DR MYHILL PUBLISHES NEW BOOK

[fibrodude84]

When will the 3rd reprint be available and what will be different?

 

[lauluce]

great! I strongly support Dr. Myhill's theory

 

[Research 1st]

Unfortunately the NHS don't accept the test Dr Myhill uses. (Mitochondrial assay). I would therefore advise people going down the investigatory route to 'prove' her theory as you will likely meet closed doors thoroughly welded shut.

We appear as patients, to be stuck in a strange time continuum, where a nothing ever changes politically, even if science based knowledge increases exponentially.

This means no matter how many books Dr Myhill writes, the general consensus is she is 'wrong' and on the 'fringe' of GP knowledge over ME and CFS.

Perhaps as patients, all we can do is read what 'ME friendly' doctors have to say and increase our own knowledge. Maybe from this we can be as well as possible whilst the professional opinion, is we don't need to go to such lengths?

It's such a sad situation but it's good to see at least a few doctors in the UK are not being hypnotized by the lure of psychobehavioural theories of CFS explaining chronic neuroimmune illness.

 

[lauluce]

Unfortunately the NHS don't accept the test Dr Myhill uses. (Mitochondrial assay). I would therefore advise people going down the investigatory route to 'prove' her theory as you will likely meet closed doors thoroughly welded shut.

We appear as patients, to be stuck in a strange time continuum, where a nothing ever changes politically, even if science based knowledge increases exponentially.

This means no matter how many books Dr Myhill writes, the general consensus is she is 'wrong' and on the 'fringe' of GP knowledge over ME and CFS.

Perhaps as patients, all we can do is read what 'ME friendly' doctors have to say and increase our own knowledge. Maybe from this we can be as well as possible whilst the professional opinion, is we don't need to go to such lengths?

It's such a sad situation but it's good to see at least a few doctors in the UK are not being hypnotized by the lure of psychobehavioural theories of CFS explaining chronic neuroimmune illness.

It's certainly ridiculous that they can't accept a theory for which exists verifiable evidence without even bothering to explain why they reject it! or do they give any explanation of why they reject so many theories based on scientific method? I always asked myself that... is it just that they don't care about hiding that all that matters to them is to benefit the psychologists that bribe them? perhaps you can enlighten me on this, Research 1st, can you?

 

[Jonathan Edwards]

It's certainly ridiculous that they can't accept a theory for which exists verifiable evidence without even bothering to explain why they reject it! or do they give any explanation of why they reject so many theories based on scientific method? I always asked myself that... is it just that they don't care about hiding that all that matters to them is to benefit the psychologists that bribe them? perhaps you can enlighten me on this, Research 1st, can you?

I think it is good not to jump to conclusions about people's motives without a little careful thought, lauluce. My only motive here is that I find ME a worthwhile problem to try to understand in my retirement. I have no time for 'cognitive' approaches. I am helping to set up an immunological study but it does not matter to me personally whether or not it gives a positive or negative answer. I am just hoping we can find something reliably effective for patients' sake.

And I do not see any substantive science in relation to Dr Myhill's work. I am not sure that I can even work out what the theory is. She has written three papers, two of which are described as 'audits', which means that there was no prospective experimental planning and the findings can only be taken as decriptive. The third paper deals with a series of tests on neutrophil respiration and I find it very hard to work out what it means. I would not be surprised if neutrophils behaved differently in PWME simply because neutrophil traffic is likely to be dependent on exercise.

So I see nothing ridiculous in not accepting this theory, if there is one, - we do not even have independent researcher verification, which is the gold standard of all science. No sensible scientist is going to take this seriously at this stage.

 

[Sasha]

She has written three papers, two of which are described as 'audits', which means that there was no prospective experimental planning and the findings can only be taken as decriptive.

I haven't followed this thread and don't have an opinion either way about Dr Myhill's theory but I think this raises an issue that we've discussed on another thread - that of clinicians doing audits of their therapies when RCTs aren't possible for them (whether because it's outside their expertise or because patients want treatment and aren't willing to be randomised).

