USA: NIH National Institutes of Health news

THIS
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Yep, thanks for brining that perspective Trish. Sometimes I forget how much worse off we’d be without the prior fights that were won.

 

@Trish I used the word “harp” which seems to have upset you. I don’t know if people are continuing to voice disapproval, or if he is just upset at the initial reaction.

We absolutely had a right to voice our disapproval and even though I don’t think he understands or is willing to admit error publicly, I would hope our negative response would help inform further decisions and planning. However, I think it’s done now, and IMHO it behooves us to move on.

I would look at the UK and US situations as v different. Nothing happened research wise or was planned after PACE that could have been focused on instead. PACE informed public health policy in a country where most healthcare is publicly provided. Its 100% wise to have protested this, NICE and Cochrane.. but, NIH is not the same thing. NIH’s research programs are faster moving and vastly better funded and much larger in scope than the situation in the UK. Their activities are much more linked to industry and pharma and drug development than health policy.

The bad parts of the deep pheno study will end up forgotten in the years to come as Recover produces vast amounts of data, and hopefully the good parts will stimulate further. We should ride that, in my opinion. Ravi’s point about the massive amount of funding is true.. we have to work with them and not alienate them.

 

To address specific points.


First, it isn’t about blame, it’s about strategy, and to do effective advocacy you have to think very seriously about strategy – figuring out what approach works in a given situation and what approach doesn’t work. Part of my criticism of the response to the Walitt-Nath study is that it’s a very different situation to the PACE trial. The ME community’s advocacy against the PACE trial was extraordinary, and incredibly impactful – but that same playbook isn’t necessarily always the most effective way to go. The PACE trial had an enormous impact on global guidelines around treatments for ME, but the intramural study is a completely different kettle of fish. "Effort preference" is bad and somewhat dangerous, but is far less dangerous than proposing CBT and GET are effective treatments. In addition, judging by the way Nath is increasingly reacting to the criticism, the current approach doesn’t particularly seem to be working in this case.


Second, I think it’s incredibly important to talk about the relative balance between focusing on research funding and responding to the BPS cabal, both more generally and in this case. In terms of the intramural study – it seems to me that there’s far more to be gained from focusing on research funding than rebutting the study because you’re dealing with the largest global funder of biomedical research. That isn’t to completely dismiss the need to rebut the study. But dealing with the NIH is different to dealing with Sharpe et al. – the UK’s BPS cabal solely needs to be kicked into touch, whereas the NIH is the only institution with the resources to actually change our lives by funding science that leads to effective treatments. Ideally, we need to find a way to sideline the likes of Walitt while simultaneously demanding more research funding.


In terms of that balance on a more general scale – I do think Long Covid advocacy strikes a better balance between research funding and responding to the BPS cabal. There are of course powerful historical reasons for this – the Long Covid community hasn’t had to spend decades fighting against BPS figures and there has been far more funding for Long Covid research in the past 4 years than probably ME has ever received, so there’s just far less need to respond to bad studies. It’s also important to say that the ME community has done extraordinary advocacy in response to the BPS cabal. But I do think there’s a need to change tracks in a post-PACE trial world. The only thing that can truly “end” the BPS cabal and lead to effective treatments is large-scale research funding.


Finally, I don’t think it’s a question of whether the LC or ME community are “better.” I have been very critical of parts of LC advocacy; you have LCAP, a group that is doing extraordinary damage to the community and that is producing very poor quality advocacy; in my view the Long Covid community took too long to shift focus from advocating for pandemic protections (which are absolutely needed, but is a losing battle in 2024) to research funding. These criticisms of the LC community don’t mean that I’m “blaming” them – I’m just trying to have a conversation about strategy. Imo the Long Covid and ME communities need to learn from each other – the Long Covid community has a lot to learn from the ME community in terms of the decades of fighting psychologization. The ME community could do with taking the Long Covid community’s lead in terms of the political fight for more research funding.

 

The NIH have dragged their heels for decades to avoid funding ME research, and avoiding approving ME research funds applications. While vilifying the patients, with prejudice and contempt for us.


A shocking incident occurred a few years ago. When asked why the NIH committee for approving ME/CFS research grants was not named, when in every other disease the committee members are named:

NIH's Vicky Whittemore explained that the committee members were 'frightened' because 'NIH members had been subjected to 'death threats' from ME 'activists'. When dug into, the lurid story was debunked, and brought down to an anonymous supposed 'threat' by a person who claimed to be a journalist, that was only tangentially related to a researcher who was not involved with the NIH, nearly 10 years earlier.



EDIT Add:
The so called 'journalist' had asserted that 'armed ME activists were planning to march on the NIH and CDC'.

