To All UK Doctors

The exce­llent infor­ma­tion below comes from the Thy­roid Patient Advocacy-UK www.tpa-uk.org.uk

7^th August 2006

PORCINE THYROID EXTRACT (ARMOUR THYROID) FOR THYROID REPLACEMENT THERAPY.

Dear Doc­tor,

There are serious mis­con­cep­tions amongst the medi­cal pro­fes­sion con­cer­ning the use of natu­ral desic­ca­ted por­cine thy­roid extract (Armour Thy­roid to USP) as an alter­na­tive to thy­ro­xine, where, amongst a sig­ni­fi­cant num­ber of patients and their medi­cal prac­ti­tio­ners, find the synthe­tic pro­duct to be inef­fec­tive in res­to­ring their opti­mal health.

Although the follo­wing infor­ma­tion may not be rele­vant to your current patients, I would urge you to keep it for refe­rence for the bene­fit of any future patients who do not thrive on T4 only. Thy­roid extract is often the most sui­ta­ble medi­ca­tion for patients who com­plain of fee­ling unwell, even though their TFT’s may show accep­ta­ble levels of hor­mone whilst taking T4 only.

Thy­roid patients are des­pe­ra­tely see­king an unders­tan­ding and part­nership with their NHS doc­tors to get the best treat­ment pos­si­ble. We believe that every patient has the right to opti­mal treat­ment. Given that a num­ber of thy­roid patients do not res­pond well to thy­ro­xine alone and con­ti­nue to have many of the debi­li­ta­ting cli­ni­cal symp­toms of hypothy­roi­dism, we feel that NHS doc­tors should be made aware that they can presc­ribe Armour Thy­roid within the NHS to those patients who do not regain their nor­mal health on thy­ro­xine. Many prac­ti­tio­ners believe wrongly that they are not allo­wed to do this. THIS IS NOT THE CASE.

There are a num­ber of mis­con­cep­tions about Armour Thy­roid, which we would like to rec­tify, as it is impor­tant that all medi­cal prac­ti­tio­ners are given the correct information.

1. Medi­cal Prac­ti­tio­ners believe they can­not presc­ribe Armour – UNTRUE

Armour Thy­roid is the brand name of natu­ral, desic­ca­ted por­cine thy­roid extract. Armour is autho­ri­sed by the FDA as medi­cine that is stan­dar­di­sed to the spe­ci­fi­ca­tion of the USP. The MHRA has not objec­ted to the impor­ta­tion of Armour thy­roid, as it is an FDA autho­ri­sed presc­rip­tion medi­cine, stan­dar­di­sed to the USP and is for the treat­ment of patients with thy­roid disease, for whom the UK licen­sed thy­ro­xine is unsui­ta­ble. Con­se­quently it can be presc­ri­bed to patients who need it, sub­ject to it being presc­ri­bed by a doctor.

I have pas­ted below a copy of a let­ter from the MHRA regar­ding the presc­ri­bing of natu­ral thy­roid extract (Armour Thy­roid to USP) within the NHS.

2. Armour qua­lity is not consistent – UNTRUE

On their res­pec­tive web­si­tes, the Bri­tish Thy­roid Asso­cia­tion and the Bri­tish Thy­roid Foun­da­tion sug­gest that:

“Armour is pre­pa­red from desic­ca­ted ani­mal thy­roid and the pre­pa­ra­tion and puri­fi­ca­tion of this pro­duct may not be at the same rigo­rous stan­dards of more modern medications”

This is either erro­neous or a deli­be­rate attempt to mis­lead UK medi­cal prac­ti­tio­ners and patients.

Forest Phar­ma­ceu­ti­cals state that the amount of thy­roid hor­mone pre­sent in the thy­roid gland may vary from ani­mal to ani­mal, and to ensure that Armour tablets are con­sis­tently potent from tablet to tablet and lot to lot, analy­ti­cal tests are per­for­med on the thy­roid pow­der and on the tablets to mea­sure actual T4 and T3 acti­vity. Dif­fe­rent lots of thy­roid pow­der are mixed together and analy­sed to achieve the desi­red ratio of T4 to T3 in each lot of tablets. This method ensu­res that each strength of Armour will be con­sis­tent with the USP offi­cial standards.

The current USP mono­graph for thy­roid tablets has an Assay to mea­sure the quan­ti­ties of liothy­ro­nine and levothy­ro­xine, a con­tent uni­for­mity test, a disin­te­gra­tion test and mic­ro­bial limits. Stan­dards are set by an expert com­mit­tee with open public com­ment. You can see cita­tions to two refe­ren­ces that dis­cuss the sta­bi­lity of thy­roid tablets and pre­pa­ra­tions at http://www.armourinfo.freeuk.com/document_1.html The first paper does not indi­cate that sta­bi­lity or uni­for­mity were major issues in thy­roid pre­pa­ra­tions. Copies of these papers can be obtai­ned, as well as copies of the USP mono­graph on Thy­roid Tablets from any medi­cal or phar­macy school library.

