had the most ill-timed vacation ever -- gone out of the country from Sat the 29th until this past Monday, and without a computer! But now that I'm back, I've already been in discussions with physicians, pharmacies, drug companies, lobbyists, scientists, and government officials, etc. around the country -- and the world -- who are intensely focused on the natural thyroid issue.

They are understandably not going public until it's clearer what's going on behind the scenes here in Washington, and what strategy to pursue.

This is a shifting situation. Right now, as we all know, the "statements" and conversations from the FDA have been clear as mud. Every day, you get a different story. So we remain faced with several issues:

1. The FDA's Unapproved Drugs Campaign appears to have identified natural desiccated thyroid as an unapproved drug. I believe it's naive to assume, especially with FDA committee members who have direct financial ties to Abbott Labs (maker of Synthroid), and Sidney Wolfe on the drug safety committee -- he being a vocal opponent of natural thyroid -- that the FDA would be planning to cherry pick only certain manufacturers for action, and leave the rest. Especially as the one official FDA letter declaring natural desiccated thyroid as an unapproved drug went to TimeCap, which was until recently the subcontractor manufacturing RLC's Nature-Throid and Westhroid. Note that we do not know whether TimeCap -- or Biotech or Major for that matter -- was also producing Armour Thyroid under subcontract, but it's a question that begs asking.

2. We don't have public information as to the behind-the-scenes negotiations going on with the two remaining companies, Forest and RLC, with the FDA. But I believe we can safely assume they are going on, as these two companies have yet to receive any public enforcement letters from the FDA. This may be viewed positively, as it may suggest some willingness on the part of the FDA to avoid cutting off the majority of patients on natural thyroid going forward. But that's speculation at this point.

3. We do have RLC's commitment to do their best to continue making desiccated thyroid, and I believe them. Whether they will be able to do so is the challenge they face themselves as a business, and depends on their acumen, their personnel and financial resources, relationship with the FDA, etc. But I know as patients, we all stand ready to support them specifically if/when they need our support.

4. We have no such commitment from Forest, and Forest has a history of a studied lack of interest and communication regarding their Armour Thyroid product. Given that they have been responsible for the majority share of the natural thyroid market, their lack of information or proactive interest is highly troubling. A number of years ago, in meetings I had with execs at Forest in NY, they made it clear to me that they allowed Armour to plod along because it wasn't a big market, and it sold itself anyway. They did not even have their sales reps discuss it with doctors, so as to avoid any conflict, given the controversy. They put no money into marketing, and felt it was unnecessary to come to Armour's defense. I even specifically asked them to respond when Sidney Wolfe's Best Pills/Worst Pills attacked Armour, called it "cow thyroid supplement" and said that the only doctors prescribing it were unscrupulous diet doctors. They refused to make any public comment, and left it to me to defend THEIR product in letters to Public Citizen and Dr. Wolfe.

5. We do not have an explanation as to the shortage of porcine thyroid raw material. It's all well and good that the raw material monopoly manufacturer, American Laboratories, keeps assuring everyone that they are working hard, but what triggered a shortage of a typically readily available product? And it's especially troubling that the shortage has occurred at the exact same time as the general shortage of drugs from the only two remaining natural thyroid manufacturers, and the disappearance of the other manufacturers.

6. We have the FDA letter re: TimeCap, but we don't have enough information on the disappearance/shutdown of Biotech and Major's natural thyroid drugs. Second-hand information has suggested that these were the result of FDA action, but it's not confirmed.

7. We face the possibility that the FDA will take action against these companies, and that raises additional questions: When? Would the drugs remain on the market during an NDA process? Would RLC be able to pursue an NDA for their natural thyroid drugs? Would Forest be able to/interested in pursuing an NDA for Armour?

Answering these questions and exploring these issues definitively is ongoing as I write.

As for all of us, right now, information-gathering, brainstorming, and communicating with our doctors is, in my opinion, the best thing that patients can do to help save natural thyroid.

Meanwhile, a national effort is being organized, but understandably, that will not be telegraphed ahead of time to the FDA or any other government entities. But when the time comes for patients to step up and speak out, there will be more than enough opportunities for each and every person to have her/his voice heard, do their part, and to take definitive action. It will be essential for success!!

I know that things have been haphazard -- that's the nature of an ever-shifting situation, esp. when dealing with the federal government and for-profit corporations over sensitive issues. I wish we could have all the information clearly from all parties involved, but that's obviously not going to happen.

I also know that at times, things have been contentious between patients, and some people seem to have a difficult time avoiding squabbling over strategies, details, and such. (This Yahoo list is at present a good example of many well-meaning people clashing).

Ideally, I'd really like to see patients put aside their differences, and try to communicate with each other effectively and constructively without attacking and name-calling.

Because there is enough name-calling headed our way already. You all do know what many doctors -- and especially endocrinologists -- are saying about us, about natural desiccated thyroid, and about our rights to be partners in our own health care, right? They are nasty, they are derisive, they have no respect for us, and some of them are even openly and vocally thrilled about the shortages. THAT is the environment in which we are operating.

We all have to toughen up and get ready. Because whatever thyroid patients have to say to each other -- rudely or otherwise -- is NOTHING compared to the battering we get every day from endocrinologists, drug reps, medical associations, etc. Some of you have first-hand experience of being treated contemptuously by endos or pharmacists. And I've been the human battering ram and point person for the rage of many endocrinologists for more than a decade, so I know how they can be! And if/when we have to defend ourselves publicly, it will only get worse. So please...save the righteous indignation and energy for the real battle ahead, and not for each other!

