LDN discussion in Select Committee of parliament

Everyday living
1

We have secured a select committee meeting in parliament on September 13th 2012.

Please send the text below to your MP so they can attend. The full transcipt of the debate and a video of the debate are available on the LDNNow.com website. This is a milestone in our pursuit for paient choice to use LDN as they wish and get trials underway, so please get involved now and when you have sent this to your MP, you can let us know and which MP on the website - thankyou in advance for your help.

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[your address]

Dear [name of MP]

Further to the Right Honourable Nia Griffith MP’s debate in the House of Commons with the Right Honourable Simon Burns MP on 8th December 2011, I am pleased to inform you that a LDN All Party Parliamentary Group is being set up to discuss how best to get a low cost effective drug available as front line treatment on the NHS.

As an avid supporter of this harmless therapy and a member of your constituency, I am sending you this email to let you know that the inauguration of this important cross party meeting will take place on:-

Thursday 13th September 2012 at Room 0, Portcullis House at 10.30am.

I would be grateful if you would put this date in your diary and lend your support to this invaluable campaign by attending this meeting.

Should you wish to read up on the debate from held on the 8th December 2011 you can find it here http://www.theyworkforyou.com/debates/?id=2011-12-08a.490.0

Thank you in advance,

[your name]

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2

It’s a pleasure to hear a measured promotion of LDN (“LDN will not guarantee a halt to relapses… I have progressed…”) on here rather than the outrageous claims that some individuals have been known to make (e.g. “LDN stops all relapses and all progress” :-o !!) and I wish you the best of luck in getting a long-overdue trial. I have to say upfront that multiple run ins with individuals like the person who said the above have left me with a very bad taste in my mouth about LDN, but I continue to tell newbies with SPMS and PPMS about it in the hope that it might do them some good, and at least do them no harm (although that has sadly not always been the case). I do, however, read any post about LDN with a cynical eye and am prone to pounce on points that I do not believe are wholly accurate or properly supported. To this end, here are the main ones from your posts on this thread…

I use Web of Knowledge. There is a distinct lack of literature relating to LDN and MS on there (24 items were returned from my search tonight) so I can only assume that you are referring to a wider selection of literature? I was unable to find a paper by Plotnikoff, Murgo and Goode, but did find one by Plotnikoff, Faith, Murgo, Herberman and Good that was published in 1997 - is this the paper you cited? It’s very interesting, but there seems to be a lack of data supporting the role of methionine enkephaIin in treating demyelination - have some empirical data been published on this since then? Also, the paper by Zagon et al is about mice. Are there any human data? (I was unable to find any.)

I am curious to understand what you mean by “effectively”. Do you mean a significant reduction in relapse rates? Do you mean a significant slowing of progression? Because, if you do, I think you will find that various DMDs do indeed provide these benefits, and more.

This is an alarming claim! What happened??

Could you please supply the data to support this? I cannot find anything about it in the literature.

This is simply not true! Please retract it.

Beta interferon has been shown to reduce progression in SPMS and is available on the NHS for eligible SPMSers. It is anticipated that current trials will show Tysabri and Gilenya to be even more effective. (Here’s hoping that they become available to all very soon!)

One last question, purely out of curiousity though - you say that you no longer relapse and that you are still progressing. Given that you are SPMS and that this is pretty much how SPMS is generally described, how can you tell that LDN is doing anything for you?

Again, good luck with getting the trial; I will be very interested in the results. Incidentally, I read with interest tonight that LDN may help Crohn’s - as my daughter has this, I am thankful that your post stimulated a bit of reading! (I’ll now be looking into how LDN might interact with her other conditions and meds, and if it is something she could try.)

Karen x

3

Thank you for posting this - l will certainly email my MP - and l will also get a copy sent to my GP. l have been taking ldn for nearly 5yrs - and it has made a big difference to my life. ln 30yrs of MS - l have been prescribed meds that have actually made my symptoms worse. LDN - really helps me - with no side-effects. l just wish l had known about it years ago.

F.

4

I just hope that the evidence presented to the select committee is a lot more accurate than the figures quoted by Nia Griffith in last year’s “debate”. It was quite obvious that she did not have the slightest idea of what it would cost to run a proper trial for LDN - and her cost for Copaxone was out by a factor of 4.

