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The 2009 FDA Ombudsman report, and why you need to contact the FDA

Good or interesting news is kinda slack right now.

But last week, the ombudsman of the FDA’s Center for Drug Evaluation and Research (CDER), came out with their 2009 report that I found interesting. The Ombudsman are those who receive and impartially look at any communications from patients to the FDA about medications.

On the fourth page, you find this under the heading Drug Shortages: Desiccated Natural Thyroid does not have FDA approval and it’s availability became quite limited in 2009. Many consumers complained to the ombudsman because of their preference of desiccated natural thyroid as thyroid replacement medication over the FDA approved synthetic versions.

Of course, the above gives a potentially false impression that the shortages were due to the lack of FDA approval–and reasons for this stupidity concerning “FDA-approval” are explained here.

To the contrary, last years shortages may be explained by production issues with the North American producer of desiccated thyroid powder, as well as demand being greater than supply thanks to patients finding out about the superiority of desiccated thyroid over T4-only meds like Synthroid. The STTM website and book is working, as are numerous good patient groups and forums!

But the above reveals that they are hearing thyroid patients speak.

So with this being a somewhat silent period, waiting to see when the FDA will require RLC (Naturethroid) to do ridiculously expensive clinical trials to prove what patients have already known for 110 years–that desiccated thyroid is safe and effective–it can be a GOOD time to continue communication with the FDA. How? By reporting YOUR EXPERIENCE AND PROBLEMS with T4 for their 2010 report next year. i.e. it will serve to cement why so many did call to state their preference. Here’s how:

If you had depression or other psychological issues while on T4, report it.

If you have rising cholesterol, low ferritin, and/or low B12 because of T4, report it.

If you had dry skin or hair, digestive issues, or aches and pains, report them.

If the quality of your life was lowered on T4, report it, outline it, detail it.

If you got adrenal stress because of being on T4, underscore that lousy truth to them.

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Having lower TSH levels when taking thyroxine not unsafe, says recent research

(Though this post was first written in 2010, it still works for today and is very pertinent!)

I am amazed.

The Society for Endocrinology in the UK reported that taking higher doses of thyroxine (which will lower the TSH lab result) may be safer than has been purported for decades.

And how low a TSH lab result did they find to be safe? As low as 0.04-0.4, the research found. It’s still safe enough to not cause an increased risk of “heart disease, abnormal heartbeat patterns and bone fractures”, aka HYPERthyroid symptoms.

And those of us worldwide who know about the superiority of having T3 in our treatment (like a working natural desiccated thyroid, T4 with T3, or even just T3-only), can also use these research results in our fight to be on enough with TSH-obsessed doctors. They tend to view research as the end-all to the truth rather than solid clinical presentation, sadly.

Because when we have enough T3 to feel fabulous again with all symptoms removed (in the presence of good cortisol levels, adequate iron levels, B12 and digestive issues), our TSH lab result is always low, aka suppressed, and without one iota of hyper symptoms.

Patients have experientially known this truth about the lousy TSH lab test, without research, for years!

P.S. You WILL feel good most of the time with a midrange free T3, but it eventually backfires. We have to get that free T3 optimal. <—Read the latter.

But here’s what’s missing from their research:

  1. Those “safe, low levels” of an ink spot on a piece of paper do not mean the 16,426 patients they followed will be without numerous issues related to being on a storage hormone alone. i.e. the body is not meant to live for conversion alone! A healthy thyroid will convert T4 to the active T3, but it will also provide direct T3 in addition to the T2, T1 and calcitonin…none of which a T4-only med provides directly.
  2. Additionally, the TSH lab test only reveals the action of a pituitary messenger hormone called the Thyroid Stimulating Hormone (TSH). The lab test does NOT measure whether your tissue is receiving enough thyroid hormone, which is why so many patients on T4 end up with depression, rising cholesterol, high blood pressure, low B12, low iron, and many symptoms, as well as adrenal fatigue thanks to the inadequate treatment of T4.
  3. Raising T4 often encourages an excess production of Reverse T3 over time, which will block cell receptors and increase the very symptoms the researcher state is avoided, as well as far more hypothyroid symptoms.

On the positive side

This is just one more research study that ends up being on our side! i.e. it fits our experiences. I have also included mention of this study on the following page on STTM, where I keep a ongoing list of research which supports what patients already know by their experience and clinical presentation: www.stopthethyroidmadness.com/medical-research/

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The FDA and their Transparency Initiative may interest some of you as thyroid patients

The FDA....In case you are interested, the following represents Phase 3 of the FDA Transparency Initiative, which could end up benefiting thyroid patients as we deal with the upcoming clinical trials for natural desiccated thyroid. The links at the bottom give more understanding, as well.

For Immediate Release: March 12, 2010

FDA Task Force Seeks Public Comments on Increasing Transparency With Regulated Industry

As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.

Posted in the March 12, 2010, Federal Register, the request for electronic or written comments has a deadline of April 12, 2010.

