Interview: Ian Lipkin’s Million Dollar Appeal for Microbiome Study

February 10, 2014

Simon McGrath recently secured an interview with the world famous Dr Ian Lipkin – a scientist who continues to believe that ME/CFS has a physical cause – to discover more about his plans for a major study of the gut microbiome and to find out why he’s asking the patient community for its support…

lipkin2

Dr W. Ian Lipkin has demonstrated a clear commitment to ME/CFS research. First came his study looking at Borna virus in the 1990′s, and then the landmark study that ruled out XMRV as a cause, and most recently we have heard about the huge pathogen and immune study – a vast collaboration with many key clinicians and researchers, including Dr Dan Peterson and Professor Jose Montoya.

That research had already found clear signs of immune activation in patients and, when I spoke to him, Lipkin was clearly excited about the very latest results to emerge from the study – I wish I could reveal more, but a paper has just been submitted and details are embargoed until publication.

Lipkin believes that immune activation may be responsible for driving the symptoms associated with ME/CFS. And that the immune activation could itself be triggered by bugs, not in the blood, but found in the vast ecosystem of bacteria, viruses and fungi, that constitute the gut microbiome.

However, he doesn’t have the funds to pursue this research and so he’s appealing to the patient community for the one million dollars he needs to get the work done. The payoff? A better understanding of the illness and the possibility of new treatments.

Dr Lipkin on ME/CFS

Lipkin made a splash in the world of ME/CFS when he led the XMRV study that both disproved its role in the illness and also managed to unite the patient community. At the press conference for that study he said his first brush with CFS was a large study in the 1990s that demonstrated no connection between the Borna virus (one of many viruses he’s discovered) and CFS. But he stressed that their findings in the same study of B-cell activation in CFS patients was a clear sign that this was not a psychosomatic disorder.  The findings in his new study have only confirmed his views:

“There is no question in my mind that this is a physical disorder. The fact that we haven‘t been smart enough or invested enough in it to sort that, doesn’t mean that this is anything else.”

The smoking gun

The immune activation he’s found could explain fatigue – it’s almost a universal symptom of infections like flu, and is actually a consequence of immune activation rather than caused by pathogens themselves.

The same could be true of other ME/CFS symptoms including disturbed sleep and brain dysfunction which again are typical symptoms of immune activation.

Lipkin is eager to build on this work. He believes the immune activation is a smoking gun and now wants to track down who or what pulled the trigger.

“I am more keen than ever … to see if we can identify the trigger”
- all quotes are from Dr Lipkin

smokeNOreuse

There are several credible places to look for the culprits triggering the activation. One is white blood cells: some viruses could be hiding out in cells and so wouldn’t have been found by the initial search in the blood plasma – and Lipkin already has a white blood cell study lined up.

However, his attention is particularly focused on the microbiome, the large ecosystem of bugs that live on our skin and within our ‘inner tube‘ that leads from mouth to bottom.

There are at least one trillion bugs in the gut microbiome – and there are more immune cells in the gut than anywhere else: it’s a great place to hunt for bugs that might be triggering immune activation.

Microbiome problems are increasingly being linked to serious illness. The most striking example is the superbug Clostridium Difficile (C. diff), which has become a major problem in hospitals. C. diff lives in most of our guts harmlessly at low levels, but it can take over (particularly if ‘good’ bacteria are killed off) – causing diarrhoea and even death. Happily, doctors have discovered that severe C. diff cases can be treated relatively easily by restoring the microbiome; unhappily, this involves a faecal transplant.

The potential to treat disease by restoring the microbiome is one reason this area of research is attracting so much attention. This recent article explains more about the microbiome, how it might link to ME/CFS and looks at other research being performed.

“If the answer were simple, it would be done by now”

Irritable Bowel Disease is another example – here inflammation is believed to result from changes in the microbiome. Lipkin’s team have just been studying women in sub-saharan Africa and found that certain bacteria in the vaginal microbiome increase the risk of HIV infection. Lipkin thinks the gut microbiome could be playing a similarly important role in ME/CFS:

“By analogy with animals and human situations, we see that different populations of fungi, bacteria and viruses in the colon can have an impact on the immune system and give rise to cytokine activation which could cause the symptom complexes we see in ME/CFS”

in other words:

changes in microbiome  >  immune activation  >  symptoms of ME/CFS

I asked Lipkin if this meant particular bugs causing inflammation and he said that is certainly possible. But, he added, another route to illness is that an overgrowth of ‘’bad’’ bacteria could form a film, preventing ‘’good’’ bacteria from interacting positively with the immune system (see this article for more) – an indirect way of causing immune dysfunction.

The exact role that microorganisms in the gut play in health and in the development of disease is complex and still being determined. There are many plausible hypotheses, says Lipkin, and only research can show which (if any) are right.

If the microbiome is the cause, is it treatable?

If the microbiome is the cause (or a cause, or even a contributor) of ME/CFS, it might be relatively easy to treat, perhaps with probiotics, restriction diets, drugs, or even faecal transplants.

Cause or effect?

Of course, the first step in this process is demonstrating a strong link between the microbiome and ME/CFS. If one is found then the next step is to look for evidence it plays a causal role: i.e. do microbiome changes cause immune dysfunction, as opposed to being a consequence of or simply associated with immune dysfunction?

Lipkin says one option is to use an animal model: the idea would be to introduce the microbes suspected of triggering ME/CFS into the gut microbiome of animals, to see if this leads to similar symptoms and immune activation as seen in humans. Something that has been used to study Metabolic syndrome.

Personalised medicine

If there is evidence of a causal role, Lipkin says they would look to establish clinical trials of treatments that could include probiotics, antibiotics followed by prebiotics, restriction diets and possibly even faecal transplants. He believes that there would not be a single microbiome cause of the illness, but different types – potentially fungal, bacterial and viral problems causing three separate types of immune dysfunction.

Lipkin calls these different types ‘endophenotypes’ and it could lead to personalised medicine, where the particular treatment depends on the specific form of the illness. There will be endophenotypes beyond those in the gut, such as genetics endophenotypes, and it is highly unlikely that the microbiome would account for all forms of ME/CFS – but this approach could tackle a very substantial proportion of cases.

The study breakdown

Lipkin’s proposed study will look at all three trees of life: bacteria, fungi and viruses in the microbiome of 100 patients and 100 controls recruited for a previous NIH study. It will cost a cool million dollars:

1. Sample collection: $150,000

Collection of faecal (and blood) samples from patients, including checking the initial ME/CFS diagnosis remains valid and shipping chilled samples back to the labs at Columbia.

2. Faecal Microbiome sequencing and Analysis: $317,000

- Separate, purify and perform high-throughput sequencing of  viruses, fungi and bacteria
- Complete sequencing of viruses; partial sequencing to identify bacteria (using 16S rRNA) and fungi (using ITS, the ‘fungal barcode’)
- Generate microbiome profile for each patient, one each for bacteria, fungi and viruses

Comparison of patient and control microbiomes: bacteria, fungi and viruses that differ in prevalence between CFS subjects and controls will be considered candidates for contributing to either health or disease.

3. Development of highly-accurate real-time PCR assays to confirm findings and levels of microbes: $328,000

This will quantify how much there is of each bug of interest (the main high throughput sequencing approach gives an indication of quantity but is less accurate than real-time PCR).

It’s possible, that the most important thing isn’t the presence or absence of a microbe, but the amount of it – as with C.Difficile. These assays will also be used to check that key microbes haven’t been missed in any patient or controls who were negative for them in initial sequencing, as PCR assays are far more sensitive than high-throughput sequencing.

4. Cytokine analysis: $86,000

The study will again measure cytokines in blood and undertake data analysis to see if there is an association between cytokine profiles and immune profiles. It would then provide strong evidence of an important relationship between the microbiome and immune dysfunction – the hypothesis driving this study.  Sophisticated analysis will be required on the vast amount of data generated by microbiome and cytokine profiling; happily, Lipkin’s Center for Infection and Immunity have a team of biostatisticians dedicated to such work.

5. Development of antibody tests for important bugs identified by the microbiome work: $249,000

It could be a few individual species or particular groups of microbes, but antibody tests will be developed by Lipkin’s lab to allow much easier testing to see if the same problems in this sample are found in the wider patient population.

As well as guiding treatments, the PCR assays and antibody tests developed here could both provide a diagnostic test for ME/CFS.

Lipkin’s record

Lipkin - CFIFeatured in the New York Times, described by Discovery magazine as the world’s foremost virus hunter, and consultant to a successful Hollywood movie, Dr W. Ian Lipkin has a higher profile than most researchers. But this profile is built on a stellar scientific reputation.

He’s discovered more viruses than anyone else. He’s part of the World Health Organization (WHO) diagnostic discovery and surveillance programme designed to catch pandemics as they arise. And the Chinese recruited him play a leading role in their fight against SARS.

Amongst other things he is John Snow Professor of Epidemiology and Director, Center for Infection and Immunity at Columbia University. Full biography.

He is passionate about communicating science to a wider audience but is insistent the science is right.

Lipkin only agreed to consult on Contagion, a movie about the terrifying potential of epidemics, because of director Steven Soderbergh’s desire to make a film that was true to the science – having turned down offers to advise on several movies with somewhat wilder plots.

When Lipkin was shown a near-final version of the film he threw up his hands at the scene near the climax where a scientist injects herself in the leg with the new vaccine, through her tights – a poor practice that could easily introduce an infection.

This might seem a small detail given everything else the film had right, but Lipkin was adamant it had to go: cue a $100,000 reshoot.

This near-obsession with getting things right is a Lipkin hallmark. The very first point he made to me about this study, before discussing any details, was the need for real, robust findings – because there have been too many false dawns in this field.

At the end of the interview he emphasised the need of crisp, rigorous data. Whatever the findings from this new study – positive or even negative, we should be able to rely on them.

Scientist in a hurry for answers

Dr Lipkin is a scientist in a hurry for answers. That’s true both in his work trying to stop a new pandemic in its tracks, and in his work on ME/CFS.

He wants to follow up as many promising leads as possible, as soon as possible – rather than waiting for the results of a single study before planning a new one if the first draws a blank.

That’s why he set up a huge study looking for specific pathogens such as EBV, but also used deep sequencing alongside that to search for any other pathogen, known or unknown.

He’s looked in blood plasma for pathogens but is also about to look for them in white blood cells too.

He set the study up to look at immune markers including cytokines as well as for pathogens – and the significant findings of immune activation show the value of backing more than one horse.

On top of all this, Lipkin has invested in a gene expression study using samples from the same study, with results expected shortly that could throw up new leads in epigenetics and genomics.

Dr Lipkin has committed a huge amount of his 60-strong institution’s time to pursuing numerous studies, all aiming to uncover what’s really going on in ME/CFS

Too much, too soon?

However, it may be that the NIH is not in such a hurry as it has declined to fund the study at this time.

But then the NIH has only ever committed relatively small amounts of funding to ME/CFS – around $5 million a year, compared with around $115 million annually for MS and $284 million for Asthma.

Its funding record firmly suggests the NIH’s priorities lie elsewhere.

So, as Lipkin says, “we are stuck”. It’s possible that the NIH will fund this work in the future, and possible they won’t.

