Natural Thyroid (off topic)

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ladyhawk21

Natural Thyroid (off topic)

Post by ladyhawk21 »

An Update from Mary Shomon on Save Natural Thyroid:

I wanted to check in, and share 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 an issue of 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 Time Cap, 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.

Renee
southernyankee
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Posts: 129
Joined: June 22nd, 2009, 10:25 pm
Location: Texas

Re: Natural Thyroid (off topic)

Post by southernyankee »

ladyhawk21, I've been waiting for an opportunity to put in my 2 cents on this topic, even tho' it is off-topic for LDL. I am also one of the individuals who recently found Armour Thyroid to be unavailable when I needed a prescription refill.  :'( I had been taking it as prescribed by my GP for about three years and had been doing so much better on it than prior to using it. Although I had Synthroid suggested to me by my endocrinologist, I am adamantly against taking these types of unnatural hormones. :thumbdown: Fortunately she respects my decision, so there is no argument there. 
After researching and discussing with my GP and my compounding pharmacist, I have learned that what are called "bio-identical" hormones are the next-best to our human hormones for people to use. [BTW, when I was told I could not get Armour refilled, I asked the pharmacy assistant, "What's the deal, are folks not eating enough pork ribs and pork chops, so the pork thyroid hormone is not as easy to obtain anymore?"  ;) She and I had a good laugh over that ~wrong~ reason for Armour Thyroid being kept from availability and being squeezed from the marketplace.  :sad:] The issue so obviously is politics and the fight over consumer $$$.
Oh well, the bottom line is my GP has now prescribed a "compounded" thyroid capsule for me that is made to the specifications from my lab blood tests that show EXACTLY what ratio of T3 and T4 I need. This has been a great turn of events, because I feel even better taking it and knew from taking my very first capsule that, "YES!" this is EXACTLY what my body needs for thyroid supplementation in just the right combination. Don't know if other LDL'ers have access to a COMPOUNDING pharmacy - this is different from the regular pharmacy that just dispenses drugs as they are manufactured at the factory. A compounding pharmacist makes up the prescription to be tailor-made to a patient's need as specified by doctors who recognize and appreciate the difference compounding pharmacies offer for patient treatment. I am also aware that nationally, Compounding Pharmacists have been threatened with lawsuits by "Big Pharma" to make them discontinue their practices - so Big Pharma can get all the prescription medicine business, I must assume. But so far, compounding pharmacy as a specialty is able to to stay in business.
Sorry this is so long - guess it really adds up to more than 2 cents worth of discussion, but it it something I've been wanting to say.
southernyankeee
southernyankee
ladyhawk21

Re: Natural Thyroid (off topic)

Post by ladyhawk21 »

can you tell me the name of your compounding phar.  maybe i can contact them and see if i can have the Dr fax a script to them and mail  the RX to me.  I have to do something.  I found some Thryoid S (out of the country though)

the FDA/insurance co. dont care about the little people-they are in it for the money.

Renee
southernyankee
Full Member
Posts: 129
Joined: June 22nd, 2009, 10:25 pm
Location: Texas

Re: Natural Thyroid (off topic)

Post by southernyankee »

ladyhawk21, Yes, I will send you a PM with the info. I'll reference "LDL" in the subject block.
southernyankee
southernyankee
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