Hypothyroid Anyone?

http://thyroid.about.com/b/2009/08/28/fda-future-natural-thyroid.htm
What is the FDA Not Saying About The Future of Natural Desiccated Thyroid Drugs?

Thyroid Disease Blog, Mary Shoman


****The Armour Thyroid and Nature-Thyroid Shortage Information Center:
http://thyroid.about.com/od/thyroiddrugstreatments/tp/desiccated-thyroid-2009.htm


This past Wednesday, August 26th, I contacted the public affairs division of the Food and Drug Administration (FDA), indicating that I was a writer and patient advocate looking into the status of natural thyroid. I explained that I had several straightforward questions:

* Is the FDA requiring ALL natural desiccated thyroid drugs to go through the new drug application (NDA) process, or only those manufacturers that have already been shut down?

* Is/will an NDA being required for the main drugs in the category: Nature-Throid, Westhroid and Armour Thyroid?

* If an NDA will be required for the drugs still on the market, will these drugs be removed from the market during the NDA process?

* If an NDA will be required for the drugs still on the market, and these drugs will be removed, WHEN would this be effective?


It took several days, but the FDA finally released an official "statement" in response to my question.

The Agency has not conducted a class action against unapproved thyroid products. As a policy matter, however, we do not discuss potential, pending, or ongoing actions except with the firms and individuals who are the subject of those actions. As information about enforcement actions becomes available it is posted on the FDA website.

In June 2006 the Agency published the guidance "Marketed Unapproved Drugs --Compliance Policy Guide" (the CPG). This guidance outlined the Agency's enforcement policies which we believe are well-suited to protecting the public health without imposing undue burdens on consumers or unnecessarily disrupting the market. For additional information regarding the FDA's actions against unapproved drugs, please access our unapproved drugs website at the following link.

While we waited for the FDA's response, thyroid patients at the Save Natural Thyroid Coalition were themselves calling the FDA's consumer information line -- (888) 463-6332 -- and were being told a variety of things by FDA staff. Some staff at the FDA have said that all natural thyroid was going to be pulled from the market, others said that the FDA denied any involvement at all in natural thyroid, others have said that the measures are currently only applying to the companies already targeted.

What's with all the contradictions? Officially, the FDA leaves the door open to do pretty much anything they want, but doesn't tell us anything that can actually help protect the health of thyroid patients. And then, in one-on-one conversations, their staff are offering all sorts of different scenarios.

Why is the FDA unable to provide clear, specific answers to thyroid patients about this critical issue?

And let's face it, we have a very troubling situation at present:

* Weeks ago, a major "big pharma" insider, Medco, sent a nationwide notice to doctors declaring that the FDA was taking all natural desiccated thyroid drugs off the market, and that doctors should switch patients to levothyroxine drugs
* We currently have an unexplained nationwide unavailability of Thyroid USP, the raw material that is used to manufacture natural thyroid drugs.
* Since the spring, production of three different natural desiccated thyroid drugs -- Biotech, TimeCapLabs and Major -- have been shut down. We know that TimeCapLabs was shut down in response to a publicly available notification letter they received from the FDA. The second-hand information is that Biotech and Major were also shut down by the FDA.
* We have the actual letter the FDA sent to TimeCapLabs, stating that natural desiccated thyroid requires a new drug application (NDA).
* Throughout the U.S., we have dwindling to non-existent supplies of Armour, Nature-Throid and Westhroid on the market, and most patients are now unable to get new or refilled prescriptions for these medications. Given the nationwide shortage of raw material, compounded capsules of natural desiccated thyroid is also unavailable to most patients.
* RLC is saying that it will be at least 90 days before they have any new product (Nature-Throid/Westhroid) to ship.
* Forest, which makes Armour, the most prescribed brand of natural desiccated thyroid, will provide no estimate whatsoever regarding when they expect to have any product available to ship.

And now, we have the FDA responding in a vague manner to a very specific request for information that affects millions of thyroid patients, patients who rely on natural desiccated thyroid drugs to treat a life-threatening health condition.

Am I being overly suspicious or alarmist? It's possible. Am I, as one FDA person apparently told a caller, just "that lady who is stirring up trouble?" I guess that could be.

But given these highly unusual circumstances, can and should we trust that the FDA has our best interests at heart?

Given that the big drug companies -- who have undue influence the FDA -- stand to benefit financially by getting natural desiccated off the market, should we assume that the lack of a clear answer from the FDA is a positive sign?

Should we all just "wait and see" for three months or more if natural thyroid drugs again become available?

What [else] does the FDA know that they're not willing to tell us?

MORE INFORMATION:
http://www.facebook.com/pages/Save-Natural-Thyroid/121680434089


XOXO
Me

Car Seats. Babies. And Americans.

Good Morning Everyone;
I am not overlooking the fact that there are things to be taken care of. (I am not forgetting that I need to do many things yet).
But I am not forgetting either.
Below is my recall of those terrible moments and days when we, collectively as Americans, truly united.

