What is a ‘biologic’ drug?
A biologic is sometimes called a biological product, biosimilar, biologic agent, or biological agent. According to the FDA a drug designated as a biological product is: a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, . . . applicable to the prevention, treatment, or cure of a disease or condition in human beings.
But NDT is none of those things!
The FDA believes that NDT meets the definition of a biologic because it is derived from the thyroid glands of pigs and the thyroglobulin should be considered a protein or analogous to a protein.
What are the implications?
By 2029 in order to legally market and sell NDT each manufacturer will need to go through an approvals process known as Biologics License Applications (BLA).
What are the long term implications?
Biologics are complicated to produce and are usually far more expensive than other medications so the price of NDT will most likely be hiked up again!
You can read the whole article here …… palomahealth.com/learn/natu...
Edit - Applicable to those who import.
Hi Radd, So they are determined to get us off NDT one way or another it would seem - I can't help but feel a bit resentful after paying out for this product for almost 30 years and saving the NHS what surely must amount to thousands of pounds. ☹️😢
The FDA is American. In the UK drugs/medicines are regulated by the MRHA. So there is no worsening of the UK NHS policy on NDT - it remains as bonkers as ever.
Unfortunately the implications of the FDA regulations will, as RADD says, adversely affect folks who import NDT.
Thanks Lalatoot - I am thinking that I am going to be forced to switch at some time and not looking forward to that at all but it's becoming more worrying as time goes on☹️
Bear in mid that this is the US FDA (fda.gov/about-fda), nothing directly to do with the NHS
Yes I realise that Red Apple - the whole business of endos and thyroid meds has really got me down - hospital endo even said he would give me a 3 month trial on combo but only if I came off of my meds completely first to see what was happening. I think I've had more stress from seeing him and the private endo than I ever could have imagined - I've lost faith in them all as they don't even want to listen but just look at blood tests - same old story - aah!
I actually did this " coming off thing" for similar reasons as you. I when off I deteriorated rapidly, felt totally cold, aches, mentally . alhzimer-like . I was on about the equivalent of 90mcg thyroid when on NDT before going cold turkey .I'm now officially on 50mcg T4 and hoping for a titrating up to 100 when next dee doc in 2 weeks time . Cold turkey from Armour ndt was awful ,I went down from slightly below lowest range number to 40% below bottom of range .
This has totally put me off going back to T4/T3 now, but hope you are doing very much better @Tythrop.
I live in hope
FortunatelyTythrop I asked on this forum what they felt about the endo wanting me to come off all medication and the answer was "Is he trying to Kill You"? You have my deepest sympathy for going through such an experience and I do so hope you are now feeling a bit better now. Is it any wonder that we end up self-medicating in an attempt to get ourselves well - it's all so wrong!
Yep ,I felt like killing myself
Aah - so glad you didn't!
but getting NDT out of the nhs is akin to getting blood out of a stone
I know! My GP prescribed it for me many years ago, and then the CCG put a stop to it. But the blame for this Biologic rubbish is on the FDA, not the NHS or even the MHRA.
Oh dear what a blow that must have been Yes that’s true re this biologic nonsense
30 years! I've been importing for about 5 years but am actually in the throws of getting it on UK private prescription as cost seems to be similar now. As you say it is very unfair that we have to pay and I'm thinking a change to T4 + T3 might be necessary soon because of cost.
Yes Radd I think you are right in that I will have to make a switch at some point. I did actually have a zoom appt. with a private endo in London abut 18 months ago who was reputedly prescribing NDT but then changed his mind by the second zoom and insisted I went over to combo. A flaming waste of money if ever there was! Sorry I didn't mean I had been importing it for nearly 30 years but that I had been on it for that amount of time (I was under Dr S. until 2014 who prescribed it) - just wish he was still here now!
Hi radd , I am beginning to think the same. Although I am having a compounded NDT from Germany at present, for this last prescription (private) the company have changed the capsules and this is causing me problems that I really can't put up with long term. Cellulose can be made from different things, and whereas the original one they gave me was good for me, this latest one is not. I have written to them and told them what has happened, but they are not willing to change the capsule for me. So, very reluctantly I think I will have to go back to T4 and T3, together with cold feet and lack of sleep again! I had the same problem with Armour and Erfa. NP Thyroid was a different kettle of fish altogether.
Sorry to hear that ☹️
I buy my own empty capsules that I'm not allergic to. Then I pull their capsules apart and tip the contents into my capsule. It's a bit of a faff, but I do a batch when I'm watching TV. Perhaps you could do this?
I had thought of this, but they also add olive oil to the capsule. Which, as far as I can see, is not really needed and makes my hair quite greasy too. If only they wouldn't put in the olive oil.
This is what I'm attempting .See above.
@radd last resort i think selenium and zinc will convert t4 to t3, also although we have to be very careful of iodine, that also uncreases t3.