fda tags

When the shor­ta­ges hit the Uni­ted Sta­tes for natu­ral desic­ca­ted thy­roid in 2009, we all had to figure out which way to turn, since the 110-year-old natu­ral desic­ca­ted thy­roid has been a far, far bet­ter treat­ment for our hypothy­roid state than levothy­ro­xine T4-only such as Synth­roid, Levoxyl, Eltro­xin, Oro­xine, etc.

Addi­tio­nally, Armour thy­roid by Forest Labs was refor­mu­la­ted in early 2009, and patients world­wide repor­ted a return of symp­toms as well a stress on their adre­nals.  So patients star­ted an exo­dus away from Armour.

Luc­kily, the FDA loo­se­ned res­tric­tions and allo­wed us to order the Cana­dian brand by Erfa Canada Inc, called simply “Thy­roid”.   Erfa’s Thy­roid pro­ved to be an exce­llent desic­ca­ted thy­roid for most, espe­cially if they rai­sed high enough once again to rid them of symp­toms.  And since it con­tains suc­rose, patients have been able to do it sublin­gually – a method which is not neces­sary for bene­fits, but is pre­fe­rred by many.

I gathe­red a list of known Cana­dian online phar­ma­cies, which you can view on the Options for Thy­roid Treat­ment page.

And just recently, I sought opi­nions from patients about the phar­ma­cies they have used:

Uni­ver­sal Drugs­tore aka Cana­dian Phar­macy Online: This phar­macy recei­ved the grea­test kudos from US patients and with the best prices.

• Awe­some — good pri­ces and fast, friendly ser­vice. Will call your drug store and get your Armour script transferred.
• Faxed my presc­rip­tion and it was mai­led the next day. I believe it took a week and a few days to arrive to Florida.
• Great cus­to­mer ser­vice, easy orde­ring, and was chea­per than paying the co-pay with my insu­rance. It takes about 10 to 14 busi­ness days to get your presc­rip­tion, accor­ding to the com­pany, but mine came soo­ner than that and it was the holi­day mail rush season!
• Rapid ser­vice, exce­llent cus­to­mer ser­vice, email remin­ders to refill, coupons
• They had the best price and were very pro­fes­sio­nal and effi­cient.  My order arri­ved within ten days.
• I paid $43.25 for 200 60 mg pills
• Online forms were easy. I faxed my presc­rip­tions and recei­ved my Thy­roid in twelve days for $7 shipping

Phar­ma­cies Online:

• Easy to regis­ter and the cus­to­mer ser­vice was exce­llent. I faxed my presc­rip­tion. A phar­ma­cist called me to see if I had any ques­tions. I paid $45.63 inc­lu­ding ship­ping for 100 60mg pills

Cross Bor­der Phar­macy:

• Exce­llent cus­to­mer ser­vice, great pri­ces, two week arri­val from date of order, wish phar­ma­cies here were this good.

Canada Drugs Online:

• Good expe­rience, prompt (7 – 10) days ser­vice get­ting my Erfa thyroid

See more recom­men­da­tions in the Com­ments sec­tion for this post. And I’m going to hope that no phar­macy “uses” this to adver­tise their phar­macy. This is FOR PATIENT COMMENTS ONLY.

What has been your expe­rience with online Cana­dian Phar­ma­cies? Do I need to remove any from the Options for Thy­roid Treat­ment for any rea­son? Do I need to add any?

ARE YOU A CANADIAN PATIENT ON DESICCATED THYROID? Use the Con­tact Me form if you’d like to be inter­vie­wed by a well-known Cana­dian repor­ter about desic­ca­ted thy­roid in Canada. I’ll need your name and email address. You need to con­tact me before Mon­day, January 25.

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Recent blog posts worth reading:

Read a guy’s email to me about his expe­rience with doc­tors being afraid of HC, which patients know is safe and WORKS!

Will the FDA be more trans­pa­rent for thy­roid patients on desic­ca­ted thy­roid with their new initiative?

Lis­ten to the second inter­view, Epi­sode 9, I had with Dr. John C. Lowe. What a bri­lliant man!

A press release just came out sta­ting that the U.S. Food and Drug Admi­nis­tra­tion (FDA) has “unvei­led the first phase of its Trans­pa­rency Ini­tia­tive which is desig­ned to explain agency ope­ra­tions, how it makes decisions, and the drug appro­val process.”

Of course, this doesn’t mean thy­roid patients can stop what seems like an inane deci­sion to require makers of desic­ca­ted thy­roid to “prove” , via expen­sive cli­ni­cal trials, that it’s a safe and effec­tive medi­ca­tion. RLC Labs, for exam­ple, the makers of Natu­reth­roid and Westh­roid, will be affec­ted.  Over 110 years of patient use, with 70 years by RLC, cer­tainly reveal it’s a safe and effec­tive treat­ment. But at least this trans­pa­rency ini­tia­tive will “poten­tially”  give us bet­ter infor­ma­tion about the pro­cess. We’ll see.

