levoxyl tags

As a thy­roid patient who was pro­foundly har­med by the use of Synth­roid and Levoxyl in the treat­ment of my hypothy­roi­dism, and as an acti­vist who sees this same harm­ful truth with poten­tially millions of other patients, I find this recent news interesting.

But you gotta won­der if they will be wea­ring noise reduc­tion head­sets and ear plugs…or not…when it comes to the scan­dal of synthe­tic T4-only medi­ca­tions.  Will they?

Just today, the U.S. Depart­ment of Health and Human Ser­vi­ces and the Food and Drug Admi­nis­tra­tion (FDA) announ­ced the Safe Use Ini­tia­tive, “a pro­gram aimed at redu­cing the like­lihood of pre­ven­ta­ble harm from medi­ca­tion use”.

Sta­te­ments I glea­ned from this ini­tia­tive include:

1. Today, tens of millions of peo­ple in the Uni­ted Sta­tes depend on presc­rip­tion and over‐the‐counter (OTC) medi­ca­tions to sus­tain their health — as many as 3 billion presc­rip­tions are writ­ten annually. Too many peo­ple, howe­ver, suf­fer unne­ces­sary inju­ries, even death, as a result of pre­ven­ta­ble medi­ca­tion errors or misuse.

2. Although FDA and many other sta­kehol­ders have been wor­king to improve how the health­care sys­tem mana­ges medi­ca­tion risks in the Uni­ted Sta­tes, it is widely recog­ni­zed that more needs to be done to pro­tect the public from pre­ven­ta­ble harm from medi­ca­tion use.

3. Medi­ca­tions offer great bene­fit, but they come with risks. Whe­ne­ver medi­ca­tions are not used opti­mally, risks of harm can inc­rease significantly.

4. FDA pro­po­ses to iden­tify, using a trans­pa­rent and colla­bo­ra­tive pro­cess, spe­ci­fic can­di­date cases (e.g., drugs, drug clas­ses, and/or the­ra­peu­tic situa­tions) that are asso­cia­ted with sig­ni­fi­cant amounts of pre­ven­ta­ble harm.

This ini­tia­tive is actually far broa­der than what I glea­ned above, and also invol­ves self-abuse, expo­sure of dan­ge­rous medi­ca­tions to chil­dren, dire side effects, and more. Five areas are also spe­ci­fi­cally tar­ge­ted:  Con­su­mer medi­ca­tion infor­ma­tion (CMI), Medi­ca­tion dosing devi­ces, Ace­ta­mi­nophen toxi­city, Alcohol-based sur­gi­cal preps, and Medi­ca­tions in vials. You can read more in the fact sheet.

But if the FDA is going to do their job with this ini­tia­tive, or do their job ove­rall, you have to won­der if they will lis­ten to and inc­lude the pro­blems asso­cia­ted with being trea­ted with a T4-only medi­ca­tion as expe­rien­ced by millions of patients world­wide. Con­ti­nuing symp­toms of hypothy­roi­dism while on this ina­de­quate treat­ment is wides­pread and dama­ging for many, cau­sing hands reaching deep in poc­kets to pay for nume­rous doc­tors appoint­ments, besi­des anti­de­pres­sants, anti-anxiety meds, blood pres­sure meds, sta­tins, cor­ti­sol meds for adre­nal fati­gue, and other medi­ca­tions which we would have never nee­ded, and would have been pre­ven­ta­ble, if we had been on natu­ral desic­ca­ted thy­roid like Natu­reth­roid or Westh­roid in the first place.

Many patients on thy­ro­xine, T4-only medi­ca­tions will also report actual hos­pi­tal visits due to the side effects of a poor treatment.

In other words, thy­ro­xine aka levothy­ro­xine aka T4 treat­ment has been an unsafe and harm­ful treat­ment, cau­sing millions to suf­fer unne­ces­sary inju­ries and side effects for over 50 years of its use­less and popu­lar use.  It fits the Safe Use Ini­tia­tive. Or at the very least, it calls for the FDA to lis­ten to patient expe­rience with this lousy choice to treat hypothy­roi­dism.

