LDN discussion in Select Committee of parliament

Thanks for everyone’s advice and input about how to get LDN licensed. We are working with various bodies in the UK with helping us achieve this. I have to say I am surprised about the lack of knowledge here about LDN. LDN is not approved for those with mental health and substance abuse problems. You are talking about Naltrexone at 50mg doses and higher which blocks the opioid receptors for a 24 hour period. Completely different to Naltrexone in LOW DOSES (low dose naltrexone).

Naltrexone is not a new drug, it does not need to go through the whole process one needs to do when developing a new drug. It is already approved at 50mg, we want to get it approved and recognised at doses of 4.5mg and less for autoimmune diseases and cancers (not just MS)

LDN is already available on the NHS - some can get it, some can’t. Why is that? Answers to that will explain why we’re campaigning to get this drug more widely accepted and used on the NHS. This isn’t a ‘LDN is better than any treatment you could possibly be offered’ effort - but it’s a damn good biotherapy that at long last is finally being recognised as such.

I appreciate everyone sharing their views on the process involved, but right now can I ask everyone to stick to the request on this thread? Debates about LDN are fascinating and important to get people to understand how it works so they can make an informed choice as to whether or not they would like to try it as part of their treatment, but this thread was put up in the hopes we could get some support with notifying MPs about the inauguration of the LDN APPG taking place on 13th September.

In the next two weeks we are going to be extremely busy working with those who will be attending the APPG so if we could delay a discussion about LDN until after this meeting I’d be grateful.

Right now, we really need some help with getting MPs notified about the LDN APPG to encourage more participation.

Thank you - and big thanks to those on here who have already contacted Andrew and advised they have sent the email off to their MP and who their MP is - this is a HUGE help and one that is greatly appreciated.

Jayne

As lapreguiceira has already asked, who in this thread has mentioned anything about being against a trial of LDN? I suggest you re-read the replies David and apologise to the people you have just accused of being against helping sick people!

Please provide me with the names of drugs that are routinely prescribed for MSers in the UK that have never been tested for safety. You make this claim a lot, but have never provided specifics - I would be interested in knowing them. (I recommend the excellent www.drugs.com website which lists side effects as well as possible drug interactions for pretty much everything. It would also be worthwhile expanding your search to the NICE website where you may find a lack of drugs specified in the MS guidelines, but you will find many recommended in the guidelines for “neuropathic pain”, “spasticity”, etc - which of course, is what they are actually prescribed for.)

Incidentally, it is my understanding that GPs can prescribe anything that they believe will help their patient, irrespective of what that drug was originally approved for (I believe you posted about this just last year?). Most GPs do not trust LDN because it is not approved for anything. It is not approved because of a lack of trial data both against placebo and against a competitor. There is no such lack of data for meds “routinely prescribed” for people with MS. And herein, I believe, lies the reason for the call for a trial?

Sorry to be blunt, but this thread was about to go onto page 2 (otherwise known as oblivion) before Geoff posted about trials.

And I’m afraid there is no controlling a thread. They are like conversations - they go where they go. Anyone who’s interested in taking part can jump in with whatever points they want to make. And telling people to go back to the point is not generally welcomed by the participants - after all, none of us is “in charge.”

rizzo

Plotnikoff Murgo and Goode is a book, ‘Cytokines, Stress and Immunity’, which talks about chronic sickness.

Tysabri did kill people in trial due to PML caused by the JC virus and was declined by NICE for it at first till the issue was forced. I believe the number was 39 or 49 deaths. The risk is real but they have got better at treating PML.

I was offered mitoxantrone only for SPMS which cuses things like heart valve failure, liver damage and brain damage. I refused it so LDN for me was the only choice. I don’t know if it does much for me, but I have had no further relapses. Progresion is about existing nerve damage which for me was made too bad by the avonex reaction in the first place. Talk to a neuro if you want to know how that works.

LDN stimulates met enkephalin (OGF) and other endorphins which interact with the immune system and are known to regulate it. If you want to see the papers, google OGF, not LDN. You will find most of the papers I am talking about that way. I research things, so when i find LDN stimulates OGF and endorphins, I look for OGF and endorphins. I have well over a hundred published peer reviewed studies on the subject and enough to convince me that taking a safe OGF stimulant is a good idea. I do want the trials though to confirm my educated guesswork, as do all of us who use LDN, but there are a lot of us who do - more than use Tysabri by the way - and that alone is reason for trials. LDN is safe too unless you include the possibility it might not work as unsafe. However that possibility makes all MS drugs unsafe too so let’s not be too pedantic now.