The question is, do we want to wait?

“We are already well behind where we should be”

Dr Lipkin has now appealed to patients to fund his latest study that aims to hunt in the gut microbiome for the ‘trigger’ of the immune activation his study found in ME/CFS. And he needs a cool million dollars to pay for the study outlined above.

Actually, the study comes to a bit over a million dollars (see above) -  $1.13 million, to which another $140,000  of costs for maintaining the high-tech equipment used and general lab costs making $1.27 million in total. However, the initial target has been set at $1 million.

In his CDC telecast to patients last September, Lipkin explained the microbiome project was being held up by this lack of funds, and urged patients to contact their representatives in Congress.

He also appealed directly to patients who could afford to do so, to invest in research:

“it may not be appropriate to pass the hat, but that is exactly what I am doing”

How long will it take for the results? “Within a year”, said Lipkin

The man is in a hurry, and the study is all set up and ready to go – once funding is available.

“As long as I can do it, I will do it. I‘m eager to start, I‘m optimistic it will bear fruit, it‘s not just an academic exercise, it could lead to treatment”

When I mentioned to Dr Mady Hornig, the Principal Investigator on this study, that I was interviewing Dr Lipkin she added: “Terrific – we need the resources to get this done”.

Crowdsourcing: Together we can make it happen

I do think we are very lucky to have Dr Lipkin on our case and believe that we should back his new study, which will be performed at his Center for Infection and Immunity, Columbia University – the world’s largest and most advanced academic center in microbe discovery, identification and diagnosis.

“Why don‘t we crowdsource this, we are all losing valuable time in our lives?”

Vanessa Li, Phoenix Rising member and fundraiser

ME/CFS patient, Vanessa Li, responded to Lipkin’’s call last year, by contacting his office and suggesting crowdsourcing in a similar way to MEandYou, which through the efforts of Dr Maria Gjerpe had raised an astonishing $0.5 million towards the Norwegian Rituximab trial in 90 days.

Lipkin was a physician in San Francisco at the start of the AIDS epidemic and commented how, when the government was reluctant to pay, much of the important early work was funded by private donors so he’s very open to this possibility. He continued to seek funds for his work from institutions, but as that hasn’t worked he is now asking patients if they can make the study happen  – and has given this interview to launch the million dollar appeal.

Donate to the the ME/CFS microbiome study

I have just donated and hope many other patients will do too. Just click on the button below and follow the instructions. The option is to donate to CFS research, but in the next page you can add ‘special instructions’ such as ‘for the microbiome study’.

We need only for every US patient to donate $1. Or one in ten patients to donate $10.

cii-donate

If people want to do more to help – and this is a big target – they can help to promote this crowdsourcing initiative at this new group, or email Vanessa Li. I will give her the last word:

The CDC says there are more than one million ME/CFS patients today in the US alone. There is no reason why, if every patient were made aware of Dr. Lipkin’s appeal and donated $1, that we should fail to raise the $1 million.  An esteemed researcher doing high-caliber work is taking a serious interest in finding out the cause of our desperately under-researched illness. Now is the time to act!

 

Simon McGrath tweets on ME/CFS research:

 

Support Phoenix Rising

Phoenix Rising is a registered 501 c.(3) non profit.  We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we’d love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

And don’t forget: you can always support our efforts at no cost to yourself as you shop online! To find out more, visit Phoenix Rising’s Donate page by clicking the button below.

donate

278 comments

{ 278 comments… read them below or add one }

aimossy February 10, 2014 at 6:41 am

I AM IN!!! Enough said. Except for thankyou!

Christopher February 10, 2014 at 6:48 am

So the CFI will not donate anything?

Simon February 10, 2014 at 7:07 am

Here's the appeal page from Ian Lipkin's The Center for Infection and Immunity

Upcoming Projects:
We are actively seeking funds to support comprehensive studies into the role of the bacteria, fungi and viruses in CFS. Research into the human microbiome is an exciting new pathway to advance our understanding of the role that over a trillion microorganisms in our body play in health and in the development of disease. An altered microbiome may cause not only gastrointestinal problems but also immunological and brain dysfunction. As the world’s largest and most advanced academic center in microbe discovery, identification and diagnosis, the Center for Infection & Immunity at Columbia University is optimally positioned to embark upon the challenge to determine how bacteria, fungi, viruses and toxins (and the immune response to them) contribute to Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (ME). Discoveries in these areas may point us toward treatment strategies that reduce vulnerability through exclusion diets, probiotics or drugs.

The initial goal of this effort is $1 million. CLICK HERE to donate now.
PLEASE BE SURE TO CHOOSE THE DROP-DOWN MENU, “CHRONIC FATIGUE SYNDROME GIFT” TO SUPPORT THIS EFFORT.

The CII is internationally recognized for expertise in microbial surveillance and discovery. We will employ state-of-the-art methods to identify and quantitate the burden of bacteria, viruses and fungi using high-throughput sequencing and advanced bioinformatic programs. Results of this work may lead to diagnostic tests and treatment for CFS.

Simon February 10, 2014 at 7:13 am
aimossy

I AM IN!!! Enough said. Except for thankyou!

Thanks, Aimossy, that's fantastic.

Christopher

So the CFI will not donate anything?

As I understand it, the CFI have contributed a great deal to the pathogen/immune study – millions of dollars I think – but are not going to fund more at this stage – they have funded a lot of other work, including a large epidemiological study, a biobanks and a 'mechanism of illness fellowship'.

MeSci February 10, 2014 at 7:37 am

I think that this research has enormous promise, and crowdfunding is a great idea.

I have one main reservation:

Lipkin is quoted as saying:

one option is to use an animal model: the idea would be to introduce the microbes suspected of triggering ME/CFS into the gut microbiome of animals, to see if this leads to similar symptoms and immune activation as seen in humans.

Yet later the article states, sensibly:

He believes that there would not be a single microbiome cause of the illness, but different types – potentially fungal, bacterial and viral problems causing three separate types of immune dysfunction.

Lipkin calls these different types ‘endophenotypes’ and it could lead to personalised medicine, where the particular treatment depends on the specific form of the illness. There will be endophenotypes beyond those in the gut, such as genetics endophenotypes, and it is highly unlikely that the microbiome would account for all forms of ME/CFS – but this approach could tackle a very substantial proportion of cases.

There is likely to be a great deal of interpersonal variability, and we may need very personalised approaches. Presumably the initial part of the research will reveal much of what we need to know about the variability of gut microbiomes.

I cannot see how an animal model will help, if there is so much variability between human patients with regard to genotype, epigenotype (is that a word?), age, environmental factors (e.g. diet and geographic factors), body mass and co-morbidities.

Add to that the substantial differences between humans and other animals: genetics (including different effects of the same genes in different species), natural habits (e.g. diet but also including things such as hygiene with regard to faeces), lifespan, bowel structure and much more, and the very poor record of translatability from animal studies to human patients…

If Dr Lipkin were to state categorically that he would not use animal studies, I would seriously consider donating, as would some other people I know.

acer2000 February 10, 2014 at 8:03 am

Wow thanks for setting this up. I am in and I will tell my friends and family!

vli February 10, 2014 at 8:12 am

Thank you so very much @acer2000 .

I would be very grateful too if anyone interested in this study and with fundraising/crowdsourcing experience could step forward and join the crowdfunding group here so that ideas for a campaign can be thrown around!

Christopher February 10, 2014 at 8:22 am
MeSci

I think that this research has enormous promise, and crowdfunding is a great idea.

I have one main reservation:

Lipkin is quoted as saying:

Yet later the article states, sensibly:

There is likely to a great deal of interpersonal variability, and we may need very personalised approaches. Presumably the initial part of the research will reveal much of what we need to know about the variability of gut microbiomes.

I cannot see how an animal model will help, if there is so much variability between human patients with regard to genotype, epigenotype (is that a word?), age, environmental factors (e.g. diet and geographic factors), body mass and co-morbidities.

Add to that the substantial differences between humans and other animals: genetics (including different effects of the same genes in different species), natural habits (e.g. diet but also including things such as hygiene with regard to faeces), lifespan, bowel structure and much more, and the very poor record of translatability from animal studies to human patients…

If Dr Lipkin were to state categorically that he would not use animal studies, I would seriously consider donating, as would some other people I know.

I don't see anything in the cost breakdown in the article referencing animal studies, @MeSci

Christopher February 10, 2014 at 8:30 am

@Wally Maybe we can try to put some pressure on the NIH to cough up some funding by shaming them for the lack of funding in the past, present, and the CDC misappropriation incident.

$1 mil is nothing relative to our collective disability.

MeSci February 10, 2014 at 8:48 am
Christopher

I don't see anything in the cost breakdown in the article referencing animal studies, @MeSci

No, but the reference to animal studies suggests that this might follow the initial research. Here is the quote with the preceding paragraph (red font indicates the connection):

Cause or effect?
Of course, the first step in this process is demonstrating a strong link between the microbiome and ME/CFS. If one is found then the next step is to look for evidence it plays a causal role: i.e. do microbiome changes cause immune dysfunction, as opposed to being a consequence of or simply associated with immune dysfunction?

Lipkin says one option is to use an animal model: the idea would be to introduce the microbes suspected of triggering ME/CFS into the gut microbiome of animals, to see if this leads to similar symptoms and immune activation as seen in humans.

The initial research all looks great, but if that is what would follow, I'm out. It's a huge shame. If this 'animal model' were the next step it would likely produce misleading results, thus delaying progress or leading to harmful human trials. This has happened time and time again.

Others are of course free to make their own decisions. Just pointing this out.

PDXhausted February 10, 2014 at 9:51 am

Anyone know if they will give an update as to how much they've collected so far and how much there is to go? I feel like that can be helpful in reaching a critical mass.

Marco February 10, 2014 at 9:52 am

Thanks Simon

I've just donated.

I feel that we are enormously fortunate to have someone of Ian Lipkin's calibre working on our 'little syndrome' and for as long as he's here we should use him to the max.

If we can't pull together and treat this as a priority then why expect anyone else to. Short of cash? Think of what you may have spent in the past or might spend in the future on all sorts or 'treatments. Have they worked?

PS – Thanks also for sorting out my evening viewing.

I've just dug the Contagion DVD out again : )

SkagitWabbit February 10, 2014 at 9:54 am

It looks like Dr Lipkin has read neither http://www.cortjohnson.org/blog/2013/09/05/changing-gut-flora-feeding-good-bacteria-chronic-fatigue-syndrome/ nor http://cfsremission.wordpress.com/ where links to pub med studies showing the results that he seems to be seeking. While duplication of prior results is good, it also delays the time to a cure.

I would strongly recommend people do http://americangut.org/ first, before donating. This allows you to put your gut bacteria available to more researchers — especially those skilled in handling BIG DATA, which is not one of Dr.Lipkin's qualifications. It is likely a faster path to a cure for all.

Ritto February 10, 2014 at 10:02 am
PDXhausted

Anyone know if they will give an update as to how much they've collected so far and how much there is to go? I feel like that can be helpful in reaching a critical mass.

