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

There are a number of great responses in this thread, but the fact that this discussion is even happening is, to me, pretty frustrating and dispiriting. The government, NIH included, has long engaged with the community in bad faith. I find it frustrating that (1) advocates continue to engage with the government as if they are not acting in bad faith and as if their goal is not to contain patient demands as much as possible and (2) the community responds to excuses made in bad faith as if they are sincere, which ends up dividing the community and achieving the ends for which they were made.

You may disagree that the government engages in bad faith, so I want to make a couple points on that front.

First, for some historical perspective, here is a link to some CFSAC testimony I wrote and read six years ago, in October 2012, that discusses many of the same flacid excuses NIH is still making, which patients are discussing in this thread:


That NIH was making the same excuses 6+ years ago, when they were engaging even less than they now are, should make it pretty obvious that the excuses made during the recent meeting were not made in good faith.

Second, the excuses made and all the complexity involved in thinking through how change might happen has the effect of moving the goalposts and distracting patients from the big picture. The community has gotten many of the small things that advocates have asked for, but it should be pretty obvious that while some boxes have been ticked off, there is still no urgency, still no real commitment to make change, and still far too little empathy and transparency in engaging with patients. We are being managed and while that management looks more benevolent now that the community has a bit more political capital, the fact that these excuses are still being made demonstrates not just a lack of urgency and commitment, but a lack of empathy. It's disgusting that they would trot out this excuse about the field being too nascent to justify investment when they made it so. Our lives are hanging in the balance. As someone in this thread noted, we are getting sicker and slowly dying while they trot out the same old self-serving bullshit. They don't believe that it's not the right time to invest; they know that we'll accept that excuse, because we have in the past, and we don't have the political capital to do anything but.

If they wanted to make change, we would see it and we would feel it. They could issue an apology for how they've damned this disease and court the press to cover that apology. That would strengthen the hand of advocates into the future. They could lay out a multi-year plan that puts us at funding parity at some reasonable point down the road. They could spend political capital to break the supposed mold in how they approach the disease. @Michiel Tack covers this point well:

They're not engaging in good faith. They're managing us. Continuing to respond as if they're sincere divides the community and leaves it reactive to whatever new excuse is made. The whole reason I wrote the testimony above was because I was pissed off at watching various officials at CFSAC trot out new excuses each meeting and act like patients were just too naive and simple to understand that they were doing everything in their power to help us and that we were being unreasonable if we were anything but stoically patient. So, if you think patience is a reasonable response to this claim about funding, how many decades more should we wait?

 

There must be a solution in shifting focus from grant financing to awareness, eduction and tissue-banking financing. I do not doubt that many of the grant proposasl are low quality.

I just don't see why that should stop a disease from reaching equal funding. The solution is not to force-feed garbage grants to anyone who applies, but to change the perception of the disease within the medical community, change the perception of the disease for students, and establish as much tissue and blood, in as good a quality as possible, so that good grants eventually we are ready. '

I know this is atypical from the NIH, which acts as more of a grant approval machine, but that is the idea for change other than just waiting for better studies. Or for this inhouse study to finish in 2059.

 

Wish the NIH hadn't removed comments from Collins' ME/CFS "Director's Blog" post from a couple years ago. As I recall, several patients told Collins that talk was cheap even back then. The blog was apparently updated last year and all the comments deleted.

https://directorsblog.nih.gov/2017/03/21/moving-toward-answers-in-mecfs/

A few of the comments are preserved by the Wayback Machine. Someone named Charlie B wrote in Mar 2017:

 

Wouldn't it be more likely that someone would make a mental connection if a lot more scientists were interested in the question, and wouldn't that be the case if the NIH were danging $250m?

I just struggle with the idea that if there's a burning and important problem to solve, the government body responsible for that area should just sit there and do nothing to encourage people to come forward and solve it. We don't tackle war, poverty, global warming and so on like this. We get boffins in. We set them onto the problem.

Why aren't we boffining?

 

The reason they are not acting quickly is probably because of the psychogenic narrative. The behaviour of managing the patient by pretending to care but avoiding any real effort to investigate the symptoms is exactly how doctors are taught to manage psychogenic symptoms.

This form of "care" is a pit where hope dies.