I agree that retrospective audits have their weaknesses but I think that if we reject clinical audits wholesale we might miss some potentially useful therapies. We're all waiting for a spectacular drug, such as rituximab has the promise to be (at least for some of us) but in the meantime, relatively low-risk, inexpensive, over-the-counter treatments with even slight-to-moderate effects would be great and could mean the difference for some people between been bedbound and being able to have some basic quality of life. Those treatments with slight-to-moderate effects are the sort that need an audit to catch them (rather than being so obvious, like rituximab, that you can go almost straight to an RCT).

I'd like to see a sort of template for our clinicians about how to do a prospective study whose results would be taken seriously. Standard diagnostic inclusion criteria, preplanned stopping points, outcome measures including actimeter data, that sort of thing.

Maybe there could be a session at the next ME conference? With experienced researchers leading the way?

 

[Jonathan Edwards]

... this raises an issue that we've discussed on another thread - that of clinicians doing audits of their therapies when RCTs aren't possible for them (whether because it's outside their expertise or because patients want treatment and aren't willing to be randomised).

But what business do clinicians have handing out treatments that have not been through reliable trials, Sasha? Trials are never outside clinicians' expertise since trial design is a standard part of all medical training. Perhaps patients would be readier to be randomised if the clinician was honest and said they had no idea if the treatment worked yet! This handing out of untested treatments in ME is something that does not occur in other specialities.

I agree that retrospective audits have their weaknesses but I think that if we reject clinical audits wholesale we might miss some potentially useful therapies. ...in the meantime, relatively low-risk, inexpensive, over-the-counter treatments with even slight-to-moderate effects would be great. Those treatments with slight-to-moderate effects are the sort that need an audit to catch them (rather than being so obvious, like rituximab, that you can go almost straight to an RCT).

I agree that audits can be useful when you seem to see a pattern, perhaps of remission, in a context that you had not thought about in advance and wanted to firm up that there really was a pattern. But when you first use a therapy there is no reason to do an 'audit' rather than a prospective trial. It is just laziness. And you've got it back to front about major and moderate effects. It is the drugs that have mild to moderate effects that need RCTs - like aspirin to prevent stroke for instance. Audits tell you nothing. When drugs obviously work the stringency you need is much less.

I'd like to see a sort of template for our clinicians about how to do a prospective study whose results would be taken seriously. Standard diagnostic inclusion criteria, preplanned stopping points, outcome measures including actimeter data, that sort of thing.

The general principles are taught to all medical students and registrars. They should know. But there are no hard and fast rules for any particular trial design. There are all sorts of ways of doing trials as long as the structure satisfies the basic common sense principles to do with blinding when needed, controls of one sort or another, outcome measures suited to the particular question.

 

[Sasha]

But what business do clinicians have handing out treatments that have not been through reliable trials, Sasha?

In ME, we're in the situation that virtually no RCTs have been done due to lack of funding. In that situation, I think it's right that clinicians should try therapies out as long as they're honest with the patient, are basing their interventions on a reasonable rationale, and are using interventions known to be reasonably safe. The alternative is to give no treatment at all, and for such a severely and chronically ill set of patients, I don't think that's right.

For example, would you really not try B12 for a patient who had been bedbound for 30 years if you thought you had a good theoretical rationale, even in the absence of an RCT?

Trials are never outside clinicians' expertise since trial design is a standard part of all medical training.

That ought to be the case but I think you've only got to look at surveys of the quality of published clinical trials to see that good trial design seems to be well outside many researchers' expertise, let alone that of clinicians. You've criticised (at least some of) the quality of the non-RCT work done in ME research and I think you're right to do so, but I think the level of that work shows how far off many clinicians would be from doing high-quality studies, whether they're RCTs or prospective audits. I don't think that's a problem restricted to ME researchers or clinicians, either.

Perhaps patients would be readier to be randomised if the clinician was honest and said they had no idea if the treatment worked yet!

I think that the clinicians honestly think that the treatments work and are basing that on their clinical experience. That doesn't mean that they're right, of course - one can deceive oneself or be mistaken in various ways.

This handing out of untested treatments in ME is something that does not occur in other specialities.