The whole point of the select committee meeting should be to get the funding for a formal trial of LDN.
The evidence presented needs to be as near 100% accurate as possible, so that the Department of Health are not in a position to weasel out of any commitment afterward.

A trial is needed. Every health service professional I have mentioned LDN to has said the same thing: where is the evidence? To their minds, no trial = no evidence = no way. As a (retired) scientist, the lack of formal evidence was the one single thing that stopped me going ahead and trying LDN for myself. Apart from money (and this will always be about the money) the biggest single problem is going to be that of finding (or constructing) a test instrument that will show exactly what benefits can be obtained from LDN. The EDSS is rather crude, both the FES people and the Fampyra people use walking speed ove a short course - which is not a lot of use to someone in a wheelchair, and most survey tools have to be validated themselves for any particular purpose. The big problem with any survey is coming up with the right questions, and that is (or can be) a major undertaking in itself - I know, I’ve done it, and for some quite big projects. Yes, there are some software tools that can help (e.g. The Cranfield Cognitive Toolset), but then you need access to quite a lot of existing LDN users to find out what benefits they get, and another big batch to test the proposed questionnaire.

A Select Committee is not going to sprinkle Magic Pixie Dust around and suddenly fix a trial - the decision will ultimately come down to evidence of costs and benefits, and that must be accurate.

Geoff

5

We intend to get the evidence presented as good as possible. The cost of a proper trial is very much up for assessment but we got an estimate together based on drug costs, analysis costs and cost of the doctors to process the patients in a trial with a contingency percentage on top. I also am a scientist and have a good understanding of the minefield of doing these things but luckily, LDN is very low cost - ie less than a pound a day so that part of the cost is low. However, it is wise to leave it to the experts to come up with a cost and go with that.
The central argument though is not about a trial at all. It is about patients being able to make their own choices when they want to use a ‘safe’ drug to tackle their condition. I chose LDN for my SPMS because the science of Opioid Growth Factor (which is stimulated by LDN) seems highly appropriate to controllng an errant immune system and reducing the population of chronically activated T and B cell populations. OGF puts the brakes on the proliferation of cells that carry the zeta receptor - hence it’s effectiveness with cancer too - and T and B cells carry this receptor. It is a direct effect into the nucleus and DNA to block proliferation (Zagon et al), which allows the apoptosos process to occur before the cells proliferate and thus reduce the chronic population of errant cells. Also, chronic diseases cause very weak immune responses due to imbalances of the cytokines (Plotnikoff, Murgo and Goode) and rebalancing this problem restores a normal immune response when you need it. So tackling chronic immune responses is a good thing and restoring normal endorphin/enkephalin levels is critical to immune system health.

Anyhow, I could waffle all day, having read hundreds of papers on the subject, but this debate is about 2 issues. Getting patients the right to request and get a safe option for their problems because in this age of the internet, we are often well informed if we can handle the science. Secondly, is getting the trials funded so doctors can have confidence to prescribe LDN without having to wait for a patient request if the trials prove good efficacy. I want to know if LDN is a good idea too, but I suspect it is based on what we do know about it’s immune suppressive capabilities already.

So please Geoff, contact your MP and add another name to our long list of MP’s and help us to make sure enough turn up on the day to get this issue sorted out. This is a genuine opportunity to make a real difference. Thankyou for your valuable comments, but lets get this thing dealt with properly now, there’s too much mythology around LDN, let’s end it now.

6

Let me get this straight, you are putting “patient choice” ahead of a proper trial, yes? You have patient choice - you chose to buy your medication privately. That is the same choice that a lot of people on this forum make when they get their vitamins over the 'net, or in the High Street.

In simple terms, what you are actually asking for is to get your preferred medication on the NHS. In the real world, however, without evidence, NICE will not approve anything - and where LDN is concerned THERE IS NO EVIDENCE.