Not to need another reminder that we need to UNITE, we need only to respect life.

Peace.

XOXO
Me

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

September 11, 2001 
From the Eyes, and the memory, of a Flintville American




Having just returned from Alabama late on the tenth- (a visit to my daughter,Roberta- son-in-law; William- and of course to see my grandson, Lawrence). I was sitting quite exactly where I am right now... Downloading and editing the zillions of pictures that I had taken from that trip. The photo above was taken on that trip... I was also babysitting my Little Miss Valerie; (full-time at that point). She was all of 7 months old.

I had fed her her breakfast- had brought her upstairs, and she was fast asleep in the magical land where babies go to see God during their naps...

My phone rang. It was Zoe, asking me if I had my television set on. I did not. She asked for me to turn it on right away, that there had been 'a terrible accident' at the World Trade Center. I assured her I would do so as soon as I was finished; and she asked me just to go take a look...

When I did turn the TV on, I saw the 1st Tower on fire- and the reports coming in that an airplane had hit it- A terrible accident... As I was thinking to return to my little office here, I heard even more commotion on the TV- Turning just in time to see the final seconds before the 2nd plane hit... At that point in time, I think my reaction was immediate horror, and thinking fast, I picked up the phone, called the high school and asked that Casey be at the front doors in about 15 minutes.Not knowing what else to say, I used the old standby "she is needed at home." I grabbed Valerie, and most unceremoniously threw her into the carseat, fastening her in securely- and thinking that our president could quickly impose a kind of lockdown of everyone everywhere. I headed to the high school. Casey, still uninformed, was packed and waiting for me- and had NO idea why on earth I would be picking her up from school? I tried to explain, but had the radio on- the announcers were doing a better job than ever I could have... I didn't want her to be away from home should the word come out that it wasn't safe for anyone to be going anywhere...

We filled the tank with gas, stopped both at the bank and the store, and headed for home. After placing Miss Valerie in the backseat of the Buick,I hurried to get all the groceries and things into the trunk.

The drive home is a county road, with two 90 degree curves thrown in for good measure... 3/4's of the way around that 1st corner, we heard this weird noise- Casey said, "Mom, pull over!" Turning to see why Casey would say such a thing, I saw that Miss Valerie's car seat had rolled and was completely upside down! (And yes, it IS funny now, but thinking that she was hurt- for even those few seconds was a sick sick feeling for me). In my hurry, I hadn't buckled the carseat in- (But in my defense, I didn't leave her at the store either)!!!

We came home- even more somber- and watched with horror as we saw the towers collapse. To this very day, that collapse is the single worse thing I have ever seen in my life- Knowing, that as those towers stood, all those people were still alive- that as they fell, all of them were simply gone; most NOT to be found, ever...

And my phone rang and rang and rang... Zoe wanting to know could she come out and stay and to be close to her own little girl- (by about 10:30, Humana had told all of its workers to go home). Jenne called too, and was already on her way out. We watched the TV for a time- then watched outside- We saw only military planes flying over- and low too- And there were none of the exhaust lines that you see trailing across the skies from all the jets and such. The air was calm, barely a breeze- a warmish day for the Eleventh Day of September... And very little traffic even out on the road- an ocassional dump truck, or a milk truck that went through- not too many cars- And the church bell rang and rang...

Later, I received about 4 calls from Roberta- at work in a gas station down in Alabama; and scared out of her wits. Scared to be so far away; and not knowing what would happen during the next while- Scared for her husband, and most importantly for her son... William has been in the Army and the Marine Corps- A "lifer" to the service of our country... He has been to the Gulf War- He has most recently been to Iraq- Someone for our Little Lawrence to be so proud of always...

I couldn't get ahold of Crystal or her family- They were living in Quantico at the time- Russell working at the Pentagon... Many emails later, to find out they were all safe and sound.

And still we held our collective breath all the day long, and the next, and onward- as we waited for even one survivor to be pulled from those towers... to be alive... and there were none...

Not knowing the futures, we made sure that our families and our homes were immediately protected, whatever it took.

In the days (daze) that followed, I know that one of the hardest things for me to do was to remain at home; only wishing I could be there to help somehow. And of course not knowing what it was I could have done anyway... But I could have helped the medics somehow- (what for ? - as no one emerged)... I could have made meals- Served them, not knowing to whom ? I could have helped with the cleanup of these now sacred grounds... But was more needed here for my own little family- ...And when you can do nothing else, you offer your heart and your prayers...

I believe we all did pray, whether we attended services or not. (Whether you 'believed' or not... You prayed, didn't you)?

We not only prayed for the people that had died, but for their families- For ourselves, for our own families, and for our own homes. For the security we will never take for granted another day in our lives. For the security that our grandchildren will now never know.

And we prayed for our America.

And we prayed for our Flag.

Where were YOU?
What did you feel?
(Did you remember to buckle the carseat)???

God Bless Our America .

God Bless Us Everyone...

Anne