Save Natural Thyroid.

[pmgamer18]

I got this thread this morning at my H2 group I mod at.
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If you all are not currently involved and can be, Mary Shoman reports that FDA is making a statement of some sort today about dessicated thyroid and perhaps will shed light on why drug companies are not being allow to produce it (Major for one).

Please be involved and contact your congress folks/FDA about this situation as it evolves. My life changed after 25 years on synthetic T4 and I don’t want to live the rest of my days with my NT 🙂

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ContactCDER/CDEROmbudsman/default.htm

Mary Shoman:
http://www.savenaturalthyroid.com/

Lori
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It’s time we take action about this.

[pmgamer18]

Here is an update on this subject a cut and paste.
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Here is the latest news about this a cut and paste from this link. And other links.
[url]http://www.stopthethyroidmadness.com…da-has-spoken/[/url]
[url]http://www.stopthethyroidmadness.com…-not-the-time/[/url]
[url]http://www.stopthethyroidmadness.com…o-mary-shomon/[/url]
[url]http://www.stopthethyroidmadness.com…to-this-story/[/url]
[url]http://www.stopthethyroidmadness.com…-info-on-erfa/[/url]
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August 28, 2009
Just spoke with Diane Blecha, who ser*ves as a mode*ra*tor and patient advo*cate on the NTH groups.

She spoke with Lena Choe of the FDA. She is a phar*ma*cist in the Divi*sion of Drug Infor*ma*tion at the FDA.

Choe sta*ted that they are not taking current action with Forest Labs and RLC Labs in regards to Armour and Natu*reth*roid. Ins*tead, they will simply be requi*ring them to go through the New Drug Appli*ca*tion pro*cess, and they will require data. Data is pos*sibly refe*rring to the cli*ni*cal trials that both com*pa*nies will have to per*form to get results on the effi*cacy and safety of desic*ca*ted thyroid.

Choe sta*ted that the FDA is very aware of pro*blems with Armour and will be loo*king into that even*tually. The FDA takes prio*rity actions on medi*ca*tions based on con*su*mer complaints.

A com*ment which I found hope*ful from Choe was her know*ledge that desic*ca*ted thy*roid has already been used in humans since the 1962 amend*ment. That’s a good track record of 47 years, folks, that the FDA is refe*rring to. Of course, many of us also know that Armour had a good track record since the 1890’s.

1962 repre*sents the year the FDA esta*blished the “Drug Effi*cacy Amend*ment”, also called the Kefau*ver Harris Amend*ment. The amend*ment requi*res that phar*ma*ceu*ti*cal drug manu*fac*tu*rers pro*vide proof of the effec*ti*ve*ness and safety of their drugs before they can receive FDA appro*val, aka cli*ni*cal trials and the data that results. The amend*ment also requi*res accu*rate mar*ke*ting infor*ma*tion on side effects (think Bob and erec*tile dys*func*tion on those irri*ta*ting, nau*sea*ting commercials).

And again, it still appears as I sta*ted below that both Major and Time Caps were told to cease pro*duc*tion due to being “new” com*pa*nies since 1962 pro*du*cing desic*ca*ted thy*roid. That is a dif*fe*rent issue than RLC and Forest.

Hang onto hope, folks. Because by the limi*ted infor*ma*tion ever*yone gets when they call the FDA, it points to a good rea*son to feel posi*tive, not to think the worst…at least for me. Sure, it’s mad*de*ning they would shut down wha*te*ver pro*duc*tion was left of desic*ca*ted thy*roid. And it’s equally frus*tra*ting that we hang by threads as far as FDA com*mu*ni*ca*tion. But right now, as I also thought a few days ago, I don’t think the FDA is shut*ting down pro*duc*tion of RLC and Forest, or will during the NDA pro*cess. We just have to wait for supply to catch up, espe*cially with RLC. So we’ll see what pas*ses.

This entry was posted on Friday, August 28th, 2009 at 1:57 pm and is filed under Armour, desiccated thyroid, fda. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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