To get that evidence, you need a trial (or maybe two or three). That is precisely why I put getting the funding for a trial as being the top priority for the select committee meeting. What would worry me, is the figures that Nia Griffith was throwing wildly around in the so-called debate last year being used again. Remember what she said:

The cost of a trial is probably considerably lower than the cost of a high-tech drug, because the drug itself is so cheap. Estimates suggest that a single trial can be done with some £7 million, but that is just an estimate based on £1,000 per patient a year for the monitoring specialists, plus up to £3,000 a year per patient for LDN. There would be the costs of recruiting 500 to 800 patients and then something to cover the analysis of the results.

When your own LDN costs you less than £400 per annum, why should the cost of LDN for a trial suddenly go up by 7 times? I would query the need for a large number of people for an initial trial (200 would be quite enough, but should these be people with RRMS or SPMS - that is a separate question), and the £1K per year to monitor each patient does seem excessive. To me, these have all the indications of numbers plucked out of thin air, and used without any attempt to get them accurate.

But, even before the costings for a trial, there is the cost of developing the measure for assessing the benefits obtained by LDN use. Get that right, and you do not need “Doctors” to process the patients. In fact, if there is not a valid assessment measure in place - or even a proposed measure - there is no point in having a trial at all. You would be right back to the anecdotal evidence - and that is not good enough for NICE.

Go back a year, and I suggested on this forum that a survey of existing LDN users could be used to gather enough evidence to ask for a trial. Properly handled, a survey could identify the benefits that LDN users believe that they obtain from it, and that could form the basis of a suitable test measure. I did suggest how it could be done for minimal cost (and even offered to provide suitable software). Needless to say, no-one took up the suggestion.

Would I ask my MP (who happens to be a GP as well, and a former combat medic) to waste his time listening to a rant about how the big drug companies will not fund a trial for poor little LDN - no way.

Would I ask him to support a properly organised trial - yes. But if the trial is not that important … well, what do you think?

Geoff

7

I am quite sure that the need for a trial will be the outcome of the LDN APPG. You are correct in saying that many Drs will not prescribe LDN without a large scale long term trial. Many Professors were contacted last year, all of whom support a clinical trial for LDN, but it is their opinion it needs to be at least 500 people, minimum 2 years.

Many people (and the LDN charity - LDN RT) have tried doing a survey of LDN users re the effectiveness of the drug, but have failed. People are reluctant to fill in surveys. There is also a LDN Database which collects people’s information but again, that is only as good as the information people add to it - and it is not updated. We were also informed that it would be far more effective for GPs to collect this information and work from there, than have ‘patients’ fill in a survey. I tend to agree with that. However, if you think surveying people in this forum would be effective, is this something you would be willing to help with?

You sound very experienced with this Geoff so your thoughts/opinions are most appreciated. You said:-

I did suggest how it could be done for minimal cost (and even offered to provide suitable software). Needless to say, no-one took up the suggestion.

Why was that do you think? Can you expand? I would be interested in knowing more.

Thank you.

Jayne

8

One other point Geoff. For those of us who buy LDN, we want continuity of supply and many of us, me included, live on income support so any cost to buy it for ourselves is too much! There is no medical reason to deny a drug that was proven to be safe and likely safer than paracetamol, and that can be prescribed too. The reasons we have difficulty getting it on the NHS have no medical basis in safety or cost, though efficacy needs proving. However, you sugtgest that patients should not be able to research and choose therapy if they find one - I disagree, some of us are intelligent enough to understand the risks and the theory, so if doctors can experiment on us, we can definitely experiment on ourselves - do you agree? When you live with a disease and study it, you often become more expert in managing it than your GP - even my neuro respects my opinion! So, if there is no medical reason to deny a drug, why do so?

We agree though, a proper trial is the best way to fix this issue that has been hanging around for over 30 years now, while over 100,000 people in this world choose to use LDN. We believe, more people use LDN for MS than any other drug! The failure to get a trial though has led many to take it for mythological reasons and that concerns me greatly, so it is time for the trials to get pushed forward. However, we have applied for the trials to NIHR, worked with MHRA and NICE and only ever been stopped by PR. We don’t believe that pharmaceutical companies are evil in this matter, but they would agree that LDN trials is no cost effective for them.

OGF by the way is expensive, but being a natural chemical, it cannot be patented, so we draw another blank there but OGF is the best option compared with LDN. Study OGF if you want to understad this therapy, Naltrerxone itself is just a way it’s production and we know that does work.