I agree, I think updates could help.

vli February 10, 2014 at 10:05 am

@PDXhausted and @Ritto , as of December 2013 they've received $1500 or so. I will keep asking the Dept. of Gifts at Columbia how much they are receiving, but I think this highlights the need for a crowdfunding campaign, because people like to see how much of the goal they have achieved. Please show your interest by joining the group here.

Dreambirdie February 10, 2014 at 10:52 am

I donated and would like to see updates too.

Sasha February 10, 2014 at 10:57 am

Great article, Simon, and many thanks to Vanessa for getting the fundraising underway. I've just donated.

I think we could get this funded very quickly. Maria Gjerpe's campaign raised $500,000 in three months and shamed her government into fully supporting the Norwegian Rituximab study. Norway's population is 5 million; the US's population is 314 million, which is over 60 times as large. Look how quickly Jen Brea's Canary in a Coalmine fund raised $200,000 – less than a month. There's serious money spread across our enormous community and our supporters, if we see a project that we want to support.

In the last year we've seen several highly successful projects that very rapidly reached their funding goals – Norwegian Rituximab, UK Rituximab (all there bar the shouting, given the large MEA pledge), Ryan Prior's Blue Ribbon, Jen Brea's Canary and most recently the OMI's B12 study (almost there with $125,000 out of the $150,000 raised in just a few weeks) – and they've one big thing in common: they've been for specific projects, not just calls to pour cash into some charity's bottomless general research fund. And all of a sudden, sums of money that we previously wouldn't have thought possible have been donated, and the many small donations of patients and supporters have often stimulated big donations from other sources.

We can do this, and we can do it fast. We've already been doing it with these other projects.

Please donate, and do it now!

Sasha February 10, 2014 at 11:11 am
MeSci

No, but the reference to animal studies suggests that this might follow the initial research [...] The initial research all looks great, but if that is what would follow, I'm out. It's a huge shame. If this 'animal model' were the next step it would likely produce misleading results, thus delaying progress or leading to harmful human trials.

Hi @MeSci – I'm no expert on the applicability of animal models to human health but this issue doesn't put me off, for several reasons:

  • the current study is aimed at trying to determine cause indirectly (correlationally) and that's the study that we're being asked to support. Depending on the results, presumably, it might or might not end up with animal studies but we can't know that now – animal studies are being described as one 'option'. The first thing to do is establish whether having ME is correlated with having certain bugs. We need to know this, regardless of what happens next. We can't afford to stay in ignorance. This is the first step in any bug-hunt and has been the same for looking for viruses in the blood, enteroviruses in gut biopsies and so on. First we need knowledge; once we've got it, I can see lots of research teams and clinicians coming on board to tackle the problem.
  • there seem to be plenty of options available that wouldn't involve animal models. Researchers could go straight to therapeutic trials, if they had a sound rationale. I can imagine patients doing their own n=1 studies, once they know what they're targetting, and our specialist clinicians giving it a go. There may be antibiotics already suitable that we could use.
  • I trust Dr Lipkin not to be stupid in his use (or choice not to use) of animal models. He's clearly an excellent scientist and I'm sure he'd be aware of the limitations. Maybe people might think I'm being naive about that but if so, you've got my first two arguments to fall back on. :cool:

Sasha February 10, 2014 at 11:22 am
SkagitWabbit

It looks like Dr Lipkin has read neither http://www.cortjohnson.org/blog/201…eding-good-bacteria-chronic-fatigue-syndrome/

Hi SW – I remember reading that a while back – it seems to be just one guy's experience.

nor http://cfsremission.wordpress.com/ where links to pub med studies showing the results that he seems to be seeking.

I've just had a quick look at that and it seems to be another one guy's experience and with shedloads of references about all sorts of things.

I don't know if you had a particular study in mind but what we need is a large study, with a well-defined population of PWME and suitable controls, and then we need the modern techniques that Lipkin's lab can offer to do a proper job of things. I don't think he'll be duplicating what's gone before.

I would strongly recommend people do http://americangut.org/ first, before donating. This allows you to put your gut bacteria available to more researchers — especially those skilled in handling BIG DATA, which is not one of Dr.Lipkin's qualifications. It is likely a faster path to a cure for all.

I'm all for people taking part in the American Gut Project and it could be a good starting point but strict diagnostic guidelines are a big deal for ME and I can imagine a lot of people with undiagnosed primary depression or idiopathic chronic fatigue who've been given a binbag 'CFS' diagnosis by an incompetent primary care physician messing up any attempt by us to piggyback on such a project.

I think we need to support Lipkin's study. Let's get that money flowing in! :)

Esther12 February 10, 2014 at 11:23 am

Ta Simon (and Prof Lipkin)!

Simon February 10, 2014 at 12:12 pm
SkagitWabbit

It looks like Dr Lipkin has read neither http://www.cortjohnson.org/blog/201…eding-good-bacteria-chronic-fatigue-syndrome/ nor http://cfsremission.wordpress.com/ where links to pub med studies showing the results that he seems to be seeking. While duplication of prior results is good, it also delays the time to a cure.

I would strongly recommend people do http://americangut.org/ first, before donating. This allows you to put your gut bacteria available to more researchers — especially those skilled in handling BIG DATA, which is not one of Dr.Lipkin's qualifications. It is likely a faster path to a cure for all.

I've written about some small scale mecfs microbiome research here (Gut bugs misbehaving? The microbiome and ME/CFS), but its' not on the scale of Ian Lipkin's new study and none of which has produced a 'prior result' that would guide treatment trials. If I've missed something, please let me know. Ian Lipkin is talking about results 'within a year' from this study, which I find very encouraging

As for Big Data, I agree it needs the right expertise and it's not one of Lipkin's qualifications – but he has assembled a team of biostatisticans at Columbia, precisely to tackle this kind of work.

Sasha

I'm all for people taking part in the American Gut Project and it could be a good starting point but strict diagnostic guidelines are a big deal for ME and I can imagine a lot of people with undiagnosed primary depression or idiopathic chronic fatigue who've been given a binbag 'CFS' diagnosis by an incompetent primary care physician messing up any attempt by us to piggyback on such a project.

I think we need to support Lipkin's study. Let's get that money flowing in! :)

I agree with Sasha about diagnosis (and am equally happy for people to take part in the Amercian Gut Project) – the patients in this study have very carefully diagnosed (Canadian Consensus Criteria) and the diagnosis is confirmed before new samples are taken.

ballard February 10, 2014 at 12:14 pm

I'm in. We are fortunate to have a researcher of Dr. Lipkin's caliber focusing on ME/CFS. Let's get behind this research in a big way!
Looking at the past history of ME/CFS funding you'd have to say that nobody is going to do it for us.

Simon February 10, 2014 at 12:16 pm
Marco

Thanks Simon

I've just donated.

I feel that we are enormously fortunate to have someone of Ian Lipkin's calibre working on our 'little syndrome' and for as long as he's here we should use him to the max.

If we can't pull together and treat this as a priority then why expect anyone else to. Short of cash? Think of what you may have spent in the past or might spend in the future on all sorts or 'treatments. Have they worked?

PS – Thanks also for sorting out my evening viewing.

I've just dug the Contagion DVD out again : )

Terrific, Marco, thank you. That's an interesting point about how much many of have spent on treatments that have gone nowhere (certainly I have been down that route).

If you really want theme viewing you can watch Ian Lipkin's lecture at Oxford last year – a good chunk of which is about Contagion as well as some really bad science movies:

Wally February 10, 2014 at 12:53 pm
Christopher

@Wally Maybe we can try to put some pressure on the NIH to cough up some funding by shaming them for the lack of funding in the past, present, and the CDC misappropriation incident.

$1 mil is nothing relative to our collective disability.

We are working on it. The pressure will most likely need to come from Congress and of course a more unified voice from the ME/CFS community. :woot: More to follow on this plan very soon . . . :nerd: Lots of :hug: working on this as we speak. ;)

anniekim February 10, 2014 at 1:42 pm
Sasha

Great article, Simon, and many thanks to Vanessa for getting the fundraising underway. I've just donated.

I think we could get this funded very quickly. Maria Gjerpe's campaign raised $500,000 in three months and shamed her government into fully supporting the Norwegian Rituximab study. Norway's population is 5 million; the US's population is 314 million, which is over 60 times as large. Look how quickly Jen Brea's Canary in a Coalmine fund raised $200,000 – less than a month. There's serious money spread across our enormous community and our supporters, if we see a project that we want to support.

In the last year we've seen several highly successful projects that very rapidly reached their funding goals – Norwegian Rituximab, UK Rituximab (all there bar the shouting, given the large MEA pledge), Ryan Prior's Blue Ribbon, Jen Brea's Canary and most recently the OMI's B12 study (almost there with $125,000 out of the $150,000 raised in just a few weeks) – and they've one big thing in common: they've been for specific projects, not just calls to pour cash into some charity's bottomless general research fund. And all of a sudden, sums of money that we previously wouldn't have thought possible have been donated, and the many small donations of patients and supporters have often stimulated big donations from other sources.

We can do this, and we can do it fast. We've already been doing it with these other projects.

Please donate, and do it now!

And invest in me managed to raise £100,000 for a gut study that is happening now too :-)

Sasha February 10, 2014 at 1:46 pm
anniekim

And invest in me managed to raise £100,000 for a gut study that is happening now too :)

Very true! I think they raised the money first over a considerable period of time (2 years?) before deciding what to spend it on (somebody correct me if I'm wrong). It would be interesting to know what would have happened if they'd specified the project beforehand. I think that's crucial to rapid success – an exciting project that everyone wants to get behind.

But you're right, £100k is a lot (about $150k) and the UK is only about 63 million people – a fifth the population of the US. The US (and us overseas patients donating too) should be able to crack $1 million in about five minutes. :cool:

anniekim February 10, 2014 at 1:50 pm

I'm very interested that Lipkin thinks treatments might involve restricted diets amongst other things. I've always caused myself a lot of stress and angst about diets. Mainly because I am not convinced enough to have the willpower to stick to them and then I feel guilty. However, if it was proven that a restricted diet could definitely help I might finally summon up enough willpower to follow one

I will certainly donate

I remember reading of a young woman who went to KDM in Belgium. She hadn't been ill for very long and he, like he does with many of is his patients, put her on a rotation of antibiotics and probiotics. She completely recovered. Yet I have heard of others who have had similar treatment of abx and probiotics from KDM with some improvements, not always, but not full recovery. I wonder if treating the gut early on in the illness increases the chance of full recovery before the downstream changes of long term immune system activation, I think it's great that someone of Lipkin's calibre is interested in our illness. I hope we can raise the funds

Esther12 February 10, 2014 at 1:53 pm
anniekim

I'm very interested that Lipkin thinks treatments might involve restricted diets amongst other things. I've always caused myself a lot of stress and angst about diets. Mainly because I am not convinced enough to have the willpower to stick to them and then I feel guilty. However, if it was proven that a restricted diet could definitely help I might finally summon up enough willpower to follow one

No reason at all to feel guilty for not sticking to diets that do not have good evidence of benefit! There are so many things that could be helpful, but could be unhelpful or worthless than PWCs could drive themselves crazy if they felt pressured to do them all!