Lis­ten to us, FDA. Lis­ten and be wise.

P.S. See the blog post below about a gene­tic rea­son why so many do lousy on T4.

Last May, a very inte­res­ting article appea­red in the May 2009 issue of the Jour­nal of Cli­ni­cal Endoc­ri­no­logy and Meta­bo­lism, tit­led For Some, L-Thyroxine Repla­ce­ment Might Not Be Enough: A Gene­tic Ratio­nale and pre­sen­ted by Endoc­ri­no­lo­gists in Bris­tol in the UK. It’s accom­pa­nied with an edi­to­rial by Endoc­ri­no­lo­gists Brian W. Kim and Anto­nio C. Bianco.

This is the same article refe­rred to by Endoc­ri­no­lo­gist Dr. Gary Pep­per on the last Thy­roid Patient Com­mu­nity Call on Talkshoe.

Basi­cally, the article sta­tes that a gene­tic varia­tion in the enzyme that con­verts T4 to T3, deio­di­nase D2 (also called Type 2 Deio­di­nase, or 5′-Deiodinase), may be res­pon­si­ble for why so many thy­roid patients don’t do well on Synth­roid, Levoxyl, levothy­ro­xine, etc, and in turn, do so much bet­ter on natu­ral desic­ca­ted thy­roid like Natu­reth­roid, Erfa’s Thy­roid, or the com­bi­ned synthe­tic T4 and synthe­tic T3 (Cytomel).

In other words, where some may have a strongly func­tio­ning deio­di­nase D2 enzyme which con­verts T4 to the active T3 well, others may have a modi­fied deio­di­nase D2 enzyme, cau­sing less opti­mal conversion.

In the Edi­to­rial, the two Endos Kim and Bianco explain the rea­lity of “polymorphism” – a con­di­tion in nature in which chan­ges or varia­tions occur, and in one patient from another, a change in the DNA.  As rela­ted to con­ver­sion of T4 to T3,  some thy­roid patients have a less effec­tive deio­di­nase D2 enzyme in the con­ver­sion of T4 to T3.  Spe­ci­fi­cally, there is a com­mon variant of the gene, threo­nine (Thr) 92 ala­nine (Ala), and it results in dec­rea­sed D2 enzy­ma­tic activity.

The study pro­po­ses that this alte­ra­tion from poly­morphism occurs in 16% of those stu­died, and conc­lu­des that the majo­rity don’t have this pro­blem, and thus, “most do fine on T4-only medi­ca­tions”. But 16% do have this pro­blem and need the com­bi­ned the­rapy of T4 with T3.

Bris­tol was also men­tio­ning this rea­lity in 2004 here, even if they thought it was as low as 5%.

As Dr. Pep­per hin­ted, this study could do won­ders to open the eyes of Endoc­ri­no­lo­gists about the use of desic­ca­ted thy­roid, or at the very least, about com­bi­ned hypothy­roid treat­ment with synthe­tic T3 added to synthe­tic T4.  And I’m glad for that when so many patients have found Endoc­ri­no­lo­gists to be narrow-mindedly stuck on Synth­roid or other T4-only thy­ro­xine products.

Of course, infor­med thy­roid patients know this is only a baby step in the right direc­tion, even if a good one! So we’ll rejoice for this study, and watch for more pro­gress from the medi­cal com­mu­nity and Endoc­ri­no­logy in gene­ral. For exam­ple, saying that “most do fine on T4” simply because they have may a non-variation might be pro­ven wrong as phy­si­cians take the time to really look at those “fine” patients, espe­cially as they age and symp­toms of an infe­rior treat­ment do pop up. And though the com­bi­na­tion of synthe­tic T3 with synthe­tic T4 defi­ni­tely gives bet­ter results, thy­roid patients who then moved to desic­ca­ted thy­roid with it’s T4, T3, T2, T1 and cal­ci­to­nin report even bet­ter results and cli­ni­cal pre­sen­ta­tion!  We’ve also lear­ned that the TSH lab test abso­lu­tely sucks when it comes to diag­no­sis and treat­ment.  Read TSH Why It’s Use­less, or see even more detail in Chap­ter Four of the STTM book, tit­led Thy­roid Sti­mu­la­ting Hooey.