I have asked two questions in this comment, I hope you answer them both and not just cherry pick the ones you can answer.

9

Oh, also, the extra cost we factored in for LDN is based on what Martidales charge to prepare LDN as a special, they charge around ten times the the cost I get it for in the UK, but a standard costing applies.

10

I must clarify.

We are not trying to force GP’s to prescribe LDN, but we do want them to know they will not get sued or referred to the GMC if they do. However, we do need a prescription to get it. Currently, about 800 GP’s do prescribe LDN or so we are told, but it still remains a postcode lottery.

NICE are not interested in LDN because there is no cost issue ( ask them! we did).

Trials are always the only legitimate way to authorise a drug, thtat cannot be changed, so securing trials is critical - that or finding another way to do the study work to prove the clinhical case for LDN.

We need government to solve this because the existing systems have failed to do so and do not look like finding a way. If you think otherwise, please try. We have tried, but you are new to this work so you have a lot to learn about the LDN story.

Also, we do not advocate a free for all where patients choose anything. LDN is a biotherapy and is exceptional. We can send you a vast library of the science if you haven’t ever seen it so just PM me if you want us to do that.

Available drugs do not manage MS effectively. I know, I was part of the Avonex trial and it accelerated my disease until I stopped. Tysabri killed a lot of people in the trial! So we do want the freedom to find ways for ourselves, and when we find good ones like LDN, we need support. I can get supplements on the NHS so why not LDN?

11

Actually, the ‘real’ cost of LDN is about £35.00 per year. That’s what I pay, if I buy a packet of 50mg Naltrexone capsules in my local farmacia (chemists).

A lot of people are making a fortune on the back of this drug - in the US and the UK. In Spain, where I live, LDN doesn’t exist. You can only get Naltrexone and titrate the dose at home. It’s very easy.

“Available drugs do not manage MS effectively. I know, I was part of the Avonex trial and it accelerated my disease until I stopped. Tysabri killed a lot of people in the trial! So we do want the freedom to find ways for ourselves, and when we find good ones like LDN, we need support. I can get supplements on the NHS so why not LDN?”

I think you may find people who will disagree with this statement. For those who qualify, the available drugs are fine and many people on Tysabri, who are relapse-free and getting on with restoring their strength are very happy to take the risk.

I had a terrible relapse on LDN and lost months of mobility. LDN isn’t risk-free and people should know that they may suffer relapses if they have RRMS.

I keep reading conflicting advice though. The LDN Trust have good info as to why it’s fine to combine beta-interferon with LDN and yet, your website has a link to Skip’s Pharmacy where they warn people NEVER to take beta-interferon with LDN. So who’s correct?

What the LDN campaigners need to do first, is to simplify the message. Stop issuing conflicting advice and for heaven’s sake, stop shooting yourselves in the foot by making sweeping negative statements about the NICE approved drugs. Avonex may not have worked for you, but that doesn’t mean that Avonex doesn’t work.

There hasn’t even been a cost-effectiveness study for LDN. Perhaps you could think about starting with that? Health economics is growing as an industry. Get a consultancy to do a cost-effectiveness study and then go and campaign. Make sure that your info is up to date though. There’s no point in campaigning on old information.

12

Avonex does work, but if you have the wrong DNA, it is bad news. The trial found that.

Also, many people using Tysabri are very happy. The ones that died in the trial are not so happy. It stops T cells crosing the blood brain barrier which cn be a problem if you have other infections in the CNS, hence the PML cases and some deaths. If you want to use Tysabri, at least make sure you understand the risks! However, these high tech therapies are powerful, so their side effects are too.

I also think you are quoting the wrong website - we are LDNNow.com, not the research trust lot. A big part of our argument has been about the conflicting advice. The best advice is to make sure you read the science that is published and make your choices based on that, and don’t listen to all the opinions out there. We try to stick to what is published and let people know what is opinion, and this gets us a lot of criticisim because we disagree with many opinions. Skip is wrong, LDN is compatible with all the immuno supprerssant therapies, the only thing it is contraindicated with is opiates. However, I still use opiates but I wait for the LDN to clear my system first.