I think that reflects the fact that just about any other major disease has had ten or a hundred times as much research done on it as we have and that there therefore exists an RCT literature that they can draw on. We've got a chicken-and-egg problem. We've got to get to RCTs somehow and I think that prospective audits, well conducted, could be such a route.

I agree that audits can be useful when you seem to see a pattern, perhaps of remission, in a context that you had not thought about in advance and wanted to firm up that there really was a pattern. But when you first use a therapy there is no reason to do an 'audit' rather than a prospective trial. It is just laziness.

I'm not sure if it's laziness or a cultural difference between doctors who see themselves purely as clinicians and those who consider themselves confident enough to also act as researchers.

And you've got it back to front about major and moderate effects. It is the drugs that have mild to moderate effects that need RCTs - like aspirin to prevent stroke for instance. Audits tell you nothing. When drugs obviously work the stringency you need is much less.

I think we're actually in agreement. The mild/moderate interventions need trials - but I think that those are the ones that it would take an audit to spot, because of their relatively low effect size. However, with something like rituximab, the effect size seems to be so big that it showed up spectacularly in a couple of patients being treated for cancer and the size of that effect enabled it to be recognised from just those two patients (and so didn't need a stringent audit) and that's what got it to trial so quickly.

The general principles are taught to all medical students and registrars. They should know. But there are no hard and fast rules for any particular trial design. There are all sorts of ways of doing trials as long as the structure satisfies the basic common sense principles to do with blinding when needed, controls of one sort or another, outcome measures suited to the particular question.

I think you're perhaps overestimating the ability of clinicians to tackle an RCT maybe ten or twenty years after they graduated. And I think that with ME, we've suffered over the years from researchers doing studies on differently-defined populations (different diagnostic criteria) and very dodgy outcome measures such as the self-reported fatigue used so controversially in the PACE trial (but not uncommon in the rest of the literature) rather than objective measures such as those using actimeters. We need efficient research, and that means being able to accurately compare effect sizes on standard, meaningful measures and on the same patient populations (which could nevertheless be tailored if necessary). I think we're a very long way from that.

I suspect we're not all that far apart on some of this. And as always, I appreciate your engaging in the debate!

Hope I haven't hijacked this thread, but I suspect I have.

 

[user9876]

I agree that audits can be useful when you seem to see a pattern, perhaps of remission, in a context that you had not thought about in advance and wanted to firm up that there really was a pattern. But when you first use a therapy there is no reason to do an 'audit' rather than a prospective trial. It is just laziness. And you've got it back to front about major and moderate effects. It is the drugs that have mild to moderate effects that need RCTs - like aspirin to prevent stroke for instance. Audits tell you nothing. When drugs obviously work the stringency you need is much less.

I assume audits are a good way of looking for side effects that may not show up in small trials?

 

[ISAS]

I am not sure when the third re-print will be available. I will post details here. Hope that is okay?

There are no big differences, just typos etc.

Many thanks for your support.

IS

 

[liverock]

But what business do clinicians have handing out treatments that have not been through reliable trials, Sasha?

I think first and foremost Dr Myhill is just a doctor who has conducted some research with limited type trials and found them effective in some of her patients. Whether this can be classified as dangerous is a mute point I think.

However, I dont think the medical profession are in a position to say they only hand out drugs after 'gold standard' research and FDA trials which I think is what you may be implying

The Medical profession(at least in the US),appears to hand out quite strong drugs with limited scientific evidence in 'off label' usage. Whilst it appears the FDA does appear to provide some approval for off label usage this appears to be largely based on 'in the field experience' by doctors and pharma companies.

An Archives of Internal Medicine report on off label usage showed that 21% of the most common drugs prescribed where for off label usage and 73% of those had little or no scientific evidence. Of those 73% doctors probably found out they helped their patients by trial and error.
All this seems to me to make Dr Myhill's limited research acceptable, with the no doubt limited funds at her disposal and the fact that she uses GRAS nutrients in her treatments.

Only time will tell how much it contributes to the answer we are all looking for however.

http://news.stanford.edu/news/2008/april9/med-offlabel-040908.html

.

 

[Jonathan Edwards]

I think first and foremost Dr Myhill is just a doctor who has conducted some research with limited type trials and found them effective in some of her patients. Whether this can be classified as dangerous is a mute point I think.

