All NDT products status will be changed from natural to biological and as such will have to go through the same rigorous process as is expected of other biologic drugs. They must comply with this and be approved by 2029 to continue. In addition the FDA has given permission to individual state to ban products with out waiting till 2029. This mainly applies to the compounded forms of NDT.
Armour Thyroid have already made an application to go through the process of achieving biologic status. Bit it's a very expensive process so smaller produces may not. Most biologic drugs are infusions or injection so there is concern what this means for NDT producers. Biologic drugs are also extremely expensive so there could well be increased cost implications.
Easylover natural was and is a poor descriptor of NDT. NDT is not natural. It is processed. As well as being processed into tablets, it also contains fillers. For example, armour contains t4, t3, dextrose, microcrystalline cellulose, sodium starch glycolate and opadry white.Biologic or rather biological at least gives the idea that NDT hormones are of animal origin rather than synthetic equivalents.
The term Desiccated Thyroid Extract (DTE) is commonly used within medicine and science.
Just as bad as NDT - after all, if you just grind thyroid glands, you are not really extracting anything. (Some of the very early experiments tried to extract the active substance.)
It's not good news Laloot as it will further restrict and put prices up..... some of the smaller suppliers may go out of business because they can't afford the cost of registering under the rules of Biologics. In addition any state can ban them without any real warning here on in.
It's a specialist group of meds that uses things like live cultures etc.... It's a bit odd that NDT has been put into this group as it's the only one in tablet form...!!! The argument I believe is that it's made from pigs thyroids..... The FDA have been making life increasingly hard for manufacturers of NDT for a few years now. Do click on the link and watch the video with Mary Shoman on she explains it better than me. It seems to principally aimec at stopping the pharmacies producing their own compounded NDT. I've put the post up because it maybe that tough times ahead for users of NDT especially if they insist on NDT remaining in Biologic group as it requires a very long expensive process to be registered. Putting prices up further, reducing choice. Biologic meds are some of the most expensive drugs on the market.
There are some points which need to be raised to make this a more complete discussion.
First, ALL levothyroxine tablets were forced to submit new drug applications around twenty or so years ago.
They too had been grandfathered (a US term not applicable to the UK, by the way) but over many years, the manufacturers had repeatedly failed to ensure adequate quality. There were numerous recalls.
At least some firms used ‘overage’ - putting in too much of the active ingredient on the basis that by the time a patient took it, it would have dropped to an acceptable level. This was wrong because some patients got super-potent tablets - receiving them before their potency had dropped. And because not all companies did this, nor to the same degree, it guaranteed widespread lack of equivalence between products.
If you were producing the most potent tablets, then anyone switching from your product to any other will suffer a dose reduction. Sometimes ignorable but sometimes significant such that the patients will say the other make is ‘rubbish’ and demand to return to the most potent.
This whole process was bitterly resented by some pharmaceutical companies. But it happened. And the products have since had somewhat better equivalence - though still far from perfect.
All in all, I think patients gained. (Not being in the USA, I do not know what happened to the costs to individual patients.) They saw the worst products disappear or improve. And saw better and more formal equivalence. I think we have seen fewer recalls!
Second, there have been plenty of issues with desiccated thyroid products. Whether recalls due to contamination, questions over potency, and the removal of the short-lived Westminster product due to issues at the factory.
On top of which being grandfathered has meant that the products have been not entirely approved. They have been more or less tolerated. The FDA have acted when they have seen issues but have never actually set a standard to which the products must conform.
I am VERY concerned that these new standards are excessive. In many ways, the hygiene issues need be nothing special - no better than ordinary foods. (Unlike injectable products which are far more concerning.)
Potency is obviously important. Up till now, we have not seen specific testing for desiccated thyroid. Could there be some techniques which would better establish the actual potency with due regard to how it is absorbed?
And the other factors like how they disintegrate, storage conditions, etc., could probably do with standardisation.
The real problems seem to be:
Whether new standards will see companies leave the market. It would end up utterly futile if the new standards have no products to be applied to! And the fallout could see competitors such as Erfa, and even Thyroid S, re-assessing viability if their product cannot be readily imported even by USA individuals.
And the resulting cost to manufacturer/price to consumer.
It's not new standards Helvella as you describe it but standards that are way above other drugs in tablet form are required to comply. Biologic is a very tough group to get approval for. More tough than any other drug group. Though this is the USA. It will affect people who purchase NDT products made in the USA. As for variability in NDT. It's a bit unfair to say there were 'big problems' with potency. Levothyroxine had far more recalls!!