OverTheHills February 10, 2014 at 2:04 pm

My philosophy is to regard everything I try – supplements, prescribed drugs, diet changes like a lottery ticket. Give it a go.

Nowadays I'm careful not to put too much investment in (ie more belief, money, or effort than I can afford) , see what happens, sometimes I get lucky sometimes I don't. I have been fairly lucky and got some really good results. It works for me because its good to have a supply of low-grade hope.

I donated to Maria's Norwegian Rituximab thing (and maybe the UK one too, can't remember) and I'll be donating to this one too. More lottery tickets.
OTH

Ember February 10, 2014 at 2:09 pm
Phoenix Rising Team

He wants to follow up as many promising leads as possible, as soon as possible – rather than waiting for the results of a single study before planning a new one if the first draws a blank.

How refreshing, after the interview with Dr. Unger!

Phoenix Rising Team

So, as Lipkin says, “we are stuck”. It’s possible that the NIH will fund this work in the future, and possible they won’t.

Dr. Lipkin may lose out to this kind of thing…

Phoenix Rising Team

1. Sample collection: $150,000

Collection of faecal (and blood) samples from patients, including checking the initial ME/CFS diagnosis remains valid and shipping chilled samples back to the labs at Columbia.

I believe that Dr. Lipkin used the CCC in defining his cohort. Would he be willing to elaborate?

anniekim February 10, 2014 at 2:16 pm

Overthehills, my problem is food is one of my only pleasures left and it would take a lot of will power for me to keep to diet strictly. I managed one ten years ago for three months and it was so hard. I did feel a bit better for a short time. However, to cut out all my favourite foods ans really tackle my cravings I would have to b convinced it would work

Other treatments I do have the philosophy of let's give it a go with no great expectations but diet is different for me

@esther, thanks for your absolution, it is appreciated. Would you only go down the restricted diet route if Lipkin showed good evidence it would benefit? I think if I. Am honest to myself I would only manage it if I was presented with good evidence for the Benefits of denying myself foods I enjoy. I don't eat much gluten as causes upset tummy but apart from that I don't cut anything else out at the mo

Firestormm February 10, 2014 at 2:22 pm

I don't think I have donated to a specific research project for several years. Funds never really permitted me to. But this one has just received a donation I am delighted to report :balloons:

This project, the interview, the many discussions, the sharing of concerns with Columbia, and the final article itself, have taken more time to put together than I think anything else I have worked on since joining Phoenix.

It is well worth supporting this effort I think. I was skeptical at first – as is my want – but I do think this is a very necessary area to investigate – along with the continuing cytokine work.

ME Science is turning the corner and I have started to feel more positive that something will come of all these high-powered and significant studies.

It's been a 14 year sentence for me thus far, it's great to finally be seeing scientists of caliber appear so confident about my disease. Hell, even my father was convinced – and that takes some doing, believe me :)

N.B. Don't forget when donating, to specify that you would like your money to go to the Microbiome Study. Just to be doubly sure it gets to the right one :thumbsup:

Dreambirdie February 10, 2014 at 2:28 pm
Firestormm

Don't forget when donating, to specify that you would like your money to go to the Microbiome Study. Just to be doubly sure it gets to the right one :thumbsup:

Yes, make sure to do this.

OverTheHills February 10, 2014 at 2:35 pm
anniekim

Overthehills, my problem is food is one of my only pleasures left and it would take a lot of will power for me to keep to diet strictly. I managed one ten years ago for three months and it was so hard. I did feel a bit better for a short time. However, to cut out all my favourite foods ans really tackle my cravings I would have to b convinced it would work

Other treatments I do have the philosophy of let's give it a go with no great expectations but diet is different for me

I know exactly what you mean. I saw Dr Myhill and she is completely dogmatic about a Paleo diet. It was really hard to get the mental energy together for something like that, and at the time I was so sick that food was one of the very few pleasures left. The paleo diet made me feel worse by the way! anyway I'll stop going OT now – hope those who can will support this appeal..

anniekim February 10, 2014 at 3:35 pm
Sasha

Very true! I think they raised the money first over a considerable period of time (2 years?) before deciding what to spend it on (somebody correct me if I'm wrong). It would be interesting to know what would have happened if they'd specified the project beforehand. I think that's crucial to rapid success – an exciting project that everyone wants to get behind.

But you're right, £100k is a lot (about $150k) and the UK is only about 63 million people – a fifth the population of the US. The US (and us overseas patients donating too) should be able to crack $1 million in about five minutes. :cool:

Hi Sasha,

At the time invest in Me said they wanted to set up the first research centre and clinic for pwme in the UK at East Anglia university which would offer research then translational (is that the right word?) treatments to patients. So there was a target so to speak which is why I think people got behind it. As it happens the money is going towards the gut study at the. University. Am not sure where they are at at getting a doctor to see patients. I think they are having problems with the university to agree to it. I think it took about 18 months to raise the money, but perhaps it was 2 years, sorry can't remember

anniekim February 10, 2014 at 3:38 pm
OverTheHills

I know exactly what you mean. I saw Dr Myhill and she is completely dogmatic about a Paleo diet. It was really hard to get the mental energy together for something like that, and at the time I was so sick that food was one of the very few pleasures left. The paleo diet made me feel worse by the way! anyway I'll stop going OT now – hope those who can will support this appeal..

Thanks OverThehills. I consulted dr m and also found her very dogmatic re stone age diet. Low carb makes me feel very ill too. I do better with some starch. I probably would do better without the sugar but it's my small daily treat. Sorry for going off track

Esther12 February 10, 2014 at 3:39 pm
anniekim

@esther, thanks for your absolution, it is appreciated. Would you only go down the restricted diet route if Lipkin showed good evidence it would benefit? I think if I. Am honest to myself I would only manage it if I was presented with good evidence for the Benefits of denying myself foods I enjoy. I don't eat much gluten as causes upset tummy but apart from that I don't cut anything else out at the mo

lol – happy to help! I'm really not keen on trying anything unless there's good evidence it will actually be helpful. I think that living with a health problem is hard enough already, and I don't want to waste time and energy on needlessly medicalising extra parts of my life. I prefer to just play about and do what I feel like, and tbh, I think this is probably marginally better health-wise too.

I understand why other people want to try different things just in case the happen to find something that works, but I don't think that this approach should be seen as 'better' or more noble than mine. It is easy to slip into thinking that if you're ill you have a responsibility to recover (and this is sometimes laid out as an explicit part of the biopsychosocial model of disability), but I really don't think that's reasonable if there's no good evidence for how to recover – it just becomes an unfair pressure.

Anyway, best of luck to all, however we decide to manage things. Hopefully researchers like Lipkin will progress in a way which means that we no longer need to work out how to best live with on-going health problems!

Esther12 February 10, 2014 at 3:44 pm
Firestormm

This project, the interview, the many discussions, the sharing of concerns with Columbia, and the final article itself, have taken more time to put together than I think anything else I have worked on since joining Phoenix.

Thanks and congrats to all those involved.

I'll be sure to make a donation at the end of the month, even if it's not a big one. (That way I'll be able to take some credit if it leads to a useful treatment!)

Simon February 10, 2014 at 3:49 pm
ballard

I'm in. We are fortunate to have a researcher of Dr. Lipkin's caliber focusing on ME/CFS. Let's get behind this research in a big way!
Looking at the past history of ME/CFS funding you'd have to say that nobody is going to do it for us.

Wally

We are working on it. The pressure will most likely need to come from Congress and of course a more unified voice from the ME/CFS community. :woot: More to follow on this plan very soon . . . :nerd:lots of :hug: working on this as we speak. ;)

Ember

How refreshing, after the interview with Dr. Unger!
Dr. Lipkin may lose out to this kind of thing…
I believe that Dr. Lipkin used the CCC in defining his cohort. Would he be willing to elaborate?

It occurred to me that the more we can raise a patients for this study, the more it would help put pressure on those in authority with the money – just as MEandYou helped persuade the Norwegian government and research boards to fund the Rituximab trial.

I'm strongly in favour of advocacy (thanks @Wally for all you do) and wonder if the money we give, as well as our voices, can help pile on the pressure.

(@Ember Dr Lipkin said he's planning to use a NIH cohort – pretty sure that was the one recruited for the XMRV study but made available for other studies too and I thought that used CCC – but presume you would know.)

Kate_UK February 10, 2014 at 4:06 pm
Firestormm

N.B. Don't forget when donating, to specify that you would like your money to go to the Microbiome Study. Just to be doubly sure it gets to the right one :thumbsup:

how to do this?

Ember February 10, 2014 at 4:11 pm
Simon

(@Ember Dr Lipkin said he's planning to use a NIH cohort – pretty sure that was the one recruited for the XMRV study but made available for other studies too and I thought that used CCC – but presume you would know.)

This may be the one:

Enrollees have consented to future use and the samples are accompanied with a code so that many characteristics can be matched with each. Inclusion requirements for cases were:

1. Established diagnosis of CFS
2. Meet both 1994 Fukuda and Canadian case definitions
3. Unable to work due to illness
4. Report “viral-like” prodrome
5. Report >/= 2 of the following (SF-36 criteria): vitality <35, social functioning subscale <62.5, role-physical subscale <50
6. Be between 18 and 70 years of age at time of informed consent
7. Ineligible if pregnant, <3 months postpartum or lactating.

Sasha February 10, 2014 at 4:16 pm
Kate_UK

how to do this?

Go here:

https://giving.columbia.edu/giveonline/?schoolstyle=5881&alloc=21677

and enter the amount you want to give, and click 'Next'. On the next page there's a message box – say there that it's 'For the microbiome study'.

Wally February 10, 2014 at 4:31 pm
Sasha

Go here:

https://giving.columbia.edu/giveonline/?schoolstyle=5881&alloc=21677

and enter the amount you want to give, and click 'Next'. On the next page there's a message box – say there that it's 'For the microbiome study'.

Not trying to rain on this parade of "happiness", but did anyone ask Columbia how the donation you make will flow through Columbia. In other words, how much of the donation goes to overhead and how much goes to the actual research? Also, does Columbia take a cut of the donation for a general Columbia University donation account.

I went ahead and contacted Columbia to ask these questions for my own due diligence before making a donation and I will share this information here on the Forum unless someone else has already researched all of this. (@Simon – sorry if this was covered in the article you wrote – I have not had a chance to read it all the way through yet.)

Wally

Simon February 10, 2014 at 4:59 pm
Wally

Not trying to rain on this parade of "happiness", but did anyone ask Columbia how the donation you make will flow through Columbia. In other words, how much of the donation goes to overhead and how much goes to the actual research? Also, does Columbia take a cut of the donation for a general Columbia University donation account.

I went ahead and contacted Columbia to ask these questions for my own due diligence before making a donation and I will share this information here on the Forum unless someone else has already researched all of this. (@Simon – sorry if this was covered in the article you wrote – I have not had a chance to read it all the way through yet.)

Yes, we did ask this, partly prompted by your questions on another thread and the breakdown was given in the article. I do hope you were persuaded to donate by what CII told you.

Actually, the study comes to a bit over a million dollars (see above) – $1.13 million, to which another $140,000 of costs for maintaining the high-tech equipment used and general lab costs making $1.27 million in total. However, the initial target has been set at $1 million.

