I’ve been reading the latest Harmony magazine and it says that Thyroid UK has had talks with the British T3 producer, Concordia International. To explain the price hike in their T3, Concordia explained to Thyroid UK that the MHRA, (Medicines and Healthcare products Regulatory Agency?) changed the standards in respect of the manufacture of the drug and it’s now difficult to produce. It goes on to say that the standards are very strict which may be why T3 is much cheaper in other parts of Europe.
Does anyone here have further information of the changes in the manufacture of liothyronine that MHRA have insisted upon?
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mfinn
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This was mentioned in The Mail article posted earlier. Actually I think that it is a load of nonesense - or any other word you choose to use. If that was the case then surely we would have been informed accordingly. So what are the changes in production ? Perhaps they are using gold dust .....
I agree Marz , I'd say they are getting their excuses in order should they need them for any investigation. I wonder...if the NHS succeed in withdrawing T3 from prescription, will CMA still consider investigation or will there be no need. And could this we why a lot of CCG's are already withdrawing T3...so they wont have anyone on T3 and therefore may not need to be involved with the consultations. or can just say they have no-one benefiting.
Like you I'm extremely sceptical and if it hadn't been in Lyn Mynott's magazine I would have rubbished it. I just wish there was more information given so if anyone's out there...
I don't think Goldshield found it awkward and they sold it very much cheaper. From what I have heard it was much better too. I think they must be using eyewash. They just seem like asset strippers to me.
Concordia have massive price hikes on lots of drugs, the ones where they have a monopoly. If they can stall for another five years they will pocket another £150m of NHS money on liothyronine alone.
You seem well informed 😊 So do you know what the changes in production are ? Would the MHRA be able to tell us what the changes in standards are all about ??
Funny so many if us are doing well on T3 from Turkey - Greece and elsewhere ....
No idea what changes in production are. I have set up a diary reminder to send an FOIA request to MHRA to try and find out. Maybe I'll get round to it tonight. Certainly UK liothyronine used to be imported from 'Europe', the manufacturers used this excuse a few years ago when there was a holdup in supplies.
Companies tend not to compete on price unless they have to. It's likely the new companies will be just a little cheaper and Concordia will be happy to sacrifice a small market share so they can claim there is genuine competition. If they try to compete Concordia can bring the price right down to a few pence and harm the new companies. The new companies are aware of this and will act accordingly. This is the way the 'market' works, in business you look at profit, a large profit margin with a small volume is the best choice for the new companies, now a premium price has been established.
This all assumes there is no link between the new companies and the investigation into Concordia's liothyronine pricing. I have seen nothing whatsoever to suggest this but we should always keep an open mind.
Certainly there were changes required for production of Levothyroxine and you can read the investigation and documents on the MHRA website. I don't know of anythiing similar for Liothyronine. LT4 was reclassified in the British Pharmacopeia and production methods must be much more tightly controlled for the new classification. I know of nothing similar for T3 but would be interested to hear more if Jimh111 finds out.
I wrote to the MHRA last year because my T3 seemed to lose potency when it was close to its 'use by' date. I also asked why these 'use by' dates are now very short, (about three months when I get it) whereas they used to be two years. I was told nothing had changed but then a month or so later the person I had been dealing with wrote to tell me that the use by dates were now to be extended to a year. Is this supposed to be an improvement? Is this the big change that is so difficult and expensive for them to deal with? In spite of this my T3 still arrives with a three month use by date,
I also complained to the MHRA about another batch number and was asked to send in the whole pot for testing. I refused, saying that Concordia had plenty to test themselves and should use their own, not expect my GP to pay. £258 so that Concordia can test it. No further investigation was made. The MHRA seems to work with the Pharma company, not the patient.
Concordia do not make liothyronine or levothyroxine tablets. This is done by Custom Pharmaceuticals. In 2015 Custom Pharmaceuticals' annual turnover was £16.3m. In 2015 NHS England spent £20.4m on liothyronine. Liothyronine is just one of many drugs Custom Pharmaceuticals make for a number of companies. Conclusion, Concordia are lying when they say the price is due to manufacturing difficulties.
That's interesting. What's going on then? It says in the magazine that Thyroid UK has had several talks with Concordia about the current situation and how they, TUK, can help patients. It also says TUK and Concordia are collaborating on specific patient-centric projects aimed at better understanding and leveraging the patient voice relating to the patient burden and unmet medical needs associated with treatment of hypothyroidism. (I understand plain English but I'm having problems with this).
Production changes? NOT. It is time the government did something about the generic loophole...when a drug goes generic there are no restrictions on charges. I am wondering if these people are responsible for the enormous increase in hydrocortisone? That is becoming prohibitive now.
Thanks for that. Very informative. Although I do wonder if these fines actually do any good. They will only put their prices up further to compensate. I would like to see a few CEO's behind bars. How can they sleep at night? Also, I understand it is extremely costly and difficult for smaller companies to get bidding rights. That should be looked at.
They sleep very well at night, their nests are very well feathered. I think the NHS should have their own pharmaceutical company so they have their own supply when the market price is not reasonable.
I agree. I could knock T3 up in my garage, not difficult to manufacture at all. However, what the government should do is approach an existing CONTRACT manufacturing pharma company and negotiate a deal, simples. That's part of what I used to do That way government pay a fair price without the complexity of owning/ paying facility/staff cost etc. Use up availability in existing pharma facility. Win win.
Long time ago now but I think we used to manufacture "compassionate product" These were pharmaceuticals that were off patent had no real financial input for the company but required by NHS patients. A fair price was negotiated as I remember.
I'll keep an eye on it and contribute if I can but I am trying to persue my own research and get it published, this is higher priority as I believe it will have more impact in the long term.
Try Billy Kenber, a Times journalist who actually exposed the Equity company who purchased Mercury Pharma. He also did a story on the human angle of T3.
T3 is so easy to manufacture you can do it in your home kitchen.
Watch YouTube if you don't believe me.
Interesting that the formulation still uses lactose which is banned in Europe, hence making it more difficult for imports from the EU as any new generic entering the market must be exactly the same as what is available already....or the pharma manufacturer needs to conduct additional testing making it cost prohibitive.....wonder why the lactose hasn't been changed yet to bring it in line with everywhere else....hmmmm
I agree with you, which is why I didn't put too much details down.
Advice should be to always discuss with your GP, but frustrating that we are being fed a load of bull about how it is difficult to manufacture.
It's been made in exactly the same way by a company down south for donkeys of years....there is no new more stringent requirements.
In fact if you dig deep you will find that there are many occasions when it is made out of specification and still approved by MHRA as the poor buggers have no choice but to approve it as nobody else makes it
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