And finally: do thy­roid patients really believe that pro­blems with T4-only treat­ment is simply due to a gene­tic abnor­ma­lity or varia­tion? Maybe. But isn’t it funny that a healthy human thy­roid does NOT depend solely on con­ver­sion, but also gives direct T3. hmmmmmm

P.S.  Patients also know that the use of the sup­ple­ment Sele­nium helps with con­ver­sion, by the way, but has never stop­ped our first-hand know­ledge that desic­ca­ted thy­roid rocks!

Some­ti­mes there is a sil­ver lining with the storm cloud of bac­kor­de­red US desic­ca­ted thyroid.

Erfa, the makers of the Cana­dian ver­sion of natu­ral desic­ca­ted thy­roid, simply called “Thy­roid”, has recently announ­ced that the FDA is not requi­ring the exten­sive FDA Form 1572 from US citi­zens and their doc­tors when they fill their presc­rip­tions from Erfa directly. i.e. it’s now a lot easier to get your presc­rip­tion filled directly from them.

http://www.erfa-sa.com/thyroid_usa.htm

And those who have star­ted to use Erfa’s Thy­roid report being quite plea­sed. A cherry on top is that Thy­roid has that old sweet taste we used to all like with the old Armour, and it can be done sublin­gually as well! You can see the ingre­dients here.

Also, I am con­ti­nuing to get emails from patients that both Armour and Natu­reth­roid is star­ting to appear on phar­macy shel­ves, even if in small quan­ti­ties.  I’m per­so­nally not too exci­ted about Armour reap­pea­ring if Forest con­ti­nues to make the refor­mu­la­ted ver­sion. Just too many patients repor­ting a return of hypo symp­toms, even when they raise it, plus new symp­toms of under­treat­ment and/or cha­llen­ged adre­nals thanks to the refor­mu­la­ted ver­sion. Sad. Oh how we will all miss the old Armour.

In the mean­time, here are options for thy­roid treat­ment we all have until we see a good return of desic­ca­ted thy­roid, inc­lu­ding Natu­reth­roid and Westh­roid. They are all far, far bet­ter than being on T4 alone like Synth­roid, Levoxyl, levothy­ro­xine, et al. You’ll also note com­poun­ded thy­roid, which can be a good option, and you can read about on a recent blog post.  Aus­tra­lians hap­pily use com­poun­ded in their own country. Any option you and your doc­tor choose may mean a read­just­ment by your body, by the way.

Want to talk to other patients on how they are dea­ling with the shor­ta­ges? Join the Coa­li­tion for Desic­ca­ted Thy­roid.  Or if you simply need patient feed­back about your hypothy­roi­dism, go to the Talk to Others page.  Remem­ber that no patient group is meant to be a subs­ti­tute for your rela­tionship with your doctor.

**The next Thy­roid Patient Com­mu­nity Call will be held Thurs­day Oct. 8^th on TalkShoe, and our topic will be iodine and your thy­roid with patient expert Stepha­nie Buist. Come join us and lis­ten right on your com­pu­ter, or you can also talk live to Stepha­nie or Janie with your questions.

I have been dri­ving all day, brin­ging my hus­band back home after serious hand sur­gery yes­ter­day. And while I was away from the com­pu­ter, I recei­ved the below via the Con­tact Me form of STTM, writ­ten by Mary Budin­ger for the Ari­zona Net News jour­nal, Sep­tem­ber 16, 2009:

Dr. Mark Starr’s office team wan­ted to send over a por­tion of an article just writ­ten for an Ari­zona health maga­zine:

Desic­ca­ted thy­roid from pigs is a bio-identical, com­plete hor­mone pre­pa­ra­tion, con­tai­ning the entire spec­trum of thy­roid hor­mo­nes inc­lu­ding T4, T3, T2, and T1 that are in the human thy­roid gland.