I'm doing my best behind the scenes here in Washington to suss out what we need to know, and assure you that we have many amazing practitioners, advocates and others who have the best interest of all thyroid patients (not Synthroid or the FDA, etc.) in mind.

I don't have any guidance at this point as to whether people should or should not be writing to representatives, or the FDA, because again, we're dealing with an ever-changing situation here. As soon as a strategy takes shape and becomes more defined, I'll hopefully have more constructive and practical suggestions for all of us.

I do think that we can encourage doctors to start writing up letters/case studies/patient profiles to document -- with data whenever available -- that support their decision to prescribe natural thyroid for their patients. If you had a TSH of 35 no matter what dose of Synthroid, but were able to get "euthyroid" on natural thyroid for example, your job should be to get your doctor to write that up in a letter or brief case study, for example. In the absence of journal research and published studies, this sort of testimony from practicing physicians will become critical.

In the meantime, I applaud everyone's passion and willingness to step up, speak out, and take action. There is tremendous energy and momentum, and it's phenomenal!!

-- Mary

Health e-Tips - Natural thyroid user? Not if the FDA has their way
Monday, September 14, 2009 7:06 AM
From:
"Nutrition and Healing - Christine O'Brien" <healthtips@healthiernews.com>

Dear Reader,

If you depend on natural thyroid replacement, I have bad news from the American Association for Health Freedom (an organization familiar to Dr. Wright's readers).

The FDA is launching an attack. According to the AAHF, they've ordered Time-Cap Labs to stop production of their generic bioidentical thyroid replacement.

The FDA's claim? Natural desiccated thyroid is a new drug, one that has not been approved.

Never mind the fact that it's been used safely since long before the FDA even existed.

Or the fact that it's far superior to the mainstream's synthetic preparations—preparations that miss half the picture (bioidentical preparations contain all four pieces necessary to match what's produced by the human body) and don't do nearly as good a job.

But it looks like the FDA has no problem offering up an inferior alternative—and wiping the natural, whole, SAFE competition off the board.

Write to the FDA to ask about this ridiculous business, and they're quick to point out that they're not conducting a class action to remove unapproved thyroid products from the market—they're just classifying them as unapproved new drugs.

As an e-Tips reader, you probably already know how incredibly expensive the new drug approval process is. Far too expensive for anyone making a non-patentable substance (like bioidentical hormone replacement).

So other words, the FDA is saying "Hey we're only requiring them to file a new drug application. It's not our fault if they can't afford it and are forced to stop making it!"

Our very own Dr. Wright had this to say to the AAHF: "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."

Couldn't have put it better myself.

The AAHF will be closely monitoring developments in this story, and I'll keep a close watch myself. In the meantime, find out how you can help protect your right to make your own choices about your healthcare at their website.

Yours in good health,

Christine O'Brien

http://www.armourthyroid.com/default.aspx - Armour

http://www.americanlaboratories.com/company_news/Press_Releases/Thyroid_Information.pdf - makers of the Thyroid USP powder used by all manufacturers in the US

Statement from Forest Laboratories Re: Availability of Armour Thyroid

Forest Laboratories and its supplier understand how frustrating the back order situation of Armour Thyroid is for patients, and we apologize for the supply interruption.

Forest Laboratories is working closely with its supplier of the product’s active ingredient, powdered Thyroid gland, and both companies are working diligently to return to normal supply levels as quickly as possible.

There are many complicated steps involved in the supply chain for a naturally desiccated thyroid product like Armour Thyroid. One factor in the supply interruption involves the manufacturing of a sufficient quantity of powdered Thyroid gland. American Laboratories, Inc., the sole U.S. supplier of Thyroid Powder Products, is working as quickly as possible to provide Forest with a sufficient quantity of this ingredient.

Forest is addressing the backlog of Armour Thyroid as quickly as possible, however, we are not prepared at this time to give a definitive date by which the product will be fully restocked. Please check for future updates on the availability of Armour Thyroid through the Forest product availability toll-free hotline at (866) 927-3260 (866) 927-3260.

In the meantime, we encourage patients to speak with their physician regarding appropriate treatment for their condition.

Statement from American Laboratories, Inc
August 19, 2009

To our knowledge, American Laboratories, Inc. is the only manufacturer in North America of Thyroid Products for use in Human Pharmaceuticals as an Active Pharmaceutical Ingredient. We have manufactured our Thyroid products for over forty years, and we understand the importance they have to our customers and ultimately the consumer patients. Today, as well as in the future, our Thyroid products will continue to be a strategic part of our business.

Through the years, the world-wide demand for our Thyroid products, as well as our human nutritional enzyme products has increased dramatically. Through careful planning and strict adherence to regulations set forth by the FDA, USDA and other government agencies, we have implemented plans to increase our production capacities. In addition, American Laboratories’ is working closely with our suppliers to help ensure a consistent supply of quality raw materials. We hope that you understand that the process to manufacture the active ingredient takes several months to complete.

Please be assured that we have placed our Thyroid production as our number one priority so that we can meet the demands of our customers.

American Laboratories, Inc

Omaha, Nebraska, USA

http://articles.mercola.com/sites/articles/archive/2009/09/19/Is-the-FDA-Poised-to-Ban-a-Century-Old-Natural-Remedy.aspx

http://www.guardian.co.uk/science/2009/sep/18/doctors-ghost-writing-pharmaceutical-research