The problem is that she cannot possibly know whether they work or not. Demonstrating drug efficacy against background of both patient and doctor expectations is pretty much impossible except for dramatic effects. Doctors have traditionally assumed that they can judge whether their treatments work but we now know that people will go on giving and receiving completely ineffective treatments for centuries. Samuel Hahnemann wrote a pharmacopeia for treatments for almost all known diseases in around 1800 and people are still using them today despite them having nothing in them. He cannot possibly have known whether they were effective anyway. It would have taken him a lifetime to get minimal evidence on all those empty tablets in all those diseases.

We start with the problem that doctors have been hopelessly overoptimistic about their ability to discover effective treatments. These doctors could be considered 'well-meaning' in the past but now we know the reality I don't think 'well-meaing' will do any more. And many of them are taking in large amounts of cash from people they are treating. I do not consider selling unproven services to people at high cost 'well-meaning'.

However, I dont think the medical profession are in a position to say they only hand out drugs after 'gold standard' research and FDA trials which I think is what you may be implying

The Medical profession(at least in the US),appears to hand out quite strong drugs with limited scientific evidence in 'off label' usage.

I think there is a major difference between medical services in the US and the UK . The great majority of medical care in the UK is NHS based and in recent times open label treatment has died down to a minimum. In the US where commercial interest dominates care policy I suspect things have not changed so much.

There are specific situations where off label treatment makes sense. For rare conditions such as dermatomyositis it may not be possible to gather enough patients to do a trial. When such conditions are life threatening it obviously makes sense to treat off label. Intravenous immunoglobulin has been used in a wide range of rare conditions as a last resort and still is. But ME is a common condition. Clinicians see hundreds of patients a year. And doing controlled trials of pills is not expensive. It might mean you are busy at the weekend transferring data from clinic notes to your trial folders and doing some statistics but it would be perfectly possible for a private practitioner to do this at more or less no cost. If you cannot get dummy pills you can compare two treatments - which is a perfectly valid way, although less powerful. I honestly do not think there is an excuse here. I have been through all this myself and done the copying at the weekend. For the first rituximab trial I bought the drug with my bank account - and it wasn't cheap!

 

[jimells]

ISAS wrote:

...the link with allergies, microorganisms and aspects of the Western lifestyle.

Whenever I see the word "lifestyle" I have the urge to retch. I think it's related to an old TV program called "Lifestyles of the Rich and Famous".

I remember reading her website a few years ago and thinking, "Where's the Beef?" (Sorry, that's a reference to a Burgerking TV ad campaign from many years ago.)

Like most folks here, I've tried any number of supplements, treatments, diets, etc. Whenever there's a slight improvement I wonder if it was a treatment or perhaps I would have improved anyway.

 

[lauluce]

I think it is good not to jump to conclusions about people's motives without a little careful thought, lauluce. My only motive here is that I find ME a worthwhile problem to try to understand in my retirement. I have no time for 'cognitive' approaches. I am helping to set up an immunological study but it does not matter to me personally whether or not it gives a positive or negative answer. I am just hoping we can find something reliably effective for patients' sake.

And I do not see any substantive science in relation to Dr Myhill's work. I am not sure that I can even work out what the theory is. She has written three papers, two of which are described as 'audits', which means that there was no prospective experimental planning and the findings can only be taken as decriptive. The third paper deals with a series of tests on neutrophil respiration and I find it very hard to work out what it means. I would not be surprised if neutrophils behaved differently in PWME simply because neutrophil traffic is likely to be dependent on exercise.

So I see nothing ridiculous in not accepting this theory, if there is one, - we do not even have independent researcher verification, which is the gold standard of all science. No sensible scientist is going to take this seriously at this stage.

thank you for your explanation Jonathan, It was very useful...