I would argue the high tech equipment maintenance costs (about $30k, I think) are actually a direct cost of the study, leaving "admin" which includes providing the building, heating and lab benches, general service costs amounting to around 9%. That struck me as fair enough.

Feel free to publish the detail here (assuming it's the same one page breakdown I had) – I checked with Columbia and they were ok for it to go public (but my article was long enough without includig any more budget detail!).

Wally February 10, 2014 at 5:21 pm
Simon

Yes, we did ask this, partly prompted by your questions on another thread and the breakdown was given in the article. I do hope you were persuaded to donate by what CII told you.
I would argue the high tech equipment costs (about $30k, I think) are actually a direct cost of the study, leaving "admin" which includes providing the building, heating and lab benches, general service costs amounting to around 9%. That struck me as fair enough.

Feel free to publish the detail here (assuming it's the same one page breakdown I had) – I checked with Columbia and they were ok for it to go public (but my article was long enough without includig any more budget detail!).

@Simon – Thanks Simon. I will post if I am provided with any information that is different from what you were provided (which I doubt would happen). I do know that some organizations will take a large cut of any fundraising efforts directly for their general fund (which may be a separate cut over and above overhead costs) and only a portion of the funds raised go to the project the funds were raised for. This is something that people need to be aware of when getting involved with fundraising projects. (Like us lawyers like to say "the devil is in the details":devil:)

I hope to be able to provide more information about the ins and outs of fundraising that might be important for our patient community to know before any commitments are made to a big fundraising event. Just juggling a lot on my plate right now and unfortunately all my plates are currently residing with me in my bed. :ill:

Chris February 10, 2014 at 5:58 pm

I am happily in! Lipkin on ME fulfills my definition of a good cause–as did Maria's Rituxumab venture. I think we are going to have to get used to crowdfunding our research, after seeing where NIH puts there money. Just think how we would feel if Lipkin did find a large part of the answer, and the NIH had to deal with that finding. That would give me pleasure out of all proportion to the pain of giving up a couple of little things.
Chris

Legendrew February 10, 2014 at 5:58 pm
MeSci

I think that this research has enormous promise, and crowdfunding is a great idea.

I have one main reservation:

There is likely to be a great deal of interpersonal variability, and we may need very personalised approaches. Presumably the initial part of the research will reveal much of what we need to know about the variability of gut microbiomes.

I cannot see how an animal model will help, if there is so much variability between human patients with regard to genotype, epigenotype (is that a word?), age, environmental factors (e.g. diet and geographic factors), body mass and co-morbidities.

Add to that the substantial differences between humans and other animals: genetics (including different effects of the same genes in different species), natural habits (e.g. diet but also including things such as hygiene with regard to faeces), lifespan, bowel structure and much more, and the very poor record of translatability from animal studies to human patients…

If Dr Lipkin were to state categorically that he would not use animal studies, I would seriously consider donating, as would some other people I know.

You make a lot of good points regarding the potential implementation of an animal study as a part of this larger initiative and I just wanted to record my own opinion on the matter. I recently read a study regarding certain animal species (I believe elephants were one of them) which are born without an established microbiome and rectify this through consuming the feces of healthy adult animals, it sounds awfully similar a process to the fecal transplants discussed in this article so it's interesting to see as a presumably innate behavior exhibited in certain species. This really stands out to me as indicating just how important the microbiome may indeed be.

We know that, in general, animal models have a lot of problems alongside their potential benefits. For quite a while it has been very popular to use animal models – usually mice – to try and simulate human diseases before testing any hypotheses the researchers may or may not have. The obvious problem this brings is that the disease they are studying is not actually the condition from which humans suffer but an analogue produced for the sole intention of being studied, this logically seems a little odd to understand as in many cases since we manufacture the disease using the knowledge we have so you'd think we stand to learn little about the condition other than the response the immune system that particular animal produces which while interesting is more often than not unrelatable to the human immune response.

We do however stand to learn a lot about diseases in which the disease processes are very similar between the animal being studied and within humans. These tend to be diseases which effect bodily organs, tissues or reaction processes that have not changed much throughout evolution – good examples being diseases which affect the organs such as with heart disease, the glands such as hypo and hyperthyroidism and vital biological processes such as respiration and the many diseases which can cause problems here.

As I see it this study is truly investigating two things, the gut microbiome and the immune response that changes in the biome can trigger. It has to be said that we know little about the microbiome overall, its importance is only very recently becoming clear, we do however know that the immune responses in many animals differ to those of humans in certain aspects so that could be a potential problem as this study progresses but it's very difficult to predict given that we know very little of how the gut microbiome and immune system interact with one another. The question then is are microbiomes in animals similar enough to humans to allow us to learn anything from this study and I think that with the little we know it's hard to say but it stands to reason that the gut microbiome is likely fairly unique to each animal, a logical assumption given their diets are very different, points which you have pricked up on and quite rightly so. I do however suspect that the basic mechanisms in place for the interaction between the microbiome and the immune system are likely to have remained a fairly similar process throughout evolution, given how accommodating the gut microbiome is to beneficial microbes I suspect there is a degree of co-evolution between the organism and the microbiome to allow the immune system to be more even more accommodating of these helpful microbes. I do however believe there must be a degree of allowing new microbes to grow in the microbiome as some of these could potentially confer advantages to the organism, whether that be allowing them to digest a previously undigestable food source or otherwise. This openess is something I suspect may lend itself to being quite a consistent feature in many organisms.

While the likely difference in the gut microbiome and different functioning of the immune system seem to imply that the animals model is of little use in this case, I believe that we stand to learn a lot about the intermediate stage of the process; studying the mechanism of the interaction between the two distinct systems. If we can learn more about the processes as they are intended to occur, it makes it a lot easier to spot when something goes wrong as is being hypothesised by Lipkin.

Overall I think this study is very ambitious in nature and we stand to learn a lot from it, not just about the potential importance of the microbiome in ME/CFS but how problems in the microbiome may cause a distinct form of disease. The animal model does have problems as they always tend to, but it seems to me that it plays a relatively small role in this study overall. From a personal standpoint I'm not yet convinced that this is where the true problem in ME/CFS lies, but I think it's certainly worth studying further and I couldn't think of many researchers better to do it than Prof. Lipkin.

Lynne B February 10, 2014 at 7:20 pm

Hi, all. I've just donated from Australia. My very first symptoms were atypical gut problems, followed by all my other symptoms. I've just recently benefited from a course of Rifaxamin. At first I didn't think it had worked, but now, 6 months later, I'm finding I can eat lots of food I haven't been able to eat for 17 years—even garlic! So I think the gut is an important area to research. I'll donate again if it looks like getting up through crowd sourcing. Way to go!

cheers, Lynne

Ruthie24 February 10, 2014 at 8:27 pm

Donated. Seems like this research has great potential as a starting point not only for ME/CFS but for a lot of the other poorly defined, but presumed-to-be-autoimmune, illnesses that kind of look like ME/CFS (but aren't) and frequently seem to "travel along with" GI problems.

I'm sure it's not going to be the answer to every question we have, nor define every subset. I'm sure there will be additional costs etc above the $1 million. The point is…we have a brilliant scientist who wants to do studies that are likely to give us some answers! Even if they're negative answers, they'll be answers. Hmmm $1 mil for Ian Lipkin's research or $1 mil for the NIH sponsored IOM project. Know where I'm putting my money and support. :)

Thanks Simon and Vanessa for getting this going!:thumbsup:

Sushi February 10, 2014 at 8:39 pm

Did it! :)

Sushi

biophile February 10, 2014 at 8:50 pm

Sounds good, but, what happens to the money if the project fails to meet target? If I recall correctly, Kickstarter projects do not charge you unless the project meets the target. I know that may not be common practice for donations, but I am reluctant to make a relatively large donation without knowing what happens if it fails.

vli February 10, 2014 at 9:21 pm

@biophile , I am chasing this particular question–a very good one–up with Columbia since you and a few other patients have already raised it. Columbia knows I am trying to get a crowdfunding campaign going, which WILL allow donors to see how much of the target they've reached and to get their money back if it isn't reached etc., but the PR content team decided that @Simon should first get the article out there, so that we can get a sense of how many would be interested in a microbiome study and willing to donate. I also need lots of help should I launch a crowdfunding campaign because I'm just not strong enough, which is why the end of the article urges readers to join the crowdfunding group I started if you have experience and/or are willing to help–my only way of knowing if a campaign can even be launched.

While I wait for Lipkin's office to answer this question, please know that they have assured me that if a campaign is launched, all gifts made at that link will be transferred to the crowdfunding campaign "pot".

acer2000 February 10, 2014 at 10:24 pm

I think some crowd funding sites don't penalize you for not meeting the target, but I'll admit I'm not an expert.

Firestormm February 11, 2014 at 12:12 am

Some more very welcome news:

We heard last night, that Jen Brea from Canary in a Coal Mine has given her support to the project and is very willing to help where she can. This is just the kind of expertise needed and perhaps a further example of how we can all come together to make such research become a reality.

Thanks Jen :balloons:

vli February 11, 2014 at 12:21 am

Just in case this has been missed

Following the requests of quite a number of members, I have made the crowdfunding group into a private one where I have been updating the group on the news about Jen Brea, for instance. Sorry if this creates inconvenience for some people but members have expressed a desire to throw ideas around but not to have them made public.

Thanks a lot.

Kati February 11, 2014 at 12:40 am

The down side to this crowdfunding efforts is that there is no 'thermometer'- we need to find a way to know how much we've raised so far. It motivates people to give and to ask others to give.

Firestormm February 11, 2014 at 12:57 am
Kati

The down side to this crowdfunding efforts is that there is no 'thermometer'- we need to find a way to know how much we've raised so far. It motivates people to give and to ask others to give.

The means of donating now, from the article above, Kati is an initial one. It simply allows folk to do something now if they wish to. Vanessa is going to regularly update the total raised by this method, and then hopefully we can launch a proper crowdsourcing effort on social media – with targets and more visible updates etc.

You might like to consider joining the Group and share any ideas you might have. With Jen Brea now also on board and others with the expertise, I think the chances are good that we will see a more visible and global effort before too much time has passed.

vli February 11, 2014 at 12:58 am

I agree @Kati –that was what I was trying to say (not very well) before your post. A proper crowdfunding page would have all those features we want–thermometer, with a more staggered approach perhaps where we try to reach the $1 mil goal in several stages, the first being for sample collection and the second for sequencing and analysis and so on–but the article's only been out a day and frankly, we did not know how much interest this project would attract! So again, if you would like to help with putting a campaign together (help that I desperately need!) please join: Lipkin's $1 million dollar appeal

Hope123 February 11, 2014 at 4:13 am

1) So far no great animal models have been developed for CFS. It would be great if one could be but not along the lines of what I've seen. A few studies have used rats forced to run or swim to replicate CFS but that model doesn't make sense to me. I and many others did not get sick merely by exercising or doing more activities. Otherwise, we'd lots more people sick. I think lazy people get ME/CFS too — much like many other medical conditions.

