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:

• March 12, 2010 Federal Register Notice
• FDA Transparency Task Force Web Page
• FDA Basics Web Page
• FDA Transparency blog: http://fdatransparencyblog.fda.gov/2010/03/final-phase-of-the-transparency-initiative-we-want-your-ideas.html
• How did we get to where we are with the FDA’s actions towards desiccated thyroid today? Go here.

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.

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.

And the anger many have felt about missed years of our lives because of such a lousy treatment has also translated to ill feelings towards a particular pharmaceutical: Abbott Laboratories. Abbott Labs has put hundreds of millions of dollars in what patients deem “brainwashing” of doctors, especially Endodrinologists, about Synthroid for years.

But I recently found a little news piece, in the form of the following video, which at least puts just a slight positive note to the term “Abbott Laboratories”, even if the name conjurs up a bit of nausea in the guts of informed thyroid patients:   http://www.youtube.com/watch?v=O8o-e-iLsUM Hope you enjoy the irony of it the way I did.  lol. Her name was Grace Groner, the secret Millionaire.

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Getting older and becoming hypothyroid: Below this post, you’ll see information that can affect your parents, relatives, spouses and friends and how they may face the same run-around we have all had to deal with—the lousy TSH lab test, being put on all sorts of band-aid drugs like statins, anti-depressants, blood pressure meds and more, or being put on a T4 med like Synthroid.  Go here.

FDA and shortages: I also mention above about a recent statement by the FDA:  Forest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. A few patients are suspicious enough of the FDA to feel it means nothing.  Others, and I am one, have honestly felt like we simply had a shortage of desiccated thyroid, not a conspiracy by the FDA to remove it.  So I found that statement confirming, even if there can be more to the story. But time will tell.

Naturethroid: Here you can read information about this med returning to pharmacies around the country, and what might have changed in the tablets. Once again, pharmaceuticals are not telling us what is going on ahead of time, and it’s aggravating when we discover changes in our medications. Thyroid patients do not care to be treated like buffoons. I suspect that pharmaceuticals are guided to say so little because of legal advice. It’s still aggravating.

Why do I rarely mention Armour anymore? Because it doesn’t seem worth my time since it was reformulated. Too many patients continue to report lingering symptoms, even occurring months after they thought they were doing great on it.  And too many report that after they switched to Erfa’s “Thyroid”, Naturethroid or compounded with acidolpholus as a filler,  they saw a resolution of those lingering symptoms.

Another reason to improve your Vit. D levels: Research shows that low levels of Vit. D in your blood can result in increased fat deposits around your waist and other areas.  From the Diabetes Journal.

And getting older increases the incidence of thyroid disease.

Even worse, those who acquire it at an older age are probably going to go through the same bunk and bull those younger have gone through–having depression, rising cholesterol, osteoporosis or ostepenia, weight gain, easy fatigue, couch potato syndrome, dry skin and hair, plus more–-all classic symptoms of undiagnosed or undertreated hypothyroidism.

But older folks are told it’s all just part of aging so here’s your latest tablet for your handy-dandy Wal Mart pill box.

I recently found a great blog by Pam whose Feb. 23rd, 2010 post is titled Older Women and Low Thyroid. She turned 65 in 2009 (and she looks a lot younger) and writes how she found herself with hypothyroid at a later age as well.  And Pam is WAY ahead of the game in her knowledge. She understands that most older folks are put on Synthroid (which can be a lousy way to treat hypothyroidism for many), that getting older means conversion from T4 to T3 can be more difficult,  that being on desiccated thyroid or T3-only just might be the better treatment, and you can get adrenal fatigue at an older age as well (thanks to poor treatment with T4, the TSH lab test, or being underdosed even on desiccated thyroid).

You can read Pam’s post here, as well as about the phone call from her friend who is 50 lbs overweight, has brain fog, is out of work, has no energy…and voila–is on Synthroid so it can’t POSSIBLY be her thyroid. Sad. In fact, what has happened to Pam’s friend is what I keep stating to those who feel they are just doing peachy on T4: watch out, because as you age, the truth about T4 will reveal itself!

