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Written by Nora.Heime.net
About the history of Thyroxine and Thyroid, Erfa Thyroid (formerly: Pfizer Canada) dessicated thyroid, Thyreoidum, Thyreodinum etc.
The standard is Thyroid, dried pig gland. All research on Thyroxin was actually done on Thyroid, because in the old days there was no T4, but diligent research was done on Thyroid, which was also called Thyroxine because people didn't know any better.
This is called Thyroid USP (United States Pharmacopeia) where the content of thyroxine and liothyronine is now strictly regulated. In the old days, T4 and T3 were not known, so it was regulated according to iodine content. A 10% deviation in strength is permitted. (90%-110%) This applies to all Thyroxine preparations, and all other medicines. For generics, 80-125% applies.
There is no generic for Thyroid, therefore the 10 percent applies. (Updated: it's been changed now, to 95-105%)
Thyroid was standardized early on and produced as brands. An example available on the internet is Merck thyroidinum.
In the beginning, the requirement was that it should be analyzed for iodine content, later when it was possible, of course, the amount of Levothyroxine and Liothyronine was measured.
Here is an interesting Cuban website where they list all the old names and manufacturers of Thyroid: http://www.sld.cu/servicios/medicamentos/medicamentos_list.php?id=399
List of old and new medicines:
Name | Country | Manufacturer |
Thyranon | Sweden | |
Thyreoïdum | Denmark, Netherlands | Biofac Kastrup, imported to Netherlands by BUFA/Fargo |
Thyroidin | Germany | |
Armour Thyroid | USA | Several over times: USV, Pfizer, Forest, now acquired by Activas Pharmaceuticals |
NP Thyroid | USA | Acella Pharmaceuticals |
Nature-Throid, Westhroid Pure | USA | Western Reseach Laboratories http://www.rlclabs.com these got a central approval in the 2000's of Nature-throid in the UK and went throught all these approval procedures |
ERFA Thyroid | Canada | Parke-Davis, acquired by Erfa (flagship: Belgia) |
Thyroid Powder, USP | Canada | Medisca (only available through compounding pharmacies) |
Cinetic | Italy | Teofarma SRL |
Thyreoid | Germany | |
Tiroides | Spain | |
? | Japan | |
Thyroidine | France | |
Thyroid-S | Thailand | Sriprasit |
Thiroyd | Thailand | Greater Pharma |
Thyroid API | Spain | Bioiberica |
Adthza | USA | Azurity Pharmaceuticals |
Thyrid Extract | Australia | Australian Custom Pharmaceuticals |
Compound Thyroid | Denmark | Glostrup Apotek |
Thyreogland | Germany | Klösterl-Apotheke, Munchen |
Schilddruesen-Extrakt | Germany | Receptura |
Whole Thyroid | New Zealand | Pharmaceutical Compounding New Zealand |
Diotroxin | South Africa | Aspen Pharmacare Ltd |
Generic Thyroid | USA | Major Pharmaceuticals |
Qualitest | USA | Time-Caps Labs |
Thyrolar | USA | Forest Labs |
Thyrogold | USA | Natural Thyroid Solution (non prescr. but recommended by Dr. Lowe) |
Some of these are no longer available on the market.
Thyroid USP has content of T4 and T3 that is strictly regulated, that's what USP means, United States Pharmacopeia. The specification zone is that 1 grain contains 38 mcg T4 plus 9 mcg T3, plus or minus 10%. This is completely reliable. 1 grain = 60 mg.
In Europe, Thyreoïdum and other similar products do not have this requirement, but all batches of Thyreoidum from Denmark are analyzed and the amount of T4 and T3 is specifically stated. So there is not even 10% wiggle room. There is a higher proportion of T3 in Thyroidum. This is probably what Wiersinga is getting at.
But his statement is being used about the unreliability of Armor Thyroid by Welsh in Australia and William Harper in Canada here.
Wiersinga is based in Holland, Welsh in Australia, and Harper in Canada.
In Australia there is no Armour, they use powder from the USA and the pharmacies make capsules.
In Holland they use Thyreoïdum, and in Canada there is no Armour, they make their own, but from imported raw material.
(It was Pfizer that owned Armor Thyroid at the time, and then Pfizer split up into Canada and the US and so Canada got the original old Armor formulation before all the reformulations. Armor got no rights for marketing abroad, it was Thyroid in Canada who received.
Then Erfa bought up a bunch of rights, and bet on Thyroid based on patient wishes. It is approved by Health Canada, which is important for us in Europe since it is often a prerequisite that the medicine must be approved in the country of origin for it to be approved in Europe at all)
Here in Europe we had Merck Thyroidin according to their own website, but I don't have an overview of all the brands that existed, I have found a brand from Switzerland as well. Thyroidum is still made in Denmark, it is what the Dutch patients use today.
Armor Thyroid from Forest does not have rights outside the US, not even Canada. It came about because Pfizer, who owned the rights, was split up in the US and Canada and they split up the rights to Armor and Thyroid. Thyroid from Canada is the original Armor due to the old rights.
Western Research Laboratories has been approved (central approval, but everyone must apply for a registration exemption, which is called named-patient program in foreign languages) for their brand Nature-Throid here in Europe, they went through the approval procedure in England and it therefore applies throughout Europe. It is just as reliable. Everything comes from the same raw material.
What distinguishes the American USP (United States Pharmacopeia) Thyroid from the European one is that the ratio between T4 and T3 is constant and that the strength is the same all the time, which is an advantage when making pills from it. (Comment from a pharmacist at Stenlake Pharmacy in Australia).