2) I'm glad Lipkin is investigating this but I'd like to hear more from him about why they think the microbiome is a cause. I've not heard a reason yet that makes a lot of sense to me other than statements like the gut makes up a huge amount of the immune system. That is true but so does the skin. It is a non-specific statement.

I do believe that some subset of people do have the gut as a starting point (for example people who started their illness with an enterovirus infection) and others have the gut affected as part of their illness if not the starting point. However, I don't think this will be the origin for others. However, I don't mind being proven wrong at all.

MeSci February 11, 2014 at 4:25 am
Legendrew

We do however stand to learn a lot about diseases in which the disease processes are very similar between the animal being studied and within humans. These tend to be diseases which effect bodily organs, tissues or reaction processes that have not changed much throughout evolution – good examples being diseases which affect the organs such as with heart disease, the glands such as hypo and hyperthyroidism and vital biological processes such as respiration and the many diseases which can cause problems here.

Having studied and worked in this area of science for a number of years (species differences in relation to animal 'models') I can tell you with certainty that there are reams of papers that discuss crucial differences that invalidate the entire 'animal model' paradigm. It's unfortunate that a large report I produced for a client in 2010 was not published. I am working on a blogpost specifically relating to the type of animal study proposed here, but it will take a while.

In the meantime here is a small extract from my report that illustrates the general problems and also refers to major heart differences:

A 2008 analysis of 27 reviews examining well over 1,000 animal experiments found that only one – possibly two – of these experiments showed the potential to be useful in advancing medical progress, and not one of the toxicity tests studied was useful in predicting toxicity in humans (Knight, 2008). Another two analyses of substantial numbers of animal studies found that animal research data were only predictive of results in humans about half of the time (Langley, 2009, Perel et al., 2006).

The use of dogs and pigs in highly-invasive heart research which requires their deaths is an example of the error of animal ‘models’, as illustrated in a video lecture (ten Tusscher, 2007). The speaker points out how ventricular fibrillation (VF) – the commonest cause of sudden cardiac death, which is suffered by hundreds of thousands of people every year – appears to be significantly different between human hearts and dog and pig hearts.

The relevant references are:

Knight, A. (2008) Reviews of Animal Experiments Demonstrate Poor Contributions Toward Human Healthcare, Reviews on Recent Clinical Trials, , vol. 3, No. 2, pp. 89-96

Langley, G. (2009) The validity of animal experiments in medical research/validité de l’expérimentation animale en recherche médicale, Revue Semestrielle de Droit Animalier, vol. 1, pp. 161-168

Perel, P., Roberts, I., Sena, E., Wheble, P., Briscoe, C., Sandercock, P., Macleod, M., Mignini, L.E., Jayaram, P. and Khan, K.S. (2006) Comparison of treatment effects between animal experiments and clinical trials: systematic review, British Medical Journal, 334 (7586): 197, online at http://www.bmj.com/cgi/content/full/334/7586/197

ten Tusscher, K., Department of Theoretical Biology/Bioinformatics, Faculty of Biology, Utrecht University (2007) Ventricular Fibrillation in the Human Heart. Why is it different from Fibrillation in the Dog and Pig Heart? Video lecture, text, diagrams and slides online at

http://videolectures.net/eccs07_tusscher_vfh/


I haven't checked the URLs – they may no longer work.

A 50% predictability rate means that one may as well toss a coin.

aimossy February 11, 2014 at 5:44 am

Just uneducated thoughts here.
Part of me wonders about kickstarter because they take a percentage and also there is a time limit….money is lost for the project if it doesn't succeed and we need to make this happen. Well in my view:)
I like the UK invest in ME rituximab face book page because it keeps you updated, plus there is no set time limit so money is not lost. It"s more like a goal to achieve.

Maybe I like the idea of cutting out the middle steps.;)
Anyway, in saying that it might make things slower. I would personally like to see it well plugged and even possibly by ME organisations. New research may publish shortly which could spur things on brightly as well.
Lots of factors to take into account.

I would love to help out @vli but lack the skills/knowledge you probably need for your group.o_O:)

anniekim February 11, 2014 at 5:53 am

Can I just ask was it Lipkin himself who said that depending on what the study finds treatments may involve antibiotics, probiotics and restricted diets? Many thanks

Jo Best February 11, 2014 at 6:05 am

This is excellent news, thanks to all involved! The lack of government initiative and funding is the reason we patients launched the "Let's do it for ME!" campaign in July 2011 in support of the work of Invest in ME charity and to raise funds for their strategy for translational biomedical ME research. The first £100k raised has fully funded the foundation research project on the gut microbiome in ME at top UK University of East Anglia/Norwich Research Park, where the Institute of Food Research and The Genome Analysis Centre are also based. Here's the link to the latest update and FAQs about the UK gut microbiota: http://www.investinme.org/LDR%20newslet%201312-01.htm
Professor Simon Carding will be speaking about the UK gut microbiota research at the 2014 Invest in ME conference, and Dr. Mady Hornig will be speaking about pathogen discovery in ME. Here's the link to the agenda so far: http://www.investinme.eu/agenda.html

Forbin February 11, 2014 at 6:39 am

If you watch the last 8 minutes or so of the lecture Dr. Lipkin gave at Oxford last year (originally posted on this thread by Simon in post #24) you can see that Lipkin's interest in the microbiome / microflora and the immune response to infection is not limited to ME/CFS. In the close of his lecture, he discusses immune response and micobiota in the context of other diseases. Jump ahead to 48:25.

Simon February 11, 2014 at 7:55 am
Hope123

I'm glad Lipkin is investigating this but I'd like to hear more from him about why they think the microbiome is a cause. I've not heard a reason yet that makes a lot of sense to me other than statements like the gut makes up a huge amount of the immune system. That is true but so does the skin. It is a non-specific statement.

I do believe that some subset of people do have the gut as a starting point (for example people who started their illness with an enterovirus infection) and others have the gut affected as part of their illness if not the starting point. However, I don't think this will be the origin for others. However, I don't mind being proven wrong at all.

I agree that the microbiome is unlikely to account for everyone's illness – indeed I doubt that any one thing could account for everyone's illness and I suspect even ME (let alone CFS) will turn out to be multiple diseases.

While there is certainly a degree of non-specificity in this approach – 'the immune system is activated, so who or what pulled the trigger?' is part of the rationale,I think it's worth pointing out that the gut microbiome is a much better candidate than, say. the skin. So it's not quite a case of 'could be this, could be anything'. here's a bit more info:
- there are more microbes in the gut than anywhere else in the body, by a trillion or so.
- there are way more immune cells in the gut than anywhere else in the body
- the gut has – has to have – a permeable lining to take food on board, making the contact between immune system and gut particularly itimate.
- there is an intimate and complex relationship between the microbiome and the gut immune system that is only beginning to be understood. For example, in gnobiotic mice (raised in sterile conditions, with no microbiome as a result), the immune system doesn't develop properly – in particular it doesn't regulate itself properly and is prone to inflammation. Interesting article on this from Science Daily
- and of course many people with ME/CFS have gut problems such as food sensitivity.

The gut microbiome is an exploding area of research and being linked to a number of diseases. This blog has more information Gut bugs misbehaving? The microbiome and ME/CFS

anniekim

Can I just ask was it Lipkin himself who said that depending on what the study finds treatments may involve antibiotics, probiotics and restricted diets? Many thanks

Yes, that's what Lipkin said – the antibiotics were as in 'antibiotics followed by probiotics', since antibiotics will wipe out much of the microbiome. He also mentioned faecal transplants were a possiblility – certainly they were used very successfully to treat drug-resistant C difficile infections. But exactly what treatment is appropriate (if any) will depend on the findings of this research.

Sasha February 11, 2014 at 8:20 am
Legendrew

The animal model does have problems as they always tend to, but it seems to me that it plays a relatively small role in this study overall. From a personal standpoint I'm not yet convinced that this is where the true problem in ME/CFS lies, but I think it's certainly worth studying further and I couldn't think of many researchers better to do it than Prof. Lipkin.

Hi Legendrew – very interesting post. Just to be clear, the animal model plays no role at all in the study we're being asked to fund. Lipkin said that an animal model is one option that he might consider, depending on the results of the study. And, depending on which, if any, bugs are associated with ME, it might make more sense to go straight to therapeutics – the animal model stuff might never happen.

Firestormm February 11, 2014 at 8:42 am
Forbin

If you watch the last 8 minutes or so of the lecture Dr. Lipkin gave at Oxford last year (originally posted on this thread by Simon in post #24) you can see that Lipkin's interest in the microbiome / microflora and the immune response to infection is not limited to ME/CFS. In the close of his lecture, he discusses immune response and micobiota in the context of other diseases. Jump ahead to 48:25.

Forbes – cool lecture wasn't it? I thought when I watched it 'where the heck is he going with it?' expecting more of a science lecture, but I think he made the points well, and I have to mention to @Bob because I forgot to (when Simon drew my attention to the lecture whilst working on the article), that Lipkin also uses the Star Trek scanner as an example of what might be possible in the very near future! :)

But yeah, I think focusing on the last section of the presentation is probably best for relevancy on this thread. Interesting when you stop and think about the things we eat – not that they might be carrying some infection per se – but in the vast array of good and bad that could be present in our guts. I'd be interested to learn – if nothing else – what differences and similarities might be found in comparison with the controls.

It's like Star Trek again: …to boldly go where no one has gone before… :thumbsup:

Jo Best February 11, 2014 at 11:21 am
Sasha

Very true! I think they raised the money first over a considerable period of time (2 years?) before deciding what to spend it on (somebody correct me if I'm wrong). It would be interesting to know what would have happened if they'd specified the project beforehand. I think that's crucial to rapid success – an exciting project that everyone wants to get behind.

But you're right, £100k is a lot (about $150k) and the UK is only about 63 million people – a fifth the population of the US. The US (and us overseas patients donating too) should be able to crack $1 million in about five minutes. :cool:

Hi Sasha, I'm new to the forum, so I hope I'm doing this right :-) I'm very pleased to let you know that, far from raising funds before deciding what to spend it on, the fundraising for the Invest in ME/UEA gut microbiome study was the first of such campaigns to set a target amount for a specified research project and was initiated by patients. This was a new approach to fundraising for ME research and these factors contribute to why it took almost two years to raise the initial £100k. The Let's do it for ME! campaign was launched in July 2011 by three people with severe ME to a) help raise awareness of Invest in ME's proposal to establish a centre of excellence for translational biomedical ME research: the first of its kind in UK/Europe and b) raise funds for the research. We set the initial fundraising target at £100k to fully fund the foundation project of the research strategy – the gut microbiome study, which Professor Simon Carding will speak about at the 2014 IiME conference (IIMEC9). Invest in ME also produced their gut study posters to help advertise this. We formed a core online planning group to develop the campaign and now have a global community of supporters and we proactively support other ME advocacy and fundraising campaigns and causes. IiME's announcement at their conference last May (IIMEC8) that the initial fundraising target had been acheived was a great boost to get us up and running (so to speak!) with phase two of the fundraising: for the UK rituximab study being organised by Invest in ME with the Clinical Trials Unit at University College London :-)

Simon February 11, 2014 at 11:30 am

Things seemed to have calmed down a fraction after a manic 24 hours or so, a chance to say thanks to everyone who is making this happen

Rolls of honour

Donors declared on this thread

aimossy

I AM IN!!!

acer2000

I am in and I will tell my friends and family!