Current FDA appro­ved thy­roid medi­ca­tions inc­lude Synth­roid, Unith­roid, Levoxyl, and Levothy­ro­xine (all only con­tain T4), and Cyto­mel (only T3). These hor­mo­nes are synthe­tic and con­tain only a por­tion of the thyroid’s hormones.

Dr. Mark Starr of Phoe­nix, Ari­zona, said patients have called him, fran­tic that desic­ca­ted thy­roid is una­vai­la­ble. “It is so key to my prac­tice, I have enough for my patients. So far, it appears that when supply catches up with demand in a few months, the shor­tage will be over.”

Dr. Starr is the author of “Hypothyroidism-Type 2.” He said synthe­tic thy­roid acts ener­ge­ti­cally dif­fe­rently in the body. “All living things have a right spin, and synthe­tic medi­ca­tions have a left spin. The desic­ca­ted thy­roid is bet­ter tolerated.”

Dr. Broda Bar­nes did a study that revea­led a rela­tive into­le­rance to a synthe­tic thy­roid pro­duct con­tai­ning T3 and T4 (Thy­ro­lar). One-fifth of the patients who had done well on desic­ca­ted thy­roid deve­lo­ped rapid heart beats and pal­pi­ta­tions when switched to Thy­ro­lar. Dr. Bar­nes also did a major research study on desic­ca­ted thy­roid that invol­ved thou­sands of patients over 30 years; it sho­wed a 94 per­cent reduc­tion in the num­ber of expec­ted heart attacks. This study is the sub­ject of the 1976 book “Sol­ved: The Riddle of Heart Attacks.”

Lipi­tor is the best selling drug in the world. But for the first half of the 20^th cen­tury, desic­ca­ted thy­roid was the stan­dard treat­ment for high cho­les­te­rol. Ele­va­ted cho­les­te­rol and trigly­ce­ri­des are one of the myriad symp­toms of hypothy­roi­dism. Dr. Bar­nes’ book inc­lu­ded a chap­ter entit­led “The Demise of the Cho­les­te­rol Theory.” Desic­ca­ted thy­roid nor­ma­li­zed cho­les­te­rol and trigly­ce­ri­des in 95% of the patients Dr. Bar­nes trea­ted. The 5% who had per­sis­tently ele­va­ted levels had no inc­rea­sed inci­dence of heart attacks. Desic­ca­ted thy­roid the­rapy also resol­ved a long list of other hypothy­roid symp­toms such as fati­gue, cold into­le­rance, joint and muscle pain, dry skin, ina­bi­lity to lose weight, hea­daches, and mens­trual pro­blems. One of the most impor­tant bene­fits that Dr. Bar­nes demons­tra­ted in stu­dies on both ani­mals and his patients was that desic­ca­ted thy­roid inc­rea­ses immu­nity and allows the body to fight off infec­tions. As we come into swine flu sea­son, this is par­ti­cu­larly important.”

Dr. Starr, I love the way you put it: “All living things have a right spin, and synthe­tic medi­ca­tions have a left spin. The desic­ca­ted thy­roid is bet­ter tole­ra­ted.” And that’s exactly why the web­site Stop the Thy­roid Mad­ness exists – patients all over the world have found out what a far bet­ter “right spin” treat­ment desic­ca­ted thy­roid has been for them!  So we pre­sent this infor­ma­tion, hoping that more and more patients can learn from the paths wal­ked before them, and take this right into their doc­tors offices.

And about Thy­ro­lar, which is a com­bi­na­tion of synthe­tic T4 and synthe­tic T3:  we’re glad it exists. But…there have been nume­rous patients over the years who tried the com­bi­na­tion of synthe­tic t3/ synthe­tic T4, and who then switched to desic­ca­ted thy­roid. And they iden­ti­cally report on the NTH thy­roid group that they got far bet­ter results from desic­ca­ted thy­roid. That is power­ful information.

And yes, Dr. Starr, we are loo­king for­ward for supply to catch up, because natu­ral desic­ca­ted thy­roid is a godsend.