LDN will not guarantee a halt to relapses either. I use it to assist other therapies, not as a relacement for them. It is a biotherapy which can help other therapies work better because it stimulates OGF. Do read about OGF please, because LDN is not the thing that helps you. It just boosts the OGF. I have progressed though, but I have acquired no new relapses, so I am happy so far. I don’t know how to stop existing lesions from grinding me to a halt though, once the nerve damage is establised, it takes it’s own course. All the therapies are used for early stages, not for Seconday Progressive like mine, we have no effective therapies.

I have no sweeping negative statements abput NICE approved drugs, if you need them, please use them! Anything that puts the brakes on an errant immune response can help you with MS, so LDN is just another one of those. I don’t wish to advocate LDN either but I do want to make sure those that choose it have access to real information - see LDNScience . com. There is a lot of bad information about LDN and we have been trying to get it sorted out but trust me, it isn’t an easy task. People get very attached to their beliefs so it’s hard to contradict them. So you make the case for getting this issue sorted out very nicely, so please get on to your MP qand help us make this select committee debate do a good job. It is time to sort this lot out, surely.

13

[quote=JayneLC

You sound very experienced with this Geoff so your thoughts/opinions are most appreciated. You said:-
I did suggest how it could be done for minimal cost (and even offered to provide suitable software). Needless to say, no-one took up the suggestion.
Why was that do you think? Can you expand? I would be interested in knowing more.
[/quote]

I could guess as to why no-one was bothered about taking up my suggestion - but it would be just a guess. You could find this suggestion by doing a long search on the forum - but some of it pre-dates the new forum.

Every year, students doing a Masters in Health Psychology have come close to completion of the taught phase of their studies in the first couple of months of a new year
They now have to carry out a project.
So, approach a number of Universities who offer such a course and offer them a project.The student starts with a series of semi-structured interviews - the object being to determine the benefits that users of LDN believe they obtain from using it. This would need access to about 50-60 users
From this, a set of statements can be developed concerning LDN use.
The set of statements can be recast into statements of benefit (or otherwise) and used in a “card-sort” procedure to determine the rank order. This can be facilitated by using the Card-Sort Tool from the Cranfield Cognitive Toolset (CCT) on a Windows laptop. Yes, I have mentioned the CCT above. This would need about 100-200 users, divided between the different types of MS (but our student might decide to run a pilot survey first on about 60-70 users).
Assuming the refined set of statements is about 10-12 statements, the card-sort routine should take about 5 minutes per person (yes, about 12 per hour) and if those who say that “their branch” of the MSSociety has several users of LDN are correct then it should not be a major problem for the student to arrange for the set of interviews, and for the subsequent card-sort exercise.
The results are roughly analysed by the software - but there is sufficient raw data for a more thorough analysis by the student.

The result of this would be a formal description of the benefits believed to be obtained from LDN use.
That would inform the subsequent development of a formal tool to measure such benefits - and without such a tool, the value of a formal trial would be minimal. Tool development would make a good base for our interested student to base a PhD on, but of more immediate concern would be the potential for the Masters student to get either a publication, or a conference paper (or both) which is the sort of evidence that is needed.

The CCT was distributed as Freeware, and I can always run off another copy from my original disk. Oh, and as to my experience - I was the Research Director for my Department for three years. I would add that the students are usually looking for a project from about December on - so approaches to the Universities should start in about October. The project would probably start in about March/April.

Geoff

14

Just in the process of getting my hands on some LDN, none of my doctors will prescribe it for me neither will my neurologist. Avonex for me was like injecting myself with pure poison! Actually i never felt so bad, im sure this Avonex stuff is to blame

mikey

15

Geoff - thank you. Working with PhD students is something that has been thought of and is something that I believe one of the pharmacies is considering doing. With all our own attempts to get something like this off the ground, we were told they were all good ideas but wouldn’t get looked at unless an academic had made the proposals. There’s many with great ideas, applying them is not that simple.

However I appreciate you going into so much detail, this is helpful.

Jayne

16

I find this discussion quite amazing, here are some people trying to use our democratic system to get our publicly funded NHS to offer a drug many people find useful in the treatment of MS and other conditions more generally available. Why should anyone with a genuine interest in the sick be against that.