 

[Sirshocking]

The problem is that she cannot possibly know whether they work or not. Demonstrating drug efficacy against background of both patient and doctor expectations is pretty much impossible except for dramatic effects. Doctors have traditionally assumed that they can judge whether their treatments work but we now know that people will go on giving and receiving completely ineffective treatments for centuries. Samuel Hahnemann wrote a pharmacopeia for treatments for almost all known diseases in around 1800 and people are still using them today despite them having nothing in them. He cannot possibly have known whether they were effective anyway. It would have taken him a lifetime to get minimal evidence on all those empty tablets in all those diseases.

We start with the problem that doctors have been hopelessly overoptimistic about their ability to discover effective treatments. These doctors could be considered 'well-meaning' in the past but now we know the reality I don't think 'well-meaing' will do any more. And many of them are taking in large amounts of cash from people they are treating. I do not consider selling unproven services to people at high cost 'well-meaning'.



I think there is a major difference between medical services in the US and the UK . The great majority of medical care in the UK is NHS based and in recent times open label treatment has died down to a minimum. In the US where commercial interest dominates care policy I suspect things have not changed so much.

There are specific situations where off label treatment makes sense. For rare conditions such as dermatomyositis it may not be possible to gather enough patients to do a trial. When such conditions are life threatening it obviously makes sense to treat off label. Intravenous immunoglobulin has been used in a wide range of rare conditions as a last resort and still is. But ME is a common condition. Clinicians see hundreds of patients a year. And doing controlled trials of pills is not expensive. It might mean you are busy at the weekend transferring data from clinic notes to your trial folders and doing some statistics but it would be perfectly possible for a private practitioner to do this at more or less no cost. If you cannot get dummy pills you can compare two treatments - which is a perfectly valid way, although less powerful. I honestly do not think there is an excuse here. I have been through all this myself and done the copying at the weekend. For the first rituximab trial I bought the drug with my bank account - and it wasn't cheap!

I am a patient of Dr Myhill, Sarah saved my life. I was seriously worried about my short term future and after going to a few different GP's and being told there is nothing wrong with you apart from being slightly overweight and an abnormal ALT so what do you want use to do about it? Is it any wonder PWME go looking elsewhere? Dr Myhill may seem expensive especially if you're on benefits but to be honest her charges are quite reasonable compared with a lot of private consultancies. She works from home and has minimal overheads.

I ask myself, how did I get this? It was triggered by my first event of chicken pox in my mid thirties..nearly 20 years ago! It has taken most of that time for the profession to start looking at ME as a real disease, how long do we have to wait for a magic bullet to cure it?..BTW.. no such thing as a magic bullet! How long will it take for Rituximab to be trialled and approved for ME..and then there is no guarantee that subsetted individuals maybe prescribed it. I for one will not take it, there are several side effects, toxicities to it proving it's not a magic bullet. Talking of toxicities...toxic elements are extremely unhealthy on the human body. This in combination with stressful lives and being fed by the food industry suspect processed foods with sugar and numbered chemicals has got me to where I am today..or moreso where I was 12 months ago before getting invaluable help from Dr Myhill. The food industry is failing us..all they are interested in is profit..not the health of the consumer. Similar could be said of the NHS.. all they have that will help are toxic drugs that they can peddle for corporate pharmas, the Gps are stressed..and giving each patient 10 mins is not enough to look at the bigger picture. They look at symptoms and not the cause..I've had some admit they are not qualified enough or are limited by NICE guidelines so cannot help. The NHS structure is doomed to fail.

Dr Myhill is much more advanced in her thinking, ME is down to failing to support our immune systems with healthy unprocessed diet (wherever the western diet goes..disease follows) Toxic drugs, antibiotics (why is it that the UK don't back these up with probiotics on the NHS like other European countries?..that's only doing half the job) and stress no doubt from failing health is all taking it's toll to contribute to illnesses. Where the NHS cannot prescribe healthy nutrition supplements or certain tests, Dr Myhill points us in the right direction.

I have been on her protocol for 13 months today and seen a huge improvement as have others..some not so much but we are all different and ME is extremely complex..perhaps everyone needs to work together to bring the jigsaw pieces to one big picture. If it wasn't for Dr Myhill I may not be here today. Some of us just don't have the time for trials and approvals on drugs which are potentially toxic.