A few believers in psychogenic illness in relevant research institutions and funding bodies is all it takes to prevent progress when competition for obtaining funding is high. Are the grant applications really of poor quality or is it just that among the reviewers there are believers in psychogenic illness that rate any biomedical application as poor?

This is not a fantasy, we know that several researchers encountered this kind of problem.

 

Hilarious!! 2059 is right!!

 

I'm not sure. I think probably they would be interested in the dollars and the promotion that comes with them. When I was working I was surrounded by people chasing money with no real idea what they were doing it for. Money will galvanise people when it is already obvious what to do next but I have no reason to think it helps make people make connections. That took me twenty years of hard thinking. When the connection came I dipped into my own bank account to get the answer I wanted. I knew nobody wold fund at that stage.

Government bodies consist of people who do not know how to solve ME. Nor do they know how to identify the person who will solve it. Life would be easier if they could but they are human beings. There may well be political problems with those making decisions but there is no Solomon around to decide who the best decision makers will be.

Hmm, have we had any luck with any of those? But I think the situation is the same - when the path forward is clear money will help, when nobody knows where the path is it may not.

 

NIH issued an RFA for collaborative research centers and received 11 applications of which they granted 3. Certainly, some of those other 8 were qualified. But NIH had only been able to come up with enough money to fund 3 plus the data coordination center. And Lipkin told NIH that the funding allocated per center was not sufficient to do what needed to be done. That's not a lack of quality applications or areas to research, that's a a lack of strategic commitment of money and resources to ME.

As CFSAC repeatedly told NIH, growing this field requires commitment of dollars to overcome the years of neglect and negative narrative that have driven researchers from the field. We may be able to eventually grow the field without set aside funding but not in a time scale that matters to people with ME.

There are numerous opportunities for research to advance critical issues that could help accelerate progress in the field and deliver outcomes to patients - further characterize subtypes, investigate/validate biomarkers, even preliminary treatment trials on therapies already being used by clinicians in subsets of patients.

We need a plan that has a focus on delivering outcomes as quickly as possible. We need a moonshot. Right now, we are just meandering.

Edited to add:
The slides used at the meeting contained a partial list of opportunities that are waiting for investigation and followup - see slide 12 and 13.

I'm sure there are other opportunities that we havent even thought of if there were money and researchers. But unless new researchers have confidence that they can build a career in ME, they are unlikely to enter the field, especially if that means diversifying from a field where they do have that confidence.

This disease is in a quagmire as a result of years of neglect and BPS misdirection. NIH has the political capital, organizational position, and human and $$ resources to dig us out of that quagmire and accelerate progress toward diagnostics and treatments.

 

Part of a 1991 letter written to me from the National Institutes of Health, National Institute of Allergy and Infectious Diseases, Department of Health and Human Services:

" I appreciate your interest in learning about CFS and its possible causes. Unfortunately, the cause or causes of CFS are not yet known. The National Institute of Allergy and Infectious Diseases (NIAID) is actively conducting and supporting research to explore the many possible causes of CFS. NIAID also supports other studies to determine how often this condition occurs in the general population and to develop the means of diagnosing and predicting the outcome of the disease accurately. As part of these efforts, NIAID cosponsored the "Workshop on the Definition and Medical Outcome Assessment of Chronic Fatigue Syndrome in Research" in March 1991. A summary of this meeting is enclosed.

NIAID anticipates that the first Chronic Fatigue Syndrome Cooperative Research Center will be established this year to supplement NIAID's existing CFS research programs. Through long-term clinical studies and basic research programs, NIAID expects to increase our understanding of CFS and to develop effective ways of treating this debilitating disease." (emphasis added)

The more things change, the more they stay the same.

 

My impression is that, if we want to get significantly greater funding in the U.S. than we currently have, then the most effective way to get it is through the political means of lobbying the U.S. Congress.

Francis Collins clearly has influence over some discretionary funding - and I appreciate that he has directed some of that influence towards ME/CFS - but I'm not at all sure that it will ever amount to as much as we would think adequate. To get amounts of that size, I'm pretty sure that the money would need to be specifically appropriated by Congress in the NIH budget, just as it is for, say, Parkinson's Disease. Michael J. Fox did not testify in front of Francis Collins. He testified in front of Congress.