Pam, I love your blog posts, and I’m going to hope to see more of those in the “venerable age range” be just as wise as you are!!

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FDA HAS MADE A STATEMENT ABOUT NATURAL DESICCATED THYROID: Just before I was going to plop into my bed for the evening, I checked my notifications to discover that right on the FDA website and their 2010 Drug Shortages page (3rd column up from bottom), it states: Forest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. BINGO. I’ve been waiting for this for months, because though websites and groups were formed last year as if we needed to “rescue” desiccated thyroid from being banned, I couldn’t join the fearful rally of a few because my gut was telling me something quite different.  And a few others, I discovered, had the same feeling.  And hooray! Our guts were right on!

Does this mean the FDA “gets it” about desiccated thyroid? Maybe, or maybe not. Yes, their timing WAS awful last year with Time Caps Labs, right when we were starting a shortage. And there does appear to be some kind of future requirement “proving” the safety and efficacy of dess. thyroid–two things we ALREADY KNOW from 110 years of safe and effective use. Duhhh on the FDA. But it’s FAR more hopeful now, and realistic, and will hopefully promote more reasonable thinking from now on.

Onward and upward, folks.

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Naturethroid is coming back in pharmacies all over the US! See the blog post below or here for information about  the “new” Naturethroid.

(If you are reading this via the Newsletter email notification, just click on the title of this blog post to come directly to the site where you can Comment).

• The typical smell of desiccated porcine is less intense with the new tablets. We have no idea why.
• The tablets are now stamped with RLC on one side, and N over 1 on the other, whereas before you’d see just NT1 or a reference to the fact that Time Caps Labs (TCL) used to make Naturethroid for RLC Labs
• The package insert is no longer inside the bottle but stuck on top of the cap
• Lot number info used to be on the edge of the label running vertically, whereas now, it runs along the bottom of the label  under the ingredients.

One grain is still 65 mg, with the T3 content being at 9 mcg and the T4 content being at 38 mcg.  The T2, T1 and calcitonin still unmeasured.

There are filler/inactive ingredients which have changed:

• Calcium filler has moved up from 16 mg to 17 mg (calcium binds thyroid, but you just take more. Don’t swallow it with milk, please.)
• The old contained Magnesium, Potassium, and Sodium (each at less than 1 mg), whereas in the new, potassium is now removed
• And here’s the best part: the old NT had Hydropropyl Methylcellulose–that’s the larger size cellulose structure which we know binds some of the thyroid hormones. Now, the new NT has Microcrystaline Cellulose, the smaller size. (Too bad we can’t see all cellulose removed!)

Below are the new NT fillers, which are identical to the old except for the cellulose change:

Carnaba Wax, Colloidal Silicon Dioxide, Dicalcium Phosphate, Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystaline Cellulose, Polyethylene Glycol (PEG)-400, Sodium Starch Glycolate, Stearic Acid.

Most all the above comes courtesy of Stephanie Buist, owner of the Iodine group on Yahoo and thyroid and adrenal patient and advocate.  Thank you, Steph!  You can read about the fillers here by scrolling down.

Oh and by the way, the new tablets are now scored. A helpful addition!

In patient groups, we are seeing a variety of experiences with the new Naturethroid.  Most folks seem happy with it so far, and even some report it seems a tad stronger than the old (the cellulose change may have caused that). Occasionally, someone will report problems, but they appear to be from underdosing or a potential RT3 problem which has arisen and needs treatment with T3-only.  Changing brands can also bring different reactions, so you have to wiggle the dosage around sometimes to find your sweet spot once again.

All in all, it looks good.

P.S. If you are reading this via the Newsletter Notification, just click on the above link to put yourself right on the actual blog post if you want to comment. Let’s gather all our experiences with the new Naturethroid.