******************************

Join the Thy­roid Patient Com­mu­nity Call on Talk Shoe this Fri­day. UPDATE: the Pre­si­dent of Hook’s Apothe­cary, a com­poun­ding phar­macy that ser­ves Illi­nois and Indiana, will be in the chat to talk about com­poun­ding desic­ca­ted thyroid.

Also check out the post below con­cer­ning pos­si­ble hints that we are clo­ser to seeing more desic­ca­ted thy­roid on our shel­ves?

There once was a gnarly, bottom-scratching and tuna-breathed man who terro­ri­zed a neigh­borhood as if he was above the law. He inti­mi­da­ted peo­ple, used threats to stop others from telling the truth about his actions, and he moo­ned his hairy but­ta­mous to anyone he didn’t like. He brought other cri­mi­nals into his large house, took bri­bes to do some of their own dirty work, and stole every sin­gle vege­ta­ble and fruit from all his neigh­bors gardens.

Finally, all the fear­ful, frus­tra­ted and hungry neigh­bors got angry, sick and tired of it all. So they sent him emails, let­ters and phone calls, asking him to stop what he was doing, and explai­ning how he was hur­ting their lives and well-being,  and spe­cu­la­ted how he was going to do this or that.

And do you think he stop­ped doing what he always did?

Finally, the neigh­bors got wise. They reached out to the police, to local radio and TV sta­tions, to the news­pa­per, and even to local poli­ti­cal lea­ders.  They sta­ted the facts as they knew them, how spe­ci­fic actions affec­ted their lives, how they had spe­cu­la­tions that they couldn’t prove but were quite uncomfortable…and they made sure ever­yone knew what was going on to get the help and sup­port they nee­ded. 

********************************

For over 100 years, thy­roid patient lives have made a huge and posi­tive turn-around on natu­ral por­cine desic­ca­ted thy­roid, a supe­rior, safe, and effec­tive medi­ca­tion as expres­sed by all our lives for over a cen­tury.  But today, we face a crisis.

The most popu­lar desic­ca­ted thy­roid brand, Armour, was refor­mu­la­ted by 2009  and most patients repor­ted a return of their hypothy­roid symp­toms. Then, the only other major phar­ma­ceu­ti­cal, RLC Labs, has their qua­lity Natu­reth­roid and Westh­roid on bac­kor­der in August of 2009. The only North Ame­ri­can makers of the desic­ca­ted pow­der, Ame­ri­can Labo­ra­to­ries, is out.

And finally, the remai­ning two gene­ric makers, Time Caps Labs and Major Phar­ma­ceu­ti­cals, are told to cease pro­duc­tion by the FDA.

We are now without desic­ca­ted thy­roid other than the remai­ning 10 tablets there, or 5 tablets here. They will all be gone soon.

The facts we know are this: because of the 1962 “Drug Effi­cacy Amend­ment”, the FDA is sud­denly deman­ding phar­ma­ceu­ti­cal drug manu­fac­tu­rers (with medi­ca­tions which have been used suc­cess­fully for 80 – 110 years) pro­vide proof of the effec­ti­ve­ness and safety of their drugs before they can receive true FDA appro­val, aka poten­tial cli­ni­cal trials and the data that results. i.e. 110 years of patient suc­cess, and a web­site like Stop the Thy­roid Mad­ness, and tes­ti­mo­nies all over the net and in patient groups with desic­ca­ted thyroid…is somehow…just…not…enough.  What is obvious, is not enough.

In other words, they want proof of effi­cacy and safety of desic­ca­ted thy­roid — a medi­ca­tion which has a safe and effec­tive track record in a huge body of patients for 110 years…in the same way they give an FDA-stamp-of-approval on a whole variety of drugs which, in 2004, killed 783,936 indi­vi­duals per year (accor­ding to the article Death by Medi­cine, co-authored by By Gary Null, PhD; Carolyn Dean MD, ND; Mar­tin Feld­man, MD; Debora Rasio, MD; and Dorothy Smith, PhD).

Does THAT make any sense to you?