I am not trying to convince everyone to take LDN or any other drug, but if I want to use LDN, there is no medical or clinical reason to deny it to me, so I should be able to get that prescription on the NHS. It is odd when my GP won’t do it on the NHS but will do it privately don’t you think - sounds like beer me to me. If they are worried about being sued or refferred tot he GMC for it, doing it privately wo’t get them off that hook so this is a hypocrisy.

Now you know why we took the political route, this is all about politics!

So, I ask again the original quest, please contact your MP and tell us at ldnnow when you have and who it is. We need as many MP’s as possible to turn up and then we can get all the ideas written into history. This is a big debate and in a time when the internet allows patients to find their way with their diseases, it is an important one. We want doctors to guide us, not just to control us, and that kind of defines the issue here, doesn’t it just! Some people wan doctors to control their therapy, I don’t need that so let’s get into the 21st century and start giving patients more powers to choose their options and influence what the options are, and do it formally. Nobody thought gay rights would ever succeed either! Patient power is coming, so this is our chance to ensure it doesnt turn into an insane free for all too.

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Sorry to be blunt, but this thread was about to go onto page 2 (otherwise known as oblivion) before Geoff posted about trials.

And I’m afraid there is no controlling a thread. They are like conversations - they go where they go. Anyone who’s interested in taking part can jump in with whatever points they want to make. And telling people to go back to the point is not generally welcomed by the participants - after all, none of us is “in charge.”

[/quote]

please don’t feel the need to apologize for being blunt - thanks for sharing.

Question - are you willing to help contact your MP to notify him/her about the LDN APPG inauguration?

When I contacted (well she’s my daughter) about the NICE attitude towards LDN, I made sure it was LDN and not Naltrexone that she was researching. I am aware of the difference and so is she.

I spent 3 years on LDN and I’m not taking it right now due to a non-MS related health problem.

The most important advice is about the QALY study. If you can show that the benefit and cost-effectiveness is so good that LDN should be offered routinely - (and I don’t understand why it isn’t for PPMS or SPMS) then you’ll have a chance.

Anecdotal evidence is no good. The evidence must come from a trial - or oddly, from a gamble trial. Patients are offered a choice - it’s purely hypothetical, but the researchers gain valuable information on patient’s attitude towards their drug.

I think LDN would have a good chance with a study like that (you’d have to ask a health economist what it is) as people enjoy their raised endorphins. I miss mine.

We are just trying to help. Honest!

LDN is a far better and more rational cause for patient power. It should have a trial for PPMS at the very least.

It is so important that evidence is presented professionally. This is the huge advantage over CCSVI issue, where the evidence is scant at them moment.

I still find this debate amazing. Here is a little group of people trying to use our democratic system to get a helpful cheap drug available now on the NHS but people who claim to want to help sick people disagree until an out of patent drug is tested to licencing standards.

Taking LDN or anything else will always be a personal choice all these people are trying to do is get this choice available to all now.

It is hardly as thought the current system has come up with that much anyway, a system that comes in for more criticism by the day anyway.

http://anh-europe.org/Big-Pharma-and-the-Watergate-moment?utm_source=The+Alliance+for+Natural+Health&utm_campaign=2a9cd88975-120829_ANH_Intl_eAlert_No_1128_29_2012&utm_medium=email

And yet, you still haven’t read the replies properly.

Just because some of us like to discuss and debate, doesn’t mean that there’s an anti-LDN movement here. There are people here who’ve gasped at your ridiculous claims for LDN over the years. You, yourself haven’t helped the LDN cause at all and have in fact turned people away through those ridiculous claims. No one else does this David. Only you.

This is a great step forward for people who want to take LDN. Jayne and Andrew have come up with an excellent case.

Read my daughter’s view on how to get past NICE. A QALY study will show how LDN could get through NICE approval easily. NICE don’t want to have to fund expensive drugs. Hence their disgraceful attitudes towards the DMDs in the late 1990s.

I find your views amazing. Here you go again, not reading replies properly and making daft assumptions that people are anti-LDN.

Geoff has shown how to get a trial. All people have to do is to find someone who is interested in taking on LDN as either a PhD clinical trial case or to get a QALY review from a health economist consultancy.