 

[Marco]

I've little doubt that a better diet can be helpful for some people and I've noticed some improvement from vitually eliminating all processed foods but I do have a problem with statements like :

“It's official - it's mitochondria, not hypochondria!"

While it's an attractive theory, not least because it seems to have some face validity, from what I've seen of the Myhill/Booth etc study, which is presumably what this claim rests on, their research approach cannot in any sense constitute 'proof'.

If I recall correctly, they used a novel test of mitochondrial function to show dysfunction in a ME/CFS population where mitochondrial dysfunction remains a theory. It may have made more sense if they had shown mito dysfunction in ME/CS using an established test or to have shown that their novel test performed better in known mitochondrial disorders. But the way they went about it just heaps one unknown on top of another. Bizarre!

ME/CFS patients may have shown different results to controls (if they used controls - I can't recall) but there's no reliable way to interpret this.

I'm happy to be corrected on the details of this.

 

[ISAS]

Correction to my previous post:

There is the addition of an Addendum to Craig Robinson's chapter on ''Catastrophe Theory and CFS'' added into the third re-print.

Many thanks for your support.

IS

 

[Sirshocking]

I do have a problem with statements like :

“It's official - it's mitochondria, not hypochondria!"

While it's an attractive theory, not least because it seems to have some face validity, from what I've seen of the Myhill/Booth etc study, which is presumably what this claim rests on, their research approach cannot in any sense constitute 'proof'.

If I recall correctly, they used a novel test of mitochondrial function to show dysfunction in a ME/CFS population where mitochondrial dysfunction remains a theory. It may have made more sense if they had shown mito dysfunction in ME/CS using an established test or to have shown that their novel test performed better in known mitochondrial disorders. But the way they went about it just heaps one unknown on top of another. Bizarre!

ME/CFS patients may have shown different results to controls (if they used controls - I can't recall) but there's no reliable way to interpret this.

I'm happy to be corrected on the details of this.

That statement gives PWME hope after many years of being rejected by GP's, Consultants, Employers and even some family members. Therefore the Mitochondrial Function Profile test is the first definitive proof that it's not a psychological disorder. Dr Myhill does not have the means to do extensive proof testing on supplements that big pharmas can. People can die from ME, do we have to wait until our retirements(if we make it that far) knowing that we can to help ourselves at least part of the way? Dr Myhill does not claim her protocol is a cure but it gets us out of bed and gives us a life so we can go back to work and enjoy family life. In my case I have come on leaps and bounds but I don't think its a cure. I think my final rung would be to defeat EBV that most PWME have. EBV has evolved over the years to become almost undectable. Gp's must know this and they hide behind a test that is out of date because it cannot find the virus in EBV's hiding places. This will no doubt have to be defeated with a strong antiviral.

The Mitochondrial Function Test was developed because there is no established test available. New tests are being developed all the time by the profession because some of the established ones are out of date and give insufficient data, this is progress. There are many established tests available on the NHS that just don't work. Dr Myhill is an innovator, a pioneer that delves into the unknown as they do to widen our knowledge on how the human body works. I maybe on a stoneage diet but I don't dwell in the stoneage by using the NHS to get me back to health.

I can't confirm if controls were used in Mito testing between DR Myhill and her lab, she has had over 5000 patients over the years and several happy ones that I communicate with. My mito test showed insufficient energy delivery 13 months ago, I am much fitter now and will be doing the mito test in time to back up the way I feel.

 

[Marco]

That statement gives PWME hope after many years of being rejected by GP's, Consultants, Employers and even some family members. Therefore the Mitochondrial Function Profile test is the first definitive proof that it's not a psychological disorder.

My mito test showed insufficient energy delivery 13 months ago, I am much fitter now and will be doing the mito test in time to back up the way I feel.

Hope is great and I'm glad you're improving but neither is proof that this test is effective or that any therapies based on its findings contributed to your improvement.

If we're ever going to make any progress then I'm afraid we need to demand the same level of proof from those Drs we consider 'friendly' as we rightly demand from others.

 

[justy]

Whilst I applaud Dr Myhill's efforts on behalf of patients I am afraid that her treatments did not help me at all. I had some initial small improvements, but over time my illness has in fact progressed, and the improvement has not been sustained.