And in the UK the potency of NDT has to meet the same potency standard as other drugs and is allowed the same percentage leeway as other drugs. A UK pharmacist told me this. So it's incorrect to say they dont have to meet set standards - they do!!
I've no idea what you mean by how to measure this? They look at the active content of the NDT tablet just as they look at the active content of levothyroxine or Liothyronine or any drug to see if it matches what the nanufacturer have listed it as.
If you mean the efficacy in each person you could apply the same logic to the others. That's a very different ball gane... Lol
It was not uproar about the subject of the post that resulted in it being closed.
It was that so many replies went off topic and it became unmanageable.
If everyone sticks to the subject, this post will remain open. If members start dragging in everything that is wrong with pharma and government bodies (e.g. FDA), this one will also be closed.
Thank Radd. Yes I did miss it. Thankyou. 😊However it's now happened according to Mary Shoman.... That video is only a few days old. More to the point the FDA now say individual states can make their own minds up and don't have to wait until 2029 & can ban NDT products at any point here on in if they wish. This could have massive implication for the production of NDT products, namely Acella NP & Armour Thyroid. And definately for compounded NDT products that pharmacies produce which we can't access but if they go greater demand will be made on the branded ones.
It seems there is a determination to finally push NDT off the market in the USA.
I'm not sure it will impact those who have it prescribed in the UK unless NDT is shipped over. I guess we could switch to compounded but I looked at that previously and its more expensive.
Thanks Radd. I think it will affect us as the cost of the product to purchase will increase if coming from USA. Eg I'm on Armour Thyroid. Acella will increase in price though they have not yet applied to start the process of registration. They may not as a small company unless they are bought up by another bigger pharma. Erfa, Canadian but made in Spain won't. I guess companies may move countries is another option. However I get the feeling that the categorisation of drugs/, medicines is an international agreement. Or have I misunderstood? If that is the case there could be far reaching consequences?
I heard about this quite some tome ago. It made me wonder whether this may be why RLC eventually gave up trying to get their products back to the market when they were pulled from the shelves back in September 2020.
You could well be right. But RLC might be one of the reasons the FDA are acting.
I note that their website keeps getting minor changes - currently dated 2023. And only the other day they took down the prescribing information for Nature-Throid and WP Thyroid. (That is, the links which you would only know about if you had already got a link - you couldn't find them on the site.)
Having never taken any of their products, I have no personal experience.
With that taken into account, the issues seemed to arise or worsen when RLC switched away from their long-term supplier of Thyroid USP. (That company had supplied the Thyroid USP for Armour as well.) We got the impression that RLC were trying to manufacture their own which was probably too much to take on in the short timescale required.
Maybe if they had sought supplies elsewhere - e.g. established manufacturers Biofac or Bioiberica - they could have kept going?
I didn't notice any difference Radd to Armour Thyroid in strength. I did notice it with Erfa though and my bloods swung around.... why I stopped being on it as have been stable for years. That's a few years back so maybe it's consistancy has improved. It is NHS approved. Whereas Acella was removed from NHS list oprions. I felt great on Acella.... Lol.
I did too... But then it was stopped forcing me into a journey of alternatives. I've never really been sure what the problem was with WP and why it's production was halted.I do fine it interesting that I do well on Armour now. I strongly think it's because I'm GF for several years.... Have to be. And maybe my gut has healed so it coped better I don't know. After Acella that I also loved took me a good three plus months to adjust to Armour. But in the end my body did.... Intrigues me....
I agree, and I honestly think it takes us a good few years to regulate properly again after being hypothyroid for so many years.
If that's the case we can't gauge which meds suit best until we have found this place and as then we don't wish to keep switching meds, we kinda stay where we're comfortable. I never felt bad on T4 + T3, just better on NDT but maybe that was a natural progression. I especially enjoy not having to multi dose but would happily try synthetics again if necessary.
Spot on. And we are all different and as such different brands and combinations suit different people. This strong trend to streaming options to just a few is storing up problems. I see it in other areas too. We need diversity not the opposite.But this is all about business knocking the competition out..... Lol...
I was taking Naturethroid at the time and my ft4 tanked, had to increase the dose by 0.5 grain and then it was taken off the market anyway. So yeah my ft4 dropped quite a lot. Didn't have same issue with Armour and I've been on it on and off since 2015 (mainly due to the cost).
The story was as you say - but the impression given was not that they absolutely had to move immediately but were concerned about future access and pricing.
It is a shame they had not looked at ingredient sourcing long ago.