Yeah. Right.


Further investigation into NIH employees' 'fears' of ME patients led straight to UK media stories about so called 'ME activists and death threats against researchers'. The same claims of 'harassment and death threats' that were later debunked in court, at the PACE FOI Tribunal, where no evidence was produced, and by emails/transcripts at the MRC which revealed 'the worst of the harassment was FOI requests, 'complaints', House of Lords Debates and Parliamentary Questions. All of those are legitimate courses of action and established parts of our democracy.


Yet the rumour, and deep prejudice against ME sufferers, had become fully embedded within the NIH.



Jennifer Spotila:

'During the March 30, 2021 NIH telebriefing with the ME/CFS community, Dr. Vicky Whittemore said that there had been death threats against grant reviewers in the past, and that this was one reason why NIH is now withholding the names of reviewers on the ME/CFS Special Emphasis Panel (referred to as the “SEP”). This is not the first time that NIH has used the story of death threats to justify withholding the grant review rosters from the public. This excuse is overblown, and every repetition of it harms the ME/CFS community by perpetuating derogatory stereotypes of advocates and people with the disease.'

https://occupyme.net/2021/04/06/the-death-threat-myth-exposed/



https://www.s4me.info/threads/blog-the-death-threat-myth-exposed-jennie-spotila.19946/

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I'm also sorry if I expressed myself too strongly haha, I can get carried away, but this is all such an important conversation to have. (Also sorry will be logging out for the rest of the day, have had a torrid few days healthwise so need to get some good rest!)

 

@RaviHVJ wrote:

"the NIH is the only institution with the resources to actually change our lives by funding science that leads to effective treatments."

We have no evidence that the NIH have ever done that, or ever will. But the evidence the NIH have failed to fund science that leads to effective treatments is overwhelming, and the evidence that the NIH intends ever to fund research that leads to ME/CFS treatments is non existent. A waffle from Avindra Nath, while displaying his hurt feelings, while still embedding Walitt in ME research, is not strong evidence of anything but the NIH determination to continue as they always have.
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Two things are true:

a) The NIH is indeed the only institution with the resources to change our lives. It's by far the largest funder of biomedical research globally - the levels of research funding in other developed countries are far smaller. The research the NIH has funded has had a transformative effect on so many other diseases - from AIDS to cancer.

b) the NIH's record on ME is catastrophically bad. The question is if and how we can get the NIH to do for ME/CFS what it has done for so many other diseases.

 

Mass hysteria.

 

That applies to third rate academics - which may be the majority but they are irrelevant. The people who actually get things done l one critique. It sharpens the arguments.

As an academic I would pile on the pressure and criticism. I don't see a lot of point in setting up drug studies if nobody has any idea why they are doing it. Ivabridine and IVIG? I wouldn't be interested as a reviewer.

Making a difference in science is a fairly lonely tough process but it pays off if you stick to what you believe in, I don't see any point in soft-soaping people who don't seem to know what they think.

 

I absolutely disagree. Science isn't about millions of dollars. It is about being very clear about reasoning and astute observation. S4ME is quite capable of changing the lives of people with ME/CFS. I am serious. There is enough intelligence here to solve the problem with just one lead from a decent study like DecodeME.

When I was working on RA I had hardly any resources and did hardly any new experiments. I was fortunate in having a team of people who really wanted to know the answer. Eventually some chance observations pointed us to what was staring us in the face. So we decided to treat with rituximab.

Sadly almost all medical research in the last 20 years has followed the wrong model - short term exploitation of fashionable stuff. Nobody goes back to first base to work out why it hasn't worked.

 

100% agree with Jonathan.

From my observations with local researchers, funding needs to be adequate for them to be able to evaluate their good ideas. Sure, biomedical research ain't cheap but you don't need squillions of dollars. You need enough to fund the assays, reagents etc, access to the right equipment and sufficient money to keep them securely employed and in the game for more than a year at a time — preferably with a post-doc and a couple of research assistants.

Exploratory research needs the funding people to take a chance that it won't work out, but recognise that if the ideas have merit, we'll learn a lot from negative results regardless.

We can spend 30 million dollars on a trial of baracitinib in LC, and while I am pleased to see that underway I recognise that instead 5 or even 10 research teams could have been looking at basic science questions that might answer more – for this disease and others.

If I had to go through this life-destroying disease and watch other family members, friends and countless new friends and comrades-in-arms around the world similarly, then I want: 1) a cure 2) for this new knowledge to revolutionise medicine and its understanding of chronic disease.