David - to me, that is either a clumsy attempt to get this thread back in page 1 or evidence that you cannot or will not read posts properly. So, once and for all: NO ONE IS AGAINST LDN BEING TRIALLED. NO ONE IS AGAINST THE PEOPLE WHO WANT TO GET LDN TRIALLED. LOTS OF US ARE AGAINST IRRESPONSIBLE CLAIMS, BAD SCIENCE AND POOR LOGIC. Clear enough?

This thread looked to be slipping into oblivion again, but it really is too important to have it just vanish (or get side-tracked into another rant about “big pharma”).

Jane and Andrew, you are both good at asking direct questions, so here are some for both of you:
What is your desired outcome from a Select Committee meeting?
Do you want a trial? Do you just want GPs to be freely able to prescribe LDN on the NHS (with the NHS picking up the tab)?

Reading this thread through, it does seem to me that the expression “Nailing jelly to a tree” applies. There are several pleas to “Get your MP to support the Select Committee”, but you do not actually specify to what end.

This is the precise reason that I suggested getting a Masters student to pick the idea up for a project. MSc courses tend to be “6 months taught, 6 month project”. Get in at the right time and you have results within a year. Usually, students have to fund their own project, so one that can be carried out for a low outlay would be particularly attractive. Given the number of Universities running Health Psychology courses, it should also be quite easy to put into practice. A few approaches to the relevant Course Directors would soon show that (or the reverse).

PhDs are a totally different proposition. They are funded differently. They are expensive. Universities do not want to see a PhD student fail (it does not do them any good in the next Research Review) and they can be quite hard on selection. I know, I have (in the past) been the person who has had to give an unsuitable person the “thumbs down”.

So, if your objective is to get a trial in this country that can provide scientific evidence that LDN does what you claim, then you need good evidence for the Select Committee – not the sort of numbers that Nia Griffith was throwing out in the “debate”. I had pointed out earlier that any trial would need some method of assessing the results. The survey approach that I suggested above could be one way of producing a “home-grown” measure. Such a measure could be correlated against the existing SF-36 measure (available free by the way from the Rand Corporation) which would also have the effect of validating the whole study. This could also form part of the evidence to the SC.

One point at issue is that of whether LDN should be treated as a new drug, or as a new use for an existing drug. Since chemicals tend to have differing effects at different concentrations, I am inclined toward the “new drug” position. That is why I support a proper trial. I think that the outcome would be favourable to LDN, but I would like to see some formal scientific proof. If anyone doubts the need for formal trials, I have just one word: Thalidomide.

As to the question:

I can only regard this as a deliberate attempt to side-track a serious thread: with contempt.

Geoff

The end to contacting your MP is to get them to join the debate in Hansard and turn up at the APPG meet on the 13th. This is to try and get trials funded and also see if we can get doctors told they can prescribe it without fear of being suued or reported if patients ask for it.

Lets keep to Occams razor here and those two objectives, but the meeting is scheduled and we want as many MP’s as possible to turn up and we can work out the details properly under the direction of a select committee. We need to change the existing systems for getting drugs approved to respond to patients demands when such demands are undeniable. Currently, there is no route for patients to get this - believe me, we have spent 4 years trying to work with NIHR, MHRA, NICE and academics but always drawn blanks. They always say there is not enough evidence to interest them, but thousands of patients are using LDN, so if healthcare has patients interests at heart, it is time to respond and do something. There are more people on LDN for MS than for any other single DMD. That is concerning if LDN is a placebo so it is time to answer the question! I use LDN and I want to know if I am wasting my ncome Support or worse, if I am missing a beter option.

Also, remember, 80% of us with MS take nothing. That says a lot about MS. I do think if it was about T cells attacking myelin as in EAE, there would be far greater damage! Many neuros actually think it is caused by damage to myelin caused by T cells attacking things like the EB virus in the CNS leading to leaky nerves, scar tissue and leaking glutamate shutting down oligodenrocytes from repairing the myelin. That model certainly fits the localised manifestation of MS lesions better than EAE. But EAE does give us a way of testing drugs to limit the immune system, regardless of the actual mechanism, it just gives us drugs fixated on one approach.

Anyhow, back to the debate, get your MP to the meeting, and lets get trials underway and get doctors comfortable to prescribe LDN if asked. 2 things, bot wanted by us who have this disease - and remember, LDN does not conflict with other therapies so why would anyone refuse it to us/

Hope that answers the questions.

Just wanted to say, thanks for keeping this thread going and I do believe that people here are trying to help. Geoff, I think it was you who said ‘this must not fail’ and with that people are going about it in their way they feel will help get us focussed on what they believe matters. So thank you.