About the upco­ming Part 2 with Dr. Lowe (see the blog post right below this): Some folks were boo­ted off last Thurs­day and had to quickly get back on. The pro­blem is when you get back on, you may lose your abi­lity to chat.  i.e. the sys­tem stops the chat abi­lity once there are 300 indi­vi­duals already on the chat.  You can lis­ten, but you can’t chat after 300 are on.

So there are three things you can do to pre­vent being boo­ted off and having to get back on:  first, make sure you have clo­sed anything else on your com­pu­ter – i.e only Talkshoe should be up. Second, make sure no other pro­grams are run­ning in the back­ground, or will come on, like your anti-virus, and 3) ahead of time, down­load Live Pro from Talkshoe and use that. It’s more stable.

I, in turn, will be doing a stra­tegy to strengthen this call from boots.  Addi­tio­nally, if neces­sary, some who aren’t chat­ting out of the first 300 will have their option chan­ged to no-chat to allow those who came in lat­ter to do it.  It’s not per­so­nal because I don’t know who a lot of you are. It’s just sprea­ding the abi­lity into the call.

Do you take regu­lar aspi­rin? Just as we warn about swa­llo­wing your meds when you have just eaten anything with cal­cium, iron or estro­gen (they bind the thy­roid hor­mo­nes), you need to be aware that aspi­rin can have a nega­tive affect on your thy­roid levels, as well.  i.e. though it may help lower high thy­roid levels, it’s not good for your thy­roid treat­ment if you regu­larly take it.

How did we get to where we are with the FDA’s actions towards desic­ca­ted thy­roid today? Go here.

Please note: Dr. Lowe is NOT an MD or DO who see’s patients and can presc­ribe. He’s a thy­roid and fibro “researcher” with good know­ledge about T3,  fibro, meta­bo­lism, sup­ple­ments etc. Many ques­tions have been coming in which are already ans­we­red on STTM, or are more tar­ge­ted to a prac­ti­cing phy­si­cian, not a researcher. FYI.

On the heels of an infor­ma­tive and won­der­ful THYROID PATIENT COMMUNITY CALL on Talkshoe last week with Dr. John C. Lowe (see posts below), we’re going to do it again this coming Thurs­day, January 14^th.  Join us for Part 2!

Dr. Lowe is a fibrom­yal­gia, thy­roid, and meta­bo­lism researcher who has always been such a cham­pion for bet­ter diag­no­sis and treat­ment in thy­roid patients. He is Editor-in-Chief of the open access jour­nal www.thyroidscience.com as well as his own www.drlowe.com

And this time, Dr. Lowe is going to spend more time ans­we­ring  your spe­ci­fic ques­tions. Check out his web­si­tes above to get an idea what his exper­tise is, which inc­lu­des the use of T3,  Hashi­mo­tos autoim­mune thy­roid disease, iodine, fibrom­yal­gia, the tyranny of the TSH lab test, good sup­ple­ments, the FDA, and more.

So here’s your chance: think of one or two ques­tions you’d like to hear him ans­wer. Please, if you have more more than two,  narrow them down to the two most impor­tant, and keep them brief.  No excep­tions. Two max only, and brief.  Then use the Com­ments below to post them.  Be sure and check out if your ques­tions have already been asked in other comments.

I’ll be collec­ting the ques­tions ahead of time and will let him pre­view them. He wants to give you his best.

TIPS ABOUT TALKSHOE: Some repor­ted being boo­ted off and having to quickly rejoin. One step that may help is to down­load the Talk Shoe Live Pro ahead of time (takes 25 minu­tes for some) and use that soft­ware during the call, since it gives you far more sta­bi­lity.  Also, make SURE you have everything else clo­sed and/or not run­ning on your com­pu­ter at the same time you are in the Talkshoe call. I will also be chat­ting with Talkshoe sup­port and will get more ideas.

Also, don’t wait until the call occurs to men­tion your ques­tion. We found it dif­fi­cult to try collec­ting them on the Chat. Ask now!!

Yes, you can also call in live during the Call, but it’s good to first let me know your ques­tion here.

And finally, at a cer­tain point of those who join (after 300 on chat), Talkshoe par­ti­ci­pants are auto­ma­ti­cally una­ble to post on the chat. You can lis­ten, but no chat­ting. So if you want to chat, join as soon as the Call opens up, which is 15 minu­tes before the actual audio begins. Times for the audio are 9 pm Eas­tern, 8 pm Cen­tral, 7 Moun­tain, and 6 pm Pacific.