And now, because there is hint that they may require RLC Labs to apply for a New Drug Application…and because we won­der if that will mean expen­sive and drawn out cli­ni­cal tes­ting to pro­vide data…and because we won­der if they will allow RLC to con­ti­nue manu­fac­tu­ring our only good supply of desic­ca­ted thy­roid which saves our lives in a com­ple­tely healthy way…we are left with a lot of uncom­for­ta­ble and unans­we­red questions.

Of course, we can admit that all the above is pure spe­cu­la­tion. We don’t know what will hap­pen until it hap­pens. But we are strongly uncom­for­ta­ble with the unk­nowns, frus­tra­ted by the pos­si­bi­li­ties, and sca­red to death we might lose the only medi­ca­tion which has remo­ved our lin­ge­ring and debi­li­ta­ting symp­toms while we were once on synthe­tic T4 – aka Synth­roid, Levoxyl, levothy­ro­xine, etc.

And by the way, synthe­tic T4 is an FDA-approved medi­ca­tion which has left most of us sick or with lin­ge­ring symp­toms to our own degree and inten­sity for YEARS. Perhaps THAT is what you need to write the FDA about.

So do we email the FDA about this situa­tion?? I am of the belief that writing/emailing the FDA is no dif­fe­rent than asking the neigh­borhood ogre to change.  I could be wrong, but it is my deep sus­pi­cion. In fact, I am sus­pi­cious that the ons­laught of com­mu­ni­ca­tion with the FDA is going to do more harm than good…if it hasn’t already…just as wri­ting and emai­ling the neigh­borhood ogre would pro­bably cause him to laugh and do even MORE harm.

So what seems the best and most logi­cal action to take with our current situa­tion? Write/email your sena­tors. Write/email your repre­sen­ta­ti­ves. Write/email news­cas­ters, talk show hosts, radio per­so­na­li­ties, news­pa­pers of merit, and anyone who has the power to spread the word. In my mind, we can­not expect to face what may be with power unless we inform the world of our plight ahead of time.

How to say what we need to say? I think, for our inte­grity in the eyes of whom we speak/email/write to, it’s impor­tant to state facts first and fore­most. For me, if I need to men­tion spe­cu­la­tion, I turn them into ques­tions: Will RLC be able to afford cli­ni­cal trials? Will the FDA stop all desic­ca­ted thy­roid? You may not agree but that’s what seems wise for me.

I have com­pi­led a list of par­ti­cu­lar con­gress­per­sons who just last year, made a reso­lu­tion against the FDA. You will see a list of those sup­por­ters at the bot­tom of the page with their con­tact info. Email them.  You will also find links to con­tact each and every other poli­ti­cal office. If I have mis­sed something, let me know and I’ll add it.

I have also com­pi­led a sim­ple tem­plate let­ter you can use, or change exactly as you need it chan­ged, for these emails.  It will not fit every sin­gle indi­vi­dual who uses it, so change it as you may. But keep it short and suc­cinct. Too much to read will turn off the reader.

I have tried hard in this post to com­mu­ni­cate my thoughts and intui­tion. I also still have some strong hope and faith that this IS going to work out, one way or the other. I’m just not into fear-mongering based on spe­cu­la­tion.  Some of you may not agree with my sen­ti­ment, but that’s okay. And some of you may agree that it’s time to strongly com­mu­ni­cate with our con­gress­per­sons, and I will hope you follow through. All of us need to follow through. I need to follow through. You need to follow through.

NEED OPTIONS FOR THYROID TREATMENT during this hard time? Go here. You’ll also find seve­ral Cana­dian Phar­ma­cies to use with a presc­rip­tion, as well, that is much easier than orde­ring directly from Erfa.

NEED A GOOD DOCTOR? Go here.

NEW TO DESICCATED THYROID? Here’s everything patients have lear­ned.

*Want to be infor­med of this blog posts? Curious what’s on Janie’s mind? Use the noti­fi­ca­tions on the left below the links.

*Spread the word! STTM T-shirts are 50% off. I love sales.