The FDA regulates products responsible for about 25 percent of the gross national product of the United States and the industries responsible for these products. Products regulated by the agency — biologics and blood products, human drugs, foods, medical devices, radiation-emitting devices, and veterinary medicines — are integral to public health and to the U.S. economy.

The agency formed an internal Transparency Task Force in response to the Obama Administration’s commitment to achieve “an unprecedented level of openness in Government.” The Task Force is developing recommendations for making information about FDA activities and decisions more useful, understandable, and readily available, while appropriately protecting confidential information.

The Task Force held public meetings in June 2009 and November 2009. Based upon input received thus far, the Transparency Initiative has been divided into three phases. The first phase, creating a Web-based resource called “FDA Basics” to provide information on commonly misunderstood aspects of the agency, has been completed. The second phase, improving FDA’s disclosure of information to the public, is underway and the agency intends to issue draft proposals for public comment soon.

The request for comment for the third phase follows a series of listening sessions with members of regulated industry in January 2010. Transcripts and summaries of those listening sessions are available at http://www.fda.gov/transparency and at http://www.regulations.gov.

For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:

  • Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements
  • The guidance development process
  • Maintaining open channels of communication with industry routinely and during crises
  • Providing useful and timely answers to industry questions about specific regulatory issues

Electronic comments may be submitted to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA—305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. All comments should be identified with docket number FDA—2009—N—0247.

For more information:

100 things to do with your bottle of Synthroid…

Well, I just can’t let this go by the wayside, says I with a cheesy grin.

When I did the lighthearted post, two posts below his one, about a woman who got filthy rich thanks to her old stock with Abbott Labs (the makers of Synthroid), it got a humorous and creative comment from “Elizabeth”:

I have found a couple of uses for a bottle of Synthroid:

A. Doorstop
B. Prop for DSL modem (so it won’t overheat)

However, I do not recommend it to be taken internally. Ever.

hahahaha. You get a blue ribbon for that gem, Mz. Elizabeth. And I think Elizabeth’s creatively-funny reply deserves expansion and a party of fun-lovin’ contributors. So now it’s your turn, fine reader of the STTM blog, to list your own innovative and hilarious ideas for that bottle of a T4-only medication. Just use the Comment below this post and let ‘er rip.

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Below this post you’ll see information on the current failure of McCain’s cockeyed anti-supplement bill, which if it had passed, would have negatively affected every single thyroid patient out there who is trying to undo the damage done by T4 meds and/or the inane TSH lab test. So though we all won right now with this failure, you betcha we’re going to have to keep our eyes and ears open for the money-grubbing Big Pharma to influence someone else about supplements.

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Senator John McCain–what in the HECK were you thinking?? Huh??

Now let me start this post by saying that Senator John McCain and Senator Byron Dorgan’s anti-supplement bill…yes, a dim-wit ANTI-supplement bill…was squashed for now because he backed down thanks to plenty of public protest.

And thank God, because it would have especially affected thyroid patients who have suffered thanks to Synthroid or other T4-only meds, and are working diligently to regain their health with their freedom in choice of important supplements, besides natural desiccated thyroid and T3. Think selenium, iron, B-vitamins, Vit. D, iodine, Grape Seed Extract, Isocort, St. Johns Wort, and a slew of other supplements we freely and wisely take to undo the damage done to us by our TSH-and-T4-worshipping medical establishment.

In case you didn’t know, McCain sponsored a bill called the The Dietary Supplement Safety Act (DSSA). It would have nullified the protection of supplements from the 1994 Dietary Supplement Health and Education Act (DSHEA). Those protected supplements are either those found in food without any chemical alteration, or those sold prior to 1994…i.e. it would somewhat stop the FDA from either banning those kind of supplements or reclassifying them as “drugs”. And with the FDA being in a financial bed with Big Pharma, you betcha we would have seen those bans and reclassifications.

And what else might have happened? We would have lost our lower cost, safer, and more effective alternative to side-effect drugs. I have helped my husband lower his high cholesterol, high LDL and high triglycerides WITHOUT the nasty statins and WITH supplements.

I like how Dr. John C. Lowe put it in his latest newsletter:

We appear to have won this time around. But a price we must pay for continuing freedom in our health care choices is to keep our noses in the air. Before long, the stench of Big Pharma’s greed will waft down upon us again in the form of some legislator’s bill. When it does, we must pay another price to keep our freedom: that is to organize once again and deliver a resounding “No!” to Congress.

Want to read more about this?? Just google “mccain’s supplement bill” and get an eye-full. And I hope to see you respond to this post with a list of IMPORTANT and LIFE CHANGING SUPPLEMENTS and how they are helping you.

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Are you from Europe and would like to see your own NTH group?? I’ve just started NTH EUROPE and if you live in Europe, you are invited to join. Note that new groups can be slow to build, so put yourself on Daily Digest or Individual Emails and watch its growth. We will be looking for level-headed moderators and your donation of good European information in the Files and Links.

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