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If you missed the last internet radio Thyroid Patient Community Call with Dr. Kent Holtorf, you missed a VERY good one. Thank you Dr. Holtorf for excellent information. But good news! All the shows are recorded.  Just go to the following link, scroll down, and you can click on any past interviews, including two with Dr.  John C. Lowe and a great one with Endocrinologist Dr Pepper–one of a rare breed of open-minded Endos.  (I’ve also stopped doing my long intro’s about me in the last two, figuring if someone wants to know, they can go to the About Me page, or read the Introduction in the book which has even more detail. lol.)

http://www.talkshoe.com/talkshoe/web/talkCast.jsp?masterId=62603&cmd=tc

Join us as I chat with him about the recent Today Show piece where an Endo said he was simply “laying on of hands”, this WEDNESDAY, FEB. 17th at 6 pm Pacific, 7 pm Mountain, 8 pm Central, and 9 pm Eastern, right on your computer’s audio on STTM’s Talkshoe Call webpage (below). Call in to ask questions, too. MARK YOUR CALENDER! SET YOUR CELL PHONE ALARM! This is one introduction that I’m going to have fun with, don’t ya think??

http://www.talkshoe.com/talkshoe/web/talkCast.jsp?masterId=62603&cmd=tc

Want to learn more about him to better appreciate this Community Call?

• His clinic’s website: http://www.holtorfmed.com/
• About him: http://www.fibro360.com/dr-kent-holtorfs-story.htm
• His new website targeted to doctors: http://nahypothyroidism.org/
• His info about RT3: http://www.holtorfmed.com/topics/thyroid/reverse-t3-is-the-best-measurement-of-tissue-thyroid-levels

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Have something to say? Use the Comment function at the bottom of this blog post. If you are reading this via the Newsletter email notification, just click on the title of this blog post to take you directly to the actual blog post.

http://www.stopthethyroidmadness.com/2010/01/28/endocrinologists-tsh-lab-test/

Well, it’s time to hear what Dr. Holtorf has to say!

Join us as I chat with him about this incident next WEDNESDAY, FEB. 17th at 6 pm Pacific, 7 pm Mountain, 8 pm Central, and 9 pm Eastern, right on your computer’s audio on STTM’s Talkshoe Call webpage (below). Call in to ask questions, too. MARK YOUR CALENDER! SET YOUR CELL PHONE ALARM! This is one introduction that I’m going to have fun with, don’t ya think??

http://www.talkshoe.com/talkshoe/web/talkCast.jsp?masterId=62603&cmd=tc

***Note that we moved it to Wednesday nights. That should help with any dropped calls that were happening on busy Thursdays.

By the way,  Dr. Holtorf recently launched his new website, called The Non-Profit National Academy of Hypothyroidism in an attempt to reach doctors about appropriate diagnosis and treatment of hypothyroidism, which patients know does NOT include just the lousy TSH lab test.  Will doctors, and especially Endocrinologists, ever figure out this clear and easy truth?  Don’t we hope so.

Have something to say? Use the Comment function at the bottom of this blog post. If you are reading this via an email notification, just click on the title of this blog post to take you directly to the actual blog post.

Then I caught a cold from hell–rare for me.  I was taking zinc and Vit. C. But a good friend reminded me about Vit. D and it’s immune enhancing effect. OMG, I forgot about it!  So later last night, I took what I thought was 12,000 IU on the first night of being sicker than a dog.  They say to take 1000 mg per 10 lbs of weight. Turned out the gel caps were not 1000 IU each, as I thought, but 2000 IU each. So I ended up taking 22,000 IU.  lol. But the long and short of it is this: though I woke up this morning quite tired and weak, I’ve slowly gotten better all day!! My congestion has hugely improved.  Read this: http://pandemicsurvivor.wordpress.com/2009/11/28/eliminate-the-common-cold/

Love your green powder drink? Just a word of caution: much of what is in many of those powdered greens are goitrogens, which inhibit thyroid production, such as wheat grass, barley grass, broccoli, spinach,  cabbage, maca and spinach, plus much more. But that doesn’t mean you can’t use the green powder. You’ll just have to be sure to use it in moderation, and not consume too many other goitrogen foods each and every day. Or, raise your thyroid meds.