Andrew already has permission for the SF-36 - got this back in 2009. Trying to get this implemented created a whole host of other challenges. Perhaps now the timing will be right to discuss this (thanks for the reminder). We hope the SC will see the benefits and value to all that’s been mentioned and as a result help with implementing them.

It’s not really about what we want but more to the point of what does it take? Above suggestions have credit and no doubt will be discussed.

Re a clinical trial:- Geoff one question - you have said a couple of times about the figures thrown around by Nia to be way out. In your mind, what do you think is a fair estimate for a trial? With all the people we have asked working in this field agreed that figure was a fair estimate for a drug like LDN so I really would love to compare this to your costing.

David Barnes, consultant neurologist at St George’s put in an application for a trial for LDN a few years ago, unfortunately it didn’t go anywhere, I believe he couldn’t get the funding. As mentioned in the debate last December, Simon Burns said:-

A clinical trial needs a sponsor. Sponsors have usually come from industry, the NHS or academia. The hon. Lady is seeking Government funding for a clinical trial to prove the efficacy and safety of LDN. I can tell her that funding is available and that university-based researchers can apply for it.

It’s good to know.

We need a minimum of 20 MPs to turn up and participate in this meeting - any less and there will be no APPG for LDN. Would appreciate people’s help of at least notifying their MP of the inauguration on 13th September and to let us know who their MP is.

Thanks!

Jayne

Correction:- Andrew has permission for the SF-54 (not SF-36).

Jayne

Cheers Jayne. By the way, I got permission to us SF-54 which is SF-36 plus 18 extra bits. Tried building a databse for it but it got the lead ballon treatment so gave up.

Actually, no, it doesn’t answer (all) the questions - I asked you several in my previous reply, as well as for a retraction of your incorrect statement about Tysabri, and you have not responded to these.

There are further questions arising from the above quote that I could add to these, if I was so inclined, but it strikes me that this thread has had more than enough air time and very few people are interested. I won’t be replying again.

However I will make one last comment: we all agree that a trial of LDN would be beneficial - why muddy the waters by introducing unnecessary and apparently less than robust information and then fail to address questions that probe the legitimacy of that information? If these questions cannot be answered, then it strikes me that the original information should not have been presented. In other words, it would be best to stick to asking for support to get a trial - and to leave the scientific speculation out of it.

this thread has had more than enough air time and very few people are interested

I would say from the responses we’ve had via email and on our website from this post on the MSS will prove you wrong! It also has the most replies so how could you possibly reach that conclusion??

I won’t be replying again.

Thank you.

However I will make one last comment:

Huh??

We are trying to stick to the topic and not get too scientific about everything, whilst at the same time be polite enough to answer questions - we didn’t bring them up - just merely asked people to contact their MP to notify them of the LDN APPG. So at long last, it’s good to see you come round to our way of thinking. Let’s just stick to that please

And again - the responses we’ve had from those who are contacting their MP - a big thank you!!

Jayne

Stick to the topic, but please do not get too scientific …

Oh, really. How can a trial of anything like LDN NOT be scientific? If the idea is to get a trial, why does Andrew introduce the concept of OGF? (Thinks to self, throw enough wild scientific sounding words around and baffle the lay person).

I see that my point about the bad information that was given to Nia Griffith has not been addressed:
£60 K per year for Copaxone. Who is she trying to kid? £16 K might be nearer the mark, so it sounds like info given down a bad phone line and not checked. We do have an answer for the £1000 per annum per patient, but this is totally unrealistic. Any University with a School of Pharmacy should be able to organise suitable strength LDN in liquid form for a tenth of that.

Costings for a formal trial would depend to a colossal extent on the design of the trial and who carried it out. Quick “back of an envelope” figuring, using several of the methods used for costings, would suggest an annual cost for a trial of:
£62,5 K, £230 K, and £600 K. A proper trial would need to run for at least two years

You do not start with the cost, you start with the design. Then you work out the number of people involved, then you can get at a cost. The usual routine is for a Research Council to invite bids for research projects (in this case, it would probably be the MRC). Interested Universities then bid, and the bid will be considered using a number of criteria. If successful, any neccessary staff are recruited and the project starts. You are looking at 3-4 years before any results emerge in a form that will support the cause of LDN.