They may have realised they wouldn't be able to afford the extra rigor and therefore cost that would be involved.... Biologics are the most expensive group of meds on the market.
Ah yes, this will just push me finally onto that "more synthetic t3,less Armour " situation in my case. I think we are so tired of having things changed constantly with NDT - out of stock, price hikes, temporarily unavailability, RLC shutting down etc etc. I believe it is the thyroglobulin component that FDA wants to classify as biologic. I'd say Armour will be available, it's Allergan, but, at what cost? Here is to hoping that maybe some other company outside of jurisdiction of the FDA will produce some good NDT in the next few years...
Allergan owns them I think? Yes, they have, they have money and resources to do it, I wonder if they will have monopoly for NDT once this is completed then. I'd say yes.
They probably will be in the USA.... Lol. RLC are not coming back. And will be able to increase their price significantly. I suspect their market outside USA will slump unless other countries decide to do the same as the FDA and all NDT product have to go down the route of registering for biologic. All scary tbh. I never got on with levo/lio so it's very worrying.
Yeah RLC are gone, I was on Naturethroid when it all happened. I'd say try German Thyrovanz if you can. There is also Tru Thyroid, which I have never tried either.
T3 might be the way to go for me, I'm trying to reduce Armour and increase that.
Thanks. I get my NDT on the NHS. The only other option currently on their pharmacogy list is Erfa. I think I will just wait and see what happens....I've retired now so don't want the expense of buying privately if avoidable.
Yeah I understand, I get mine heavily subsidised, I pay 1/3 of the price, the rest is covered by health service. I wonder if Erfa will go under the same process? Of course, I prefer not to do it either
Erfa is a Canadian product so hopefully not.I've never heard of having to pay for part of a NHS prescription. That is very unusual. Why do you have to part pay for it?
I'm in Ireland, it's a Drug Payments Scheme, all medical expenses are capped at 80 euros a month. I get Armour and Thybon and other meds (antibiotics if necessary) for 80 euros. But that had to be approved by our NHS, which is called HSE.
No no, I only pay 80 euros a month for whatever meds I need, when they exceed 80 euros. So Armour is about 200 euros, then Thybon another 30, but I pay 80 euros capped.
That's something I guess. Still a lot buy yes a lot cheaper than paying for all of it. So they don't have any exceptions like in the UK if you are diagnosed with Hypothyroidism you don't have to pay a set contribution?
Sorry Radd. In England we don't have to pay for our NHS meds if we are diagnosed with Hypothyroidism or are over state pension age or if on benifits.Sorry for the confusion. Incognito lives in Ireland.... Different system. No contribution scheme but if you don't qualify for the above the pharmacy you a set fee per item. Not sure what that is these days.
I never attempted seeing public endo, the waiting time was 2 years so I abandoned this idea for now 😀 some endos in Ireland add t3 to Levo, but most private doctors like using Armour in Ireland for some reason. In fact, my GP put me on Armour in 2015 as Levo didn't nothing for me.
They are calling it biologics because It’s made from pigs and most if not all insurance companies probably will follow the biologics protocols (try every thing else first) before AT is considered…. Such a crock of bull.
Interestingly, the use of NDT has grown 10% in the last few years in the USA. Could the potential loss of income from other drugs have triggered this?
When you consider that cannabis is legal now in a number of states in the USA, and this is certainly biological, are they just targetting us with wonky thyroids again?
I think it's about commercial business knocking the competition out for sure but why the FDA have made this decision I really don't know why. It's odd.
Maybe FDA are holding hands with AbbVie or Allergan? Otherwise I have no clue, but this will be the first time they have them under their jurisdiction. If this improves NDT in any way - amazing! But this may have some cost implication, but then I'm not an expert on how to manufacture a biologic drug.
From the classification point of view, yes, protein, in this case from an animal is biologic, but does thyroglobulin helps with modulating the immune system? Nah. So is this going to be a new type of a biologic drug? Because Armour certainly is not a stem cell therapy!
Ah I remember the good times when Armour was 40 euros a month and Naturethroid was 30.
I think you will find the cost will rise expedentially especially if the competition has been knocked out.I feel the best hope maybe buying elsewhere and hopefully other countries won't follow what the FDA has done/is doing. Lol...
Yes, for sure, there is a German NDT and some other ones. I am trying to be 6-9 months ahead in supply, but that's still nothing.T3 might be the way to go for me, Armour on its own doesn't suit me unfortunately 😕
I don't think they lose out if people swap between the two. In fact, they appear more likely to lose out if people have to switch from Armour to levothyroxine (which might not be Synthroid) and/or liothyronine.
