fda tags

I am plea­sed to note that Mary Sho­mon of about.com,  who in her blog post on Thurs­day, April 22, 2010, has not only sof­te­ned her wor­ding about self-treatment by hypothy­roid patients, but has also writ­ten expres­si­vely con­cer­ning surroun­ding issues. These are also issues which I pre­sen­ted in two blog posts ear­lier this week con­cer­ning the immense pro­blem with doc­tors as expres­sed by patients, and self-treatment.

Good for Mary!

As wit­nes­sed by Sheila Turner’s exce­llent edi­to­rial towards those who cri­ti­cize self-treatment, as well as angst expres­sed by many patients toward those who cri­ti­cize,  self-treatment is an impor­tant issue and can’t be dilu­ted down as simply “self-destructive” in our current medi­cal climate.

The follo­wing are dif­fe­ren­ces in how this is vie­wed, though, with one com­mon thought:

• Is self-treatment one  of the “most con­tro­ver­sial” issues with thy­roid patients? The ans­wer is “only to those who make it so”. Far more trou­bling to thy­roid patients is a medi­cal esta­blish­ment which worships a medi­ca­tion which has left millions under­trea­ted, and which makes a pitui­tary hor­mone lab called the TSH as if it’s from God Almighty. Equally as trou­bling to patients are doc­tors whom they report as con­des­cen­ding, close-minded, robo­tic, and/or igno­rant about issues that keep thy­roid patients sick – low ferri­tin, adre­nal fati­gue, and more. Self-treatment is only the symp­tom of a much lar­ger, more con­tro­ver­sial problem.
• Does self-treatment have “obvious draw­backs” for thy­roid patients who feel for­ced to do it? The ans­wer is “yes”, but no dif­fe­rent and pro­bably far less than the “obvious draw­backs” patients face with clue­less doc­tors.  The com­ments on my blog posts are bloa­ted with patients who have been left sick, or made sic­ker, by one doc­tor, after another doc­tor, after one more.  It’s not a pretty picture.
• Is there a “risk of under­treat­ment” for thy­roid patients who self-treat? Yes, but pro­bably far less  than the huge num­ber of patients who report being left “under­trea­ted” by doc­tors who are blind to the pro­blems of T4, or doc­tors who remain clue­less about the ina­de­quacy of trea­ting by the TSH.
• Is the “grea­test con­cern” about self-treatment the pro­blem of being “over-medicated”? You betcha. But in the vast majo­rity of these unfor­tu­nate cases with patients who choose to self-treat, the pro­blem is undiag­no­sed or under­trea­ted low cor­ti­sol and/or low ferri­tin, which results in thy­roid hor­mo­nes poo­ling in the blood and crea­ting hyper-like symp­toms.  This is a risk for self-treatment.
• Have “dozens of thy­roid patients” ended up in emer­gency rooms due to over-medication? “Dozens” is spe­cu­la­tion.  It may be more rea­lis­tic to state that “some”, yes, have sta­ted this unfor­tu­nate out­come when they made the choice.  But research and com­ment all over the inter­net shows anyone that hun­dreds of thou­sands of all patients can end up in the emer­gency room due to poor doc­to­ral deci­sions, or bad reac­tions to phar­ma­ceu­ti­cal medi­ca­tions which doc­tors love to presc­ribe. Ending up in an emer­gency room is not solely con­nec­ted to self-treatment.
• Do “patients face many major obs­tac­les that pre­vent them from get­ting accu­rate and effec­tive thy­roid diag­no­sis and treat­ment?” Yes! That is where Mary is in agree­ment with me with her six exce­llent  points, inc­lu­ding the tra­gic situa­tion in the UK. And here are 10 rea­sons patients are frus­tra­ted, angry and sick.
• Has one nega­tive jour­nal article about someone who self-treated “resul­ted in desic­ca­ted thy­roid  get­ting grea­ter scru­tiny by the FDA?” The ans­wer can easily be:  no worse than the body of patients who were made fear­ful that the FDA was ban­ning desic­ca­ted thy­roid, and who follo­wed a strong cam­paign to con­tact the FDA about desic­ca­ted thy­roid. I was also per­so­nally told by two phar­ma­ceu­ti­cal repre­sen­ta­ti­ves that this action to con­tact the FDA made the pharms very uncom­for­ta­ble and put too much atten­tion on desic­ca­ted thy­roid. Time will tell, but it’s not help­ful to blame anything.
• Does “acti­vely pro­mo­ting self-medication” with natu­ral desic­ca­ted thy­roid “work against thy­roid patient inte­rests”. The ans­wer to this loa­ded ques­tion resi­des in who you ask. Whether “acti­vely pro­mo­ted” or simply “read about”, there seems to be a body of patients who report that fin­ding out about desic­ca­ted thy­roid, and fee­ling for­ced to self-treat because of not fin­ding any doc­tor to help them, was one of the best deci­sions they ever made.

And to the last com­ment above, and since there have been “impli­ca­tions”, I want to unders­core (and ad nau­seum) that the patient-to-patient Stop the Thy­roid Mad­ness was not crea­ted as a self-treatment site, nor does it “acti­vely pro­mote” it.  STTM is a site with a goal to edu­cate patients who can, in turn, take that infor­ma­tion into their doc­tors offi­ces and push for change. And it’s been wor­king, one doc­tor at a time, as wit­nes­sed by patients who report those doc­tors on patient groups, and by emails I get from some of those doctors.

But it’s also clear that those who self-medicate may be using STTM, as well as many other web­si­tes and books out there by doc­tors, advo­ca­tes and non-professionals alike, to help them. So at least there is edu­ca­tion out there to help those who choose this, even if none was crea­ted for that purpose.

Sum­mary

There are impor­tant dif­fe­ren­ces in opi­nion, and much more to the story as I out­li­ned above.

But the bot­tom line is this: for up to 60 years, hun­dreds of millions of thy­roid patients around the world have been sub­jec­ted to

1. a medi­ca­tion called thy­ro­xine which has left a heap of lin­ge­ring hypothy­roid symp­toms,
2. a new debi­li­ta­ting con­di­tion like adre­nal fati­gue,
3. a lab test (TSH) which has dela­yed diag­no­sis for years or kept patients under­trea­ted, and
4. too many doc­tors who aren’t up to speed about most any of this, and have left patients frus­tra­ted, angry and still sick.

And all the above is a far worse sce­na­rio which only pushes some patients to self-treat as a side-effect. But if  you aren’t totally wiped out finan­cially and emo­tio­nally in trying to find an infor­med doc, two sug­ges­tions: http://www.stopthethyroidmadness.com/how-to-find-a-good-doc as well as pos­ting your city/state in the sub­ject line of patient groups here: http://www.stopthethyroidmadness.com/talk-to-others

P.S. Please note that you will never see this blog, or this web­site, kno­wingly allow non-professional,  nega­tive, nasty, false, abu­sive and/or pro­found slan­der about a collea­gue, as has been done elsewhere.

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:

• Call or fax them and report what hap­pe­ned to you on T4: 1 – 800-332‑1088
• Fill out their form: http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf and fax or mail to Med­Watch; 5600 Fishers Lane; Rock­vi­lle, MD 20852 – 9787
• Con­tact the FDA rep for your state: http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default.htm

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.

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:

• 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.

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.

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. 23^rd, 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 (3^rd 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).