If, on the other hand, you expected the APPG to tell the Government of the day to tell the NHS to tell all GPs that they can prescribe LDN as an NHS-funded medication, then all I can say is “Get Real”. Patients do not have much choice about their NHS medication (the DMDs being an exception), other than the “Take it or leave it” choice. If they buy LDN privately, it is because they made that choice. This whole affair (and thread) is starting to look like a promotional exercise for “LDN Now”, rather than a genuine attempt to get LDN available for a wider group of people with MS. If I am wrong, no doubt you will tell me.

Geoff

Tysabri - read this rizzo http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid=1905

Geoff. The point of talking about OGF by the way is simple. LDN is used to stimulate endorphins, in particular met-enkephalin (aka OGF) which is the prime mover in modulating the immune system and controlling cell proliferation in T and B cells and of course, tumours.

Geoff, you seem to have much to contribute to this debate, have you contacted your MP yet and contributed? Please do if not, the point of this process is to resolve all these issues and neither you nor we know all the answers, hence the select comittee. That is a get real deal! We like you so dont take offence, just please stop talking and do something to help.

RETRACTION: I made a statement that I would not reply again. This was true at the time of posting, but has (clearly) been revised because of new information…

…which made me angry.

So I am happy to continue this thread for as long as necessary now. After all, I’m all in favour of a trial of LDN, so I couldn’t care less if this thread stays on page 1 for the next 10 years.

Why am I replying? Two reasons. Firstly, somehow or other, I missed ABarnett’s reply to my earlier questions and I need to address his response. Secondly, JayneLC’s latest reply to me contains points that I would like to expand upon.

I will start with JayneLC’s latest post and reply separately to ABarnett otherwise this might get too long. (Please note that my second post may be delayed.)

“It also has the most replies so how could you possibly reach that conclusion??”

How did I reach the conclusion that not many people are interested? Perhaps because it does not have the most responses. Moreover, of the 36 replies (before I began writing this one), you and your colleague have made 15. Of the remaining 21, only 1 mentions contacting an MP. If we consider the number of people instead, 8 people have posted on this thread; 2 of whom are yourself and your colleague. Of the remaining 6, Campion has said she will contact her MP, Geoff has been advising on research methods, lapreguicera has provided some very useful information about the cost of LDN and the NICE approval process, Mikey has told us that he is trying to get LDN, David603 has accused us of not supporting sick people (?!) and I have asked some questions about the science that your colleague first introduced to the thread. QED.

“Thank you”

Now see, that’s the response that got me annoyed. You claim to want to generate interest in your cause and yet you want to see the back of people who ask difficult questions? Sorry to disillusion you, but until you can answer difficult questions (or at least try!), you will never achieve your aim. Research starts with a question. The response to this question has to be well considered and structured (as per some of the points that Geoff has made), otherwise it will be simply laughable. Much as I find the twisting of some of my words.

Or perhaps you want rid of people who ask difficult questions because it shows up the holes in your understanding and the cause itself?

“Huh??”

The word “reply” and “comment” have completely different meanings. This is obvious from both the context and the semantics of this forum. You seem to have a good grasp of English, therefore I can only assume that you said this for another purpose. Perhaps you would like to explain?

“We are trying to stick to the topic and not get too scientific about everything, whilst at the same time be polite enough to answer questions - we didn’t bring them up”

One thing your colleague has absolutely NOT done is to stick to the topic. It was he who first introduced OGF etc. I suggest you re-read this thread and acknowledge this.

You have also not answered all questions, but I will leave this to my next reply.

The word “polite” is not an adjective I would apply to the tone of your reply.

“So at long last, it’s good to see you come round to our way of thinking”

I stated in my first reply, and subsequently, that I am in favour of a trial of LDN. No “at long last” about that whatsoever. However, as far as coming “round to [y]our way of thinking” goes? Never.

I will respond to your earlier reply to my questions later (my apologies for not doing it sooner - somehow I missed it), but I can easily respond to this in the meantime.

I am fully aware of the stats concerning Tysabri and PML.

You wrote that “Tysabri killed a lot of people in the trial.” Not only is it PML that is sometimes fatal and not Tysabri, it is simply not true that lots of people died during Tysabri trials. Please see here (e.g.) for clarification: http://www.medicalnewstoday.com/releases/38881.php

If someone is going to make statements of an inflammatory nature, they should ensure the statements are true and, at the very least, retract them when they discover the error. To do otherwise may completely undermines the regard with which others view that individual and opens their mind to the possibility that perhaps a lot of what that individual says is unfounded, pure speculation or just plain wrong.

Incidentally, I gave an example of how to make a retraction in my previous post. It may be of help.