Dr. Peter Gott can give even better information to readers. I noticed that a column on the Tulsa website by Peter Gott, MD of the Newspaper Enterprise Association  could have given different information to a distressed reader who couldn’t find Armour anywhere.  He recommended to this reader, who already stated that Synthroid is not a well-handled treatment, to see if her physician could “alter the Synthroid dosage to find a level”  that could be tolerated.  Actually, there are far better options during this backordered time, which I have compiled here, and includes Erfa’s Thyroid and more.

Naturethroid is appearing in pharmacies! Yup, patients are reporting it! No, it’s not all pharmacies. But you might want to call and see if YOUR local pharmacy has it. Otherwise, it’s coming.  For options during the current natural desiccated thyroid shortages, go here. To see why we are where we are today, read this.

Is there research to prove having a free T3 in the upper quarter of the range when on desiccated thyroid?? A gal emailed me, wanting studies to show her doc. But unfortunately, the answer appears to be no. Instead, this is what patients all over thyroid groups discovered from their lab results when they were feeling fabulous again with no lingering symptoms.  So we simply spread the word. Patient experiences DO count for something.  P.S. Here’s an ongoing list of research that DOES prove some things patients KNOW first hand.  And by the way, when you have a high free T3 and continuing symptoms, time to do labs for ferritin and adrenal fatigue.

By using a code, you can save on labs from HealthcheckUSA. I was informed from HealthcheckUSA that many patients were forgetting to mention the discount code. So look again, and be sure and use it from the Recommended Labwork page.

Janie on radio shows, and a great guest for the upcoming Talkshoe Thyroid Patient Community Call. Can’t say much more, because it’s in the works. Watch for announcements soon.

A new way to be informed of these thyroid posts. The former Notifixious notifications went out of business. But we have a new and GOOD one, referring to the notification as a newletter, and you can sign up free and with no strings attached.  See on left below on the links.   Also, there are many more important posts right below this.

You may have seen the segment on NBC’s Today Show this morning, January 29th, 2010, or you may have heard about it on the internet. But in case you didn’t, the Today Show had a rare short piece about hypothyroidism and diagnosis which presented a Nurse Practitioner, Eola Force, with clear symptoms of hypo, including extreme tiredness, feeling like she’s dying, huge weight gain, depression, and brain fog, to name a few.

Yet, she had a so-called “normal  “TSH” lab test. The explanation for her symptoms?? She’s FAT, HORMONAL and FEMALE, of course!

And because she is under the care of a wise and knowledgeable doctor named Dr. Kent Holtorf and his clinic, which uses additional tests besides the TSH, he diagnosed her clearly, put her on thyroid hormones, and changed her life.

And the response by Dr. Singer, an Endocrinologist? There is “no real scientific basis” for what Holtorf does in his practice, and it was equivalent to the “laying on of hands”.

Well my dear Dr. Singer sir, if hundreds of millions of patients all over the world waited on “science” to prove what they know by decades of miserable experience because of the TSH, we’d all still be sick as dogs. The mutually accepted delusion by the Endocrinology field about the TSH lab test has left millions of thyroid patients undiagnosed and undertreated for nearly 40 years of its existence.

Other than to potentially diagnose a pituitary problem, no, the TSH lab test is NOT the gold standard for thyroid screening anymore than reading tea leaves tells me what kind of day I’m going to have.

Read more about the TSH lab test here, or find even more detail in Chapter 3 in the book called TSH: THYROID STIMULATING HOOEY.

See much better labwork than simply the TSH here.  Find what your results mean here. And here’s how to find a much better doctor.

P.S. Thyroid patient Lynn Dunning emailed me about talking about the craziness of current thyroid treatment at her work, and one of her colleagues put this up on the work website:
http://www.spunout.ie/health/Healthy-body/Thyroid-madness Good for Lynn and the SpunOut website!