Our current ‘evidence based system’ has failed to come up with anything particularly effective, people with MS are routinely prescribed multiple off label drugs in combinations never tested on anyone for anything even for safety let alone effectiveness.

The licenced drugs are not even available to most people with MS in the UK so for most the ‘evidenced based system’ does not even offer any treatment at all.

http://summaries.cochrane.org/CD005278/treatment-of-multiple-sclerosis-ms-patients-at-a-very-early-stage-of-the-disease-with-recombinant-interferon-beta-ifn-beta-1a-and-ifn-beta-1b–or-glatiramer-acetate-ga-could-be-useful-in-preventing_irreversible-damage-in-the-central-nervous-system

They are not trying to stop anyone getting access to any other treatment.

Why is anyone against such an attempt to help sick people?

17

“Why is anyone against such an attempt to help sick people?”

Who, David? Try re-reading the replies. No one is against it - but it must be put in a trial.

18

[quote=ABarnett]

Avonex does work, but if you have the wrong DNA, it is bad news. The trial found that.

I’d have quoted more, but it would have been huge. Thanks for the very balanced and well thought out reply.

I’m going to post the view of a health economist - based on the NICE advice. I can’t get the links to work either, but maybe someone can. This is how it works and if any of this info helps you, then I’ll be very happy.

No, it’ll have to be in a separate reply - under this one.

19

[quote=ABarnett]

Avonex does work, but if you have the wrong DNA, it is bad news. The trial found that.

I’d have quoted more, but it would have been huge. Thanks for the very balanced and well thought out reply.

I’m going to post the view of a health economist - based on the NICE advice. I can’t get the links to work either, but maybe someone can. This is how it works and if any of this info helps you, then I’ll be very happy.

No, it’ll have to be in a separate reply - under this one.

20

I have a family member who is a health economist - here’s her view.

So, the NICE guidance website says that LDN is ‘not in remit’. Here’s the search results an here’s the guidance document. I can’t get it to load, I’m not sure if its because I’m not on an NHS network. Though there’s a lot of random links on the NICE website that are just not working tonight so probably that.

From what I can tell though LDN is only approved for use by people who have either mental health or substance abuse problems.

Basically how NICE works is someone develops a drug, gets it through the ‘not kill people’ stage so its licensed to be used on humans, but then they need to get it onto the NHS. To do that they need to prove cost-effectiveness to NICE in a certain way, which is cost per QALY gained and below a certain threshold, which is between £20,000 and £30,000 per patient, they keep moving it (don’t even get me started on the discounting). So the company who develop the drug has to prove that the drug gives increased quality of life in the form of QALYs or quality adjusted life years. These are generally generic measures of quality of life that can then be compared across different interventions. (Technically this is cost-utility analysis and no cost effectiveness but we’ll call it cost effectiveness anyway). Quality of life is assessed by instruments such as the EuroQol EQ-5D or the SF-36 and use those time trade off and standard gamble techniques I was telling you about earlier.

So the company ‘proves’ that the drug works and can provide the increased benefits for the price under the threshold and sends the report to NICE, who then use some nice freshly graduated health economists to pick it apart and see whether their numbers hold water. If they do, and NICE is happy that the drug provides more benefit than the competitor currently in the market (hence why the benefit measures need to be generic and comparable) the drug enters the NHS formulary. It can also be approved conditional on more research being done once its on the market (which was how beta interferon eventually got passed through, though the research ended up not being done), approved for use in research only (the polite way of rejecting the drug) or rejected.

So for LDN to get onto the NHS a company will need to want to market it and sell it to the NHS, prove that it works in a large, well designed, randomised controlled trial, cost it so it comes out at less that £20,000 per QALY and then have it all verified by the guys at NICE.

I checked google scholar and the last 2 years no one seems to be publishing much on LDN and MS and those that are are only doing so in journals such as ‘Acupuncture and Medicine’ and other complementary medicine publications. So as the push is away from complementary medicine (as is right as the NHS should NOT be funding unscientific bullshit such as that) I don’t think its going to go through.

(I think some patient advocate groups could theoretically campaign to get a complementary medicine like LDN onto the books but I think it would be unlikely, and without the pharma money pushing it I doubt it would happen. Also they would still need to prove cost-effectiveness.)