Arggh sorry Helvella you are right on Google it says Nov 22 above the link I posted.... And that says as you said May 2020!It's no wonder confusion abounds!! 🙄🤔🤣
I am well aware we are all perplexed by the FDA decision re biologics.
And I agree - in that it is difficult to understand why there is any more risk than with any other animal products with one major exception. Few animal products are consumed without being cooked or cured in some way.
Whether the processing of desiccated thyroid constitutes "curing", I really don't know. Or whether some changes to the process could achieve that?
But the use of animal products in medicine has been a major issue. Albeit, in the specific case I refer to the source is human blood rather than animal - the risks are broadly similar. But exacerbated with respect to animals due to the possibility of unrecognised zoonotic diseases.
Man who sold HIV infected blood products admits to inquiry he knew they were dangerous
7 Nov
This week the Infected Blood Inquiry heard evidence from former Armour UK (part of Revlon Healthcare) manager Christopher Bishop. Throughout the 1970s and 1980s, Armour manufactured a blood product called Factorate. It was infected with Hepatitis C and HIV.
People with the bleeding disorder haemophilia used Factorate and in the UK at least 1,500 people have died after receiving infected blood products.
Bishop admitted today that by 1981 he and his colleagues were aware of the hepatitis risk, that non-A non-B Hepatitis could lead to severe chronic liver damage and that it could occur in up to 50% of patients. He was also aware that plasma used to make Armour's Factorate product was taken from paid donors in the United States.
Despite the dangers and risky sources, if clinicians raised concerns about Hepatitis, Bishop said his sales team would reassure them about the safety of Factorate.
Lots more about the issue on that site - but the selected quote is interesting because of its specific mention of Armour. Though do note that in 1985 Armour Thyroid was taken over by Rorer (later known as Rhône-Poulenc Rorer) and then by Forest in 1991.
They knowing sold that product so I see where you are coming from.Interesting.... I don't actually know the actual process of what happens to the pigs thyroids to produce the dessicated thyroid extract. Be interesting to know.
However dessicated thyroid extract production involves freeze drying. Wouldn't that kill off any 'live' factor and contamination?Given I've been taking it for years I'd like to know am not putting myself at risk... Lol..
Oh gosh. I'd never really thought about it before. I tried to find out more about the process but Internet searches are more limited these days.... Saw one but couldn't read much of it because it said I was in the UK and wouldn't let me open it.I'll take heart that I've had NDT Daily for over 15yrs not caught anything yet....
Hi Helvela. I'm in the U.S and have been buying thyroid s for 3 yrs now. Last purchase was in May. Never had no problems receiving it. Do you think there will be a problem in the future when ordering?
thankyou for all you do. I follow your blog also on the latest thyroid s potencies on all the batches coming out. I find it to be a big help when starting a new batch. Thanks again !
Wow, pretty serious, thanks helvella. If all true, then it is worrying that the quality and processing is not good. My labwork on Naturethroid got worse at the time and I was wondering why it wasn't working well..it is unacceptable that this happens when we jump through hoops constantly and try to get stable.
Honestly it's a disgrace and so depressing. I dont get on anywhere near as well with levo and Liothyronine. Am not sure what I will do if NDT goes belly up.What I do know is that the NHS still supply Armour and Erfa. My pharmacist said because they are consistant and don't breach the percentage allowance of 5% for active ingredients. He told me they pulled Acella because it breached the strength by a lot more than 5%..
I meant above that range Helvella. And yes I agree totally not acceptible. Sorry I'm not very scientific. And of course if that happens it makes it much harder for patients to control their thyroid hormone levelsThankyou for all the info. Is this why they also want to stop the compounding pharmacies making their own versions of NDT?
We all come with our own backgrounds to these questions.
If the FDA really does have patient well-being at the top of its agenda, then it might indeed be seen as a good thing for them to stop compounding pharmacies producing poor quality medicines.
But that leaves open the question of what patients who have been dependent on them are supposed to do? Especially if they become unaffordable.
In years past, I've seen people claim that their compounded "Armour" was actually made using ordinary synthetic levothyroxine and liothyronine and some sort of bulking agent! The USA compounding industry has had some serious scandals.
How terrible Helvella. Such practises have to be squashed totally agree. What worries me if instead of helping the industry to improve NDT products if needed, it's used as a mechanism to get rid. We will the end up with a black market with something completely unregulated and the consequences that go with that.
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