3. Armour Thy­roid is made from bovine extracts — UNTRUE

I con­tac­ted the Drug Infor­ma­tion Phar­ma­cist of the Pro­fes­sio­nal Affairs Depart­ment at Forest Phar­ma­ceu­ti­cals, who state that Armour Thy­roid comes from Uni­ted Sta­tes grain-fed pig thy­roid. The pigs are domes­tic. Armour Thy­roid does not come from bovine thy­roid. The rea­son some con­fu­sion may have ari­sen could be because many years ago, the manu­fac­tu­rers did pro­duce a thy­roid pro­duct, called ‘Thy­rar’ (not to be con­fu­sed with Thy­ro­lar), that was made from bovine thy­roid. Please see Annex for full list of Armour Ingredients

The disease sta­tus of por­cine ani­mals born, rai­sed, and slaugh­te­red in the USA or Canada can be acces­sed through the World Health Orga­ni­za­tion, Office Inter­na­tio­nale des Epi­zoo­ties (OIE) web­site at http://www.oie.int. Here you will find that the USA and Canada are clas­si­fied as being free of List ‘A’ por­cine disea­ses inc­lu­ding foot-and-mouth disease, hog cho­lera, swine vesi­cu­lar disease, and Afri­can swine fever. This disease infor­ma­tion can also be con­fir­med through USDA Ani­mal Plant and Health Ins­pec­tion Ser­vice (APHIS) Armour is a natu­ral pre­pa­ra­tion of USP grade desic­ca­ted thy­roid pow­der deri­ved from por­cine thy­roid glands.

Armour Thy­roid meets all the requi­re­ments set by the USP for thy­roid medi­ca­tions and manu­fac­tu­ring spe­ci­fi­ca­tions are tightly con­tro­lled, con­trary to the BTA and BTF’s current mis­con­cep­tions about desic­ca­ted thy­roid. The natu­ral por­cine thy­roid pow­ders are not ste­rile pro­ducts nor are they desig­ned to be such. The finished lots are tes­ted for and meet all USP com­pen­dial requi­re­ments inc­lu­ding those for the absence of Sal­mo­ne­lla and E.coli patho­gens. The manu­fac­tu­rers also verify that the Total Aero­bic Plate Count (TAPC) does not exceed 10,000 Colony For­ming Units per gram (CFU/g). The entire thy­roid pro­cess is per­for­med in accor­dance with the Food & Drug Admi­nis­tra­tion (FDA) Current Good Manu­fac­tu­ring Prac­ti­ces (cGMP) requi­re­ments. After pro­ces­sing, the thy­roid pro­ducts are pac­ka­ged, sto­red, and hand­led in a man­ner to pre­vent any cross-contamination.

SO WHY THE CONTINUED MISCONCEPTIONS?

The BTF Sta­te­ment on Armour Thy­roid has inco­rrect infor­ma­tion regar­ding the rea­sons why Armour Thy­roid is not currently licen­sed in the UK. They also give out inco­rrect infor­ma­tion about the rea­son it was with­drawn after synthe­tic thy­ro­xine had been deve­lo­ped in the 1970’s. This was NOT due to qua­lity con­trol pro­blems; the sug­ges­tion that it was is bla­tantly untrue, and there are NO stu­dies to sup­port it.

Armour and seve­ral other thy­roid medi­ca­tions were ‘grand­fathe­red’ in when Con­gress pas­sed the Kefauver-Harris Drug Effi­cacy Amend­ments of 1962, to tigh­ten con­trol over drugs. Before mar­ke­ting a drug, firms had to prove safety and effec­ti­ve­ness for the product’s inten­ded use. The requi­re­ment was applied retroac­ti­vely to 1938, when the FDC Act was pas­sed. Pre-1938 drugs were allo­wed because they were gene­rally recog­ni­sed as safe and effec­tive, pro­vi­ded no evi­dence to the con­trary deve­lo­ped. Too much evi­dence to the con­trary deve­lo­ped con­cer­ning the levothy­ro­xine pro­ducts and the FDA deci­ded none was gene­rally recog­ni­sed as safe and effec­tive, so these synthe­tic pro­ducts lost their ‘grand­fathe­red’ pri­vi­lege and had to go through the NDA pro­cess. Armour retains its’ grand­fathe­red’ sta­tus since no evi­dence to the con­trary has deve­lo­ped con­cer­ning its safe and effec­tive status.