 

@RaviHVJ I think you are absolutely right in that there has to be a larger strategic focus on how more funding for ME be increased long-term. I’ve seen how others have tried and failed for decades and I just don’t know how to change that, so all I am left with is reading studies of shoddy quality.

But I would like to point-out one thing I think can be viewed as a flaw in this type of “LC-advocacy logic”.

That runs under the assumption that large scale research funding finds an answer within a limited amount of time and that this is the only way to find answers to this problem. i.e. that throwing a lot of money at the problem for a short period of time will work and that it is the only thing that will work. It is my impression that that is not necessarily how biomedical research works. If things would work that way Alzheimers/Dementia research would not be in the state it is in, nor would a bunch of other conditions have been solved in the way they were solved. Large-scale long-term funding certainly increases your chances and is necessary to a certain extent and it should be a massive focus, but doing good research is no less important, those strategies are not mutually exclusive.

It is my hope that LC research secures 1 billion in annual funding for 5 years. But I also have to realise, that doesn’t mean one will automatically get any results, 5 billion and 5 years will pass quicker than most expect. In the very likely case where you don’t get meaningful results after 5 years, funding may likely be decreased again and you will be left where you had started, albeit your closet will be filled with an abundance of meaningless studies that then make up the literature. Those studies then become the evidence basis.

If that evidence basis is centered around meaningless null results confusing noise for signals and “effort preference” that is what will stick. In that time the classically shoddy, unblinded and not adequately controlled CBT/GET studies in LC will possibly have yielded some “positive results”, whilst the few well run pharmaceutical DBRCT are less likely to find a positive effect if it doesn’t exist and if their methodology is better. At that point you will be left where you never wanted to be, exactly where ME/CFS is today. I know that this quite doomsdayish and possibly painting the scenario a bit black. I hope it will not occur and I certainly hope someone figures out LC by just being given enough money, but I’m not sure of it, especially once I look at the published Long-Covid studies and RECOVER to date.

Only a very small handful of LC studies are of any interest at all and those that are interesting didn’t require much funding at all, they were rather small studies which still have to be followed up on. Nothing that required much funding or anything special. Sufficient funding is certainly necessary.

LC patient criticism also certainly helped to move the LC research field along, which started off with “something occurred for 4 weeks after someone had an infection, let’s bundle it all together”, towards a nowadays sometimes more meaningful and phenotypic approach. Perhaps if some of that patient criticism had occurred earlier RECOVER would not have gone down the path it went, perhaps the criticism was smooth enough to ensure that a better second round of RECOVER will happen, rather than upsetting everyone and making future funding and projects less likely. But all the flaws in RECOVER should have been apparent to everybody from the beginning and yet RECOVER still went down its path. Similarly flaws in a new funding round will likely be equally apparent and some small optimisation will have occurred. Whether this optimisiation will be sufficient I cannot say, but I would guess there won't be infinitely many round of optimisation if the first couple of rounds yield nothing tangible.

In this case the current LC advocacy groups and the LCAP are perhaps not too different, they look at HIV/AIDS and see: All you need is a lot of funding all we have to do is follow that playbook. It however seems that in many cases that playbook doesn’t work.

In that case you have to hedge your bets to ensure that good research is happening and that there is sufficient funding. Perhaps at that point LC and ME/CFS advocacy can learn from each other as they seem to have their strengths in different fields.

 

I don't think this is a fully accurate portrayal of LC advocacy logic in that a) almost every major LC advocacy organisation has demanded large-scale funding over a 10-year period (the moonshot has demanded $1 billion a year for 10 years), and b) there has actually been a great deal of emphasis on the quality of research. On the political side of things, you have all these groups calling for a tonne of research funding, but then you also have patient-led research collaborative on the more scientific side of things. PLRC is made up of patients who have advanced degrees in the sciences. They've published various studies, but most importantly, almost every member of PLRC has worked as a patient-representative within the RECOVER initiative. Of course, there's only a certain amount they're able to do - no-one could control the fact that RECOVER decided in 2021 that Long Covid was an entirely novel entity, or that RECOVER decided early on to spend the vast majority of its funding on essentially a very large symptom survey. But the efforts of those patient advocates have had a significant impact - they helped somewhat temper the exercise trial, but most importantly they've created a situation where, if the NIH spent a lot of money on Long Covid today, that money would be better spent than it was 4 years ago.

