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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.


  • Want to keep track of these “fringe web­site” blog posts? ;-) Curious what’s on Janie’s mind? Use the noti­fi­ca­tion on the lower left of the links, called a News­let­ter, or an RSS Feed.
  • The extre­mely hip and sophis­ti­ca­ted STTM t-shirts are half price! Great BUMPER STICKERS, too. Spread the word – YOU may make a dif­fe­rence in someone’s life.
  • Check out the patient-to-patient book with even more detail (and which doc­tors seem to res­pect more than websites).
  • Need to unders­tand all your best options for thy­roid treat­ment? Go here.
  • Keep infor­med of each live Thy­roid Patient Com­mu­nity Call on Talkshoe by sig­ning up as a follo­wer.

Gee golly: something positive associated with the makers of Synthroid??

A large and gro­wing body of hypothy­roid patients have found out the hard way why they have felt like patooey crap for years…or at the very least, why they had pesky lin­ge­ring symp­toms of hypothy­roi­dism:  being on Synth­roid or any other T4-only med.

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.


  • Want to keep track of these “fringe web­site” blog posts? ;-) Curious what’s on Janie’s mind? Use the noti­fi­ca­tion on the lower left of the links, called a News­let­ter, or an RSS Feed.
  • The extre­mely hip and sophis­ti­ca­ted STTM t-shirts are half price! Great BUMPER STICKERS, too. Spread the word – YOU may make a dif­fe­rence in someone’s life.
  • Check out the patient-to-patient book with even more detail (and which doc­tors seem to res­pect more than websites).
  • Need to unders­tand all your best options for thy­roid treat­ment? Go here.
  • Keep infor­med of each live Thy­roid Patient Com­mu­nity Call on Talkshoe by sig­ning up as a follo­wer.

It ain’t for sissies: getting older and hypothyroidism (plus FDA says it did NOT tell pharms to stop desiccated thyroid)

Yup, we’re all hea­ding in the same direc­tion — being just a tad older every sin­gle year and get­ting that first mai­ling from AARP.  Yup.

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).


  • Want to keep track of these “fringe web­site” blog posts? ;-) Curious what’s on Janie’s mind? Use the noti­fi­ca­tion on the lower left of the links, called a News­let­ter, or an RSS Feed.
  • The extre­mely hip and sophis­ti­ca­ted STTM t-shirts are half price! Great BUMPER STICKERS, too. Spread the word – YOU may make a dif­fe­rence in someone’s life.
  • Check out the patient-to-patient book with even more detail (and which doc­tors seem to res­pect more than websites).
  • Need to unders­tand all your best options for thy­roid treat­ment? Go here.
  • Keep infor­med of each live Thy­roid Patient Com­mu­nity Call on Talkshoe by sig­ning up as a follo­wer.

Here’s the skinny about the “new” Naturethroid: the good, the bad, and the curious

As the one grain tabs of Natu­reth­roid desic­ca­ted thy­roid by RLC Labs are hit­ting phar­macy shel­ves again all across the nation here and there after the recent shor­ta­ges and the sad refor­mu­la­tion of Armour,  and patients are star­ting to use the new Natu­reth­roid, we are gathe­ring some good infor­ma­tion, both anec­do­tal and factual:

  • 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


  • Want to keep track of these “fringe web­site” blog posts? ;-) Curious what’s on Janie’s mind? Use the noti­fi­ca­tion on the lower left of the links, called a News­let­ter, or an RSS Feed.
  • The extre­mely hip and sophis­ti­ca­ted STTM t-shirts are half price! Great BUMPER STICKERS, too. Spread the word – YOU may make a dif­fe­rence in someone’s life.
  • Check out the patient-to-patient book with even more detail (and which doc­tors seem to res­pect more than websites).
  • Need to unders­tand all your best options for thy­roid treat­ment? Go here.
  • Keep infor­med of each live Thy­roid Patient Com­mu­nity Call on Talkshoe by sig­ning up as a follo­wer.

This and that – an array of interesting info for your thyroid pleasure

I’ve been dis­trac­ted the past week, having to do exten­sive research and tra­ve­ling to find the per­fect “new used car”.

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.


  • Want to keep track of these “fringe web­site” blog posts? ;-) Curious what’s on Janie’s mind? Use the noti­fi­ca­tion on the lower left of the links, called a News­let­ter, or an RSS Feed.
  • The extre­mely hip and sophis­ti­ca­ted STTM t-shirts are half price! Great BUMPER STICKERS, too. Spread the word – YOU may make a dif­fe­rence in someone’s life.
  • Check out the patient-to-patient book with even more detail (and which doc­tors seem to res­pect more than websites).
  • Need to unders­tand all your best options for thy­roid treat­ment? Go here.
  • Keep infor­med of each live Thy­roid Patient Com­mu­nity Call on Talkshoe by sig­ning up as a follo­wer.
Do NOT follow this link or you will be banned from the site!