The Stop the Thy­roid Mad­ness Talkshoe page: http://www.talkshoe.com/talkshoe/web/talkCast.jsp?masterId=62603&cmd=tc

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See the blog post below those about Lowe for a very insight­ful Guest Blog Post by Amy about her role as an Under­co­ver Thy­roid Advo­cate. Below that, you can read how I was wrong about what it was like to be thy­roid­less, and seve­ral great comments.

The year of 2009 will long be remem­be­red for two night­ma­res straight out of Twi­light Zone for thy­roid patients: 1) Armour desic­ca­ted thy­roid by Forest Labs was refor­mu­la­ted with patients glo­bally repor­ted a return of symp­toms and new frus­tra­ting ones, and 2) shor­ta­ges of all US-made natu­ral desic­ca­ted thy­roid like Armour, Natu­reth­roid and Westh­roid occu­rred, as well as no more gene­rics thanks to the FDA.

Addi­tio­nally, as I write this, Natu­reth­roid and Westh­roid by RLC Labs are still hard to get – making too slow a return on phar­macy shel­ves which may not improve until 2010. You can read details and a good sum­mary about this on about.com.

But there’s been a sil­ver lining to this situa­tion: Canada’s “Thy­roid” by Erfa.

Many patients made a switch to this desic­ca­ted thy­roid pro­duct, using online phar­macy web­si­tes and their presc­rip­tions from their doc­tors. And ove­rall, the expe­rience of patients with Erfa’s Thy­roid has been extre­mely positive.

I had a won­der­ful chat this week with Dr. Henri Knafo, the Direc­tor of Medi­cal Affairs at Erfa Canada Inc.  My first and most impor­tant ques­tion: Is there enough Thy­roid for all your patient cus­to­mers?? And I got an une­qui­vo­cal “Yes” from Dr. Knafo.  He explai­ned there are no con­cerns with run­ning out and they have plenty in stock, now and in the future. He sta­ted that if their stock gets low from sud­den demand, they can easily get more and quickly.

I also asked: Is ship­ping timely? Defi­ni­tely yes, Dr. Knafo sta­ted. But he also qua­li­fied that Erfa is over­loa­ded with orders. And though they are kee­ping up, your presc­rip­tion order can take time to pro­cess. But, he sta­ted “Be Patient. It will arrive!”

What is going on with the FDA and Erfa? He unders­co­red that the FDA is coo­pe­ra­ting com­ple­tely, and they see a good future with the FDA.  They are com­ple­tely tole­rant, said Dr. Knafo, because they seem to unders­tand the shor­ta­ges. Erfa’s Thy­roid is also com­ple­tely appro­ved and regu­la­ted by Health Canada. As far as the future and the FDA, Dr. Knafo strongly feels that once the FDA is reas­su­red about desic­ca­ted thy­roid, things will only get bet­ter for US patients with brands and avai­la­bi­lity. He feels that issues with the FDA are far more posi­tive than many thy­roid patients and lea­ders seem to get or want to see.

Do you see chan­ges towards opi­nion of desic­ca­ted thy­roid?  Defi­ni­tely, yes. Dr. Knafo recently atten­ded a Euro­pean medi­cal con­fe­rence with over 50 spe­cia­lists and he saw many doc­tors not satis­fied with Synth­roid and noti­cing the bet­ter treat­ment with desic­ca­ted thy­roid. “It’s boo­ming in Europe”, he unders­co­red about Erfa and desic­ca­ted thy­roid  “Even Endo’s are noti­cing”.  He also said that Bel­gium was expe­rien­cing a huge medi­cal trend away from T4 and towards desic­ca­ted thyroid.

Why has the cost of Erfa’s Thy­roid gone up even more than 50%?? His expla­na­tion was three-fold:  it was first a finan­cial deci­sion, since they have never made much of a pro­fit on desic­ca­ted thy­roid. Second, Health Canada requi­res a lot of expen­sive tes­ting from Erfa on pro­ducts. And third, since they buy their pow­de­red desic­ca­ted thy­roid from Europe, an inc­rease in Euros meant they nee­ded to inc­rease the price.

Any final com­ments? Dr. Knafo cla­ri­fied: Erfa has been making Thy­roid for 30 years and not only will that con­ti­nue, they will not change the for­mula. He thinks the sugar in Thy­roid is what makes absorp­tion so good, and that will con­ti­nue as an ingre­dient just as it is.  Nothing will change! To see ingre­dients of Erfa’s Thy­roid and other brands, go here.

You can read more about Erfa from my Sep­tem­ber 2^nd post.   Thank you to Dr. Knafo for being so can­did and informative!

See my post below about my mother, who lived her entire adult life under­trea­ted on T4 with depres­sion and elec­tric shock treat­ment and had no inter­net to com­pare notes. If you have a rela­tive from the past with a simi­lar story, add the story to the Comments.