Marco

I've just donated.

Dreambirdie

I donated.

ballard

I'm in

anniekim

I will certainly donate

OverTheHills

I donated to Maria's Norwegian Rituximab thing… and I'll be donating to this one too.

Firestormm

I don't think I have donated to a specific research project for several years. Funds never really permitted me to. But this one has just received a donation I am delighted to report :balloons:

Esther12

I'll be sure to make a donation at the end of the month, even if it's not a big one. (That way I'll be able to take some credit if it leads to a useful treatment!)

Chris

I am happily in!

Lynne B

Hi, all. I've just donated from Australia. … I'll donate again if it looks like getting up through crowd sourcing.

Ruthie24

Donated.

Sushi

Did it!

Sasha

I've donated. :)

Also @Wally and @biophile say they are considering but need a bit more info.

Initial Team
Vanessa Li (@vli) started this whole thing off by contacting Ian Lipkin's team, which led to the offer of the interview. She, @Firestormm and @Sasha spent countless hours over the last month discussing the research project, how best to explain it, getting the extra info we needed from Columbia, discussing timing and crowdsourcing plans, and more (especially editing – thanks Fire). It was an unbelievable amount of work for everyone, and sometimes it seemed we'd never get there. Thank you all – esp Vanessa without whom nothing would have happened and who has pushed on despite very poor health.

The fundraising group: Lipkin's $1 million dollar appeal
Currently has 25 members signed up. I think this group is essential if we are to hit the million dollar target. Thanks to all who have joined and still room for more!

Everyone on this thread
Wow, 1,764 views, 68 comments and 206 'Recommended' on facebook – zero is the normal number for recommendations of the thread (as opposed to the blog itself).
View attachment 6423

Dr Ian Lipkin
Well, obviously for the study, but also for being generous with his time for the interview: nearly thre-quarters of an hour with someone who clearly had never interviewed anyone before :whistle:. Also to Dr Mady Hornig who will be Principal Investigator on the project and has done much of the planning work.

Thank you – and take a bow all

Sasha February 11, 2014 at 12:05 pm
Simon

Things seemed to have calmed down a fraction after a manic 24 hours or so, a chance to say thanks to everyone who is making this happen

Thanks, @Simon – actually I don't recall doing much in the 'making it happen' stakes but I've donated. :)

Thanks to you (you did't thank yourself!) for all you've done on this project – you're a star. :thumbsup:

Sasha February 11, 2014 at 12:06 pm
Jo Best

Hi Sasha, I'm new to the forum, so I hope I'm doing this right :) I'm very pleased to let you know that, far from raising funds before deciding what to spend it on, the fundraising for the Invest in ME/UEA gut microbiome study was the first of such campaigns to set a target amount for a specified research project and was initiated by patients.

Thanks, Jo – good to know. :)

Firestormm February 11, 2014 at 12:20 pm

Oh! So that's what that means at the bottom of this page! Recommend to Facebook. Oh very clever…. I am such a plonker. Never noticed it before :oops: :D

Daisymay February 11, 2014 at 2:58 pm

This is brilliant, thanks so much to everyone involved, donated and will pass on. I agree with others it would be good if we could see a thermometer to see the money coming in.

5150 February 11, 2014 at 5:30 pm

The AIDS community needs to step forward on this project! When your butts were on the line, many non-AIDS people within the community of Caring People sprang forward to your assistance. I was one of them, and my entire family has contributed to Aids treatment since the beginning: 1982.

Now, it would say "Thank You" to all those who aided your cause, by all of you paying it forward to our millions who now are suffering from ME. God knows, we need the help.

It's a challenge you all should warmly embrace. The opportunity to be of service is a blessing.

5150 February 11, 2014 at 5:33 pm
5150

The AIDS community needs to step forward on this project! When your butts were on the line, many non-AIDS people within the community of Caring People sprang forward to your assistance. I was one of them, and my entire family has contributed to Aids treatment since the beginning: 1982.

Now, it would say "Thank You" to all those who aided your cause, by all of you paying it forward to our millions who now are suffering from ME. God knows, we need the help.

It's a challenge you all should warmly embrace. The opportunity to be of service is

The Opportunity to be of Service is, A Blessing.

vli February 11, 2014 at 7:45 pm
Simon

Things seemed to have calmed down a fraction after a manic 24 hours or so, a chance to say thanks to everyone who is making this happen

@Simon , thou art too humble… obviously the two people I owe the greatest thanks to are yourself and @Firestormm , about whom I can say the same thing–without either of you this also would not have happened! Shouts out also go to @Sasha , @Legendrew, @Mark and any other member of the Content Team I might've missed.

Thought I would take this opportunity to report that Columbia has informed me that, from 10/2013-2/2014, they have received 14 gifts for ME/CFS research totaling $2,935 :balloons::balloons::thumbsup: Unfortunately I do not know how much of that total went to the microbiome study, and I strongly suspect that not all donations given after Simon's article came out have been processed (seeing that I only sent Columbia this enquiry yesterday evening). If you would like me to find out please tag me in a reply and I will ask how much of that total went to the microbiome study specifically.

:woot: THANK YOU EVERYONE!!! :thumbsup:

vli February 11, 2014 at 8:32 pm

Just wanted to add that the $2935 figure is definitely NOT accurate (it has to be more than that amount) because Columbia counts 14 gifts and Simon counted 14 declared donors on this thread–and I know for a fact there exists at least a handful of folk who gave but who did not declare it! This is where a crowdfunding thermometer would be most helpful–available if we put a crowdfunding campaign together :)

Esther12 February 11, 2014 at 8:46 pm
vli

Simon counted 14 declared donors on this thread

I'm going to have to wait a month… I've not donated anything yet!

dannybex February 11, 2014 at 9:19 pm
anniekim

Thanks OverThehills. I consulted dr m and also found her very dogmatic re stone age diet. Low carb makes me feel very ill too. I do better with some starch. I probably would do better without the sugar but it's my small daily treat. Sorry for going off track

I have great respect for Dr. Myhill, but the notion that there is or should be 'one' diet for all people, sick or not, just defies common sense. Increased levels of carbs are recommended by many if one has cortisol issues…which many of us have.

Daffodil February 12, 2014 at 12:17 am

I haven't read most of this thread, but haven't there already been studies on gut bacterial profiles of CFS patients? it seems that demeirleir's team, who has already tested actual gut tissue, found HERV proteins and is now looking into why HERV proteins are expressed, is way ahead of lipkin.

Kati February 12, 2014 at 12:22 am

For the record, I have made a donation to Columbia as well.

Jon_Tradicionali February 12, 2014 at 1:38 am
Daffodil

I haven't read most of this thread, but haven't there already been studies on gut bacterial profiles of CFS patients? it seems that demeirleir's team, who has already tested actual gut tissue, found HERV proteins and is now looking into why HERV proteins are expressed, is way ahead of lipkin.

My thoughts exactly.

KDM has figured this out long before Lipkins idea for this study. Plus there have been countless other studies which have been conducted on the microbiome and its role in human disease.

But I guess it's still great that we are getting closer to finding a concrete cause and subsequent treatment.

Sometimes I wonder if it will hold much value after some, such as myself, have already lost decades of life.

vli February 12, 2014 at 2:04 am
Daffodil

it seems that demeirleir's team, who has already tested actual gut tissue, found HERV proteins and is now looking into why HERV proteins are expressed, is way ahead of lipkin.

Jon_Tradicionali

KDM has figured this out long before Lipkins idea for this study.

I can certainly understand if there are members who feel this way.

However when I was asking around for opinions (which occurred before the article was published), a De Meirleir supporter pointed out to me the fact that De Meirleir did not make an appeal to the public specifically and neither does he have a study "ready to fund", while Dr Lipkin did and does.

I would be very happy to donate to any campaign that could be drawn up to support a De Meirleir study into HERVs, if he has one :)

Jon_Tradicionali February 12, 2014 at 2:22 am

@vli

The only missing link in the CFS bubble is the greed and pride of each and every CFS "specialist" which has resulted in extremely limited collaborations and subsequently extremely limited results.

It is 2014 and the CFS pandemic has not been solved yet. It will be 2020 and I bet it would be the same old story.

People like us on PR being our own investigators.

Thumbs up to Lipkin saying he is in a hurry to want to solve an overdue mystery. Even if KDM has already provided the blueprint years ago.

vli February 12, 2014 at 2:52 am

@Jon_Tradicionali

I agree the funding situation regarding ME is far from ideal to say the very very least. However, I think the whole reason I contacted Lipkin in the first place is that I would feel worse than I did if I did nothing. Now, if De Meirleir draws up a study and appeals to us to fund it I think posts like yours, and Daffodil's, are proof that he would have people backing him and organising crowdfunding for him almost immediately… neither Lipkin nor anyone here is preventing that from happening, and like I said I would be more than happy to give to a crowdfunding campaign for Prof. De Meirleir.

Sean February 12, 2014 at 3:20 am

Is there any reason that the work of both Lipkin AND De Meirleir cannot be supported by the patient community? :rolleyes:

As to donating to Lipkin's study, I will chip in a $100 AUD (and pretty sure I can get one two family and friends to donate), as soon as I know what happens to the money if we don't reach the target amount (or enough of it to get the study underway while we look for more funds).

Well done, Simon, for scoring the interview, and thanks to Dr Lipkin for giving you the time.

August59 February 12, 2014 at 3:46 am

This study could be a very, very good thing for us. I also, and I believe Dr. Lipkin does to that the science and data from this study could reach way past ME/CFS patients well into other diseases with unknown cause. As well it could lead to better and more efficient treatments for many known diseases that currently have treatments available.

This is what I wish the NIH and CDC could envision and do what it takes to get this study completely funded now!!!!

I believe it is time to write my senator another letter! In the mean time I think I might have a yard sale to see how much I can come up with to make my contribution. If we have to build this road one brick at a time, then that's what we have to do. We should be use to it as we have done before in some form or fashion!

Ritto February 12, 2014 at 3:53 am
vli

Just wanted to add that the $2935 figure is definitely NOT accurate (it has to be more than that amount) because Columbia counts 14 gifts and Simon counted 14 declared donors on this thread–and I know for a fact there exists at least a handful of folk who gave but who did not declare it! This is where a crowdfunding thermometer would be most helpful–available if we put a crowdfunding campaign together :)

For the number count, I donated a week ago.

Bob February 12, 2014 at 3:57 am

I'm really excited about all the donations that folks are making. :thumbsup:
I just wanted to briefly say that if anyone can't donate, then they shouldn't feel at all guilty about it.
We all do what we can, when we can.
Only donate what you can afford.
And no one should feel excluded from this thread if they can't make a donation.
Just wanted to say that in case some people are feeling bad about not having any spare cash. (I expect that most of us have cash problems.)
:hug:

Firestormm February 12, 2014 at 5:04 am
Daffodil

I haven't read most of this thread, but haven't there already been studies on gut bacterial profiles of CFS patients? it seems that demeirleir's team, who has already tested actual gut tissue, found HERV proteins and is now looking into why HERV proteins are expressed, is way ahead of lipkin.