I'm also not sure how much influence Collins actually has over the specific appropriations Congress makes for the NIH budget. Even if he does have a lot of influence, his lobbying efforts may be in vain without outside political pressure to sway Congress, especially when there are a host of other diseases all vying for attention.

I guess what I'm trying to get at is that, for really substantial amounts, I don't think it's Collins who calls the shots, but rather Congress. The current efforts to gain influence in Congress may be the most productive path to take.

 

Excellent point, Trish - why is the bar so low for crap BPS research? Possibly the same everywhere re ME?

We are still living in this vicious circle of the science not being ready due to lack of funding, and lack of funding due to the science not being ready. The ME community can fund some research to help with this dilemma, but I'm doubtful we can make a big enough dent in the science not being ready to interest NIH and other government bodies. Our only other choice, as I see it, is what is already being discussed here.

 

Objective clinical documentation on a day to day basis - hasn't that been done by the CCC, MEICC, and IACFSME primer authors, @Jonathan Edwards? Or, do we need more detailed studies on the abnormal physical findings we already know about, such as orthostatic intolerance?

 

The ME/CFS community is not strongly counting on the numbers. If we were to demonstrate the epidemic, they would have a nightmare on their hands. I know a few people w Cfs that are not diagnosed as Cfs and when I hear details I am 100%sure they have it.
Doctors still some don’t believe in it ( they think is a waste basket tittle) and patients don’t know better.
If we do paid tv and a campaigne to educate the public so they get diagnosed, and we have the real numbers, the public pressure will mount. They will look bad and we can use it to pressure.
I agree that we are being “handled” like we are children and being disrespected. We are
Not respected as a force because we do not act like one ( like HIV) did back in the day, we have more power than we realize, and the power is in the numbers and the
Obvious neglect from NIH. Make a public relations nightmare and watch the money flow.

 

Perhaps not popular with some but the phrase “talk is cheap” (used in the title) comes to mind when people sign a petition for more research. It’s not particularly interesting that someone with an illness wants more research for their condition: with any condition people will want more research into it.

If you’re willing to donate to and/or fundraise for research or to those lobbying, it’s probably a better measure that the cause is important enough to you to make a sacrifice.

 

@Seven says, what about an ad campaign?

First fund some research with visuals, eg. the Nasa Lean test. Then publicize this study including the visuals.

OK, I know...where is the money going to come from? We have such a large community, if many contributed a little, maybe this could get done.

 

I think the likely obstacle within NIH is internal opposition. As the point has been made and it's likely the main obstacle here, all it usually takes is someone to be obstinate about arguing the point that it's a waste of time and that's the end of that discussion. And since most medical professionals have no understanding of this disease than that's what they'll argue because if it was serious they would have learned about it and on and on it goes.

I think Collins would do more if he could, it seems sincere, but he doesn't have sole authority for something that would require a complete paradigm reversal built on decades of confident arguments that of course this is a fake disease and don't waste a single cent on this nonsense when people are dying of cancer and whatnot. If he made that decision he would likely be ousted as NIH director because of the outrage it would cause. He would be vindicated over time, but he would still be a pariah until the full picture comes into focus and people see the scale and severity of the horror that the medical profession has inflicted on millions. We're essentially dependent on people sacrificing their career for the greater good, and how often does that ever happen?

At this point it's just tradition. Some diseases have just always been blacklisted and even generational replacements aren't quite enough to more the needle. Chronic migraines come to mind, they barely get any more funding than we get despite being one of the most common causes of work absences. They've always been trivialized and everyone in charge of making those decisions has operated with that paradigm and will do so until they can be directly observed.

 

What are you thinking in terms of? I am not aware of any database classifying activity patterns in daily life. The situation with orthostatic intolerance seems very confused - some people talking in terms of POTS, others in terms of neurally mediated hypotension and still others unknown mechanisms. I am keen to know about any data available but at the moment I am not clear we have an objectively documented record of the physiological disturbance that needs explaining.

 

I believe the same patient can meet diagnostic criteria for POTS one day and for NMH (or orthostatic hypotension?) another day.

 

Jennie Spotila has been doing a great job of reporting on these NIH issues in many blogs like these.

http://occupyme.net/2018/05/21/the-nih-pilot-program-wait-and-see/

http://occupyme.net/2018/10/21/nih-funding-for-me-goes-down-in-2018/