*HO HO HO! Have a STTM book sent to someone  you care about as a CHRISTMAS or HOLIDAY pre­sent. A card will be inc­lu­ded, and the book will be in an enve­lope with a red bow!! Save money the more you buy!

(This post gar­ne­red a lot of atten­tion, up to FIFTY com­ments just a few hours after it went up. Peo­ple are very inte­res­ted in sha­ring their expe­rien­ces in coping with the shor­ta­ges! See below and add your own.)

This year will go down in his­tory as shoc­kingly mise­ra­ble for enligh­te­ned thy­roid patients on natu­ral desic­ca­ted thy­roid.

First came a refor­mu­la­tion in the most popu­lar brand – Armour by Forest Labs. Patients world­wide in groups and forums repor­ted a serious return of their hypothy­roid symp­toms on this pro­duct. A huge disappointment.

Second came the pro­duc­tion shut­down of the two gene­ric makers of desic­ca­ted thy­roid: Time Caps Labs and Major Phar­ma­ceu­ti­cals. It’s the first step in the FDA’s com­pliance plan to corral all grandfathered-in drugs (drugs already in exis­tence when the the FDA was crea­ted in 1938) and make them each prove the effi­cacy and safety of their medi­ca­tion via very expen­sive cli­ni­cal trials.  i.e. over 110 years of safe and effec­tive use of desic­ca­ted thy­roid is not enough for the FDA?? We are still wai­ting to see the out­come of that plan with RLC  and Forest Labs. – the two who were actually in exis­tence before 1938.

Third came demand being grea­ter than supply and shor­ta­ges. Because of infor­ma­tive patient web­si­tes like Stop the Thy­roid Mad­ness,  Sheila’s TPA-UK, Lyn’s Thy­roi­dUK, Stephanie’s Natu­ral Thy­roid Choi­ces, some areas of about.com (and other good web­si­tes I don’t mean to miss here), plus many fine patient forums and groups,  patients found out why they had con­ti­nuing symp­toms on T4 thy­ro­xine, and demand for natu­ral desic­ca­ted thy­roid grew exponentially.

STTM then crea­ted a list of options for all thy­roid patients until the shor­ta­ges resol­ved them­sel­ves, and also crea­ted CDT (Coa­li­tion for Desic­ca­ted Thy­roid) where patients could dis­cuss alter­na­ti­ves in a sup­por­tive and fac­tual atmosphere.

And we’ve seen some inte­res­ting expe­rien­ces and comments:

The new Armour: One grain tabs star­ted to appear on some phar­macy shel­ves the past month.  Other phar­ma­cies have still been wai­ting.  Many patients appear to have switched to other alter­na­ti­ves, though. One gal still on it feels she is fin­ding suc­cess by adding T3 to the amount of new Armour she is on.  Time will tell if patients can ever find suc­cess with the newly for­mu­la­ted Armour, and most feel it’s a huge loss.

Natu­reth­roid and Westh­roid: Patients repor­ting on their switch to either of RLC Lab’s two iden­ti­cal pro­ducts report doing well, having to raise it slightly or lower it slightly, or just not liking them at all. Others have had a hard time fin­ding it on their phar­macy shel­ves, but have been seeing some appear in the last few weeks.

Erfa’s Thy­roid from Canada: When it became clear that the FDA was allo­wing this exce­llent pro­duct to be ship­ped to patients, many switched and had their presc­rip­tions faxed to a Cana­dian phar­macy. Pri­ces at many of those phar­macy web­si­tes were dou­bled after presc­rip­tions star­ted to come in from the US. Most patient who stuck with it seem to love it, repor­ting you can do it sublin­gually, as well. A few haven’t been impres­sed, but were fin­ding their for­mer suc­cess by rai­sing it.

Com­poun­ded desic­ca­ted thy­roid: In spite of being a more expen­sive option, some patients found suc­cess with this. Others lear­ned they pre­fe­rred the filler to be Aci­dophi­les.  If not the lat­ter, Mic­rocrys­ta­lline Cellu­lose was pre­fe­rred over Methyl Cellu­lose – the lat­ter which appea­red to les­sen the effec­ti­ve­ness of the com­poun­ded thyroid.

Synthe­tic T4 and Synthe­tic T3: some patients switched back to the synthe­tic com­bi­na­tion, but many report that it hasn’t been as effec­tive as desic­ca­ted thy­roid was.

Other options: Patients moved to OTC pro­ducts like Nutri-Meds, etc, which can be much wea­ker. Others sought desic­ca­ted thy­roid from other coun­tries and have found success.

So I’d like to hear from all of you.   Did you go back to synthe­tic T4?  What desic­ca­ted thy­roid did you switch to? What wor­ked and why? What didn’t work for you and why?  What pro­duct do you hope to switch to once you run out of your current meds?