David Tuller: Trial By Error: “Talk is Cheap,” Patients Tell NIH

http://www.virology.ws/2018/12/26/trial-by-error-talk-is-cheap-patients-tell-nih/

 

Not too enthused by the publicity for the "ICC is the one true definition of ME" crowd, and the less said about Erik Johnson the better, all in my own opinion of course. #MEAction may have their flaws, as all of us do, but at least, as far as I can see, they are trying to be as inclusive and as representative, as is possible, rather than exclusive based on personal opinion.

 

Thats clever

As i posted in the MEAction thread

It seems their real goal is to divide and conquer, by pretending they are on our side they can keep us off track and just keep denying resources to ME research. By attempting to gaslight us they can keep us off track, assuage their own cognitive dissonance and hopefully keep us busy trying to meet their goalposts which will keep moving because the real goal is to not fund research (that part is also silent).

How many Nobel prize winners will it take, do we need to bring a few hundred back to life before one gets funding? How many other diseases need more then we have before they start funding research above a pittance?

If anyone wants to calculate such a ratio i'm sure the results will be illuminating. Or if someone with Twitter wants to point out we have several but they won't fund any that would be great. Since a Nobel prize can't get funding from the NIH what will? I'd like to see the answer to that question.

 

I agree we're stuck in a situation where the funding is withheld because our knowledge is limited, yet funding is the only way to advance knowledge.

The plan by the NIH seems to be to wait for an indefinite number of years until they feel that the risk of research waste is low enough to commit to substantially higher funding.

 

“NIH leadership is not yet ready to significantly accelerate NIH’s approach and commitment to ME because they feel the science is not ready, and that the field lacks the needed researchers and high-quality grant applications.”

I can imagine that his may well be the situation and I think the NIH may be right. I am not hearing of lots of projects not being funded by NIH that look worthy of big funding.

NIH is giving out funding. The money is available. Parity with other conditions means the same height of bar for research quality. There are serious issues about quality evaluation but it makes no sense to dish out money unless there is a reasonable chance of success.

I can imagine that it does not help persuade the NIH to have some of the comments that follow. They illustrate why there has to be quality control. Looking for moulds is not going to help anyone and nor, I think, is a focus on ICC. The Incline Outbreak is history and probably of no real interest now.

What I think is needed is some objective clinical documentation of the illness in day to day circumstances that leads to intelligent research questions about its origin. I think a lot of research groups are starting at the wrong end.

 

Nobody is asking for money given out randomly.

NIH needs to make a plan for how to get from here to there.

M.E. got left behind decades ago when research standards were different. It's not clear how you get from knowing not much to doing high-quality research, in any kind of reasonable time frame.

However it's unconscionable to leave patients to rot, and continue to be stigmatized, because you don't like the odds of finding something by casting a wide net.

NIH needs to fix this, and they need to fix it considering time to be of the essence. There's no other decent option.

 

Not sure about that. Maybe success should not solely be defined as a good study or paper but as getting the research field going and attracting new researchers. It seems like we're in a vicious cycle of inertia: there aren't any good researchers because there is no secure funding, and there is no funding because there are no good researchers. The NIH could break that cycle by RFA's and it's quite possible that they only have to do it once.

I also see no reasons why they don't set up another high quality study themselves, for example following up on persons who get EBV (there has to be something that changes biologically that explains why a small fraction never recovers from such infections).

 

Tht sounds like exploratory research without a hypothesis. The NIH doesn't fund this kind of research.

The way the NIH is doing things works for illnesses that are well enough understood but it doesn't work for ME/CFS.

 

How does the funding work, if say they budget $100M are they committed to spending it all or could it just be earmarked as available should sufficiently high quality research proposals be received ? As it is nobody is going to propose a high quality $20M research study if there is no indication that it could ever be funded.

 

It isn't really without a hypothesis. The hypothesis is that there are one or more objectively documentable abnormal clinical patterns in ME. I am thinking in terms of using accelerometers to document changes in activity patterns. The hypothesis is almost certain to be right but more importantly it is highly likely that with intelligent analysis the patterns can be documented specifically. So it is a solid bet for NIH.

Moreover, NIH do fund work of this sort. They are funding work at the UK ME Biobank which is pretty similar in terms of trying to document objective abnormalities - whatever they might be.

 

We all want a plan to get from here to there but plans in scientific research are not there ready to take off the shelf. The whole point about scientific research is that it involves thinking of a solution to a question that nobody has so far thought of. You have to have an application from a scientist who has hit on the right idea about how to get an answer. You cannot put that out to tender like buying a telephone service!

I realise that I sound negative but I am currently acting as independent advisor for exactly the same process in the UK through the equivalent government body. And although there are some sensible ways forward being proposed that will have applications made on it is very far from clear that any of us can see an obvious way to go. UK scientists have got together to pool resources and try to think of a really promising way to test an idea and it is far from easy. You have to have the right idea and also someone with the right expertise in a position to test the idea.

I am all for emphasising the urgency of the problem but I think it is all too easy to put the science community off by making criticisms of NIH that may not be that reasonable.

 

Because of a specific political problem that needs addressing.

I agree things are out of kilter but the inappropriate funding of bad studies is a different issue from failure to fund good studies. Things are not right but my main point is that the message from the NIH does not sound so unreasonable.

 

If a study that deserves $20M is proposed then I see no reason why it should not get funded by NIH or MRC (other than the fact that the peer review system is a lottery across the board). But as we are at the moment I cannot think of anything that would justify $20M. There are leads that could well be followed with $2-5M projects maybe.

The basic problem is persuading people in the funding bodies that projects are good enough to fund. Once you have done that the funds will be routed as needed. Ring fencing might seem to help. But ring fencing for AIDS and Alzheimer's was done at a time when it was obvious to funding bodies that the questions to ask were well enough understand for there to be large numbers of scientists out there who could think of sensible ways of getting answers. NIH is saying we are not there yet for ME and I tend to agree.

 

Has anyone tried to track metabolomics/ immune profiles for 7 to 10 days after a challenge that causes PEM to figure out how it resolves?

 

Do not know the details but didn’t the great success stories in medicine like polio or AIDS turn into a success because of political action and campaigning instead of waiting for good research proposals to arise?

To me it seems like NIH is mostly willing to fund what researchers find interesting instead of what is relevant for society. In the case of AIDS, activism was needed to reorient research funding into this disease and stop it from killing more people. Researchers and government agencies did not have the incentives to do that in an apt pace. ME rarely kills but given the numbers of patients and disability it causes, I think we could make a similar argument.

Medical research isn’t merely about doing geeky science stuff IMHO. There isn’t anything admirable in choosing to fund only well designed studies if these miss the topics that are most pressing to society. Bureaucratic procedures can sometimes obscure how irrational it is that we are funding so little research in a disease that torments so many of us.

 

I think the argument would be that the majority of patients have politely, some might say meekly, waited for adequate research/funding for many decades and therefore, arguably, a change in tactic has been required for a long time. Whether or not it is an explicit tactic, but my interpretation would be that it's along the lines of "The squeaky wheel gets the grease". And if it's a counterproductive tactic, then it probably doesn't put us in any worse situation than we are at the moment.

 

I don't think anyone is suggesting doing geeky stuff. Far from it. When I say a good study I mean one that has a chance of solving a problem pressing to society.

I am sceptical about the idea that political pressure had much to do with medical breakthroughs. I think AIDS got funding when it was realised (a) that is was an epidemic that potentially could kill everyone and (b) enough was known about a likely virus for lab groups to switch on to it with a high chance of success.