As Armour Thy­roid has NEVER been licen­sed in the UK, it has NEVER been with­drawn. The falling demand was the result of asser­tions by cer­tain drug manu­fac­tu­rers and medi­cal autho­ri­ties that the synthe­tic thy­ro­xine was, by defi­ni­tion, bet­ter, and that por­cine thy­roid was greatly infe­rior. There have been NO stu­dies to sup­port this and BTF are seriously in error when making these assertions.

Inte­res­tingly, in a 1980 study, a num­ber of gene­ric ver­sions of desic­ca­ted thy­roid were found to be unre­lia­ble in potency. The amounts of T4 and T3 in Armour, on the other hand, were found to be cons­tant (ref 1). Moreo­ver, two-year old tablets of Armour Thy­roid con­tai­ned simi­lar amounts of T4 and T3 as did fresh tablets.

The follo­wing quote from the bible of thy­roid treat­ment, Good­man and Gilman’s “ The Phar­ma­co­lo­gi­cal Basis of The­ra­peu­tics”, sheds some light on this ques­tion. The rea­son why ‘other’ brands of desic­ca­ted por­cine thy­roid extract were with­drawn is:

” Seve­ral years ago (1963), a large batch of mate­rial came into the hands of a num­ber of dis­tri­bu­tors in the Uni­ted Sta­tes and Europe and, although of pro­per iodine con­tent, it later pro­ved not to be thy­roid extract at all. This epi­sode gave desic­ca­ted thy­roid a bad name because seve­ral publi­ca­tions about the unre­lia­bi­lity of thy­roid extract appea­red before the hoax was uncovered”.

A further alle­ga­tion from the BTF state that the use of Armour cau­ses “subs­tan­tial fluc­tua­tions to T3 levels”. This is once again quite unsup­por­ted by evi­dence. Doc­tors using natu­ral desic­ca­ted thy­roid (NDT) have found that over time T3 levels some­ti­mes rise to a small degree without any sig­ni­fi­cant con­se­quence. The asser­tion that these so-called minor varia­tions in T3 can cause stro­kes and osteo­po­ro­sis is again com­ple­tely without foun­da­tion or sup­por­tive evidence.

We are all aware that over dosage with T4 and T3 is unde­si­ra­ble, but Armour is no more likely to cause such pro­blems than is synthe­tic T4 and T3. Split­ting the daily dose would obviate any poten­tial con­cern about tran­sient ele­va­tions of T3 levels.

All thy­ro­xine, whether made by the thy­roid itself, or given exo­ge­nously, has to be con­ver­ted to the active T3; and the thy­roid pro­du­ces just the right com­bi­na­tion of T4 and T3 (and T2 and T1 and other uns­pe­ci­fied hor­mo­nes) that are avai­la­ble in Armour thy­roid. Since T4 and T3 have been relea­sed together by the thy­roid gland in all mam­mals (and many other spe­cies) throughout evo­lu­tio­nary his­tory, it is absurd for the BTF to sug­gest that this com­bi­na­tion is poten­tially dama­ging. Desic­ca­ted thy­roid has been used for a cen­tury in hypothy­roid patients with great bene­fit and no harm, and the sug­ges­tion, again by the BTA and BTF that the long-term effects are not known are patently inco­rrect. This is how nature does it and Armour is almost iden­ti­cal to human thyroid.

WHERE NEXT?

Des­pite an exten­sive lite­ra­ture search I can find no scien­ti­fic evi­dence to sup­port the fact that synthe­tic thy­ro­xine is supe­rior to natu­ral desic­ca­ted thy­roid extract. These stu­dies have quite simply not been done. The logic of sup­ple­men­ting a fai­ling thy­roid has to be that it is as close to nature as pos­si­ble; giving T4 alone is not and accounts for the unsa­tis­fac­tory results in many patients. There is a gro­wing body of scien­ti­fic evi­dence that shows that many patients often do not regain a true sense of well being on pure synthe­tic thy­ro­xine and pre­fer Armour because it works and actually makes them feel bet­ter. It is also quite untrue for the BTF to sug­gest that blood tes­ting in patients taking Armour is less than satis­fac­tory; indeed, it pre­sents no dif­fi­cul­ties of any kind.

It appears that con­ven­tio­nal medi­cine has not made ANY attempt to eva­luate the evi­dence regar­ding the empi­ri­cal use of Armour. Its who­le­sale dis­mis­sal by the BTA and BTF repre­sents, at least in part, a bia­sed atti­tude. TPA-UK would like to see the ins­ti­ga­tion of a pro­perly con­duc­ted pros­pec­tive ran­do­mi­sed con­trol trial as soon as possible.

Hypothy­roi­dism is one of the few medi­cal con­di­tions where peo­ple are joi­ning Inter­net sup­port groups, and ending up self-prescribing and fee­ling bet­ter. There are valua­ble les­sons to be lear­ned by endoc­ri­no­lo­gists on these boards.