And on the question of large-scale funding - there is no way lots of good research happens without consistent research funding. There are several reasons for this. In the first place, significant funding significantly increases the odds of good research happening. But more importantly, consistent funding would help actually establish post-viral illnesses as a field - at the moment, it's near-impossible for biomedical researchers to have a career in ME research because there's next to no guarantee that in 5 years their research will be funded. And you need researchers working at a problem not just for 2-3 years, but for much longer stretches. Researchers also need to be in dialogue with each other - which means that lots of different people need to get funding. Certainly, if Long Covid research received a billion a year there would be a lot of wastage and a lot of low-quality research. But you'd also be guaranteeing the fact that some good researchers would receive a fair bit of funding over a longer period, and I'd be very surprised if the quality of research didn't improve over time.

RECOVER is a good example of how research is supposed to improve over time - probably the main reason it has been so poor is that the NIH treated Long Covid as if it was an entirely novel entity, so they were essentially starting from scratch, which you never really want to do as an academic - you want to work off a large and pre-existing literature. Four years on, RECOVER has spent its money very poorly, but the NIH is far more aware of the good research produced outside of RECOVER, and they're also very aware of the various criticisms patient-representatives and the advocacy community has made of RECOVER. Now for me those criticisms center a bit too much on the need for treatment trials as opposed to fundamental research, but this is all a case study in how research improves over time - at first you're feeling around in the dark, which means you'll almost certainly waste a lot of your money, but as the field develops, research becomes much more focused.

The viral persistence literature is another case in point here - we're seeing a steady stream of increasingly focused viral persistence studies because it's the only hypothesis within the Long Covid field that's received a consistent amount of funding, primarily from polybio but also from other funding sources. Within a few years, we'll have much more precise answers about viral persistence - whether it is solely viral remnants rather than live, replicating virus that persists within the body, whether there are indeed viral reservoirs in places like the gut. And the only way to get those kind of answers is to have lots of teams attacking viral persistence from a number of different angles, which requires lots of funding.

Also, it seems to me that dementia and alzheimers are the exception - in general, throwing money at a problem is the way to get results. Why do we have far better treatments for most diseases today than 50 years ago? Because most diseases have, globally, received hundreds of millions of dollars in research funding a year during that period which has all but guaranteed that there have been top researchers continually working at the problem for decades. Why are there no treatments for ME? Partly because of the dominance of the BPS cabal, partly because there's been no research funding so it's been near-impossible for good researchers to consistently delve into the disease on any sort of scale. Until research receives proper funding, that divergence between most diseases and ME will never change.

 

But being realistic, how do you create a situation where that $30 million for baracitinib goes to 5-10 exploratory studies? Why, in the case of other diseases, does the NIH consistently fund large treatment trials but also then fund lots of smaller biomedical studies? Because the average disease at the NIH receives $200 million a year, so they can very easily spend $5 million a year for 6 years (the baracitinib trial) on a specific treatment trial, but you're then left with $195 million a year to spend on other studies. So in the case of those other diseases, it just doesn't matter if that $5 million a year is wasted on a trial which produces null results (though null results are still useful). Also, wastage isn't unique to Long Covid or ME - scientific spending is almost certainly inefficient in every single field, though it probably varies depending on certain factors, including how much research has historically been done on a condition - probably in general, with exceptions, the more research that's done, the easier it is to do more focused research, the more efficiently you spend money. So why take a different approach to wastage in ME and LC vs any other field? Rather than seeking to minimise wastage through trying to make sure that the few studies that get funded are very good, which seems near-impossible to do through governmental funders, do what is done for almost every other disease - get lots of funding, allow for plenty of wastage, but virtually guarantee that some good research gets done. In other words, there is only one realistic way of guaranteeing that lots of good researchers consistently receive funding - even allowing for a lot of wastage - and that's making sure a disease receives a lot of funding over an extended period of time.

 

But if you get $200 million a year, you also need $200 million a year's-worth of ideas. Otherwise you can't spend it, and spend it you must.

Money helps, but it won't produce results on its own. Guaranteed money can mean it's not in anyone's interest to be too successful.

If you want to make progress on a challenge like ME, you need people who ask really stupid questions. It's a rare kind of intelligence, at least after the age of six, and I'm not hopeful of finding much of it in large bureaucracies like the NIH. They seem trained to think in furrows.

 

Do you think ARPA-H might be more promising in that regard? According to axios there are some politicians in the US trying to get 200million for ARPA-H for Long Covid. According to Wikipedia:

The Advanced Research Projects Agency for Health (ARPA-H) is an independent entity within the National Institutes of Health.[1] Its mission is to "make pivotal investments in break-through technologies and broadly applicable platforms, capabilities, resources, and solutions that have the potential to transform important areas of medicine and health for the benefit of all patients and that cannot readily be accomplished through traditional research or commercial activity."
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https://en.m.wikipedia.org/wiki/Advanced_Research_Projects_Agency_for_Health

Does anyone know if this is mostly fluff or ARPA-H could really make a difference?