The European Thyroidum has varying strengths and ratios of T4 to T4 for each batch, which lasts approximately one year. On direct request to the users, they say that it has no consequences (the forum in Holland). In addition, Thyroid is still available in Japan and Thailand.
Updated: According to their own forum, Erfa says that they obtained Thyroid raw material in Europe. It may well be from biofac in Denmark, and tens of millions of pig glands are exported from Denmark, according to a Dane on Sonja's Stoffskifteforum. They can therefore presumably make Thyroid with USP specifications as well.
In any case, the effect is absolutely excellent according to all patients who have tried it. The amount of active ingredient is also stated as less than Armour had, but the effect is the same as old Armor from when it was good. Other patients have also noted that for Levothyroxine, the effect of European tablets was stronger than that of American ones.
Now it was thought that thyroxine (=t4) was the active substance in Thyroid, and levothyroxine (=t4) came on the market. It was claimed to be exactly the same as Thyroid. Double blind tests were never conducted to prove that Levothyroxine worked as well on the patients as Thyroid for that reason (Note that at least 14 comparison studies have been done).
That is the reason why today we cannot show double blind tests that Armor Thyroid is as effective as Thyroxin, or that patients in such tests felt better or worse. It comes from the makers of Thyroxin who all along claimed it was the same as Thyroid.
Update: Dr. Lowe has found at least 14 direct comparisons of Thyroid vs Thyroxin in the literature. He says it is wrong, a repeated lie, that there are no comparative studies between the two. Thyroid was recognized as stable and effective.
Then came a clean-up of medicines in the United States. All that had been used for many years and proved effective were given the status of approved on historical grounds. Note that when applying for approval in Norway, an exception may be granted to submit documentation in clinical trials, namely historical use. Digitalis and Thyroid are just such remedies.
Synthroid, as thyroxine was called in the US, claimed historical status and referred to Thyroid, that it was the same as Thyroid. They managed to get away with it until the FDA cut through and decided that all Levothyroxine products were new drugs and that they had to go through new approval procedures and prove their shelf life and dose stability.
Synthroid was notorious for repeatedly changing the ingredients and active substances and that the strength could be much more or less than stated. Many patients were very dissatisfied because they became so unwell that they functioned poorly at work etc.
A bigger scandal was also the case where Knoll, who owned Synthroid, then prevented a research report that was to be printed, stating that Synthroid was no better than other brands. It was such a big scandal when it came out that they fired the researcher and prevented the publication of correctly conducted research.
And then there was a larger compensation case in the wake of this, where the patients got back a few dollars for the overcharge they had to pay, when in reality all Levothyroxine preparations were equal. The patients had paid a huge premium because Synthroid had claimed to be far superior to the others. Synthroid costs about 52 dollars for 90 tablets compared to Thyroxine in England about £2.50 and Levaxin here about NOK 70 for 100 tablets.
Synthroid is known to be inconsistent, not Thyroid. If you search the database for recalls in the USA, it is Levothyroxine that has been recalled, not Thyroid.
The different brands of Levothyroxine, despite the fact that they should contain the same, should not be used interchangeably because they will give different blood values. If you switch, you must take new blood tests after 6 weeks.
The various manufacturers of Levothyroxine fought for many years against having to apply for approval. They constantly claimed that their product was identical to Thyroid, which was recognized as stable and with good effect.
NDA = New Drug Application. Approval on historic grounds is called "Grandfathered In".
References:
Have followed closely the questions about metabolic drugs.
Note that the Federal Register is the most official thing that can be done in the US, it is where new laws are registered. A rather important document on the instability of Levothyroxine. Nobody can come here and come here and say that it is a lie that Levothyroxine is unstable. It is Levothyroxine and not Thyroid USP that is unreliable and unstable.
http://www.pharmabiz.com/article/detnews.asp?Arch=&articleid=6645§ionid=14 Abbott submits NDA application.
About the history, Thyroid extract etc.
A brief overview of medications in the United States including Thyrolar.
More on the Synthroid and Boots/Knoll scandal and trial.
"In April of 1997, the Journal of the American Medical Association (JAMA) published a study, commissioned by Knoll, that concluded that Synthroid -- a synthetic thyroid hormone -- is no better than two generic alternatives or the brand-name drug Levoxyl . Knoll disagreed with the study, and considered suing to stop its publication. Betty Dong, the researcher at the University of California at San Francisco who conducted the study, told the journal that Knoll had suppressed her findings for more than six years."
Unithyroid approved as the first L-Thyroxine preparation in 2000.
2001 "Levothyroxine sodium tablets are also currently not listed in the Orange Book. In the words of the FDA, "Levothyroxine sodium was first introduced into the market before 1962 without an approved NDA, apparently in the belief that it was not a new drug. "
See also below for an explanation of bioequivalence.
2001 Synthroid still not approved: FDA is penalizing companies that filed late for approval of Levothyroxine Sodium products by forcing reductions in distribution over the next 2 years.
Synthroid approved 2002
Among other things
"The US Food and Drug Administration (FDA) states that all approved levothyroxine sodium preparations should be considered therapeutically inequivalent unless equivalence has been established and noted in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)."
More about innovative drugs og generic drugs "In 1980, the FDA first published a list of approved drugs, consisting of innovator drugs approved through the NDA process and the generic products considered by the FDA to be therapeutically equivalent to these innovator products."
http://www.fda.gov/foi/warning_letters/g4190d.html (no longer exists, has been replaced by a new warning) an example of an FDA warning that one must apply for approval
PDF about the application process from the FDA
Letter to FDA from Finland about Armor Thyroid
About a patient who prefers Armor Thyroid over synthroid etc.
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