TPA-UK have asked the Bri­tish Thy­roid Foun­da­tion to correct their mis­lea­ding and inco­rrect sta­te­ments about Armour on their web­site. Clearly, to date, they have fai­led to do so and TPA-UK con­si­ders this extre­mely irres­pon­si­ble. I recei­ved the follo­wing let­ter from BTF (dated 1t Decem­ber 2005) in res­ponse to my request:

“Thank you for your let­ter dated 2^nd Novem­ber. The Trus­tees of the Bri­tish Thy­roid Foun­da­tion note the com­ments in your let­ter and we stand by the details pro­vi­ded in our pre­vious let­ter of 11^th May. We now con­si­der this mat­ter clo­sed and shall not be ente­ring into any further corres­pon­dence with you on this sub­ject”. This was sig­ned by Janis Hic­key, Direc­tor and Sec­re­tary to the Trustees”.

Kee­ping an open mind is, clearly, the one thing that BTA and BTF is not doing. Since natu­ral desic­ca­ted por­cine thy­roid extract has been avai­la­ble since 1894, long before synthe­tic T4, and making patients bet­ter, it is up to such medi­cal autho­ri­ties to PROVE on the con­trary, that synthe­tic T4 is as good, safe and relia­ble as Armour.

As I have already said, we are keen to work with medi­cal prac­ti­tio­ners to get the best treat­ment. Get­ting the correct thy­roid medi­ca­tion right for the patient impro­ves qua­lity of life, and has hel­ped many suf­fe­rers to return to work, relin­quish state bene­fits and con­tri­bute towards the nation’s wealth.

The current situa­tion, whe­reby hypothy­roid patients are being left to self-diagnose, self-treat, and self-monitor because most prac­ti­tio­ners are unwi­lling to con­si­der alter­na­tive medi­ca­tion, owing to their mis­con­cep­tions about Armour, is unac­cep­ta­ble. We are see­king to work in part­nership with our medi­cal practitioners.

I would wel­come your sug­ges­tions as to how we might work together to inc­rease gene­ral awa­re­ness and unders­tan­ding of the issues.

Yours sin­ce­rely

Sheila Tur­ner
Thy­roid Patient Advocate

Refe­rence: 1) Rees-Jones RW, Rolla AR, Lar­sen PR. Hor­mo­nal con­tent of thy­roid repla­ce­ment pre­pa­ra­tions. JAMA 1980;243:549 – 550.

Annex 1

Armour Ingre­dients

Active Ingre­dients:

Armour Thy­roidT Tablets, USP con­tain the labe­lled amounts of levothy­ro­xine (http://www.armourthyroid.com/glossary.html#sodium) and liothy­ro­nine (http://www.armourthyroid.com/glossary.html#liothyronine), as esta­blished by the USP. The ratio of Armour Thy­roid T4 to T3 is 4.22:1 (4.22 parts of T4 to one part of T3).

Inac­tive Ingredients:

1.Thyroid Pow­der, USP
2. Dex­trose, Anhy­drous
3. Mic­rocrys­ta­lline Cellu­lose, NF
4. Sodium Starch Gly­co­late, NF
5. Cal­cium Stea­rate, NF
6. Opadry White (tita­nium dio­xide used as a whi­te­ning agent)

Armour Thy­roidT does not con­tain glu­ten or lactose.

You can find con­fir­ma­tion of their ingre­dients and their qua­lity con­trol pro­ce­du­res on the manu­fac­tu­rers web­site: http://www.armourthyroid.com/.

Annex 2

If Armour thy­roid were labe­lled as USP it would be expec­ted to meet the requi­re­ments of the USP mono­graph throughout its shelf life. The current USP mono­graph for thy­roid tablets has an Assay to mea­sure the quan­ti­ties of liothy­ro­nine and levothy­ro­xine, a con­tent uni­for­mity test, a disin­te­gra­tion test and mic­ro­bial limits. Stan­dards are set by an expert com­mit­tee with open public com­ment. Cita­tions to two refe­ren­ces that dis­cuss the sta­bi­lity of thy­roid tablets and pre­pa­ra­tions can be seen at http://www.armourinfo.freeuk.com/document_1.html The first paper does not indi­cate that sta­bi­lity or uni­for­mity were major issues in thy­roid pre­pa­ra­tions. Copies of these papers as well as copies of the USP mono­graph on Thy­roid, Thy­roid Tablets can be seen at any medi­cal or phar­macy school library.

The onus is on Idis, as impor­ter and sup­plier, to prove that Armour is being sup­plied for the per­mit­ted indi­ca­tion, and a spo­kes­per­son for Idis has agreed that doc­tors now only need to write on the presc­rip­tion “requi­red for the treat­ment of hypothyroidism”.