Jon_Tradicionali

My thoughts exactly.

KDM has figured this out long before Lipkins idea for this study. Plus there have been countless other studies which have been conducted on the microbiome and its role in human disease.

But I guess it's still great that we are getting closer to finding a concrete cause and subsequent treatment.

Sometimes I wonder if it will hold much value after some, such as myself, have already lost decades of life.

Morning :)

The article at the top of this thread, links to Simon's initial article about the Microbiome in several places, where he talks about previous and current research, including the ongoing study from Invest in ME in the UK:

Microbiota and ME/CFS
Gastrointestinal symptoms are common in ME/CFS and could be linked to microbiota problems, and even chronic inflammation. Research on the microbiota is just beginning to appear in the ME/CFS literature:

  • Professor Kenny De Meirlier’s small 2013 study on the microbiota of patients from Norway and Belgium had mixed results with differences seen between Norwegian patients but not between Belgian patients and controls.
  • A recent paper details 60 CFS cases treated (in the 1990s) with colonic ‘bacteriotherapy’ and reported a 58% rate for “resolution of CFS symptoms”, though it wasn’t clear how the study measured outcomes.
  • Pilot results from a CAA-funded microbiome study by Dr Shukla indicated that the microbiome of CFS patients responds differently to exercise than healthy controls. Data from the full study is now being analysed.

Two important new microbiome studies underway
Invest in ME have raised £100,000 (wow) for a microbiome study aiming to establish ‘whether microbe-driven inflammatory responses can provide an explanation for the pathophysiology of ME’. The study, run by the impressive Professors Tom Wileman at the University of East Anglia and Simon Carding at Norwich, began last October as a three-year studentship and initial results could emerge in 2015. They will be looking at the microbiota of ME patients including both bacteria and viruses, testing for leaky gut and using metabolomics to look at the metabolism of the whole microbiota.
Professor Ian Lipkin is focused on the microbiota for the same reason, particularly because his latest study found evidence of abnormal immune response in ME/CFS patients – could the microbiota be the cause? …

I think the main point for me about past research, has been its relative size and competence in comparison to that proposed from Lipkin and his team. I also think that this area is worth investigating further with this proposed study from Lipkin because, at least in part, our forums that talk about the Gut and Treatments for gut issues, as well as diet etc. are one of the most active places on the entire site. It is clearly an area of importance to a great many people.

Lipkin, if we can raise the money, will be looking at 100 patients and 100 controls in a way that has NEVER before been done – there is a reason it will cost so much – and a reason why perhaps previous studies have really only touched the surface.

Also, remember, that included in this study, Lipkin and his team will be seeking to confirm their initial work relating to cytokines and immune activation – work that you will hear more about and I hope also be excited by, when the submitted paper is published – hopefully very soon – perhaps even next month.

When Lipkin looks at the microbiome it will be with more tenacity and scope in the search for pathogens and patterns, than anything that has gone before. It could help confirm De Meileir's treatment practices, and any others we hear about involving anti-biotics and pro-biotics, and the presence of specific bacteria etc. but in any event it will shed much needed light on this entire ecosystem and it's potential role in ME.

And once he gets the money, Lipkin has said he estimates it taking only a year to complete! :)

I have a great deal of confidence in the competence of Lipkin and the expertise he and Mady Hornig have put together at Columbia. This is great news for the ME community :)

Firestormm February 12, 2014 at 5:12 am
Bob

I'm really excited about all the donations that folks are making. :thumbsup:
I just wanted to briefly say that if anyone can't donate, then they shouldn't feel at all guilty about it.
We all do what we can, when we can.
Only donate what you can afford.
And no one should feel excluded from this thread if they can't make a donation.
Just wanted to say that in case some people are feeling bad about not having any spare cash. (I expect that most of us have cash problems.)
:hug:

I agree Bob. As I said earlier in the thread, this is the first study I have not only felt I really wanted to invest in, but it's the first time really I have been able to invest. And I do regard all donations as investments. But that said:

There is no minimum donation amount to Columbia and I don't believe there should be any minimum when the main campaign comes on stream either, other than $1.

$1 from 1million people. $10 from 100,000 people. $100 from 10,000 people. $1,000 from 1,000 people. $10,000 from 100 people.

We can all I think do something, even if it is alerting others to the Appeal and sharing the article on Facebook or re-tweeting it (whatever that means!) or passing it among our Support Groups locally. And if we cannot afford to make a donation, then perhaps we know someone who will.

If 1 million patients can't raise $1 million, then it wont take many outside of the American patient community to lend a hand and achieve the goal.

Good luck to everyone :thumbsup:

MeSci February 12, 2014 at 5:17 am
Jo Best

This is excellent news, thanks to all involved! The lack of government initiative and funding is the reason we patients launched the "Let's do it for ME!" campaign in July 2011 in support of the work of Invest in ME charity and to raise funds for their strategy for translational biomedical ME research. The first £100k raised has fully funded the foundation research project on the gut microbiome in ME at top UK University of East Anglia/Norwich Research Park, where the Institute of Food Research and The Genome Analysis Centre are also based. Here's the link to the latest update and FAQs about the UK gut microbiota: http://www.investinme.org/LDR newslet 1312-01.htm
Professor Simon Carding will be speaking about the UK gut microbiota research at the 2014 Invest in ME conference, and Dr. Mady Hornig will be speaking about pathogen discovery in ME. Here's the link to the agenda so far: http://www.investinme.eu/agenda.html

Here is some more info about the Invest in ME research (private email):

The gut microbiome research being started is not using animals. It aims to establish a cohort of patients who will participate in the research using faecal samples from the patient cohort which are then are analysed by genome sequencing.

The rituximab clinical trial administers the rituximab drug under trial conditions.

We have no funding toward animal research in mind or planned.

MeSci February 12, 2014 at 5:19 am
Firestormm

And once he gets the money, Lipkin has said he estimates it taking only a year to complete!

Does anyone else think that this sounds unusually fast and perhaps over-optimistic?

Bob February 12, 2014 at 5:21 am
MeSci

Does anyone else think that this sounds unusually fast and perhaps over-optimistic?

If he is using the samples from his earlier study, then I think that may explain the unusually fast estimated turn-around time.

Firestormm February 12, 2014 at 5:25 am
MeSci

Does anyone else think that this sounds unusually fast and perhaps over-optimistic?

Back up a bit on this thread (last page I think) and see Lipkin's presentation to Oxford from December 2013. He talks about how things have become so much quicker and more accurate in terms of processing. I also think this helps explain the optimism in his estimated time-frame. Of course it will depend on when he can begin, and I dare say other factors such as ensuring his team are all available, and the speed with which samples can be collected accurately etc. etc. But Columbia has the technology and expertise. Though as you know MeSci, there are no guarantees, hence it is an estimate.

Jo Best February 12, 2014 at 5:32 am
anniekim

Hi Sasha,

At the time invest in Me said they wanted to set up the first research centre and clinic for pwme in the UK at East Anglia university which would offer research then translational (is that the right word?) treatments to patients. So there was a target so to speak which is why I think people got behind it. As it happens the money is going towards the gut study at the. University. Am not sure where they are at at getting a doctor to see patients. I think they are having problems with the university to agree to it. I think it took about 18 months to raise the money, but perhaps it was 2 years, sorry can't remember[/quote

Hi anniekim, yes, Invest in ME announced their proposal for the translational biomedical ME research centre at their conference in 2010 and published the proposal on their website. The idea was for patients examined by an ME consultant at the hospital to take part (according to patient selection criteria) in research at the University of East Anglia/Norwich Research Park (where The Genome Analysis Centre is based) and yes the idea is that the research will translate to treatment/s. They felt that a study of the gut microbiome was a good starting point for the research strategy and they devised this in 2010 with an estimated cost of £100k. Professor Simon Carding gave a talk on the gut at the May 2011 Invest in ME conference. I am the initiator of the patient campaign launched in July 2011 to show community support for the proposal and to raise the £100k for the gut study, called Let's do it for ME! It did take us almost two years to raise the funds but we were three people with ME starting from scratch from our homes/beds, and this was a new way to raise funds for ME research (we're heading towards the next target of £350k needed for the UK rituximab and related B cell study that Invest in ME is organising with the Clinical Trials Unit at University College London at a much faster rate – £283k raised since IiME announced this on 6th June 2013). The sticking point in East Anglia had been the hospital agreeing to an ME consultant, but Norfolk PCT agreed to fund a consultant for the patient examinations and said that clinic space would be made available, so good progress was being made by IiME until the NHS reforms caused the PCTs to be disbanded. As there is still no ME consultant in Norfolk, patients for the gut study will be selected from the patient database of Dr. Bansal from St Helier and Epsom Hospital Trust in Sutton. The latest update on the IiME/UEA UK gut microbiome study is here: http://www.investinme.org/LDR newslet 1312-01.htm

Tuha February 12, 2014 at 5:34 am

Center for Infection and Immunity posted Simon´s article on their facebook page. Maybe we can "like" it or post some comments to show our interest and support. Here you can find it:
https://www.facebook.com/CII.Columbia

vli February 12, 2014 at 5:34 am
Firestormm

If 1 million patients can't raise $1 million, then it wont take many outside of the American patient community to lend a hand and achieve the goal.

Love this @Firestormm! :D :D
@MeSci I just wanted to say I'm aware of your fears; I'm not oblivious to them. However I'm not up to scratch on the science frankly and I'm in no position to argue with you about whether the microbiome of a human could be successfully replicated in an animal (or if that work would even show anything). However I'm not sure but I think I pleaded to Simon and Sasha to answer you, and I think they did. I hope their replies were at least satisfactory to you.

Simon February 12, 2014 at 5:39 am
MeSci

Does anyone else think that this sounds unusually fast and perhaps over-optimistic?

Not at all. Remember, Ian Lipkin is part of the World Health Organisation global pandemic surveillance and action system. Pandemics don't wait for scientists to spend a couple of years figuring out what's going on: fast is the way he works.

As far as the study goes, they already have a cohort lined up (from the original NIH/XMRV study) and a network of physicians ready to check the diagnosis of those patients, take and ship samples. His team have a lot of experience of the high-throughput sequencing approach required (Lipkin has done a lot to develop such tools himself), PCR assay development and antibody test development. He has over 60 people working for him at the Center for Infection and Immunity and can commit a lot of man/woman power to the project – and has done so already in the ME/CFS pathogen/immune study.

So 'within a year' is not unusually fast by Ian Lipkin's standards. Probably the hardest and slowest part is assembling the diagnosed cohort and network of physicians needed (which is what held up the original XMRV study) – but that has already been done. The project is planned, cued up and ready to go – once the cash is there.

Firestormm February 12, 2014 at 5:41 am
Tuha

Center for Infection and Immunity posted Simon´s article on their facebook page. Maybe we can "like" it or post some comments to show our interest and support. Here you can find it:
https://www.facebook.com/CII.Columbia

Thanks for letting us know, Tuha! Brilliant :)

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